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1.
Int J Psychiatry Clin Pract ; 26(3): 228-233, 2022 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34565277

RESUMO

OBJECTIVE: This study aims to compare the reliability and acceptability of psychiatric interviews using telepsychiatry and face-to-face modalities in the emergency room setting. METHODS: In this prospective observational feasibility study, psychiatric patients (n = 38) who presented in emergency rooms between April and June 2020, went through face-to-face and videoconference telepsychiatry interviews in a non-randomised varying order. Interviewers and a senior psychiatry resident who observed both interviews determined diagnosis, recommended disposition and indication for involuntary admission. Patients and psychiatrists completed acceptability post-assessment surveys. RESULTS: Agreement between raters on recommended disposition and indication for involuntary admission as measured by Cohen's kappa was 'strong' to 'almost perfect' (0.84/0.81, 0.95/0.87 and 0.89/0.94 for face-to-face vs. telepsychiatry, observer vs. face-to-face and observer vs. telepsychiatry, respectively). Partial agreement between the raters on diagnosis was 'strong' (Cohen's kappa of 0.81, 0.85 and 0.85 for face-to-face vs. telepsychiatry, observer vs. face-to-face and observer vs. telepsychiatry, respectively).Psychiatrists' and patients' satisfaction rates, and psychiatrists' perceived certainty rates, were comparably high in both face-to-face and telepsychiatry groups. CONCLUSIONS: Telepsychiatry is a reliable and acceptable alternative to face-to-face psychiatric assessments in the emergency room setting. Implementing telepsychiatry may improve the quality and accessibility of mental health services.Key pointsTelepsychiatry and face-to-face psychiatric assessments in the emergency room setting have comparable reliability.Patients and providers report a comparable high level of satisfaction with telepsychiatry and face-to-face modalities in the emergency room setting.Providers report a comparable level of perceived certainty in their clinical decisions based on telepsychiatry and face-to-face psychiatric assessments in the emergency room setting.


Assuntos
Transtornos Mentais , Psiquiatria , Telemedicina , Humanos , Transtornos Mentais/diagnóstico , Transtornos Mentais/terapia , Reprodutibilidade dos Testes , Serviço Hospitalar de Emergência
2.
J Thromb Thrombolysis ; 45(1): 13-17, 2018 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-29230625

RESUMO

Systemic lupus erythematosus (SLE) is a significant risk factor for cardiovascular disease. The relationship between SLE and perioperative cardiovascular risks following non-cardiac surgery is uncertain. We investigated associations between a diagnosis of SLE and outcomes following major non-cardiac surgery in a large national database from the United States. Patients age ≥ 18 years requiring major non-cardiac surgery were identified from Healthcare Cost and Utilization Project's National Inpatient Sample data from 2004 to 2014. Systemic lupus erythematosus and perioperative major adverse cardiovascular events (MACE; myocardial infarction, ischemic stroke or death) were defined by ICD-9 diagnosis codes. Perioperative MACE were reported for SLE patients stratified by age and sex. From 2004 to 2014, a total of 17,853,194 hospitalizations for major non-cardiac surgery met study inclusion criteria. SLE was identified in 70,578 (0.4%) hospitalizations. Overall, the frequency of perioperative MACE was higher in patients with vs. without SLE [2.4 vs. 2.0%, p < 0.001; adjusted OR (aOR) 1.25; 95% CI 1.18-1.31]. Perioperative MACE associated with SLE was largely driven by increased death (aOR 1.58 95% CI 1.40-1.77) and myocardial infarction (aOR 1.32; 95% CI 1.05-1.66) in younger patients with SLE. The increased risk of perioperative MACE associated with SLE in younger patients was attenuated with increasing age. A diagnosis of SLE is associated with increased risk of perioperative MACE, particularly among younger patients. Efforts to improve the perioperative management and outcomes of patients with SLE are needed.


