Diane-Michel.com

  Source:  Weill Cornell Medical College

Promises Broad Clinical Benefits, From Bone Marrow Transplantation to Therapies for Heart, Brain, Skin and Lungs

NEW YORK (March 4, 2010) — In a leap toward making stem cell therapy widely available, researchers at the Ansary Stem Cell Institute at Weill Cornell Medical College have discovered that endothelial cells, the most basic building blocks of the vascular system, produce growth factors that can grow copious amounts of adult stem cells and their progeny over the course of weeks. Until now, adult stem cell cultures would die within four or five days despite best efforts to grow them.

“This is groundbreaking research with potential application for regeneration of organs and inhibition of cancer cell growth,” said Dr. Antonio M. Gotto Jr., the Stephen and Suzanne Weiss Dean of Weill Cornell Medical College and Provost for Medical Affairs of Cornell University. “We are indebted to Shahla and Hushang Ansary for founding this Institute and to the Starr Foundation Tri-Institutional Stem Cell Initiative for ongoing support.”

This new finding sets forth the innovative concept that blood vessels are not just passive conduits for delivery of oxygen and nutrients, but are also programmed to maintain and proliferate stem cells and their mature forms in adult organs. Using a novel approach to harness the potential of endothelial cells by “co-culturing” them with stem cells, the researchers discovered the means to manufacture an unlimited supply of blood-related stem cells that may eventually ensure that anyone who needs a bone marrow transplant can get one.

The vascular-cell model established in this study could also be used to grow abundant functional stem cells from other organs such as the brain, heart, skin and lungs. An article detailing these findings appears in the March 5 issue of the journal Cell Stem Cell.

In adult organs, there are few naturally occurring stem cells, so using them for organ regeneration is impractical. Until now, strategies to expand cultures of adult stem cells, which invariably used animal-based growth factors, serum, and genetically manipulated feeder cells, have only been marginally successful. This study, which employs endothelial cells to propagate stem cells without added growth factors and serum, will likely revolutionize the use of adult stem cells for organ regeneration, as well as decipher the complex physiology of the adult stem cells.

“This study will have a major impact on the treatment of any blood-related disorder that requires a stem cell transplant,” says the study’s senior author, Dr. Shahin Rafii, the Arthur B. Belfer Professor in Genetic Medicine, co-director of the Ansary Stem Cell Institute and a Howard Hughes Medical Institute Investigator, at Weill Cornell Medical College. Currently, stem cells derived from bone marrow or umbilical cord blood are used to treat patients who require bone marrow transplants. Most stem cell transplants are successful, but because of the shortage of genetically matched bone marrow and umbilical cord blood cells, many patients cannot benefit from the procedure.

“Over the last few decades, substantial funding has been spent to develop platforms to expand adult stem cell cultures, but these efforts have never been able to coax an authentic adult stem cell to self-renew beyond a few days,” continues Dr. Rafii. “Most stem cells, even in the presence of multiple growth factors, serum, and support from generic non-endothelial stromal cells, die after a few days. Now, employing our endothelial stem cell co-cultures, we can propagate bona fide adult stem cells in the absence of external factors and serum beyond 21 days with an expansion index of more than 400-fold.”

If this vascular-based stem cell expansion strategy continues to be validated, physicians could use any source of hematopoietic (blood-producing) stem cells, propagate them exponentially, and bank the cells for transplantation into patients.

In a true first, the study demonstrates how this novel vascular cell platform or “vascular niche” can self-renew adult hematopoietic stem cells for weeks, both in vitro and in vivo, by co-culturing them on a bed of endothelial cells. The researchers chose endothelial cells because they are in close contact with blood stem cells, and previous work from Dr. Rafii’s lab had demonstrated that endothelial cells produce novel stem-cell-active growth factors. However, maintenance of the endothelial cells is cumbersome and if they are not “fed” specific substances, such as growth factors known as “angiogenic factors,” they immediately die. To get around this problem, the researchers genetically engineered the endothelial cells to stay in a long-term survival state by inserting a recently discovered gene cloned from adenoviruses, which does not promote oncogenic transformation of the human cells. This earlier discovery, using a single gene to put endothelial cells into a long-lasting “suspended animation” state without harming their ability to produce blood vessels, was also discovered in Dr. Rafii’s lab and published in the journal Proceedings of National Academy Sciences in 2008.

Endothelial Cells Could Generate Stem Cells and Their Differentiated Progeny

In this study, the researchers also discovered that endothelial cells not only could expand stem cells, but also instruct stem cells to generate mature differentiated progeny that could form immune cells, platelets, and red and white blood cells, all of which constitute functioning blood.

“We are the first group to demonstrate that endothelial cells elaborate a repertoire of stem-cell-active growth factors that not only stimulate stem cell expansion but also orchestrate differentiation of these stem cells into their mature progeny,” says Dr. Jason Butler, a senior investigator at Weill Cornell Medical College and first author of the study. “For example, we have found that expression of specific stem-cell-active factors, namely Notch-ligands, by the endothelial cells lining the wall of working blood vessels promote proliferation of the blood-forming stem cells. Inhibition of these specific factors on the endothelial cells resulted in the failure of the regeneration of the blood-forming stem cells. These findings suggest that endothelial cells directly, through expression of stem-cell-active cytokines, promote stem cell reconstitution.”

Further describing this innovative concept, in a high-impact article published in the January 2010 issue of Nature Reviews Cancer, Drs. Rafii and Butler, and Dr. Hideki Kobayashi, who is also a co-author of the current study, have elaborated on specific endothelial cell-produced growth factors that promote the growth of tumor cells besides stem cells.

Development of the vascular-cell technology that supports long-lasting growth of stem cells will also allow scientists to generate abundant sources of functional and malignant stem cells for genetic and basic studies. This study has also resolved a long-standing controversy in which several groups had claimed that bone-forming cells (osteoblasts) exclusively support the expansion of blood-forming stem cells. “However, using a highly sophisticated molecular imaging approach, we show that regenerating blood-forming stem cells in the bone marrow are in intimate contact with the blood vessels, indicating that endothelial cells are the predominant regulator of stem cell repopulation in the adult bone marrow,” states Dr. Daniel Nolan, a senior scientist in Dr. Rafii’s lab and a co-author of the new study.

One other important concern addressed in this study was whether forced expansion of the stem cells over a long period of time would induce cancerous mutations in the stem cells. However, the authors of this study show that, even after one year, there was no indication of tumor formation, such as leukemias, when the expanded stem cells were transplanted back into mice. This suggests that the endothelial cells provide a milieu that proliferates stem cells without creating cancer risk.

The current breakthrough represents the culmination of many years of work by Dr. Rafii and his lab, including their research in converting adult mouse spermatogonial stem cells to endothelial cells (Nature, September 2007) and in deriving stable, copious endothelial cells from human embryonic stem cells (Nature Biotechnology, Jan. 17, 2010).

