4-30-10 Community E-Newsletter/Call
In today's Community Call, we'll have the opportunity to comment on some relevant articles related to the OurMed cause as well as review progress on our Phase 2 development and request input from the community.
This is an open invitation to get more involved with the world's first ever, unbiased, free license and dynamic medical/health knowledge base.
Time: Friday (Today!) 2 - 2:45pm EST
If you would like to opt out of these emails, please let me know. Thank you for your continued interest in the OurMed initiative--we couldn't make this happen without your participation and are grateful for you pitching in!
Greg Miller, Executive Director at OurMed.Org
Watch our OurMed YouTube Video:http://www.youtube.com/watch?v=zqgYfFxEkLk
OurMed's Technology Update
This morning OurMed's web design team had another coordinationhe OurMed community's input into a world class website, complete with a new look and expanded features--Not an easy task!
In today's community call, we'd like you to give your feedback several critical issues related to the site development.
1) We'd like to address the Multi-language issue of our global site. We will discuss the possibilities presented by Blueliner today which will include a splash page (like Wikipedia) or a user account settig (like Facebook). Our contract calls for the site to be done in over 10 languages and we can discuss how to choose those languages.
2) Split Screen--One of our objectives to build a new site is to marry the meritocracy of Healthcare Professional authored acyrticles with patient and consumer feedback that represent the Democracy of Information--This is a critical inner page that we'd like your feedback on.
3) The Search Algorhythm is something that is a highly technical part of our -site. Using geo-targeting strategies we will need to determine how we search for sites considering ip addresses, an author of an article's location, or the searcher's location. Blueliner's Arbab will suggest an algorhythm.
4) New Facebook technology to effect OurMed!
Arbab wanted to draw your attention to latest features that are being launched by Facebook. Arbab believes Facebook made the announcement yesterday. Have a look at the presentation: http://apps.facebook.com/feightlive/
The new features will really re-shape how users interact with other site and how they share information. It will also encourage sites to incorporate Facebook's new APIs to draw more traffic.
5) Using an image on our homepage to communicate "collaboration". This very important aspect of the OurMed branding will be in the Featured Spotlight section of our homepage design.
Building content – What to write about?
Changes or additions can be made easily with our WYSYWIG editor (what you see is what you get), making it much easier than Wikipedia and cutting the volume ramp up rate to the new site significantly faster.
At times posting new material may be difficult to give attributions for so it may be easier to publish previously published work
Alternatively, you can choose content from one of the many free content ("copy left") sites such as much of the content on:
2. NIH's PubMedCentral.gov from the National Library of Medicine
4. GanFyd.org (original medical wiki site that claims Medpedia copied them and boasts 2000 site visitors per day)
7. Open.Michigan from the University of Michigan
Posting on OurMed.Org
In addition to the Symbiosis Project, OurMed offers writers of original work to publish a vast range of medical topics. Under the three pillar approach of 1) Being Referenced 2) Being Bold and 3) Being Polite, OurMed strives to be a forum through which multiple health and medical issues are presented and debated.
To write, you must have a free OurMed account. You can write about nearly anything, just keep your comments about new ideas,health and medicine.--It's really important that OurMed gets off the ground using a communities collaborative approach to building it, just as Wikipedia did nine years ago.
We are furthering our editorial policies to include a Style Guide. Feel free to suggest ideas to make this a global "go-to" resource for all healthcare needs fit for any patient or healthcare professional.
Please click on this link to make a small post about whatever's on your mind. You can suggest articles, design or features that you'd like to see on the site. http://ourmed.org/index.php/New_Ideas_for_Site
Most Active Authors in The Past Month:
* D Joiner
OurMed's MedTool Project
As we develop OurMed's Phase 2 site, we want to announce a competition to inspire our content contributors to come up with the most useful healthcare diagnostic tools from around the world.
Submissions will eventually be open-sourced and written in Joomla so that it will "plug-in" to our new site as well as be available to all around the world in a copy-left offering. To contribute, a contestant need not be tech savy but only be familiar with common health and medical needs. Will it be a simple Body-Mass calculator, Symptom Disease matcher, Diabetic Insulin calculator--the list may go on and one but we want the most popular, best and easiest to use!
How to get health advice online: A Doctor's Guide
Monday, Apr 26, 2010 14:35 ET Editor: Steve Kornacki
Physicians may debate the Web's influence, but patients must simply be savvy when they seek a medical diagnosis By Rahul K. Parikh, M.D.
A recent article in the New England Journal of Medicine by Harvard doctors Jerome Groopman and Pamela Hartzband fired up a decade-long debate about patients who use the Internet to learn about their health. Though the physicians praised the Web for fundamentally changing the doctor-patient relationship, giving more control to patients than ever before, they went on to sound the alarm. "Falsehoods are easily and rapidly propagated on the Internet," they sternly cautioned. And for hypochondriacs, the Web is "perilous."
Many e-patients, as they're called, were not pleased. "Dear Dr. Hartzbrand & Dr. Groopman: The Internet is here to stay. Let's move on," tweeted Susannah Fox of the influential Pew Internet and American Life Project, which closely follows e-health trends. Gilles Frydman, the founder of one of the largest cancer support websites, chimed in: "I was saddened to see that [the] opinion piece shows one more time that many doctors remain uncomfortable about rebalancing the control to a more transparent system ... there is no examination of the positive aspects of the growing number of informed, activated and engaged networked patients," he wrote.
It was the old medical establishment versus a new cadre of Internet-informed e-patients, and as such, it reminded me of a spat two years ago, when Time magazine's medical columnist Dr. Scott Haig called patients using the Internet "brainsuckers." That essay was nothing more than a petulant rant. Groopman and Hartzband, on the other hand, raise valid concerns about the uneasy alliance of health and technology at a time when the Internet's presence in our lives keeps growing. Don't misunderstand: I encourage my patients to use the Web -- to better understand health and medicine, and to hold doctors accountable for their decisions. But in my experience, many patients are not as savvy as Gilles Frydman and his fellow e-patients. The truth is, the Internet cuts both ways. Let's dial down the rhetoric and get on with something more important: helping others be smarter health consumers on the Web.