Assuntos
Doenças Cardiovasculares/etiologia , Lúpus Eritematoso Sistêmico/complicações , Período Perioperatório , Adolescente , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Doenças Cardiovasculares/mortalidade , Feminino , Hospitalização , Humanos , Lúpus Eritematoso Sistêmico/mortalidade , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio , Fatores de Risco , Fatores Sexuais , Acidente Vascular Cerebral , Adulto Jovem
3.
Curr Atheroscler Rep ; 17(3): 485, 2015 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-25651784

RESUMO

Since the advent of percutaneous coronary intervention, enormous advances have been made in the treatment of coronary artery disease. Angioplasty and bare metal stents were plagued by high rates of restenosis leading to repeat revascularization procedures. Examination of the underlying pathophysiology of restenosis led to the development of drug-eluting stents to reduce neointimal hyperplasia. However, as restenosis rates declined, length of dual antiplatelet therapy use and risk of long-term stent thrombosis associated with drug-eluting stents increased. Subsequent generations have improved each facet of stent design. Novel alloys maintain durability and reduce strut thickness to increase deliverability, biocompatible polymers decrease the inflammatory response and improve drug elution kinetics, and new generations of drugs predictably inhibit restenosis. Developments on the horizon include stents with bioabsorbable polymers and platforms. The purpose of this review is to assess the evolution of stent design and the evidence behind each generation and to peer into the future of stent technology.


Assuntos
Angioplastia Coronária com Balão , Fármacos Cardiovasculares/uso terapêutico , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Trombose/terapia , Angioplastia Coronária com Balão/métodos , Animais , Humanos , Neointima/prevenção & controle
4.
Instr Course Lect ; 63: 465-72, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-24720331

RESUMO

The unsustainable rising cost of medical care is creating financial pressures that will critically alter the way that health care is paid for and delivered. Limited resources dictate that physicians must become more efficient at providing high quality care. In an effort to provide financial incentive for delivering quality care, the federal government instituted value-based purchasing to transform Medicare from a passive payer of claims to an active purchaser of medical care. Healthcare providers must follow the basic tenants of certain quality principles to maximize reimbursement under the value-based purchasing system.


Assuntos
Medicare/economia , Ortopedia/organização & administração , Patient Protection and Affordable Care Act , Qualidade da Assistência à Saúde/organização & administração , Hospitalização , Humanos , Estados Unidos , Aquisição Baseada em Valor
5.
JMIR Form Res ; 7: e37190, 2023 Jan 26.
Artigo em Inglês | MEDLINE | ID: mdl-36416499

RESUMO

BACKGROUND: While the lung cancer (LC) treatment landscape has rapidly evolved in recent years, easing symptom burden and treatment side effects remain central considerations in disease control. OBJECTIVE: The aim of this study was to assess the relative importance of dimensions of LC care to patients, and to explore the disease burden, including socioeconomic aspects not commonly covered in patient-reported outcomes instruments. METHODS: A questionnaire was sent to patients with LC and their caregivers to rate the value of a diverse set of quality of life dimensions in care, to evaluate communication between health care professionals (HCPs) and patients, and to explore the economic impact on respondents. The survey included questions on the dimensions of care covered by patient-reported outcomes instruments for quality-of-life evaluation (Functional Assessment of Cancer Therapy-Lung scale, EQ-5D, the European Organization for Research and Treatment of Cancer's Core Quality of Life questionnaire, and the European Organization for Research and Treatment of Cancer's Core Quality of Life in lung cancer 13-item questionnaire), as well as the International Consortium for Health Outcomes Measurement (ICHOM) standard set of patient-centered outcomes for LC. The survey respondents were participants on Carenity's patient community platform, living either in France, the United Kingdom, Germany, Italy, or Spain. RESULTS: The survey included 150 respondents (115 patients and 35 caregivers). "Physical well-being" and "end-of-life care" (median scores of 9.6, IQR 7.7-10, and 9.7, IQR 8.0-10, on a 10-point scale) were rated highest among the different value dimensions assessed. "Physical well-being and functioning" was the dimension most frequently discussed with health care professionals (82/150, 55%), while only (17/100, 17%) reported discussing "end-of-life care." After diagnosis, 43% (49/112) of patients younger than 65 years stopped working. Among respondents who indicated their monthly household income before and after diagnosis, 55% (38/69) reported a loss of income. CONCLUSIONS: Our results showed the relevance of a broad range of aspects of care for the quality of life of patients with LC. End-of-life care was the dimension of care rated highest by patients with LC, irrespective of stage at diagnosis; however, this aspect is least frequently discussed with HCPs. The results also highlight the considerable socioeconomic impact of the disease, despite insurance coverage of direct costs.

