A Pragmatic Historical Assessment Tool: A New Systematic Framework for the Collation and Evaluation of Documented Empirical Effectiveness and Safety of Traditional Plant Medicines in the European Materia Medica.

INTRODUCTION: Traditional plant medicines (TPMs) are plant-derived therapeutic products prepared and applied according to longstanding medical customs. Around the world they are widely used in primary and preventative health care. The World Health Organization (WHO) calls in its Traditional Medicine Strategy 2014-2023 for Member States to provide a regulatory framework so that the formal contribution of traditional therapeutics can be advanced in national systems of health care. Evidence of effectiveness and safety is paramount for the regulatory integration of TPMs; however, a presumed lack of such "evidence" is one obstacle for full integration. The consequential health policy question is how to systematically evaluate therapeutic claims relating to herbal remedies when the extant evidence is predominantly based on historical and contemporary clinical usage, i.e., is empiricist in nature. This paper introduces a new method along with several illustrative examples. METHOD: Our research design employs a longitudinal, comparative textual analysis of standard textbooks of the professional European medical literature from the early modern period (1588/1664) onwards to today. It then triangulated these intergenerationally documented clinical observations on two exemplars (Arnica and St. John's Wort) with corresponding listings in multiple qualitative and quantitative sources. A Pragmatic Historical Assessment (PHA) tool was developed and tested as a method to systematically collate the large amount of pharmacological data recorded in these judiciously selected sources. The evidential validity of longstanding professional clinical knowledge could thus be compared with therapeutic indications approved in official and authoritative sources (pharmacopoeias, monographs) and with those supported by contemporary scientific research (randomised-controlled trials [RCTs], experimental research). RESULTS: There was high congruency between therapeutic indications that are based on repeated empirical observations from professional patient care (empirical evidence), those approved in pharmacopoeias and monographs, and modern scientific evidence based on RCTs. The extensive herbal triangulation confirmed parallel records of all main therapeutic indications of the exemplars across all qualitative and quantitative sources over the past 400 years. CONCLUSIONS: Historical clinical medical textbooks and contemporary phytotherapeutic equivalents are the key repository of repeatedly evaluated therapeutic plant knowledge. The professional clinical literature proved to be a reliable and verifiable body of empirical evidence that harmonised with contemporary scientific assessments. The newly developed PHA tool provides a coding framework for the systematic collation and evaluation of empirical data on the effectiveness and safety of TPMs. It is suggested as a feasible and efficient tool to extend evidence typologies that substantiate therapeutic claims for TPMs as part of an evidence-based regulatory framework that formally integrates these medically and culturally important therapeutics.Traditionelle pflanzliche Arzneimittel sind aus Pflanzen gewonnene Heilmittel, die gemäß langjähriger medizinischer Praxis zubereitet und angewendet werden. Weltweit sind sie in der