Monday, December 19, 2016

Oh, look. Naturopathic oncologists are pretending that theirs is a real medical specialty again.

Given that I’m not a fan of naturopathy, it probably comes as no surprise to our readres that I’m even less of a fan of the emerging “specialty” of naturopathic oncology. As I and other bloggers here have described time and time again, naturopathy is a cornucopia of quackery that encompasses modalities as diverse as acupuncture and traditional Chinese medicine (TCM), applied kinesiology, chelation therapy, UV blood irradiation, organ repositioning, and, yes, The One Quackery To Rule Them All, homeopathy. Indeed, as I’ve pointed out many times, homeopathy is an integral part of naturopath training, so much so that it is part of the NPLEX, the examination naturopaths take for licensing purposes. (And, as I say every time I mention the NPLEX, I would really, really love to see some questions from the exam.) While it’s true that naturopaths also emphasize diet, exercise, and lifestyle interventions, whatever legitimacy they have as a specialty is completely undermined by the massive amounts of quackery they “integrate” with such advice, which often goes far beyond what the evidence supports anyway. We’ve frequently asked whether there is a naturopathic standard of care and come to the conclusion time and time again that there is not.

So, just because naturopaths have decided to subspecialize and produce a “specialty” that they’ve dubbed “naturopathic oncology” does not in any way legitimize naturopathy, although clearly by taking on the trappings of conventional medicine and its specialties naturopaths hope that they seem more like a real medical specialty. Unfortunately, in the ultimate failure to heed the warning that it’s good to be open-minded but not so open-minded that your brains fall out, the Society of Integrative Oncology not only admits naturopaths as members but includes them as authors in their attempts to legitimize the integration of pseudoscience into medicine with the publication of dubious clinical guidelines for breast cancer and other cancers.

To give you an idea what I mean about how clueless physicians practicing “integrative oncology” are regarding naturopathy, I like to repeat an anecdote from time to time. Back when I published my review article, Integrative oncology: Really the best of both worlds? in Nature Reviews Medicine two years ago, the SIO immediately criticized me for spending so much of it discussing homeopathy. Of course, the amusing thing was that homeopathy was a far smaller part of the first draft, but reviewers made me add more. Even more amusing (or disappointing—or both) was that it was clear that the SIO had no clue how integral homeopathy is to naturopathy, forcing me to point out that naturopathy schools include many hours of homeopathy in their curricula and that naturopaths are tested are tested on homeopathy in the NPLEX. I also couldn’t resist twisting the knife a little bit by pointing out that one of the authors of the SIO clinical guidelines for breast cancer was a naturopath who had an open clinical trial of homeopathy listed on ClinicalTrials.gov.

The bottom line is that naturopathic oncologists, as they like to call themselves, can form their own society (Oncology Association of Naturopathic Physicians, or OncANP) and append “FABNO” after their name as much as they’d like. None of this makes them actually oncologists or any less quacks than regular naturopaths. That doesn’t stop them from trying, though. Jann Bellamy sent me an example of them doing just that again in the form of an article published this year in Integrative Cancer Therapies by naturopaths from a variety of clinics.

Applying the Delphi method to nonsense: Prelude

The article I’m referring to is by Hill et al and entitled Naturopathic Oncology Modified Delphi Panel. I had heard of the Delphi method before. As described in the introduction of the paper, it’s a structured communication method developed by the RAND Corporation in the 1950s, which describes it thusly:

RAND developed the Delphi method in the 1950s, originally to forecast the impact of technology on warfare. The method entails a group of experts who anonymously reply to questionnaires and subsequently receive feedback in the form of a statistical representation of the “group response,” after which the process repeats itself. The goal is to reduce the range of responses and arrive at something closer to expert consensus. The Delphi Method has been widely adopted and is still in use today.