* Continue reading
Frydman is certainly right that the Internet can empower patients, in turn promoting sensible medicine. I'll illustrate with the following story: An infant in my practice developed severe constipation. When the therapies we tried didn't help, I began to suspect a condition called Hirschsprung's disease, in which a child is born lacking nerves to the parts of the rectum and lower colon that help them have bowel movements. I saw them in my office for an exam. The parents had done research on the Web before they came to see me, so they knew about Hirschsprung's disease and that it would entail a referral to a specialist and a biopsy to diagnose it. They were anxious, no doubt, but they also came prepared with questions enabling us to get their child the right care.
Groopman and Hartzband are also right that e-patients have plenty to be cautious about. When they are not, the risks of the Internet outstrip its benefits, driving up cost, lowering quality and hurting the doctor-patient relationship. Again, a story from my own practice: I recently saw a teenager who had multiple minor complaints -- a little fatigue, a string of recent colds, some sores in the mouth being treated by the dentist. Her mother pushed a piece of paper at me, asking me to order a specialized test for Lyme disease, one that I had never seen or heard of. The mother, having done Internet research and communicated with others over the Lyme disease message boards, was convinced that this was her daughter's diagnosis, even though nothing in her history and exam suggested it. Yet she wouldn't relent, and waved more and more printouts at me with information to support her diagnosis. I felt pressure to cave -- after all, she was just asking me to sign a piece of paper. But there was more at stake here: If the test came back positive, her daughter would need at least six months of antibiotics. This would require her to have an intravenous line surgically placed into her body (putting her at risk for serious infections) and regular home visits from a nurse to administer the medication.
For an hour, I held my ground, eventually agreeing to look into the matter further before making a final decision. It didn't take long to learn that the test she had championed basically lowers the bar for what constitutes a diagnosis of Lyme disease, so that essentially everybody who takes it has it. Yet when I explained my concerns to her, she wouldn't have it. "There's no such thing as a false positive Lyme test," she insisted. Doctor or not, anybody who has taken a basic statistics class can tell you that it's impossible for a test to be 100 percent accurate. Before I could respond, she got angry and accused me of obstructing her child's path to health. Needless to say, we parted ways.
Experiences like that have taught me that it's still more about people than the Internet. If you are an e-patient and you see Dr. Scott Haig, you're going be upset because he called you a brainsucker instead of addressing your needs. On the other hand, if you're an e-patient like the mother of that teen, you're going to be upset because you expected your doctor to take your order like a waiter at a fancy restaurant. What patients need more of is, in Gilles Frydman's words, "respectful discourse" with their doctors. What doctors need more of is a patient's acceptance that, in Groopman and Hartzband's words, "information and knowledge do not equal wisdom."
With that in mind, we need to help the masses surf the Web wisely. The first lesson is: Don't panic. This is, perhaps, the hardest lesson to learn; countless worriers have Googled themselves into a lather over misunderstandings. But every doctor has stories of a patient who came in expecting cancer and left with nothing more than, say, a prescription for antibiotics. A parent in my practice anxiously brought in her 3-year-old son with back pain. The night before, she looked online at the diagnostic possibilities. Many were listed, but, of course, it was the most frightening ones that stuck with her: tumor, infection, degenerative neurological disease. When I examined her son, there was nothing abnormal at all. In fact, it turns out he had been squeezing into his parents' bed to sleep with them over the past few nights, the back pain nothing more than the result of sleeping in an awkward position. When I spoke with the boy's mom, I wanted her to know that, like that list she had looked at on the Web, doctors always consider a wide range of possible diagnoses, but a good history and physical will quickly narrow things down, and provide some context to relieve uncertainty and anxiety. I'm betting the next time she goes online to learn about her child's health, she will keep that in mind and perhaps shoot me an e-mail before she fights traffic and the notorious parking lot at my medical center.
It sounds mundane, but teaching Web surfers to check references that back up health claims, and to see who is sponsoring the site, could really help them separate sound advice from, say, the Huffington Post. There are also a lot of games that dubious advocacy groups play on the Web to stay visible. Google "autism" and one of the highest-ranking pages is the Autism Research Institute, which is a conglomerate of anti-vaccine groups offering "biomedical" treatments for children with the disorder, all of which cost a lot of money and none of which have been proven to work. That means it also makes a lot of sense for people to search multiple sites, and ones that aren't hyperlinked to each other so they perpetuate a single person or group's agenda. One terrific place to get these kinds of pointers is from the National Library of Medicine, which offers an online tutorial about smart ways to use the Internet to find health information. As for my own advice on where to go, you can start by looking at sites that minimize conflicts of interest and have reputations for developing and maintaining high-quality, accurate and up-to-date health content. The CDC, NIH and other government agencies fit that bill, as do multispecialty medical groups like the Mayo Clinic, Kaiser Permanente (full disclosure: I'm a Kaiser doc) and the Cleveland Clinic.
Finally, believe me when I tell you that as much as the Internet has helped patients become better informed of their health, it's helping doctors do the same, and look smart as a result. A while back a colleague of mine ran over to my office asking me if I remembered McMurray's sign. This is a maneuver one performs on the knee to check how stable it is, and whether the anterior cruciate ligament is damaged. I did not, I told him. But as I was reaching for a textbook off my shelf I stopped, spun around to face my computer, pulled up YouTube and typed in McMurray's sign. Up popped several "how to" videos. We watched one of them, and off went my colleague to try it on his own patient, giving new meaning to the medical school adage "see one, do one, teach one."
* More Rahul K. Parikh, M.D.
Consort 2010 Statement: updated guidelines for reporting parallel group randomised trials
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[[Image:|Open Access]][[Image:|Highly Access]]Research
1 Family Health International, Research Triangle Park, NC 27709, USA
2 Centre for Statistics in Medicine, University of Oxford, Wolfson College, Oxford, UK
3 Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada
The electronic version of this article is the complete one and can be found online at: http://www.trialsjournal.com/<wbr></wbr>content/11/1/32
This is an Open Access article distributed under the terms of the Creative C://ommons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
The CONSORT statement is used worldwide to improve the reporting of randomised controlled trials. Kenneth Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience.
