Documenting Hope Program Methodology

STUDY DESIGN

The Documenting Hope Project believes that chronic health issues can only be understood and must be studied from a multifactorial and multidimensional perspective. This approach, unlike the classic “gold standard” clinical study, takes into account the truly complex nature of chronic illness. A strong gene-environment interaction is also increasingly accepted to be at the root of most chronic illnesses. Studies show that environmental factors, such as lifestyle choices, behaviors, exposures, beliefs, etc., are of greater significance than genetics with regard to health outcomes.

Chronic illness study designs to date have largely lacked the capacity to fully elucidate etiology because they are too narrow in scope and breadth. The Documenting Hope Project intends to develop a more robust picture of the multifactorial nature of health using a new study design. Asking flat linear questions about complex multivariable conditions will yield little new knowledge about the condition. Complex conditions require complex study design.

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METHODOLOGY: THE IMPERATIVE FOR NEW STUDY DESIGN TO ACCOUNT FOR THE MULTIFACTORIAL NATURE OF CHRONIC ILLNESS ETIOLOGY AND REMISSION

In contrast to a traditionally designed clinical study that studies one molecule (or a single intervention) at a time, an observational assessment allows scientists to observe a multiplicity of variables in a given study environment. Instead of analyzing the impact of one variable (e.g. assessing the impact of one drug on a group of people), an observational assessment permits scientists to collect a large volume of seemingly unrelated information that, upon analysis, may give insight into complex medical problems when mined for multi-system changes over time.

Traditional clinical trials are rarely successful in increasing understanding of the root causes of complex systemic disease or complex epidemiological processes. Many scientists now believe that the complexity of modern illness requires a more complex study design, one that leaves room for multiple, simultaneous factors in exploration of causation, and by extension, in prevention and reversal. We believe that solutions to complex illness will continue to elude us until we learn to ask questions differently.

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Garland AF, Accurso EC, Haine-Schlagel R, Brookman-Frazee L, Roesch S, Zhang JJ. Searching for elements of evidence-based practices in children’s usual care and examining their impact. J Clin Child Adolesc Psychol. 2014;43(2):201-15.

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Hamre HJ, Witt CM, Kienle GS, Meinecke C, Glockmann A, Willich SN, et al. Anthroposophic therapy for children with chronic disease: a two-year prospective cohort study in routine outpatient settings. BMC Pediatr. 2009;9:39.

Hamre HJ, Witt CM, Kienle GS, Schnurer C, Glockmann A, Ziegler R, et al. Anthroposophic therapy for asthma: A two-year prospective cohort study in routine outpatient settings. J Asthma Allergy. 2009;2:111-28.

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Jerome RN¹, Pulley JM², Edwards TL², Dickerson AB², Conway D², Van Driest SL³, Bernard GR², Harris PA².We’re not all cut from the same cloth: TAILORing treatments for children with chronic conditions. J Patient Rep Outcomes. 2019 Apr 29;3(1):25. doi: 10.1186/s41687-019-0117-2.

INDIVIDUALIZED, COLLABORATIVE, INTEGRATIVE, AND PARTICIPATORY CARE

The Documenting Hope Project offers a uniquely comprehensive and personalized healing program whose hallmarks are collaborative interdisciplinary teams of clinicians and health professionals, the use of bio-individual assessments, personalized therapeutic care and support (including personalized nutrition) and home and environs modification. The program emphasizes the importance of nutrition and lifestyle, and requires full engagement from participants and their families. A strong foundation of literature demonstrates how this methodology can positively impact health outcomes, even though combining these components is uncommon in most clinical settings.

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Hamre HJ, Witt CM, Glockmann A, Ziegler R, Willich SN, Kiene H. Anthroposophic medical therapy in chronic disease: a four-year prospective cohort study. BMC Complement Altern Med. 2007;7:10.

Hamre HJ, Witt CM, Kienle GS, Glockmann A, Ziegler R, Rivoir A, et al. Anthroposophic therapy for migraine: a two-year prospective cohort study in routine outpatient settings. Open Neurol J. 2010;4:100-10.

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COMMUNITY-BASED SCIENCE

Carlson JA, Crespo NC, Sallis JF, Patterson RE, Elder JP. Dietary-related and physical activity-related predictors of obesity in children: a 2-year prospective study. Child Obes. 2012;8(2):110-5.

Emmett P. Assessing diet in longitudinal birth cohort studies. Paediatr Perinat Epidemiol. 2009;23 Suppl 1:154-73.

Hamre HJ, Witt CM, Glockmann A, Ziegler R, Willich SN, Kiene H. Anthroposophic medical therapy in chronic disease: a four-year prospective cohort study. BMC Complement Altern Med. 2007;7:10.

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O’Brien M, Nader PR, Houts RM, Bradley R, Friedman SL, Belsky J, et al. The ecology of childhood overweight: a 12-year longitudinal analysis. Int J Obes (Lond). 2007;31(9):1469-78.

HEALTH COACHING/PERSONALIZED HEALTH MANAGEMENT

Health care practitioners confirm that their patients with complex chronic illnesses requiring substantial dietary and/or lifestyle changes have improved health outcomes when supported by a trained health coach or wellness consultant. While much of this research involves an aging population, evidence supports this approach with children.

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Karagiozoglou-Lampoudi T, Daskalou E, Agakidis C, Savvidou A, Apostolou A, Vlahavas G. Personalized diet management can optimize compliance to a high-fiber, high-water diet in children with refractory functional constipation. J Acad Nutr Diet. 2012;112(5):725-9.

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ELECTRONIC HEALTH RECORDS, BIOINFORMATICS AND DATA CAPTURE

The Electronic Health Record and Bioinformatics System utilized by the Documenting Hope Project will serve several key functions:

Track and monitor the cases of children enrolled in the recovery program.

Store complex sets of data on each program participant including, but not limited to: clinical laboratory data, daily logging (sleep, diet, exercise, emotions, behaviors, etc.), experts assessments (e.g. structural or functional assessments)

Act as a communication tool and platform for clinicians and experts to use while collaborating and conferring on cases.

Capture survey data from thousands of applicants on environmental exposures and health history.

Facilitate the mining and analytics of collected data both during and after the completion of the program.

Similar programs and bioinformatics systems are currently in use to track longitudinal data, assess relative risk, severity of illness, multivariate interventions and health outcomes. A robust cloud-based informatics system that can upload electronic data from labs, consumer apps, and clinician desktops is a central feature of the Documenting Hope Project. This type of platform is readily available, customizable and has been demonstrated to be an efficient way to track “big data” that can then be analyzed, interpreted, and contribute to great advances in the understanding of human health and physiology.

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