Now, it might sound weird that a group communication process to achieve a convergence of opinion from experts in a specific field regarding a specific question that was designed during the Cold War to forecast the impact of technology in warfare, but the system has evolved since then and has been applied to many other areas. If you search PubMed for “Delphi method” or “Delphi consensus,” you’ll find thousands of articles on topics ranging from developing consensus on the diagnosis and treatment of personality disorders, identifying language impairments in children, founding multidisciplinary units for treating psoriatic arthritis, and even the treatment of chronic constipation. (To be honest, I couldn’t help but think of chronic constipation as I read Hill et all attempt to do a Delphi panel on key issues in naturopathic oncology.)

So what is the Delphi method? Basically, it is a process that is based on the idea that forecasts or decisions from structured groups of individuals will be more reliable than those from unstructured groups. Basically, a panel of experts is chosen and then serially queried. The experts answer questionnaires, after which a facilitator provides an anonymous summary of the experts’ answers, forecasts, and recommendations from the previous round, as well as reasons provided for the answers given, after which the experts are queried again and can change their answers in light of each round of answers shared among the panel. Thus, the Delphi method is supposed to result in a convergence of opinion from the experts towards the “correct” forecast or answer. The process is in general stopped after pre-defined stopping criteria are reached, such as number of rounds of questioning, achievement of consensus, or stability of answers). The method can be illustrated thusly:

delphi-method-flowchart

Obviously, this is the simplest outline of the Delphi method. There are now many variations. There are also several key characteristics that should be briefly mentioned:

  • Anonymity: Usually the participants remain anonymous in order to prevent prestige and authority or force of personality from skewing the results too much. Anonymity is generally maintained even after the final report is published. I note that this general feature of Delphi panels was not followed in this study, as the members of the panel were named in the methods section and listed as co-authors of this paper. In fact, there was no anonymity at all among the panelists, as far as I could tell.
  • Structured information flow: Initial contributions are collected in the form of answers to questionnaires.and panel members’ comments about these questions and why they answered the way they did. This prevents the negative effects of interpersonal interaction by minimizing problems of group dynamics.
  • Regular feedback: Participants comment on their own answers, on other participants’ answers, and on the emerging consensus.
  • Facilitator: The facilitator sends out the questionnaires, collects and analyzes the responses, and prepares the summary for each iteration of questioning.

As you can imagine, though, there are a lot of complexities here, and everything depends on the definition of the problem and how the questions related to the problem are phrased. Let’s take a look at how this Delphi panel went.

Applying the Delphi method to nonsense: And so it begins

There were eight experts participating in the panel. They were chosen by a rather involved process, beginning with the requirement that any panel member must:

  1. Hold a degree of Doctorate of Naturopathic Medicine from a 4-year accredited medical school
  2. Attend the third annual OncANP conference during the date and time of the modified Delphi panel
  3. Have a minimum of 7 years of experience with a majority (>50%) of patients seeking cancer treatment or support
  4. Sign a consent form providing permission to use the participant’s name, biography, and any recorded dialogue in the final publication

So you can see right there that all the advantages with respect to anonymity of responses was thrown right out the window. The eight panel members met at the third annual OncANP conference in person. It should also be noted that their discussion was recorded, although it was structured this way:

Flowsheet

This, of course, demonstrates that this “modified Delphi panel” also doesn’t do anything that the Delphi method was intended to do to minimize group dynamics, influence due to personality, and the like. This is basically no different from a typical roundtable or panel discussion that you can see at any professional meeting, only a bit more structured, with time limits for each panelist to make a statement and conclusion and for the open discussion.

Be that as it may, how were the panelists selected? Here is the methodology:

A summary of the Delphi study and protocol was distributed on the OncANP online forum. The members of the OncANP were encouraged to select and nominate 8 physicians to represent the field of naturopathic oncology and sit on the Delphi panel to discuss and debate questions regarding ethics, philosophy, and research development. The members were encouraged to self-nominate if they desired to be considered for selection to the panel of experts. The OncANP members were asked to share the e-mail, study summary, and nomination request with any colleague in the field of naturopathic oncology. This request was made in an attempt to allow naturopathic oncologists who are not members of OncANP to nominate themselves or their desired representatives. A total of 389 members subscribed to the forum at the time the study summary was posted, and 39 physicians received nominations from their colleagues in the field of naturopathic oncology.

