Background: The opioid epidemic is a complex national crisis in the United States with a 400% increase in related deaths over the past two decades with no signs of slowing. The purpose of this study was to assess the incidence of opioid use, based on the geographic and population characteristics. Methods: The opioid-related hospital inpatient stays and emergency department visits obtained from the 2010 to 2018 Healthcare Cost and Utilization Project and demographic confounders, including age, race, education, and income gathered from US Census data were analyzed through generalized linear mixed models and reported by community size and region. Results: Opioid use varies among population center sizes and the region analyzed. In general, opioid visits in the southwest region were greatest across the majority of population center sizes. Rural usage was greatest in the northeast, southeast, and southwest. Unemployment and diverse ethnicities were commonly associated with opioid use in the metro areas studied but these associations were not seen in rural areas. Conclusion: Opioid use remains significant among diverse populations across the United States. Understanding the unique dynamics associated with opioid usage in populations within the regions studied is important in guiding future interventions to fight this crisis. In the late 1990s, the undertreatment of pain made headlines, leading to the “Decade for Pain Control and Research” in the early 2000s  and incrIn the United States, there has been a dramatic rate increase of 64% in opioid-related inpatient hospital stays and a 99% rate increase in ED visits between 2005 and 2014 ,9,12. ToOpioid use has also exacted a heavy toll on the healthcare system. Published studies from 2010 approximated both indirect and direct costs associated with nonmedical use of prescription opioids to be USD 53.4 billion; abuse, dependence, and misuse USD 55.7 billion; and overdose USD 20.4 billion. Healthcare costs associated with opioids include medical costs related to criminal justice and legal matters, substance abuse treatments, loss of work due to decreased productivity and/or disability, and even premature death ,19. In 2Early studies focused on rural and urban opioid use, suggested increased risk for opioid-related harm in rural communities compared to urban or metropolitan areas . HoweverInpatient and Emergency Department data made available by the Healthcare Cost and Utilization Project (HCUP) was utilized for this study . Data onThis study focused on contrasting regional trends between associations of opioid-related hospital visits and demographic factors, with a special focus on communities with different population sizes. Gathered data was organized into several population characteristics within the HCUP database including a total for all populations, age, sex, community-level income, and patient location. The values, which are reported quarterly for each year from 2005–2018, represent rates of either inpatient-related hospital stays or ED discharges per 100,000 US residents. Determination of population size was based on a six-category, county level scheme developed by the National Center for Health Statistics (NCHS), which divided counties into large central metropolitan, large fringe metropolitan (suburbs), medium metropolitan, small metropolitan, micropolitan, and noncore. HCUP combined the micropolitan and noncore categories into one category, deemed rural, creating a total of five patient locations. Community size type descriptions are summarized in Confounding covariates other than population size that might affect opioid hospital use were gathered from publicly available state data obtained from the Census and yearly American Community Surveys conducted from 2010 to 2018. The American Community Survey is a stratified sample that is roughly 1% of the total United States population and performed every year outside of the Census years. The data was divided by all 50 states, the District of Columbia, and Puerto Rico for each year. This particular time frame of census data was chosen as it coincided with the data available from HCUP and could be consistently matched to the same time period. Many covariates, such as population density, age, gender, race, education level, and income level, were identified as being important considerations. Within age, the population was divided into categories: under 18, 18–24, 25–65, and over 65. Within the category of race, the population was divided into White (Not Hispanic), Black or African-American, Asian, American/Alaskan Indian, Hispanic or Latino, Pacific Islander, and other. Education was further divided into less than a high school graduate, high school graduate , some college or associates degree, and bachelor’s degree or more. Finally, income was divided into household adjusted income, percent below the poverty level, and percent unemployed.Descriptive statistics for census and HCUP data were estimated for the full data set and categorized by the US Department of Health and Human Services defined regions with outcomes being presented as per these defined regions . Inpatiep ≤ 0.05. Multiple testing correction is highlighted when achieved and was performed through the Bonferroni method. A curated dataset is available as a United States Department of Health and Human Services region plots were generated using least square mean estimates for each model fitted. These values were coded with three color gradients (green-white-red) based on their numeric estimate value starting from dark green for the least affected region to dark red for the worst affected region, white being in the center indicating neutrality. HCUP and Census demographic covariate associations were generated and are presented as estimate difference values, where the estimate value represents the value increase per unit of increase or decrease in the covariate units for continuous variables and as a difference from the reference category set arbitrarily for categorical values. All analyses were performed on SAS/STAT v.9.4 . Statistical significance was set at p-values are presented in The generalized linear mixed model analysis of the data revealed a variety of demographics to be associated with an increased risk of hospital visits. All of the demographics were evaluated and their respective Each population size had a variety of different demographics influencing opioid-related hospital visits. In rural communities, all inpatient stays showed a positive association with opioid visits while hospital settings showed a negative association. In small metro communities, positive associations were seen with all inpatient stays while negative associations were seen with hospital settings, percent under 25, percent White, percent Native American, and percent unemployment. In medium metro communities, positive associations were seen with all inpatient stays, percent White, percent Asian, and percent Native American while negative associations were seen with hospital setting, household adjusted income, and percent unemployment. In large fringe metro communities, positive associations were seen in all inpatient stays, total population, and percent of people aged 25 to 65. In large central metro communities, positive associations were seen in all inpatient stays and percent unemployment while negative associations were seen