Developing evidence-based immunization recommendations and GRADE

The Strategic Group of Advisory Experts (SAGE) on immunization is an independent advisory committee with a mandate to advise the World Health Organization (WHO) on the development of vaccine and immunization related policies. SAGE working groups are established on a time-limited basis to review and provide evidence-based recommendations, together with their implications, for open deliberation and decision-making by SAGE. In making its recommendations, SAGE takes into consideration: the epidemiologic and clinical characteristics of the disease; vaccine and immunization characteristics; economic analysis; health system considerations; the existence of and interaction with other intervention and control strategies; costing and social impacts; and legal and ethical concerns. Since 1998, WHO has produced evidence-based vaccine position papers for use primarily by national public health officials and immunization programme managers. Since April 2006 all new or updated position papers have been based on SAGE recommendations. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach has been adopted by WHO and, since 2008, GRADE tables that rate the quality of evidence have been produced in support of key recommendations. SAGE previously expressed concern that GRADE was not ideally suited to many immunization-specific issues such as the vaccine population level effect and the inclusion of surveillance system data, particularly for vaccine safety. Extensive productive interactions with various advisory groups including the US Advisory Committee on Immunization Practices, the European Centres for Disease Control, the German Standing Committee on Vaccination (STIKO), WHO's Global Advisory Committee on Vaccine Safety and the GRADE working group resulted in key enhancements to accommodate vaccine-relevant evidence. This facilitated integration and acceptability of the GRADE approach in the development of immunization related SAGE and WHO recommendations. Ongoing utilisation should result in further fine-tuning of the approach to ensure that recommendations are based on the full range of appropriate evidence.     

Core services and priority-setting: the New Zealand experience

Like people in other countries, New Zealanders have been struggling with the issue of how to decide which health services should be delivered and to whom. The government has established a Core Services Committee to advise on core services, that is, those health care and disability support services to be made available on affordable terms and without unreasonable waiting time. Such a core has a similar role to a standard package of benefits within a managed competition framework. Services not in the core would be left to individuals' own responsibility. Specific objectives for a core are to promote accountability of purchasers, to make explicit the services that are core and those that are not, to promote an efficient and equitable allocation of resources, to limit government expenditure on health care and to involve the public in decision-making. A number of different options for defining a core are identified, and the work undertaken so far is discussed. The original concept of a core has not been implemented in New Zealand. The Core Services Committee has established broad priorities and facilitated a series of consensus development conferences to provide advice on the effectiveness of services. Some of the committee's recommendations have been incorporated into policy guidelines, which set out what the government expects of purchasers. These guidelines include priority areas for health gains, service obligations and principles for purchasing. Service obligations are not sufficiently detailed to meet the specific objectives of a core and do not meet equity objectives, as they allow in effect each of the four purchasers to develop their own core of services. The key issue for the government now is to decide whether to allow RHAs flexibility in determining their own priorities or whether a national approach to efficiency and equity is to be preferred.     

Canada's National Advisory Committee on Immunization (NACI): Evidence-based decision-making on vaccines and immunization

The National Advisory Committee on Immunization (NACI) provides medical, scientific, and public health advice on the use of vaccines in Canada. This article describes the structure and processes of NACI, as well as its approach to evidence-based decision-making. In a rapidly evolving and complex immunization environment, NACI has faced challenges in its endeavour to make thorough and timely evidence-based recommendations. Making population-level recommendations without formally considering the full spectrum of public health science (e.g. cost-effectiveness) presents difficulties in the implementation of NACI's recommendations. Although an improved and more transparent evidence-based NACI decision-making process is now in place, this is continuing to evolve with a current review of structures and processes underway to further improve effectiveness and efficiencies.     

