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Medical research

Medical research (or biomedical research ), also known as experimental medicine , encompasses a wide array of research, extending from " basic research " (also called bench science or bench research ), [1] – involving fundamental scientific principles that may apply to a preclinical understanding – to clinical research , which involves studies of people who may be subjects in clinical trials . Within this spectrum is applied research , or translational research , conducted to expand knowledge in the field of medicine .

Both clinical and preclinical research phases exist in the pharmaceutical industry's drug development pipelines , where the clinical phase is denoted by the term clinical trial . However, only part of the clinical or preclinical research is oriented towards a specific pharmaceutical purpose. The need for fundamental and mechanism-based understanding, diagnostics , medical devices , and non-pharmaceutical therapies means that pharmaceutical research is only a small part of medical research.

The increased longevity of humans over the past century can be significantly attributed to advances resulting from medical research. Among the major benefits of medical research have been vaccines for measles and polio , insulin treatment for diabetes , classes of antibiotics for treating a host of maladies, medication for high blood pressure , improved treatments for AIDS , statins and other treatments for atherosclerosis , new surgical techniques such as microsurgery , and increasingly successful treatments for cancer . New, beneficial tests and treatments are expected as a result of the Human Genome Project . Many challenges remain, however, including the appearance of antibiotic resistance and the obesity epidemic .

Most of the research in the field is pursued by biomedical scientists , but significant contributions are made by other type of biologists . Medical research on humans has to strictly follow the medical ethics sanctioned in the Declaration of Helsinki and hospital review board where the research is conducted. In all cases, research ethics are expected.

1.1 Basic medical research
1.2 Pre-clinical research
1.3 Clinical research
2.1 Government-funded biomedical research
2.2 US federal funding trends
2.3 Privately (industry) funded biomedical research
2.4 Conflicts of interests
2.5 Transparency laws
3.1 Ancient to 20th century in other regions
3.2 20th and 21st century in the United States
4 Regulations and guidelines
5 Flaws and vulnerabilities
6 Commercialization
7 Fields of research
9 References

Phases of medical research

Basic medical research

Example areas in basic medical research include: cellular and molecular biology , medical genetics , immunology , neuroscience , and psychology . Researchers, mainly in universities or government-funded research institutes, aim to establish an understanding of the cellular, molecular and physiological mechanisms of human health and disease.

Pre-clinical research

Pre-clinical research covers understanding of mechanisms that may lead to clinical research with people. Typically, the work requires no ethical approval, is supervised by scientists rather than physicians , and is carried out in a university or company, rather than a hospital.

Clinical research

Clinical research is carried out with people as the experimental subjects . It is generally supervised by physicians and conducted by nurses in a medical setting, such as a hospital or research clinic, and requires ethical approval.

Biomedical research and development expenditures classified by region in 2012 in billions of U.S. dollars:
Region	Total	Public	Industry
United States	119.3	48.9	70.4
Canada	5.3	3.3	2.0
Europe	81.8	28.1	53.6
Asia-Oceania	62.0	19.3	42.7
Total	268.4

Research funding in many countries derives from research bodies and private organizations which distribute money for equipment, salaries, and research expenses. United States, Europe, Asia, Canada, and Australia combined spent $265.0 billion in 2011, which reflected growth of 3.5% annually from $208.8 billion in 2004. [3] The United States contributed 49% of governmental funding from these regions in 2011 compared to 57% in 2004. [3]

In the United Kingdom , funding bodies such as the Medical Research Council derive their assets from UK tax payers, and distribute revenues to institutions by competitive research grants . The Wellcome Trust is the UK's largest non-governmental source of funds for biomedical research and provides over £600 million per year in grants to scientists and funds for research centres. [4]

In the United States, data from ongoing surveys by the National Science Foundation (NSF) show that federal agencies provided only 44% of the $86 billion spent on basic research in 2015. [5] The National Institutes of Health and pharmaceutical companies collectively contribute $26.4 billion and $27 billion, which constitute 28% and 29% of the total, respectively. Other significant contributors include biotechnology companies ($17.9 billion, 19% of total), medical device companies ($9.2 billion, 10% of total), other federal sources, and state and local governments. Foundations and charities, led by the Bill and Melinda Gates Foundation , contributed about 3% of the funding. These funders are attempting to maximize their return on investment in public health . [6] One method proposed to maximize the return on investment in medicine is to fund the development of open source hardware for medical research and treatment. [7]

The enactment of orphan drug legislation in some countries has increased funding available to develop drugs meant to treat rare conditions, resulting in breakthroughs that previously were uneconomical to pursue.

Government-funded biomedical research

Since the establishment of the National Institutes of Health (NIH) in the mid-1940s, the main source of U.S. federal support of biomedical research, investment priorities and levels of funding have fluctuated. From 1995 to 2010, NIH support of biomedical research increased from 11 billion to 27 billion [8] Despite the jump in federal spending, advancements measured by citations to publications and the number of drugs passed by the FDA remained stagnant over the same time span. [9] Financial projections indicate federal spending will remain constant in the near future. [9]

US federal funding trends

The National Institutes of Health (NIH) is the agency that is responsible for management of the lion's share of federal funding of biomedical research. [8] It funds over 280 areas directly related to health. [10] Over the past century there were two notable periods of NIH support. From 1995 to 1996 funding increased from $8.877 billion to $9.366 billion, [11] years which represented the start of what is considered the "doubling period" of rapid NIH support. [8] The second notable period started in 1997 and ended in 2010, a period where the NIH moved to organize research spending for engagement with the scientific community. [11]

Privately (industry) funded biomedical research

Since 1980 the share of biomedical research funding from industry sources has grown from 32% to 62%, [12] which has resulted in the development of numerous life-saving medical advances. The relationship between industry and government-funded research in the US has seen great movement over the years. The 1980 Bayh–Dole Act was passed by Congress to foster a more constructive relationship between the collaboration of government and industry funded biomedical research. The Bayh Doyle Act gave private corporations the option of applying for government funded grants for biomedical research which in turn allowed the private corporations to license the technology. [13] Both government and industry research funding increased rapidly from between the years of 1994–2003; industry saw a compound average annual growth rate of 8.1% a year and slowed only slightly to a compound average annual growth rate of 5.8% from 2003 to 2008. [14]

Conflicts of interests

" Conflict of interest " in the field of medical research has been defined as "a set of conditions in which professional judgment concerning a primary interest (such as a person's welfare or the validity of research) tends to be unduly influenced by a secondary interest (such as financial gain)." [15]

Regulation on industry funded biomedical research has seen great changes since Samuel Hopkins Adams declaration. In 1906 congress passed the Pure Food and Drugs Act of 1906. [16] In 1912 Congress passed the Shirley Amendment to prohibit the wide dissemination of false information on pharmaceuticals. [16] The Food and Drug Administration was formally created in 1930 under the McNarey Mapes Amendment to oversee the regulation of Food and Drugs in the United States. [16] In 1962 the Kefauver-Harris Amendments to the Food, Drug and Cosmetics Act made it so that before a drug was marketed in the United States the FDA must first approve that the drug was safe. [16] The Kefauver-Harris amendments also mandated that more stringent clinical trials must be performed before a drug is brought to the market. [17] The Kefauver-Harris amendments were met with opposition from industry due to the requirement of lengthier clinical trial periods that would lessen the period of time in which the investor is able to see return on their money. In the pharmaceutical industry patents are typically granted for a 20-year period of time, and most patent applications are submitted during the early stages of the product development. [17] According to Ariel Katz on average after a patent application is submitted it takes an additional 8 years before the FDA approves a drug for marketing. [17] As such this would leave a company with only 12 years to market the drug to see a return on their investments. After a sharp decline of new drugs entering the US market following the 1962 Kefauver-Harris amendments economist Sam Petlzman concluded that cost of loss of innovation was greater than the savings recognized by consumers no longer purchasing ineffective drugs. [17] In 1984 the Hatch-Waxman Act or the Drug Price Competition and Patent Term Restoration Act of 1984 was passed by congress. [16] The Hatch-Waxman Act was passed with the idea that giving brand manufacturers the ability to extend their patent by an additional 5 years would create greater incentives for innovation and private sector funding for investment. [18]

The relationship that exists with industry funded biomedical research is that of which industry is the financier for academic institutions which in turn employ scientific investigators to conduct research. A fear that exists wherein a project is funded by industry is that firms might negate informing the public of negative effects to better promote their product. [17] A list of studies shows that public fear of the conflicts of interest that exist when biomedical research is funded by industry can be considered valid after a 2003 publication of "Scope and Impact of Financial Conflicts of Interest in Biomedical Research" in The Journal of American Association of Medicine. This publication included 37 different studies that met specific criteria to determine whether or not an academic institution or scientific investigator funded by industry had engaged in behavior that could be deduced to be a conflict of interest in the field of biomedical research. Survey results from one study concluded that 43% of scientific investigators employed by a participating academic institution had received research related gifts and discretionary funds from industry sponsors. [12] Another participating institution surveyed showed that 7.6% of investigators were financially tied to research sponsors, including paid speaking engagements (34%), consulting arrangements (33%), advisory board positions (32%) and equity (14%). [12] A 1994 study concluded that 58% out of 210 life science companies indicated that investigators were required to withhold information pertaining to their research as to extend the life of the interested companies' patents. [12] Rules and regulations regarding conflict of interest disclosures are being studied by experts in the biomedical research field to eliminate conflicts of interest that could possibly affect the outcomes of biomedical research.