in sex ratio, percent White, percent Asian, and percent Native American. The percentage of White individuals, percentage of Native Americans, and percent unemployment all appear to have the greatest impact on opioid hospital visits across most population sizes.The statistical data for inpatient stays and ED visits was combined into one analysis and was thereafter modeled by community population size and United States Department of Health and Human Services region using the geographical areas defined. A visual representation of these regions by community size type is presented in Opioid-related visits across metro populations varied greatly from region to region. Large central metro and small metro areas in Region 8 had the highest number of opioid-related visits while large fringe metro and medium metro areas in Region 9 had the highest number of opioid-related visits. Both of these regions include much of the Southwestern and Rocky Mountain regions of the United States. Other large central metro areas with high incidence of opioid-related hospital visits include Regions 3, 5, and 10. Other large fringe metro areas with high incidence included Regions 1, 2, 4, and 6. Other medium metro areas with high incidence included Regions 3, 4, and 6. Other small metro areas with high incidence include Regions 1, 5, and 9.From 1999 to 2014, the number of opioid-overdose-related deaths in the US almost quadrupled, with more than 400,000 documented mortalities in a 20-year timeframe ,18,19,26The purpose of this study was to assess the community size types and regions of the United States with the highest incidence of opioid-related hospital visits. The assessment was based on the number of patients presenting to EDs secondary to opioids combined with the number patients admitted to hospitals for opioid-related complaints. The prevalence of opioid use is variable across regions of the US and involved a multitude of demographic factors . For exaThe percentages of White, Native American, and unemployed people have the strongest association to opioid-related hospital visits. However, the association with population size was variable. Previous studies between 1999 and 2016 found the “age-adjusted opioid-related mortality increased by 158% in Large Central Metro counties, 507% in Large Fringe Metro counties, 388% in Medium Metro counties, 584% in Small Metro counties, 682% in Micropolitan Non-Metro counties, and 721% in Noncore Non-Metro counties” . ConversAlternatively, the current study used a novel analysis which found several trends. It was found that higher opioid usage correlates with Region 1. The Midwest had the highest opioid use, which correlates with Regions 6, 7, and 8 in this study. Usage was also consistently high in large central metro population centers in this study. The current study used additional regional stratifications, allowing high opioid usage levels to be identified in large central metro areas in Region 8, in small metro areas in Region 8, and in large fringe metro areas in Region 6, but not in medium metro or rural areas. Previous studies also found rates of opioid usage were highest in the large fringe metro and medium metro areas in the southern region. This trend held true in the current study and was particularly evident in Region 6; however, the current study also found rural areas in this region not lagging far behind in their opioid usage. In addition, Region 4 showed high rates of opioid usage in rural areas but not in small metro or large central metro population centers. Further to the West, past studies  found rates to be consistently higher in small and medium metro areas and non-metro areas. Correlating the data from these previous studies with the analogous Regions 9 and 10 in the current study, it becomes essentially impossible to determine a definitive trend in opioid usage among different size population centers. While Region 9 has the highest incidence of opioid-related hospital visits in medium metro and large fringe metro areas followed closely by rural areas, Region 10 shows comparably lower incident levels with the notable exception of large central metro areas.The analysis performed as part of our study shows the impact of opioid-related hospital visits is intimately related to specific demographic descriptors and tends to vary across geographical regions, giving a more complete picture of the opioid crisis across the entire US. Furthermore, since the current study utilized the HSS regional breakdown, it can be directly used by those creating regional policy to further inspect and analyze the causes of increased visits due to opioid usage in particular regions as well as population size areas. Moreover, this analysis can be employed in conjunction with public health measures to provide support to stem the opioid epidemic locally. Although there is some understanding of the factors fueling the opioid crisis, this paper provides an important analytical tool to better identify key regional contributors and covariables to the opioid epidemic. These regional differences also suggest a single generalized nationwide approach to mitigate the impact of the opioid epidemic is not likely to be effective. Armed with this knowledge, targeted interventions may be identified to reduce opioid misuse and its associated negative effects.The use of a large, multiyear, hospital database coupled with employment data from the census allowed the assessment of general trends of opioid use. The Census in particular “can be an essential tool for understanding county-level variation in drug mortality rates and in driving policy responses to the crisis” . The curDespite the important findings outlined in this report, it is not without its limitations. Over the past few years, the opioid crisis has continued to evolve, developing into an opioid epidemic ,37. SubsSince this study measured hospital visits, not the use of opioids in general, the data may be biased towards the more severe cases of opioid misuse, ultimately falling short of addressing the opioid burden as a whole. Furthermore, the current data was limited by the reporting date ranges since some states only provided a few years of data while other states have no data reported to HCUP. Another limitation was the use of ICD-9-CM and ICD-10-CM codes from records of patients who were admitted to the hospital or discharged from the ED to determine opioid-related hospital stays. ICD-10-CM were utilized for all data after 1 October 2015 when these codes replaced ICD-9-CM codes . ICD 9 aThe current study demonstrated how population centers across various regions are affected differently by the opioid epidemic. The factors impacting population centers of similar sizes can be different from region to region; these differences must be considered to develop more effective strategies to mitigate opioid misuse. Health professionals and public health officials must understand and consider the specific conditions of their locality to better serve their community . The dat


