Protocol of a randomised controlled multicentre trial investigating the effectiveness and safety of a wilderness programme on the mental and physical well-being of adolescents and young adults affected by cancer: the WAYA-2 study.

INTRODUCTION: Adolescents and young adults (AYAs) affected by cancer are an understudied group. Effective interventions are needed to support coping with the late effects of cancer, its treatment and to promote quality of life. Nature-based interventions may be promising in support of the self-management and health of AYAs affected by cancer. However, randomised controlled studies (RCTs) on the effectiveness of such interventions are lacking. We performed a first pilot RCT (n=42) that showed that it is feasible and safe to conduct such a study. Here, we propose a full-scale RCT to investigate the effectiveness and safety of a wilderness programme on the mental and physical health of AYAs affected by cancer. METHODS AND ANALYSIS: Participants are 150 AYAs affected by cancer, aged 16-39 years, who will be randomised to a wilderness (n=75) or a hotel stay (n=75). The wilderness programme is an 8-day intervention including a 6-day wilderness expedition. This is followed 3 months later by a 4-day intervention including a 2-day basecamp. Activities include hiking, backpacking, kayaking, rock climbing, mindfulness and bush-crafting. The comparison group is an 8-day hotel stay followed by a 4-day hotel stay (interventions include two travel days) at the same hotel after 3 months. Primary outcomes are psychological well-being and nature connectedness up to 1 year after the study start. Secondary outcomes are quality of life, physical activity and safety parameters. ETHICS AND DISSEMINATION: The Swedish Ethical Review Authority approved the study protocol on 27 September 2023 (reference: 2023-05247-01). The recruitment started on 19 February 2024 and the first part is planned to end on 31 December 2027. Study results will be disseminated by means of scientific publications, presentations at conferences, popular articles, interviews, chronicles and books. News items will be spread via social media, websites and newsletters. TRIAL REGISTRATION NUMBER: ISRCTN93856392.

Supporting Personal Growth in Childhood, Adolescent and Young-Adult Cancer Survivors Through Challenges in Nature - A Qualitative Study of WAYA Wilderness Programme Participation.

Background: Childhood, adolescent and young-adult (AYA) cancer survivors often experience health problems due to late or long-term effects of their cancer or the treatment thereof. The general population gains health benefits from immersion in nature, and nature-based programmes seem to be an intervention that can promote health among childhood and AYA cancer survivors. Objective: To explore the impact of the WAYA wilderness programme on the health of childhood and AYA cancer survivors. Methods: The study had a qualitative approach, with data from individual interviews (n = 18) 3 months after completion of the WAYA programme. In addition, case report data was collected during follow-up talks (1, 2 and 12 months after the programme) (n = 19). The WAYA programme consisted of an 8-day expedition, followed 3 months later by a 4-day base camp. The programme included activities such as hiking, backpacking, kayaking, rock climbing, bushcraft and mindfulness. Data was analysed according to a qualitative content analysis. The consolidated criteria for reporting qualitative research (COREQ) were followed. Results: An overarching theme was identified: "Personal growth from challenges in nature supported by deep connections with others". In 4 additional themes, participants' experiences describe how deep personal connections arose, as they developed a feeling of being able and competent in nature. Nature provided a space that supported relaxation and respite from everyday challenges and stimuli, which also led to an experience of being more connected to nature. Conclusion: The WAYA programme was experienced as being of support to childhood and AYA cancer survivors. The programme provided them with skills and tools to be safe in nature. When connected to nature, the participants developed trust and self-confidence, personal growth, relaxation and recovery from stress. Their engagement in outdoor activities continued after completion of the programme, when they returned to everyday life at home.

Mapping of systematic reviews on traditional medicine across health conditions: a protocol for a systematic map.