6.
Hand Surg Rehabil ; 42(4): 337-341, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37329983

RESUMO

The Questionnaire for Patient-Surgeon Relationship (Q-PASREL) is a French "Patient-Reported Experience Measure" for hand surgery patients. It is the only one which considers the impact of the patient-surgeon relationship on time to return to work and cooperation by the surgeon for administrative issues. It has been shown that a good Q-PASREL score is associated with shorter sick leave and faster return to work. To make this instrument available to more countries, we translated the Q-PASREL into six languages (English, Spanish, German, Italian, Arabic and Persian), following a validated "translation and cultural adaptation" process guideline. This process includes multiple forward and backward translations, discussions and reconciliations with final harmonization and cognitive debriefing. For each language, a team was set up, comprising a key in-country hand surgery consultant, native target-language speaker and fluent in French, and several forward and back translators. The final translated versions were reviewed and approved by the project manager. The six versions of Q-PASREL are now available in the appendices of this publication.


Assuntos
Idioma , Cirurgiões , Humanos , Traduções , Inquéritos e Questionários , Licença Médica
7.
Compr Psychiatry ; 53(6): 850-3, 2012 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-22197215

RESUMO

BACKGROUND: The influence of ethnicity on different aspects of psychiatric hospitalization is far from clear. THE AIM OF THE STUDY: The main aim of the study was to compare the Arab and the Jewish inpatients, at the time of admission, for the demographic factors, severity of psychotic, and affective psychopathology and comorbid drug abuse rate. POPULATION, METHOD, AND TOOLS: Among 250 consecutively admitted patients in the Jerusalem Mental Health Center-Kfar Shaul Hospital, 202 Jews and 42 Arabs (aged 18-65 years) were examined within 48 hours after admission. The psychiatric diagnoses were made according to the criteria of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. For the differential measurement of psychopathologic severity, the following rating scales were used: 21-item Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, Positive and Negative Syndrome Scale (PANSS), and Young Mania Rating Scale. Urine tests for Δ9-tetrahydrocannabinol (THC), cocaine, opiates, amphetamines, and methamphetamine were performed using the Sure Step TM kits (Applied Biotech, Inc, San Diego, CA, USA). The Structured Clinical Interview Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, criteria for drug abuse were applied based on self-report and results of urine analysis. RESULTS: The comparison of the 2 population showed that among the Arab inpatients, there were more males (81% vs 67.4%; P < .005). No significant difference in psychiatric diagnosis was observed. The overall severity of positive symptoms (PANSS positive) in Arab group was higher, but only slightly so (P = .05). No significant difference was observed for total rates of PANSS negative subscale. The rates of PANSS-general were also similar. The Arab patients were significantly less depressive according to 21-item Hamilton Depression Rating Scale (P = .032), and the total score of Hamilton Anxiety Rating Scale for the Jewish group was significantly higher (P = .001). No significant difference in general severity of manic symptoms for 2 groups was detected according to Young Mania Rating Scale. The rate of comorbid drug abuse for Jewish inpatients was borderline higher (P = .068). CONCLUSIONS: The issue of referral to psychiatric hospitalization could be culturally influenced; it may be the result of disparities in demographic, psychopathologic, and drug abuse comorbid presenting symptoms, which are demonstrated upon admission by patients of different ethnic origins.


Assuntos
Árabes/psicologia , Hospitalização , Judeus/psicologia , Transtornos Mentais/etnologia , Transtornos Relacionados ao Uso de Substâncias/etnologia , Adulto , Diagnóstico Duplo (Psiquiatria) , Feminino , Humanos , Pacientes Internados , Israel , Masculino , Transtornos Mentais/diagnóstico , Pessoa de Meia-Idade , Escalas de Graduação Psiquiátrica , Índice de Gravidade de Doença , Transtornos Relacionados ao Uso de Substâncias/diagnóstico
8.
Instr Course Lect ; 61: 587-93, 2012.
Artigo em Inglês | MEDLINE | ID: mdl-22301264

RESUMO

The American Board of Orthopaedic Surgery requires that each board-certified orthopaedic surgeon recertify every 10 years. This formal procedure of demonstrating competence as a surgeon, which used to be known as recertification, has been replaced by a more comprehensive process termed maintenance of certification (MOC). Even an experienced orthopaedic surgeon may find achieving MOC a daunting prospect. Simply preparing for and taking the recertification examination is an enormous challenge, but it is important to remember that the examination is merely one aspect of maintaining certification. Prior to sitting for the examination, each physician is required to complete the other MOC requirements, including amassing continuing medical education credits, compiling a case list, and soliciting peer recommendations. Familiarity with the MOC process, understanding the details of the examination, and proper preparation techniques will help orthopaedic surgeons gain insights into how to approach MOC.