Transparency laws

Two laws which are both still in effect, one passed in 2006 and the other in 2010, were instrumental in defining funding reporting standards for biomedical research, and defining for the first time reporting regulations that were previously not required. The 2006 Federal Funding Accountability and Transparency Act mandates that all entities receiving over $25,000 in federal funds must report annual spending reports, including disclosure of executive salaries. [19] The 2010 amendment to the act mandates that progress reports be submitted along with financial reporting. [19] Data from the federal mandate is managed and made publicly available on usaspending.gov. [19] Aside from the main source, usaspending.gov, other reporting mechanisms exist: Data specifically on biomedical research funding from federal sources is made publicly available by the National Health Expenditure Accounts (NHEA), data on health services research, approximately 0.1% of federal funding on biomedical research, is available through the Coalition of Health Services Research, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, the Centers for Medicare & Medicaid Services, and the Veterans Health Administration. [20]

Currently, there are not any funding reporting requirements for industry sponsored research, but there has been voluntary movement toward this goal. [21] In 2014, major pharmaceutical stakeholders such as Roche and Johnson and Johnson have made financial information publicly available and Pharmaceutical Research and Manufacturers of America (PhRMA), the most prominent professional association for biomedical research companies, has recently begun to provide limited public funding reports. [21]

Ancient to 20th century in other regions

The earliest narrative describing a medical trial is found in the Book of Daniel , which says that Babylonian king Nebuchadnezzar ordered youths of royal blood to eat only red meat and wine for three years, while another group of youths ate only beans and water. [22] The experiment was intended to determine if a diet of vegetables and water was healthier than a diet of wine and red meat. At the experiment endpoint, the trial accomplished its prerogative: the youths who ate only beans and water were noticeably healthier. [22] Scientific curiosity to understand health outcomes from varying treatments has been present for centuries, but it was not until the mid-19th century when an organizational platform was created to support and regulate this curiosity. In 1945, Vannevar Bush said that biomedical scientific research was "the pacemaker of technological progress", an idea which contributed to the initiative to found the National Institutes of Health (NIH) in 1948, a historical benchmark that marked the beginning of a near century substantial investment in biomedical research. [23]

20th and 21st century in the United States

The NIH provides more financial support for medical research than any other agency in the world to date and claims responsibility for numerous innovations that have improved global health. [23] The historical funding of biomedical research has undergone many changes over the past century. Innovations such as the polio vaccine, antibiotics and antipsychotic agents, developed in the early years of the NIH lead to social and political support of the agency. Political initiatives in the early 1990s lead to a doubling of NIH funding, spurring an era of great scientific progress. [24] There have been dramatic changes in the era since the turn of the 21st century to date; roughly around the start of the century, the cost of trials dramatically increased while the rate of scientific discoveries did not keep pace. [24]

Biomedical research spending increased substantially faster than GDP growth over the past decade in the US, between the years of 2003 and 2007 spending increased 14% per year, while GDP growth increased 1% over the same period (both measures adjusted for inflation). [20] Industry, not-for-profit entities, state and federal funding spending combined accounted for an increase in funding from $75.5 billion in 2003 to $101.1 billion in 2007. [20] Due to the immediacy of federal financing priorities and stagnant corporate spending during the recession, biomedical research spending decreased 2% in real terms in 2008. [20] Despite an overall increase of investment in biomedical research, there has been stagnation, and in some areas a marked decline in the number of drug and device approvals over the same time period. [20]

As of 2010, industry sponsored research accounts for 58% of expenditures, NIH for 27% of expenditures, state governments for 5% of expenditures, non NIH-federal sources for 5% of expenditures and not-for-profit entities accounted for 4% of support. [20] Federally funded biomedical research expenditures increased nominally, 0.7% (adjusted for inflation), from 2003 to 2007. [20] Previous reports showed a stark contrast in federal investment, from 1994 to 2003, federal funding increased 100% (adjusted for inflation). [20]

The NIH manages the majority, over 85%, of federal biomedical research expenditures. [20] NIH support for biomedical research decreased from $31.8 billion in 2003, to $29.0 billion in 2007, a 25% decline (in real terms adjusted for inflation), while non-NIH federal funding allowed for the maintenance of government financial support levels through the era (the 0.7% four-year increase). Spending from industry-initiated research increased 25% (adjusted for inflation) over the same time period of time, from 2003 to 2007, an increase from $40 billion in 2003, to $58.6 billion in 2007. [20] Industry sourced expenditures from 1994 to 2003 showed industry sponsored research funding increased 8.1%, a stark contrast to 25% increase in recent years. [20]

Of industry sponsored research, pharmaceutical firm spending was the greatest contributor from all industry sponsored biomedical research spending, but only increased 15% (adjusted for inflation) from 2003 to 2007, while device and biotechnology firms accounted for the majority of the spending. [20] The stock performance, a measure that can be an indication of future firm growth or technological direction, has substantially increased for both predominantly medical device and biotechnology producers. [20] Contributing factors to this growth are thought to be less rigorous FDA approval requirements for devices as opposed to drugs, lower cost of trials, lower pricing and profitability of products and predictable influence of new technology due to a limited number of competitors. [20] Another visible shift during the era was a shift in focus to late stage research trials; formerly dispersed, since 1994 an increasingly large portion of industry-sponsored research was late phase trials rather than early-experimental phases now accounting for the majority of industry sponsored research. [20] This shift is attributable to a lower risk investment and a shorter development to market schedule. [20] The low risk preference is also reflected in the trend of large pharmaceutical firms acquiring smaller companies that hold patents to newly developed drug or device discoveries which have not yet passed federal regulation (large companies are mitigating their risk by purchasing technology created by smaller companies in early-phase high-risk studies). [20] Medical research support from universities increased from $22 billion in 2003 to $27.7 billion in 2007, a 7.8% increase (adjusted for inflation). [20] In 2007 the most heavily funded institutions received 20% of HIN medical research funding, and the top 50 institutions received 58% of NIH medical research funding, the percent of funding allocated to the largest institutions is a trend which has increased only slightly over data from 1994. [20] Relative to federal and private funding, health policy and service research accounted for a nominal amount of sponsored research; health policy and service research was funded $1.8 billion in 2003, which increased to $2.2 billion in 2008. [20]

Stagnant rates of investment from the US government over the past decade may be in part attributable to challenges that plague the field. To date, only two-thirds of published drug trial findings have results that can be re-produced, [25] which raises concerns from a US regulatory standpoint where great investment has been made in research ethics and standards, yet trial results remain inconsistent. Federal agencies have called upon greater regulation to address these problems; a spokesman from the National Institute of Neurological Disorders and Stroke, an agency of the NIH, stated that there is "widespread poor reporting of experimental design in articles and grant applications, that animal research should follow a core set of research parameters, and that a concerted effort by all stakeholders is needed to disseminate best reporting practices and put them into practice". [25]

Regulations and guidelines

Medical research is highly regulated. National regulatory authorities are appointed in most countries to oversee and monitor medical research, such as for the development and distribution of new drugs. In the United States, the Food and Drug Administration oversees new drug development; in Europe, the European Medicines Agency (see also EudraLex ); and in Japan , the Ministry of Health, Labour and Welfare . The World Medical Association develops the ethical standards for medical professionals involved in medical research. The most fundamental of them is the Declaration of Helsinki . The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) works on the creation of rules and guidelines for the development of new medication, such as the guidelines for Good Clinical Practice (GCP). All ideas of regulation are based on a country's ethical standards code. This is why treatment of a particular disease in one country may not be allowed, but is in another.