In addition to nominating other physicians in the field, the OncANP members were encouraged to self-nominate, indicating that they were interested in participating in the study, able to attend the panel at the designated time and location, and met all the criteria and qualifications required to participate.

This large group was then winnowed down thusly. Nominees had to provide more information, including:

  1. Personal statement of philosophy to naturopathic oncology
  2. Years of clinical experience
  3. Type of clinical work (hospital/private practice, licensed/unlicensed state or province)
  4. Research and publications
  5. Additionally related information

And then:

This additional required information and total number of nominations was organized into a rubric format used to compare the physicians. The rubric assisted in selecting panel members with a combination of the following: (1) the most years of clinical and/or research experience, (2) varied philosophical approaches to naturopathic oncology, (3) relevant additional oncology experience pertinent to the topic of ethics, philosophy, and/or research development, and (4) a higher number of colleague nominations. A total of 15 physicians provided self-nominations and the required additional information for consideration for panel selection. Two physicians were removed from consideration because they had less than 7 years of clinical experience. The research team unanimously selected the physicians who satisfied the rubric categories for panel qualification to the greatest degree.

This resulted in the following panel:

  • Tim Birdsall, ND, FABNO
  • Daniel Rubin, ND, FABNO
  • Gurdev Parmar, ND, FABNO
  • Neil McKinney, NDa
  • Davis Lamson, ND, MSa
  • Lise Alschuler, ND, FABNO
  • Dugald Seely ND, MS, FABNO
  • Shauna Birdsall, ND, FABNO

We’ve met Dugald Seely before. He runs the Ottawa Integrative Cancer Centre and somehow has managed to score some rather two rather rich grants from an anonymous benefactor to run clinical studies of naturopathy in cancer patients, one for $4 million and then another for $3 million. He was also the naturopath co-author of the SIO guidelines that I meant when I mentioned how naturopathy and homeopathy can’t be separated.

We’ve also met Tim Birdsall before. He was the Vice President of Integrative Medicine at the Cancer Treatment Centers of America from 2002 to 2012 and has been voted physician of the year by the American Association of Naturopathic Physicians. In 2013 he was promoted by CTCA and now serves as Senior Vice President of Information Services, Chief Medical Information Officer & Naturopathic Physician Western Regional Medical Center. (He’s also quite adept at spinning negative studies of supplements to look not quite so negative.) Shauna Birdsall also works for CTCA and is the Medical Director of Naturopathic Medicine and Integrative Oncology at Western.Regional Medical Center. Now, I’m clearly no expert in the Delphi method, but it appears to me that it would not be a good thing for avoiding the “bandwagon effect” or minimizing bias to have two members of the panel working at the same medical center, much less for them to be related to each other. It just goes to show that, whenever naturopaths try to undertake science or other structured, evidence-based undertakings, they just can’t seem to follow the protocol expected.

But what about the questions? Here’s the method used to formulate the six questions:

A request for question suggestions for the panel discussion was distributed on the OncANP online forum. OncANP members were encouraged to share the question submission request with any colleague in the field of naturopathic oncology. OncANP members were encouraged to develop questions that (1) discuss the main topics of the panel, which are ethics, philosophy, and research development of naturopathic oncology; (2) integrate these main topics with a subset of topics relevant to the field of naturopathic oncology, including, but not limited to, clinical approach, research, and future goals of the field; (3) are open-ended, possibly multifaceted, controversial, and able to initiate thorough debate among the physicians on the panel. A total of 45 questions were submitted for consideration for question selection. Questions were categorized to assist in selecting topics of interest as identified by the physicians in the field of naturopathic oncology. The research team indicated their preferred questions and topics, and the principal investigator for the study selected and formatted the top 6 questions that were used in the discussion.