To encourage dissemination of the CONSORT 2010 Statement, this article is freely accessible on bmj.com and will also be published in the Lancet, Obstetrics and Gynecology, PLoS Medicine, Annals of Internal Medicine, Open Medicine, Journal of Clinical Epidemiology, BMC Medicine, and Trials.
Randomised controlled trials, when appropriately designed, conducted, and reported, represent the gold standard in evaluating healthcare interventions. However, randomised trials can yield biased results if they lack methodological rigour [[|]]. To assess a trial accurately, readers of a published report need complete, clear, and transparent information on its methodology and findings. Unfortunately, attempted assessments frequently fail because authors of many trial reports neglect to provide lucid and complete descriptions of that critical information [[|]][[|]][[|]][2-4].
That lack of adequate reporting fuelled the development of the original CONSORT (Consolidated Standards of Reporting Trials) statement in 1996 [[|]] and its revision five years later [[|]][[|]][[|]][6-8]. While those statements improved the reporting quality for some randomised controlled trials, [[|]][[|]][9,10] many trial reports still remain inadequate [[|]]. Furthermore, new methodological evidence and additional experience has accumulated since the last revision in 2001. Consequently, we organised a CONSORT Group meeting to update the 2001 statement [[|]][[|]][[|]][6-8]. We introduce here the result of that process, CONSORT 2010. [[|]]
Intent of CONSORT 2010
The CONSORT 2010 Statement is this paper including the 25 item checklist in the table (Table [[|]]1) and the flow diagram (Figure [[|]]1). It provides guidance for reporting all randomised controlled trials, but focuses on the most common design type-individually randomised, two group, parallel trials. Other trial designs, such as cluster randomised trials and non-inferiority trials, require varying amounts of additional information. CONSORT extensions for these designs, [[|]][[|]][11,12] and other CONSORT products, can be found through the CONSORT website http://www.consort-statement.<wbr></wbr>org webcite. Along with the CONSORT statement, we have updated the explanation and elaboration article, [[|]] which explains the inclusion of each checklist item, provides methodological background, and gives published examples of transparent reporting.
Table 1. CONSORT 2010 checklist of information to include when reporting a randomised trial*
[[Image:|thumbnail]Figure 1.] Flow diagram of the progress through the phases of a parallel randomised trial of two groups (that is, enrolment, intervention allocation, follow-up, and data analysis).
Diligent adherence by authors to the checklist items facilitates clarity, completeness, and transparency of reporting. Explicit descriptions, not ambiguity or omission, best serve the interests of all readers. Note that the CONSORT 2010 Statement does not include recommendations for designing, conducting, and analysing trials. It solely addresses the reporting of what was done and what was found.
Nevertheless, CONSORT does indirectly affect design and conduct. Transparent reporting reveals deficiencies in research if they exist. Thus, investigators who conduct inadequate trials, but who must transparently report, should not be able to pass through the publication process without revelation of their trial's inadequacies. That emerging reality should provide impetus to improved trial design and conduct in the future, a secondary indirect goal of our work. Moreover, CONSORT can help researchers in designing their trial. [[|]]
Background to CONSORT
Efforts to improve the reporting of randomised controlled trials accelerated in the mid-1990s, spurred partly by methodological research. Researchers had shown for many years that authors reported such trials poorly, and empirical evidence began to accumulate that some poorly conducted or poorly reported aspects of trials were associated with bias [[|]]. Two initiatives aimed at developing reporting guidelines culminated in one of us (DM) and Drummond Rennie organising the first CONSORT statement in 1996 [[|]]. Further methodological research on similar topics reinforced earlier findings [[|]] and fed into the revision of 2001 [[|]][[|]][[|]][6-8]. Subsequently, the expanding body of methodological research informed the refinement of CONSORT 2010. More than 700 studies comprise the CONSORT database (located on the CONSORT website), which provides the empirical evidence to underpin the CONSORT initiative.
Indeed, CONSORT Group members continually monitor the literature. Information gleaned from these efforts provides an evidence base on which to update the CONSORT statement. We add, drop, or modify items based on that evidence and the recommendations of the CONSORT Group, an international and eclectic group of clinical trialists, statisticians, epidemiologists, and biomedical editors. The CONSORT Executive (KFS, DGA, DM) strives for a balance of established and emerging researchers. The membership of the group is dynamic. As our work expands in response to emerging projects and needed expertise, we invite new members to contribute. As such, CONSORT continually assimilates new ideas and perspectives. That process informs the continually evolving CONSORT statement.
Over time, CONSORT has garnered much support. More than 400 journals, published around the world and in many languages, have explicitly supported the CONSORT statement. Many other healthcare journals support it without our knowledge. Moreover, thousands more have implicitly supported it with the endorsement of the CONSORT statement by the International Committee of Medical Journal Editors http://www.icmje.org webcite. Other prominent editorial groups, the Council of Science Editors and the World Association of Medical Editors, officially support CONSORT. That support seems warranted: when used by authors and journals, CONSORT seems to improve reporting [[|]]. [[|]]
Development of CONSORT 2010
Thirty one members of the CONSORT 2010 Group met in Montebello, Canada, in January 2007 to update the 2001 CONSORT statement. In addition to the accumulating evidence relating to existing checklist items, several new issues had come to prominence since 2001. Some participants were given primary responsibility for aggregating and synthesising the relevant evidence on a particular checklist item of interest. Based on that evidence, the group deliberated the value of each item. As in prior CONSORT versions, we kept only those items deemed absolutely fundamental to reporting a randomised controlled trial. Moreover, an item may be fundamental to a trial but not included, such as approval by an institutional ethical review board, because funding bodies strictly enforce ethical review and medical journals usually address reporting ethical review in their instructions for authors. Other items may seem desirable, such as reporting on whether on-site monitoring was done, but a lack of empirical evidence or any consensus on their value cautions against inclusion at this point. The CONSORT 2010 Statement thus addresses the minimum criteria, although that should not deter authors from including other information if they consider it important.