The ability to generate many stable endothelial cells from human embryonic stem cells leads to new research opportunities, according to Dr. Zev Rosenwaks, who is a co-author in this study and director and physician-in-chief of the Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine, as well as the director of the Tri-Institutional Stem Cell Initiative Derivation Unit at Weill Cornell Medical College.

Dr. Rosenwaks says, “Generation of endothelial cells derived from diseased embryonic stem cells that are being propagated in our Derivation Unit will open up new avenues of research to molecularly eavesdrop on the communication between vascular cells and stem cells. This innovative line of investigation — to determine how normal and abnormal human vascular cells induce the formation of organs during development of embryos and how dysfunction of endothelial cells results in developmental defects — will lay the foundation for novel platforms for therapeutic organ regeneration.”

Dr. Rafii sees even more opportunities. “Identification of as yet unrecognized growth factors produced by human embryonic cell-derived endothelium and adult endothelial cells that support stem cell expansion and differentiation will establish a new arena in stem cell biology. We will be able to selectively activate endothelial cells not only to induce organ regeneration, but also to inhibit specifically the production of endothelial cell-derived factors in order to block the growth of tumors. Our findings are the first steps toward such goals and they highlight the potential of vascular cells for generating sufficient stem cells for therapeutic organ regeneration, tumor targeting, and gene therapy applications,” concludes Dr. Rafii.

Co-authors include Daniel J. Nolan, Eva L. Vertes, Hideki Kobayashi, Andrea T. Hooper, Koji Shido, Ian A. White, Mariko Kobayashi, Yuki Kimura and Marco Seandel of the Howard Hughes Medical Institute and the Department of Genetic Medicine and Ansary Stem Cell Institute at NewYork-Presbyterian Hospital/Weill Cornell Medical Center; Zev Rosenwaks, Chad May and Larry Witte of NewYork-Presbyterian Hospital/Weill Cornell Medical Center; Carrie Shawber and Jan Kitajewski at NewYork-Presbyterian Hospital/Columbia University Medical Center; Barbara Varnum-Finney of ImClone Systems Incorporated; and Irwin D. Bernstein at Fred Hutchinson Cancer Research Center, Seattle. The study received funding from the Howard Hughes Medical Institute.

Ansary Stem Cell Institute

The Ansary Stem Cell Institute, established at Weill Cornell Medical College in 2004 through the generous donation of Shahla and Hushang Ansary, brings together a premier team of scientists to focus on stem cells — the primitive, unspecialized cells with an unrivaled capacity to form all types of cells, tissues and organs in the body. The vision of the Ansary Institute is to help lead the way in 21st-century medicine by employing this new field of research with tremendous potential to relieve human suffering. The Institute permits the multidisciplinary collaboration and creativity of Weill Cornell’s researchers, as well as helps to attract the best and brightest young researchers in the field. Scientists at the Institute hope to discover the wellspring of adult stem cells in the body and ways to manipulate them to treat human illness. In particular, they hope to understand the regulation of cells that give rise to such essential components as blood vessels, insulin-producing cells in the pancreas (which are damaged in diabetics), and neurons of the brain and nervous system.

Weill Cornell Medical College

Weill Cornell Medical College, Cornell University’s medical school, located in New York City, is committed to excellence in research, teaching, patient care and the advancement of the art and science of medicine, locally, nationally and globally. Physicians and scientists of Weill Cornell Medical College are engaged in cutting-edge research from bench to bedside, aimed at unlocking mysteries of the human body in health and sickness and toward developing new treatments and prevention strategies. In its commitment to global health and education, Weill Cornell has a strong presence in places such as Qatar, Tanzania, Haiti, Brazil, Austria and Turkey. Through the historic Weill Cornell Medical College in Qatar, the Medical College is the first in the U.S. to offer its M.D. degree overseas. Weill Cornell is the birthplace of many medical advances — including the development of the Pap test for cervical cancer, the synthesis of penicillin, the first successful embryo-biopsy pregnancy and birth in the U.S., the first clinical trial of gene therapy for Parkinson’s disease, and most recently, the world’s first successful use of deep brain stimulation to treat a minimally conscious brain-injured patient. Weill Cornell Medical College is affiliated with NewYork-Presbyterian Hospital, where its faculty provides comprehensive patient care at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. The Medical College is also affiliated with the Methodist Hospital in Houston, making Weill Cornell one of only two medical colleges in the country affiliated with two U.S.News & World Report Honor Roll hospitals. For more information, visit www.med.cornell.edu.

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Source:  Washington Post 

President Obama on Saturday repeated his call for Congress to give an “up-or-down vote” on his plan to revamp the nation’s health-care system, saying that doing so would yield immediate benefits for the uninsured and small businesses, while prohibiting the most unpopular actions of health insurance companies.

Source:  WhiteHouse.gov
February 23, 2010 

The following proposal President Barack Obama will bring to his Thursday health ’summit’ with Congressional leaders contains many of the ideas from the bills already passed by the Democratic House and Senate, including a mandate that individuals buy insurance and a promise to ‘end discrimination’ from pre-existing conditions.”

Over the past year the House and the Senate have been working on an effort to provide health insurance reform that lowers costs, guarantees choices, and enhances quality health care for all Americans. Building on that year-long effort, the President has now put forth a proposal that incorporates the work the House and the Senate have done and adds additional ideas from Republican members of Congress. The President has long said he is open to any good ideas for reforming our health care system, and he looks forward to discussing ideas for further improvements from Republicans and Democrats at an open, bipartisan meeting on Thursday.  

The proposal will make health care more affordable, make health insurers more accountable, expand health coverage to all Americans, and make the health system sustainable, stabilizing family budgets, the Federal budget, and the economy: 

• It makes insurance more affordable by providing the largest middle class tax cut for health care in history, reducing premium costs for tens of millions of families and small business owners who are priced out of coverage today.  This helps over 31 million Americans afford health care who do not get it today – and makes coverage more affordable for many more. 
• It sets up a new competitive health insurance market giving tens of millions of Americans the exact same insurance choices that members of Congress will have.  
• It brings greater accountability to health care by laying out commonsense rules of the road to keep premiums down and prevent insurance industry abuses and denial of care.  
• It will end discrimination against Americans with pre-existing conditions.
• It puts our budget and economy on a more stable path by reducing the deficit by $100 billion over the next ten years – and about $1 trillion over the second decade – by cutting government overspending and reining in waste, fraud and abuse.

Key Provisions in the President’s Proposal:

The President’s Proposal builds off of the legislation that passed the Senate and improves on it by bridging key differences between the House and the Senate as well as by incorporating Republican provisions that strengthen the proposal.