Implementation science frameworks aided the development of a new, evidence-based clinical physical therapy program. The purpose of this report is to describe the process of sustaining a clinical program in practice for over 4 years. We present a framework for integrating tools for sustainability with the Knowledge-to-Action model in the context of a proactive physical therapy (PAPT) program for individuals with early-stage Parkinson’s disease.Sustainability of implementation strategies was addressed using the Dynamic Sustainability Framework and sustainability assessment tools. Repeated retrospective medical record reviews and phone interviews were used to evaluate the reach and adoption of the PAPT over 4 years. Characteristics of those who engaged with PAPT, implementation fidelity, and clinical effectiveness were assessed for year 1 and year 3. Sustainability was measured using RE-AIM, NHS Sustainability Model, and Clinical Sustainability Assessment Tool.p > 0.05). The program sustained its effect to help participants increase or maintain self-reported exercise . However, upon evaluation PAPT users in year 3 had longer time since symptom onset and worse UPDRS motor scores compared to the PAPT users in year 1 (p < 0.05). All sites sustained the core intervention components, with sustainability scores of 71/100 (± 9.9) on the NHS Sustainability Model and 6.1/7 (± 0.9) on the Clinical Sustainability Assessment Tool.Reach increased from 28 to 110 total patients per year and spread occurred from one to three sites. PAPT user age, sex, Hoehn and Yahr rating, time since diagnosis, and type of insurance were similar in year 1 and year 3 (Integrating multiple sustainability models and assessments supported continued effectiveness, spread, and sustainment of PAPT for 4 years. Effective planning, anticipating common healthcare changes, and addressing sustainability determinants early in program implementation were essential aspects of long-term success.The online version contains supplementary material available at 10.1186/s43058-021-00205-x. Contribution to the literatureDefining sustainability goals early in the implementation process, applying implementation frameworks, and using sustainability assessments may increase the maintenance of a novel evidence-based, clinical program.Repeating implementation evaluation frameworks, such as RE-AIM, can improve understanding of the clinical programs’ sustainment outcomes.A successful, evidenced-based proactive physical therapy program for individuals with early-stage PD can be sustained with careful attention to processes, staff, and organizational priorities.Clinical practice guidelines support physical therapy (PT) in early Parkinson’s disease (PD) . DespiteEstablished implementation frameworks informed the development of PAPT. The Knowledge-to-Action (KTA) Cycle was used to organize the process of implementation . The ConSustainment, an essential component of implementation, has been described as using methods to preserve fidelity in an ever-changing healthcare environment , 7, 8. DThis report describes the sustainment of PAPT as it spread to additional clinical sites over 4 years. We examine how integrating sustainability frameworks and clinical sustainability assessments supported sustainability.Proactive physical therapy was initially adopted at one urban, outpatient department within a large healthcare organization, designated as a Parkinson’s Center of Excellence . PAPT reImplementation and sustainability strategies were identified through meetings with various stakeholders including therapists and leadership and further refined in an iterative process through ongoing monthly stakeholder meetings with clinician champions. As initial implementation transitioned to sustainment phases at the end of the first cycle through the Knowledge-to-Action Process Fig. , we idenn = 3) and one program facilitator were invited to complete the NHS Sustainability Model and the CSAT. Additionally, five organization leaders and three referrers were invited to complete the CSAT.Data sources include [1] administrative data from the outpatient department on referrals and utilization (2016–2019), [2] retrospective electronic medical records (EMR) of first-time PAPT users in year 1 (Y1) (2016) and year 3 (Y3) (2018), [3] structured interview responses conducted over the phone with first-time PAPT users from Y1 and Y3 who responded to a quality improvement phone interview request, and [4] stakeholder survey results from the NHS Sustainability Model and CSAT to evaluate sustainment after completion of year 4 (Y4). PAPT users include those who were referred and attended the PAPT program. Eligible PAPT users were referred with a mild or moderate PD diagnosis or suspected prodromal PD  who accessed the program for the first time in Y1 and Y3. PAPT users opted in to interviews after they were sent a letter and screening phone call. Three researchers  reviewed information from the interviews. Participants were excluded from this analysis if they were referred to the PAPT program with a different diagnosis. A champion at each site . Effectiveness and satisfaction were evaluated with quality improvement phone interviews. Questions included (1) PAPT user self-reported changes in exercise, (2) self-reported benefit of PAPT on an 11 point scale from 0  to 10 , and (3) recommendation to others on a similar scale from 0  to 10 (extremely likely to recommend). Adoption was measured as the (1) number of sites, (2) number of physical therapists trained and using the PAPT care model, (3) referral numbers from targeted referrers, (4) proportion of PAPT users who attended versus the number referred to PAPT, and (5) number of PAPT users who engaged in a long-term follow-up episode of care. Implementation fidelity was assessed by EMR review of (1) physical activity and exercise prescription for PAPT users through documented home exercise prescription and (2) PAPT care path utilization.The RE-AIM framework was used to assess and describe the spread and sustainment outcomes of PAPT, comparing outcomes from Y1 and Y3 or Y4. Maintenance was assessed through sustainability assessments that were administered after year four. The NHS Sustainability Model includes ten questions in three domains: staff, organization, and processes. Each item is measured on a 4-point categorical scale and summed into a total score with a maximum of 100 points. This model’s training materials propose that a score over 55 indicates optimism toward sustaining the program [ program . The CSA program .t-test or Chi-square test based on the type of data.Data are presented with descriptive statistics. PAPT user characteristics, interview responses, and documentation of information related to program fidelity from Y1 and Y3 were compared with an unpaired Because of the nature of quality improvement and program evaluation the Northwestern University Institutional Review Board determined that this EMR data extraction and structured interviews did not qualify as human subjects research. Data from all sources were collected and maintained using HIPAA compliant methods. Reporting was completed using the Standards for Quality Improvement Reporting Excellence  over the first 4 years and is presented in Fig. The PAPT program’s  doubled 8 to 62 oeffectiveness were completed in 71% of 28 users in Y1 and 53% of 62 new users in Y3 . The proportion of individuals in Y1 and Y3 with self-reported increased or maintained exercise is presented in Table χ2df=2 = 0.228, p = 0.3283).There was increased adoption by outpatient clinics, physical therapists, and referrers . Clinicians also documented explicit aerobic exercise prescription during the initial PAPT