Assuntos
Certificação , Educação Médica Continuada , Ortopedia/educação , Certificação/organização & administração , Certificação/normas , Competência Clínica , Humanos , Habilidades para Realização de Testes
9.
J Arthroplasty ; 27(6): 870-6, 2012 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-22397861

RESUMO

Preoperative screening and decolonization of methicillin-sensitive and methicillin-resistant Staphylococcus aureus (MSSA and MRSA, respectively) are advocated to reduce surgical site infections. We determined the rate and duration of decolonization in patients undergoing elective orthopedic surgery. Patients undergoing elective orthopedic surgery were seen in our preoperative testing program (PAT) and had their anterior nares cultured for MRSA and MSSA. All patients were treated with intranasal mupirocin and a topical chlorhexidine solution. A cohort of patients returned to PAT before a subsequent elective procedure and were recultured. All culture results and time between PAT visits were recorded, and the rates of successful initial and persistent decolonization were determined. Six hundred ten patients visited PAT 1290 times. Overall, 94 (70.1%) of 134 patients with initially MRSA- or MSSA-positive cultures remained decolonized at a mean time of 156 days (SD=140), whereas 40 patients (29.9%) were not decolonized by the time of repeat testing at a mean time of 213 days (SD=187). At repeat testing, there were 2 newly MRSA-positive and 35 newly MSSA-positive patients. Staphylococcus aureus decolonization with intranasal mupirocin and topical chlorhexidine was effective but not persistent in a significant proportion of patients. A small number of previously uncolonized patients became colonized. Staphylococcus aureus screening and decolonization protocols must be repeated before any readmission, regardless of prior colonization status.


Assuntos
Clorexidina/farmacologia , Staphylococcus aureus Resistente à Meticilina/efeitos dos fármacos , Staphylococcus aureus Resistente à Meticilina/crescimento & desenvolvimento , Mupirocina/farmacologia , Staphylococcus aureus/efeitos dos fármacos , Staphylococcus aureus/crescimento & desenvolvimento , Administração Intranasal , Administração Tópica , Idoso , Clorexidina/administração & dosagem , Clorexidina/uso terapêutico , Estudos de Coortes , Relação Dose-Resposta a Droga , Quimioterapia Combinada , Procedimentos Cirúrgicos Eletivos , Feminino , Humanos , Masculino , Programas de Rastreamento , Pessoa de Meia-Idade , Mupirocina/administração & dosagem , Mupirocina/uso terapêutico , Estudos Retrospectivos , Infecções Estafilocócicas/diagnóstico , Infecções Estafilocócicas/tratamento farmacológico , Resultado do Tratamento
10.
Transfusion ; 51(3): 578-86, 2011 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-21126259

RESUMO

BACKGROUND: This study explores pregnant women's awareness of cord blood stem cells and their attitude regarding banking options in France, Germany, Italy, Spain, and the UK. STUDY DESIGN AND METHODS: Questionnaires were distributed in six maternities. This anonymous and self-completed questionnaire included 29 multiple-choice questions based on: 1) sociodemographic factors, 2) awareness and access to information about cord blood banking, 3) banking option preferences, and 4) donating cord blood units (CBUs) to research. RESULTS: A total of 79% of pregnant women had little awareness of cord blood banking (n = 1620). A total of 58% of women had heard of the therapeutic benefits of cord blood, of which 21% received information from midwives and obstetricians. A total of 89% of respondents would opt to store CBUs. Among them, 76% would choose to donate CBUs to a public bank to benefit any patient in need of a cord blood transplant. Twelve percent would choose a mixed bank, and 12%, a private bank. A total of 92% would donate their child's CBU to research when it is not suitable for transplantation. CONCLUSION: The study reveals a strong preference for public banking in all five countries, based on converging values such as solidarity. Attitudes of pregnant women are not an obstacle to the rapid expansion of allogeneic banking in these EU countries. Banking choices do not appear to be correlated with household income. The extent of commercial marketing of cord blood banks in mass media highlights the importance for obstetric providers to play a central role in raising women's awareness early during their pregnancy with evidence-based medical information about banking options.


