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EditorialEditorials

Assessing Clinical Discoveries

Ian R. McWhinney
The Annals of Family Medicine January 2008, 6 (1) 3-5; DOI: https://doi.org/10.1370/afm.801
Ian R. McWhinney
OC, MD, FRCGP, FCFP, FRCP
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  • Open access journals: Re: Commentary on Assessing Clinical Discoveries
    Laura A. McLellan
    Published on: 28 March 2008
  • To humanize our profession: Single Patient Based Medicine.
    Sergio Stagnaro
    Published on: 08 March 2008
  • Clinical discoveries, randomized controlled trials and surveys.
    Rodolfo J. Stusser
    Published on: 24 February 2008
  • Clinical Insights, Inquiries, and Discoveries
    Allen J Daugird
    Published on: 30 January 2008
  • Commentary on Assessing Clinical Discoveries
    Robert P. Blankfield
    Published on: 20 January 2008
  • Why clinicians don't (or can't) do research
    Michelle Greiver
    Published on: 20 January 2008
  • �Clinical Discoveries�: Remedy for lack of published clinical research in the Annals
    David L. Hahn
    Published on: 19 January 2008
  • Published on: (28 March 2008)
    Page navigation anchor for Open access journals: Re: Commentary on Assessing Clinical Discoveries
    Open access journals: Re: Commentary on Assessing Clinical Discoveries
    • Laura A. McLellan, Cleveland, OH, USA

    This response to Dr. Blankfield's comments regarding open-access journals is written as a personal statement, not as a representative of the Annals of Family Medicine. As a librarian/information specialist (and current member of the medical publishing community) I have been monitoring the open access movement for years. The phrase "open access" is often used inconsistently, which contributes to confusion about its definition....

    Show More

    This response to Dr. Blankfield's comments regarding open-access journals is written as a personal statement, not as a representative of the Annals of Family Medicine. As a librarian/information specialist (and current member of the medical publishing community) I have been monitoring the open access movement for years. The phrase "open access" is often used inconsistently, which contributes to confusion about its definition. The open access movement's most important goals are to offer free online public access to published research, and to reduce copyright restrictions.

    Philosophy professor Peter Suber, PhD, JD, a prominent member of the open access movement, offers a concise definition: "Putting peer-reviewed scientific and scholarly literature on the internet. Making it available free of charge and free of most copyright and licensing restrictions. Removing the barriers to serious research."[1] More expansive introductions to open access are available at www.earlham.edu/~peters/fos/.

    Many scientific and medical open access journals are peer-reviewed and have large readerships. Significantly more journals have embraced a major aspect of the movement: allowing free online public access to peer-reviewed literature. Entrez PubMed is part of the open access timeline, as is the more recent PubMed Central. As of 25 March 2008, PubMed Central lists 407 journals with content freely available in the PMC digital archive.[2] Some of these journals are true open-access publications with non-traditional copyright/licensing "that generally allows more liberal redistribution and reuse than a traditional copyrighted work,"[3] although the majority currently maintain traditional copyright restrictions while offering free content to anyone in the world with Internet access.

    To summarize, open access and peer review are separate issues. Authors and readers cannot assume that an open-access medical journal is not peer-reviewed or that it has automatically has low readership. For instance, all research articles in journals published by BioMed Central (BMC) and PLoS (Public Library of Science) are peer-reviewed before publication.[4,5] They are major publishers of widely-read (and cited) scientific literature.[6,7] Free digital peer-reviewed content, restricted by traditional copyright, is available from many other respected journals - such as the Annals of Family Medicine, BMJ, New England Journal of Medicine, and The Lancet - whether complete and immediate free access (AFM), immediate free access to certain content (Lancet), or a combination of delayed free access and immediate free access to some content (BMJ, NEJM). The open access movement is rapidly gaining momentum, and should not be underestimated or dismissed.