INTRODUCTION: Traditional medicine (TM) is an important part of healthcare either as the main healthcare system or as a complement to conventional medicine. The effectiveness of TM has been assessed in clinical trials that have been synthesised into thousands of systematic reviews (SRs). This study is commissioned by the World Health Organization (WHO) and is aimed at providing a systematic map of SRs of TM interventions across health conditions, as well as identifying gaps in the research literature in order to prioritise future primary research. METHODS AND ANALYSIS: This is the protocol for a systematic map of SRs reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P). We will search 17 electronic databases to identify SRs of TM. The literature search covers the last 5 years, from January 2018 to December 2022. At least two independent reviewers will perform the database search, screening of eligible SRs, data extraction and quality assessments using the A MeaSurement Tool to Assess Systematic Reviews (AMSTAR 2). The characteristics and extent of SRs will be analysed according to disease classification, and type of TM intervention, and visualised by means of (interactive) graphical maps. ETHICS AND DISSEMINATION: Ethical approval is not required as this is a systematic map of published studies. The findings of the study will be disseminated through online-available maps, presentations and scientific publications. PROSPERO REGISTRATION NUMBER: CRD42023416355.

Program evaluation of a wilderness experience for adolescents facing cancer: A time in nature to heal, connect and find strength.

OBJECTIVE: Despite advances in cancer treatment and increased survival, adolescents in treatment for cancer often suffer from psychosocial distress, negative mood, and chronic health problems. Wilderness therapy is considered a promising program to address psychosocial issues among adolescents with mental or behavioral health issues. There is little research on whether it may benefit adolescents in cancer treatment. METHODS: This program evaluation in the form of a pilot study uses qualitative and quantitative measures to describe the feasibility, acceptability, safety, and to explore the impact of a nine-day wilderness program among adolescents aged 13-17 in treatment or who recently finished treatment for a cancer. Quantitative tracking documented recruitment, retention, safety, and participant satisfaction. PROMIS measures assessed mental and social health, positive affect, fatigue, pain interference and intensity over three time-points: pre, post, and three-months after the nine-day wilderness experience. Mean differences were compared over time. Qualitative data collection involved participant observation and open-ended interviews. RESULTS: Study enrollment goals were met, enrolling eight adolescent participants with 100% participant retention. No serious adverse events were reported and participants described high satisfaction (9.25/10) with the wilderness experience on the final day and at three-months follow-up (9.5/10). Exploratory data analysis showed scores in a favorable direction indicating improved psychosocial outcomes in physical functioning, anxiety, depression, fatigue, and peer relations. From qualitative analysis it is suggested that program participation supported: increased self-confidence and peer connection. The program was evaluated as increasing personal accomplishment, supporting social interaction, having strong staff support, and capitalizing on the natural surroundings. CONCLUSION: Use of a wilderness program is feasible, acceptable, and safe among this highly vulnerable adolescent cancer population. Participants described greater self-confidence and peer connection which developed as participants experienced physical competency, group leadership, and personal strength. Larger randomized controlled studies are needed to learn whether these programs can improve psychosocial outcomes.

The resilience of Jewish communities living in the diaspora: a scoping review.

Introduction: Throughout history, Jewish communities have been exposed to collectively experienced traumatic events. Little is known about the role that the community plays in the impact of these traumatic events on Jewish diaspora people. This scoping review aims to map the concepts of the resilience of Jewish communities in the diaspora and to identify factors that influence this resilience. Methods: We followed the Joanna Briggs Institute (JBI) methodology. Database searches yielded 2,564 articles. Sixteen met all inclusion criteria. The analysis was guided by eight review questions. Results: Community resilience of the Jewish diaspora was often described in terms of coping with disaster and struggling with acculturation. A clear definition of community resilience of the Jewish diaspora was lacking. Social and religious factors, strong organizations, education, and communication increased community resilience. Barriers to the resilience of Jewish communities in the diaspora included the interaction with the hosting country and other communities, characteristics of the community itself, and psychological and cultural issues. Discussion: Key gaps in the literature included the absence of quantitative measures of community resilience and the lack of descriptions of how community resilience affects individuals' health-related quality of life. Future studies on the interaction between community resilience and health-related individual resilience are warranted.

A Qualitative Study Among Healthcare Providers on Risks Associated With the Use of Supportive Care for Cancer Treatment-Related Symptoms in Children and Adolescents.

