Committee Advice Research Articles

OP124 Disinvestment – A Global Challenge Requiring Collaboration?

IntroductionAustralia has had some success at utilizing Health Technology Assessment (HTA) to disinvest and reassess medical services. This has been achieved through a range of methods including identifying services through initiatives such as ‘Choosing Wisely’, examining real world service data and seeking expert clinical opinion. This presentation will discuss how better international collaboration in disinvestment and reassessment methods using HTA could lead to more efficient health care systems.MethodsBoth the Australian and South Korean governments have a particular interest in disinvestment and reassessment in their health care systems. These countries have been sharing information over the past two years with a common goal of improving their health systems through a rigorous reassessment process. The Australian Government is in the process of reviewing all publicly funded services utilizing expert clinical committee advice, often referring the reassessment of services to a HTA process. A similar process is also being undertaken in South Korea.ResultsAustralia has disinvested in a wide range of services using HTA, including hip arthroscopy, lipectomy and hyperbaric oxygen therapy. It is also undertaking an extensive reassessment of 5,700 services. Reassessment may not lead to HTA, but it often includes an examination of whether a service should be subjected to HTA to remain publicly funded. Australia and South Korea have similar approaches in undertaking disinvestment and reassessment. HTA disinvestment and reassessment strategies have generated good outcomes for consumers, health care providers and funders in both countries.ConclusionsDisinvestment and reassessment of medical services require funders that support the continual improvement of health care systems. Disinvestment and reassessment HTA can be difficult, mainly due to external interests - an issue experienced by many countries. Further international collaboration in this area may provide a more supportive environment to undertake HTA for disinvestment.

Phase 3 randomized study of adjuvant anastrozole (A), exemestane (E), or letrozole (L) with or without tamoxifen (T) in postmenopausal women with hormone-responsive (HR) breast cancer: The FATA-GIM3 trial.

515 Background: Uncertainty still exists regarding the optimal schedule of adjuvant treatment of breast cancer with aromatase inhibitors (AI) and no trial has ever compared all the three AI. Methods: FATA-GIM3 is a multicenter, open label, 2x3 factorial phase 3 randomized study of adjuvant A, E and L upfront (UP - for 5 years) or sequentially (SEQ - for 3 years after 2 years of T) in postmenopausal HR breast cancer pts. Two comparisons were planned: UP vs SEQ and A vs E vs L. DFS (including local or distant relapse, second breast or non-breast cancer, DCIS and death, whichever came first) was the primary end-point; 2% at 5 yrs (corresponding to a HR of 0.79) was defined as the minimum difference required to declare superiority of UP vs SEQ. With two-tailed alfa 0.05, power 80%, 669 events and the enrolment of 3600 patients were planned. Following Data Monitoring Committee advice, final analysis was performed after 5yrs median follow-up. For each comparison a Cox regression model was applied adjusted by stratification factors and stratified by the other treatment factor. Analyses were based on intention-to-treat. Results: from 3/2007 to 7/2012, 3697 patients were enrolled at 76 centres. Median age 64, pT1 69.7% , pN0 64.3%, ER and PgR positive 88.9%, HER2 positive 8.9%, previous chemotherapy 38.3%. At 60 months median follow-up, 401 events were reported. 5yrs DFS was 89.8 with UP and 88.5 with SEQ (delta 1.32%, 95% CI -0.90-3.54; HR 0.89, 95% CI 0.73-1.08; P=0.23). 5yrs DFS was 90.0 with A, 88.0 with E and 89.4 with L (P=0.19). Conclusions: in the FATA-GIM3 trial there is a small non statistically significant DFS advantage for UP vs SEQ. No significant difference is evident among the three AI. Supported by the FARM5K3MEE AIFA grant from the Italian Drug Agency. Clinical trial information: NCT00541086.

SAGE committee advice on dengue vaccine

SAGE committee advice on dengue vaccine

PMO-019 Evaluation of evidence-based recommendations in current British society of gastroenterology guidelines

IntroductionClinical practice guidelines aim to improve patient care. They are based on best available evidence and are frequently viewed as “gold-standard” care for the disease or intervention that they address....

Weekly paclitaxel combined with monthly carboplatin versus single-agent therapy in patients age 70 to 89: IFCT-0501 randomized phase III study in advanced non-small cell lung cancer (NSCLC).