How should cost-effectiveness analysis be used in health technology coverage decisions? Evidence from the National Institute for Health and Clinical Excellence approach

BACKGROUND: In the National Health Service in England and Wales, technology coverage decisions are taken by the National Institute for Health and Clinical Excellence (NICE). The intention formally to apply cost-effectiveness analysis to the decision-making process distinguishes NICE from most other bodies making similar policy recommendations. We carried out a case study of the NICE Appraisals Committee to explore the influence and use of economic evaluation in the decision-making process. METHODS: Qualitative case study methodology. This involved analysis of all relevant secondary sources, observations of Appraisals Committee deliberations and interviews with a cross-section of Committee members. FINDINGS: Economic evaluation is integrated into the Committee's work. There are two main ways in which the use of economic analysis is understood by Committee members: an ordinal approach, whereby cost-effectiveness is only considered if the technology has passed a clinical effectiveness hurdle; and a framework approach, whereby the economic evaluation and model provide a structure for considering the decision problem and the evidence. These two approaches appear to operate simultaneously but are, in essence, inconsistent. CONCLUSIONS: The NICE 'experiment' has seen cost-effectiveness analysis move to the centre-ground of UK national policy deliberations regarding technology coverage. However, our case study implies that there may be room for further refinement of the appraisal process in order to resolve the observed tension between two different ways of incorporating cost-effectiveness analysis in NICE's decision-making.     

Governments Need Better Guidance to Maximise Value for Money: The Case of Australia’s Pharmaceutical Benefits Advisory Committee

In Australia, the Pharmaceutical Benefits Advisory Committee (PBAC) makes recommendations to the Minister for Health on which pharmaceuticals should be subsidised. Given the implications of PBAC recommendations for government finances and population health, PBAC is required to provide advice primarily on the basis of value for money. The aim of this article is twofold: to describe some major limitations of the current PBAC decision-making process in relation to its implicit aim of maximising value for money; and to suggest what might be done toward overcoming these limitations. This should also offer lessons for the many decision-making bodies around the world that are similar to PBAC. The current PBAC decision-making process is limited in two important respects. First, it features the use of an implicit incremental cost-effectiveness ratio (ICER) threshold that may not reflect the opportunity cost of funding a new technology, with unknown and possibly negative consequences for population health. Second, the process does not feature a means of systematically assessing how a technology may be of greater or lesser value in light of factors that are not captured by standard measures of cost effectiveness, but which are nonetheless important, particularly to the Australian community. Overcoming these limitations would mean that PBAC could be more confident of maximising value for money when making funding decisions.     

Immunization of health-care personnel: recommendations of the Advisory Committee on Immunization Practices (ACIP)

This report updates the previously published summary of recommendations for vaccinating health-care personnel (HCP) in the United States (CDC. Immunization of health-care workers: recommendations of the Advisory Committee on Immunization Practices [ACIP] and the Hospital Infection Control Practices Advisory Committee [HICPAC]. MMWR 1997;46[No. RR-18]). This report was reviewed by and includes input from the Healthcare (formerly Hospital) Infection Control Practices Advisory Committee. These updated recommendations can assist hospital administrators, infection-control practitioners, employee health clinicians, and HCP in optimizing infection prevention and control programs. The recommendations for vaccinating HCP are presented by disease in two categories: 1) those diseases for which vaccination or documentation of immunity is recommended because of risks to HCP in their work settings for acquiring disease or transmitting to patients and 2) those for which vaccination might be indicated in certain circumstances. Background information for each vaccine-preventable disease and specific recommendations for use of each vaccine are presented. Certain infection-control measures that relate to vaccination also are included in this report. In addition, ACIP recommendations for the remaining vaccines that are recommended for certain or all adults are summarized, as are considerations for catch-up and travel vaccinations and for work restrictions. This report summarizes all current ACIP recommendations for vaccination of HCP and does not contain any new recommendations or policies. The recommendations provided in this report apply, but are not limited, to HCP in acute-care hospitals; long-term-care facilities (e.g., nursing homes and skilled nursing facilities); physician's offices; rehabilitation centers; urgent care centers, and outpatient clinics as well as to persons who provide home health care and emergency medical services.     

Final recommendations for a voluntary national accreditation program for state and local health departments: steering committee report.