One key improvement, for example, is eliminating the Nebraska FMAP provision and providing significant additional Federal financing to all States for the expansion of Medicaid.  For America’s seniors, the proposal completely closes the Medicare prescription drug “donut hole” coverage gap.  It strengthens the Senate bill’s provisions that make insurance affordable for individuals and families, while also strengthening the provisions to fight fraud, waste, and abuse in Medicare and Medicaid to save taxpayer dollars.  The threshold for the excise tax on the most expensive health plans will be raised from $23,000 for a family plan to $27,500 and will start in 2018 for all such plans.  And another important idea included is improving insurance protections for consumers and creating a new Health Insurance Rate Authority to review and rein in unreasonable rate increases and other unfair practices of insurance plans. 

• Download the full PDF of the President’s key improvements.
• Read the Overview.
• Read the President’s Proposed Policies to Improve Affordability and Accountability.
• Read the President’s Policies to Crack Down on Waste, Fraud and Abuse.
• Read the President’s Policies to Contain Cost and Ensure Fiscal Sustainability.
• Read the President’s Other Proposed Policy Improvements.

Summaries of Key Elements of the President’s Proposal:

• Title I: Quality, Affordable Health Care for All Americans
• Title II: The Role of Public Programs
• Title III: Improving the Quality and Efficiency of Health Care
• Title IV: Prevention of Chronic Disease and Improving Public Health
• Title V: Health Care Workforce
• Title VI: Transparency and Program Integrity
• Title VII: Improving Access to Innovative Medical Therapies
• Title VIII: Community Living Assistance Services and Supports Act (CLASS Act)
• Title IX: Revenue Provisions
• Title X: Reauthorization of the Indian Health Care Improvement Act

Resource:  PLoS Medicine

David Moher^1,2*, Kenneth F. Schulz³, Iveta Simera⁴, Douglas G. Altman⁴

1 Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada, 2 Department of Epidemiology and Community Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada, 3 Family Health International, Research Triangle Park, North Carolina, United States of America, 4 Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom

Citation: Moher D, Schulz KF, Simera I, Altman DG (2010) Guidance for Developers of Health Research Reporting Guidelines. PLoS Med 7(2): e1000217. doi:10.1371/journal.pmed.1000217

 

Published: February 16, 2010

Copyright: © 2010 Moher et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Funding: No specific funding was received to write this piece. DGA is supported by Cancer Research UK, DM by a University of Ottawa Research Chair, and KFS by Family Health International.

Competing interests: Competing interests: DM, KFS, IS, and DGA are members of the EQUATOR Network. DM, KFS, and DGA are members of the CONSORT executive. DM and DGA are members of the PRISMA executive. DM is on the Editorial Board of PLoS Medicine.

Abbreviations: CONSORT, CONsolidated Standards Of Reporting Trials; CONSORT for NPT, CONsolidated Standards Of Reporting Trials for Non-Pharmacological Treatment interventions; E&E, Explanation and Elaboration; EQUATOR, Enhancing the QUAlity and Transparency Of health Research; PRISMA, Preferred Reporting Items for Systematic reviews and Meta-Analyses; QUOROM, QUality Of Reporting Of Meta-analyses; RCT, randomized controlled trial; SPIRIT, Standard Protocol Items for RandomIzed Trials; STARD, STAndards for Reporting of Diagnostic accuracy; STREGA, STrengthening the REporting of Genetic Association Studies; STRICTA, STandards for Reporting Interventions in Controlled Trials of Acupuncture; STROBE, STrengthening the Reporting of OBservational studies in Epidemiology

* E-mail: dmoher@ohri.ca

Provenance: Not commissioned; externally peer reviewed.

Introduction Top

Publishing health research is a thriving, and increasing, enterprise. On any given month about 63,000 new articles are indexed in PubMed, the United States National Library of Medicine’s public access portal for health-related publications. However, the quality of reporting in most health care journals remains inadequate. Glasziou and colleagues [1] assessed descriptions of given treatments in 80 trials and systematic reviews for which summaries were published during one year (October 2005 to October 2006) in Evidence-Based Medicine, a journal that is aimed at physicians working in primary care and general medicine. Treatment descriptions were inadequate in 41 of the original published articles, which made their use in clinical practice difficult if not impossible to replicate. This is just one of numerous examples of a large and disturbing literature indicating the general failure in the quality of reporting health research [2]–[6]. Many publications lack clarity, transparency, and completeness in how the authors actually carried out their research.

Inadequate reporting is problematic for several reasons. If authors do not provide sufficient details concerning the conduct of their study, readers are left with an incomplete picture of what was done. As such, they are not able to judge the reliability of the results and interpret them. There are also ethical and moral reasons for reporting research adequately [7].

The EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network is a new international initiative seeking to improve the quality of scientific publications by promoting transparent and accurate reporting [8]. The Network (http://www.equator-network.org) provides resources and training relating to the reporting of health research and assists in the development, dissemination, and implementation of reporting guidelines. As part of its initial resource development, the Network’s Web site contains a comprehensive and up-to-date database of reporting guidelines relevant to heath research. A recent systematic review of 81 reporting guidelines found their development was often inadequate [9].

Reporting guidelines need to be differentiated from other efforts that produce a checklist or other guidance not specific to reporting research. We propose here a working definition of a reporting guideline: a checklist, flow diagram, or explicit text to guide authors in reporting a specific type of research, developed using explicit methodology. Some reporting guidelines recommend a flow diagram so that authors can clearly report information about sequential stages of their research project. A consensus process [10] should be a crucial characteristic of developing a reporting guideline.

The main motivation for the development of reporting guidelines is to help researchers improve the completeness and transparency of their research reports and limit the number of poorly reported studies. However, reporting guidelines can be also used by peer reviewers and editors to strengthen manuscript review. And research funders can benefit from introducing reporting guidelines into the research application system [11]. Ensuring clear and complete reporting of funded research through the use of reporting guidelines should facilitate more efficient use of the new findings and bring better returns on research investments. There are enormous potential benefits of good reporting. However, despite the impressive recent upsurge in the number and range of reporting guidelines, the literature on how individual guidelines were developed remains sparse [12],[13] and there is no generic guidance on how to develop one.

In this paper we update and expand upon an earlier effort to outline a strategy for developing reporting guidelines that was published only in Spanish [14]. We recognize that there is no single best or correct approach. However, this paper benefits from our collective experiences of helping to develop more than ten reporting guidelines over the last 16 years, over which period these ideas have evolved considerably. If reporting guidelines are to be useful and more widely disseminated, they need to be developed using robust and widely accepted methodologies.

This strategy assumes the involvement of an executive group to facilitate the guideline development and the expectation of having a face-to-face meeting as part of the reporting guideline development. We propose 18 steps to occur in five phases, which are outlined in Table 1.