visit similarly in Y1 and Y3 .maintenance was measured using two sustainability assessments. All stakeholders who were sent a request for the NHS Sustainability Model completed the survey (n = 4) and all but two referrers completed the CSAT (n = 10). The average NHS Sustainability score 71 (out of a possible 100 points) and the average CSAT score was 6.1 (out of a possible 7). Specific category scores are presented in Table Program Attention to sustainability frameworks has facilitated PAPT program spread to three sites within one healthcare organization and long-term sustainment. In Fig. Use of existing sustainability frameworks aids in identifying and addressing sustainability barriers. Changing barriers over time could result in “program drift,” or deviation from the program’s original aims . The DSFThis program evaluation uniquely focuses on sustainability of a clinical program targeting an outpatient physical rehabilitation setting. In two recent reviews on program sustainability, none occurred in similar departments , 18. HowFollowing initial implementation, demand from stakeholders, including referrers, patients, therapists, and managers, led to the spread of PAPT through our regional system of care. PAPT program growth was associated with minor population changes in the PAPT program Table , and incUnintentional spread also occurred through adoption of the proactive, consultative care model by speech, and occupational therapy for people with PD, as well as for other patient diagnoses, like Huntington’s disease. Data from these clinical areas were excluded from this analysis but are well supported in the literature and bolstered PAPT sustainability , 20–22. Two limitations include the lack of generalizability of retrospective quality improvement data and lack of well-studied sustainability measures. The use of retrospective measurement in a single health system limits generalizability to other organizations. However, documenting strategies to spread from academic to suburban clinics in the same health system may be impactful in similar contexts. The retrospective methods also present challenges such as inability to control potential confounding factors, including new leadership positions within the organization. The second limitation is that the existing clinical sustainability measures have limited reliability and validity data , 13. ImpDemonstrating the application of sustainability frameworks has implications for implementation practice and research. Figure We integrated sustainability into implementation frameworks to assist with creating a resilient program and to provide a tool to improve program development. Attention to sustainability when selecting adaptable implementation strategies, repeated evaluation, and sustainability assessments successfully assisted with the 4-year sustainment of the PAPT program.Additional file 1. Initial and sustained implementation strategies. Strategies are organized via Expert Recommendations for Implementing Change (ERIC) taxonomy  Strategies bolded are those that continue within the organization. Strategies described in ERIC that were not applied are not included in this table.Additional file 2. SQUIRE.


This study documents evaluation of the Her Tribe and His Tribe Aboriginal-designed empowerment pilot programs. The programs were designed to support Victorian Aboriginal people to strengthen mental health, social and emotional wellbeing, community connection, and to reduce psychological distress. A second aim was to explore participants’ experiences of the programs, including the feasibility and acceptability of the evaluation component. Her Tribe ran for 16 weeks and His Tribe for 12 weeks. In total, 43 women and 26 men completed assessments at pre- and post-program completion, and 17 and 10, respectively, participated in yarning circles at the 6-month follow up. For both programs, there were significant increases in participants’ access to personal strengths and resources, relationship–community–cultural strengths and resources, and decreases in psychological distress. These changes were associated with small to moderate effects that were maintained at the 6-month follow up. There was a significant increase in aerobic fitness for female but not male participants, and no significant changes in weight for either group. Participants described a range of benefits from the programs, including positive elements and areas for improvement. They also viewed the evaluation as feasible and acceptable, and the findings of value. The outcomes from both pilot programs provide evidence that Aboriginal-designed programs, with a focus on physical and cultural activities, can help to strengthen mental health and wellbeing, community connection, and reduce psychological distress in Victorian Aboriginal communities. In the 2018–19 National Aboriginal and Torres Strait Islander Health Survey, 71 per cent of Aboriginal and Torres Strait Islander people aged 15 years and over reported being in the overweight or obese range, representing a five percent increase from previous national survey data . FindingWithin Australia, there is a limited evidence base supporting the effectiveness of physical activity programs involving Aboriginal and Torres Strait Islander peoples with respect to mental health and wellbeing-related outcomes. A recent systematic scoping review conducted by Macniven and colleagues  identifiTo address the need for strengthening mental health and social and emotional wellbeing, and reducing psychological distress and the risk of chronic disease within the Victorian Aboriginal community, healthy lifestyle manager Laura Thompson (co-author) and her team from the Victorian Aboriginal Health Service (VAHS) in Melbourne, Australia, developed the Her Tribe and His Tribe pilot programs. Her Tribe, developed in 2017, was a 16-week program for Aboriginal and Torres Strait Islander women. His Tribe, a 12-week program for Aboriginal and Torres Strait Islander men, was developed in 2018. Both programs were designed with a strong community health promotion and chronic disease prevention focus. The present study is an evaluation of the two programs.The first aim of the evaluation was to investigate pre- and post- program changes for participating women and men, across multiple physical and social and emotional wellbeing domains. The social and emotional domains included personal, relationship, community and cultural strengths and resources. These strengths and resources were assessed using the Aboriginal Resilience and Recovery Questionnaire (ARRQ) , an AborAdditional evaluation measures included changes in participants’ levels of psychological distress, aerobic fitness and weight. Based on the extant research, initial hypotheses predicted significant increases in women and men’s access to strengths and resources, significant reductions in psychological distress, significant increases in women and men’s aerobic capacity and significant decreases in body weight. The second aim was to investigate participants’ qualitative feedback about the programs, including perceived benefits of the program for participants, areas for improvement, and participants’ overall experience with the research component of the programs.From October 2016 to January 2017, and January to March 2018, the VAHS Healthy Lifestyle unit used its Facebook, Instagram