sou · H7B315 · 2019-03-28 00:00:00 — Measures to promote confidence and positive expectations are in concert with the basic principles of EBM, while using placebo therapy under the that it has specific effects is not in accordance with the individual’s right to make well-informed decisions. How- ever, practitioners generally stress that the therapies do have specific effects. We have reviewed a limited number of methods that have pre- viously been considered as therapies and have now been partially introduced in healthcare. Was it possible to discern a common pattern? We observed no such pattern. In Swedish healthcare, there is a generally accepted model for introduction of new methods in publicly financed healthcare. Im- portant components in this governance by knowledge are systematic reviews with grading of evidence, a national priority-setting model, and national and local guidelines with systematic follow-up of im- plementation in clinical practice. In the inquiry, we consider that this model also should be applied for methods that are candidates to be adopted by healthcare. Thus, the model should be neutral as to origin, i.e., no special track for methods with a origin should be initiated. To provide a high-quality basis for priority-setting, we suggest that the government commission the for Assessment and Assessment of to per- form an inventory of what methods could be candidates to be introduced in healthcare and conduct assessments of the scientific support of those methods that are judged to be particularly relevant from this point of view. Task 6: To promote contact and understanding in order to improve patient safety From the terms of reference: …contribute to improve contacts and understanding between the established care and care out of the established care in order to improve patient safety. If the communication needs to be improved, proposals to this end shall be presented. “Improved understanding” may be interpreted in various ways. We have deemed it unrealistic to present proposals aimed at practitioners at large to share the epistemology and models of explanation of healthcare and vice versa. Instead, we propose that healthcare professionals improve their knowledge of and CAC and the thinking underlying the most common systems and methods. We also propose that the professional organi- sations work to improve knowledge about the methods of healthcare and their underlying models of explanation. In accordance, we advise universities and colleges involved in education of physicians, nurses, physiotherapists, psychologists and dieticians to introduce a brief course. The aim is that patients and healthcare professionals should be able to discuss methods and thus facilitate patients’ possibilities to make well-informed decisions. Improved knowledge about methods and possible interactions with healthcare methods could contribute to improved patient safety. We suggest that is commissioned to develop educational material on and CAC for health care professionals. Other proposals that serve to contribute to “improved contacts and understanding” between CAC and healthcare concern variables in selected national quality registers, a policy for accepting methods in healthcare and a system for information to the public on and CAC, which may also be used by healthcare professionals. Task 7: Information system for citizens From the terms of reference: …deliver a proposal of a system that contributes to patients getting such information that is needed to make well-informed choices of care and avoid unserious and hazardous treatment options. Presently, independent public information in Swedish on and CAC is only presented in fragments on websites such as the official information site of the public healthcare providers (“1177 Vård- guiden”) or at websites of governmental agencies. An independent information system would improve the possibilities for citizens to exert an influence on their own care. We deem that there is a need for independent information in on what characterises various methods, what is known about possible benefits and risks and what a potential customer/ patient should know more generally if use of a is considered. Information directed to citizens and healthcare staff should be available at a common portal and searchable by therapeutic methods, symptoms and diagnoses. We propose that an editorial board is placed at and that this authority is source owner of the information. The editorial board is proposed to be supported by an advisory committee including representatives of users, practitioners, healthcare and govern- mental agencies. To facilitate the production of information, we suggest agreements with existing information sites in and . This information should be adapted to the Swedish setting by the editorial board. We consider the information site 1177 Vårdguiden to be the most appropriate site for making the information available to the citizens. The information at 1177 may also be a source of information for healthcare staff seeking information on methods. At the websites of governmental agencies in the healthcare arena, there is no easily accessed information on regulations, insurances or where to turn for complaints on a treatment or a CAC practi- tioner. We therefore propose that be commissioned to coordinate generic information on CAC to citizens by governmental authorities. In addition, the Health and Social Care Inspectorate () should be mandated to clarify its role concerning handling of complaints in the area. We propose that the is commis- sioned to provide generic information on at its website “Hallå konsument”. Proposals to improve patient safety Although not included in our specific tasks, the need for improved patient safety is emphasised in more general terms in the terms of reference. Several of our proposals are aimed at strengthening safety in complementary and alternative care. Our upcoming