    1. Suber P. Open Access News. www.earlham.edu/~peters/fos/fosblog.html. Accessed 25 March 2008.
    2. PubMed Central Journals — Full List. www.pubmedcentral.nih.gov/fprender.fcgi?cmd=full_view. Accessed 25 March 2008.
    3. PMC Open Access Subset. www.pubmedcentral.nih.gov/about/openftlist.html. Accessed 25 March 2008.
    4. BioMed Central: about us: What is BioMed Central? www.biomedcentral.com/info/about/whatis. Accessed 25 March 2008.
    5. Public Library of Science: FAQs: Questions about the PLoS journals. www.plos.org/about/faq.html#plosjournals. Accessed 25 March 2008.
    6. BioMed Central: about us: General FAQ: 8. Do journals published by BioMed Central have Impact Factors and are their citations tracked? www.biomedcentral.com/info/about/faq?name=impactfactor. Accessed 25 March 2008.
    7. Public Library of Science: Which is the right journal for my research? www.plos.org/journals/journals.php. Accessed 25 March 2008.

    This comment is a personal contribution. It was not written to represent the AFM editorial team.

    Competing interests:   My salary is funded by the Annals of Family Medicine, Inc.

    Show Less
    Competing Interests: None declared.
  • Published on: (8 March 2008)
    Page navigation anchor for To humanize our profession: Single Patient Based Medicine.
    To humanize our profession: Single Patient Based Medicine.
    • Sergio Stagnaro, Riva Trigoso (Genova )Italy

    This paper is really fascinating and intriguing, and I like underscore only a paramount statement:"Because every patient is different, we know them as individuals." WE, i.e., General Practitioners.For the first time, I communicated earlier to my colleagues, in a intentionally provocative way, the existence of Single Patient Based Medicine (SPBM) by an e-letter to BMJ.com, in May 2003, cited by website “Planning for the EU...

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    This paper is really fascinating and intriguing, and I like underscore only a paramount statement:"Because every patient is different, we know them as individuals." WE, i.e., General Practitioners.For the first time, I communicated earlier to my colleagues, in a intentionally provocative way, the existence of Single Patient Based Medicine (SPBM) by an e-letter to BMJ.com, in May 2003, cited by website “Planning for the EU public Health Portal” at the URL:

    http://europa.eu.int/comm/health/ph_information/documents/ev_20030710_co01_en.pdf, although in every my pubblication, in internet or in paper reviews, such as theory was implicitly present from both epistemological and practical utilization view-point (See in this website www.semeioticabiofisica.it).It appears clear that I do not intend absolutely to set SPBM against EBM.

    On the contrary, in my opinion, the two theories must interact, since they complete and integrate each with the other, deriving certainly a great utility for physicians, patients, and National Health Services, as allows me to state 52-year-long clinical experience (1,2).

    1. Stagnaro Sergio. Single Patient Based Medicine: its paramount role in Future Medicine. Public Library of Science. http://medicine.plosjournals.org/perlserv/?request=read-response 2005 2. Stagnaro S., Stagnaro-Neri M., Single Patient Based Medicine.La Medicina Basata sul Singolo Paziente: Nuove Indicazioni della Melatonina. Ed.Travel Factory, Roma, 2005. http://www.travelfactory.it/

    Competing interests:   None declared

    Show Less
    Competing Interests: None declared.
  • Published on: (24 February 2008)
    Page navigation anchor for Clinical discoveries, randomized controlled trials and surveys.
    Clinical discoveries, randomized controlled trials and surveys.
    • Rodolfo J. Stusser, Havana, Cuba, http://rational.fortunecity.com, http://havanacenter.familydoctors.net

    Agreeing with most points of view and spirit of the very interesting Editorial “Assessing Clinical Discoveries” of Professor Ian R. McWhinney,[1] although belated I will add some ideas to his valuable comments and suggestions to the Annals of Family Medicine (AFM)’s Editorial Board and Review Panel, and specially to the physicians readers of the Journal.

    ...
    Show More

    Agreeing with most points of view and spirit of the very interesting Editorial “Assessing Clinical Discoveries” of Professor Ian R. McWhinney,[1] although belated I will add some ideas to his valuable comments and suggestions to the Annals of Family Medicine (AFM)’s Editorial Board and Review Panel, and specially to the physicians readers of the Journal.