and other social media platforms to recruit female and male members of the Melbourne Aboriginal community to participate in the Her Tribe and His Tribe programs. The programs were also advertised and promoted by staff for community members using the Family Counselling Services of VAHS. Hence, composition of the participants is best viewed as Aboriginal and Torres Strait Islander people within the Melbourne community who access Aboriginal Community Controlled Health services, rather than being representative of the whole Victorian Aboriginal and Torres Strait Islander population. In addition, as the primary function of VAHS is service delivery, maximum community participation and program accessibility was a priority. Therefore, community members were invited to participate at any stage of the programs. Engagement in the research evaluation component of the program was viewed as a secondary goal, as the team did not want to discourage participants from receiving the benefits of the program due to concerns about the research component.A single group, pre- and post-test study design was used for both programs to assess short-term outcomes, followed by a 6-month post-program assessment that included qualitative yarning circles . Prior Aboriginal Resilience and Recovery Questionnaire (ARRQ): The ARRQ is a 60-item multidimensional strengths questionnaire that was designed to assess strengths and resources associated with resilience, healing and recovery among Aboriginal and Torres Strait Islander help-seeking populations. The ARRQ uses a 5-point Likert scale response format with ratings from 1 = Not at all to 5 = A lot, and it includes a range of strength-based constructs and sub-scales (2–5 items), such as the following: community connection, cultural identity, self-worth, emotion regulation, strong relationships, safety, a personal sense of mastery, spirituality as a source of strength, and participation in cultural practices. The measure comprises several single items, and two major subscales that represent personal strengths (29 items) and relationship–community–cultural strengths (21 items). The two major subscales can be summed to yield a composite total strengths score. Both subscales and the total strength scores of the ARRQ have previously demonstrated high internal consistency, with a Cronbach’s alpha value of 0.89 for the personal strengths component, 0.88 for the relationship–community–cultural strengths component, and 0.93 for the total strengths composite measure of the AARQ .Kessler Psychological Distress Scale (K10): The K10  is a 10-Body Weight: Participant body weight was measured at baseline (week one) and final week of the programs (week 16 and 12) using electronic scales.Aerobic capacity: Aerobic capacity was measured at baseline (week one) and final week of the programs week 16 and 12) using the 20 metre Multistage Fitness Test (Beep Test) [ and 12 uParticipants were invited to be involved in yarning circles at six months post-program. Three audio-recorded yarning circles for 17 Her Tribe participants and one for 10 His Tribe participants were conducted using a semi-structured group interview format. Participants were asked five questions during the yarning circles, which included the following: (1) What was your experience of the program and why did you keep coming back? (or why did you not?) (2) What (if any) changes did you experience and has that continued? (3) How could we improve the program? (4) How did you feel about it being a research project? (5) Is there anything that we have not asked about that you would like to add?A safety and wellbeing protocol was developed that included multiple wellbeing check-in processes to engage any participants who reported significantly high levels of psychological distress during the program and might require support. First, an Aboriginal psychologist from VAHS attended all sessions to provide participants an opportunity for support if required. Second, following the weekly evening sessions, the psychologist and designated team member met to discuss whether there were any participants who had approached the team for support, and/or whether the team had observed any participants who appeared to require support. Third, during the assessment weeks , the designated team member and the Aboriginal psychologist reviewed participant scores on the K10 measure of psychological distress. If a participant scored in the very high range (>30), they were contacted. The initial call comprised a ‘wellbeing check’ to let the participant know about the high psychological distress score and a general enquiry about their current wellbeing and whether they needed any support(s). The option for formal support was provided through referral to either a VAHS Aboriginal psychologist or two other psychologists external to the organisation that were available throughout the duration of the programs.d was used to calculate the measure of effect size, with 0.20, 0.50 and 0.80 representing small, moderate, and large effect sizes [Descriptive statistics were conducted to examine demographic characteristics of participants from both programs. The IBM statistical software package SPSS Version 22  was usedct sizes . To asseFor the yarning circles, thematic analysis  was usedThe study was reviewed and approved by the VAHS research subcommittee and the University of Melbourne Human Research Ethics Committee in 2016 (Ethics ID 1648120.1). The methodology that underpinned the study followed Rigney’s ,22) IndiIn total, 120 women and 37 men attended at least one session of the programs. Of those, 86 women and 31 men elected to participate in the evaluation study of the program, with some joining after the baseline assessment. The week one baseline and post program assessments were completed by 43 women and 26 men. The demographic characteristics of all participants who elected to complete at least one assessment are presented in Descriptive statistics of pre-and post-program, and 6-month follow up outcomes are presented in Independent coding of the four yarning circles, held between 2017–2018 by authors LT, LD and GG, resulted in an initial set of 40 open-coded, broad categories. The axial coding phase involved re-reading transcripts and the three authors meeting to discuss and explore new connections and relationships between codes. This iterative process of comparison and differentiation resulted in narrowing to 23 axial codes. These codes were then utilized as a primary coding framework. In the final phase of selective coding, two important processes influenced the generation of sub-themes and core themes. First, the codes were examined with the five yarning circle research questions in mind, and this began to frame themes according to participants’ experiences and impacts of the program, and program content and structure. Second, researcher reflexivity was an important part of the selective process, as all three researchers’ cultural and professional backgrounds were recognized as influencing interpretation of participants’ experiences of the program. For example, the influence of lead program director LT’s extensive experience in health promotion helped shape discussions that resulted in generating sub-themes and recognizing connections between program improvement and post-program loss. The extensive counseling background of researcher