A recently released report of the Exploring Accreditation Project affirmatively answered the questions regarding the desirability and feasibility of establishing a national voluntary public health accreditation program. The report's recommendations were made after 10 months of inquiry from public health experts, elected officials, the general public health workforce, academicians, and other interested parties, more than 650 public health professionals in all. Recommendations regarding how such a program might be implemented insofar as its governance, principles for standards development, financing and incentives, and evaluation were included. The report provides a blueprint for establishing a national voluntary public health accreditation program. This article describes key aspects of the Steering Committee recommendations, with limited linkage to implementation strategies where relevant, in the four areas in which the project was designed. Details are provided in the final reports of the Steering Committee (www.exploringaccreditation.org) and in other articles in this issue.     

Proposals for the reform of public health services in Catalonia

In the year 2004 the government of Catalonia undertook a process to reform its public health services. In this context, it created a working groupinvolving experts from diverse backgrounds to analyse the reforms to be undertaken, the Scientific Committee for the Reform of Public Health in Catalonia. Its members produced eight documents on specific aspects of public health, from which a global report of the Committee was compiled by the end of 2005. This paper makes a synthesis of their production, and includes as an annex their recommendations and proposals. Public health policies should be structured around three main goal: the reduction of health inequalities, the control and removal of social and environmental risks, and effective improvements in quality of life. To reach them, common criteria are defined as main directions. These are based in favouring decentralization of public health services and their administration, linking public health activities with health care services, designing interventions with a population perspective, and reinforcing cross-sectional implications of public health. The work of this Committee is produced in the context of an international debate on the future of public health services and the disproportion between its contribution to health and well being and its resources and visibility. The Committee produced proposals and recommendations which can he grouped in five facets: consolidating a solid and coherent system, developing an organizational reform, defining a port-folio of services, adopting improvements in management, and taking into account cross sectional aspects relating to public health.     

The current status of decision-making procedures and quality assurance in Europe: an overview

The 2005 Report on Social Responsibility and Health of the UNESCO International Bioethics Committee (Ibc) proposes a new approach to implementing the right to healthcare and suggests a number of Courses of Action to be followed in various fields. Based on the latest available data, we intend to present an overview of the current state of European health systems in two of those fields—decision-making procedures and quality assurance in health care—and to attempt a comparison of the situation with the Report’s provisions, in order to pave the way for the identification of what still has to be done to bridge international recommendations and the reality of policy and practice in Europe’s health care.     

德国卫生技术评估决策转化路径及方法探析

德国与我国有着相似医疗保障体系背景,并且已经形成以国家层面三大卫生技术评估(Health Technology Assessment,HTA)机构为主的严谨的HTA管理流程和高效的决策转化路径,是全球基于HTA进行卫生领域循证决策的典型代表。本文通过文献研究和实地调研,分析梳理了德国HTA应用及其决策转化的路径和方法,最终结合我国现阶段HTA决策转化面临的问题和挑战,有针对性地提出了几条促进我国HTA决策转化的启示性建议。     

Impact of CEDIT recommendations: An example of health technology assessment in a hospital network

OBJECTIVES: The objective of this study is to assess the impact of CEDIT (French Committee for the Assessment and Dissemination of Technological Innovations) recommendations on the introduction of technological innovations within the AP-HP (Assistance Publique-H?pitaux de Paris), the French hospital network to which this body is attached. METHODS: In 2002, a study based on semidirective interviews of fourteen people affected by these recommendations and a case study relating to thirteen recommendations issued between 1995 and 1998 were conducted. RESULTS: The CEDIT is very scientifically reputable among interviewees. There is generally widespread interest for the recommendations. They are used as decision-making tools by administrative staff and as negotiating instruments by doctors in their dealings with management. Based on the case study, ten of thirteen recommendations had an impact on the introduction of the technology in health establishments. One recommendation appears not to have had an impact. Furthermore, the impact of two technologies was impossible to assess. CONCLUSIONS: This study highlights the significant impact of recommendations arising from a structure that is attached to a hospital network and the good match between CEDIT's objectives and its assignments.     