    I have enjoyed very much this illuminating Editorial of the Annals and its four e-Responses. In my view, the young AFM Journal has faced openly a universal problem of most clinical journals, also because family practice and the other clinical specialties need a major production of clinical scientific discoveries of practical impact in health classification and promotion, disease and injury prevention, diagnosis, therapeutics and rehabilitation of patients, and other clinical areas, within the known standing paradigms and into new paradigms as well.

    In my clinical research concept, simplifying to the minimal three phases the bad known clinical discovery process of a new scientific fact, qualitative description, classification, measurement, quantitative description, explanation, prediction; invention or innovation of a new method or technology, different things are: the generation, very well described by Prof. McWhinney in its main steps,[1] the confirmation in quasi-experimental randomized controlled trials or observational surveys, and the publication of the clinical discovery partial or totally verified or not at all yet.

    Today, most practical and theoretical clinical medicine journals’ editorial boards and review panels used to work safely and comfortably with reports within the known and accepted paradigms (incremental normal science), [2] without the criticisms from main noted medical personalities and institutions, but restraining involuntarily even the lean out of new breakthroughs in their earliest phases (qualitative change science) and the advance of our general and special clinical sciences, unless main authorities take the liberty to criticize the no so creative status quo of a past research period and suggest an opening to more contradictory issues of the established paradigms for a deeper scientific debate and progress.

    The paradoxical total subordination from the 1940s of the clinical physicians to the successful basic biomedical and epidemiological research methodological concepts and tools of narrowest focus of inquiry and sampling and analytic designs to confirm all kind of clinical hypotheses in all their phases, has blocked the two-century patho-physiologic two-way bridge from hospital bedside to lab bench [3] and past 60 years biopsychosocial health two-way viaduct from home and community office to bedside and bench, and the discovery of new hypotheses very needed in clinical research and practice.

    In my view the possibility of the physicians in the last decade to post in personal and other non reviewed web sites and blogs all type of ideas, data and reports, has reduced the medical journals opportunities to inform first about novel key scientific hypothesis, limiting their forum capacity for deepest discussions and widest diffusion.

    After six rich decades of basic pre-clinical and post-clinical research and applied clinical research advances, clinical physicians and investigators are discouraged by the methodological and technological complexities that have reached their clinical investigations and tend to trust less in their basic powerful clinical research method of scientific discovery, due to a complex causal web of clinical and non-clinical research objective issues and subjective beliefs and confusions none well clarified yet,[4] which perhaps would be worthwhile to comment with more details someday in the future.

    In family medicine research, clinical scientific discovery has an implicit logic and diverse phases and methods different from those of the most modern clinical trials and studies usually designed with many explicit details. Although screening and confirmation trials as well as descriptive, case-control and cohort surveys have produced many medical discoveries, usually the clinical discovery generation process of the concrete contribution is practically implicit and not enough formalized logical and methodologically in detail.

    A broader clinical propedeutics with full scientific research logic, phases and rules of discovery for the individual (and family) patient is needed, after the basic pre-clinical and post-clinical sciences methods are taught in the medical career from the beginnings of the clinical, surgical and psychiatric subject matters, and the specialized training in the clinical residencies, masters and philosophical doctors in “clinical sciences”.

    Thank you.

    References:

    1. McWhinney IR. Editorial. Assessing Clinical Discoveries. Ann Fam Med. 2008;6:3-5. http://www.annfammed.org/cgi/reprint/6/1/3

    2. McWhinney IR. Changing models: The impact of Kuhn's theory on medicine. Fam Pract. 1983;1:3-8.

    3. Feinstein AR. Basic biomedical science and the destruction of the pathophysiologic bridge from bench to bedside. Am J Med. 1999;107:461-467.

    4. Stusser RJ. Reflections on the Scientific Method in Medicine. In:. EOLSS. Biological, Physiological and Health Sciences Chapter. Oxford: UNESCO/ EOLSS Pub., 2006. www.eolss.net http://rational.fortunecity.com/reflections3.htm

    Competing interests:   None declared

    Show Less
    Competing Interests: None declared.
  • Published on: (30 January 2008)
    Page navigation anchor for Clinical Insights, Inquiries, and Discoveries
    Clinical Insights, Inquiries, and Discoveries
    • Allen J Daugird, Chapel Hill, NC, USA

    Several of us involved in the Family Physicians Inquiries Network have been asked to comment on Ian McWhinney's editorial. I'm hopeful that Bernard Ewigman will comment-his thoughts about this are much deeper than mine. I first heard the FPIN vision at a special research plenary session at an annulal STFM meeting several years ago. Basically, the vision was to be able to get answers to clinical questions at the point of c...

