Advancing the Mission of Integrative Medicine

through Systematic Practice-Based Data Collection

Martha R Herbert PhD, MDHarvard Medical School, MGH Neurology

Martinos Center for Biomedical Imaging, TRANSCEND ResearchHigher Synthesis Foundation & Higher Synthesis Health – highersynth.org

www.AutismRevolution.org

Learning Objectives

1. To explain what practice-based research is2. To review the process of developing practice-based

data standards3. To go over the multi-scale levels of data collection

we can use to make the case for integrative medicine and optimize outcomes

Types of Research:Clinical vs. Practice-Based

CLINICAL RESEARCH• Putting people into groups

based on a few criteria, predominantly diagnosis

• Focus on single interventions that are standardized across individuals

• Use of placebos and control groups for comparison

• Focus on outcomes that are statistically significant for the whole group

PRACTICE-BASED RESEARCH• Collecting data related to the

actual individualized, ongoing practice of medicine

• Documentation of the results you are actually getting in your practice

• Recording of patient outcomes• Individualized, personalized; no

placebo or double-blind

How are the questions different in Clinical vs. Practice-Based Research?CLINICAL RESEARCH• All have same diagnoses and are

uniform in other ways, such as age, gender, weight

• Looking at correlation, not usually at cause

• Criteria you are trying to prove or disprove

• Efficacy at group level may mean covering symptoms rather than fixing causes or problems

PRACTICE-BASED RESEARCH• Interest in the complexity of

contributors for this individual• Multiple contributors

• Emotional, physical, spiritual• Contributors over time

• Looking for causes that can be overcome, not just symptoms

• Comparing what approaches works for which people

To everything there is a season: What times, places and circumstances merit which kinds of research?

CLINICAL RESEARCH• Testing the safety of potentially

dangerous interventions • These may have problems that

didn’t show up in pre-clinical phase

• Looking for side effects• Comparing approaches• Tracking longer-term effects of

treatments• Duration of effects• Adverse effects

PRACTICE-BASED RESEARCH• Trying to find answers for people with

complex, inter-related chronic problems

• Trying to provide answers after other approaches have failed

• Trying to learn from what we are doing

• Looking for least amount we can do to make a constructive difference

• Looking for stable long-term outcomes

• Trying to improve our approaches

Challenges and problems with group studies in clinical research• May miss the utility of things that are effective for smaller subgroups

but not for larger subgroups• May focus on magic bullets rather than long-term strategies of

lifestyle change• May be biased against non-patentable nutrition and exercise

interventions• May be biased against combinations of interventions to synergize

with each other

Evidence-Based Medicine (EBM): Levels of Evidence - LEVELS

• Level I: Evidence obtained from at least one properly designed randomized controlled trial.

• Level II-1: Evidence obtained from well-designed controlled trials without randomization.

• Level II-2: Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group.

• Level II-3: Evidence obtained from multiple time series designs with or without the intervention. Dramatic results in uncontrolled trials might also be regarded as this type of evidence.

• Level III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.

Assessment of quality of evidencein “Evidence-Based Medicine” (“EBM”)

• Level A: Good scientific evidence suggests that the benefits of the clinical service substantially outweigh the potential risks. Clinicians should discuss the service with eligible patients.

• Level B: At least fair scientific evidence suggests that the benefits of the clinical service outweighs the potential risks. Clinicians should discuss the service with eligible patients.

• Level C: At least fair scientific evidence suggests that there are benefits provided by the clinical service, but the balance between benefits and risks are too close for making general recommendations. Clinicians need not offer it unless there are individual considerations.

• Level D: At least fair scientific evidence suggests that the risks of the clinical service outweighs potential benefits. Clinicians should not routinely offer the service to asymptomatic patients.

• Level I: Scientific evidence is lacking, of poor quality, or conflicting, such that the risk versus benefit balance cannot be assessed. Clinicians should help patients understand the uncertainty surrounding the clinical service.

How does the usual EBM apply and how does it NOT apply to integrative medicine?