After the meeting, the CONSORT Executive convened teleconferences and meetings to revise the checklist. After seven major iterations, a revised checklist was distributed to the larger group for feedback. With that feedback, the executive met twice in person to consider all the comments and to produce a penultimate version. That served as the basis for writing the first draft of this paper, which was then distributed to the group for feedback. After consideration of their comments, the executive finalised the statement.
The CONSORT Executive then drafted an updated explanation and elaboration manuscript, with assistance from other members of the larger group. The substance of the 2007 CONSORT meeting provided the material for the update. The updated explanation and elaboration manuscript was distributed to the entire group for additions, deletions, and changes. That final iterative process converged to the CONSORT 2010 Explanation and Elaboration [[|]]. [[|]]
Changes in CONSORT 2010
The revision process resulted in evolutionary, not revolutionary, changes to the checklist (Table [[|]]1), and the flow diagram was not modified except for one word (Figure [[|]]1). Moreover, because other reporting guidelines augmenting the checklist refer to item numbers, we kept the existing items under their previous item numbers except for some renumbering of items 2 to 5. We added additional items either as a sub-item under an existing item, an entirely new item number at the end of the checklist, or (with item 3) an interjected item into a renumbered segment. We have summarised the noteworthy general changes in Appendix 1 and specific changes in Appendix 2. The CONSORT website contains a side by side comparison of the 2001 and 2010 versions. [[|]]
Implications and limitations
We developed CONSORT 2010 to assist authors in writing reports of randomised controlled trials, editors and peer reviewers in reviewing manuscripts for publication, and readers in critically appraising published articles. The CONSORT 2010 Explanation and Elaboration provides elucidation and context to the checklist items. We strongly recommend using the explanation and elaboration in conjunction with the checklist to foster complete, clear, and transparent reporting and aid appraisal of published trial reports.
CONSORT 2010 focuses predominantly on the two group, parallel randomised controlled trial, which accounts for over half of trials in the literature [[|]]. Most of the items from the CONSORT 2010 Statement, however, pertain to all types of randomised trials. Nevertheless, some types of trials or trial situations dictate the need for additional information in the trial report. When in doubt, authors, editors, and readers should consult the CONSORT website for any CONSORT extensions, expansions (amplifications), implementations, or other guidance that may be relevant.
The evidence based approach we have used for CONSORT also served as a model for development of other reporting guidelines, such as for reporting systematic reviews and meta-analyses of studies evaluating interventions [[|]], diagnostic studies [[|]], and observational studies [[|]]. The explicit goal of all these initiatives is to improve reporting. The Enhancing the Quality and Transparency of Health Research (EQUATOR) Network will facilitate development of reporting guidelines and help disseminate the guidelines: http://www.equator-network.org webcite provides information on all reporting guidelines in health research.
With CONSORT 2010, we again intentionally declined to produce a rigid structure for the reporting of randomised trials. Indeed, SORT [[|]] tried a rigid format, and it failed in a pilot run with an editor and authors [[|]]. Consequently, the format of articles should abide by journal style, editorial directions, the traditions of the research field addressed, and, where possible, author preferences. We do not wish to standardise the structure of reporting. Authors should simply address checklist items somewhere in the article, with ample detail and lucidity. That stated, we think that manuscripts benefit from frequent subheadings within the major sections, especially the methods and results sections.
CONSORT urges completeness, clarity, and transparency of reporting, which simply reflects the actual trial design and conduct. However, as a potential drawback, a reporting guideline might encourage some authors to report fictitiously the information suggested by the guidance rather than what was actually done. Authors, peer reviewers, and editors should vigilantly guard against that potential drawback and refer, for example, to trial protocols, to information on trial registers, and to regulatory agency websites. Moreover, the CONSORT 2010 Statement does not include recommendations for designing and conducting randomised trials. The items should elicit clear pronouncements of how and what the authors did, but do not contain any judgments on how and what the authors should have done. Thus, CONSORT 2010 is not intended as an instrument to evaluate the quality of a trial. Nor is it appropriate to use the checklist to construct a "quality score."
Nevertheless, we suggest that researchers begin trials with their end publication in mind. Poor reporting allows authors, intentionally or inadvertently, to escape scrutiny of any weak aspects of their trials. However, with wide adoption of CONSORT by journals and editorial groups, most authors should have to report transparently all important aspects of their trial. The ensuing scrutiny rewards well conducted trials and penalises poorly conducted trials. Thus, investigators should understand the CONSORT 2010 reporting guidelines before starting a trial as a further incentive to design and conduct their trials according to rigorous standards.
CONSORT 2010 supplants the prior version published in 2001. Any support for the earlier version accumulated from journals or editorial groups will automatically extend to this newer version, unless specifically requested otherwise. Journals that do not currently support CONSORT may do so by registering on the CONSORT website. If a journal supports or endorses CONSORT 2010, it should cite one of the original versions of CONSORT 2010, the CONSORT 2010 Explanation and Elaboration, and the CONSORT website in their "Instructions to authors." We suggest that authors who wish to cite CONSORT should cite this or another of the original journal versions of CONSORT 2010 Statement, and, if appropriate, the CONSORT 2010 Explanation and Elaboration [[|]]. All CONSORT material can be accessed through the original publishing journals or the CONSORT website. Groups or individuals who desire to translate the CONSORT 2010 Statement into other languages should first consult the CONSORT policy statement on the website.