    Show More

    Several of us involved in the Family Physicians Inquiries Network have been asked to comment on Ian McWhinney's editorial. I'm hopeful that Bernard Ewigman will comment-his thoughts about this are much deeper than mine. I first heard the FPIN vision at a special research plenary session at an annulal STFM meeting several years ago. Basically, the vision was to be able to get answers to clinical questions at the point of care in near real time. This was the Google approach to sifting through massive amounts of medical data, but before Google was around. The vision was to have a community of practicing FP's who would work on analyzing and synthesizing available research, put it through an evidence and patient orientation sifter, and store it in an easily retrieveable way. The key factor was that it would be done in the context of how practicing physicians ask clinical questions when seeing patients. One of the truly innovative approaches Bernard had was to develop a web-based method for physicians to ask clinical questions and store them. These then were (and still are) collected and voted on by the FPIN community to prioritize which questions to tackle first. The FPIN community, made up of many medical school family medicine departments and community residency programs, then volunteers to work on trying to answer these questions, but in a structured way, with evidence grades. The most rigorous FPIN answers are Clinical Inquiries, published in the J of Family Practice and American Family Physician. Of course, there is often no good evidence based answer to many of these questions, and this in turn should be able to help drive research agendas.

    What does this have to do with Dr. McWhinney's editorial? I believe approaching things from questions we have while seeing patients is another form of "clinical insights." As Dr. McWhinney hopes for, it begins with a relationship with a patient, or perhaps many patients with the same problem. By definition, it is patient-centered. I would argue that the first discovery we should pursue is seeing whether there already is an answer to our question. (And how more efficient and effective if we share our answer with the medical community!) And, as is very often the case, we find no good answer, we can synthesize our own observations, formulate hypotheses, and if we don't have the time or resources to test them ourselves, at least share them, and perhaps stimulate others to test them. But what a waste if there is no forum to share this. So the bottom line is that I would encourage the Annals to consider taking the risk on publishing "clinical insights" work.

    Competing interests:   None declared

    Show Less
    Competing Interests: None declared.
  • Published on: (20 January 2008)
    Page navigation anchor for Commentary on Assessing Clinical Discoveries
    Commentary on Assessing Clinical Discoveries
    • Robert P. Blankfield, Berea, Ohio

    Dr. McWhinney makes several astute observations regarding the role of observation in the development of new medical knowledge. Dr. Whinney’s editorial encourages family medicine journals and reviewers to be more receptive to clinician observations and discoveries, and he uses as examples Alexander Fleming and James Fleming. Dr. McWhinney mentions that there are currently practitioners “who have made important discoveries...

    Show More

    Dr. McWhinney makes several astute observations regarding the role of observation in the development of new medical knowledge. Dr. Whinney’s editorial encourages family medicine journals and reviewers to be more receptive to clinician observations and discoveries, and he uses as examples Alexander Fleming and James Fleming. Dr. McWhinney mentions that there are currently practitioners “who have made important discoveries but whose work has been rejected by family medicine journals.” Since Drs. Fleming and Mackensie lived and worked decades ago, a more contemporary example (or examples) might illustrate for family medicine journal editors and reviewers the type of insights that Dr. McWhitney believes deserve publication.

    One aspect of contemporary medical publication that Dr. McWhinney does not mention is the proliferation of open-access journals that are available via the Internet. If a physician or medical scientist is willing to pay a fee, almost anything can be published nowadays. For many of these journals, there is little or no peer review involved. Consequently, it is difficult for the casual reader to discern what is meritous and what is not. While the open-access journals offer an outlet for physicians who are frustrated by the decision of peer-reviewed journals to reject an original idea, it is likely that almost no one is reading what is ultimately published in these journals.

    I agree with Dr. McWhinney that it would be a welcome development if peer-reviewed family medicine journals took an interest in publishing observations and ideas that do not fit the conventional mold.

