RESUMEN
Physicians engaged in cardiovascular implantable electronic device (CIED)-related practice come from diverse training backgrounds with variable degrees of CIED implant training. The objective of the Canadian Heart Rhythm Society Task Force on CIED Implant Training was to establish a common structure and content for training programs in CIED implantation, related activities and maintenance of competency. This executive summary presents the essence of the report with key recommendations included, with the complete version made available in a linked supplement. The goals are to ensure that future generations of CIED implanters are better prepared for continuously evolving CIED practice and quality care for all Canadians.
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Comités Consultivos/estadística & datos numéricos , Cardiología/educación , Desfibriladores Implantables , Educación de Postgrado en Medicina/métodos , Marcapaso Artificial , Médicos/normas , Sociedades Médicas , Arritmias Cardíacas/terapia , Canadá , Competencia Clínica/normas , Cardioversión Eléctrica/normas , Electrónica , Guías como Asunto , HumanosRESUMEN
BACKGROUND: Treatment and diagnostic recommendations are often made in clinical guidelines, reports from advisory committee meetings, opinion pieces such as editorials, and narrative reviews. Quite often, the authors or members of advisory committees have industry ties or particular specialty interests which may impact on which interventions are recommended. Similarly, clinical guidelines and narrative reviews may be funded by industry sources resulting in conflicts of interest. OBJECTIVES: To investigate to what degree financial and non-financial conflicts of interest are associated with favourable recommendations in clinical guidelines, advisory committee reports, opinion pieces, and narrative reviews. SEARCH METHODS: We searched PubMed, Embase, and the Cochrane Methodology Register for studies published up to February 2020. We also searched reference lists of included studies, Web of Science for studies citing the included studies, and grey literature sources. SELECTION CRITERIA: We included studies comparing the association between conflicts of interest and favourable recommendations of drugs or devices (e.g. recommending a particular drug) in clinical guidelines, advisory committee reports, opinion pieces, or narrative reviews. DATA COLLECTION AND ANALYSIS: Two review authors independently included studies, extracted data, and assessed risk of bias. When a meta-analysis was considered meaningful to synthesise our findings, we used random-effects models to estimate risk ratios (RRs) with 95% confidence intervals (CIs), with RR > 1 indicating that documents (e.g. clinical guidelines) with conflicts of interest more often had favourable recommendations. We analysed associations for financial and non-financial conflicts of interest separately, and analysed the four types of documents both separately (pre-planned analyses) and combined (post hoc analysis). MAIN RESULTS: We included 21 studies analysing 106 clinical guidelines, 1809 advisory committee reports, 340 opinion pieces, and 497 narrative reviews. We received unpublished data from 11 studies; eight full data sets and three summary data sets. Fifteen studies had a risk of confounding, as they compared documents that may differ in other aspects than conflicts of interest (e.g. documents on different drugs used for different populations). The associations between financial conflicts of interest and favourable recommendations were: clinical guidelines, RR: 1.26, 95% CI: 0.93 to 1.69 (four studies of 86 clinical guidelines); advisory committee reports, RR: 1.20, 95% CI: 0.99 to 1.45 (four studies of 629 advisory committee reports); opinion pieces, RR: 2.62, 95% CI: 0.91 to 7.55 (four studies of 284 opinion pieces); and narrative reviews, RR: 1.20, 95% CI: 0.97 to 1.49 (four studies of 457 narrative reviews). An analysis combining all four document types supported these findings (RR: 1.26, 95% CI: 1.09 to 1.44). One study investigating specialty interests found that the association between including radiologist guideline authors and recommending routine breast cancer screening was RR: 2.10, 95% CI: 0.92 to 4.77 (12 clinical guidelines). AUTHORS' CONCLUSIONS: We interpret our findings to indicate that financial conflicts of interest are associated with favourable recommendations of drugs and devices in clinical guidelines, advisory committee reports, opinion pieces, and narrative reviews. However, we also stress risk of confounding in the included studies and the statistical imprecision of individual analyses of each document type. It is not certain whether non-financial conflicts of interest impact on recommendations.