Flaws and vulnerabilities

A major flaw and vulnerability in biomedical research appears to be the hypercompetition for the resources and positions that are required to conduct science. The competition seems to suppress the creativity, cooperation, risk-taking, and original thinking required to make fundamental discoveries. Other consequences of today's highly pressured environment for research appear to be a substantial number of research publications whose results cannot be replicated, and perverse incentives in research funding that encourage grantee institutions to grow without making sufficient investments in their own faculty and facilities. [26] [27] [28] [29] [30] Other risky trends include a decline in the share of key research grants going to younger scientists, as well as a steady rise in the age at which investigators receive their first funding. [31]

Commercialization

After clinical research, medical therapies are typically commercialized by private companies such as pharmaceutical companies or medical device company. In the United States, one estimate found that in 2011, one-third of Medicare physician and outpatient hospital spending was on new technologies unavailable in the prior decade. [32]

Medical therapies are constantly being researched, so the difference between a therapy which is investigational versus standard of care is not always clear, particularly given cost-effectiveness considerations. [33] Payers have utilization management clinical guidelines which do not pay for "experimental or investigational" therapies, or may require that the therapy is medically necessary or superior to cheaper treatments. For example, proton therapy was approved by the FDA, but private health insurers in the United States considered it unproven or unnecessary given its high cost, although it was ultimately covered for certain cancers. [34]

Fields of research

Fields of biomedical research include:

Behavioral health
Biochemistry
Biomaterials
Cellular biology
Molecular biology
Cardiovascular
Biostatistics
Endocrinology
Epigenetics
Epidemiology
Microbiology
Nanomaterials
Neuroendocrinology
Neuroscience
Ophthalmology
Pharmacology
Preventive medicine
Psychopharmacology
Public Health
Tissue Engineering
Otolaryngology
Palliative Medicine
Animal testing
Biomedical informatics
Biomedical research in the United States
Biomedical technology
Biomedicine
Cancer research
Gain-of-function research
Medical research scientist
Medical Scientist Training Program
Pharmaceutical company
Preclinical imaging
Title 21 of the Code of Federal Regulations (US)
↑ Chakma J, Sun GH, Steinberg JD, Sammut SM, Jagsi R (January 2014). "Asia's ascent--global trends in biomedical R&D expenditures". The New England Journal of Medicine . 370 (1): 3–6. doi : 10.1056/NEJMp1311068 . PMID 24382062 .
↑ 3.0 3.1 Moses, Hamilton; Matheson, David H. M.; Cairns-Smith, Sarah; George, Benjamin P.; Palisch, Chase; Dorsey, E. Ray (2015-01-13). "The Anatomy of Medical Research: US and International Comparisons". JAMA . 313 (2): 174–89. doi : 10.1001/jama.2014.15939 . ISSN 0098-7484 . PMID 25585329 .
↑ "Henry Wellcome: from backwoods boy to medicine man" . The Guardian . 9 January 2011. Archived from the original on 11 February 2012 . Retrieved 12 June 2011 .
↑ Mervis J (9 March 2017). "Data check: U.S. government share of basic research funding falls below 50%" . Science | AAAS . Archived from the original on 7 July 2022 . Retrieved 2 July 2022 .
↑ Buchsbaum S. "How Do We Measure The Impact of Grand Challenges" . Impatient Optimists . Archived from the original on 2018-03-10 . Retrieved 2018-03-10 .
↑ Pearce JM (2017). "Maximizing returns for public funding of medical research with open-source hardware" . Health Policy and Technology . 6 (4): 381–382. doi : 10.1016/j.hlpt.2017.09.001 . Archived from the original on 2022-02-05 . Retrieved 2022-07-02 .
↑ 8.0 8.1 8.2 "National Institutes of Health (NIH)" . nih.gov . Archived from the original on 2019-10-02 . Retrieved 2022-07-02 .
↑ 9.0 9.1 Frist WH (April 2002). "Federal funding for biomedical research: commitment and benefits". JAMA . 287 (13): 1722–4. doi : 10.1001/jama.287.13.1722 . PMID 11926898 .
↑ "NIH Categorical Spending -NIH Research Portfolio Online Reporting Tools (RePORT)" . report.nih.gov . Archived from the original on 2019-02-28 . Retrieved 2018-03-10 .
↑ 11.0 11.1 Steinbrook R (April 2009). "The NIH stimulus--the recovery act and biomedical research". The New England Journal of Medicine . 360 (15): 1479–81. doi : 10.1056/NEJMp0901819 . PMID 19357402 .
↑ 12.0 12.1 12.2 12.3 Bekelman JE, Li Y, Gross CP (22 January 2003). "Scope and impact of financial conflicts of interest in biomedical research: a systematic review". JAMA . 289 (4): 454–65. doi : 10.1001/jama.289.4.454 . PMID 12533125 .
↑ Loffler A, Stern S. "The Future of the Biomedical Industry in an Era of Globalization" (PDF) . Archived (PDF) from the original on 2017-10-13 . Retrieved 2022-07-02 .
↑ Dorsey ER, de Roulet J, Thompson JP, Reminick JI, Thai A, White-Stellato Z, Beck CA, George BP, Moses H (January 2010). "Funding of US biomedical research, 2003–2008" . JAMA . 303 (2): 137–43. doi : 10.1001/jama.2009.1987 . PMC 3118092 . PMID 20068207 .
↑ Thompson DF (August 1993). "Understanding financial conflicts of interest". The New England Journal of Medicine . 329 (8): 573–6. CiteSeerX 10.1.1.466.1945 . doi : 10.1056/nejm199308193290812 . PMID 8336759 .
↑ 16.0 16.1 16.2 16.3 16.4 "Significant Dates in U.S. Food and Drug Law History" . U.S. Food and Drug Administration. Archived from the original on 4 February 2017.
↑ 17.0 17.1 17.2 17.3 17.4 Katz A. "Pharmaceutical Lemons: Innovation and Regulation in the Drug Industry" (PDF) . Archived from the original (PDF) on 2014-12-28.
↑ Rumore M (August 15, 2009). "The Hatch-Waxman Act--25 Years Later: Keeping the Pharmaceutical Scales Balanced" . www.pharmacytimes.com . Archived from the original on November 27, 2020 . Retrieved July 2, 2022 .
↑ 19.0 19.1 19.2 "Requirements for Federal Funding Accountability and Transparency Act Implementation" . hrsa.gov . 2017-04-13. Archived from the original on 2020-10-18 . Retrieved 2022-07-02 .
↑ 20.00 20.01 20.02 20.03 20.04 20.05 20.06 20.07 20.08 20.09 20.10 20.11 20.12 20.13 20.14 20.15 20.16 20.17 20.18 20.19 Dorsey ER, de Roulet J, Thompson JP, Reminick JI, Thai A, White-Stellato Z, Beck CA, George BP, Moses H (January 2010). "Funding of US biomedical research, 2003–2008" . JAMA . 303 (2): 137–43. doi : 10.1001/jama.2009.1987 . PMC 3118092 . PMID 20068207 .
↑ 21.0 21.1 "Industry and Non-Profits Join Forces to Accelerate Discovery of Therapies for Alzheimer's, Diabetes, RA, and Lupus" . policymed.com . Archived from the original on 2021-04-25 . Retrieved 2022-07-02 .
↑ 22.0 22.1 Collier R (January 2009). "Legumes, lemons and streptomycin: a short history of the clinical trial" . CMAJ . 180 (1): 23–4. doi : 10.1503/cmaj.081879 . PMC 2612069 . PMID 19124783 .
↑ 23.0 23.1 "Basic Research: the pacemaker of progress" . scienceguide.nl/ . 2012-12-06. Archived from the original on 2017-10-18 . Retrieved 2022-07-02 .
↑ 24.0 24.1 Johson J (December 23, 2013). "Brief History of NIH Funding: Fact Sheet" (PDF) . Archived (PDF) from the original on July 5, 2021 . Retrieved July 2, 2022 .
↑ 25.0 25.1 "Improving Reproducibility and Transparency in Biomedical Research" . drugabuse.gov . 2013-09-12. Archived from the original on 2019-10-18 . Retrieved 2022-07-02 .
↑ Alberts B, Kirschner MW, Tilghman S, Varmus H (April 2014). "Rescuing US biomedical research from its systemic flaws" . Proceedings of the National Academy of Sciences of the United States of America . 111 (16): 5773–7. Bibcode : 2014PNAS..111.5773A . doi : 10.1073/pnas.1404402111 . PMC 4000813 . PMID 24733905 .
↑ Kolata G (April 23, 2009). "Advances Elusive in the Drive to Cure Cancer" . The New York Times . Archived from the original on 2012-01-14 . Retrieved 2009-12-29 .
↑ Kolata G (June 27, 2009). "Grant System Leads Cancer Researchers to Play It Safe" . The New York Times . Archived from the original on 2011-06-08 . Retrieved 2009-12-29 .
↑ Leaf C (2004-03-22). "Why We're Losing The War On Cancer" . Fortune Magazine (CNN Money). Archived from the original on 2014-05-02 . Retrieved 2022-07-02 .
↑ Powell K (October 2016). "Young, talented and fed-up: scientists tell their stories" . Nature . 538 (7626): 446–449. Bibcode : 2016Natur.538..446P . doi : 10.1038/538446a . PMID 27786221 . S2CID 4465686 .
↑ Daniels RJ (January 2015). "A generation at risk: young investigators and the future of the biomedical workforce" . Proceedings of the National Academy of Sciences of the United States of America . 112 (2): 313–8. doi : 10.1073/pnas.1418761112 . PMC 4299207 . PMID 25561560 .
↑ Frakt A, Bagley N, Chandra A (2005-10-07). "Correcting signals for innovation in health care" . Brookings . Archived from the original on 2020-08-03 . Retrieved 2019-05-20 .
↑ Moses RE, Feld AD (January 2008). "Legal risks of clinical practice guidelines". The American Journal of Gastroenterology . 103 (1): 7–11. PMID 18184116 .
↑ Bekelman JE, Denicoff A, Buchsbaum J (August 2018). "Randomized Trials of Proton Therapy: Why They Are at Risk, Proposed Solutions, and Implications for Evaluating Advanced Technologies to Diagnose and Treat Cancer" . Journal of Clinical Oncology . 36 (24): 2461–2464. doi : 10.1200/JCO.2018.77.7078 . PMC 6366815 . PMID 29985746 .