Basics of Bavarian health assessment reporting

Management information systems which support a demand-oriented, integrative and comprehensive decision-making in health care policy are of pre-eminent importance for the health care system. Present health care legislation in Bavaria underlines the importance of health reporting as a tool for periodical assessment of the situation and starting-point for decision-making in health care. Demands made on the Bavarian health report stem from both European and national levels and also from the regional structure within the state. It is intended that the health reporting should reach the local level. Single reports cannot cover all relevant aspects. Therefore, health reporting in Bavaria has a modular structure. There is a need for integrated, flexibly useful information. Following an evidence-based approach, health information may be subject to critical assessment. This approach enables decision makers to assess the grade of certainty of recommendations. Health reporting in Bavaria aims at following the people through time. The intelligent use of new media will have to play a key role.     

Representing uncertainty: the role of cost-effectiveness acceptability curves.

Decision-making in health care is inevitably undertaken in a context of uncertainty concerning the effectiveness and costs of health care interventions and programmes. One method that has been suggested to represent this uncertainty is the cost-effectiveness acceptability curve. This technique, which directly addresses the decision-making problem, has advantages over confidence interval estimation for incremental cost-effectiveness ratios. However, despite these advantages, cost-effectiveness acceptability curves have yet to be widely adopted within the field of economic evaluation of health care technologies. In this paper we consider the relationship between cost-effectiveness acceptability curves and decision-making in health care, suggest the introduction of a new concept more relevant to decision-making, that of the cost-effectiveness frontier, and clarify the use of these techniques when considering decisions involving multiple interventions. We hope that as a result we can encourage the greater use of these techniques.     

Methods for developing evidence-based recommendations by the Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention (CDC)

The Advisory Committee on Immunization Practices (ACIP) provides expert external advice and guidance to the Director of the Centers for Disease Control and Prevention and the Secretary of the U.S. Department of Health and Human Services on use of vaccines and related agents for control of vaccine-preventable disease in the United States. During the October 2010 ACIP meeting, the ACIP voted to adopt a new framework for developing evidence-based recommendations that is based on the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. Key factors considered in the development of recommendations include the balance of benefits and harms, type of evidence, values and preferences of the people affected, and health economic analyses. Category A recommendations will be made for all persons in an age- or risk-factor-based group. Category B recommendations will be made for individual clinical decision making; category B recommendations do not apply to all members of an age- or risk-factor-based group, but in the context of a clinician-patient interaction, vaccination may be found to be appropriate for a person. Evidence tables will be used to summarize the benefits and harms and the strengths and limitations of the body of evidence. The new evidence framework will enhance the ACIP's decision-making process by making it more transparent, consistent and systematic.     

Health disparities and health equity: the issue is justice

Eliminating health disparities is a Healthy People goal. Given the diverse and sometimes broad definitions of health disparities commonly used, a subcommittee convened by the Secretary's Advisory Committee for Healthy People 2020 proposed an operational definition for use in developing objectives and targets, determining resource allocation priorities, and assessing progress. Based on that subcommittee's work, we propose that health disparities are systematic, plausibly avoidable health differences adversely affecting socially disadvantaged groups; they may reflect social disadvantage, but causality need not be established. This definition, grounded in ethical and human rights principles, focuses on the subset of health differences reflecting social injustice, distinguishing health disparities from other health differences also warranting concerted attention, and from health differences in general. We explain the definition, its underlying concepts, the challenges it addresses, and the rationale for applying it to United States public health policy.     

Reducing pain at the time of vaccination: WHO position paper,September 2015—Recommendations

This article presents the World Health Organization's (WHO) recommendations for pain mitigation at the time of vaccination from the WHO position paper on reducing pain at the time of vaccination: WHO position paper—September 2015, recently published in the Weekly Epidemiological Record [1]. This position paper summarizes the evidence and integrates information pertaining to the reduction of pain, distress and fear during immunization across all age groups.In accordance with its mandate to provide guidance to Member States on health policy matters, WHO issues a series of regularly updated position papers on vaccines and combinations of vaccines against diseases that have an international public health impact, and on vaccination-related policy questions particularly concerning the use of vaccines in large-scale immunization programmes. They summarize essential background information and conclude with the current WHO position. This position paper addresses a cross-cutting issue which is relevant for all injectable vaccines and reflects the recommendations of WHO's Strategic Advisory Group of Experts (SAGE) on immunization. These recommendations were discussed by SAGE at its April 2015 meeting. The evidence presented at the meetings can be accessed at http://www.who.int/immunization/sage/previous/en/index.html.     