review of the Patient regarding care provided by non-healthcare professionals will focus on safety issues. This part of the inquiry will be presented in a later report. A couple of our proposals aim at providing a person who uses CAC improved information to make well-informed decisions. The suggested information system described above includes information on what is known about possible health hazards. Our proposed policy for introducing methods in health- care also has a patient safety dimension. We suggest that methods should not have a special track but be introduced according to the same model as other methods that are candidates to be adop- ted in healthcare. This includes a review of what is known about possible risks. Also, our proposal to introduce an education package on and CAC has patient safety aspects. If it is materialised, there are prerequisites for more improved, more trustful communication on CAC issues between patients and healthcare professionals. The risk for interactions as well as the risk that the patient terminates effect- tive treatment prescribed in healthcare will be reduced. Our proposal to include CAC variables in some of the national quality registers in healthcare will create the possibility to follow-up on safety issues in a more systematic way, when CAC is used. Proposals directed to CAC practitioners and their organisations In addition to proposals directed toward governmental agencies, universities and colleges and publicly financed healthcare, we find a need for the CAC sector to ascertain good patient safety. Thus, CAC professional organisations are encouraged to ensure that practitioners have basic education about the methods used in health- care and their underlying models of explanation. Safety aspects, such as a risk for interruption or reduction of effective treatment and possible interactions with treatment prescribed in healthcare should be addressed. We emphasise the need for a strengthened dialoque between the CAC sector and the . A collaboration could result in a branch agreement between the major orga- nisations and the Agency. If so, the agreement would clarify relevant rules and regulations for CAC practitioners. It would also provide the citizen who considers using CAC a basis for selection of a prac- titioner that meets certain standards regarding education, insurance and handling of complaints. Our general task was to investigate the question of a possible national register of CAC practitioners, but not a specific term of reference on this point. This question has been reviewed by previous governmental inquiries. None of the proposals has led to any initia- tives by the government. Some of the professional organisations have registers of their member that are publicly available on websites. If such organisa- tions sign branch agreements with the , it will become easier for those seeking CAC to identify what organi- sations that exist and to what extent they work on systematic quality improvement and safety issues among their members. We estimate that registers kept by the organisations, combined with branch agreements, at least partly meet the requirements that citizens may, in a reasonably safe , identify appropriate practitioners. In view of this and previous difficulties in realising propositions on a national register by governmental inquiries, we consider the potential advan- tages of a register run by the state not being in proportion to the resources that would be required. issues have been the subject of several previous governmental inquiries. One of these (1989) was commissioned to deal with the entire area, whereas others have concerned limited questions within the area. In the present Patient , one of the paragraphs concerns healthcare-related interventions by non-licensed practitioners. This act dates back to a year 1915 law with successive minor modifica- tions since then. Modifications of parts of this law/paragraph have been suggested by four inquiries since 1989, not resulting in any substantial changes. It is also striking that very few of the other proposals by previous inquiries have been implemented. These have included compulsory basic education for practitioners, register of practitioners, an independent public-oriented information system on methods, and targeted support for research. Professional organisations and educations Without any claim to be complete, we have identified approximately 30 professional organisations in . Most of them are oriented toward a particular method or therapeutic system, but there are also umbrella organisations. The majority have some kind of ethical guidelines and some require that members have insurance. Most professional organisations are also running more general questions like dissemination of information, quality and patient safety issues, requests for more research, licensing and improved economic conditions for practitioners. Usually, the organisations request their members to have training in a specific method, sometimes also basic education. education is, with very few exceptions, privately run. We have also mapped to what extent the education of healthcare professionals-to-be involves knowledge about . Such elements appear but to a low extent, varying considerably between univer- sities. A few optional courses with elements have been identi- fied, usually corresponding to one month of study. No compiled official statistics on practitioners or CAM enterprises exist in . The total membership of organi- sations known to us is around 8 000, but far from all practitioners are members of any professional organisation. According to Statistics , there are 21 900 enterprises, most of them with sole pro- prietors, in which the activities is reported to be “other human health activities not elsewhere classified” or “physical well-being activities”; it is likely that many of them offer some kind of CAC. In an inquiry to