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Animal testing on non-human primates
First-in-man study
Multicenter trial
Seeding trial
Vaccine trial
Risk–benefit ratio
Systematic review
Replication
Meta-analysis
Intention-to-treat analysis
Selection bias
Survivorship bias
Correlation does not imply causation
Null result
Sex as a biological variable
List of topics
Articles with hatnote templates targeting a nonexistent page
Missing redirects

Medical research (or biomedical research ), also known as experimental medicine , encompasses a broad range of investigations ranging from "basic research" (also known as bench science or bench research) – which involves the investigation of fundamental scientific principles that may be applicable to a preclinical understanding – to clinical research, which involves the investigation of individuals who may be subjects in clinical trials. Applied research, also known as translational research, is a subset of this spectrum that is undertaken to advance knowledge in the area of medicine.

Drug development pipelines in the pharmaceutical industry include both clinical and preclinical research stages, with the clinical phase being indicated by the phrase clinical trial, and the preclinical research phase being denoted by the term preclinical research phase. Only a small portion of clinical or preclinical research, on the other hand, is directed at a particular pharmacological goal or indication. Because of the need for basic and mechanism-based knowledge, diagnostics, medical devices, and nonpharmaceutical treatments, pharmaceutical research accounts for just a tiny proportion of total medical research expenditure.

It is possible to trace a major portion of the increase in human lifespan over the last century to breakthroughs made possible by medical science. Immunization against measles and polio, insulin treatment for diabetes, antibiotic classes for treating a variety of ailments, medication for high blood pressure, improved treatments for HIV/AIDS and other cardiovascular diseases, new surgical techniques such as microsurgery, and increasingly successful cancer treatments are just a few of the major benefits of medical research that have been realised. As a consequence of the Human Genome Project, it is envisaged that new and valuable tests and treatments will be developed. Numerous obstacles, such the emergence of antibiotic resistance and the obesity pandemic, continue to exist, must be addressed.

The majority of the research in this topic is carried out by biomedical scientists, although other types of biologists also make substantial contributions to the field. Medical research on people must adhere to the medical ethical standards set out in the Declaration of Helsinki, as well as the policies and procedures of the hospital where the study is being done. In all circumstances, researchers are obliged to adhere to ethical standards.

Staff Directory

En Español

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The NIH Director

Monica M. Bertagnolli, M.D., is the 17 th director of the National Institutes of Health, officially taking office on November 9, 2023.

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NIH Leadership

NIH leadership plays an active role in shaping the agency's research planning, activities, and outlook.

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Organization

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J Med Internet Res
v.17(2); 2015 Feb

Medical Wikis Dedicated to Clinical Practice: A Systematic Review

Alexandre brulet.

1 Département de médecine générale, Faculté de Médecine Lyon Est, Université Claude Bernard Lyon 1, Lyon CEDEX 08, France

2 Département de rhumatologie, Centre Hospitalier Lyon Sud, Pierre-Bénite, France

Laurent Letrilliart

3 Equipe d’Accueil 4129 « Santé Individu Société », Faculté de Médecine Laënnec, Université de Lyon, Lyon, France

Wikis may give clinician communities the opportunity to build knowledge relevant to their practice. The only previous study reviewing a set of health-related wikis, without specification of purpose or audience, globally showed a poor reliability.

Our aim was to review medical wiki websites dedicated to clinical practices.

We used Google in ten languages, PubMed, Embase, Lilacs, and Web of Science to identify websites. The review included wiki sites, accessible and operating, having a topic relevant for clinical medicine, targeting physicians or medical students. Wikis were described according to their purposes, platform, management, information framework, contributions, content, and activity. Purposes were classified as “encyclopedic” or “non-encyclopedic”. The information framework quality was assessed based on the Health On the Net (HONcode) principles for collaborative websites, with additional criteria related to users’ transparency and editorial policy. From a sample of five articles per wikis, we assessed the readability using the Flesch test and compared articles according to the wikis’ main purpose. Annual editorial activities were estimated using the Google engine.

Among 25 wikis included, 11 aimed at building an encyclopedia, five a textbook, three lessons, two oncology protocols, one a single article, and three at reporting clinical cases. Sixteen wikis were specialized with specific themes or disciplines. Fifteen wikis were using MediaWiki software as-is, three were hosted by online wiki farms, and seven were purpose-built. Except for one MediaWiki-based site, only purpose-built platforms managed detailed user disclosures. The owners were ten organizations, six individuals, four private companies, two universities, two scientific societies, and one unknown. Among 21 open communities, 10 required users’ credentials to give editing rights. The median information framework quality score was 6 out of 16 (range 0-15). Beyond this score, only one wiki had standardized peer-reviews. Physicians contributed to 22 wikis, medical learners to nine, and lay persons to four. Among 116 sampled articles, those from encyclopedic wikis had more videos, pictures, and external resources, whereas others had more posology details and better readability. The median creation year was 2007 (1997-2011), the median number of content pages was 620.5 (3-98,039), the median of revisions per article was 17.7 (3.6-180.5) and 0.015 of talk pages per article (0-0.42). Five wikis were particularly active, whereas six were declining. Two wikis have been discontinued after the completion of the study.

Conclusions

The 25 medical wikis we studied present various limitations in their format, management, and collaborative features. Professional medical wikis may be improved by using clinical cases, developing more detailed transparency and editorial policies, and involving postgraduate and continuing medical education learners.

Introduction

Access to information is a daily concern for clinicians, especially in general practice where the expertise field is particularly wide. Clinicians have to apply evidence-based knowledge as far as possible to manage varied and complex medical issues [ 1 ]. The medical information they use for practice must be accurate, readable, reliable, and up to date. As the use of primary sources requires documentary research methods and is time-consuming, clinicians usually refer to available syntheses such as practice guidelines, educational journals, or medical textbooks. However, these resources are often limited by language barriers [ 2 ], missing evidence [ 3 ], low acceptability [ 4 ], and conflicts of interest [ 5 ].

Wikis are websites characterized by a collaborative edition between users. A “wiki” is a type of content managing system differing from others in that the content is created without any defined owner [ 6 ]. Wikis belong to Web 2.0, which includes other interactive Web tools such as blogs (where users edit their own content), forums (where users discuss), and social networks (where users post comments) [ 7 ]. Since the wiki principle was initiated in 1995 on WikiWikiWeb, a site dedicated to programmers, hundreds of types of software have been developed to operate it [ 8 ]. Among them, MediaWiki is a worldwide reference that supports the 285 languages of the general encyclopedia Wikipedia. Subsequently, various medical wikis have emerged, including orphan diseases’ resources, terminology databases, care decision supports, and medical teaching resources [ 9 - 12 ]. Wikis may help to remediate other medical resources’ limitations by giving clinician communities the opportunity to build knowledge relevant to their practice [ 13 ].

The recent review of the literature about wikis and collaborative writing applications in health care by Archambault et al broadly explored use patterns, quality of information, and knowledge translation interests, and brought out a need for primary research on these applications [ 14 ]. Among the 25 articles in this review assessing the quality of the information, all but one targeted Wikipedia [ 15 ], whose medical content is controversial [ 16 - 18 ]. In the study published in 2009 by Dobrogowska-Schlebusch [ 15 ], 52 health-related wikis were included without specification of purpose or audience and assessed using the online Health Summit Working Group Information Quality tool (HSWG IQ tool) [ 19 ]. It globally showed poor quality scores, except for a few wikis having implemented expert moderation or peer reviews. The “quality of information” in a website actually refers either to its framework, including transparency and policy considerations such as in the HSWG IQ tool, or to its content, especially its scientific value. Assessing the content in wikis is problematic as it is only a snapshot of a long-lasting interaction [ 20 - 22 ].

Our study aimed at systematically reviewing medical wikis dedicated to clinical practices according to their purposes, platform, management, information framework, contributions, content, and activity.

Screening Strategy

In October 2011, we performed Google queries searching for the phrase “list of medical wikis” translated in the 10 most spoken languages on the Internet (English, Chinese, Spanish, Japanese, French, Portuguese, German, Arabic, Russian, and Korean), using the Google translation tool when necessary [ 23 ]. The phrase was expanded as far as possible within the limit of 500 resulting pages. The English query was filtered in order to remove an extensively cited page, which has been kept once for data extraction [ 24 ]. Every resulting page was browsed in order to extract Internet addresses (uniform resource locators [URLs]) linking to potentially relevant sites ( Multimedia Appendix 1 ).

