Medical Research

Talking with Certified Legal Nurse Consultants and CLNC^® students, I sometimes hear things that take my breath away. The most recent incident occurred when a student asked whether or not she could cite Wikipedia in her work product.

I’m giving her credit for at least asking in advance because there’s apparently an entire class of people who think Wikipedia is an authoritative resource. I myself use Wikipedia, but when I do I’m never sure why, because Wikipedia is nothing more than a collection of fact, fiction, opinion and speculation. It’s often moderated and edited by people who often have little or no knowledge regarding the subject matter and the content can easily be manipulated by people with an interest in the subject matter of the article.

Occasionally you’ll find a well-written and researched article, but use it for your own convenience only (and even then, cross reference what you learn). Never cite Wikipedia in your medical research to an attorney. Attorneys are used to citing the law in their briefs and legal documents. They know the difference between fact and fiction. Citing Wikipedia is the kiss of death for your professional relationship. That’s a fact.

I’m just sayin’

Pharmaceutical manufacturers have long utilized ghostwriters to help “write” scientific papers emphasizing benefits and minimizing risks of their products. This culminated in a 2010 Congressional Report calling on medical schools, journals and the National Institute of Health to limit the practice.

You’d think that would have put an end to such shady practices, but it hasn’t. A recent article in the Guardian reports that there are more than 250 companies engaged in the business of planning clinical publications for the pharmaceutical industry. There is even an International Society for Medical Publication Professionals, which claims in excess of 1,100 members dedicated to publication of medical research.

As a Certified Legal Nurse Consultant, you’ve probably heard of the NuvaRing^®. That’s the trade name for a combined hormonal contraceptive vaginal ring used for birth control. The NuvaRing has been associated with adverse side effects such as:

• Blood clots
• Cerebrovascular accidents
• Deep vein thrombosis (DVT)
• Myocardial infarction
• Pulmonary embolism
• Stroke
• Venous thromboembolism (VTE)
• And, if that’s not enough, death

Interestingly, two recent studies had completely different results. The first study, presented May 7, 2012 at the American Congress of Obstetricians and Gynecologists (ACOG) 60th Annual Clinical Meeting, found no increased risk of VTE development between the NuvaRing and combined oral contraceptives.

The second study, published May 10, 2012 by the BMJ, found a 90% higher risk of venous thrombosis in NuvaRing users.

Aside from studying different cohorts of women what accounts for the differences in results? Would you be surprised to learn that the first study was funded by Merck, one of the manufacturers of the NuvaRing while the second study, published by the BMJ, was done by a group of independent researchers? Did the funding make the difference or influence the results?

You may remember it was alleged in the Vioxx^® cases that Merck tried to influence a doctor who was getting ready to publish a medical journal article critical of Vioxx. Could this NuvaRing study be a case of a different type of influence?

As a Certified Legal Nurse Consultant, whether plaintiff or defense, don’t always believe what you read – even in a medical journal. Pay attention to the authors and their conflicting affiliations as well as who’s funding the research. Notify your attorney-client of any conflicts. And remember, when it’s too good to be true, it pays for the Certified Legal Nurse Consultant to check whether the study was paid for by the manufacturer.

I’m just sayin’,

Certified Legal Nurse Consultants know the utility of searching MEDLINE and other wonderful National Library of Medicine (NLM) databases when doing research for your legal nurse consulting work product. In case you’ve gotten rusty, this week’s Tuesday Tech Tip is a quick review on searching MEDLINE through PubMed.

Seasoned CLNC^® consultants all know that the fastest way to start their research is with PubMed. It’s easy to use and reaches out to resources beyond the NLM and it includes citations that haven’t yet been indexed by MEDLINE. It also includes OLDMEDLINE which, my CLNC^® amigos, is not the LARGE PRINT VERSION but are citations from pre-1966. The best part is the Tech Tip Tom-approved PubMed tutorials to help you sharpen your research skills.

As Sherlock Holmes said, “Watson, the game is afoot!” so is the research, get to it!