HOW IT APPLIES• Need to establish some stable

protocols regarding looking at certain things

• Can include rigorous comparisons – that is, while treatments are individualized, measurements can be standardized at least at core measures level

HOW IT DOES NOT APPLY

• Cannot standardize treatments – • biochemical individuality, • immunological, exposure

individuality

How do you do research on personalized medical practices? Results of group brainstorm - 1 of 2• Tracking what you do

• Standard measures

• Tracking background and context – background checks, info on differences in metabolizing drugs and other substances

• Share your insights and good questions with others to help everyone

• Sending out questionnaires before thy come to the office visit, and then documenting consistent progress

• Having questionnaires as quantitative as possible – if you repeat the same question later, ou can compare

• Same questionnaire before and after treatment – checkboxes to rate symptoms

• Add what they’ve tried and what they haven’t tried

• MSQ first and annual

How do you do research on personalized medical practices? Results of group brainstorm - 2 of 2• Consistently – lab progress – • Photographs or other measurements – HRV for example over time, devices,

handwriting samples• Cowden - 100 questions on scale 0-10 – maximum score was 1000, and then

question 101 on later visits – required 70 point reduction to be able to say they had improved

• Doctor and patient data may differ when the doctor does more probing• Need to learn to use, and to validate use of, measurement instruments such as

zyto or hrv - - • Family and or teachers, caregivers can be involved in logging experience and data• Can incorporate metrics from Ophthalmology – acuity, contrast sensitivity, VEP,

computerized visual fields

What has helped you improve how you treat patients with MCCs (Multiple Chronic Conditions)? (results of group brainstorm)

• ACIM • Ask what their goals and expectations, not just their symptoms

• What is the number one thing they want to achieve – put on top

• Diet and lifestyle• Documentation by families

• Do very strict SOAP notes, list all problems, and educate the patients on each and every one so they understand the whole picture, and then involve them in prioritizing

• Identifying cause of disease and cause of blocked regulation – to unpeel the onion with all its layers – what is the most energetic disruption on the outside of the onion – ELITE – causes of blocked regulation and of disease

• Even focusing on the top two or three can make a big difference

• Deal with the emotions• Richie Horowitz – multiple systemic infections diseases – lyme doc • Improving results depends on identifying the cause – thinking in dimensions – 5 levels of healing concept

= physical mental energetic intuitive financial etc.

How and why do you think we should do research on treatment of patients with MCCs (Multiple Chronic Conditions)?

How do you track change rigorously?

What kinds of assessments would help you to track change rigorously? (group brainstorm)• Likes the MSQ – get a numerical value, apply it to the matrix – don’t have to reinvent wheel

though we may want to modify it• Having a really good lab flow sheet – a lot of EMRs don’t have the ability to have good flow sheets• PROMIS – Patient Reported Outcome Medical Info reporting System – government-generated

online software – includes 60 different domains• Horowitz – he would walk in room, facing patient close – would not focus on any other person –

would ask top three sx – including have they improved, gotten better• HRV – since added to practice, can rigorously compare• Do this before and after Hg fillings removed• Develop a baseline elite or EDS questionnaire and do repeat studies – e.g. hormones,

neurotransmitters compared to an initial HRV and post HRV – both systems designed to play back and forth with autonomic nervous system

• Alkaline diet – why don’t doctors get people to do this – for toxins parasites

Advantages and Disadvantages of Standardized and/or Validated Assessments (group brainstorm)

ADVANTAGES• Speaking to outside world in language they understand• Discern changes (hrv) before they feel the

improvement themselves• Historical like SF36 – have a way to follow a patient

along with a validated questionnaire – validated in research literature

• Motivated patient with a goal – patients not motivated enough until they are concerned – PREMIER HEART – perfected ECG – tells you way ahead without any stress test who will die of a heart attack – i.e. highly predictive quickly – have something to work toward

• Cancer – Caprofile.net – PHI + plus ultrasensitive HCG• Memory lapses- alzheimers, cancer, heart disease• Mark Hyman with diabesity made everyone a little sick

by upping the threshold of being well, and giving people reason to work on changing

DISADVANTAGES• CD57 – wants to stop – immune

marker on lyme – they start focusing more on that than they do on themselves

• Standardized removes a factor from findings – emotional direction

• May not track everything being done or all the valuable or difficult outcomes

• DNA testing with mouth swab – for what drugs the patient can take

• Some tests are insensitive (e.g. thyroid)

In what ways might rigor and convenience compete with each other in assessments?• Rigor may take too long• Convenience may be too superficial

• The “magic” is in achieving the best of both rigor and convenience

In what ways might rigor and convenience synergize in assessments?

Achieving the right balance between rigor and convenience might capture the most information with the least aggravation

What about Case Studies?

• The CARE guidelines: consensus-based clinical case reporting guideline development

• Joel J Gagnier12, Gunver Kienle3, Douglas G Altman4, David Moher56

, Harold Sox7, David Riley8* and the CARE Group9

• Journal of Medical Case Reports 2013, 7:223 doi:10.1186/1752-1947-7-223

• The electronic version of this article is the complete one and can be found online at: http://www.jmedicalcasereports.com/content/7/1/223

• Abstract on next slide

The CARE guidelines: consensus-based clinical case reporting guideline development ABSTRACT:

• Background A case report is a narrative that describes, for medical, scientific, or educational purposes, a medical problem experienced by one or more patients. Case reports written without guidance from reporting standards are insufficiently rigorous to guide clinical practice or to inform clinical study design.