INTRODUCTION: Although more than 300 000 children and adolescents worldwide are diagnosed with cancer yearly, little research has been conducted investigating how healthcare providers consider risk and patient safety connected with supportive care (including complementary and alternative medicine [CAM]) in this age group. This study aimed to explore how different healthcare providers perceive and evaluate risk when patients combine supportive care and conventional medicine in clinical practice and how they communicate and inform parents about the use of these modalities. MATERIALS AND METHODS: In-depth semi-structured interviews were conducted with 22 healthcare providers with expertise in treating pediatric oncology patients from 5 countries. Systematic content analysis was conducted using Nvivo 1.61. RESULTS: The analysis resulted in 3 themes and 8 subthemes. Generally, participants were cautious about implementing unproven new modalities or therapies when recommending supporting care modalities to parents of children and adolescents with cancer. The most important criterion when recommending a modality was evidence for safety based on a risk/benefit evaluation. Negative interactions with conventional medicine were avoided by using the half-life of a drug approach (the time it takes for the amount of a drug's active substance in the body to reduce by half). For patients with severe symptoms, less invasive modalities were used (ear seeds instead of ear needling). To enhance safety, participants practiced open and egalitarian communication with parents. CONCLUSION: Healthcare providers reported using a variety of approaches to achieve a safe practice when parents wanted to combine supportive care and conventional cancer treatment. They emphasized that these modalities should be foremost safe and not become an extra burden for the patients. Providers highlighted patient-centered care to meet the individual's specific health needs and desired health outcomes. A lack of national and regional standardized training programs for supportive care in pediatric oncology was considered a hazard to patient safety.

A randomized controlled pilot study assessing feasibility and safety of a wilderness program for childhood, adolescent, and young adult cancer survivors: the WAYA study.

BACKGROUND: The majority of childhood, Adolescent and Young Adult (AYA) cancer survivors suffers from long-lasting health issues following cancer treatment. It is therefore critical to explore effective health promotion strategies to address their needs. Exposure to nature is a promising approach to support the needs of young cancer survivors. This study investigated whether it is feasible to conduct a randomized controlled trial (RCT) of a wilderness program for childhood and AYA cancer survivors. METHODS: Eligible participants were aged 16-39 years, had a cancer diagnosis, and met minimal criteria. Seventy-one individuals expressed interest and 59 were randomized to either a wilderness or a holiday program. The wilderness program involved an 8-day expedition including backpacking, sea kayaking, gorge climbing, camping, bush-craft skills, and mindfulness-practices. It was followed by a 4-day basecamp after 3 months. The comparison was an 8-day holiday program at a Spa-hotel followed by a 4-day holiday program at the same hotel after 3 months. Primary outcome was study feasibility and safety. RESULTS: Ultimately, 19 AYAs participated in the wilderness and 23 in the holiday program. All completed the study at one-year follow-up. Participants were mostly female (70%) and represented diverse cancers. Clinical characteristics were similar between study arms excepting greater age at cancer diagnosis in the wilderness program (age 19.1 vs. 12.5; p = 0.024). Program adherence and data completeness was high (> 90%) in both arms. Adverse Effects (AEs) in the wilderness vs. the holiday program were similar (Relative Risk: 1.0, 95% Confidence Interval 0.8-1.3). The most frequent AE was tiredness, all were mild to moderate in severity, and serious AEs were not reported. Nature connectedness significantly increased over time in the wilderness program participants, but not in the holiday program (p < 0.001). No differences were found between the two study arms regarding quality of life, self-esteem, or self-efficacy. CONCLUSION: It is feasible to conduct a RCT and a supervised wilderness adventure is equally safe for childhood and AYA cancer survivors as a holiday program. This pilot study lays the foundation for a larger RCT to investigate the effectiveness of wilderness programs on the health of young cancer survivors. TRIAL REGISTRATION DATE AND NUMBER: 18/02/2021, NCT04761042 (clinicaltrials.gov).

Supportive care for cancer-related symptoms in pediatric oncology: a qualitative study among healthcare providers.