primären und präventiven Gesundheitsversorgung weit verbreitet. Die Weltgesundheitsorganisation (WHO) ruft in ihrer Traditional Medicine Strategy 2014­2023 die Mitgliedstaaten dazu auf, regulatorische Rahmenbedingungen zu schaffen, welche den formellen Beitrag traditioneller Therapeutika in den nationalen Gesundheitssystemen fördern. Der Nachweis von Wirksamkeit und Sicherheit ist von zentraler Bedeutung für die regulatorische Integration traditioneller pflanzlicher Arzneimittel, doch das angebliche Fehlen solcher "Nachweise" ist eine der Hürden für die vollständige Integration. Daraus ergibt sich die gesundheitspolitische Frage, wie man therapeutische Anwendungsgebiete pflanzlicher Heilmittel systematisch evaluieren kann, wenn die vorliegende Evidenz überwiegend auf deren historischer und aktueller klinischen Verwendung beruht, also empirischer Natur ist. In dieser Arbeit wird eine neue Methode mitsamt veranschaulichenden Beispielen vorgestellt.Unser Forschungsansatz beruhte auf einer longitudinalen, vergleichenden Textanalyse von Standard-Lehrwerken der europäischen medizinischen Fachliteratur ausgehend von der frühen Neuzeit (1588/1664) bis heute. Die über Generationen dokumentierten klinischen Beobachtungen wurden anhand von zwei Beispielen (Arnika and Johanniskraut) mit den diesbezüglichen Angaben in unterschiedlichen qualitativen und quantitativen Quellen trianguliert. Ein Pragmatisch­Historisches Auswertungstool (PHA) wurde als Methode entwickelt und getestet, um die großen Mengen der in diesen kritisch ausgewählten Quellen enthaltenen pharmakologischen Daten systematisch zu erfassen. Die Evidenzvalidität des langjährigen klinischen Fachwissens konnte so mit den therapeutischen Anwendungsgebieten verglichen werden, die in offiziellen und autoritativen Quellen (Pharmakopöen, Monografien) zugelassen sind, sowie mit denjenigen, die durch zeitgenössische wissenschaftliche Forschung gestützt werden (randomisierte kontrollierte Studien [RCTs], experimentelle Forschung).Es bestand ein hohes Maß an Kongruenz zwischen den therapeutischen Anwendungsgebieten, welche auf wiederholte empirische Beobachtung aus der professionellen Patientenversorgung beruhen (empirische Evidenz), den zugelassenen Indikationen in Pharmakopöen und Monographien sowie der aktuellen wissenschaftlichen Evidenz basierend auf klinischen Studien. Die umfassende pflanzenbezogene Triangulation bestätigte parallele Aufzeichnungen aller wesentlichen Anwendungsgebiete der untersuchten Beispiele in allen qualitativen und quantitativen Quellen über die letzten 400 Jahre hinweg.Historische Lehrbücher für klinische Medizin und zeitgenössische phytotherapeutische Äquivalente sind die wichtigsten Quellen von wiederholt evaluiertem therapeutischem Wissen zu Heilpflanzen. Die klinische Fachliteratur erwies sich als zuverlässiger und verifizierbarer Korpus empirischer Evidenz, der mit aktuellen wissenschaftlichen Untersuchungen übereinstimmte. Das neu entwickelte PHA-Verfahren bietet ein Kodierungs­Instrument für das systematische Erfassen und Auswerten empirischer Daten zur Wirksamkeit und Sicherheit von traditionellen pflanzlichen Arzneimitteln. Das PHA­Verfahren wird als praktikables und effizientes Instrument zur Erweiterung der Evidenz­Typologien empfohlen, indem es therapeutische Indikationen für traditionelle pflanzliche Arzneimittel untermauern kann, so dass diese medizinisch und kulturell wichtigen Therapeutika in einen evidenz-basierten regulatorischen Rahmen integriert werden können.