Assuntos
Bancos de Sangue , Transplante de Células-Tronco de Sangue do Cordão Umbilical , Sangue Fetal/citologia , Conhecimentos, Atitudes e Prática em Saúde , Gestantes/psicologia , Adulto , Pesquisa Biomédica , Europa (Continente) , Feminino , Humanos , Renda , Gravidez
11.
Curr Psychiatry Rep ; 13(3): 187-92, 2011 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-21365216

RESUMO

Jet lag syndrome appears after multiple time zone transitions as bodily rhythms shift out of phase with the local environment. The possible psychiatric complications of jet lag have been underinvestigated. In the present review, the symptoms of jet lag in the general population, the chronobiological aspects of psychosis, as well as a possible correlation between jet lag and psychosis are discussed. The conclusions are that jet lag, through disruption of biological rhythm and probably sleep deprivation, may yield an exacerbation of existing psychotic conditions. The evidence concerning the appearance of de novo psychosis triggered by jet lag is inconsistent and far from convincing.


Assuntos
Síndrome do Jet Lag/psicologia , Periodicidade , Transtornos Psicóticos/psicologia , Sono , Humanos , Síndrome do Jet Lag/complicações , Transtornos Psicóticos/complicações , Viagem
12.
Psychiatry Clin Neurosci ; 65(5): 499-504, 2011 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-21851459

RESUMO

AIM: The main goals of this chart-review study were to examine the rate of tachyphylaxis during treatment of dysthymia with antidepressants, to compare the incidence of tolerance during trials of selective serotonin reuptake inhibitors (SSRI) and non-SSRI and to give descriptive analysis of the cases of tachyphylaxis. METHODS: The retrospective naturalistic chart review study included 52 cases of successfully treated (with different antidepressants) patients suffering from dysthymia. The overall number of the cases of tolerance to antidepressants were registered as well as the rate of these phenomena in the groups treated with SSRI and non-SSRI. RESULTS: The cases of tolerance/tachyphylaxis were observed in 12 patients (23% of patients) and in 13 trials (22.4% of trials). All cases of tolerance occurred during monotherapy. No cases of tachyphylaxis were observed in the non-SSRI group while in the SSRI group, tolerance at some stage of the treatment was detected in 41.9% of the successful cases (P < 0.001). CONCLUSION: During the treatment of dysthymia with antidepressants in the SSRI group, tachyphylaxis/tolerance might be observed in a relatively in high proportion of cases.


Assuntos
Antidepressivos/farmacologia , Transtorno Distímico/tratamento farmacológico , Inibidores Seletivos de Recaptação de Serotonina/farmacologia , Taquifilaxia , Adolescente , Adulto , Idoso , Antidepressivos/uso terapêutico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Inibidores Seletivos de Recaptação de Serotonina/uso terapêutico
13.
J Arthroplasty ; 26(1): 36-40, 2011 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-20452180

RESUMO

Hip arthroplasty has become the standard treatment of end-stage osteoarthritis. However, postoperative complications are the risks associated with joint arthroplasty, which most significantly impact patient results and the total cost of care. Currently, no predictive system has been developed for categorizing levels of risk for the development of postoperative complications in patients undergoing total hip arthroplasty. We examined the association between the medical clearance risk rating by the physician performing the preoperative clearance examination and postoperative complications after total hip arthroplasty. We have demonstrated a significant association between the medical clearance risk rating and postoperative urinary track infection, and the American Society of Anesthesiologist score but no significant association to other complications. This study presents a predictive patient characteristic that may help us identify among our patients the ones that may benefit from a personally tailored preoperative planning and evaluation but demonstrates further work is necessary to better predict the risk of complications after total hip arthroplasty.


Assuntos
Artroplastia de Quadril , Testes Diagnósticos de Rotina , Pacientes Internados , Complicações Pós-Operatórias/epidemiologia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Pneumonia/epidemiologia , Valor Preditivo dos Testes , Estudos Retrospectivos , Fatores de Risco , Infecção da Ferida Cirúrgica/epidemiologia , Trombose Venosa/epidemiologia , Adulto Jovem
14.
Isr Med Assoc J ; 13(6): 329-32, 2011 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-21809727