Table 1. Recommended steps for developing a health research reporting guideline.

doi:10.1371/journal.pmed.1000217.t001

Initial Steps Top

1. Identify the Need for a Guideline

Developing a reporting guideline is complex and time consuming, so a compelling rationale is needed. Most reporting guidelines have been developed because researchers are convinced of the need to improve the quality of reporting of a certain type of health research. For some study aspects there may be direct evidence that inadequate reporting is associated with biased reports or harmful consequences. At this early stage, the executive group needs to set out clearly and explicitly their objectives and consider the scope of recommendations. For example, an early decision of the STROBE (STrengthening the Reporting of OBservational studies in Epidemiology) group was to restrict consideration to three main epidemiological study designs [15], leaving the way open to extension guidelines dealing with other designs, such as STREGA (STrengthening the REporting of Genetic Association Studies) [16].

Reporting guideline developers also need to consider whether a need exists to develop a new reporting guideline or to extend or implement an existing guideline.

1.1. Develop new guidance.

Developing a new reporting guideline assumes that there is no existing guideline on the topic under consideration. The development of STARD (STAndards for Reporting of Diagnostic accuracy), a reporting guideline for diagnostic accuracy studies, was undertaken because no guidance in this area existed previously and evidence suggested the need for one [17].

1.2. Extend existing guidance.

Sometimes there may be the view that an existing broad guideline can usefully be augmented by additional guidance for a specific set of studies. An example of such an extension is the recently published CONSORT (CONsolidated Standards Of Reporting Trials) for nonpharmacological treatments (CONSORT for NPT) [18]. Here we felt that there were specific issues for some types of trials (e.g., surgical) for which sufficient guidance was not offered in the original CONSORT publications. The NPT extension still considers the original 22-item CONSORT checklist as a minimum set of criteria to consider when reporting a randomized controlled trial (RCT), but it extends 11 of these items for further consideration when reporting a trial that has used an NPT intervention.

1.3. Implement existing guidance.

Most guidelines are defined by the study aims and methodology, leaving plenty of scope to illustrate their implementation in particular medical specialties. For example, recently a group implemented the CONSORT Statement for behavioral medicine [19], although this implementation was not done in collaboration with the CONSORT Group. Such implementations will generally include requests for additional topic-specific information. The distinction between an extension and an implementation can be unclear.

2. Review the Literature

2.1. Identify previous relevant guidance.

At this early stage, prospective guideline developers should search for any existing reporting guideline covering all or part of the area being considered. We developed a search strategy to identify and characterize reporting guidelines as part of an ongoing project. In addition to electronic searching, developers are encouraged to search the EQUATOR Network database of reporting guidelines (http://www.equator-network.org). We recommend that reporting guideline developers interested in extending or implementing an existing guideline contact the authors and discuss their plans.

2.2. Seek relevant evidence on the quality of reporting in published research articles.

We recommend searching for relevant evidence on the quality of reporting of published research articles within the domain of interest. Such reports provide an initial and important insight into the items to consider for inclusion in an eventual checklist and potential stakeholders to invite to a meeting. However, this literature can be elusive and appear in any journal. A more thorough process, such as a systematic review, would be useful here. The existence of such literature can be most readily ascertained by conducting comprehensive electronic searches of several databases. In preparing for the 2005 QUOROM (QUality Of Reporting Of Meta-analyses) meeting, among other activities we conducted a systematic review of studies that had reviewed the quality of reporting of systematic reviews. To help inform updating of the CONSORT Statement we search the literature every month for new studies of the reporting of randomized trials.

2.3. Identify key information related to the potential sources of bias in relevant studies.

For any guideline, both new and revised, there will be key pieces of information that must be included. For example, in a 1993 meeting that ultimately led to the development of the CONSORT Statement, we identified emerging empirical data on the importance of the methods and reporting of allocation concealment when describing the randomization process [20]. The 2010 update of the CONSORT Statement includes new checklist items on identifying any changes to trial outcomes after the trial commenced, and on trial registration. The new item on outcomes follows from empirical evidence [21] indicating that authors frequently do not provide analyses of outcomes in their published papers that were the pre-specified outcomes in their protocols (i.e., selective outcome reporting). The addition of a new trial registration item reflects current journal practice [22] stemming from some researchers hiding results of randomized trials [23].

3. Obtain Funding for the Guideline Initiative

To date, no published data inform the costs required to develop a reporting guideline. Even if funding is available, most developers limit their fiscal requests to cover only the main reporting guideline meeting. In our experience, considerable resources are required for pre-meeting activities, such as literature searching and conducting a Delphi exercise, and post-meeting activities, including the need for a small writing group to be able to meet in person, perhaps on several occasions, during the drafting of the guidance and development of an explanation and elaboration (E&E) document.

Depending on the extent of the pre-meeting activities we recommend allocating at least Can$10,000 for them. In our experience the main meeting costs are approximately Can$75,000. This covers the travel and accommodation costs of bringing together 20 to 30 participants. For new guidance in the form of a checklist, with a more detailed and extensive E&E, we recommend at least Can$35,000 for a small writing group to meet several times.

There is no obvious choice as to where reporting guideline developers can seek funding; we are unaware of any granting agency or other group that has a specific remit to provide funding to those interested in improving ways to report health research. Of the 30 respondents to our survey [24], 47% had received funds from a non-profit agency, 17% from the pharmaceutical industry, and 6% from government. We recommend that developers seek funds from all of these sources.

Pre-meeting Activities Top

4. Identify Participants

Most reporting guidelines have been developed by an international multidisciplinary group involving 22 (median) people [24], although not all may participate in meetings. The expertise of these individuals should reflect the particular guidance under consideration; participants will usually include statisticians, epidemiologists, methodologists, content experts, journal editors, and perhaps consumer representatives. The proportion of content experts needs to be at least a quarter, and perhaps larger depending on the content area under consideration. When developing the herbal extension of the CONSORT Statement we included pharmacognosy experts to provide input on several issues pertinent to reporting herbal interventions.

Well ahead of the proposed meeting date, a list of participants to invite should be developed. The CONSORT executive has typically invited participants in a two-stage process. First, we identify a small group of invitees whose participation we consider essential to hold a meeting. We invite this small group immediately. Once they have accepted our invitation and a date has been settled we invite the remaining participants. We also keep an additional smaller list of people to consider inviting should some second-wave invitees not be able to participate in the meeting. We recommend sending out the meeting invitations well in advance, ideally six months before the meeting date.

5. Conduct a Delphi Exercise

Not all potential meeting participants can be invited or will be able to come to the main guideline development meeting. These people can still be engaged in the guideline development process. The CONSORT group has started using a Delphi consensus method [25] to achieve this goal. The Delphi method is a structured process of obtaining information from a group of experts by means of a series of questionnaires, each one refined based on the feedback from respondents on a previous version [10].

To help develop CONSORT for RCT abstracts, we used a three-stage Delphi process. Journal editors, health care professionals, methodologists, clinical trialists, and others with expertise in the reporting of RCTs (n = 109) who were known to have an interest in the reporting of randomized trials, the structure of abstracts, or both were invited by e-mail to participate in a Web-based survey and rate the importance of 27 suggested checklist items selected from previous research. During three rounds of the survey, participants were asked about their views on the relative importance of the possible checklist items [25].