We emphasise that CONSORT 2010 represents an evolving guideline. It requires perpetual reappraisal and, if necessary, modifications. In the future we will further revise the CONSORT material considering comments, criticisms, experiences, and accumulating new evidence. We invite readers to submit recommendations via the CONSORT website. [[|]]
Uniform disclosure of potential conflicts of interest: all authors have completed the ICMJE unified competing interest form at http://www.icmje.org/coi_<wbr></wbr>disclosure.pdf webcite (available from the corresponding author) and declare (1) DM received grants for this work from Johnson & Johnson, BMJ, and American Society for Clinical Oncology; KFS and DGA received support for travel to meetings for this work from Johnson & Johnson, BMJ, and American Society for Clinical Oncology; (2) KFS and DA had travel expenses reimbursed by the EQUATOR Network; KFS has received honoraria for delivering educational presentations for the American Board of Obstetrics and Gynecology Foundation for Excellence in Women's Health Care, Ortho-McNeil Janssen Scientific Affairs, and the American College of Obstetrics and Gynecology; and has done consultancy for Wyeth. All authors also declare (3) no spouses, partners, or children with relationships with commercial entities that might have an interest in the submitted work; (4) no non-financial interests that may be relevant to the submitted work. [[|]]
KFS, DM, and DGA participated in meetings and regular conference calls, planned the CONSORT 2007 meeting at Montebello, developed the agenda, prepared background research, identified and invited participants, contributed to the CONSORT meeting, drafted the manuscript, and, after critical review by the CONSORT Group, finalised the text of the manuscript. Members of the CONSORT Group attended the meeting, except for those noted below, and provided input on and review of the revised checklist and text of this article. Some members also prepared background material. [[|]]
Appendix 1: Noteworthy general changes in CONSORT 2010 Statement
• We simplified and clarified the wording, such as in items 1, 8, 10, 13, 15, 16, 18, 19, and 21
• We improved consistency of style across the items by removing the imperative verbs that were in the 2001 version
• We enhanced specificity of appraisal by breaking some items into sub-items. Many journals expect authors to complete a CONSORT checklist indicating where in the manuscript the items have been addressed. Experience with the checklist noted pragmatic difficulties when an item comprised multiple elements. For example, item 4 addresses eligibility of participants and the settings and locations of data collection. With the 2001 version, an author could provide a page number for that item on the checklist, but might have reported only eligibility in the paper, for example, and not reported the settings and locations. CONSORT 2010 relieves obfuscations and forces authors to provide page numbers in the checklist for both eligibility and settings. [[|]]
Appendix 2: Noteworthy specific changes in CONSORT 2010 Statement
Item 1b (title and abstract)-We added a sub-item on providing a structured summary of trial design, methods, results, and conclusions and referenced the CONSORT for abstracts article [[|]].
Item 2b (introduction)-We added a new sub-item (formerly item 5 in CONSORT 2001) on "Specific objectives or hypotheses"
Item 3a (trial design)-We added a new item including this sub-item to clarify the basic trial design (such as parallel group, crossover, cluster) and the allocation ratio
Item 3b (trial design)-We added a new sub-item that addresses any important changes to methods after trial commencement, with a discussion of reasons
Item 4 (participants)-Formerly item 3 in CONSORT 2001
Item 5 (interventions)-Formerly item 4 in CONSORT 2001. We encouraged greater specificity by stating that descriptions of interventions should include "sufficient details to allow replication"[[|]]
Item 6 (outcomes)-We added a sub-item on identifying any changes to the primary and secondary outcome (endpoint) measures after the trial started. This followed from empirical evidence that authors frequently provide analyses of outcomes in their published papers that were not the prespecified primary and secondary outcomes in their protocols, while ignoring their prespecified outcomes (that is, selective outcome reporting) [[|]][[|]][4,22]. We eliminated text on any methods used to enhance the quality of measurements
Item 9 (allocation concealment mechanism)-We reworded this to include mechanism in both the report topic and the descriptor to reinforce that authors should report the actual steps taken to ensure allocation concealment rather than simply report imprecise, perhaps banal, assurances of concealment
Item 11 (blinding)-We added the specification of how blinding was done and, if relevant, a description of the similarity of interventions and procedures. We also eliminated text on "how the success of blinding (masking) was assessed" because of a lack of empirical evidence supporting the practice as well as theoretical concerns about the validity of any such assessment [[|]][[|]][23,24]
Item 12a (statistical methods)-We added that statistical methods should also be provided for analysis of secondary outcomes
Sub-item 14b (recruitment)-Based on empirical research, we added a sub-item on "Why the trial ended or was stopped" [[|]]
Item 15 (baseline data)-We specified "A table" to clarify that baseline and clinical characteristics of each group are most clearly expressed in a table
Item 16 (numbers analysed)-We replaced mention of "intention to treat" analysis, a widely misused term, by a more explicit request for information about retaining participants in their original assigned groups [[|]]
Sub-item 17b (outcomes and estimation)-For appropriate clinical interpretability, prevailing experience suggested the addition of "For binary outcomes, presentation of both relative and absolute effect sizes is recommended" [[|]]
Item 19 (harms)-We included a reference to the CONSORT paper on harms [[|]]
Item 20 (limitations)-We changed the topic from "Interpretation" and supplanted the prior text with a sentence focusing on the reporting of sources of potential bias and imprecision
Item 22 (interpretation)-We changed the topic from "Overall evidence." Indeed, we understand that authors should be allowed leeway for interpretation under this nebulous heading. However, the CONSORT Group expressed concerns that conclusions in papers frequently misrepresented the actual analytical results and that harms were ignored or marginalised. Therefore, we changed the checklist item to include the concepts of results matching interpretations and of benefits being balanced with harms
Item 23 (registration)-We added a new item on trial registration. Empirical evidence supports the need for trial registration, and recent requirements by journal editors have fostered compliance [[|]]
Item 24 (protocol)-We added a new item on availability of the trial protocol. Empirical evidence suggests that authors often ignore, in the conduct and reporting of their trial, what they stated in the protocol [[|]][[|]][4,22]. Hence, availability of the protocol can instigate adherence to the protocol before publication and facilitate assessment of adherence after publication
Item 25 (funding)-We added a new item on funding. Empirical evidence points toward funding source sometimes being associated with estimatedeatment effects [[|]] [[|]]
The CONSORT Group contributors to CONSORT 2010: DG Altman, Centre for Statistics in Medicine, University of Oxford; Virginia Barbour, PLoS Medicine; Jesse A Berlin, Johnson & Johnson Pharmaceutical Research and Development, USA; Isabelle Boutron, University Paris 7 Denis Diderot, Assistance Publique des Hôpitaux de Paris, INSERM, France; PJ Devereaux, McMaster University, Canada; Kay Dickersin, Johns Hopkins Bloomberg School of Public Health, USA; Diana Elbourne, London School of Hygiene & Tropical Medicine; Susan Ellenberg, University of Pennsylvania School of Medicine, USA; Val Gebski, University of Sydney, Australia; Steven Goodman, Journal of the Society for Clinical Trials, USA; Peter C Gøtzsche, Nordic Cochrane Centre, Denmark; Trish Groves, BMJ; Steven Grunberg, American Society of Clinical Oncology, USA; Brian Haynes, McMaster University, Canada; Sally Hopewell, Centre for Statistics in Medicine, University of Oxford; Astrid James, Lancet; Peter Juhn, Johnson & Johnson, USA; Philippa Middleton, University of Adelaide, Australia; Don Minckler, University of California Irvine, USA; D Moher, Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Canada; Victor M Montori, Knowledge and Encounter Research Unit, Mayo Clinic College of Medicine, USA; Cynthia Mulrow, Annals of Internal Medicine, USA; Stuart Pocock, London School of Hygiene & Tropical Medicine; Drummond Rennie, JAMA, USA; David L Schriger, Annals of Emergency Medicine, USA; KF Schulz, Family Health International, USA; Iveta Simera, EQUATOR Network; Elizabeth Wager, Sideview.