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Comités Consultivos/ética , Conflicto de Intereses , Conjuntos de Datos como Asunto/ética , Guías de Práctica Clínica como Asunto , Publicaciones/ética , Comités Consultivos/estadística & datos numéricos , Autoria , Sesgo , Conflicto de Intereses/economía , Consultores , Conjuntos de Datos como Asunto/estadística & datos numéricos , Industria Farmacéutica/ética , Políticas Editoriales , Equipos y Suministros/ética , Humanos , Radiólogos , Literatura de Revisión como AsuntoRESUMEN
OBJECTIVE: To estimate the proportion of accidental drug-related deaths and suicides classified as pregnancy-related from 2013 to 2014 (preimplementation of standardized criteria) and 2015 to 2016 (postimplementation). METHODS: Based on Centers for Disease Control and Prevention pregnancy-related death criteria, the Utah Perinatal Mortality Review Committee developed a standardized evaluation tool to assess accidental drug-related death and suicide beginning in 2015. We performed a retrospective case review of all pregnancy-associated deaths (those occurring during pregnancy or 1 year postpartum for any reason) and pregnancy-related deaths (those directly attributable to the pregnancy or postpartum events) evaluated by Utah's Perinatal Mortality Review Committee from 2013 to 2016. We compared the proportion of accidental drug-related deaths and suicides meeting pregnancy-related criteria preimplementation and postimplementation of a standardized criteria checklist tool using Fisher's exact test. We assessed the change in pregnancy-related mortality ratio in Utah from 2013 to 2014 and 2015 to 2016 using test of trend. RESULTS: From 2013 to 2016, there were 80 pregnancy-associated deaths in Utah (2013-2014: n=40; 2015-2016: n=40), and 41 (51%) were pregnancy-related (2013-2014: n=15, 2015-2016: n=26). In 2013-2014 (preimplementation), 12 women died of drug-related deaths or suicides, and only two of these deaths were deemed pregnancy-related (17%). In 2015-2016 (postimplementation), 18 women died of drug-related deaths or suicide, and 94% (n=17/18) of these deaths met one or more of the pregnancy-related criteria on the checklist (P<.001). From 2013 to 2014 to 2015-2016, Utah's overall pregnancy-related mortality ratio more than doubled, from 11.8 of 100,000 to 25.7 of 100,000 (P=.08). CONCLUSION: After application of standardized criteria, the Utah Perinatal Mortality Review Committee determined that pregnancy itself was the inciting event leading to the majority of accidental drug-related deaths or suicides among pregnant and postpartum women. Other maternal mortality review committees may consider a standardized approach to assessing perinatal suicides and accidental drug-related deaths.
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Prevención de Accidentes , Abuso de Medicamentos , Revisión por Pares/normas , Complicaciones del Embarazo , Trastornos Puerperales/mortalidad , Prevención del Suicidio , Suicidio , Adulto , Comités Consultivos/estadística & datos numéricos , Abuso de Medicamentos/mortalidad , Abuso de Medicamentos/prevención & control , Fracaso de Rescate en Atención a la Salud/estadística & datos numéricos , Femenino , Humanos , Mortalidad Materna/tendencias , Mortalidad , Embarazo , Complicaciones del Embarazo/mortalidad , Complicaciones del Embarazo/prevención & control , Suicidio/estadística & datos numéricos , Utah/epidemiologíaRESUMEN
The maternal mortality ratio in the United States is increasing; understanding the significance of this change and developing effective responses requires a granular analysis of the contributing factors that a well-informed maternal mortality review committee can provide. Data collection and analysis, clinical factors, preventability, social determinants of health, and racial inequities combine to affect this outcome, and each factor must be considered individually and in combination to recommend a robust response. Obstetrician-gynecologists formed the State of Michigan's Maternal Mortality Review Committee (the Committee) in 1950 to identify gaps in care that needed to be systematically addressed at the time. In the early years, the Committee witnessed a reduction in the number of maternal deaths; over time, prioritization of maternal mortality decreased, yet the Committee witnessed changing patterns of death, varied data collection and evaluation processes, delayed reviews, and unimplemented recommendations. The calculation of the maternal mortality ratio was not informed by the outcomes of Committee reviews. Today, the Committee, with increased support from the Michigan Department of Health & Human Services, can clearly identify and report preventable pregnancy-related mortality along with its causes and is close to achieving a near real-time surveillance system that allows the development of timely clinical and policy recommendations and interventions. The Committee's adaptations in response to the rise in maternal mortality have resulted in several lessons learned that may be helpful for currently operating committees and in the formation of new ones.