Second, we searched PubMed and Web of Science (using “wiki” AND [“medic*” OR “clinic*”]) and Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS) (using “wiki”) in full texts for articles published until September 2012. Every open-access abstract and open access article was read, coupled with Web searches when necessary, in order to identify any potentially relevant URL ( Multimedia Appendix 2 ).

Finally, we included any other potentially relevant URL retrieved through Web extra-browsing or expert advice, until September 2012. One author (AB) made all data extractions of the screening.

Sites’ Inclusion and Exclusion

Websites were included if they were (1) accessible from a public Internet protocol address; (2) operating a wiki tool, defining a “wiki” as “a type of content managing system (CMS) used for collaborative edition, where the content is created without any defined owner” [ 6 ], excluding wiki-based platforms used as non-collaborative CMS, like Wikinu [ 25 ], and websites where a collaborative edition was allowed on owned contents, like Google Knols [ 26 ]; (3) aimed at building some knowledge relevant for a clinical practice, defining “clinical” as “of or relating to the bedside of a patient, the course of a disease, or the observation and treatment of patients directly” [ 27 ], excluding medical topics not directly linked to the care of patients (medical research, medical informatics, biomedical sciences, medical curriculums, pharmacology, public health), and topics not specifically interesting physicians (other health care disciplines, patient information, first aid); and (4) explicitly targeting physicians or medical students in audiences. Wikis orientated toward general public, like Wikipedia, were excluded [ 28 ]. In addition, websites were excluded if they were dysfunctional, explicitly interrupted, only aiming at displaying external resources. Some clinical-oriented wikis, like Medical Matters Wiki, were excluded as bibliographic resources [ 29 ].

The inclusion and exclusion was done by 2 authors (AB and LL), and disagreements were solved by discussion.

Sites’ Description and Assessment

All data collections from the included sites were performed in October and November 2012. The main language interface of each wiki, that is, the one having the biggest amount of content, was used as a reference to collect data. No direct contact to sites’ administrators was undertaken. The data retrieval was done by 1 author (AB), and their assessments were performed by 2 authors (AB and LL). Disagreements were solved by discussion.

Wikis’ main purposes were described on the basis of sites’ disclosures. Defining the term “encyclopedic” as a comprehensive reference work within a knowledge field [ 30 ], wikis were classified as “encyclopedic” or “non-encyclopedic” according to their statement of main purpose. Target audiences were described on the basis of sites’ disclosures, considering only physicians, medical students, and lay persons.

Platforms were described according to software, user data, ergonomics, and clinically relevant utilities, by systematically browsing sites and using their functionalities.

Management was described on the basis of sites’ disclosures and technical characteristics. The access for editing was systematically tested anonymously and after login whenever registration was possible. A user community was defined as “closed” when the editing rights accreditation was not publicly opened. The registration process was defined as “automated” when filling out a form triggered the login access, and “on credentials” when some personal information had to be first checked. In case of hierarchy between registered users, those having special rights were consistently named “super-users”, and their nomination procedure and specific roles were described. We named “administrators” those super-users having enlarged rights such as deleting or massively editing content, assigning or removing rights to users, blocking pages, blocking users, etc.

Information Framework

The Health On the Net ethical code of conduct (HONcode), as adapted for collaborative websites, was used as a reference to perform the information framework quality assessment [ 31 ]. However, the adaptation of its principle about the authoritativeness of the information only makes mandatory the disclosure of the credentials of “moderators”. The wiki context makes every editing user responsible for edited content, and in a professional context, more author details than just credentials should be disclosed. We therefore built a set of 16 criteria for assessing the information framework quality, including 11 derived from the HONcode and 5 fitted to medical wikis. An operational definition was assigned to each of these criteria, including four definitions validated by Bernstam et al ( Table 1 ) [ 32 ]. The assessment of these criteria was performed by 2 authors (AB and LL). Their agreement was measured by calculating an r correlation coefficient [ 33 ].

The 16 information framework quality criteria.

Screened criteria			Operational definition

	1	Identity (p2)	Indication of the entity that owns the information presented on the website (o1).
	2	Contact details (p6)	The webmaster or other official can be contacted. The presence of email address, telephone, fax, or online form (o2).
	3	Funding (p7)	The presence of a disclosure about owner’s funding.
	4	Conflicts of interest (p7)	The presence of a disclosure about owner’s conflicts of interest.

	5	Medical advisory statement (p2)	The presence of a statement about the value of the medical content displayed on the website.
	6	Users privacy policy (p3)	The presence of a disclosure about the management of the users’ personal information.
	7	Advertising policy (p8)	The presence of a disclosure about the advertising displayed (or not) in the website.

	8	Review policy (p1)	The presence of a claim of use of an editorial review process or the listing of an editorial review committee or medical advisory board (o3).
	9	Patients data protection rule (p3)	The presence of a rule for using patients’ data.
	10	Information referencing rule (p4)	The presence of a rule for referencing information.
	11	True statement rule (p5)	The presence of a rule for editing with honesty.
	12	Content organization rule	The presence of a rule for organizing the content.

	13	Editing users’ identity	The presence of the disclosure of the identity, mandatory for every editing user.
	14	Editing users’ credentials	The presence of the disclosure of the authority and qualification (o4), mandatory for every editing user.
	15	Editing users’ conflicts of interest	The presence of the disclosure of eventual conflicts of interest, mandatory for every editing user.
	16	Administrators’ identity	The presence of the disclosure of the identity, mandatory for every administrator.

a Criteria referring to the HONcode principles [ 31 ]: p1=Information must be authoritative; p2=Purpose of the website; p3=Confidentiality; p4=Documented information; p5=Claims justification; p6=Website contact details; p7=Funding source disclosure; p8=Advertising policy.

b Operational definitions validated by Bernstam et al [ 32 ]: o1=Disclosure of ownership; o2=Feedback mechanism provided; o3=Editorial review process; o4=Author’s credentials disclosed.

Contributions

Physicians were considered as contributors by default, except when they were not targeted in the audience. The contributions of medical learners (students or physicians) were described based on educational objectives, or when mentioned in super-users’ credentials. Lay persons’ contributions were described according to the registration requirements. The presence of clinical case reports was systematically searched by querying sites with the key word “case”. Any content reporting some clinical materials issued from users’ practice was considered.

This part of the study aimed at describing the characteristics of the contents and assessing their readability. However, the scientific value of contents in itself was not assessed. From each wiki, we selected a sample of the 5 most revised articles. Articles were included if they had a clinically relevant topic and were written in the main language of the wiki. In sites where the numbers of revisions were not available, we subjectively selected the most finalized articles. We described characteristics related to content (presence of pictures, videos, diagrams, posology details, evidence levels and external resources, and numbers of words and references per article) and data related to edition (numbers of revisions and authors per article, and related talks). The sampled articles were assessed with Flesch’s reading ease test adapted to each language and performed with automated hyphenation [ 34 ]. Characteristics of articles were compared between encyclopedic and non-encyclopedic groups by using Fisher’s exact test for qualitative data and the Wilcoxon rank test for quantitative data.

Wikis’ global activities were described on the basis of available data from sites (absolute numbers of content pages, revisions, and talk pages). Displayed numbers of users were considered globally inaccurate since we suspected tens of false user registrations across several sites, presumably due to vandalism attacks. In order to estimate annual activity, content pages were counted according to their last edition date by performing empty queries on Google, filtered on each URL, and for each year since the wiki’s creation. A recent editorial rate was estimated by reporting the number of pages last edited in the 365 previous days to that edited since creation. Rates higher than 50% were considered as “very high”, and rates lower than 10% were considered as “very low”. A recent editorial trend was estimated by reporting the number of pages last edited in the 365 previous days to that last edited in the 365 days before. Trends higher than 300% were considered as “sharply increasing” and trends lower than 33% as “sharply decreasing”.

Sites’ Screening

The Google search yielded 341 pages, including 27 linking to some potentially relevant URLs. After extraction and removing duplicates, 141 URLs were collected ( Multimedia Appendix 1 ). The literature search yielded 133 articles, 104 after removing duplicates. After identification of potentially relevant URLs and removing duplicates, 38 URLs were collected ( Multimedia Appendix 2 ). Four additional potentially relevant URLs were retrieved from other sources. Merging all results and removing duplicates, 176 potentially relevant URLs were finally collected ( Figure 1 , Multimedia Appendix 3 ).

An external file that holds a picture, illustration, etc.
Object name is jmir_v17i2e48_fig1.jpg

Site screening, exclusion, and inclusion flow diagram.

Sites’ Exclusion and Inclusion

Of the 176 collected URLs, 31 met the inclusion criteria. Six of them became inoperative during the study. Finally, 25 wikis were retained for analysis [ 35 - 59 ] ( Figure 1 ; Multimedia Appendix 3 ).