Keep on Techin’,

Tom

I asked the CLNC^® Pros to share the websites they use most often for researching their medical-related cases. I invite you to bookmark your favorites.

Agency for Healthcare Research and Quality
Offers links to clinical information and current clinical research.

American Academy of Family Physicians (AAFP)
Offers links to journals, policies, position statements, references and resources pertaining to family practice.

American Association of Critical-Care Nurses (AACN)
Provides clinical resources, standards, journals, education and certification information for the critical care nurse.

American College of Physicians (ACP) PIER^® (Physician Information and Education Resource)
Comprises over 490 modules focusing on clinical topics as well as an extensive drug database and helpful patient information. Free to ACP members.

American College of Radiology (ACR)
Outlines standard of care, quality and safety resources, clinical research and news and publications.

American Heart Association
Provides statements, guidelines, clinical updates, news, continuing education, publications and statistics.

American Medical Directors Association
Supplies links to AMDA’s publications and products, news releases and resource library. Specific sections address the interests of medical directors and physicians who practice in long term care.

American Nursing Association (ANA)
Contains the nursing scope of practice including administration.

American Society of PeriAnesthesia Nurses (ASPAN)
Contains standards, education, links and publications.

Association of periOperative Registered Nurses (AORN)
Contains education, standards of practice and peer networking for the OR nurse.

Centers for Disease Control and Prevention (CDC)
Promotes health, prevention of disease, injury and disability and preparedness for new health threats. Also provides intra-agency support and resource-sharing for cross-cutting issues and specific health threats.

CINAHL
Provides the Cumulative Index to Nursing and Allied Health Literature (CINAHL^®), the most comprehensive resource for nursing and allied health literature.

Code of Federal Regulations – Title 42 – Public Health
Presents Chapter IV – Centers for Medicare & Medicaid Services, Department of Health and Human Services.

Department of Health and Human Services Office of the Inspector General
Allows you to check on the exclusion status of a healthcare provider or facility. Contains the list of sanctions and definitions of exclusions for Medicare fraud and other sanctions.

Elder Abuse Information
Helps you recognize and fight against elder abuse. Discusses different forms of elder abuse, causes and symptoms and gives the legal rights of the elderly.

Elsevier
Contains access to a variety of science and health information, books and journals.

eMedicine
Contains peer-reviewed online medical textbooks. Physicians continually update and revise this site. The standard format for each disease or condition includes diagnosis and treatment, differential diagnoses, and a list of additional references.

Federation of State Medical Boards
Contains a databank of board actions and physician disciplinary actions. Includes links to state medical boards.

Food and Drug Administration (FDA)
Helps you investigate concerns about products in the FDA database.

Harrison’s Online
Features the complete contents of Harrison’s Principles of Internal Medicine, 17th Edition.

Health Medicine refdesk.com
Contains an alphabetical list of health and disease-related links useful as a starting point for finding medical literature and other sites.

The Health Pages
Allows you to search for a physician by name and state or by specialty practice. This site has more current contact information than other physician directory sites, particularly telephone numbers. Links to state medical boards offering physician discipline information and reports on physicians and facilities are planned for this site.

Healthcare Financing Administration
Links to Medicare, Medicaid, SCHIP and other federal search resources.

Hippocrates Magazine
Contains clinical updates in primary care and practice management with access to archives and search features.

Infusion Nurses Society (INS)
Sets the standard for infusion care.

Institute for Healthcare Improvement (IHI)
Provides access to improvement knowledge and trustworthy content focused on healthcare quality across a broad array of topics.

Institute for Safe Medicine Practices
Presents links to newsletters, educational programs, medication safety tools and resources, articles, guidelines, products lists and reports.

Johns Hopkins Division of Infectious Diseases Antibiotic Guide
Provides information about infectious diseases and antibiotics. The site requires registration (free).

The Joint Commission
Accredits and certifies more than 17,000 healthcare organizations and programs in the U.S.

The Journal of the American Medical Association (JAMA)
Offers the most widely circulated, peer-reviewed, general medical journal in the world.