6. Generate a List of Items for Consideration at the Face-to-Face Meeting

There is no best way to generate the list of items for consideration, which will likely come from a number of sources, such as the Delphi process discussed above (see item 5). For example, the Delphi process for the SPIRIT (Standard Protocol Items for RandomIzed Trials) meeting resulted in 63 nominated items to consider for inclusion in the checklist discussed during the face-to-face consensus meeting. The executive may reduce the initial list of items to a more manageable number for discussion during the face-to-face meeting (see item 8).

7. Prepare for the Meeting

7.1. Decide size and duration of the face-to-face meeting.

Regardless of the available funding we recommend keeping the size of the meeting to no more than about 30 participants. Larger meetings can lose their spontaneity and limit interaction among the participants, both important attributes of a successful meeting. The CONSORT for herbal medicines meeting was small, involving 16 participants. In contrast, the CONSORT for NPT meeting was large, at 32 participants. Here we were interested in many types of interventions, such as surgery and psychotherapy, requiring a broader number of clinical content experts. It is valuable to have several people who have participated in previous similar meetings.

Reporting guideline meetings that we have been involved in have lasted from one to three days. We recommend a minimum of one day for developing a reporting guideline regardless of whether the guidance is new, an implementation, or an extension.

7.2. Develop meeting logistics.

The successful planning and implementation of any reporting guideline meeting requires thorough organization. If funding permits a coordinator should be hired to organize the meeting, including venue selection, meal plans, participant travel and accommodation, and finances.

7.3. Develop meeting agenda.

The executive must develop the form and structure of the meeting to ensure adequate time to discuss all of the agenda items. The most important outcome of the face-to-face meeting is an early version of the guidance checklist. We recommend that the following points be considered as part of developing the meeting agenda.

7.3.1. Consider presentations on relevant background topics, including summary of evidence. A useful way to set the stage and maximize participant dialogue is to devote at least a few hours to presentations on topics underpinning the reporting guideline development. Presentations might also be usefully devoted to specific items that are being proposed for the checklist and any relevant empirical evidence.

Ideally, by the conclusion of this session all participants should have up-to-date knowledge about the quality of reporting of the literature at which the guidance is aimed and the evidence relevant to considering the merits of including specific checklist items. Some of this material can be circulated in advance, but it is unlikely that people have time to read extensive materials. A major advantage of the Delphi exercise is that participants can think about some key issues before the meeting.

7.3.2. Plan to share results of Delphi exercise, if done. We have found that a Delphi exercise provides important information when developing a reporting guideline, regardless of whether the guidance is new, an extension, or implementation. The results of a Delphi exercise were presented to participants during the first day of the following three meetings: CONSORT for abstracts, CONSORT for NPT, and SPIRIT.

7.3.3. Invite session chairs. The main meeting will most likely be divided into sessions. While some of the chairs of sessions should be members of the executive group, other participants should also be invited to chair sessions, particularly if they have previous experience developing reporting guidelines and/or chairing meetings. It is essential that chairs have known ability to handle sessions effectively, to ensure that decisions are made.

7.4. Prepare materials to be sent to participants prior to meeting.

We recommend sending some materials to participants before the meeting, even though the same materials, and additional ones, should be readily available for each participant during the meeting. Sending the meeting agenda, participant list, one or two papers that might best highlight the quality of reporting of the content area, and the results of any Delphi exercise, if done, is a useful minimum and should be sent to the participants at least a week ahead of the meeting.

7.5. Arrange to record the meeting.

The options include audio (and possibly visual) recording of the entire event (this has proved valuable), hiring someone to take comprehensive minutes, or a combination of both. Depending on the meeting agenda, a more focused recording and/or minuting of certain parts of the meeting is another option. As a minimum we recommend comprehensive minuting of all discussions specifically related to the checklist development. Such minuting provides all participants with a record of events and decisions taken during the meeting.

The Face-to-Face Consensus Meeting Itself Top

The meeting should follow closely the pre-meeting plans, although timings should be flexible. It is unlikely that all the participants will know each other, so it is helpful for everyone to introduce themselves and indicate the relevance of their particular experience. One of the first tasks of the meeting is to review the objectives and the way the meeting will run, and to clarify any outstanding issues among the participants.

8. Present and Discuss Results of Pre-meeting Activities and Relevant Evidence

The substantive meeting begins with any formal presentations of background topics, empirical evidence from the literature, and results of any Delphi process (see item 5 above).

8.1. Discuss the rationale for including items in the checklist.

The most detailed and structured discussions at the meeting revolve around which checklist items to include in the guideline; these discussions should focus on information content and not get distracted by seeking agreed wording at this stage. We have always considered the items included in a checklist to be a minimum essential set of items that should be reported, and some discussion of this perspective is valuable before the detailed discussions begin.

The inclusion of each item is ideally supported by empirical evidence, when available. For example, the inclusion of allocation concealment as a checklist item of the original CONSORT Statement was based on an empirical study [20]. There are few such cases. More often there is a consensus that the information is methodologically important to assess in a study; there may also be good evidence that it is frequently not reported. Similarly, evidence and/or conceptual importance in one domain may be transferable from one guideline to another. For example, a specific checklist item on trial registration has been added to the CONSORT 2010 Statement. Similarly, during the 2005 QUOROM meeting we agreed to include a checklist item requesting that authors provide registration information about their systematic review, if available [26]. There may be other reasons for a focused discussion about the inclusion of an item. For example, the CONSORT Statement requests that the study be identified in the title as a randomized trial to aid searching for such studies.

The views expressed in a Delphi exercise, and perhaps also how similar issues were handled in other reporting guidelines, are also important. Ultimately the views of the meeting participants will usually converge, although it may occasionally be necessary to vote on some issues. We recommend considering a classification scheme for selecting items for inclusion in the checklist; we provide an example of this approach that we’ve used for including items in the CONSORT checklist (see Table 2).

Table 2. Classification of categories of items for consideration for inclusion in a reporting guideline checklist, illustrated by some items from the CONSORT checklist.

doi:10.1371/journal.pmed.1000217.t002

8.2. Discuss the development of a flow diagram.

The majority of reporting guidelines have been limited to developing a checklist [24]; a few groups have also developed a flow diagram, the most well known of which is the CONSORT diagram. We recommend that the meeting agenda include discussion of the possibility of developing a diagram and, if appropriate, consideration of its content.

8.3. Discuss strategy for producing documents; identify who will be involved in which activities; discuss authorship.

The most important deliverable is the final reporting guideline. Commonly this will be in the form of a journal article, written after the meeting that introduces the checklist (and flow diagram) and summarises the processes used to develop it. Some groups such as CONSORT refer to this document as a “Statement” to distinguish it from other types of publication. A detailed explanatory paper, an E&E, may also need consideration. Sufficient time needs to be included in the meeting agenda to discuss these activities. Developing an E&E is very time consuming, and will require further input from the meeting participants (see item 10). To accomplish this task we have often asked meeting participants, all of whom would be considered for authorship, to volunteer to help draft particular sections. Time needs to be set aside to discuss these issues during the meeting and the authorship model needs to be agreed upon.