• Primary Objective. Develop, disseminate, and implement systematic reporting guidelines for case reports.

• Methods We used a three-phase consensus process consisting of (1) pre-meeting literature review and interviews to generate items for the reporting guidelines, (2) a face-to-face consensus meeting to draft the reporting guidelines, and (3) post-meeting feedback, review, and pilot testing, followed by finalization of the case report guidelines.

• Results This consensus process involved 27 participants and resulted in a 13-item checklist—a reporting guideline for case reports. The primary items of the checklist are title, key words, abstract, introduction, patient information, clinical findings, timeline, diagnostic assessment, therapeutic interventions, follow-up and outcomes, discussion, patient perspective, and informed consent.

• Conclusions We believe the implementation of the CARE (CAse REport) guidelines by medical journals will improve the completeness and transparency of published case reports and that the systematic aggregation of information from case reports will inform clinical study design, provide early signals of effectiveness and harms, and improve healthcare delivery.

• Keywords: Case report; Case study; EQUATOR Network; Patient reports; Meaningful use; Health research reporting guidelines

Journal of Medical Case ReportsThe CARE (CAse REport) Guidelines and the Standardization of Case Reports

Richard A Rison, Michael R Kidd, Christian A KochDisclosuresJ Med Case Reports. 2013;7(261)

Discussion at http://www.medscape.com/viewarticle/817436

What about Case Series?

• Publish case series with standard way of reporting each case• Then you are empowered to compare and pool data

Can we use conventional metrics to assess unconventional treatments? How?

What are your thoughts and feelings about your experiences with electronic health/medical records? (group brainstorm responses)

• for comparison studies – especially when docs are used to navigating on paper

• With EMR got poorest care and then pass Eclipse• Medical lab but energetic picks up 12-18 months before disease

process starts – but EMR not configured to track this• Many have opted out of medicare, Medicaid, insurance and aren’t

required to have EMRs• EMRs biggest disaster in medicine – spend more time filling out

computerized form than making eye contact – check boxes etc.

Do you have ideas about how electronic health/medical records might better interface with integrative medicine – particularly advanced integrative medicine?• Voice recognition software• Apps

• Younger generation more used to this to track feelings, experiences, journaling, sharing data – app to help remind you to take your supplements, a weekly recipe, updates on new findings

What risks do you see about using electronic health/medical records in integrative practices?(Group brainstorm results)

• Three interventions re - confidentiality• When you go online you can download https:// and then all the sites you visit most will have some security• Startpage (Netherlands) nstead of google – goes in between you and google

• Don’t click directly but through startmail/startpage• Hotmail, yahoo, gmail – almost anyone can break in – startmail – Kathryn Albrecht – might be offshore, encrypted to some degree

• Depersonalization• IRS audit don’t use the word liberty on your emails – it is word that triggers them to research you – freedom also• Other audits – FDA, FTC, licensing boards, etc.

• They usually need a complaint brought to them• If they snoop and find things they can get ammunition

• Continuity of care – easier to flip back to a paper note than to flip back to • Advantage – can design report forms• Someone from outside of practice - - e.g. ND doing peroxide or intravenous ozone - - if you have to enter

nonconventional unproven treatments it could be a risk• Electrodermal screening – ay need a statement at the top of these forms – energetic biofeedback not a diagnosis• Will ACIM come up with a generic form that we could u

Can you think of ways to reduce or overcome these risks?

How do you feel about typing?

Have you had experience (lately or ever) with voice-to-text software? What do you think?

How do (or might) your patients feel about filling out questionnaires online?

Would your patients cooperate with wearable gizmos for measuring heart rate, sleep, stress, etc.?

Are you familiar with wearable measurement devices like FitBit, Zeo, Basis Watch, etc.?

How might you make the use of these devices financially feasible?

What metrics are/were used in your training programs to track learning, productivity, outcomes, effectiveness, etc.?

Can you think of better ways or reasons to use metrics in training?• Tracking progress of trainees• Get trained in using metrics• Book by Robin Cook – Cell – the cell phone may become your primary

care practitioner – smart phone may measure HRV, blood sugar, core temperature, etc.

• Also drop of blood

• Patient portal

Any ideas about how to use electronic health records to facilitate writing case reports or case series?

Now that we’ve had this discussion, how would you define practice-based research?

After this discussion, how would you assess the value and importance of practice-based research for integrative medicine?

Any other thoughts or comments?

THANK YOU!!!