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Abuso de Medicamentos , Mortalidad Materna/tendencias , Complicaciones del Embarazo , Servicios Preventivos de Salud , Mejoramiento de la Calidad , Prevención del Suicidio , Suicidio , Adulto , Comités Consultivos/normas , Comités Consultivos/estadística & datos numéricos , Abuso de Medicamentos/mortalidad , Abuso de Medicamentos/prevención & control , Fracaso de Rescate en Atención a la Salud/estadística & datos numéricos , Femenino , Disparidades en Atención de Salud/normas , Humanos , Michigan/epidemiología , Mortalidad , Embarazo , Complicaciones del Embarazo/mortalidad , Complicaciones del Embarazo/prevención & control , Servicios Preventivos de Salud/métodos , Servicios Preventivos de Salud/normas , Mejoramiento de la Calidad/organización & administración , Mejoramiento de la Calidad/tendencias , Determinantes Sociales de la Salud/etnología , Suicidio/estadística & datos numéricosRESUMEN
BACKGROUND: The Society of Thoracic Surgeons (STS) has intermittently surveyed its workforce, providing isolated accounts of the current state of thoracic surgical practice. METHODS: The 70-question survey instrument was received by 3834 STS surgeon members, and responses were gathered between September 16 and November 1, 2019. The return rate was 27.9%. RESULTS: The median age of the active United States (US) thoracic surgeons is 56 years. Women comprise 8.4% of the responders, constituting 6.2% of adult cardiac, 10.6% of congenital heart, and 12.6% of general thoracic surgeons. Most practicing US surgeons (83.5%) graduated from medical school in the US. Survey respondents had 7 (21.8%), 8 (25.0%), 9 (22.1%) or 10 (29.2%) or more years of post-MD training before entering practice. Educational debt was increased compared with previous years, as were salaries. Overall career satisfaction was 54.1% (very or extremely satisfied), and overall average hours per week worked decreased compared with past surveys. However, 55.7% of surgeons had symptoms of burnout and depression. STS Database participation was high (90.5%), with the most common reason for not participating being cost (32.6%). Operative volume over the past 12 months decreased for 23.7% of surgeons. Of those who responded, 46.9% plan to retire between the age of 66 and 69 years and a further 25.6% at age 70 or older. CONCLUSIONS: These data provide a current, detailed profile of the specialty. Ongoing challenges remain length of training and educational debt. Case volumes, scope of practice, and career satisfaction have remained relatively constant: however, symptoms of burnout or depression or both, are common.
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Comités Consultivos/estadística & datos numéricos , Educación de Postgrado en Medicina/métodos , Satisfacción en el Trabajo , Sociedades Médicas , Cirugía Torácica , Procedimientos Quirúrgicos Torácicos/educación , Recursos Humanos , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Encuestas y Cuestionarios , Estados UnidosRESUMEN
The Psychopharmacologic Drug Advisory Committee (PDAC) is one of 33 advisory committees of the Food and Drug Administration (FDA). During committee meetings, an open public hearing takes place where speakers provide testimonies about the drug in question and are asked, not required, to disclose any conflicts of interests (COIs) before speaking. These speakers may present with COIs which include, but are not limited to, reimbursement for travel and lodging by the pharmaceutical company to attend the meeting; previous or current payments for consulting from the pharmaceutical company and compensation as a paid investigator in previously conducted clinical trials for the drug under review. Our study aimed to investigate the characteristics and COIs of public speakers at PDAC meetings of the FDA. We evaluated 145 public speakers at FDA committee meetings over a 10-year period. We found a total of 52 public speakers disclosed a COI with travel and lodging being the most prominent. Among these speakers, 82.4% provided a positive testimony regarding the psychiatric drug in question. Speakers who had the condition in question were not more likely to provide a positive statement than those who did not. Our results showed that disclosing a COI was associated with increased odds of public speakers providing a favourable testimony for the recommendation of psychiatric drugs. The implications of these findings are concerning since COIs have the potential to skew public speaker's testimonies and persuade committee members to recommend a drug through emotionally charged tactics.