8.4. Discuss knowledge translation strategy.

One of the last major sessions of the meeting should be devoted to issues pertaining to disseminating the reporting guideline. There are several points to consider here, especially a publication strategy. Since the simultaneous publication in three journals of the 2001 CONSORT Statement, several reporting guidelines have been published in multiple journals. Ultimately reporting guideline developers want to positively influence the reporting of health research and will need to consider how best to ask journals and editorial groups (such as the International Committee of Medical Journal Editors), for help achieving these goals. To address these issues adequately the PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) Group formed a three-member dissemination committee. How to maximize journal endorsement and adherence to the reporting guideline can also be discussed during the meeting. Additional points for discussion can include: whether and how the guidance will be formally evaluated; how any criticism will be handled; and whether to create a Web site and what it might contain.

Post-meeting Activities Top

Together with drafting and finalizing guideline documents the reporting guideline developers need to consider their implementation strategy, including publication issues (open access, copyright, peer review, and multiple and possibly simultaneous publications), website development, and seeking or monitoring endorsement of and adherence to the reporting guideline.

9. Develop the Guidance Statement

We recommend that initial efforts be focused on drafting the checklist for the proposed reporting guideline. Efforts aimed at extending or implementing existing reporting guidelines should make very clear which parts of their checklist remain the same as the original and which items have been modified or added. The process of developing the checklist is very likely to require several iterations. Initially, this entails taking the discussions from the face-to-face meeting (item 8.1 above) and crafting each item into a crisply and unambiguously worded checklist item. The most appropriate order for the checklist items also needs consideration.

For a new reporting guideline we recommend a short document of about 2,000 words reporting on the rationale for developing the guidance and the development process, including a brief description of the meeting and participants involved. The article will include the checklist and flow diagram, if developed. In our experience drafting the checklist and article is best done by a small writing group made up primarily of members of the executive team and perhaps one or two others. This group will usually constitute the guideline authors on behalf of the reporting guideline group, although group authorship may be preferred. For extending an existing reporting guideline a similar approach is recommended. Whether a new guideline is being developed or an existing one is being extended, the full guideline group will need to sign off on the document’s content prior to journal submission.

9.1. Pilot test the checklist.

Pilot testing the checklist and flow diagram is worth considering. During the development of the QUOROM Statement, two members of the executive group independently asked two separate sets of students taking a systematic review course for their feedback on the checklist that was used to help report their systematic review. Their comments were incorporated into the checklist revisions.

10. Develop an Explanatory Document (E&E)

To date most reporting guidelines have not been accompanied by a detailed justification and explanation of the recommendations (e.g., STRICTA [STandards for Reporting Interventions in Controlled Trials of Acupuncture]). However, we believe that it is vitally important to provide an explanation of the rationale and evidence for a guideline item’s inclusion and an elaboration on the details of an item, hence the title Explanation and Elaboration, or E&E, adopted by CONSORT and several other groups.

While there will undoubtedly be an urge to complete all of the guideline revisions rapidly and submit the paper for publication consideration, we recommend holding off doing so until an E&E has been prepared (see Box 1). The E&E will be considerably longer than the guideline statement (probably 10,000–20,000 words). As with the short guideline statement (see item 13) the full guideline group will need to sign off on the E&E’s content before journal submission.

Discussion Top

We hope this guidance on how to develop a reporting guideline, including an 18-step checklist, will fill a gap in the literature and be of help to potential and practicing developers. While some of the items are optional, there is a core set of steps we believe necessary to ensure adequate development of a reporting guideline. In the future, the EQUATOR Network might consider providing an appraisal grade for the reporting guidelines included on their database, reflecting the robustness of the guideline development process. We also encourage prospective guideline developers to contact the EQUATOR Network team to inform them about their work; this might prevent duplication of effort.

We will make the 18-step checklist available on the EQUATOR Network Web site. We will continue to monitor the literature to help maintain the guidance, particularly the checklist. Furthermore, we will annually review the need to update the checklist.

While there is increasing evidence that use of reporting guidelines is associated with improvements in the quality of reporting health research [37],[39],[41],[42], there is a growing anecdotal belief that reporting guidelines indirectly have a positive impact on how researchers design and conduct their research [43]. More formal research is required to substantiate these claims. Beyond the possible benefit in the design and conduct of health research, reporting guidelines are now starting to be used as an adjunct in developing educational courses in the design and conduct of health research.

Reporting guidelines are currently focused at the end of the knowledge generation cycle. However, we believe that investigators would benefit from the knowledge of key principles of health research reporting and relevant guidelines at the beginning of their research, having the end in mind. Indeed, guidelines are possibly equally useful earlier on in this process, and some granting agencies have acted upon this concept. The SPIRIT initiative is aimed at providing guidance for writing protocols of RCTs. Similarly, the UK National Institute of Health Research developed a research process flowchart (http://www.rdinfo.org.uk/) to guide researchers in how to start developing a research project. The flowchart includes reference to reporting guidelines and encourages researchers to “consult a relevant guideline in the early stages of research planning.”

Given the broad range of health research now covered by reporting guidelines, funders might start to require prospective applicants to use some parts of an “approved” reporting guideline when developing their research application and to include a completed checklist as part of this process. This might increase the overall quality of the applications to funders while increasing the potential return on their investment by emphasizing the importance of reporting much earlier in the knowledge generation cycle.

Reporting health research in a complete, accurate, transparent, and timely manner is a shared responsibility of all stakeholders involved in research funding, conduct, and publication. High-quality research reports contribute to more efficient translations of new research findings into clinical practice and help advance scientific knowledge and patient care. We will all benefit from these collective efforts.

Author Contributions Top

ICMJE criteria for authorship read and met: DM KFS IS DGA. Wrote the first draft of the paper: DM. Contributed to the writing of the paper: KFS IS DGA.