Manufacturer and User Facility Device Experience Database (MAUDE)
Gives links to reports of product and device failure and other information.

Mayo Clinic
Provides online resources for diseases and medical conditions, drugs and supplements and tests and procedures.

MDLinx.com
Contains links to 40 medical specialty websites for the latest developments and access to top journals. Also offers an email subscription service to alert you to news in specialties you select.

MedBioWorld
Contains links to publishers of medical and nursing journals in all fields and a complete list of all available journals worldwide.

Medical Library Association (MLA)
Provides educational opportunities, supports a knowledgebase of health information research and works with a global network of partners to promote the importance of quality information for improved health to the healthcare community and the public.

Medical Matrix
Provides ranked, peer-reviewed and annotated clinical medicine online resources for a variety of journals, texts, diseases and medical conditions.

Medical News Today – Litigation/Medical Malpractice News
Includes news and articles published daily on lawsuits, legislation, compensation claims, pharmaceutical company disputes and more.

Medicare
The official U.S. government site for Medicare.

MediLexicon
Contains searches, information, news and resources for the medical, pharmaceutical and healthcare professional, including medical abbreviations, medical dictionary, medical news, ICD-9 search, drug search, medical equipment and surgical instruments and other searches.

MedlinePlus^®
Presents health information from the National Library of Medicine.

Medscape
Supplies medical news, full-text journal articles and resource centers.

MedTerms
Clarifies difficult medical language as defined by doctors in easy-to-understand explanations of over 16,000 medical terms.

Merck Manuals Online
Contains links to search the Merck Manual of Medical Information, Merck Manual of Geriatrics and Merck Manual of Diagnosis and Therapy.

Merck Medicus
Contains information specific to your specialty, including clinical tools, specialty textbooks, journals and professional societies.

Micromedex Healthcare Series
Contains information on drugs, diseases, acute care, toxicology and alternative medicine.

Mosby’s Nursing Consult
Offers a vast array of information relevant to nurses including 38 leading nursing textbooks, 38 leading full-text nursing journals, evidence-based nursing monographs, drug information and calculators, over 370 practice guidelines, 8,000 patient handouts, 8,000 images, “Best Practice” clinical updates, dictionary, MEDLINE, Mosby’s Index and nursing and medical news.

National Association for Home Care & Hospice
Represents the interests and concerns of home care agencies, hospices and home care aide organizations.

National Cancer Institute
Contains information on cancer topics, clinical trials, cancer statistics, research and news.

National Center on Elder Abuse (NCEA)
Helps national, state and local partners in the field be fully prepared to ensure that older Americans will live with dignity, integrity, independence and without abuse, neglect and exploitation.

National Council of State Boards of Nursing (NCBSN)
Offers links to most U.S. nurse practice acts, regulations and state boards of nursing.

National Guideline Clearinghouse
Serves as a public resource for evidence-based clinical practice guidelines.

National Hospice and Palliative Care Organization (NHPCO)
Promotes access to palliative care and to maintaining quality care for persons facing the end of life and their families.

National Patient Safety Goals (NPSGs)
Delivers outlines and chapters for all applicable programs published by the Joint Commission.

National Pressure Ulcer Advisory Panel (NPUAP)
Contains online resources for pressure ulcer staging and links to public policy, education and research of pressure ulcers.

The New England Journal of Medicine
Contains a variety of clinically relevant medical information, including clinical and research articles, analysis and opinion articles and materials for both learning and teaching.

Occupational Safety and Health Administration (OSHA)
Presents comprehensive information about OSHA regulations, services, safety programs and employee training manuals with news and an online library.

Oncologic Nurses Society (ONS)
Represents over 37,000 registered nurses and other healthcare providers dedicated to excellence in patient care, education, research and administration in oncology nursing.

Pam Pohly’s Net Guide – Medical Academies & Healthcare Professional Associations
Contains links to hundreds of healthcare societies, academies, professional organizations and associations.

PubMed
Comprises more than 19 million citations for biomedical articles from MEDLINE and life science journals. Citations may include links to full-text articles from PubMed Central or publisher web sites.