So basically, they polled the OncAMP membership. That’s probably an OK method, but note how the research team “indicated their preferred questions and topics.” No chance of bias there, is there?

Applying the Delphi method to nonsense: The naturopathic panel speaks

Here are the questions that this convoluted process ultimately yielded for the panel to answer:

  • What are 3 topics in naturopathic oncology that generate consensus among practicing physicians? What are 3 issues in naturopathic oncology that generate the most controversy?
  • How do you approach research evidence that contradicts other research when making a clinical decision? How do you approach research evidence (or lack of evidence) that contradicts your clinical experience and/or personal philosophy to the practice of naturopathic oncology?
  • What ethical responsibility does a naturopathic oncologist have when a patient’s wishes are contrary to evidence or contrary to the physician’s philosophy? Please provide a real or hypothetical example of how this situation should be managed.
  • What research evidence will make the most difference to the clinical practice of naturopathic oncology? What type of research is needed to benefit the field of naturopathic oncology? Explain how and why.
  • What criteria should determine the priorities for the development of “best practice” guidelines with respect to naturopathic oncology?
  • What symptoms or diagnoses should naturopathic doctors who have no additional oncology training be able to treat? For example, is it ethical for primary care NDs to treat side-effects of chemotherapy and/or directly treat the cancer?

These questions are, as far as panel questions go, reasonable enough, even somewhat uninteresting. What interested me more were the answers. For instance, for the first part of question #1, answers number one and two were, by far, supporting “quality of life” and “focusing on the whole person.” Of course, as I’ve said many times before, the whole issue of “focusing on the whole person” is a common trope used in “integrative medicine.” It’s a false dichotomy, where it’s implied (or even outright claimed) that you have to embrace the “unconventional” modalities (translation: the quackery) in order to be able to take care of the whole patient. I know several science-based family practice doctors and internists who would beg to differ on that.

There was also quite a bit of mention that naturopathic oncology should be “integrative” in that it should work within the standard of care and not be an alternative to the standard of care. for example, panelist 6 said:

I think most in naturopathic oncology would agree that naturopathic oncology is typically integrative and not alternative to the standard of care.

And panelist 4 added:

I agree that one of the consensus is that naturopathic oncology is inherently integrative and that our role is to play within the system to help support people going through that, and not as a source of alternative care.

Clearly, the naturopathic definition of “standard of care” is very different from a physician’s science-based definition of standard of care. By this standard then, other than diet and exercise, naturopathic oncologists have nothing to offer patients, and there’s no reason a dietician and an science-based supportive and palliative care physician couldn’t do that. After all, everything else naturopaths offer ranges from the unproven (such as most supplements) to pure quackery like homeopathy, energy medicine, “detoxification,” UV blood irradiation, applied kinesiology, and the like. If naturopathic oncologists—heck, if naturopaths—practiced according to this standard, they’d have to get rid of the vast majority of what they’ve been taught in naturopathy school. The “specialty” would have no purpose. (OK, from my perspective, it already has no purpose.)

A couple of the answers to question 2 stood out to me. For instance, panelist 7 said:

That actually is one of my pet peeves, is naturopathic doctors not reading the primary source of the research, the full article, themselves, and relying on somebody’s analysis that immediately dismisses the evidence because they don’t like it, and finds all the faults of the study. I think that it needs to be weighed much more carefully.

One wonders if he’s referring to the many studies that show that modalities favored by naturopaths have no effect detectable other than placebo effects or to crappy studies that purport to show a benefit that “evil” skeptics like those of us here at SBM deconstruct and show not to have sufficient evidence to support the conclusions made. Inquiring minds want to know.

Then panelist 4 says:

I think while within the context of limited evidence, and it’s being framed, I think we really have to rely also on the art of the practice of naturopathic medicine, and be guided by clinical experience, because there is a limit to what we can derive from the information

In other words, rely on anecdotal evidence and “clinical experience,” both of which can be profoundly misleading, as I’ve explained many times before.