References Top

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21. Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan AW, et al. (2008) Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS ONE 3: e3081. doi:10.1371/journal.pone.0003081.
22. De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, et al. (2004) Clinical trial registration: a statement from the International Committee of Medical Journal Editors. Lancet 364: 911–912. Find this article online
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24. Simera I, Altman DG, Moher D, Schulz KF, Hoey J (2008) Guidelines for reporting health research: the EQUATOR Network’s survey of guideline authors. PLoS Med 5: e139. doi:10.1371/journal.pmed.0050139.
25. Hopewell S, Clarke M, Moher D, Wager E, Middleton P, et al. (2008) CONSORT for reporting randomized controlled trials in journal and conference abstracts. Lancet 371: 281–283. Find this article online
26. Tricco AC, Pham B, Brehaut J, Tetroe J, Cappelli M, et al. (2009) An international survey suggested that unpublished systematic review exist. J Clin Epidemiol 62: 617–623. Find this article online
27. Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, et al. (2006) Reporting Randomized, Controlled Trials of Herbal Interventions: An Elaborated CONSORT Statement. Ann Intern Med 144: 364–367. Find this article online
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TED 2010 is now going on.  Don’t miss out on learning from some of the most brilliant minds on the planet.  Here is a spreadsheet of all the speakers and their topics:   http://tinyurl.com/rc7llb

Topics of interest include:

• 15 ways to avert a climate crisis
• Debunking third-world myths with the best stats you’ve ever seen
• Do schools kill creativity?
• Greening the ghetto
• When it comes to tech, simplicity sells
• Why we do what we do, and how we can do it better
• “Letting Go of God” (an excerpt)
• Designing the Seattle Central Library
• A secular, scientific rebuttal to Rick Warren
• Living a life of purpose
• TED Prize wish: Help stop the next pandemic
• TED Prize wish: Open-source architecture to house the world
• TED Prize wish: Unite the world on Pangea Day, a global day of film
• The vision behind One Laptop Per Child
• Unveiling the genius of multi-touch interface design
• Dazzling set by 11-year-old violinist
• Magical improv from 14-year-old pianist
• Simple designs that could save millions of childrens’ lives
• The power and beauty of organic design
• Goodbye, textbooks; hello, open-source learning
• How a ragtag band created Wikipedia
• How blogs are building a friendlier worl
• What’s so funny about the Web?
• Finding happiness in body and soul
• The science of love, and the future of women
• What is our place in the cosmos?
• The paradox of choice
• Why are we happy? Why aren’t we happy?
• My dream about the future of medicine
• Why we age and how we can avoid it
• Investing in Africa’s own solutions
• The power of the mobile phone to end poverty
• How to fix broken states
• Why a free press is the best investment

Source:  National Institutes of Health

Wide Variety of Bacteria Mapped Across the Human Body

By analyzing bacterial communities in and on several people, scientists have begun to create an atlas of bacterial diversity that documents the different types of microbes that thrive in distinct regions of the human body. This research sets the stage for determining how changes in bacterial communities help to cause or prevent disease.

Our bodies play host to a wide variety of microbes, called the human microbiota, that outnumber our own cells by about 10 to 1. Many of these microbes help us stay healthy—for instance by aiding digestion or crowding out disease-causing microbes. But details about how microbial communities vary in different body regions, among people or over time are not yet well understood.

In a study funded in part by NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Dr. Rob Knight and his colleagues at the University of Colorado, Boulder, and George Washington University, St. Louis, began to chart a baseline map of the human microbiota in healthy people. The results were published on November 5, 2009, in the advance online edition of Science.

The scientists surveyed bacterial communities in up to 27 different locations on the bodies of 9 healthy adults. Sampled regions included hair on the head, ear canals, nostrils, mouth, lower gut and 18 different skin sites ranging from foreheads and armpits to navels and feet. Swabs from these regions were collected 4 times over 3 months.

As in other recent studies of the human microbiota, Knight and colleagues identified bacteria by extracting DNA from each sample and then analyzing a bacteria-specific gene, called the 16S ribosomal RNA gene. Overall, the detected microbes belong to 22 bacterial phyla. Four phyla were dominant, representing more than 90% of the identified bacteria.

The researchers found wide variability in bacterial communities on each person and between people. The greatest diversity over time was seen on hair, nostril and ear canal sites, as well as some skin regions, especially the forearms, palm, index finger, back of the knee and sole of the foot. These regions were also the most divergent between people, as was the lower gut. The mouth had the least bacterial variability of any tested region.

The researchers also tested how well bacteria from one body region could survive on another. They transferred bacteria from the tongue to the disinfected forearms and foreheads of some volunteers and tracked them for up to 8 hours. Tongue bacteria persisted longer on the forearms than foreheads, suggesting that the oily forehead may be too harsh a habitat for some bacteria. Bacterial communities transplanted from forehead to forearms and vice versa could not survive well in the new habitats, coming to resemble the native mix rather than the transplants within hours.

“This is the most complete view we have yet of the microbial side of ourselves, one that our group and others will be adding to over the coming years,” says Knight. “If we can better understand this variation, we may be able to begin searching for biomarkers for disease.”

—by Vicki Contie

Reference:
National Institutes of Health (November 16, 2009) Wide variety of bacteria mapped across the human body.  Retrieved November 16, 2009 from http://www.nih.gov/researchmatters/november2009/11162009bacteria.htm

Zheng W, Lee SA.

Vanderbilt-Ingram Cancer Center, Vanderbilt University School of Medicine, Nashville, TN 37203-1738, USA. wei.zheng@vanderbilt.edu

PMID: 19838915 [PubMed - in process]

Resource:  National Cancer Institute

1.  
   • arsenic (a heavy metal toxin)
   • benzene (a chemical found in gasoline)
   • beryllium (a toxic metal)
   • cadmium (a metal used in batteries)
   • chromium (a metallic element)
   • ethylene oxide (a chemical used to sterilize medical devices)
   • nickel (a metallic element)
   • polonium–210 (a chemical element that gives off radiation)
   • vinyl chloride (a toxic substance used in plastics manufacture)
2. What is secondhand smoke?
3. How is secondhand smoke exposure measured?
4. Does secondhand smoke contain harmful chemicals?
5. Does exposure to secondhand smoke cause cancer?
6. What are the other health effects of exposure to secondhand smoke?
7. What is a safe level of secondhand smoke?
8. What is being done to reduce nonsmokers’ exposure to secondhand smoke?

Secondhand smoke (also called environmental tobacco smoke) is the combination of sidestream smoke (the smoke given off by the burning end of a tobacco product) and mainstream smoke (the smoke exhaled by the smoker) (1, 2, 3, 4). Exposure to secondhand smoke is also called involuntary smoking or passive smoking. People are exposed to secondhand smoke in homes, cars, the workplace, and public places such as bars, restaurants, and other recreation settings. In the United States, the source of most secondhand smoke is from cigarettes, followed by pipes, cigars, and other tobacco products (4).

 Secondhand smoke is measured by testing indoor air for nicotine or other smoke constituents. Exposure to secondhand smoke can be tested by measuring the levels of cotinine (a nicotine by-product in the body) in the nonsmoker’s blood, saliva, or urine (1). Nicotine, cotinine, carbon monoxide, and other evidence of secondhand smoke exposure have been found in the body fluids of nonsmokers exposed to secondhand smoke.

Yes. Of the more than 4,000 chemicals that have been identified in secondhand tobacco smoke, at least 250 are known to be harmful, and 50 of these are known to cause cancer. These chemicals include (1):

Many factors affect which chemicals are found in secondhand smoke, including the type of tobacco, the chemicals added to the tobacco, the way the product is smoked, and the paper in which the tobacco is wrapped (1, 3, 4).