Applying Community-Based Participatory Research to Create a Diabetes Prevention Documentary with New Zealand Maori.

BACKGROUND: Type 2 diabetes is almost three times more prevalent in the indigenous people of New Zealand (Maori) than non-Maori. Despite the high rate of diabetes in the Maori population, little is known about their personal understanding or experience of the disease. OBJECTIVES: To engage Maori in a participatory process to develop a culturally relevant diabetes prevention documentary. METHODS: Principles of community-based participatory research (CBPR) were applied to a qualitative research design employing key informant interviews and focus groups to develop a diabetes prevention documentary. CONCLUSIONS: A CBPR approach provides an appropriate model for enacting local action-oriented approaches in the creation of a documentary that reflects Maori cultural beliefs and practices.

Prepared for what? addressing the disaster readiness gap beyond preparedness for survival.

BACKGROUND: Conventional disaster preparedness messaging focuses largely on promoting survival actions and communications planning for the immediate post-disaster period. While such preparedness is vital, we have long-observed a gap in preventive medicine and disaster planning for building personal resilience--preventatively--to persevere through prolonged recovery timeframes. There are many helpful attitudes and behaviors that people can develop to increase their readiness and capacity for drastic life changes, encompassing not only health-protective preparedness actions but health-promoting attitudes for "minding the risk" and "practicing resilience" as well. For instance, quality of life assessments and well-being interventions are widely-known for the clinically significant improvements they can produce in patient-reported outcomes. Similarly, health promotion interventions are implemented preventatively when a risk is identified yet a disease is not present, and can provide health benefits throughout people's lives, regardless of the type of adversities they eventually encounter (medical, environmental, or other). DISCUSSION: We argue there is an overlooked opportunity to leverage well-being theories and methods from clinical settings and public health practice for the purpose of preventatively boosting disaster readiness and bolstering capacity for long-term resilience. We also highlight our previously-published research indicating a role for integrating personal meaning into preparedness messages. This is an opportune time for applying well-being concepts and practices as tools for developing disaster readiness, as risk awareness grows through real-time tracking of hazardous events via social media. For example, two sudden-onset disasters occurred within ten days of each other in 2014 and caught worldwide attention for their extreme hazards, despite dramatic differences in scale. The 22 March 2014 landslide tragedy in Washington State, USA, and the 1 April 2014 Chilean earthquake and Pacific-wide tsunami alerts brought home how persistently vulnerable we all are, and how developing intrinsic personal readiness for scientifically-known risks before disaster unfolds is essential policy. Gap programming that addresses personal readiness challenges in prevention timeframes could save lives and costs. We contend that bridging this readiness gap will prevent situations where people, communities, and systems survive the initial impact, but their resilience trajectories are vulnerable to the challenges of long-haul recovery.

Building an educated health informatics workforce--the New Zealand experience.

New Zealand has a rapidly expanding health information technology (IT) development industry and wide-ranging use of informatics, especially in the primary health sector. The New Zealand government through the National Health IT Board (NHITB) has promised to provide shared care health records of core information for all New Zealanders by 2014. One of the major barriers to improvement in IT use in healthcare is the dearth of trained and interested clinicians, management and technical workforce. Health Informatics New Zealand (HINZ) and the academic community in New Zealand are attempting to remedy this by raising awareness of health informatics at the "grass roots" level of the existing workforce via free "primer" workshops and by developing a sustainable cross-institutional model of educational opportunities. Support from the NHITB has been forthcoming, and the workshops started in early 2013, reaching out to clinical and other staff in post around New Zealand.

Centralized drug review processes in Australia, Canada, New Zealand, and the United kingdom.

Many countries have centralized the clinical and economic assessments necessary for evidence-based drug coverage policy. We analyze such processes in Australia, Canada, New Zealand, and the United Kingdom. These countries apply comparable approaches to the assessment and appraisal of evidence but apply the processes to different types of drugs and use the reviews within different decision-making contexts. Review processes applied to all medicines and clearly tied to coverage decisions appear to influence national drug use. Rigor of process and transparency of data and rationale are believed to be important for maximizing the impact and political acceptability of the processes.

Prioritisation of elective surgery in New Zealand: The Reliability Study.

AIMS: This paper describes the rationale and methodology of a study assessing the reliability of tools for clinical prioritisation (Clinical Priority Assessment Criteria [CPAC]) of patients for elective surgery in New Zealand. METHODS: Surgeons from three specialties (general, vascular, and orthopaedic surgery) completed a computerised evaluation rating clinical vignettes across a range of diagnoses using several priority tools. The study design is described and an outline of the individual tool development and definitions is given. RESULTS: Of the 124 surgeons that participated in this study, 48% (60) were general surgeons, 21% (26) were vascular surgeons and 31% (38) were orthopaedic surgeons. The response rates in the first phase of data collection were 67%, 79%, and 63% for general, vascular, and orthopaedic surgery respectively. Completion rates were high with 100%, 93%, and 98% of the same groupings of surgeons completing the first round evaluations. A further 77% to 89% of the participants from the first round also completed the re-test evaluation. CONCLUSION: This study indicates that assessment of the reliability of CPAC tools currently in use in New Zealand is feasible using a vignette-based approach. In the future, study designs that allow for some face-to-face contact may be preferable for achieving optimal response and completion rates among surgeons. Further work from this study will focus on the individual results for each specialty and examining whether altering ethnicity status in vignettes had any effect on scoring behaviour.