BACKGROUND: The aim of this study is to gain insight into the clinical experiences and perceptions that pediatric oncology experts, conventional healthcare providers, and complementary and alternative medicine (CAM) providers in Norway, Canada, Germany, the Netherlands, and the United States have with the use of supportive care, including CAM among children and adolescents with cancer. METHODS: A qualitative study was conducted using semi-structured in-depth interviews (n = 22) with healthcare providers with clinical experience working with CAM and/or other supportive care among children and adolescents with cancer from five different countries. Participants were recruited through professional associations and personal networks. Systematic content analysis was used to delineate the main themes. The analysis resulted in three themes and six subthemes. RESULTS: Most participants had over 10 years of professional practice. They mostly treated children and adolescents with leukemia who suffered from adverse effects of cancer treatment, such as nausea and poor appetite. Their priorities were to identify the parents' treatment goals and help the children with their daily complaints. Some modalities frequently used were acupuncture, massage, music, and play therapy. Parents received information about supplements and diets in line with their treatment philosophies. They received education from the providers to mitigate symptoms and improve the well-being of the child. CONCLUSIONS: Clinical experiences of pediatric oncology experts, conventional health care providers, and CAM providers give an understanding of how supportive care modalities, including CAM, are perceived in the field and how they can be implemented as adaptational tools to manage adverse effects and to improve the quality of life of children diagnosed with cancer and the families.

The Development and Acceptability of a Wilderness Programme to Support the Health and Well-Being of Adolescent and Young Adult Cancer Survivors: The WAYA Programme.

Detailed descriptions of theory, structure, and activities with causal links to specified outcomes of wilderness programs are lacking. Addressing this gap, the present qualitative study gives a thorough description of the development of the Wilderness programme for Adolescent and Young Adult (AYA) cancer survivors (WAYA). WAYA is adapted to the individual needs of AYA cancer survivors. It was conceived around Næss's ecosophy and the Positive Health Model, and refined based on findings from a scoping review and patient/public involvement. Programme aims were to increase physical activity, self-confidence, personal growth, joy, safety within nature, meaningful relationships, and self-efficacy. The programme was an eight-day expedition followed three months later by a four-day base-camp. Activities included hiking, backpacking, kayaking, rock climbing, mindfulness and bushcrafting. Evaluation of the programme through focus group and individual interviews with 15 facilitators and 17 participants demonstrated that a diverse group of participants, challenging activities, and mindfulness-based practices were found to positively influence group bonding and the learning process. Furthermore, including an expedition and base-camp component was found to be beneficial in supporting the development of participants' own personal outdoor practices. In conclusion, this study demonstrated that the WAYA programme is safe and well accepted by AYA cancer survivors.

Safety and use of complementary and alternative medicine in Norway during the first wave of the COVID-19 pandemic using an adapted version of the I-CAM-Q; a cross-sectional survey.

BACKGROUND: The COVID-19 pandemic lockdown has had a profound impact on physical and mental well-being throughout the world. Previous studies have revealed that complementary and alternative medicine (CAM) is frequently used for, and can be potential beneficial for strengthening physical mental resilience. The aims of this study were therefore to determine the prevalence and reasons for use of CAM during the first wave of the COVID-19 pandemic among a representative sample of the Norwegian population, and further determine self-reported effects and adverse effects of the CAM modalities used. METHODS: Computer assisted telephone interviews using a COVID-adapted I-CAM-Q questionnaire were conducted with 1008 randomly selected Norwegians aged 16 and above using multistage sampling during April and May 2020 applying age and sex quotas for each area. Frequencies, Pearson's chi-square tests, Fisher exact tests, and independent sample t-test were used to identify the users of CAM, what they used, why they used it and whether they experienced effect and/or adverse effects of the modalities used, and further to describe differences in sociodemographic factors associated with CAM use. Cronbach's alpha tests were used to test for internal consistency in the different groups of CAM. Significance level was set to p < 0.05. RESULTS: The study revealed that two thirds of the respondents (67%) had used CAM within the first 3 months of the COVID-19 pandemic, in particular CAM modalities that did not involve a provider. Most used were natural remedies and dietary supplement (57%, mainly vitamins and minerals), but self-help practices like yoga and meditation were also widely used (24%). Women used CAM modalities significantly more than men (77% vs. 58%). Most of the respondents found the modalities they used beneficial, and few reported adverse effects of the treatments. CONCLUSIONS: A large proportion of the Norwegian population used CAM during the first wave of the COVID-19 pandemic with high satisfaction and few reported adverse effects. CAM was rarely used to prevent or treat COVID-19, but rather to treat a long-term health condition, and to improve well-being.

Safety of Complementary and Alternative Medicine (CAM) treatment among children and young adults who suffer from adverse effects of conventional cancer treatment: A systematic review.