The National Committee for Vaccines Regulation and Surveillance of Vaccine-Preventable Diseases in the Sultanate of Oman: Evidence-based approach and consensus decision-making

The National Committee for Vaccines Regulation and Surveillance of Vaccine-Preventable Diseases serves as the National Immunization Technical Advisory Group (NITAG) in the Sultanate of Oman. It is the only advisory body to assist the Government in establishing policies and strategies and in evaluating new vaccines with respect to technology, quality and safety. It has six to eight core members as well ex officio members. Committee members are appointed for a period of 3 years by the Minister of Health and committee members declare their potential conflicts of interests and sign a confidentiality agreement. The cost of vaccines and the overall immunization program are considered when the committee makes its recommendations. Evidence-based decision-making could be facilitated by introducing more economic expertise to the committee.     

The evolution of physical activity recommendations: how much is enough?

Physical inactivity is a major public health problem, and compelling evidence suggests that it is a contributing factor in several chronic diseases and conditions. Recognition of the health and functional hazards of a sedentary way of life has led numerous groups to promulgate public health recommendations for physical activity. In this report, we review the evolution of physical activity recommendations, discuss reasons for differences in the recommendations, and provide a summary recommendation in an attempt to harmonize existing differences. Current public health recommendations for physical activity are for 30 min of moderate-intensity activity each day, which provides substantial benefits across a broad range of health outcomes for sedentary adults. This dose of exercise may be insufficient to prevent unhealthful weight gain for some persons who may need additional exercise or caloric restriction to minimize the likelihood of further weight gain. Persons who get 30 min of moderate-intensity exercise per day are likely to achieve additional health benefits if they exercise more. In addition to aerobic exercise, people should engage in resistance training and flexibility exercises at least twice a week, which will promote the maintenance of lean body mass, improvements in muscular strength and endurance, and preservation of function, all of which enable long-term participation in regular physical activity and promote quality of life.     

Guidelines for malaria prevention in travellers from the United Kingdom for 2001

These guidelines on malaria prevention are designed to aid health care workers who advise travellers, particularly those who will be overseas for less than a year. The present, and any future, revisions are the responsibility of the Advisory Committee on Malaria Prevention in UK travellers (ACMP; membership given at the end of the Guidelines). This has replaced the consensus meetings which produced earlier versions from 1980 to the the 1997 version. The guidelines are in three parts. The first part is a summary that emphasises modifications to the advice given in the last set of guidelines, published in 1997. The second part discusses the issues addressed in formulating the guidelines. Oversimplified lists of recommendations by country can be misleading. The second part also addresses the health care worker's consultation with prospective travellers. Doctors, practice nurses and pharmacists are asked to read this section to ensure that due attention is paid to the traveller's history and destination. The third part gives specific recommendations for travellers to specific destinations and some details of individual drugs. Fuller information on some drugs now less used was given in earlier versions of the guidelines. These guidelines reflect experienced professional opinion. Data are inadequate for unequivocal views to be given on several issues, but all available evidence has been taken into consideration. There is often a range of acceptable options, but to meet the requests of general practitioners the guidelines aim to give one recommended option and state the alternatives, suggesting when and how different regimens can be used to good effect. However, there are now several options for effective prophylaxis of highly chloroquine-resistant falciparum malaria, and the choice between them will depend on details of the journey and individual preferences. Decisions on the terms under which different drugs are licensed for use are the responsibility of the Licensing Authority, advised by the Committee on Safety of Medicines and not of the ACMP. The guidelines should therefore be read as a supplement to and not as a substitute for the relevant data sheets. In concept and practice, chemoprophylaxis lies somewhere between vaccinations (for which people expect governments to lay down schedules) and treatment of ill people (which is determined by individual clinical need and choice). The risks of malaria need to be balanced against the risks of the preventive measures, on the basis of the data available. Travellers may ask for an explanation of these risks and doctors and practice nurses need to be well informed and able to present this information to travellers. The second part of these guidelines may also be of use to prospective travellers who wish to read about the options themselves. All readers are recommended to read part two in its entirety to get a balanced picture.