Design, delivery and effectiveness of health practitioner regulation systems: an integrative review.

BACKGROUND: Health practitioner regulation (HPR) systems are increasingly recognized as playing an important role in supporting health workforce availability, accessibility, quality, and sustainability, while promoting patient safety. This review aimed to identify evidence on the design, delivery and effectiveness of HPR to inform policy decisions. METHODS: We conducted an integrative analysis of literature published between 2010 and 2021. Fourteen databases were systematically searched, with data extracted and synthesized based on a modified Donabedian framework. FINDINGS: This large-scale review synthesized evidence from a range of academic (n = 410) and grey literature (n = 426) relevant to HPR. We identified key themes and findings for a series of HPR topics organized according to our structures-processes-outcomes conceptual framework. Governance reforms in HPR are shifting towards multi-profession regulators, enhanced accountability, and risk-based approaches; however, comparisons between HPR models were complicated by a lack of a standardized HPR typology. HPR can support government workforce strategies, despite persisting challenges in cross-border recognition of qualifications and portability of registration. Scope of practice reform adapted to modern health systems can improve access and quality. Alternatives to statutory registration for lower-risk health occupations can improve services and protect the public, while standardized evaluation frameworks can aid regulatory strengthening. Knowledge gaps remain around the outcomes and effectiveness of HPR processes, including continuing professional development models, national licensing examinations, accreditation of health practitioner education programs, mandatory reporting obligations, remediation programs, and statutory registration of traditional and complementary medicine practitioners. CONCLUSION: We identified key themes, issues, and evidence gaps valuable for governments, regulators, and health system leaders. We also identified evidence base limitations that warrant caution when interpreting and generalizing the results across jurisdictions and professions. Themes and findings reflect interests and concerns in high-income Anglophone countries where most literature originated. Most studies were descriptive, resulting in a low certainty of evidence. To inform regulatory design and reform, research funders and governments should prioritize evidence on regulatory outcomes, including innovative approaches we identified in our review. Additionally, a systematic approach is needed to track and evaluate the impact of regulatory interventions and innovations on achieving health workforce and health systems goals.

Stakeholder attitudes to the regulation of traditional and complementary medicine professions: a systematic review.

BACKGROUND: There has been a considerable increase in the number of traditional and complementary medicine (T&CM) practitioners over the past 20 years and in some jurisdictions are estimated to outnumber general practitioners. Despite this globally significant role, it is apparent that worldwide not all T&CM professions operate under adequate accountability and regulatory oversight for maintaining public protection. To date there has been no published systematic examination of stakeholder opinions regarding regulated and unregulated T&CM occupations. In response, this review aims to investigate, describe, and analyse attitudes held by a range of stakeholder groups towards the regulation of T&CM professions. METHODS: A database search of AMED, CINAHL, Embase, Ovid MEDLINE, ProQuest, PsycINFO, PubMed, Scopus, and Google Scholar was conducted for original research published between 2000 and 2020 on stakeholder opinions regarding the regulation of T&CM professions. RESULTS: Sixty studies across 15 countries reported on the views of six health care stakeholder groups: consumers, T&CM practitioners, conventional medicine practitioners, professional associations, education providers, and policy-makers. Across all stakeholder groups there was between 15% and 95% (median 61%) support for, and 1% to 57% (median 14%) opposition to the regulation of various T&CM professions. The main reasons for supporting regulation included providing greater public protection, raising training and practice standards, establishing title protection, and gaining acceptance from conventional medicine providers. Concerns regarding regulation included potential restrictions to practice, misappropriation of practice, and medical oversight of T&CM practitioners. Few studies canvassed the views of professional associations (n = 6), education providers (n = 2), and policy-makers (n = 2). CONCLUSIONS: There appears to be broad support for the regulation of T&CM professions, although there was wide variation in attitudes as to how this should be applied. Further research, with a particular focus on policy-makers, education providers, and professional associations, is critical to inform appropriate health policy and practice recommendations relating to T&CM professional regulation across jurisdictions. Systematic review registration: the a priori protocol for this systematic review was registered in PROSPERO and is available at: www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42020198767 .

The effects of Sambucus nigra berry on acute respiratory viral infections: A rapid review of clinical studies.