The main languages were English (19 wikis), German (3), French (2), and Chinese (1), and four wikis had a second language interface. The purpose was encyclopedic for 11 wikis, including one also aiming at reporting clinical cases. Among the 14 wikis having a non-encyclopedic purpose, five aimed at editing a textbook, three medical lessons, two oncology protocols, one a single focused article, and three at reporting clinical cases, including one also displaying a textbook-like wiki area. Whereas 16 wikis were specialized to specific themes or disciplines, nine were not. Physicians were explicitly targeted by 22 wikis, medical learners by 18, and lay persons by five ( Table 2 ).

Wikis’ purposes.

Wiki		Language	Main purpose(s)	Target audience

	Medpedia [ ]	English	Medical encyclopedia	Physicians, Learners, Laypeople
	Ganfyd [ ]	English	Medical knowledge base	Physicians
	AskDrWiki [ ]	English	Medicine	Physicians, Learners
	DocCheck Flexikon [ ]	German, English	Medical lexicon	Physicians
	Toxipedia [ ]	English, Spanish	Toxicology encyclopedia	Physicians, Learners
	EyeWiki [ ]	English	Ophthalmology encyclopedia	Physicians, Learners
	Radiopaedia [ ]	English	Radiology encyclopedia & clinical case reports	Physicians
	Wikiecho [ ]	English	Echography encyclopedia	Physicians
	wikiRadiography [ ]	English	Radiography resource	Physicians
	Pathowiki [ ]	German	Pathology encyclopedia	Physicians, Learners
	Pathpedia [ ]	English	Pathology wikibook	Physicians, Learners, Laypeople


	WikiDoc [ ]	English	Medical textbook	Physicians, Learners, Laypeople
	WardWiki [ ]	English	Junior doctors help	Physicians, Learners
	WikEM [ ]	English	Emergency Medicine point of care reference	Physicians, Learners
	Open Anesthesia [ ]	English	Anesthesia textbook & critical care manual	Physicians, Learners
	ECGpedia [ ]	English, Dutch	ECG textbook & tutorial	Physicians, Learners

	MedRevise [ ]	English	Medical course revision	Learners
	Mediwiki.fr [ ]	French	Medical course revision	Learners
	Wikia Biomedwiki [ ]	German	Bio-medical learning aid	Physicians, Learners

	Oncologik [ ]	French	Oncology protocols	Physicians
	OncoWiki [ ]	English	Oncology regimens	Physicians

	Open Medicine Live Wiki [ ]	English	Second line oral therapy in type 2 diabetes	Physicians, Learners, Laypeople

	Dermpedia [ ]	English	Dermatology knowledge and experience sharing	Physicians, Learners
	Orthochina [ ]	Chinese, English	Orthopedic clinical cases	Physicians, Learners, Laypeople
	UCLA Radiology Residents Pediatric Imaging [ ]	English	Radiology clinical cases	Learners

MediaWiki in its native form was supporting 15 sites. Three sites were hosted by online “wiki farms”, that are ready-to-use multifunctional platforms [ 60 - 62 ]. The remaining seven sites had purpose-built platforms, including two developed upon MediaWiki. As opposed to every purpose-built platform, only one site using MediaWiki natively systematically managed users’ real names and credentials. Wiki farms and purpose-built platforms included various forms of forums and social networks. Editing on MediaWiki required using a specific mark-up language, whereas all other software had a “What You See is What You Get” editing interface. Three wikis had automated links to PubMed or Cochrane library external databases. Two wikis operated a semantic management for synonyms or keywords. Two wikis provided some medical imaging facilities ( Table 3 ).

Wikis’ platform.

Wiki		Software	Purpose-built	User disclosures management	Relevant utilities

	Medpedia [ ]	MediaWiki	✓	✓
	Ganfyd [ ]	MediaWiki			Bibl. links
	AskDrWiki [ ]	MediaWiki
	DocCheck Flexikon [ ]	MediaWiki	✓	✓
	Toxipedia [ ]	Other	✓	✓
	EyeWiki [ ]	MediaWiki
	Radiopaedia [ ]	Other	✓	✓	Imaging + semantics
	Wikiecho [ ]	MediaWiki
	wikiRadiography [ ]	Online wiki farm
	Pathowiki [ ]	MediaWiki
	Pathpedia [ ]	Other	✓	✓


	WikiDoc [ ]	MediaWiki			Bibl. links + semantics
	WardWiki [ ]	MediaWiki
	WikEM [ ]	MediaWiki		✓
	Open Anesthesia [ ]	MediaWiki
	ECGpedia [ ]	MediaWiki

	MedRevise [ ]	MediaWiki
	Mediwiki.fr [ ]	MediaWiki
	Wikia Biomedwiki [ ]	Online wiki farm

	Oncologik [ ]	MediaWiki			Bibl. links
	OncoWiki [ ]	MediaWiki

	Open Medicine Live Wiki [ ]	MediaWiki

	Dermpedia [ ]	Other	✓	✓
	Orthochina [ ]	Other	✓	✓	Imaging
	UCLA Radiology Residents Pediatric Imaging [ ]	Online wiki farm

a Bibl. links=automatized links to external resources (PubMed, Cochrane, etc); Semantics=key words management; Imaging=medical imaging facilities.

Sites’ owners were non-profit organizations (n=10), individuals (n=6), private companies (n=4), scientific societies (n=2) or universities (n=2), and one could not be identified. Six wikis restricted access to their talk pages and users’ profile areas, and one wiki restricted access to its articles. Two wikis allowed any visitor to edit without registering. Registration was automated in 11 wikis, based upon credentials in 10, and limited to a closed community in four. A hierarchy between registered users existed in 14 wikis, among which three restricted the edition (or the validation of edition proposals) to super-users only. Super-users could be organized in “editorial boards” (n=9), responsible for the whole content, in “lead authors” (n=4), responsible for some articles, or in “moderators” (n=2), responding on call. Super-users were nominated without any explicit procedure in 10 wikis, subjectively in consideration of users’ credentials or activity in two wikis, and following a systematic procedure based on a score or a vote in two wikis. Super-users were divided in more than two types of roles in four wikis ( Table 4 ).

Wikis’ management.

Wiki		Governance	Edit right accreditation	Authoring structure	Super-users nomination	>2 super-user roles

	Medpedia [ ]	Universities	Super-uservonly	Lead authoring	On credentials + on score
	Ganfyd [ ]	NPO	On credentials	None	-
	AskDrWiki [ ]	NPO	Super-user only	Lead authoring	On credentials	✓
	DocCheck Flexikon [ ]	PC	(any visitor)	None	-
	Toxipedia [ ]	NPO	Automated	Editorial board	N/A
	EyeWiki [ ]	SS	On credentials	Editorial board	N/A
	Radiopaedia [ ]	PC	Automated	Editorial board	N/A
	Wikiecho [ ]	NPO	Automated	Editorial board	N/A
	wikiRadiography [ ]	Individuals	Automated	Moderators	N/A
	Pathowiki [ ]	University	On credentials	None	-
	Pathpedia [ ]	PC	Automated	Editorial board	N/A


	WikiDoc [ ]	NPO	On credentials	Editorial board	N/A	✓
	WardWiki [ ]	N/A	Closed	-	-
	WikEM [ ]	NPO	Automated	Editorial board	On credentials + editorial activity	✓
	Open Anesthesia [ ]	SS	Automated	Editorial board	N/A
	ECGpedia [ ]	NPO	On credentials	Lead authoring	N/A

	MedRevise [ ]	Individuals	On credentials	None	-
	Mediwiki.fr [ ]	Individuals	On credentials	None	-
	Wikia Biomedwiki [ ]	Individual	(any visitor)	None	-

	Oncologik [ ]	NPO	Closed	-	-
	OncoWiki [ ]	Individual	Closed	-	-

	Open Medicine Live Wiki [ ]	NPO	Automated	None	-

	Dermpedia [ ]	PC	Automated	Editorial board + lead authoring	N/A
	Orthochina [ ]	NPO	Super-user only	Moderators + editorial board	Automated + on score + vote	✓
	UCLA Radiology Residents Pediatric Imaging [ ]	Individual	Closed	-	-

a NPO=non-profit organization; PC=private company; SS=scientific society

b Proof of credentials required.

c Score based on forum contributions and edit proposals.

d Score based on a multiple choice test and forum contributions.

The owner’s identity was displayed on 19 wikis, its contact details on 21, its funding sources on 14, and its potential conflicts of interest on seven. A medical advisory statement was displayed on 17 wikis, a policy for users’ privacy on 17, and a policy about advertising on 10. A review policy was displayed on 10 wikis, a rule for the protection of patients’ data on 11, a rule for referencing information on nine, a rule for delivering true information on 11, and a rule for organizing content on five. The editing users’ identity was systematically displayed on nine wikis, their credentials on seven, their potential conflicts of interest on two, and the administrators’ identity was systematically displayed on three wikis, which were all made by students [ 51 , 52 , 59 ]. The total information framework quality score ranged from zero to 15 out of 16, with a median score of 6 ( Table 5 ). The correlation between raters was fair ( R 2 =.68). Beyond these criteria, only one wiki organized standardized peer-reviews [ 39 ].