Contributors to CONSORT 2010 who did not attend the Montebello meeting: Mike Clarke, UK Cochrane Centre; Gordon Guyatt, McMaster University, Canada.
Funding: We received financial support from United Kingdom National Institute for Health Research and the Medical Research Council; Canadian Institutes of Health Research; Presidents Fund, Canadian Institutes of Health Research; Johnson & Johnson; BMJ; and the American Society for Clinical Oncology. DGA is supported by Cancer Research UK, DM by a University of Ottawa Research Chair, and KFS by Family Health International. None of the sponsors had any involvement in the planning, execution, or writing of the CONSORT documents. Additionally, no funder played a role in drafting the manuscript.
In order to encourage dissemination of the CONSORT 2010 Statement, this article is freely accessible on bmj.com and will also be published in the Lancet, Obstetrics and Gynecology, PLoS Medicine, Annals of Internal Medicine, Open Medicine, Journal of Clinical Epidemiology, BMC Medicine, and Trials. The authors jointly hold the copyright of this article. For details on further use, see the CONSORT website http://www.consort-statement.<wbr></wbr>org. [[|]]
[[|]]Jüni P, Altman DG, Egger M: Systematic reviews in health care: assessing the quality of controlled clinical trials.
[[|]]Chan AW, Altman DG: Epidemiology and reporting of randomised trials published in PubMed journals.
[[|]]Glasziou P, Meats E, Heneghan C, Shepperd S: What is missing from descriptions of treatment in trials and reviews?
[[|]]Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan AW, Cronin E, Decullier E, Easterbrook PJ, Von Elm E, Gamble C, Ghersi D, Ioannidis JP, Simes J, Williamson PR: Systematic review of the empirical evidence of study publication bias and outcome reporting bias.
[[|]]Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, Pitkin R, Rennie D, Schulz KF, Simel D, Stroup DF: Improving the quality of reporting of randomized controlled trials. The CONSORT statement.
[[|]]Moher D, Schulz KF, Altman DG: The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials.
[[|]]Moher D, Schulz KF, Altman DG: The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials.
[[|]]Moher D, Schulz KF, Altman D: The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials.
[[|]]Plint AC, Moher D, Morrison A, Schulz K, Altman DG, Hill C, Gaboury : Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review.
[[|]]Hopewell S, Dutton S, Yu L-M, Chan A-W, Altman DG: The quality of reports of randomised trials in 2000 and 2006: a comparative study of articles indexed by PubMed.
[[|]]Campbell MK, Elbourne DR, Altman DG: CONSORT statement: extension to cluster randomised trials.
[[|]]Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ: Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement.
[[|]]Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al.: CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials.
[[|]]Schulz KF, Chalmers I, Hayes RJ, Altman DG: Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials.
[[|]]Moher D, Pham B, Jones A, Cook DJ, Jadad AR, Moher M, Tugwell P, Klassen TP: Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses?
[[|]]Moher D, Liberati A, Tetzlaff J, Altman DG, for the PRISMA Group: Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement.
[[|]]Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, Lijmer JG, Moher D, Rennie D, de Vet HC, Standards for Reporting of Diagnostic Accuracy: Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative.
[[|]]von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP, for the STROBE Initiative: Strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies.
[[|]]Standards of Reporting Trials Group: A proposal for structured reporting of randomized controlled trials.
[[|]]Rennie D: Reporting randomized controlled trials. An experiment and a call for responses from readers.
[[|]]Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, Schulz KF, CONSORT Group: CONSORT for reporting randomised trials in journal and conference abstracts.
[[|]]Chan AW, Hróbjartsson A, Haahr MT, Gøtzsche PC, Altman DG: Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles.
[[|]]Sackett DL: Commentary: Measuring the success of blinding in RCTs: don't, must, can't or needn't?
[[|]]Schulz KF, Grimes DA: Blinding in randomised trials: hiding who got what.
[[|]]Montori VM, Devereaux PJ, Adhikari NK, Burns KE, Eggert CH, Briel M, Lacchetti C, Leung TW, Darling E, Bryant DM, Bucher HC, Schünemann HJ, Meade MO, Cook DJ, Erwin PJ, Sood A, Sood R, Lo B, Thompson CA, Zhou Q, Mills E, Guyatt GH: Randomized trials stopped early for benefit: a systematic review.
[[|]]Hollis S, Campbell F: What is meant by intention to treat analysis? Survey of published randomised controlled trials.