BACKGROUND: Complementary and Alternative Medicine (CAM) is widely used around the world to treat adverse effects derived from cancer treatment among children and young adults. Parents often seek CAM to restore and maintain the child's physical and emotional condition during and after cancer treatment. OBJECTIVES: The objectives of this review were (i) to identify literature that investigates CAM use for treating adverse effects of conventional cancer treatment, (ii) to investigate the safety of the included CAM modalities, and (iii) to evaluate the quality of included studies. METHODS: Five scientific research databases were used to identify observational, quasi-experimental, and qualitative studies from January 1990 to May 2021. Included studies investigated the use of CAM to treat adverse effects of cancer treatment in childhood cancer. RESULTS: Fifteen studies were included in this review. Ten quasi-experimental, 3 observational studies (longitudinal/prospective), 2 qualitative studies, and 1 study with a quasi-experimental and qualitative arm were identified. Less than half (n = 6; 40%) of the studies included reported adverse effects for the CAM modality being studied. Among the studies that reported adverse effects, they were mostly considered as direct risk, as 13% reported mainly bleeding and bruising upon acupuncture treatment, and dizziness with yoga treatment. All adverse effects were assessed as minor and transient. CAM modalities identified for treating adverse effects of cancer treatment were alternative medical systems, manipulative and body-based therapies, biologically-based therapies, and mind-body therapies. CAM modalities were used to alleviate anxiety, pain, toxicity, prevent trauma, and improve health-related quality of life, functional mobility, and physical activity levels. All studies assessed scored 70% or above according to the Joanna Briggs Institute critical appraisal for study quality checklists. CONCLUSION: Most of the studies (58.3%) included in this review did not report adverse effects from CAM modalities used to treat adverse effects of cancer treatment in children and young adults. This lack of safety information is of concern because parents need to know whether the modality represents an extra burden or harm to the child. To improve awareness about safety in the field, a universal and uniform reporting system for adverse effects in CAM research is needed.

Mapping the Concept, Content, and Outcome of Family-Based Outdoor Therapy for Children and Adolescents with Mental Health Problems: A Scoping Review.

Outdoor therapy and family-based therapy are suggested to be promising interventions for the treatment of mental health problems. The aim of the present scoping review was to systematically map the concept, content, and outcome of combining family- and outdoor-based therapy for children and adolescents with mental health problems. The Joanna Briggs Institute methodology and PRISMA guidelines were applied. Eligible qualitative and quantitative studies were screened, included, and extracted for data. Seven studies were included. Findings from these studies indicated that family-based outdoor therapy programs have a positive impact on family- and peer relationships, adolescent behavior, mental health, self-perceptions (self-concept), school success, social engagement, and delinquency rates. However, participant characteristics, study design, and content and mode of delivery of the interventions varied substantially, hence preventing detailed comparison of outcomes across studies. In addition, most of the studies included few participants and lacked population diversity and comparable control groups. Although important ethical concerns were raised, such as non-voluntary participation in some of the programs, there was a lack of reporting on safety. This review indicates that a combination of family- and outdoor-based therapy may benefit mental health among children and adolescents, but due to the limited number of studies eligible for inclusion and high levels of heterogeneity, it was difficult to draw firm conclusions. Thus, future theory-based studies using robust designs are warranted.

Protocol of a mixed-method randomised controlled pilot study evaluating a wilderness programme for adolescent and young adult cancer survivors: the WAYA study.