Wikis’ information framework quality assessment.

Wiki		Owner disclosures (n=4)	Disclaimers (n=3)	Editorial policy (n=5)	User disclosures (n=4)	Total (n=16)

	Medpedia [ ]	4	3	5	3	15
	Ganfyd [ ]	3	2	2	0	7
	AskDrWiki [ ]	4	1	2	0	7
	DocCheck Flexikon [ ]	3	2	0	0	5
	Toxipedia [ ]	4	3	3	3	13
	EyeWiki [ ]	4	3	3	0	10
	Radiopaedia [ ]	4	3	4	2	13
	Wikiecho [ ]	2	2	1	0	5
	wikiRadiography [ ]	0	2	0	0	2
	Pathowiki [ ]	3	2	3	0	8
	Pathpedia [ ]	4	2	3	2	11


	WikiDoc [ ]	4	3	5	0	12
	WardWiki [ ]	0	2	3	0	5
	WikEM [ ]	2	1	0	3	6
	Open Anesthesia [ ]	3	0	2	0	5
	ECGpedia [ ]	3	2	2	0	7

	MedRevise [ ]	3	2	2	1	8
	Mediwiki.fr [ ]	2	1	1	1	5
	Wikia Biomedwiki [ ]	0	2	0	0	2

	Oncologik [ ]	2	0	1	1	4
	OncoWiki [ ]	1	1	0	0	2

	Open Medicine Live Wiki [ ]	0	0	0	0	0

	Dermpedia [ ]	3	2	2	2	9
	Orthochina [ ]	1	2	1	2	6
	UCLA Radiology Residents Pediatric Imaging [ ]	2	1	1	1	5

Physicians were considered as contributors by default in all wikis except the three made by and for students [ 51 , 52 , 59 ]. Medical learners contributed according to a formal educational goal on four wikis, and as super-users on five wikis. Lay persons contributed to four wikis. Clinical cases were reported on nine wikis ( Table 6 ).

Wikis’ contributions.

Wiki		Lay people	Learners	Formal educational goal	Clinical case reports

	Medpedia [ ]				✓
	Ganfyd [ ]
	AskDrWiki [ ]
	DocCheck Flexikon [ ]	Free edition
	Toxipedia [ ]	Registered only
	EyeWiki [ ]
	Radiopaedia [ ]				✓
	Wikiecho [ ]
	wikiRadiography [ ]				✓
	Pathowiki [ ]		PG		✓
	Pathpedia [ ]


	WikiDoc [ ]				✓
	WardWiki [ ]
	WikEM [ ]		PG	✓
	Open Anesthesia [ ]		PG	✓
	ECGpedia [ ]		PG		✓

	MedRevise [ ]		UG		✓
	Mediwiki.fr [ ]		UG + PG
	Wikia Biomedwiki [ ]	Free edition	UG

	Oncologik [ ]
	OncoWiki [ ]

	Open Medicine Live Wiki [ ]	Registered only

	Dermpedia [ ]				✓
	Orthochina [ ]		CME	✓	✓
	UCLA Radiology Residents Pediatric Imaging [ ]		PG	✓	✓

a UG=undergraduate, PG=postgraduate, CME=practicing physicians in continuing medical education.

As only one wiki displayed a single article and another did not allow access to its relevant content, 116 articles were sampled, including 58 most revised and 58 most finalized. Numbers of authors were not available for five encyclopedic articles. Numbers of revisions and of authors were not available for five non-encyclopedic articles. Pictures, videos, and external resources were more frequent in articles from encyclopedic wikis. Posology details were more frequent in articles from non-encyclopedic wikis ( P <.01). The Flesch reading ease scores were lower in encyclopedic wikis ( Table 7 ).

Features of content, of edition, and readability of articles according to wiki purpose (N=116 articles).

Wiki purpose		Encyclopedic (n=55)	Non-encyclopedic (n=61)	value
		n (%) or median (min-max)	n (%) or median (min-max)

	Pictures, n (%)	33 (60.0)	23 (37.7)	.025
	Videos, n (%)	7 (12.7)	0 (0.0)	.004
	Diagrams, n (%)	3 (5.5)	8 (13.1)	.211
	Posology, n (%)	5 (9.1)	24 (39.3)	< .001
	Evidence levels, n (%)	0 (0.0)	2 (3.3)	.497
	External resources, n (%)	33 (60.0)	21 (34.4)	.009
	References, median (min-max)	3 (0-87)	2 (0-105)	.400
	Words, median (min-max)	1248 (94-4945)	654 (38-16265)	.353

	Revisions	40 (2-261)	40.5 (2-516)	.953
	Authors	3 (1-34)	3 (1-6)	.067
	Talks	0 (0-24)	0 (0-2)	.099

	Flesch’s reading ease score	26.1 (-11.4-50.6) (college graduate)	33.9 (-55.5-87.6) (college)	.041

Wikis had been created between 1997 and 2011 (median year: 2007). Content pages per wiki varied from 3 to 98,039 (median 620.5), revisions per content page from 3.6 to 180.5 (median 17.7), and talk pages per content page from 0 to 0.42 (median 0.015). Among five particularly active wikis, three had a high previous year editorial rate and three a sharply increasing editorial trend. Among six wikis almost unused, six had a low previous year editorial rate, and three a sharply decreasing editorial trend. The activity of one wiki having a sharply increasing trend upon a very low previous editorial rate was not interpreted ( Table 8 ). Two wikis included in this review were discontinued after the completion of the study [ 35 , 47 ].

Wikis’ activities.

Wiki		Year of creation	Content pages	Revisions / content pages	Talk pages / content pages	2011-12 editorial rate , %	2010-12 editorial trend

	Medpedia [ ]	2002	4000	85.3	0.02	36	→
	Ganfyd [ ]	2005	7979	6.7	0.14	18	→
	AskDrWiki [ ]	2006	1406	4.8	< 0.01	4	→
	DocCheck Flexikon [ ]	2002	18,017	8.5	0.02	73	↗
	Toxipedia [ ]	2006	1910	N/A	N/A	34	→
	EyeWiki [ ]	2010	142	79.2	0.20	41	→
	Radiopaedia [ ]	2005	5131	N/A	N/A	44	→
	Wikiecho [ ]	2007	N/A	N/A	N/A	N/A	N/A
	wikiRadiography [ ]	2006	1730	N/A	N/A	10	↘
	Pathowiki [ ]	2010	425	11	< 0.01	27	→
	Pathpedia [ ]	2006	N/A	N/A	N/A	0	N/A


	WikiDoc [ ]	2006	98,039	6.7	< 0.01	38	↗
	WardWiki [ ]	2010	324	11.4	0	0	↘
	WikEM [ ]	2010	126	N/A	0.01	64	→
	Open Anesthesia [ ]	2008	1023	N/A	0.02	60	→
	ECGpedia [ ]	2006	1241	17.7	0.02	16	→

	MedRevise [ ]	2008	597	21.8	0.01	8	→
	Mediwiki.fr [ ]	2008	216	29.4	0.02	32	↗
	Wikia Biomedwiki [ ]	2006	75	36.0	0.02	4	↗

	Oncologik [ ]	2011	152	180.5	0.42	48	→
	OncoWiki [ ]	2011	112	3.6	0.01	N/A	N/A

	Open Medicine Live Wiki [ ]	2011	3	29.0	0	0	↘

	Dermpedia [ ]	2008	601	N/A	N/A	18	→
	Orthochina [ ]	1997	N/A	N/A	N/A	N/A	N/A
	UCLA Radiology Residents Pediatric Imaging [ ]	2008	640	N/A	0	17	→

a Estimated with Google.

b [Last year edited pages]/[total pages]: >50%=high rate; <10%=low rate

c [Last year edited pages ]/[year before edited pages]: ↗=sharply increasing trend (>300 %); ↘=sharply decreasing trend (<33 %); →=stable trend.

Principal Findings

From this international review, we identified 25 medical wikis dedicated to clinical practices. The majority were in English and four were bilingual. They had various purposes, dominated by encyclopedic perspectives (44%), and most were specialized (64%). The MediaWiki software was commonly used (68%), often in its native form (60%). Site owners were mostly non-profit organizations (40%) and individuals (24%); only two were universities. While practicing physicians were major contributors (88%), medical learners (36%) and lay persons (16%) sometimes contributed.

Cross-reading our results, the relevancy for clinicians of the medical wikis can be discussed according to four information properties: accuracy, readability, reliability, and currency. Accuracy may be impaired in wikis not displaying a review policy (60%) and in those not delivering rules for organizing content (80%) [ 63 , 64 ]. The articles from encyclopedic wikis presented characteristics less relevant for professional use than the others, including more pictures, videos, and external resources but fewer posology details. The Flesch reading ease scores were globally low, especially for encyclopedic articles. In regard to reliability, 64% of wikis fulfilled less than half of the information framework quality criteria. In addition, articles were poorly referenced, and evidence level notifications were exceptional. Finally, 88% of the wikis had fewer than 50% of articles revised in the last year, and 24% of the sites were almost unused.