    Robert P. Blankfield, MD, MS

    Competing interests:   None declared

    Show Less
    Competing Interests: None declared.
  • Published on: (20 January 2008)
    Page navigation anchor for Why clinicians don't (or can't) do research
    Why clinicians don't (or can't) do research
    • Michelle Greiver, Toronto, Ontario

    Dr McWhinnie argues for the value of insight during routine clinical practice, and the ability of front line clinicians to recognize, record and study what is new and important.

    It is well known that we normally have more questions than answers during daily practice. As a front line clinician, I can attest to the fact that I am faced with new discoveries in my own practice on a routine basis, but I probably f...

    Show More

    Dr McWhinnie argues for the value of insight during routine clinical practice, and the ability of front line clinicians to recognize, record and study what is new and important.

    It is well known that we normally have more questions than answers during daily practice. As a front line clinician, I can attest to the fact that I am faced with new discoveries in my own practice on a routine basis, but I probably fail to recognize them or neglect to follow-up in the vast majority of cases. When I do have what I think is a valuable clinical insight, what do I then do with it?

    Doing research takes time, knowledge and money. An insight remains an insight unless it leads to accurate knowledge that others can use. The value of front line physicians is in the questions that we raise (stemming directly from daily patient care); it may not necessarily be in the ability to conduct studies. The barriers to research (obtaining grants, difficult, bureaucratic and time consuming REB applications, time to write and publish) are now so high that they keep practicing physicians out. I may be able to recognize important problems in my own practice, but I can't study them in a form that is publishable as "research".

    I don't think we need to throw "rigour" out; there are valuable aspects to methodology, such as the ability to replicate experiments, or a reliable estimate of how accurate a result is. What we do need to think about removing are the aspects of research that do not add value, but simply make studies frustrating and difficult to do (and there are now many of those).

    I think collaborations between front-line clinicians and experienced researchers, such as practice-based networks, are likely to lead to fruitful projects. I would like to see more of those in Canada.

    Competing interests:   None declared

    Show Less
    Competing Interests: None declared.
  • Published on: (19 January 2008)
    Page navigation anchor for �Clinical Discoveries�: Remedy for lack of published clinical research in the Annals
    �Clinical Discoveries�: Remedy for lack of published clinical research in the Annals
    • David L. Hahn, Madison, Wisconsin, USA

    In his thoughtful editorial, Dr. McWhinney notes that the editors of the Annals of Family Medicine “regretted that very little clinical research had been published” and proposes that the Annals initiate a category called “Discoveries.” I was invited to submit a brief comment on his editorial and I hope to make two points by telling a story about my own “discovery”: (1) a “Clinical Discoveries” category would be consisten...

    Show More

    In his thoughtful editorial, Dr. McWhinney notes that the editors of the Annals of Family Medicine “regretted that very little clinical research had been published” and proposes that the Annals initiate a category called “Discoveries.” I was invited to submit a brief comment on his editorial and I hope to make two points by telling a story about my own “discovery”: (1) a “Clinical Discoveries” category would be consistent with editorial policy of a previous incarnation of the Journal of Family Practice and (2) the lack of clinical research reports in the Annals is, in part, a self-inflicted wound that can be remedied.

    Chapter 1: A simple observation I made 30 years ago (that some patients with “viral-type” respiratory illnesses appeared to benefit from antibiotics) motivated me to perform research in my practice on a newly described (circa 1986) respiratory pathogen (Chlamydia pneumoniae) that, in retrospect, probably explained the observation (1, 2).

    Chapter 2: During my initial study of patients with acute respiratory illnesses (3), I started noticing that wheezing patients almost always had high titers of antibodies against C. pneumoniae. I began to speculate about a causal association of infection with asthma. Later during this study I enrolled an adult experiencing her first-ever acute wheezing illness. Her “wheezy bronchitis” progressed to full blown persistent asthma. During the early illness her acute and convalescent serologies were diagnostic for a primary C. pneumoniae infection. As she developed persistent asthma she also developed persistently elevated antibody titers. I offered her prolonged antibiotic treatment. She accepted. Her asthma went into complete remission.