INTRODUCTION: The majority of childhood, adolescent and young adult (AYA) cancer survivors suffer from long-term and late effects such as fatigue, psychological distress or comorbid diseases. Effective health promotion strategies are needed to support the health of this vulnerable group. This protocol provides a methodological description of a study that aims to examine the feasibility and safety of performing a randomised clinical trial (RCT) on a wilderness programme that is developed to support the health of AYA cancer survivors. METHODS AND ANALYSIS: The pilot RCT study has a mixed-method design, including quantitative and qualitative evaluations. Participants are AYAs, aged 16-39 years, that have been diagnosed with cancer during childhood, adolescence or young adulthood. A total of 40 participants will be randomly assigned to a wilderness programme (n=20) or a holiday programme (n=20). Both arms include participation in an 8-day summer programme, followed by a 4-day programme 3 months later. Primary outcomes are feasibility and safety parameters such as time to recruitment, willingness to be randomised, programme adherence and adverse effects. Secondary outcomes include self-reported health such as self-esteem, quality of life, self-efficacy and lived experiences. Descriptive statistics will be used to analyse outcomes and explore indications of differences between the programmes. Interviews are analysed by directed content analysis and hermeneutic phenomenology. A convergent parallel mixed-method analysis design will be applied to integrate quantitative and qualitative data. Results of this feasibility study will inform the preparation for a larger RCT with AYA cancer survivors. ETHICS AND DISSEMINATION: The study protocol is approved by the Swedish Ethical Review Authority (reference: 2020-00239). This study will be performed between January 2021 and December 2023. Results will be published in international peer-reviewed journals, presented at conferences and disseminated to participants, cancer societies, healthcare professionals and outdoor instructors. TRIAL REGISTRATION NUMBER: NCT04761042.

Complementary and alternative medicine modalities used to treat adverse effects of anti-cancer treatment among children and young adults: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Dealing with the symptom burden of cancer diagnosis and treatment has led parents to seek different self-management strategies including Alternative and Complementary Medicine (CAM). The aim of this study was to perform a systematic review and meta-analysis about the use and effect of CAM modalities to treat adverse effects of conventional cancer treatment among children and young adults. METHODS: Six scientific research databases were used to identify randomized controlled trials (RCTs) from 1990 to September 2020. Included studies investigated the use of CAM to treat cancer treatment related adverse effects in children and young adults compared to controls. RESULTS: Twenty RCTs comprising 1,069 participants were included in this review. The included studies investigated acupuncture, mind-body therapies, supplements, and vitamins for chemotherapy-induced nausea and vomiting (CINV), oral mucositis, and anxiety among children and young adults who underwent conventional cancer treatment. Seven studies (315 participants) were included in the meta-analysis. The overall effect of CAM (including acupuncture and hypnosis only) on chemotherapy-induced nausea and/or vomiting and controls was statistically significant with a standard mean difference of -0.54, 95% CI [-0.77, -0.31] I2 = 0% (p < 0.00001). There was a significant difference between acupuncture and controls (n = 5) for intensity and/or episodes of CINV with an SMD -0.59, 95% CI [-0.85, -0.33] (p < 0.00001). No significant difference was found between hypnosis and controls (n = 2) for severity or episodes of CINV with an SMD -0.41, 95% CI [-1.09, 0.27] I2 = 41% (p = 0.19). CONCLUSION: Current evidence from this meta-analysis of randomized controlled trials shows that CAM, including acupuncture and hypnosis only, is effective in reducing chemotherapy-induced nausea and vomiting in children and young adults. More rigorous trials and long-term effects should be investigated if acupuncture and hypnosis are to be recommended for clinical use.

The Use of the Bolk Model for Positive Health and Living Environment in the Development of an Integrated Health Promotion Approach: A Case Study in a Socioeconomically Deprived Neighborhood in The Netherlands.

BACKGROUND: Despite considerable efforts, health disparities between people with high and low socioeconomic status (SES) have not changed over the past decades in The Netherlands. To create a culture of health and an environment in which all people can flourish, a shift in focus is needed from disease management towards health promotion. The Bolk model for Positive Health and Living Environment was used as a tool to guide this shift. This study aimed to describe how this model was used and perceived by stakeholders in a case study on an integrated health promotion approach for residents with low SES. METHODS: An instrumental case study was undertaken in Venserpolder, a neighborhood in Amsterdam South East of approximately 8500 residents. A participatory action approach was used that allowed continuous interaction between the residents, health care professionals, researchers, and other stakeholders. The Bolk model is a tool, based on the conceptual framework of positive health, that was developed to guide health promotion practice. Its use in the case study was evaluated by means of semistructured interviews with stakeholders, using qualitative directed content analyses. RESULTS: The Bolk model was found to be a useful tool to identify and map the needs and strengths of residents with low SES. The model facilitated the development and implementation of eight health promotion pilots by transforming the needs and strengths of residents into concrete actions carried out by responsible actors in the neighborhood. Although the Bolk model seemed to be accepted by all stakeholders, the shift towards positive health thinking appeared to be more embodied by local professionals than by residents. Adjustments were proposed to enhance the applicability of the model in a multicultural setting, to increase its cultural sensitivity and to use language more familiar to residents. CONCLUSIONS: The Bolk model for positive health and living environment seems to be promising in the guidance of health promotion practices in Amsterdam South East. Further research and development are needed to improve its cultural sensitivity and to investigate its applicability in a broader range of public health settings.