[[|]]Nuovo J, Melnikow J, Chang D: Reporting number needed to treat and absolute risk reduction in randomized controlled trials.
[[|]]Ioannidis JP, Evans SJ, Gøtzsche PC, O'Neill RT, Altman DG, Schulz K, Moher D, CONSORT Group: Better reporting of harms in randomized trials: an extension of the CONSORT statement.
[[|]]De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJ, Schroeder TV, Sox HC, Weyden MB: International Committee of Medical Journal Editors. Clinical trial registration: a statement from the International Committee of Medical Journal Editors.
[[|]]Lexchin J, Bero LA, Djulbegovic B, Clark O: Pharmaceutical industry sponsorship and research outcome and quality: systematic review.
[[|]]Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, Schulz KF, CONSORT Group: CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration.
[[|]]Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P: Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration.
[[|]]Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C: Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement.
[[|]]Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D, CONSORT group: Pragmatic Trials in Healthcare (Practihc) group. Improving the reporting of pragmatic trials: an extension of the CONSORT statement.
Welcome to Trials
Just like the Wikimedia Foundation that created Wikipedia, OurMed will mostly be driven by volunteers. In addition to the occasional business or technology consultant, the profile for OurMed’s volunteer community will be talented professionals that want to make bring forward the OurMed mission to the end-goal of having a global impact.
To incentivize our founders, we have created the Founding Framer Program. To date, the following folks are eligible and working toward a goal to volunteer more than 100 Communty hours:
212 444 2633 firstname.lastname@example.org
Research Specialist @ Weill Medical College
Online Database Manager @ Scientists Without Borders
I have done basic science research for over 15 years in the area of prostate cancer. During this time I have had the privilege of working on the development of monoclonal antibodies targeting prostate cancer from concept through clinical trials. This has afforded me a keen insight into development process of therapeutic drugs. In addition, a strong interest in computers has seen me pursue a graduate degree in computer science in addition to my undergraduate in Chemistry. As a result I have designed and developed a clinical trials management system in my laboratory. I am currently the Online Database Manager for Scientists Without Borders. There, I am responsible for the administration of the database and development of the web portal.
Eileen McGinn, MPH (OurMed Content Committee)
MPH/Certificate in Aging, email@example.com
Worked in international health and development for 25 years, including several years living in Africa and Asia. Currently PT Research Manager for Nathan Kline Institute, working on the interrelation of poverty and mental health and health equity for persons with disabilities. PT tutor for immigrant high school students at Manhattan Comprehensive Night and Day High School. Volunteer work for many different agencies, including health, disability, immigrant, women's, peace, international. Have written for various websites on health issues. Especially interested in translating technical work into comprehensible language, community-based participatory research and the Capabilities Framework for development and justice.
Geoff Hayden, MD (OurMed Content Committee)
Geoffhayden@gmail.com 615.479.6499 (Cell)
I am a practicing Emergency Physician, splitting time between NYC and South Carolina. I have been in academic practice since 2005 (Residency at Vanderbilt University, Fellowship at University of Pennsylvania), with an emphasis on resident education and emergency ultrasound. My interest in OurMed.org stems from a dissatisfaction regarding the abysmal state of preventive care and a general lack of health care coverage in the U.S. I see OurMed.org as an essential resource to connect patients to health information and health providers.
I imagine my role with OurMed.org in terms of producing content, recruiting other physicians for ongoing contribution, and assisting Greg with the development of a user-friendly, comprehensive clearinghouse of useful health care information.
Geoffrey E. Hayden, MD, FAAEM, FACEP
Adjunct Clinical Professor Vanderbilt University Medical Center Department of Emergency Medicine Nashville, TN Piedmont Medical Center Emergency Department Attending
222 South Herlong Ave Rock Hill, SC 29732
Vanessa Moore (OurMed Recruitment Committee Chair)
MVanellen@ourmed.org 914-665-4534 (home) 914-751-9758 (cell)
Vanessa Moore is a native New Yorker who brings 7 years recruiting experience to the Ourmed recruitment effort. She would like to leverage her experience recruiting volunteers to Ourmed, a forward thinking and progressive approach to disseminating unbiased healthcare information to the public. She has worked in both corporate and nonprofit settings including a consulting engagement for the Department of Education and most recently at the Westchester Independent Living Center, an advocacy group for people with disabilities. She studied Social Sciences at the Lincoln Center campus of Fordham University.
Stephen Press, DC, PhD (OurMed Content Committee Chair)
A practicing Chiropractic physician (33 years). Was chief physician for the "Unified Team" (former USSR) at the XVIth Winter Olympic Games in Albertville, France in 1992. Founded the World Governing body for sports Chiropractic known as "FICS", for Fédération Internationale de Chiropratique du Sport, now headquartered in Lausanne, Switzerland at the Maison Internationale du Sports, and administered in Toronto, at the World Federation of Chropractic offices. I served on the Medical commission of two IOC recognized World Sports Governing bodies; 1st as Chairman for the Fed. Int'l de Roller Sports, and then as Vice-Chairman for FIDE (Chess). Founded the website IAOCO.org, and co-founded WikiChiro.org. Today, I serve as advisor for the International Sports Chiropractic Association, which is the liaison body interacting with the World Olympian's Association. I speak, English, French, Russian and Spanish, play the cello and clarinet, compete in pool, and follow biblical archeology and do artist blacksmithing, making swords and medieval armor as hobbies.
John Volpe (OurMed Tech Committee Content Liaison)
My background is primarily in accounting, finance and business operations, primarily in the financial services industry. While I'm not a technical professional, I have participated in and managed numerous technical and business projects, primarily involving financial systems. I also worked as a management consultant for a Virginia based company that I did consulting work for the federal and state governments. I am currently retired. In addition to playing tennis and engaging in other physical activities, I volunteer my time and an Account Director with an NYC based organization that provides service grants in the form of a volunteer project team that manages strategy, financial, marketing and development projects for non-profits. My interest in this project is really from the perspective of someone who is a consumer of medical information and is interested in the efficient delivery of medical information to the public.