RESUMO

BACKGROUND: Some specialists and policy makers advocate progression of the mental health reform in Israel by transferring beds from psychiatric to general hospitals. OBJECTIVES: To compare the demographic, diagnostic and psychopathological profiles of psychiatric inpatients hospitalized in psychiatric and general hospitals, as well as their patterns of drug abuse, and to estimate the preparedness of general hospitals for the possible expansion of their psychiatric services. METHODS: Between 2002 and 2006 a total of 250 patients were consecutively admitted to the Jerusalem Mental Health Center-Kfar Shaul Hospital and 220 to the psychiatric department of Sheba Medical Center, a general hospital in central Israel; the patients' ages ranged from 18 to 65. The two groups were compared for demographic features, psychiatric diagnoses and severity of psychopathology (utilizing PANSS, HAD-21, YMRS rating scales). Drug abuse was diagnosed by urine analyses and self-report. RESULTS: The patients in the psychiatric hospital were significantly younger, predominantly male, and more dependent on social security payments. In the general hospital, diagnoses of affective and anxiety disorders prevailed, while in the psychiatric hospital schizophrenic and other psychotic patients constituted the majority. The patients in the general hospital were decidedly more depressed; in the psychiatric hospital, notably higher rates of manic symptoms as well as positive, negative and general schizophrenic symptoms were reported. For the most abused substances (opiates, cannabis and methamphetamines) the rates in the psychiatric hospital were significantly higher. CONCLUSIONS: The differences between the two groups of inpatients were very pronounced, and therefore, the transferring of psychiatric beds to general hospitals could not be done without serious and profound organizational, educational and financial changes in the psychiatric services of general hospitals. Since each of the two inpatient systems has particular specializations and experience with the different subgroups of patients, they could coexist for a long time.


Assuntos
Hospitais Gerais/estatística & dados numéricos , Hospitais Psiquiátricos/estatística & dados numéricos , Pacientes Internados , Unidade Hospitalar de Psiquiatria/estatística & dados numéricos , Transtornos Psicóticos/epidemiologia , Transtornos Relacionados ao Uso de Substâncias/epidemiologia , Adolescente , Adulto , Distribuição por Idade , Idoso , Feminino , Humanos , Incidência , Israel/epidemiologia , Masculino , Pessoa de Meia-Idade , Transtornos Psicóticos/complicações , Estudos Retrospectivos , Fatores de Risco , Distribuição por Sexo , Transtornos Relacionados ao Uso de Substâncias/complicações , Adulto Jovem
15.
Eye Vis (Lond) ; 8(1): 11, 2021 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-33789766

RESUMO

BACKGROUND: The Catquest-9SF questionnaire is a patient reported outcome measure that quantifies the visual benefits from cataract surgery. The purpose of this study was to translate and adapt the Catquest-9SF questionnaire for France, to assess its psychometric properties via Rasch analysis, and to assess its validity when completed using an electronic notepad. METHODS: The Catquest-9SF questionnaire was translated following the guidelines of the International Society for Pharmacoeconomics and Outcomes Research. Catquest-9SF and clinical data were collected from patients before and after routine cataract surgery. All questionnaire data were collected via an electronic notepad. Rasch analysis was performed to assess psychometric properties, and sensitivity to change was analysed for patients with complete paired pre- and post-operative questionnaires. RESULTS: A complete filled-in preoperative questionnaire was obtained for 848 patients. Rasch analysis showed good precision (person separation: 2.32, person reliability: 0.84), ordered category probability curves, no item misfit, and unidimensionality. The respondents were slightly more able than the level of item difficulty (targeting: -1.12 logits). Sensitivity was analysed on 211 paired questionnaires, and the postoperative questionnaires showed a clear ceiling effect. The effect size was 2.6. The use of an electronic notepad for completing the questionnaire worked out very well after some adjustments. CONCLUSIONS: The French version of Catquest-9SF has good psychometric properties and is suitable for use in French-speaking patients. The use of the Catquest-9SF questionnaire in an electronic format showed good validity.

16.
Ther Innov Regul Sci ; 55(1): 228-238, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-32857313

RESUMO

Real-world data (RWD) and real-world evidence (RWE) appear now as complementary to traditional randomized controlled trials (RCT), that remain the gold standard of the evidence. This review aims to illustrate how health authorities in France, United States (USA) and United Kingdom (UK) can integrate RWD and RWE in market authorization discussions and in new pathways of price and reimbursement negotiations. We conducted a review from the literature, online investigations and interviews. RWD and RWE can be valuable in the context of market access, reimbursement decisions, price negotiation, pharmacovigilance and positive patient outcomes. While RWD could open new areas of innovative approaches and improve the efficiency of health systems, they have methodological limitations requiring further analysis to reach a sufficient level of proof. Moreover, misleading use of "RWD" and "RWE" terms is very frequent and even the definitions used by stakeholders (when they have one) are heterogenous. Because of the intrinsic characteristics of each product, the value given to these RWD may differ a lot, making them a useful tool more than an indispensable one. In sum, RWD and, more precisely, RWE have the potential to bring value to the health system at every step of the drug development process, from the discovery to the pharmacovigilance phase.