    Chapter 3: I became excited. I read everything I could on asthma. My clinical experience coincided with the best quality epidemiological studies but not with the descriptions I read from referral based specialty sources.

    Chapter 4: I submitted some of my earlier (exciting, provocative, less rigorous) research studies to asthma specialty journals. Two of my “favorite” reviewer comments: (1) “Dr. Hahn is probably studying something that he is mistaking for asthma” (I used ATS criteria to diagnose asthma) and (2) “this article should be rejected because Dr. Hahn has failed to prove that Chlamydia causes asthma” (in response to a submission entitled “Chlamydia and asthma: an hypothesis.”)

    Chapter 5: I was able to publish many of my early clinical observations (4, 5) and a treatment case series (6) in the Journal of Family Practice. These and other studies form the foundation of a growing body of evidence (from case-series, case-control, cohort, and randomized clinical trial studies) indicating that C. pneumoniae may fulfill all nine of Hills criteria for causation (7). This “clinical discovery” is now widely acknowledged within the research community (8, 9).

    Chapter 6: We recently completed a practice-based effectiveness study of antibiotics in asthma. The feasibility results were published in another family medicine journal (10). The effectiveness results were published in the Public Library of Science (PLoS) Clinical Trials (11). Ironically, I first submitted the data for both these papers to the Annals of Family Medicine – and was rejected.

    Moral: “Impeccable methodology usually follows the development of new ideas with some delay…real creativity in medicine lies in the hands of the world community of innovative investigators who together carry out hundreds of thousands of small research studies"(12).

    Epilogue (hopefully): …the Annals of Family Medicine dramatically increased its content of clinical research publications….by broadening its editorial perspective…and calling for all sorts of clinical observations…of various designs…from practice.

    1. Kalayoglu MV, Hahn DL, Byrne GI. Chlamydia infection and pneumonia. In: Paradise LJ, Friedman H, Bendinelli M, eds. Opportunistic Intracellular Bacteria and Immunity. New York: Plenum Press; 1999:233-253. 2. Hahn DL. Role of Chlamydia pneumoniae in acute respiratory tract infections, excluding pneumonias. Antibiotics for Clinicians. 1998;2 (Supplement 3):9-18. 3. Hahn DL, Dodge R, Golubjatnikov R. Association of Chlamydia pneumoniae (strain TWAR) infection with wheezing, asthmatic bronchitis and adult- onset asthma. JAMA. 1991;266:225-230. 4. Hahn DL. Acute asthmatic bronchitis: A new twist to an old problem. J Fam Pract. 1994;39:431-435. 5. Hahn DL, Golubjatnikov R. Asthma and chlamydial infection: a case series. J Fam Pract. 1994;38:589-595. 6. Hahn DL. Treatment of Chlamydia pneumoniae infection in adult asthma: a before-after trial. J Fam Pract. 1995;41:345-351. 7. Fredricks DN, Relman DA. Sequence-based identification of microbial pathogens: a reconsideration of Koch's postulates. Clinical Microbiology Reviews. 1996;9:18-33. 8. Black PN. Antibiotics for the treatment of asthma. Current Opinion in Pharmacology. 2007;7:266-271. 9. Blasi F, Johnston SL. The role of antibiotics in asthma. International Journal of Antimicrobial Agents. 2007;29:485-493. 10. Hahn DL, Plane MB. Feasibility of a practical clinical trial for asthma conducted in primary care. J Am Board Fam Pract. 2004;17(3):190- 195. 11. Hahn DL, Plane MB, Mahdi OS, Byrne GI. Secondary outcomes of a pilot randomized trial of azithromycin treatment for asthma. PLoS Clin Trials. 2006;1(2):e11 DOI: 10.1371/journal.pctr0010011. 12. Anon. Should we case-control? Lancet. 1990;335:1127-1128.

    Competing interests:   None declared

    Show Less
    Competing Interests: None declared.
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The Annals of Family Medicine: 6 (1)
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Vol. 6, Issue 1
1 Jan 2008
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Assessing Clinical Discoveries
Ian R. McWhinney
The Annals of Family Medicine Jan 2008, 6 (1) 3-5; DOI: 10.1370/afm.801

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Ian R. McWhinney
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