Adverse effects in homeopathy. A systematic review and meta-analysis of observational studies.

BACKGROUND: Almost all health care interventions have the potential to be associated with risk to patient safety. Different terminologies are used to define treatment induced risk to patient safety and a common definition is the term adverse effect. Beyond the concept of adverse effect and specific to homeopathy is the concept of homeopathic aggravation. Homeopathic aggravation describes a transient worsening of the patients' symptoms, which is not understood as an adverse effect. In order to ensure patient safety within a homeopathic treatment setting, it is important to identify adverse effects, as well as homeopathic aggravations, even though it may be challenging to distinguish between these two concepts. To date there is an obvious lack of systematic information on how adverse effects and homeopathic aggravations are reported in studies. This systematic review and meta-analysis focuses on observational studies, as a substantial amount of the research base for homeopathy are observational. METHOD: Eight electronic databases, central webpages and journals were searched for eligible studies. The searches were limited from the year 1995 to January 2020. The filters used were observational studies, human, English and German language. Adverse effects and homeopathic aggravations were identified and graded according to The Common Terminology Criteria for Adverse Effects (CTCAE). Meta-analysis was performed separately for adverse effects and homeopathic aggravations. RESULTS: A total of 1,169 studies were identified, 41 were included in this review. Eighteen studies were included in a meta-analysis that made an overall comparison between homeopathy and control (conventional medicine and herbs). Eighty-seven percent (n = 35) of the studies reported adverse effects. They were graded as CTCAE 1, 2 or 3 and equally distributed between the intervention and control groups. Homeopathic aggravations were reported in 22,5% (n = 9) of the studies and graded as CTCAE 1 or 2. The frequency of adverse effects for control versus homeopathy was statistically significant (P < 0.0001). Analysis of sub-groups indicated that, compared to homeopathy, the number of adverse effects was significantly higher for conventional medicine (P = 0.0001), as well as other complementary therapies (P = 0.05). CONCLUSION: Adverse effects of homeopathic remedies are consistently reported in observational studies, while homeopathic aggravations are less documented. This meta-analysis revealed that the proportion of patients experiencing adverse effects was significantly higher when receiving conventional medicine and herbs, compared to patients receiving homeopathy. Nonetheless, the development and implementation of a standardized reporting system of adverse effects in homeopathic studies is warranted in order to facilitate future risk assessments.

Consultations with health care providers and use of self-management strategies for prevention and treatment of COVID-19 related symptoms. A population based cross-sectional study in Norway, Sweden and the Netherlands.

OBJECTIVES: The present study was initiated to determine consultations with health care providers and use of self-management strategies for prevention or treatment of COVID-19 related symptoms in countries with a full lockdown (Norway), a partial lockdown (the Netherlands) and no lockdown (Sweden) during the first three months of the COVID-19 pandemic, and if such use correlates with worries of being infected by COVID-19 disease. DESIGN: Data were collected in collaboration with Ipsos A/S in April-June 2020. An adapted version of the International Questionnaire to measure use of Complementary and Alternative Medicine (I-CAM-Q) was used with the categories "for prevention of COVID-19" and "to treat COVID-19-related symptoms" added. Data were collected among a representative sample in Norway, Sweden and the Netherlands using data assisted telephone interviews (Norway, n=990 and Sweden, n=500), and an online survey (the Netherlands, n=1004). Total response rate was 30%. RESULTS: Very few consulted a health care provider with the intention to treat or prevent COVID-19 (1.2% and 1.0% respectively) with medical doctors mostly visited (1.0% and 0.9% respectively). Similarly, the use of self-management strategies to prevent or treat COVID-19 was low (3.4% and 0.2% respectively); most commonly used for prevention of COVID-19 were vitamins and minerals (2.8%). Consultations with health care providers and use of self-management strategies for prevention of COVID-19 were positively associated with worries of being infected with COVID-19. CONCLUSIONS: The COVID-19 pandemic does not seem to have evoked a large-scale difference in behavior related to consultations with health care providers or the use of self-management strategies in any of the three countries.