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Comités Consultivos/ética , Conflicto de Intereses , Industria Farmacéutica/ética , Psicotrópicos/uso terapéutico , Habla/ética , United States Food and Drug Administration/ética , Comités Consultivos/estadística & datos numéricos , Revelación/ética , Revelación/estadística & datos numéricos , Aprobación de Drogas/métodos , Humanos , Estados Unidos , United States Food and Drug Administration/organización & administración , United States Food and Drug Administration/estadística & datos numéricosRESUMEN
Introduction: Tobacco control policies have helped to reduce the health, social, and economic burden of commercial tobacco use worldwide. Little is known about the long-term impact of regulatory policies and functioning bodies that make recommendations to inform policies. The Tobacco Products Scientific Advisory Committee (TPSAC) of the U.S. Food and Drug Administration (FDA) was formed in 2009 to evaluate the safety, health, and dependence of tobacco products and provide related advice and recommendations to the FDA and the Secretary of Health and Human Services. This article describes the first 10 years of the TPSAC activities and reflects on the impact of their service on regulatory actions.Methods: We reviewed public documents from the 2010-2019 TPSAC meetings to examine the purposes, TPSAC decisions, public health participation in meetings, and concordance of the TPSAC recommendations with regulatory actions. Meeting agendas, transcripts, public testimony, and presentations were reviewed to obtain this information.Results: Since 2010, the TPSAC held 25 public meetings with 178 speakers who provided oral public testimony. Sixty-four percent of meetings were held from 2010 to 2012, when three congressionally mandated reports were due on the topics of menthol cigarettes, harmful and potentially harmful constituents in tobacco products, and dissolvable tobacco products. Forty-four percent of meetings focused on menthol cigarettes, 32% on modified risk tobacco products, 16% on harmful and potentially harmful constituents, 12% on dissolvable tobacco, and 4% on tobacco addiction/dependence. FDA regulatory actions were largely nonconcordant with voting decisions by TPSAC.Conclusions: The TPSAC has evaluated an enormous amount of science during the first 10 years, but their influence on regulatory policies has been limited. The TPSAC roles and functioning should be reevaluated to determine how TPSAC can better fulfill its mandate to inform the FDA's regulatory decision making, which could ultimately reduce the burden of tobacco use in the United States.
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Comités Consultivos/organización & administración , Regulación Gubernamental , Productos de Tabaco/legislación & jurisprudencia , Uso de Tabaco/legislación & jurisprudencia , United States Food and Drug Administration , Comités Consultivos/historia , Comités Consultivos/estadística & datos numéricos , Historia del Siglo XXI , Estados UnidosRESUMEN
Objective The aim of this study was to get a better understanding of the frequency of Pharmaceutical Benefits Advisory Committee (PBAC) hearings, the factors that influence a sponsor's decision to proceed with a hearing and to assess the impact hearings may have had on PBAC decision making. Methods All public summary documents (PSDs) from March 2014 to November 2016 PBAC meetings, obtained from the Pharmaceutical Benefits Scheme (PBS) website, were examined to identify major submissions for which sponsor hearings were conducted. Each PSD was analysed to determine the topics discussed at the sponsor hearing and the 'usefulness' of a sponsor hearing from the PBAC's perspective. Results During the study period there were 472 PSDs. 74 sponsor hearings (28% of major submissions) were conducted during the study period. A clinician external to the sponsor presented at the majority of the hearings (78%) and accordingly, the main topics presented related to clinical positioning/use and clinical benefit/use. Conclusion The PBAC considered approximately 45% of sponsor hearings to be informative or moderately informative whereas 18% were classed as uninformative. What is known about the topic? Although the sponsors of medicines being considered by the Pharmaceutical Benefits Advisory Committee (PBAC) for public subsidy have been able to give a 10 min presentation to the Committee at the time of decision making for several years, it is unknown whether these hearings are beneficial. What does this paper add? We present what is believed to be the results of the first analysis of PBAC sponsor hearings. What are the implications for practitioners? All stakeholders should consider the findings of our research and associated recommendations to ensure that future sponsor hearings enhance PBAC decision making and promote good public health policy.