Spine Universe
Contains detailed information involving conditions, treatments and wellness surrounding the spine. Additional resources include links to clinical trials, glossary of terms, recommended textbooks about spinal anatomy, videos and animations.

STAT!Ref
Offers access to cross-searchable, full-text medical, nursing and pharmacology electronic textbooks from a wide variety of reputable authors, publishers and societies.

Surgical-Medical-New Terms Glossary
Offers the most complete list of medical products, devices and pharmaceuticals, with links to manufacturers’ websites and Food and Drug Administration information on each product.

UpToDate
Provides evidence-based, peer-reviewed-information resource for clinical knowledge and improved patient care. Available by subscription.

Wound Care Strategies
Contains products, education and news related to wound care.

Wound, Ostomy and Continence Nurses Society
Represents an international society of nurses who are experts in the care of patients with wound, ostomy or continence problems.

Wrong Diagnosis
Contains links to symptoms, diseases, diagnosis, videos, tools, misdiagnosis, doctors, hospitals, drugs and articles.

Thank you to Suzanne Arragg, RN, BSN, CDONA/LTC, CLNC; Laura M. Averette, RN, MSN, CPHRM, CLNC; Dale Barnes, RN, MSN, PhN, CLNC; Nikki J. Chuml, RNC, CCE, FMC, CLNC; Larry Frace, RN, CLNC; Margaret Gallagher, RN, BSN, MSN, CLNC; Dorene Goldstein, RNC, CLNC; Sandra Higelin, RN, MSN, CS, CWCN, CLNC; Jane Hurst, RN, CLNC; Camille Joyner, RN, CCM, CLNC and Mildred Mannion, RN, BSN, CNOR, CLNC for sharing the websites they use most to research their legal nurse consulting medical-related cases.

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Our CLNC^® Pros deliver their top techniques to boost the efficiency and thoroughness of your medical research.

1. Use only authoritative websites for medical research. Accessing research studies may require a fee which is billable to the attorney.
2. As a member of the NACLNC^® Association, Certified Legal Nurse Consultants have free access to the Internet’s preeminent legal nurse consulting resources including CLNC^® resource links, a peer-reviewed collection of hundreds of the best Internet links on medical, nursing and scientific research.
3. Simplify your medical research with the National Library of Medicine. From this site you can enter MedlinePlus^®, a comprehensive database of article summaries from international medical literature and also search biomedical journal literature from MEDLINE/PubMed.
4. Subscribe to MD Consult and conduct a minimal search for general and specific information. The site contains many authoritative and up-to-date text and journal references. As you review individual journal publications, you can search for more articles on specific topics, instead of starting a new search. This time-saver allows you to cross-reference pertinent literature and identify key search words during your original search. You can even identify literature that is critical of the researchers or their methods, sometimes with notes citing conflicting results from other studies.
5. Screen the case to analyze and prepare a brief overview of the essence of the case. This helps you focus on the relevant injuries, treatment protocols and causation issues when researching.
6. Always review the standards of any pertinent professional organization. You can identify the relevant associations through the Healthcare Standards Directory (HCS) Online. This ensures that you include these standards in your research so you don’t miss professional standards that aren’t found in your online search. For example, for an emergency room case, contact the American Board of Emergency Medicine. For an obstetrical case, contact the National Association of Neonatal Nurses and The American Congress of Obstetricians and Gynecologists. These sites offer a wealth of information. Request the information these associations publish for consumers as well. The references cited in the bibliography of any standards are also useful.
7. Decide whether you want to conduct broadly defined research or narrowly defined research. This will shape the words that you use for your research. For example “GI bleed” is more broad than “stress-related mucosal bleeding manual ventilation.”
8. Keep your beginning search simple, then do a more complex search. Sometimes the simple things are the most pertinent to the case. Don’t make it harder than it has to be. Ask yourself what you really need to find, verify or compare. Recognize when enough is enough. Gain a sense of when you’ve got enough material and move on to applying the research to the case.
9. When searching for a primary subject, such as diabetes, remember to search at the same time for related issues relevant to the case, such as decubitus. This helps you avoid duplicating your efforts later.
10. Always check the bibliography of any journal article for additional research sources. While searching for general information in texts and Internet sources, make a list of the authors who are most widely published or referenced. This list could provide additional literature sources or potential testifying experts.
11. Make note of the medications and medical products used. Then search for any drug interactions or medical device incidents that could have contributed to the case in any way. Systematically reviewing this information keeps you from overlooking any potential product liability issues resulting from defective products. If you need to research a particular drug, or medical device, don’t overlook company sponsored websites.
12. Provide copies of the research articles to the attorney and highlight relevant information in the article to emphasize what is significant and to expedite the attorney’s review.