providers of publicly financed healthcare, only a few CAM-related activities emerged, for example non-financial sup- port to integrative care, information on CAC, education in mindful- ness and projects on green rehabilitation. Use of and attitudes We identified 20 Swedish surveys (scientific studies or polls) pub- in the years 1987–2018, in which the use of and/or attitudes about CAC had been mapped either in the population at large or in restricted groups of patients. In surveys with the best coverage from the last 20 years, 17–39 percent of the population re- port that they have used CAC or taken medicines during the preceding year. In other studies, higher proportions (up to approxi- 70 percent) have been reported. Most often, this has included the use of chiropractic and naprapathy. A majority of the population studies have reported more frequent use of , including medicines, by women compared to men. Many studies have also observed that a higher level of education (in general associated with higher income) and lower self-estimated health are associated with CAC use. Among patients with diagnosed disease, the proportion that have been using some form of CAC at the time of survey or during the preceding year has been 29–58 percent. The most commonly used methods, apart from chiro- practic treatment and naprapathy, are massage, acupuncture, medicines and relaxation techniques, such as yoga. We have collected information on regulations and other aspects of in the Nordic countries and, to a limited extent, in , , the UK and the US. In most countries, there are restric- tions on the treatment of serious disorders, for example cancer, by others than licensed healthcare staff. In , and , there is special legislation regarding and voluntary national registers of practitioners. In and , CAC may be exempted from VAT under certain circumstances. is the only Nordic country with a national research centre for CAC. A small proportion of German physicians have a supplementary education in a field, such as acupuncture, anthroposophical medicine or homeopathy. In , there is special regulation of care conducted by others than licensed healthcare professionals that includes limitations on what conditions are permitted to be treated. The compulsory German health insurance does not cover out-patient treatment, although there are a few exceptions. Some insurance companies have a CAC profile and cover a broader spectrum of CAC interventions. In the UK, there is no legislation on who may practice CAC. However, there are restrictions on what disorders the practitioners are allowed to treat. In the US, there are state regulations on what services a practitioner may offer. Usually, publicly financed insurance systems do not cover expenses for CAC, but private insurances do so to an increasing extent. A national centre for complementary and integra- tive health has been in operation since 1991. Review of and CAC The area involves a broad spectrum of diagnostic and thera- peutic systems and methods. We classify the therapies into five cate- gories: (a) therapeutic systems, (b) manual and other body-oriented therapies, (c) mind-body-therapies and other psychological therapies, (d)natural medicines and other therapeutic products and (e) other therapies. We describe examples of seven systems and some 30 therapies in total, chosen because they are common, prin- cipally interesting or particularly controversial. In addition, we de- scribe a few diagnostic methods. Some recurrent themes when proponents are describing are presented. Examples are the historical background of many systems and therapies, holism and focus on the individual, energies, reference to new physical theories and phenomena, mobili- sation of a person’s healing capacities and focus on well-being rather than disease. Some common societal values may contribute to an interest in , for instance a focus on personal well-being and fulfilment, pluralism and a critical attitude toward “the ”. Com- mercial interests and widespread attention in traditional and social media may also contribute. Scientific studies have shown some motivations that occur particularly often in people seeking CAC, for instance striving for the original, the natural and the holistic. The inquiry’s terms of reference include issues on patient safety. We have therefore searched for information on patient or customer safety in the area. A national register on adverse effects does not exist. From the scientific literature, we give examples of adverse effects and harm related to acupuncture, homeopathy, treatment with herbal medicines and psychologically oriented therapies. A consider- able number of adverse and harmful events have been reported, mild as well as serious, even fatal. This should be seen in the light of the widespread use of these therapies. treatment prescribed by healthcare may involve particularly high risks in patients with serious diseases, such as cancer or psychosis. Criticism of healthcare by proponents In discussions of and CAC, it is common that proponents criticise healthcare. The criticism includes healthcare being culturally and sociopolitically constrained, having a narrow biomedical perspec- tive, being too expensive and focusing on disease rather than health. It is also said to rely too heavily on scientific evidence and not on other elements of good care. People seeking attention who are critical of healthcare point out the lack of time at consultations and shortfalls in the personal encounter, and they often presume that the risks of treatment are lower than those in healthcare. The debate on and CAC Criticism of and CAC primarily comes from healthcare pro- fessionals, scientists in medicine and natural sciences as well as from other people with a sceptical standpoint regarding what they call pseudoscience. A considered lack of scientific evidence and lack of plausible explanation are crucial