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Comités Consultivos/estadística & datos numéricos , Toma de Decisiones , Aprobación de Drogas/estadística & datos numéricos , Australia , Aprobación de Drogas/métodos , Humanos , Seguro de Servicios Farmacéuticos , Evaluación de la Tecnología Biomédica/estadística & datos numéricosRESUMEN
BACKGROUND: We sought to determine the extent to which US Preventive Services Task Force (USPSTF) 2012 Grade D recommendations against prostate-specific antigen screening may have impacted recent prostate cancer disease incidence patterns in the United States across stage, National Comprehensive Cancer Network (NCCN) risk groups, and age groups. METHODS: SEER*Stat version 8.3.4 was used to calculate annual prostate cancer incidence rates from 2010 to 2015 for men aged ≥50 years according to American Joint Committee on Cancer stage at diagnosis (localized vs metastatic), NCCN risk group (low vs unfavorable [intermediate or high-risk]), and age group (50-74 years vs ≥75 years). Age-adjusted incidences per 100,000 persons with corresponding year-by-year incidence ratios (IRs) were calculated using the 2000 US Census population. RESULTS: From 2010 to 2015, the incidence (per 100,000 persons) of localized prostate cancer decreased from 195.4 to 131.9 (Ptrend < .001) and from 189.0 to 123.4 (Ptrend < .001) among men aged 50-74 and ≥75 years, respectively. The largest relative year-by-year decline occurred between 2011 and 2012 in NCCN low-risk disease (IR, 0.77 [0.75-0.79, P < .0001] and IR 0.68 [0.62-0.74, P < .0001] for men aged 50-74 and ≥75 years, respectively). From 2010-2015, the incidence of metastatic disease increased from 6.2 to 7.1 (Ptrend < .001) and from 16.8 to 22.6 (Ptrend < .001) among men aged 50-74 and ≥75 years, respectively. CONCLUSIONS: This report illustrates recent prostate cancer "reverse migration" away from indolent disease and toward more aggressive disease beginning in 2012. The incidence of localized disease declined across age groups from 2012 to 2015, with the greatest relative declines occurring in low-risk disease. Additionally, the incidence of distant metastatic disease increased gradually throughout the study period.
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Comités Consultivos/estadística & datos numéricos , Guías de Práctica Clínica como Asunto , Servicios Preventivos de Salud/estadística & datos numéricos , Antígeno Prostático Específico/sangre , Neoplasias de la Próstata/diagnóstico , Comités Consultivos/organización & administración , Comités Consultivos/normas , Anciano , Detección Precoz del Cáncer/métodos , Humanos , Incidencia , Masculino , Tamizaje Masivo/métodos , Persona de Mediana Edad , Estadificación de Neoplasias , Servicios Preventivos de Salud/organización & administración , Servicios Preventivos de Salud/normas , Neoplasias de la Próstata/sangre , Neoplasias de la Próstata/epidemiología , Factores de Riesgo , Programa de VERF/estadística & datos numéricos , Estados Unidos/epidemiologíaAsunto(s)
Comités Consultivos/estadística & datos numéricos , Detección Precoz del Cáncer/métodos , Guías de Práctica Clínica como Asunto , Servicios Preventivos de Salud/métodos , Antígeno Prostático Específico/sangre , Neoplasias de la Próstata/diagnóstico , Comités Consultivos/organización & administración , Comités Consultivos/normas , Anciano , Humanos , Incidencia , Masculino , Tamizaje Masivo/métodos , Persona de Mediana Edad , Servicios Preventivos de Salud/organización & administración , Neoplasias de la Próstata/sangre , Neoplasias de la Próstata/epidemiología , Factores de Tiempo , Estados Unidos/epidemiologíaRESUMEN
The survey involves examining the applications from 142 institutions that have consented to make available all certification applications from 2015 and 2016 to a research project for building a certification system for an ethics committee run by the Agency for Medical Research and Development. The number of certified institutions is 20 (14.1%). In the applications from uncertified institutions, there are cases in which requirements of ethics guidelines are unmet, and there is insufficient information provided on regulation and procedure. An analysis of the committee members who can contribute as members of the general public (general public committee members) has indicated that the number of committee members who do not belong to an institution in which an ethics committee is instituted (external committee members) is 41 (95.7%) among the certified institutions and 224 (84.5%) among the uncertified institutions. The proportion of general public committee members drawn internally from institutions tends to be higher among uncertified institutions. While a separate committee examined conflicts of interest in research in 19 certified institutions (95.0%), such conflicts were found in 41 uncertified institutions (33.9%) by the ethics committee. The survey confirms that the challenge lies in increasing the number of external committee members and in further improving the system to manage conflicts of interest, and the education and training regime.