Assuntos
Negociação , Humanos , Reino Unido , Estados Unidos
17.
Transfus Apher Sci ; 42(3): 307-16, 2010 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-20395177

RESUMO

Paradoxically, France is one of the leading exporters of cord blood units worldwide, but ranks only 17th in terms of cord blood units per inhabitant, and imports 64% of cord blood grafts to meet national transplantation demands. With three operational banks in 2008, the French allogeneic cord blood network is now entering an important phase of development with the creation of seven new banks collecting from local clusters of maternities. Although the French network of public banks is demonstrating a strong commitment to reorganise and scale up its activities, the revision of France's bioethics law in 2010 has sparked a debate concerning the legalisation of commercial autologous banking. The paper discusses key elements for a comprehensive national plan that would strengthen the allogeneic banking network through which France could meet its national medical needs and guarantee equal access to healthcare.


Assuntos
Bancos de Sangue/organização & administração , Doadores de Sangue/legislação & jurisprudência , Sangue Fetal , Comércio/ética , Comércio/legislação & jurisprudência , Comércio/organização & administração , Transplante de Células-Tronco de Sangue do Cordão Umbilical , França , Humanos , Transplante Autólogo , Transplante Homólogo
18.
Compr Psychiatry ; 51(1): 37-41, 2010.
Artigo em Inglês | MEDLINE | ID: mdl-19932824

RESUMO

The influence of cannabis abuse on the severity of existing psychotic and affective symptoms is still unclear. Among 470 consecutively admitted psychotic or affective patients, 54 active (in the previous month) cannabis abusers were detected via urine tests (Sure Step TM kits; Applied Biotech Inc, San Diego, Calif) and Structured Clinical Interview for DSM-IV (SCID- IV) questionnaire. In 24 cases, substances other than cannabis were abused; 392 patients were nonabusers. All patients were diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, criteria. The following rating scales were used: Hamilton Depression Rating Scale (HAM-D-21), Positive and Negative Syndrome Scale (PANSS), and Young Mania Rating Scale (YMRS). Cannabis abusers (n = 54) were significantly younger and more frequently males than nonuser patients. In this group, there were more schizophrenic patients and fewer affective and anxiety patients (chi(2) = 11.76; P < .01). The double-diagnosed patients had more prominent psychotic symptoms than the nonusers (n = 392)-PANSS positive: 19.056 +/- 8.30 vs 16.128 +/- 8.031 (P < .02; t(446) = 2.510). The difference was statistically significant for hallucinatory behavior, excitement, grandiosity, and hostility. General PANSS scale rate of abusers was lower: 33.012 +/- 9.317 vs 37.3575 +/- 11.196 (P < .01; t = 2.727), especially for depression, anxiety, somatic concern, guilt feelings, tension, motor retardation, and volition disturbances. Rates of PANSS negative scale of abusers and nonusers were not significantly different (13.815 +/- 6.868 vs 14.983 +/- 6.446) except for lower rates of social withdrawal and stereotyped thinking for abusers. No significant difference in general level of manic symptoms (YMRS) between abusers and nonusers was observed (6.778 +/- 10.826 vs 4.910 +/- 7.754), but severity of thought/language disturbances and poor insight was found significantly higher in the abusers. Cannabis abusers are obviously less depressive (HAM-D): 5.944 +/- 10.291 vs 12.896 +/- 13.946 (P < .0005, t = 3.535). Such differences were observed in the high number of the subscales. Abusers' rates were higher (although not significantly) for paranoid symptoms and general somatic symptoms. Cannabis possibly produces some antidepressive and anxiolytic effect on psychotic and affective inpatients. The "price" of this effect is often an exacerbation of psychotic and some manic symptoms.