The impact of COVID-19 on complementary and alternative medicine providers: A cross-sectional survey in Norway.

BACKGROUND: The Norwegian authorities decided in March 2020 to implement a nationwide lockdown to prevent spread of the COVID-19 virus. The lockdown had vast socioeconomic consequences for the society. The aim of this study was to investigate how COVID-19 affected Complementary and Alternative Medicine (CAM) providers' practice, financial situation, recommendations to patients, and how they perceived their future practice as CAM providers. METHOD: Data were collected in this cross-sectional survey using a self-administrated electronic questionnaire. A total of 581 CAM providers completed the questionnaire, which was designed to describe consequences for CAM providers and their clinical practice caused by the nationwide lockdown. Descriptive statistics were carried out using frequency analyses to describe the demographics and consequences of the lockdown. Between group differences (gender and age) were analyzed using Pearson chi-square tests and Fisher's exact tests for categorical variables, and ANOVA tests and t-tests for continuous variables. Significance level was defined as p < 0.05 without adjustment for multiple comparisons. RESULT: During the nationwide lockdown of Norway, 38.4% of the respondents were able to provide CAM treatment to their patients. Of those, the majority (96.4%) had reorganized their clinical practice in accordance with COVID-19 hygiene regulations, offered video consultations (57.4%) or telephone consultations (46.6%). To manage financially during the lockdown, half of the providers spent their savings (48.7%). More than one third (35.1%) was supported by their partner, and 26.7% received compensation from the Norwegian state. A total of 26.3% of the CAM providers had other paid work that provided them with income. Nearly a fifth (18.6%) borrowed money from friends and family, changed their loan terms, or took out new bank loans. More than half (62.7%) expressed uncertainty about the future of their practice. CAM providers who had reorganized their practice to online consultations were more optimistic. CONCLUSION: The impact of COVID-19 on CAM providers was considerable. It adversely affected their clinical practice, financial situation, and view on their future practice. To ensure that the health needs of the Norwegian population regarding CAM use are met during pandemic times like COVID-19, it is recommended to support and train CAM providers in the development of online CAM services, as well as efficient implementation of infection prevention and control measures.

Safety of Anthroposophic Medicinal Products: An Analysis of Adverse Drug Reactions from German Pharmacovigilance Databases.

BACKGROUND: Anthroposophic medicinal products (AMPs) are widely used in Europe and world-wide. OBJECTIVE: To determine the frequency of reported adverse drug reactions (ADRs) from all AMPs on the market, in absolute numbers and relative to the maximum daily administration doses (MDADs). PATIENTS AND METHODS: Retrolective safety analysis of AMP-related ADRs in pharmacovigilance databases of four AMP Marketing Authorisation Holders in Germany. For each ADR, information about the patient, outcome, causality and AMP was retrieved. Primary outcome was the frequency of reported ADRs relative to MDADs sold. RESULTS: In the period 2010-2017, a total of 5506 ADRs were reported that had occurred in 2765 different patients, comprising 370 different AMPs. A total of 104 ADRs (1.9%) were classified as serious. The frequency of ADRs for all AMPs was 1.50 per million MDADs. For serious ADRs the frequency was 0.03 per million MDADs. ADRs were more frequently reported with parenteral AMP administration (injections) than with oral or local administration (18.85 vs. 0.59 vs. 1.61 ADRs per million MDADs, respectively; p < 0.0001). The large majority of users (91.9%) had recovered or were recovering from the ADRs and there were no reports with a fatal outcome. Most frequently reported ADR symptom was injection site inflammation for parenteral AMPs (4.66 ADRs per million MDADs), nausea for oral AMPs (0.03 ADRs per million MDADs), and eye irritation for locally administered AMPs (0.23 ADRs per million MDADs). CONCLUSIONS: In this retrolective safety analysis of pharmacovigilance data, the frequency of ADRs to AMPs was 1.50 per million MDADs. Notably, the ADR frequency in this study based on spontaneous reporting is not directly comparable to frequencies in prospective clinical studies nor to frequencies based on other measures of patient exposure than MDADs.