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Comités Consultivos/estadística & datos numéricos , Comités de Ética en Investigación/estadística & datos numéricos , Investigación Biomédica/ética , Revisión Ética , Humanos , JapónAsunto(s)
Enfermedad Crónica , Publicaciones Periódicas como Asunto , Servicios Preventivos de Salud/métodos , Comités Consultivos/estadística & datos numéricos , Investigación Biomédica/métodos , Enfermedad Crónica/epidemiología , Enfermedad Crónica/prevención & control , Humanos , Factor de Impacto de la Revista , Publicaciones Periódicas como Asunto/estadística & datos numéricos , Publicaciones Periódicas como Asunto/tendencias , Salud PúblicaRESUMEN
BACKGROUND: In Australia, the Pharmaceutical Benefits Advisory Committee (PBAC) advises on the reimbursement of drugs to be subsidised through the Pharmaceutical Benefits Scheme (PBS). This study aims to provide insights into the PBAC process and key considerations regarding the reimbursement of MS drugs in Australia. METHODS: The factors considered by the PBAC and its advice on whether to reimburse a drug are documented in public summary documents (PSDs). Qualitative content analysis of PSDs was conducted for all MS drugs considered by the PBAC between January 2006 and January 2018. Key issues identified by the PBAC were extracted and categorised. Common issues were identified and compared between drugs indicated for MS. RESULTS: A total of 23 submissions were evaluated relating to 13 MS drugs. Eight were recommended for reimbursement; an approval rate of 35% per submission and 62% per drug. Approval rates were higher for disease modifying treatments (73% per drug) than for symptomatic drugs (0% for nabiximols and fampridine submissions). The most frequently discussed issues in PSDs, irrespective of PBAC decision, were: (1) the validity of the indirect comparisons formed (nâ¯=â¯11); (2) the validity of the approach to obtain utilities (nâ¯=â¯6); (3) the lack of appropriate/long-term safety data (nâ¯=â¯8); and (4) the time horizon used in the economic models (nâ¯=â¯3). CONCLUSION: A small but important number of issues have been consistently identified by the PBAC in relation to submissions for reimbursement of MS drugs. Drug developers and clinical trial investigators who are aware of these issues will be able to anticipate data requirements for reimbursement decision-making and thus potentially improve the evidence submitted for listing of MS drugs in Australia.
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Comités Consultivos/normas , Toma de Decisiones , Aprobación de Drogas/métodos , Factores Inmunológicos/uso terapéutico , Esclerosis Múltiple/tratamiento farmacológico , Esclerosis Múltiple/psicología , Comités Consultivos/estadística & datos numéricos , Australia/epidemiología , Análisis Costo-Beneficio , Aprobación de Drogas/economía , Femenino , Humanos , Factores Inmunológicos/economía , Masculino , Estudios RetrospectivosRESUMEN
BACKGROUND: The All Wales Medicines Strategy Group (AWMSG) develops prescribing advice and is responsible for appraising new medicines for use in Wales. In this article, we examine the medicines appraisal process in Wales, its timeliness and its impact on medicines availability in Wales, and compare its processes and recommendations with the two other UK health technology appraisal bodies [the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC)]. METHODS: We reviewed the medicines appraisals conducted by AWMSG between October 2010 and September 2015. The duration of the process and the recommendations made by AWMSG were compared with those of NICE and SMC. Only publicly available data were considered in this review. RESULTS: AWMSG conducted 171 single technology appraisals for 137 medicines during the study period (34 were for medicines previously appraised by AWMSG but these were for new indications). Of these, 152 appraisals were supported for use in NHS Wales (33 with restrictions) and 19 were not supported. Recommendations broadly concurred with SMC and NICE for the majority of appraisals. Compared with NICE recommendations, the median time advantage gained in Wales for those medicines that received a positive AWMSG recommendation and which were subsequently superseded by NICE advice was 10.6 months (range 3.5-48.3 months; n = 17). CONCLUSION: This review highlights the work carried out by AWMSG over a 5-year period, and provides evidence to support the effectiveness of the appraisal process in terms of patients in Wales gaining earlier access to medicines and efficiency through reduced duplication with NICE.