That ties in to question 4, which is about research evidence and naturopathy, specifically what research evidence will make the most difference to the clinical practice of naturopathic oncology and what type of research is needed to benefit the field of naturopathic oncology. I found these to be very odd questions. I can’t picture any other medical specialty even asking these questions, at least not this way. In oncology, for instance, we might ask what the most pressing unanswered questions are in the diagnosis and treatment of various cancers, but I can’t picture anyone asking what would make the most difference, and especially asking what sort of research is needed to benefit the field of oncology. We’d ask what research is needed to benefit our patients with cancer, not the field. Not surprisingly, strange questions provoked strange answers. For instance, panelist 6 said:

In my opinion, the research that’s needed most, that will make the most difference in the practice and I think general acceptance of naturopathic oncology, is a systems approach. Naturopathic medicine teaches us to treat the whole person, to address their main health determinants such as diet, lifestyle, exercise, stress management, with a multitude of modalities that we have that are at our disposal. I think a study of one vitamin, or amino acid, or herb at a time, although critical and essential, it does not represent the practice of naturopathic oncologists and I think we need to be doing systems approach studies.

This is what I like to refer to as woo babble, which is like technobabble from Star Trek, but with woo. It also represents the predictable whine about “reductionistic” techniques of research that science-based physicians supposedly do. Unfortunately, naturopaths and other quacks have latched on to “systems biology” in the way that Deepak Chopra latched onto “quantum,” as an all-purpose term to make what they do sound scientific and plausible to people who have little science background.

Here’s the one, though, that best encapsulated why naturopaths shouldn’t be considered physicians under any circumstances and will never be science-based. Behold the answer from panelist #3:

I propose 4 projects that we can do now that will take us far. One is the publication of case studies by individual naturopathic oncologists should be highly fostered. These can document for the rest of us what may have helped or did not, and that’s the best kind of data at present to help us reach consistency consensus in treatment

No, no, no, no. Case studies and case reports are among the lowest forms of clinical evidence. They are useful to generate hypotheses to test by more rigorous methodology up to and including randomized, double-blind controlled clinical trials, but to develop treatment consensus guidelines? Absolutely not, with the possible exception of very uncommon or rare diseases for which it is just not possible to do rigorous clinical trials because there are too few patients. Panelist 3, whoever it was, just distilled the essence of what is different between naturopathy and science-based medicine into a brief paragraph.

Naturopathic oncology: They still don’t get it

Leaving aside the way that this “modified Delphi panel” used by the naturopaths doing this study was so modified from what a Delphi panel normally is that it’s unclear why they bothered to use the name and didn’t just refer to their discussion as a structured panel or roundtable discussion, the results of this discussion were quite informative, just not in the way naturopaths hoped. There was one thing lacking that would have likely been the a key question in such a panel discussion in any other medical specialty, and that would be the most pressing areas where evidence is lacking. For instance, in a breast cancer panel, one would expect someone to bring up the lack of targeted therapies for triple negative breast cancer, as that’s a perennial problem that we haven’t solved yet. In a naturopathic panel, I was shocked to see no specific clinical problems mentioned or specific kinds of evidence lacking. And, no, the handwaving about “systems biology” doesn’t count, because it’s too vague to be meaningful. Systems biology with respect to what condition, what clinical problem what disease? The naturopaths don’t say, or, if they did, the study coordinators chose not to cite those quotes. Instead they cited more than one panelist advocating for anecdotal evidence and not even mentioning clinical trials.

That is one key reason why naturopathic oncology, like all of naturopathy, is a fake medical specialty and will remain so until it embraces science and evidence. Of course, that will never happen, because if naturopaths ever embraced science and evidence, their specialty would disappear.



from Science-Based Medicine http://ift.tt/2hLQi5f

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