GG, in working with community mental health and developing Aboriginal-designed assessment tools, informed discussion about exploring connections and codes associated with mental health. The non-Aboriginal background of researcher LD provided informed contrasts and differences in worldviews, and her key program involvement in all participant assessments and co-facilitation of yarning groups provided reflections and discussion based on her in-depth immersion with participants. Taken together, this provided a rich diversity of perspectives, with regards to reaching consensus around removing codes with not enough supporting data and generating sub-themes and core themes. The axial codes were reduced to 12 subthemes, thematically arranged according to three core overarching themes. The three core themes are titled ‘Individual changes’, ‘Relationship changes’, and ‘Program Structure and Content’, each with four associated subtheme areas. The core theme ‘Individual changes’ represents personal experiences shared by participants from both programs that included a wide range of changes, related to personal strengths and skills (subtheme), and changes in lifestyle choices and behaviours (subtheme). The types of personal strengths, skills and benefits frequently identified across both programs included feelings of positivity (‘I kept coming back because I loved it’), and increased confidence and self-belief (‘It gave you belief in yourself’), as a result of being challenged to push past one’s comfort zone . The types of lifestyle changes discussed by participants focused on areas of life such as diet and exercise , as well as changes in self-care strategies. For example, one participant spoke about changing her capacity for self-care by expanding her range of strategies, stating ‘‘I find other ways to, I do other things, I’ll take the dog for a walk… or just take time out to myself…actually make time for myself now, whereas I never used to, it used to always just be work, go home, deal with the family and then pretty much go to bed and then repeat every day.’ A third, and among the most prominent, subthemes identified by participants, was the notable benefits in mental health (‘It was because of Her Tribe that my head changed…. I was able to look to the future’). Participants also spoke about the programs as a culturally safe space that fostered cultural connection and cultural identity (subtheme) .‘We all connected as mothers or as women, but we all had the same issues and just being in a place that it’s okay to feel like that because everybody has been through that moment or felt like that before or could understand I could just talk to somebody even if it was an aunty or another women that has a young child the same age. I could just get some comfort to say, it is okay and I’m doing a good job’.‘Relationship changes’, as a core theme, referred to several different dimensions of participant relationships that changed throughout the programs. Possibly the strongest qualitative subtheme to emerge in all yarning circles was the overwhelming number of participants that described experiencing a sense of strengthened community connection. For some participants, this was seen within contexts of past adversity  and more broadly, connection in general . Importantly, the role of strengthening connection appeared to function in ways beyond simply increasing the number of supports and connections that participants experienced. For example, community connections helped one participant with grief and loss . For other participants, the increased community connection and support helped to validate their roles as parents, as seen below:Participants also identified safety (subtheme) in the environment as being important , and the opportunity to be role models (subtheme) for children who were welcomed to attend . The last relationship subtheme was that of receiving inspiration and support from others, both in terms of other participants and the speakers that shared personal stories at the beginning of each weekly session .The core theme, titled ‘Program structure and content’, contains several distinct subthemes. Positive feedback provided by participants included the holistic design of the program (subtheme), notably the inclusiveness of inviting whole families and people of all ages from the community to attend . Participants also identified the value of having speakers share personal stories of success and overcoming adversity, the variety of weekly activities rather than a set routine, and the end of program camps were widely praised as a highlight (‘I loved the camp. The camp is probably where I had my ‘ah-hah moment’).Limitations and improvements (subthemes) for future programs were also identified by participants. For example, the set weekly evening time was seen as a positive by many participants because it allowed working community members to attend and bring their children. However, this timeslot posed challenges for some families. While healthy meals were provided during the weekly session, this didn’t necessarily equate to a full family meal, and parents described the challenge of needing to try and prepare children’s meals before the program or having to ‘quickly grab something on the way home’, which didn’t necessarily align with the healthy foods focus of the program. Transportation was a challenge for some families that limited regular attendance at the weekly sessions. Some improvements suggested by participants included switching the order of activities, for example not sitting down for a shared meal before the evening speaker, and instead engaging in the training and physical activities first. Other suggestions for improvement included introducing additional cultural activities, such as basket weaving and cultural dance, and also having a camp at the beginning of the program.A notable subtheme that emerged across all yarning circles was experiencing a sense of loss following the program completion. Some participants reported losing momentum and regularity of training. The most common loss described by participants was a loss of connection and group support , and this prompted participants to query whether scaled-down versions of the programs could be run in the future.The final subtheme related to ‘Program structure and content’ reflects the consistent feedback from participants that the evaluation component of the program was acceptable and that the findings were of value. Some participants spoke about an initial reluctance . However, as the program progressed, participants shared that they developed a better understanding of the purpose of the research, and they valued seeing personal changes after filling out the questionnaires . Reflections on the use of the Aboriginal Resilience and Recovery Questionnaire (ARRQ) that was designed at the Victorian Aboriginal Health Service were important to capture in the evaluation, as it was the first time the tool had been used by the organisation within a service delivery program context to assess pre- and post- changes among community members. Positive feedback was received in the yarning circles, as well as in a feedback section added to the paper form of the ARRQ to gather information about participants’ experience of filling it out. Experiences of feeling safe, a strengthened sense of community connection, and positive mental