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Comités Consultivos/estadística & datos numéricos , Análisis Costo-Beneficio/métodos , Toma de Decisiones , Evaluación de la Tecnología Biomédica/métodos , Humanos , Guías de Práctica Clínica como Asunto , Escocia , Factores de Tiempo , Reino Unido , GalesRESUMEN
PURPOSE: The National Cancer Institute (NCI) requirement that clinical trials at NCI-designated cancer centers undergo institutional scientific review in addition to institutional review board evaluation is unique among medical specialties. We sought to evaluate the effect of this process on protocol activation timelines. METHODS: We analyzed oncology clinical trials that underwent full board review by the Harold C. Simmons Comprehensive Cancer Center Protocol Review and Monitoring Committee (PRMC) from January 1, 2009, through June 30, 2013. We analyzed associations between trial characteristics, PRMC decisions, protocol modifications, and process timelines using the χ2 test, Fisher's exact test, Wilcoxon rank sum test, Kruskal-Wallis test, and logistic regression. RESULTS: A total of 226 trials were analyzed. Of these, 77% were industry sponsored and 23% were investigator initiated. The median time from submission to PRMC approval was 55 days. The length of review was associated with trial phase, timing of approval, and number of committee changes/clarifications requested. The median process time was 35 days for those approved at first decision, 68 days for second decision, and 116 days for third decision ( P < .001). The median process time was 39 days if no changes/clarifications were requested, 64 days for one to three changes/clarifications, and 73 days for four or more changes/clarifications ( P < .001). Requested changes/clarifications had a greater effect on industry-sponsored trials than on investigator-initiated trials. CONCLUSION: NCI-mandated institutional scientific review of oncology clinical trials contributes substantially to protocol activation timelines. Further evaluation of this process and the value added to research quality is warranted.
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Neoplasias/tratamiento farmacológico , Comités Consultivos/estadística & datos numéricos , Protocolos Clínicos , Comités de Ética en Investigación/estadística & datos numéricos , Humanos , National Cancer Institute (U.S.)/estadística & datos numéricos , Proyectos de Investigación/estadística & datos numéricos , Estados UnidosRESUMEN
The Royal Commission into Institutional Responses to Child Sexual Abuse is the largest royal commission in Australia's history and one of the largest public inquiries into institutional child abuse internationally. With an investment from the Australian government of half a billion dollars, it examined how institutions with a responsibility for children, both historically and in the present, have responded to allegations of child sexual abuse. Announced in the wake of previous Australian and international inquiries, public scandals and lobbying by survivor groups, its establishment reflected increasing recognition of the often lifelong and intergenerational damage caused by childhood sexual abuse and a strong political commitment to improving child safety and wellbeing in Australia. This article outlines the background, key features and innovations of this landmark public inquiry, focusing in particular on its extensive research program. It considers its international significance and also serves as an introduction to this special edition on the Australian Royal Commission, exploring its implications for better understanding institutional child sexual abuse and its impacts, and for making institutions safer places for children in the future.
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Comités Consultivos , Abuso Sexual Infantil/prevención & control , Abuso Sexual Infantil/estadística & datos numéricos , Práctica Institucional , Comités Consultivos/legislación & jurisprudencia , Comités Consultivos/estadística & datos numéricos , Australia , Niño , Abuso Sexual Infantil/legislación & jurisprudencia , Comparación Transcultural , Estudios Transversales , Humanos , Práctica Institucional/legislación & jurisprudencia , Práctica Institucional/estadística & datos numéricosRESUMEN
National Immunization Technical Advisory Groups (NITAGs) provide independent, evidence-informed advice to assist their governments in immunization policy formation. However, many NITAGs face challenges in fulfilling their roles. Hence the many requests for formation of a network linking NITAGs together so they can learn from each other. To address this request, the Health Policy and Institutional Development (HPID) Center (a WHO Collaborating Center at the Agence de Médecine Préventive - AMP), in collaboration with WHO, organized a meeting in Veyrier-du-Lac, France, on 11 and 12 May 2016, to establish a Global NITAG Network (GNN). The meeting focused on two areas: the requirements for (a) the establishment of a global NITAG collaborative network; and (b) the global assessment/evaluation of the performance of NITAGs. 35 participants from 26 countries reviewed the proposed GNN framework documents and NITAG performance evaluation. Participants recommended that a GNN should be established, agreed on its governance, function, scope and a proposed work plan as well as setting a framework for NITAG evaluation.