2 Background: Incidence of advanced NSCLC in the elderly is increasing. Specific trials for elderly are seldom and those patients are not optimally treated. Current recommendations are monotherapies with gemcitabine or vinorelbine. Methods: French multicentric randomized phase III study in pts aged 70 to 89, PS 0-2 with advanced NSCLC not irradiable, comparing a 3-weekly single agent therapy (gemcitabine 1,150 mg/m2 or vinorelbine 30 mg/m2, d1, d8: arm A) with carboplatin AUC 6 every 4 weeks + paclitaxel 90 mg/m2 (d1,8,15) doublet (arm B). Five cycles of single agent and 4 cycles of the doublet were to be given. Second-line in case of toxicity or progressive disease was fixed with erlotinib 150 mg/d. The main endpoint was overall survival. Results: 451 pts were included from 04/2005 to 12/2009 by 60 centers. Males were 73.8%, median age was 77.2 years (range 70-89). PS was 0-1 in 73.6%. The 2 arms were well-balanced for pts characteristics. At time of second planned intermediate analysis (after two-third of expected deaths, i.e. 224), 451 pts were randomized, out of the 522 initially planned. The steering committee advice was to stop the inclusions. Overall survival of the 313 pts analysed at this time was significantly longer in arm B (median: 10.4 months, 95%CI: [8.2; 15.0] vs. 6.2 months, 95%CI: [5.3; 7.5] for arm A, (HR = 0.60, 95%CI : [0.46; 0.78], p = 0.0001). Median PFS was 6.3 months, 95%CI: [5.5; 6.9] in arm B vs. 3.2 months, 95%CI: [0.44; 0.70] (HR = 0.55, 95%CI: [0.44; 0.70], p < 0.0001). Grade 3-4 haematological toxicities were significantly more frequent in arm B (17.9% vs. 54.1%). No significant difference was observed in early deaths (arm A: 23.7%, arm B: 16.6%). Survival, response and toxicity data for the whole series of 451 pts will be updated at time of the meeting. Conclusions: Paclitaxel and carboplatin doublet provides a significantly longer survival in elderly pts with advanced NSCLC than current standard single agent therapy, with acceptable toxicity, making it a new treatment paradigm for PS 0-2 pts ≥ 70 years. [Table: see text]

Committee Advice on Embryo Splitting

Committee Advice on Embryo Splitting

ICE Reservoirs Committee's advice on applications for appointment and reappointment as a panel engineer

In 2003, and again in 2006, retiring chairmen of the Reservoirs Committee's two sub-committees published articles in Dams and Reservoirs to give advice to existing and aspiring panel engineers about how to become appointed and, when the term of appointment is due to expire, become reappointed. This article is intended to reinforce the advice given in those two articles and includes some observations about applications now being received.

Vaccinations : élaboration des recommandations et de leur évolution en France

French guidelines for immunization are elaborated by a permanent advisory committee (Comité technique des vaccinations), which is part of the Public Health Council. This committee is composed of 20 experts from the different medical specialties involved in the immunization process, who are appointed for 3 years by the French Ministry of Health. Other members, without voting power, represent de different agencies, affiliated to the health minister, other ministers and different institutions. All members have to declare and update their potential conflicts of interests. The committee establishes official guidelines concerning topics submitted from the National Health Care Authorities, industrial firms awarded marketing approval for a new vaccine, or in the event of a modification concerning a previous registration. The advisory committee can also decide itself to establish official guidelines on a given topic. A submission usually leads to the creation of a specific working group assigned the task of preparing a report and an advice project. The project is proposed for committee vote and subsequently validated by the Commission for Transmissible Diseases of the Superior Public Health Authority (Haut Conseil de la santé publique). The committee guidelines stipulate whether the vaccine should be recommended or not, the target population (universal or limited to a selected population) and the immunization schedule. The committee's advice statement may also mention the need for a specific survey of the impact of the vaccination on epidemiology, as well as a broader survey related to its safety. Usually, when a vaccine is recommended, the Transparency Commission of the Haute Autorité de santé and the economic committee on drugs decide on its reimbursement by the public health care fund. The guidelines become part of the immunization schedule, which is updated annually and published in the Official Bulletin of the Minister of Health and in the Bulletin épidémiologique hebdomadaire.