Thanks to Suzanne Arragg, RN, BSN, CDONA/LTC, CLNC; Laura M. Averette, RN, MSN, CPHRM, CLNC; Dale Barnes, RN, MSN, PhN, CLNC; Nikki J. Chuml, RNC, CCE, FMC, CLNC; Larry Frace, RN, CLNC; Margaret Gallagher, RN, BSN, MSN, CLNC; Dorene Goldstein, RNC, CLNC; Sandra Higelin, RN, MSN, CS, CWCN, CLNC; Jane Hurst, RN, CLNC; Camille Joyner, RN, CCM, CLNC and Mildred Mannion, RN, BSN, CNOR, CLNC for sharing their strategies for researching medical-related cases.

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Certified Legal Nurse Consultants have long known that the pharmaceutical and medical device industries have a vested interest in not only making sure that their products get wide distribution on the market, but also that they gain favorable press coverage in the healthcare and mainstream media. The extent of the “full court press” they make to gain such coverage takes on different extremes. Everything from parties, trips, gifts and research sponsorships are used to help influence writers. Another popular but hidden measure is the use of ghostwriters. They are often hired by the pharmaceutical or device industries themselves to write the articles, which are then submitted under the signature of an “impartial” doctor. Sometimes the so-called “ghost” may simply have ties, such as a sponsorship from the related industry or manufacturer, but other times the ghost may actually be part of the industry being written about. Just to name a few, many of you will remember the controversy surrounding disclosures of this practice related to Fen-Phen, Vioxx^® and Premarin^®.

According to The New York Times, many major medical journals are taking baby-steps in the right direction to identify and hopefully stop this practice, while others are not yet committed to the process. The Public Library of Science in its PLoS Medicine journal has called for a “zero-tolerance” ban on such ghostwriting and has suggested various remedies, including sanctions in situations where the ghostwriting is not disclosed.

Given the fact that many medical and other healthcare providers rely on these journals for unbiased information to make decisions regarding the use of different drugs, devices and treatments or even when creating standards of care, policies and procedures, etc., the information should be free of slant, spin or other bias. But apparently this isn’t true or at least doesn’t happen as often as we would hope.

The author of an article should be the person or persons who wrote or contributed the majority of the article, not the person who signs their name to it or submits it to a medical journal or other publication. At the very least the ghosts should be disclosed in the article’s acknowledgments, contributions or references.

Unfortunately, it appears that the major medical journals have not completely adopted nor have they enforced this policy. I am also not aware of any research being done to determine whether the professional nursing journals have adopted a similar policy. Until an impartial organization looks into this, or at least until the nursing journals adopt a policy of transparency, we’ll have to assume that nursing journals have the same potential level of bias or influence as do the medical journals.

What should be done? First the journals (scientific, medical or nursing) should put into effect a sanction policy for those situations in which a ghostwriter, sponsorship or other potential for bias is later disclosed or discovered. The second is for those same journals to adopt a transparency policy which then should disclose such bias as soon as it is discovered.

It’s imperative that healthcare professionals and ultimately the consumer are able to fully trust professional journals. Until ghostwriting is “ghostbusted,” we’re not in a position to place that trust. Until that day, Certified Legal Nurse Consultants should continue to question and challenge the validity of research studies where indicated.

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