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Comités Consultivos , Salud Global , Política de Salud , Programas de Inmunización/organización & administración , Comités Consultivos/legislación & jurisprudencia , Comités Consultivos/organización & administración , Comités Consultivos/estadística & datos numéricos , Congresos como Asunto , Francia , Humanos , Programas de Inmunización/legislación & jurisprudencia , Programas de Inmunización/estadística & datos numéricos , Programas de Inmunización/tendencias , Colaboración Intersectorial , VacunasRESUMEN
We provide evidence for the causal impact of social status on longevity by exploiting a natural experiment in which subjects undergo a shift in their social status without considerable economic impact. We gather data on 4190 scientists who were either nominated for or successfully elected to the Chinese Academy of Science or of Engineering. Being elected as an academician in China is a boost in social status (vice-ministerial level) with negligible direct economic impact (US$30 monthly before 2009). After correcting for two sources of bias, (1) some potential academicians decease too young to be elected, leading to selection bias in favor of academicians and (2) the endogenous relationship between health and social status, we find that the enhanced social status of becoming an academician leads to approximately 1.2 years longer life. Copyright © 2015 John Wiley & Sons, Ltd.
Asunto(s)
Comités Consultivos/estadística & datos numéricos , Longevidad , Clase Social , Comités Consultivos/tendencias , China , Países en Desarrollo , Estado de Salud , Humanos , Persona de Mediana Edad , PolíticaAsunto(s)
Aprobación de Drogas/legislación & jurisprudencia , Distrofina/biosíntesis , Morfolinos/uso terapéutico , Músculo Esquelético/metabolismo , Distrofia Muscular de Duchenne/tratamiento farmacológico , United States Food and Drug Administration , Comités Consultivos/estadística & datos numéricos , Codón de Terminación/efectos de los fármacos , Codón de Terminación/genética , Distrofina/genética , Exones/efectos de los fármacos , Honorarios Farmacéuticos , Humanos , Morfolinos/economía , Distrofia Muscular de Duchenne/genética , Distrofia Muscular de Duchenne/metabolismo , Ensayos Clínicos Controlados Aleatorios como Asunto , Tamaño de la Muestra , Resultado del Tratamiento , Estados UnidosRESUMEN
OBJECTIVE: The International League Against Epilepsy (ILAE) Epilepsy Guidelines Task Force, composed of 14 international members, was established in 2011 to identify, using systematic review methodology, international epilepsy clinical care guidelines, assess their quality, and determine gaps in areas of need of development. METHODS: A systematic review of the literature (1985-2014) was performed in six electronic databases (e.g. Medline, Embase) using a broad search strategy without initial limits to language or study design. Six gray literature databases (e.g., American Academy of Neurology [AAN], ILAE) were also searched to minimize publication bias. Two independent reviewers screened abstracts, reviewed full text articles, and performed data abstraction. Descriptive statistics and a meta-analysis were generated. RESULTS: The search identified 10,926 abstracts. Of the 410 articles selected for full text review, 63 met our eligibility criteria for a guideline. Of those included, 54 were in English and 9 were in other languages (French, Spanish, and Italian). Of all guidelines, 29% did not specify the target age groups, 27% were focused on adults, 22% included only children, and 6% specifically addressed issues related to women with epilepsy. Guidelines included in the review were most often aimed at guiding clinical practice for status epilepticus (n = 7), first seizure (n = 6), drug-resistant epilepsy (n = 5), and febrile seizures (n = 4), among others. Most of the guidelines were therapeutic (n = 35) or diagnostic (n = 16) in nature. The quality of the guidelines using a 1-7 point scale (7 = highest) varied and was moderate overall (mean = 4.99 ± 1.05 [SD]). SIGNIFICANCE: We identified substantial gaps in topics (e.g., epilepsy in the elderly) and there was considerable heterogeneity in methodologic quality. The findings should offer a valuable resource for health professionals caring for people with epilepsy, since they will help guide the prioritization, development, and dissemination of future epilepsy-related guidelines.