BRIEF OVERVIEW: Collectively the evidence obtained from across five clinical studies involving 936 adults indicate that mono-herbal preparations of Sambucus nigra L. berry (S.nigra), when taken within 48 hours of the onset of acute respiratory viral infection, may reduce the duration and severity of common cold and influenza symptoms in adults. There is currently no evidence to support the use of S.nigra berry for the treatment or prevention of COVID-19. Given the body of evidence from preclinical studies demonstrating the antiviral effects of S.nigra berry, alongside the results from clinical studies involving influenza viral infections included in this review, pre-clinical research exploring the potential effects of S.nigra berry on COVID-19 are encouraged. VERDICT: The evidence included in this review is mostly derived from clinical studies involving adult participants and examining short-term use of commercial formulations of S.nigra berry for up to 16 days. Findings from included studies suggest that mono-herbal preparations of S.nigra berry (in extract or lozenge formulation) may reduce influenza-type symptoms, including fever, headache, nasal congestion and nasal mucous discharge in adults, when taken within the first 48 hours of symptom onset. Within 2-4 days of S.nigra treatment, most adult participants experienced significant symptom reduction, by an average of 50%. Evidence regarding the effectiveness of S.nigra berry on the symptom of cough, and need for/use of medicines (including antibiotics) to treat acute respiratory infections, is currently unclear and inconsistent. Adverse events were rare with no serious events reported. Adverse events, reported in two studies, were more common in comparators than in treatments. There is currently no reliable or sufficient scientific evidence to support the use of S.nigra in pregnant or lactating women.

The effect of Echinacea spp. on the prevention or treatment of COVID-19 and other respiratory tract infections in humans: A rapid review.

BRIEF OVERVIEW: Current evidence suggests that Echinacea supplementation may decrease the duration and severity of acute respiratory tract infections; however, no studies using Echinacea in the prevention or treatment of conditions similar to COVID-19 have been identified. Few adverse events were reported, suggesting that this herbal therapy is reasonably safe. Because Echinacea can increase immune function, there is a concern that it could worsen over-activation of the immune system in cytokine storm; however, clinical trials show that Echinacea decreases levels of immune molecules involved in cytokine storm. VERDICT: Echinacea supplementation may assist with the symptoms of acute respiratory infections (ARI) and the common cold, particularly when administered at the first sign of infection; however, no studies using Echinacea in the prevention or treatment of conditions similar to COVID-19 have been identified. Previous studies have reported that Echinacea may decrease the severity and/or duration of ARI when taken at the onset of symptoms. The studies reporting benefit used E. purpurea or a combination of E. purpurea and E. angustifolia containing standardized amounts of active constituents.Few adverse events from the use of Echinacea were reported, suggesting that this herbal therapy is reasonably safe. No human trials could be located reporting evidence of cytokine storm when Echinacea was used for up to 4 months.When assessing all human trials which reported changes in cytokine levels in response to Echinacea supplementation, the results were largely consistent with a decrease in the pro-inflammatory cytokines that play a role in the progression of cytokine storm and Acute Respiratory Distress Syndrome (ARDS), factors that play a significant role in the death of COVID-19 patients. While there is currently no research on the therapeutic effects of Echinacea in the management of cytokine storm, this evidence suggests that further research is warranted.

The effects of Hedera helix on viral respiratory infections in humans: A rapid review.

BRIEF OVERVIEW: Based on the evidence identified in this rapid review, Hedera helix preparations and herbal complex preparations including H. helix may be a therapeutic option for treating early symptoms of respiratory tract infections. The best effectiveness for H. helix preparations has been proven for coughing, as an expectorant and to reduce the frequency and intensity of cough. Only weak evidence was found for all other researched symptoms. Both adults and children tolerate H. helix well. Currently, there is insufficient evidence to recommend the use of this supplement in the treatment or prevention of COVID-19. However, the current evidence justifies further research to better understand its applicability in coronavirus infections. VERDIC: tCurrent evidence suggests H. helix may improve the frequency and intensity of cough associated with viral respiratory infection. The overall applicability of additional findings is limited by the poorly defined outcome measures employed. However, studies focused explicitly on expectoration did report an increased conversion from dry to productive cough, and an improvement in expectoration amount, consistency and colour. These effects may be explained by a related finding of reduced oropharyngeal congestion and improved inflammatory markers (erythrocyte sedimentation rate and c-reactive protein). A decrease in frequency of night cough and respiratory pain was also reported, as was improved sleep quality and reduced cough-related sleep disturbance.Some studies also measured general respiratory tract infection symptoms and identified clinical improvement or resolution of fever, fatigue, sore throat, sneezing, wheezing, nasal congestion, post-nasal drip and body-ache. A reduced need for antibiotic prescriptions was also identified. While not consistently reported, the majority of studies also found H. helix reduced the overall severity of viral bronchitis and related conditions. Tolerability was rated as between 'good' and 'high'. Adverse events were rare or non-existent in almost all studies, and those that were reported were defined as non-serious and not drug-related.