Bush Administration Asks for Authority to Approve Generic Biologics; U.K. to Require Earlier Release of Adverse Trial Data; FDA Plans More Communication on Drug Risks; FDA Sets Out Rules for Distribution of Papers on Unapproved Uses; Grassley Asks GAO to Probe FDA Approvals; Supreme Court Splits on Rezulin Question; Medical Device Amendments Shield Manufacturers; PDUFA Deadlines Associated with More Approvals

Bush Administration Asks for Authority to Approve Generic Biologics; U.K. to Require Earlier Release of Adverse Trial Data; FDA Plans More Communication on Drug Risks; FDA Sets Out Rules for Distribution of Papers on Unapproved Uses; Grassley Asks GAO to Probe FDA Approvals; Supreme Court Splits on Rezulin Question; Medical Device Amendments Shield Manufacturers; PDUFA Deadlines Associated with More Approvals

NIH Funding of the Independent Investigator

Unlike previous editorials ([1][1]–[4][2]), this one contains a table, deals with science policy, and pertains to just one country. I apologize for this last deviation because Physiology intends to serve a world-wide audience. Nonetheless, readers from outside the USA may resonate with some of the

Using the Standards to Evaluate the Redesign of the U.S. Naturalization Tests: Lessons for the Measurement Community

In 2001, the U.S. Citizenship and Immigration Services (USCIS) began the process of redesigning the U.S. naturalization tests due to concerns that the current testing procedure may not be sufficiently uniform, and that the test content may not be appropriate. A National Research Council committee issued recommendations, based largely on the Standards, to ensure that the redesigned tests would be scientifically and politically defensible; however, USCIS chose not to follow much of the committee's advice. This article summarizes some lessons for the measurement community and possible strategies for getting policymakers to pay more attention to the Standards.

Renewal of Mural Thrombus Releases Plasma Markers and Is Involved in Aortic Abdominal Aneurysm Evolution

Human abdominal aortic aneurysm (AAA) expansion has been linked to the presence of a mural thrombus. Here we explored the mechanism of the continual luminal renewal of this thrombus and its ability to release biological markers potentially detectable in plasma. We also explored the ability of platelet inhibition to pacify the thrombus and to limit aneurysm progression in an experimental model. Blood samples and mural thrombi were collected in 20 AAA patients. In parallel, segments of sodium dodecyl sulfate-decellularized guinea pig aorta were xenografted onto the abdominal aorta of 30 rats to induce aneurysms. Fifteen rats received abciximab treatment and fifteen received irrelevant immunoglobulins. Procoagulant activity and platelet activation markers (microparticles, sP-selectin, sGPV, sCD40L) were increased threefold to fivefold in eluates from the luminal thrombus layer compared to other layers. All these markers were increased twofold to fivefold in patients' plasma compared to matched controls (P < 0.005). In the rat model, abciximab reduced both thrombus area and aneurysmal enlargement (P < 0.05). Platelet aggregation is probably responsible for the renewal of the thrombus in AAA. The luminal thrombus released markers of platelet activation that could easily be detected in plasma. Platelet inhibition limited aortic aneurysm expansion in a rat model, providing new therapeutic perspectives in the prevention of AAA enlargement.

Review of Contributions to the International Co-operation on Nuclear Data for Radiation Shielding

Contributions to the international co-operation initiatives relevant to nuclear data for radiation shielding are reviewed, with reference to the activities in the field at ENEA in the past years and recently and to the related results, following the requests in the context of fission and fusion reactor studies and projects and of accelerator applications, in particular for research and advanced radiotherapy purposes. In particular, the relationships are pointed out with the NEA initiatives, according to the Nuclear Science Committee advice, concerning the relevant microscopic nuclear data and their validation with respect to integral benchmark experiments, and the co-operation activities on shielding aspects of the accelerators.

Institutional Ethics Committees and the Shield of Immunity

Institutional ethics committees have been hailed as a good resource for physicians confronting complex ethical issues in patient care. Physicians may seek ethics committee consultations to receive impartial assistance in decision making, to resolve conflicts, and to avoid cumbersome court procedures and unwieldy litigation. The endorsement of ethics committees by the President's Commission, the American Hospital Association, the American Medical Association, and the Department of Health and Human Services, along with recent state legislation governing committees in Maryland, New Jersey, and Hawaii, raises questions about the proper scope and authority of ethics committees. We examined the accountability of institutional ethics committees and argue against immunity-conferring statutes that shield physicians who follow a committee's advice from civil and criminal liability.