elements of this critique. According to the critics, many of the proponents are characterised by knowledge resistance and a general scepticism against “the ”. Perceived improvements reported by people seeking CAC may, according to the critics, be explained by unspecific effects, spontaneous improvement or other mechanisms not directly related to the specific treatment. Ethical aspects of and CAC Most professional organisations in the CAC sector have ethical guide- lines for their members. They are usually similar to those adopted by healthcare professional organisations. The four “classical” ethical principles in healthcare (beneficence, non-maleficence, autonomy and ) may be applied also in the In addition, we discuss, from an ethical perspective, ques- tions on integrity, secrecy, informed consent, pluralism, hope and commercial interests. According to the Swedish ethical plat- form for prioritisation in healthcare, allocation of publicly financed resources should be by need, not demand. Since CAC is privately financed, demand plays a greater role. How we have worked The investigator appointed an expert committee with insights into (both proponents and a critic), a representative of prac- titioners, and representatives of governmental agencies, healthcare professions and healthcare providers. The investigator did not strive for consensus in the expert committee. Although the report is based on discussions with the members of the expert committee members, they are not responsible for the content of the report. In addition to meetings with the expert committee and its in- dividual members, they have commented on preliminary versions of the text. A special working group was appointed for questions on treatment of mental disorders. We have consulted with the Affairs and the , governmental agencies concerned, representatives of regional health- care provider and other actors in the area. We have also consulted other governmental inquiries working on topics close to . In addition, we have had a large number of meetings with prac- titioners, healthcare professionals and their representatives, labour unions, researchers, research funding organisations, patient organi- sations, media, insurance companies and politicians. We have made study visits in , , and , participated in conferences and seminars and arranged a dialogue meeting to which all interviewees were invited. Information was collected from scientific literature, textbooks, governmental reports, existing regulations and their preparatory work, court decisions and websites. Questionnaires were used to survey academic education on and continuing education on . We mapped Swedish professional organisations and reviewed non-academic education in . Assessment of and have made inventories of their activities in the area. A bibliometric analysis of the scientific literature, with special emphasis on Swedish research, has been performed by researchers at . We have made several delineations and set priorities. However, we have not addressed various kinds of drugs; the drug area is gen- erally well regulated in . We have not included diets and food supplements, unless they constitute a part of a therapeutic system. Interventions to promote general well-being and not related to ill- ness have not been covered, nor have aesthetic interventions and religious activities. During our work, many actors have supplied us with extensive material on the effects of different methods. In accordance with the terms of reference, this inquiry proposes a policy for evaluation of methods that could be candidates to introduce in Swedish healthcare, but we have not evaluated single methods or therapeutic systems. Regeringen tillsatte en utredning med flera uppdrag rörande ”annan vård och behandling än den som bedrivs inom den etablerade vården”. Utredningen antog namnet , där står för komplementär och alternativ medicin, den inter- nationellt mest förekommande benämningen. viuttrycket komplementär och alternativ vård (KAV) när vi avser det praktiska utövandet av . Dessutom använder vi begreppet integrativ vård när KAV integreras med hälso- och sjukvård. Det kan röra sig om omfattande system för hur man betraktar hälsa och ohälsa, t.ex. antroposofisk medicin, ayurvedisk medicin och traditionell kinesisk medicin. Det kan också handla om specifika behandlingsmetoder som akupunktur, zon- terapi eller örtmediciner. Vissa av KAM-metoderna har uråldriga traditioner, andra är helt nya. Några har tydlig religiös eller annan livsfilosofisk bakgrund, andra är baserade på fysiologiska resonemang. Många söker sig till KAV för att de tycker att KAV ger något annat, eller något utöver, vad hälso- och sjukvården ger. I utred- ningen gör vi en översikt över de svar som den vetenskapliga litte- raturen ger på frågan: Varför söker sig människor till KAV? Vi ger också en översikt över KAM-system och KAM-metoder som är vanliga i eller principiellt särskilt intressanta. Utifrån direktivet har vi i utredningen kartlagt KAM-forskningen inklusive de metoder som används för att utvärdera KAM-metoder, behandlat frågan om ökad kunskap om bland hälso- och sjuk- vårdens medarbetare och sett över möjligheterna för allmänheten att få neutral information om och . På dessa punkter kommer Vi föreslår, också utifrån vårt direktiv, vilken policy som bör användas för att ta upp KAM-metoder i den offentligt finansierade hälso- och sjukvården. Utredaren är professor emeritus i medicin vid . Han har varit generaldirektör för och är ordförande för (Smer). Han har länge arbetat med prioriteringsfrågor i hälso- och sjukvården, bl.a. som sakkunnig i den statliga . Hans forsk- ning inom KAM-området inkluderar studier av åderlåtning, ginkgo och akupunktur. Till utredningen har en expertkommitté knutits. Även om betän- kandet i många avseenden bygger på diskussioner med expertkom- mitténs medlemmar, har den särskilde utredaren ensam ansvaret för innehållet.