Richard Knipel, OurMed Content Committee
I have been a volunteer for Wikipedia and other free culture efforts for several years, with a special focus on outreach initiatives to New York area cultural institutions, such as Wikipedia classes at the New York Public Library, museum photography with Wikipedia Loves Art, and urban photography with the TOPP nonprofit with Wikis Take Manhattan. I have served as President of the nonprofit Wikimedia New York City since September 2008. I hope to bring these experiences in helping to build Ourmed into an innovative and rich online healthcare community along the wiki model.
Elise Passikoff, OurMed Tech Committee
Elise Passikoff, OurMed Tech Committee
From a background in print and educational publishing, I entered the online world as an editor and technical writer at a start-up software company. There I learned the tools of the trade and gained valuable experience in writing, editing and posting online content. In 2000, I moved to the New York Academy of Sciences [www.nyas.org], where, first as online producer and then as web senior project manager I led the development, implementation, and maintenance of complex online projects, including the ground-breaking website Scientists Without Borders [[[scientistswithoutborders.org|scientistswithoutborders.org]]].
Diane Joiner, OurMed Content Committee
I have more than 25 years experience in print publishing. I began my career in publishing with Scientific American Magazine; and then transferred to Scientific American Medicine where I was a member of the production department. While at Scientific American Medicine I produced the 2,500 page, two volume, loose-leaf for internal medicine (Scientific American Medicine), as well as the 2,200 page two volume, loose-leaf for surgery (Scientific American Surgery: Practice and Principles). In 2000 I became a member of WebMD’s Professional Publlishing Division. While at WebMD I continued to produce books, pamphlets, and on-line products.
Greg Miller, OurMed Executive Director
at OurMed firstname.lastname@example.org 212-740-1850
Have 17 years of Corporate Finance and Marketing experience for Fortune 500 companies including nine years abroad (Germany, England and Japan). I've been here in New York since 1996, always passionate about developing new brands, ideas and products. Did Marketing Analysis for ANA, a Japanese Airline, Finance for Cablevision's HD Satellite business and Revlon. Since 2005, I've been inspired by non-profits, created New York's Dance Parade and have worked on OurMed since the Fall of 2008. I'm inspired by the transparent, non-profit approach to the democratization of healthcare. OurMed has a small office at Columbia Medical Center's Audubon Business and Technology Building--Come by and visit us!
3960 Broadway (Entrance on 166th Street) Suite 301 o (212) 740-1850 c (917) 627-7155 email@example.com
Watch the OurMed Presentation: http://docs.google.com/present/edit?id=0Ad4ohgeyfGzCZGRoNnFuNW1fMzljMmh2OW5jdw&hl=en
OurMed's Board of Directors:
OurMed Board Member firstname.lastname@example.org
Florence Devouard served as one of the elected representatives to the Wikimedia Foundation Board starting June 2004, and was the Chair of the WMF Board from October 21, 2006 until July 16th, 2008. Florence was born in Versailles (France). She grew up in Grenoble, and has been living since then in several French cities, as well as Antwerpen in Belgium and Tempe in Arizona. She holds two masters, one in Agricultural Sciences (a 5-year degree in agronomical engineering (Diplome d'Ingénieur Grande Ecole) from ENSAIA and the other a postgraduate degree (DEA) in Genetics and Biotechnologies from INPL.She has been working in public research, first in flower plant genetic improvement, and second in microbiology to study the feasability of polluted soil bioremediation. She was employed until 2005 in a French company, to conceive decision-making tools in sustainable agriculture. She is now a consultant in Internet Communication Strategy. She joined the Wikipedia adventure in February 2002 and is known as a contributor under the pseudonym Anthere. Florence is 39, and lives in Clermont Ferrand with her husband Bertrand and her three children, Anne-Gaëlle aged nine, William eleven and Thomas two. On May 16 2008, Florence was made a knight in the French National Order of Merit, proposed by the Ministry of Foreign Affairs as "chair of an international foundation"
OurMed Board Secretary email@example.com
Alex Fotopoulos has served on the board since October 2008. He attended Rutgers College in New Brunswick, NJ and then received his Juris Doctor degree from Southwestern University in Los Angeles, California in 1990. He has experience as a litigation attorney and as an entrepreneur. He has held held positions as an attorney and as part of the management team of such high technology companies including AT&T Wireless, T-mobile, Nextel, Metricom, GTE Internetworking as well as small local start-up ventures. He is a licensed Attorney in New York, New Jersey and California.
OurMed Board Chair firstname.lastname@example.org
Stan Kachnowski is one of America’s distinguished scholars in health-care information policy and management having taught e-health and health-care e-business for nearly 20 years. He has authored over 100 scholarly papers and presentations for the world’s leading journals and societies in health-care technology management, informatics and e-governance. In 2003 he was elected as a Fellow in the Royal Society of Medicine in the United Kingdom for his research with the National Health Service in using handhelds to track patient data. In 1996 he was elected to the US-based College of Healthcare Information Management Executives. Stan is currently a visiting professor at the Indian Institute of Technology, New Delhi, India.
OurMed Board Treasurer Newsgirl_fl@hotmail.com
Oleta McHenry was born in Washington D.C. and grew up in Ohio. After graduating high school, she briefly attended Wright State University in Dayton, studying Political Science. She transferred to St. Petersburg College in St. Petersburg, FL and received her A.A. degree in Liberal Arts. Oleta earned her B.S. in Accounting from Florida Metropolitan University in Clearwater, FL in 2006.
Oleta worked for the Pulitzer prize winning newspaper, St. Petersburg Times as a circulation manager. After receiving her degree in accounting, she worked briefly in the insurance industry before joining the Wikimedia Foundation as the fulltime accountant of record. While at the Wikimedia Foundation, Oleta helped put in place accounting practices that would help the company in growth and development. She did not follow Wikimedia to San Francisco and now works for a large medical supply company managing the General Ledger for several regions within the United States. Oleta resides in St. Petersburg, FL and works as an accountant.