health and wellbeing were all prominent themes shared by participants from the yarning circles. This is consistent with the quantitative results that demonstrated reductions in psychological distress and increases in access to personal strengths and relationship–community–cultural strengths. These two ARRQ subscales include several smaller subscales , specific to safety, community connection, positive emotions and self-worth . As a way of triangulating findings from the yarning circle subthemes, a series of post-hoc independent sample t-tests were conducted to explore potential pre-and post-changes for both programs, for the safety, community connection, positive emotions, and self-worth ARRQ subscales. As illustrated in The Her Tribe and His Tribe Aboriginal-designed empowerment programs were innovative pilot programs initiated by the Victorian Aboriginal Health Service (VAHS) healthy lifestyle team, with a focus of strengthening wellbeing and reducing the risk of chronic disease within the Melbourne Aboriginal and Torres Strait Islander community. Both programs aimed to support community members that were connected VAHS , to increase their capacity to access a range of strengths and resources associated with positive mental health and social and emotional wellbeing, reduce psychological distress, and increase aerobic fitness and decrease weight. The programs provided a secondary opportunity for VAHS to implement a program evaluation, which included utilising and further validating the Aboriginal Resilience and Recovery Questionnaire (ARRQ) and conducting yarning circles to better understand community members’ experiences of the programs.The reductions in psychological distress that were maintained at the 6-month follow up are an important finding given that Victorian Aboriginal and Torres Strait Islander people report elevated rates of psychological distress in comparison to other Victorians . It suggA third positive impact for the program, from a mental health perspective, was that feedback from participants (and staff) from both programs about the opportunity for support via referrals to an Aboriginal psychologist, or psychologists well-linked to the community-was viewed as a positive initiative. Twenty-eight participants from the programs reported very high psychological distress at least once during the program, and of those, 10 elected to utilise one of the psychologists (six participants from the Her Tribe program and four from the His Tribe program). Anecdotal feedback from these participants was that the opportunity for counselling had been a valuable experience and that the offer of support had been appreciated. Of the participants who declined any formal support, reasons given included that they were already seeing a counsellor or psychologist and had adequate support; that despite the elevated score they were doing well enough not to need support; or, they had experienced a stressful week during the time of filling out the questionnaire but were doing well since then. We suggest that offering opportunities for mental health support in programs such as these can help to normalize and de-stigmatise the process of reaching out to others and seeking help. It would be of benefit in future programs to systematically investigate participants perspectives about whether having explicit support processes in place can help to decrease stigma associated with experiencing mental health and social and emotional wellbeing difficulties.There was a significant increase in aerobic capacity for female, but not male, participants. One possible reason for this differing result is that the Her Tribe program was four weeks longer in duration and provided a greater frequency of training and time of exposure to exercise. Another is that the number of men who completed the pre- and post-program aerobic assessment was low. Injuries and physical disabilities contributed to only six of 34 male participants completing both assessments, and such a low number resulted in an underpowered t-test analysis. It is worth noting, however, that the number of female participants who completed pre- and post-program aerobic assessments was also low, with only 18 of 43 participants completing both. The small participant numbers mean these findings need to be interpreted with caution, and the poor completion rates suggest that the multistage fitness test may not be the most appropriate form of aerobic assessment for future programs.There were no significant changes in weight for either group at post-program assessment. It should be noted that this was not the primary goal of either program, as the emphasis for both programs was on wellbeing, increasing personal agency, and healthy lifestyle changes. One plausible explanation is that one hour of exercise a week was not enough exposure to physical activity, from an intervention design perspective, to expect significant reductions in weight. For example, Canuto and colleagues  reportedData from the yarning circles suggested the men and women experienced a wide range of social and emotional wellbeing benefits from the programs. This finding is consistent with those of a scoping review that found evidence for relationships between physical activity programs involving Aboriginal and Torres Strait Islander people, and social outcomes that included strengthened identity, community connection, and reconnection to culture . Our finThe yarning circle theme of ‘Program structure and content’ included participants’ thoughts about ways to improve the programs. A common suggestion for program improvement was to try and find a way to extend the duration of the programs, and this was directly linked to many participants experiencing a sense of loss after the programs had ended. This raises important issues about how programs, such as Her Tribe and His Tribe, can be funded and resourced in a sustainable way that allows for program longevity. That is, how to embed access to health and wellbeing programs for community members on an ongoing basis. The yarning circles and discussion among VAHS staff included ideas of paring or stripping back the contents and structure of the programs, to potentially minimise the amount of staffing and resourcing required for running such programs. Exactly which areas of program content and delivery are essential, and which areas could be pared back, requires further investigation. Future research could involve investigating the ‘core elements’ of success for program implementation, from both participant and staff perspectives, as a way to adapt program design and funding needs, and achieve sustainability and program translation.Implementation of a research and evaluation component for both programs was viewed as acceptable and feasible by participating community members, and the findings of value. The ‘how’ and ‘why’ the research component was deemed acceptable and valued is important to consider. We suggest that it was largely due to the level of input and contribution from Aboriginal community members. For example, the programs were designed by an Aboriginal manager and the VAHS healthy lifestyle team, and the evaluation was led by an Aboriginal psychologist, who worked at VAHS and developed the ARRQ during that time. Key Aboriginal Elders and leaders from the community were involved at different levels , all of whom played a role