Assuntos
Pacientes Internados/psicologia , Abuso de Maconha/complicações , Transtornos do Humor/diagnóstico , Transtornos Psicóticos/diagnóstico , Índice de Gravidade de Doença , Adolescente , Adulto , Fatores Etários , Idoso , Distribuição de Qui-Quadrado , Depressão/complicações , Depressão/diagnóstico , Manual Diagnóstico e Estatístico de Transtornos Mentais , Feminino , Humanos , Israel , Masculino , Pessoa de Meia-Idade , Transtornos do Humor/complicações , Transtornos Psicóticos/complicações , Fatores Sexuais , Inquéritos e Questionários
19.
Ther Innov Regul Sci ; 53(5): 701-705, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-30392396

RESUMO

There is no such thing as a drug that is 100% safe or effective. Determining whether or not a new oncology treatment (or an additional indication for an existing medicine) should be approved by a regulatory licensing authority is, ultimately, as much regulatory science as public health art and nuance. There are many dynamic shifts in regulatory science (expedited review pathways, biomarker validation, use of real-world evidence, expanded off-label usage, etc) interpreted and expressed within the context of 21st-century oncology drug development, and these new tools and the learnings gleaned from them are helping to advance patient care. They are also helping us to carefully reconsider the levels of uncertainty we find in benefit-risk data and clinical calculations. New-Age Pharmacovigilance can be a tool in product development, regulatory review, postmarketing surveillance and enhanced clinical outcomes.


Assuntos
Antineoplásicos/efeitos adversos , Aprovação de Drogas/legislação & jurisprudência , Legislação de Medicamentos/normas , Ensaios Clínicos Adaptados como Assunto , Inteligência Artificial , Aprovação de Drogas/métodos , Guias como Assunto , Humanos , Farmacovigilância , Medição de Risco , Estados Unidos
20.
J Bone Joint Surg Am ; 101(15): 1366-1374, 2019 Aug 07.
Artigo em Inglês | MEDLINE | ID: mdl-31393427

RESUMO

BACKGROUND: Upper-limb injuries and musculoskeletal disorders represent a major economic burden for both patients and society, largely due to limitations in returning to work. We hypothesized that a positive patient-surgeon relationship may facilitate patients' recovery and lead to a faster return to work. METHODS: This longitudinal observational study comprised 219 patients, from 8 French hand trauma centers, who were 18 to 55 years of age and were on sick leave from work because of an injury or musculoskeletal disorder of the upper limb. In addition to instruments measuring patients' functional scores and quality of life, the quality of the patient-surgeon relationship was assessed at enrollment using a specific questionnaire (Q-PASREL [Quality of PAtient-Surgeon RELationship]). Six months after enrollment, the return-to-work status was assessed. Logistic and Cox regression models were developed to identify predictors of return to work (yes/no) and the time off from work in days. RESULTS: Overall, 74% of the patients who returned to work within 6 months after enrollment had a high or medium-high Q-PASREL score, whereas 64% of the patients who were still on sick leave had a low or medium-low Q-PASREL score. The odds of patients with a low or medium-low Q-PASREL score returning to work were, respectively, 95% and 71% lower than the odds of patients with a high score doing so, with a percent difference of 56% (95% confidence interval [CI] = 40% to 71%) for low versus high (odds ratio [OR] = 0.05 [95% CI = 0.02 to 0.13]) and 25% (95% CI = 6% to 44%) for medium-low versus high (OR = 0.29 [95% CI = 0.11 to 0.76]). All Q-PASREL items and scores were significantly associated with return to work. CONCLUSIONS: Patients with a lower Q-PASREL score and more severe disability were less likely to return to work within 6 months and had a longer time off from work. Efforts to improve the quality of patient-surgeon relationships may minimize the duration of sick leaves and accelerate patient recovery. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.


Assuntos
Traumatismos do Braço/cirurgia , Avaliação da Deficiência , Custos de Cuidados de Saúde , Retorno ao Trabalho/economia , Licença Médica/economia , Adolescente , Adulto , Fatores Etários , Traumatismos do Braço/diagnóstico , Traumatismos do Braço/reabilitação , Estudos de Coortes , Feminino , França , Humanos , Escala de Gravidade do Ferimento , Modelos Logísticos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Avaliação das Necessidades , Procedimentos Ortopédicos/métodos , Procedimentos Ortopédicos/reabilitação , Relações Médico-Paciente , Valor Preditivo dos Testes , Modelos de Riscos Proporcionais , Medição de Risco , Fatores Sexuais , Inquéritos e Questionários , Centros de Traumatologia , Adulto Jovem
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