Strengths and Limitations

Our review may not have been exhaustive as the Google search was restricted to lists of medical wikis and several sites reported in the health literature were not accessible. Furthermore, the Web 2.0 field is rapidly changing, and some new medical wikis may have emerged since October 2012. Re-browsing the lists of medical wikis used in this study, we found only one relevant wiki after the inclusion period: the Australian Cancer Guidelines Wiki [ 65 ]. Among the 25 included sites, Medpedia and WardWiki have been discontinued [ 35 , 47 ], and a few changes occurred in the structure of the others: Open Anesthesia has been reorganized [ 49 ], WikiEcho and MedRevise changed their “skin” [ 42 , 51 ], and Oncologik added a missing link to its owner [ 54 ].

Among the tools available for assessing the quality of health information on websites, none is currently validated and none is fitted either to wikis or to a professional audience [ 66 , 67 ]. The HSWG IQ tool does not take into account collaborative features, as acknowledged by Dobrogowska-Schlebusch [ 15 ], and it has been removed from the Web [ 19 ]; the DISCERN tool targets health consumers and is restricted to information on treatments [ 68 ]; and the Bomba and Land Index has also been designed for health consumers [ 69 ]. Numerous items are common between these questionnaires and major guidelines such as the eHealth code of ethics [ 70 ], the American Medical Association guideline [ 71 ], or the eEurope 2002 quality criteria [ 72 ]. The HONcode ethical code of conduct is unique to provide specifications for collaborative websites [ 31 , 73 ]. For example, the item “is the information referenced?” will be transposed for collaborative websites as “is there a statement asking platform users to give references to the information they provide?”. Such specifications do not directly apply to the content, but indirectly through the editorial framework. However, the right influence of the framework on the content deserves to be investigated in future research projects.

The relevancy of low readability scores, corresponding to college and higher, is arguable since medical doctors have de facto a high level of reading. It has been long demonstrated that readability impacts both the understanding and the cross-reading ability, even for highly educated readers [ 74 ], and the need for simplicity is expressed by clinicians themselves for practice guidelines [ 4 ]. The relevancy of the Flesch reading ease test for medical writings is also debatable, but more specific tools are not yet validated [ 75 ]. Although it includes adjustment parameters adapted to several languages [ 34 ], a linguistic bias cannot be excluded in this study since multilingual comparisons have not been documented.

To check the validity of the estimation of annual editorial activities using Google, we measured the agreement between the number of content pages declared on the site and the corresponding estimate from the Google search engine, for 20 wikis. Although there was a strong agreement (Spearman correlation coefficient=.88, P <.001), automated page creation and vandalism may bias both figures.

Unmet Clinical Needs

Our results suggest that no medical wiki meets all four information properties needed by clinicians. The encyclopedic format does not seem to fit in terms of both accuracy and readability. However, whatever the wikis’ purposes, the organization of contents is often unclear, apart from very focused purposes such as oncology protocols, where the knowledge granularity is adapted to a particular audience [ 54 ]. The Medical Subject Headings (MeSH) indexing system is sometimes integrated, but it requires specific training for contributors, which is challenging in a multi-authoring context [ 76 ]. Whereas some semantic utilities can help manage indexation constraints [ 10 , 77 ], add-ons aimed at improving either medical knowledge management or ergonomics are rarely implemented in medical wikis. If such gaps impact both accuracy and readability, they may also hamper the involvement of users. Contrary to pure knowledge content, the frequent clinical case reports in medical wikis, supporting the emergence of concrete questions of practice, are likely to meet strong clinical interest.

Reliability is widely, and sometimes critically, impaired by lack of management. Although authoring transparency requires both technical and policy supports [ 5 ], our framework assessment particularly shows gaps in users’ disclosures and editorial policies. Since almost only purpose-built platforms are able to manage detailed user data, technical issues are important. Among open communities, only 48% of medical wikis ask for credentials to register, with two requiring some proof [ 35 , 36 ]. As an alternative, users’ medical skills can be assessed during an automated registration including medical tests [ 58 , 78 ]. Interestingly, the fully opened Wikipedia’s articles are commonly consulted by clinicians and medical students [ 79 ], while their relevancy has been recurrently questioned [ 7 , 14 , 16 - 18 , 21 ]. However, Wikipedia, including its Wikiproject Medicine, cannot respond to specific clinical needs as it does not target any specific audience [ 28 ]. As an encyclopedic media, it is also likely to meet the limitations highlighted in this study.

In most wikis, weak and poorly collaborative activity jeopardizes content updates. The talk pages, when available, are exceptionally used, and the discussion threads included in forums or social networks are not directly connected to content pages [ 80 ]. As a consequence, adversarial debates are lacking, although they are a foundation for building evidence [ 3 ].

The Open Community Challenge

Users’ regulation in wikis is complex since the lower the control of their editors, the higher their growth [ 81 ]. For example, Wikipedia’s English article on atrial fibrillation has been revised approximately 1345 times and discussed 150 times [ 82 ], and the article on the recent drug dabigatran 555 times and 35 times respectively [ 83 ]. Apart from the severe reliability issues due to anonymity in Wikipedia [ 84 ], it has been shown that its development, based only on volunteering, leads articles to be unevenly readable, complete, and reliable [ 17 , 20 , 85 ]. In our study, we paradoxically observed the highest page revision and discussion levels in a small wiki reserved to a closed community [ 54 ]. This finding suggests that a strong user commitment can overcome volunteering limitations.

Although multi-authoring requires a thorough organization [ 86 ], communities attached to medical wikis are often poorly structured. Super-user nominations are usually opaque, and only one wiki provides a standardized peer-review process [ 39 ]. As implemented in two wikis, the extent of users’ rights can depend on their participation level [ 35 , 58 ], which represents a reward for authors [ 87 ]. However, in order to open scientific debates, the organization of bottom-up relations between users should be further considered [ 88 ]. In this way, the public expertise promoted by Wikipedia, which is based on consensus, uses a complex and democratic moderation system, detailed editorial rules, and standardized peer-reviews [ 21 ].

While the HONcode principle about the authoritativeness of the information protects the moderators’ privacy by allowing their anonymity [ 31 ], it cannot guarantee the trustworthiness of what they have written [ 84 , 89 ]. The professional scope of our review highlights a lack of audience specifications in health information quality initiatives, in particular for collaborative applications where readers and writers are mixed altogether. The extensive review of social media by Grajales et al provides a useful tutorial for health care professional end users, which may be a first step to building more detailed guidelines for professional health information on the Internet [ 7 ]. Indeed, some professional knowledge may generate adverse outcomes, as information on drugs with potential for misuse is commonly sought on the Internet [ 90 ]. Therefore, as included in the wikiproject Medicine of Wikipedia [ 21 ], a policy specifying the nature and the limits of publicly accessible content is critical, and a model for displaying health information is needed [ 67 , 73 ].

Educational Value Added

Among eight medical wikis including learners’ contributions, five include spontaneous undergraduate or postgraduate students’ contributions. The three others have a formal educational goal, targeting postgraduate students or practicing physicians in continuous medical education [ 49 , 58 , 59 ]. Educational goals may represent an alternative to mere volunteering since learners’ contributions can be part of their curricula. As works performed in training are frequently based on clinical cases as starting points for gathering scientific evidence [ 91 , 92 ], the wiki principle seems particularly fitted to archive, share, discuss, and gradually improve the related materials [ 93 ]. From a theoretical point of view, the wiki medium, as an asynchronous communication tool, embodies learning principles based on constructivism and cooperation [ 94 ]. Nevertheless, if Internet-based educational programs can be an alternative to live interactive workshops [ 95 ], the effectiveness of collaborative writing applications in medical education requires further research [ 12 , 14 ].

The 25 medical wikis reviewed present various limitations in their format, management, and collaborative features. Encyclopedic wikis have less accurate and readable content. Reliability is widely impaired by lack of transparency. Currency is commonly jeopardized by low editorial activity. Professional medical wikis may be improved by using clinical cases, developing more detailed transparency and editorial policies, and involving postgraduate and continuing medical education learners.

Acknowledgments

We would like to thank Ewa Dobrogowska-Schlebusch for sharing her original work; Meik Michalke for improving the koRpus package of the R cran project; Martin Wedderburn for providing English editorial help; and Patrick M Archambault and Tom H Van de Belt for their valuable external review. We are grateful to the College of teaching general practitioners of Lyon (CLGE) to have supported this work.

Abbreviations

CMS	Content Managing System
HONcode	Health On the Net code of ethics
HSWG IQ tool	Health Summit Working Group Information Quality tool
MeSH	Medical Subject Headings
URL	Uniform Resource Locator

Multimedia Appendix 1

Google search.

Multimedia Appendix 2

Literature search.

Multimedia Appendix 3

Site exclusions and inclusions.

Conflicts of Interest: None declared.

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