 

Yes. The U.S. Environmental Protection Agency (EPA), the U.S. National Toxicology Program (NTP), the U.S. Surgeon General, and the International Agency for Research on Cancer (IARC) have classified secondhand smoke as a known human carcinogen (cancer-causing agent) (1, 3, 5).

Inhaling secondhand smoke causes lung cancer in nonsmoking adults (4). Approximately 3,000 lung cancer deaths occur each year among adult nonsmokers in the United States as a result of exposure to secondhand smoke (2). The Surgeon General estimates that living with a smoker increases a nonsmoker’s chances of developing lung cancer by 20 to 30 percent (4).

Some research suggests that secondhand smoke may increase the risk of breast cancer, nasal sinus cavity cancer, and nasopharyngeal cancer in adults, and leukemia, lymphoma, and brain tumors in children (4). Additional research is needed to learn whether a link exists between secondhand smoke exposure and these cancers.

Secondhand smoke causes disease and premature death in nonsmoking adults and children (4). Exposure to secondhand smoke irritates the airways and has immediate harmful effects on a person’s heart and blood vessels. It may increase the risk of heart disease by an estimated 25 to 30 percent (4). In the United States, secondhand smoke is thought to cause about 46,000 heart disease deaths each year (6). There may also be a link between exposure to secondhand smoke and the risk of stroke and hardening of the arteries; however, additional research is needed to confirm this link.

Children exposed to secondhand smoke are at an increased risk of sudden infant death syndrome (SIDS), ear infections, colds, pneumonia, bronchitis, and more severe asthma. Being exposed to secondhand smoke slows the growth of children’s lungs and can cause them to cough, wheeze, and feel breathless (4).

There is no safe level of exposure to secondhand smoke. Studies have shown that even low levels of secondhand smoke exposure can be harmful. The only way to fully protect nonsmokers from secondhand smoke exposure is to completely eliminate smoking in indoor spaces. Separating smokers from nonsmokers, cleaning the air, and ventilating buildings cannot completely eliminate secondhand smoke exposure (4).

Many state and local governments have passed laws prohibiting smoking in public facilities such as schools, hospitals, airports, and bus terminals. Increasingly, state and local governments are also requiring private workplaces, including restaurants and bars, to be smoke free. To highlight the significant risk from secondhand smoke exposure, the National Cancer Institute, a component of the National Institutes of Health, holds meetings and conferences in states, counties, cities, or towns that are smoke free, unless certain circumstances justify an exception to this policy.

More information about state-level tobacco regulations is available through the Centers for Disease Control and Prevention (CDC) State Tobacco Activities Tracking and Evaluation (STATE) System Web site. The STATE System is a database containing up-to-date and historical state-level data on tobacco use prevention and control. This resource is available at http://apps.nccd.cdc.gov/statesystem/ on the Internet.

On the national level, several laws restricting smoking in public places have been passed. Federal law bans smoking on domestic airline flights, nearly all flights between the United States and foreign destinations, interstate buses, and most trains. Smoking is also banned in most Federally owned buildings. The Pro-Children Act of 1994 prohibits smoking in facilities that routinely provide Federally funded services to children.

The U.S. Department of Health and Human Services (DHHS) Healthy People 2010, a comprehensive, nationwide health promotion and disease prevention agenda, includes the goal of reducing the proportion of nonsmokers exposed to secondhand smoke from 65 percent to 45 percent by 2010 (7). More information about this program is available on the Healthy People 2010 Web site at http://www.healthypeople.gov/ on the Internet.

Internationally, several nations, including France, Ireland, New Zealand, Norway, and Uruguay, require all workplaces, including bars and restaurants, to be smoke free.

Selected References

1. National Toxicology Program. Report on Carcinogens. Eleventh Edition. U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program, 2005. 
2. National Cancer Institute. Cancer Progress Report 2003. Public Health Service, National Institutes of Health, U.S. Department of Health and Human Services, 2004. 
3. International Agency for Research on Cancer. Tobacco Smoke and Involuntary Smoking. Lyon, France: 2002. 
4. U.S. Department of Health and Human Services. The Health Consequences of Involuntary Exposure to Tobacco Smoke: A Report of the Surgeon General. Rockville, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Coordinating Center for Health Promotion, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2006. 
5. U.S. Environmental Protection Agency. Respiratory Health Effects of Passive Smoking (Also Known as Exposure to Secondhand Smoke or Environmental Tobacco Smoke–ETS). U.S. Environmental Protection Agency, 1992. 
6. California Environmental Protection Agency, Office of Environmental Health Hazard Assessment. Proposed Identification of Environmental Tobacco Smoke as a Toxic Air Contaminant: Part B Health Effects, 2005. 
7. U.S. Department of Health and Human Services. Healthy People 2010: Understanding and Improving Health. 2nd ed. Washington, DC: U.S. Government Printing Office, 2000. 

Related NCI materials and Web pages:

• National Cancer Institute Fact Sheet 10.16, Questions and Answers About Cigar Smoking and Cancer
  (http://www.cancer.gov/cancertopics/factsheet/Tobacco/cigars)
• National Cancer Institute Fact Sheet 10.19, Quitting Smoking: Why To Quit and How To Get Help
  (http://www.cancer.gov/cancertopics/factsheet/Tobacco/cessation)
• Smoking and Tobacco Control Monograph 10: Health Effects of Exposure to Environmental Tobacco Smoke
  (http://cancercontrol.cancer.gov/tcrb/monographs/10/index.html)
• NCI’s Smoking and Cancer Home Page
  (http://www.cancer.gov/cancertopics/smoking)

For more help, contact:

NCI’s Cancer Information Service
Telephone (toll-free): 1–800–4–CANCER (1–800–422–6237)
TTY (toll-free): 1–800–332–8615
LiveHelp^® online chat: https://cissecure.nci.nih.gov/livehelp/welcome.asp

Reference:

National Cancer Institute (2009). Secondhand smoke questions and answers.  Retrieved November 2, 2009 from http://www.cancer.gov/cancertopics/factsheet/Tobacco/ETS

Resource: American Medical Association 
For immediate release
Oct. 26, 2009

CHICAGO -  As the nation continues to debate health reform, the American Medical Association (AMA) continues to advocate for reforms that will make the health care system work better for America’s patients and physicians. A new full-page advertisement under the headline, “A Healthier Tomorrow Depends on What We Do Today,” will run Tuesday in the Wall Street Journal’s special report “Fixing Healthcare.”

“Through reform our health care system can be improved for America’s patients and the physicians who dedicate their lives to caring for them,” said AMA President J. James Rohack, MD. “This new ad reiterates the AMA’s role in the reform debate as an advocate for patients and physicians, and shows that we will continue to be actively engaged until meaningful health reform is a reality.”

This ad is another piece of the AMA’s campaign to make health reform a reality. To view all AMA activity related to health reform, visit www.hsreform.org.

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Media contact:

Lisa Lecas
American Medical Association
(312) 464-5980