Divisive Dispute Smolders over Definition of Scientific Misconduct

Until recently, the Public Health Service (PHS) faced few obstacles to its plan to narrow its definition of what constitutes scientific misconduct. But now a committee of the House of Representatives has made it clear it will not accept a major change PHS plans to propose. And the National Science Foundation's (NSF) refusal to limit its misconduct definition has revealed a wide gap between the two federal agencies responsible for most basic academic research. Last year, PHS's Advisory Committee on Research Integrity recommended dropping from the definition the controversial phrase practices that seriously deviate from those that are commonly accepted within the scientific community, among other changes. committee's advice reflects fears that the inexplicit wording invites persecution of unconventional researchers. phrase was also unanimously rejected by the National Academy of Sciences' (NAS) panel on scientific responsibility and the conduct of research. The panel wishes to discourage th...

Results of tuberculosis contact tracing: Blackburn 1982–1990

Between 1982 and 1990, 649 index cases of tuberculosis were seen of which 429 (66·1%) were of Indian Subcontinent (ISC) ethnic origin: 7017 close contacts of these cases were screened, 50 cases of tuberculosis were detected (7·7% of notifications) and 372 children given chemoprophylaxis. All cases of tuberculosis detected in the white ethnic group were contacts of smear-positive pulmonary disease, six (46%) found at initial screening, five (38%) at 1 year and one (8%) at 2 year follow-up. Of 37 cases detected in the ISC ethnic group, only 14 (38%) were contacts of smear-positive disease, 17 (46%) being contacts of other respiratory disease, and six (16%) contacts of non-respiratory disease. Eighteen (49%) of ISC cases detected were at initial screening, with six (16%), eight (22%) and three (8%), respectively, at 6 month, 1 year and 2 year follow-up. The results support the revised Joint Tuberculosis Committee advice on contact tracing, with differential contact programmes depending on type of disease and ethnic group of index cases.

Ethics Committees: Decisions by Bureaucracy

In Siegler's opinion, institutional ethics committees (IECs) threaten to undermine the physician patient relationship by removing or attenuating the physician's decision making authority. Though a majority of committees do not view themselves as final decision makers but as advisors or consensus developers, a physician who goes against committee advice is bucking considerable social pressure. Ethics committees should not consult on cases or even review decisions already made, but should develop and coordinate staff training programs to educate personnel to make decisions in their own areas of expertise. In place of IECs, there should be small advisory groups in particular specialty areas such as burn units, medical oncology services, neurosurgical or neonatal units, emergency rooms, or transplantation services.

Scientific Films in War-Time

THE London Scientific Film Society gave four shows last winter of scientific and documentary films and received encouraging support. A new form of programme was generally appreciated. Several films with a common subject or theme were shown together; programmes on contrasting or complementary treatments of psychology, civics in Great Britain, and agriculture being presented. All films shown by the Society are approved by the Scientific Films Committee of the Association of Scientific Workers, 30 Bedford Row, London, W.C.I. This body was set up in 1937 to further the interests of the scientific documentary film, to encourage the making and to sponsor the exhibition of such films. The films are broadly of three kinds: interpretative films, which bring out the relations of science to society and which try to smooth out the difficulties arising from developments and changes in science and social life; educational films, aiming simply to instruct; and research films, serving as a scientific instrument in the hands of the research worker. The Scientific Films Committee grades films into classes in this way, and also appraises their scientific value. The Committee's lists can be obtained on application; universities, schools and scientific societies can use them to help in making up programmes of scientific films. The work of appraising films will go on through the summer. In addition, the Committee's advice is available to producers, and recommendations for new films are to be made; certain subjects, such as chemistry, are very inadequately covered. The Committee wants the opinions of teachers and heads of scientific departments on what is needed, and the special requirements of war-time will be borne in mind.

Chemical Patents Committee

A CHEMICAL PATENTS COMMITTEE of the Department of Scientific and Industrial Research has been appointed to advise on the patenting and exploitation of results of the Department's chemical researches that may have industrial possibilities. The Committee is the result of negotiations that have been taking place for some time between the Department and various industrial organisations with the object of promoting closer co-operation and of avoiding unnecessary overlapping. It is hoped that one result of the Committee's advice will be that research results may be brought to the notice of industry and translated into practice at an earlier stage than hitherto, and under conditions that will take existing industrial activities into account. Sir Frank Smith, secretary of the Department of Scientific and Industrial Research, will act as chairman, and in addition to departmental members, the Committee will include: Mr. F. H. Carr and Mr. J. Davidson Pratt, representing the Association of British Chemical Manufacturers, and Mr. J. Arthur Reavell, representing the British Chemical Plant Manufacturers Association.