in overseeing how the program was implemented. Of relevance to this level of local Aboriginal engagement, we note that 15 years ago a series of Victorian Aboriginal community wide consultations about research were conducted, resulting in one report titled ‘We can like research…. In Koori Hands’ . One of There are several limitations in the study design that need to be acknowledged. For example, whilst community engagement at any stage of both programs was a service delivery priority, such flexibility in program participation meant that attendance rates varied throughout the programs, and it was difficult to measure dose–response effects for either program. Community members’ prior mental health vulnerabilities were also not assessed, nor was nutritional/energy intake throughout the programs. Both of these factors are potential confounding factors that could have influenced changes reported by participants during the programs. We also acknowledge that there is a likely selection bias in that participants recruited were already engaged with VAHS, either as direct service users or connected to VAHS via its’ social media platforms. Although we are confident that the participants represent a broad and diverse part of the Victorian Aboriginal and Torres Strait Islander community, we cannot claim that they are representative of the respective general population. Finally, the number of participants was relatively low, which resulted in reduced statistical power for the quantitative analyses.These limitations notwithstanding, there are some strengths that underpin the study.Perhaps most importantly, both programs and the research were designed and led by Aboriginal and Torres Strait Islander people/staff from the community, and this contributes to the self-determination and empowerment of the community. Another strength of the study is the utilisation of the ARRQ, an Aboriginal-designed measure that was developed at VAHS for service use in the local Victorian Aboriginal and Torres Strait Islander community. The ARRQ had previously demonstrated content, discriminant, and predictive validity, with regards to lower mental health difficulties  . Now it The Her Tribe and His Tribe programs involved Aboriginal leadership at all levels of design and implementation, and the research and evaluation component of the programs alone were accessed by over 100 community members. Despite the limitations of the study, the multi-method evaluation showed clear association with, and/or evidence of, increased personal, relationship, community and cultural strengths and resources, reduced psychological distress, and increased community connection among participating community members. When led by Aboriginal researchers and services, it is possible to utilise Aboriginal research methodologies and combine qualitative and quantitative evaluation methods that include the use of validated, Aboriginal-designed tools, to demonstrate the benefits of Aboriginal-designed health and empowerment programs.


Amid an international pandemic and a worsening mental health crisis, ketamine-assisted therapy is emerging as a promising solution for those deemed “treatment resistant.” Post-traumatic stress disorder (PTSD) and depression are on the rise, with accelerating direct  and indirect  costs. Psychedelic-assisted therapies show significant promise in the treatment of a number of clinically challenging conditions, including depression, anxiety, PTSD, addiction, and end-of-life distress. Ketamine is currently the only safe, effective and legal widely available psychedelic-like medicine. To address the echo pandemic of health care provider distress, a multi-disciplinary team was charged with developing a ketamine-assisted psychotherapy program, delivered in a community of practice (CoP) group model and evaluated in a quality improvement framework. Program evaluation occurred through mixed methods. Quantitative mental health assessments included the PHQ-9 for depression, the PCL-5 for PTSD, GAD-7 for generalized anxiety disorder (GAD), and B-IPF for work/life functionality. Participant narrative feedback was collected to evaluate outcomes and for quality improvement purposes. Mean mental health scores were collected across three cohorts, totaling 94 patients. The mean aggregate scores of participants meeting the mental health assessment cut-off criteria (screening positive) were analyzed to assess clinical significance. Mean aggregate results comparing baseline vs. outcome measures (measured within 1–2 weeks after completion of the 12-week program) were clinically significant, demonstrating significant improvements in depression, post-traumatic stress disorder, generalized anxiety disorder and work/life functionality. In summary, 91% saw improvements in generalized anxiety, 79% saw improvements in depression, 86% of those who screened positive for PTSD now screen negative, and 92% had significant life/work functionality improvements. Qualitative feedback was overwhelmingly positive, with several unsolicited self-reports of transformation. Participant and team feedback enables the program to continue improving with each iteration. Results speak to the effectiveness of ketamine for psychedelic-assisted therapy, supported by a CoP framework. Outcomes are relevant for mental health programming, education and healthcare policy. The impetus for embedding ketamine-assisted therapy (KaT) within a group-oriented community of practice (CoP) revolves around the growing mental health crises in Canada, with healthcare providers (HCP) disproportionately impacted . Due to Biological Psychiatry and the Decade of the Brain (1990's). The belief at the time was that we were on the threshold of a new psychiatry, where we could reduce mental illness to defined perturbations of neuroreceptors, trusting that our novel antidepressants and antipsychotics would provide definitive treatment.Modern psychiatry was strongly influenced by the emergence of so-called treatment resistant patients. Perhaps our patients are not treatment resistant at all, perhaps we are simply using the wrong treatments.By any standard, this has been a failed experiment. Despite an exponential increase in prescribing over the recent decades, even before the pandemic, the costs of mental health disability were higher than ever before and steadily rising , with dedistress that is a product of living in an increasingly frenetic and disconnected world. Instead, we label distress as disorder, failing to recognize that many of our disorders are simply an adaptation to increasingly hostile and toxic environments. The failure of frontline therapies for a growing number of people is accelerating the re-emergence of psychedelic-assisted therapies.Modern psychiatry is failing to get to the source of the Psychedelic-assisted therapies are demonstrating positive outcomes in the treatment of depression, PTSD, addiction, and end-of-life distress . They arTo safely incorporate these new therapies, the current biomedical model of Canada's public healthcare system will need significant capacity-building. Currently, ketamine is the only legal and widely available psychedelic-like medicine. Ketamine is an FDA-approved drug, mainly used as an anesthetic in high doses with persons with MDD and PTSD . When keAn interdisciplinary and multi-agency team innovated by combining KaT, using ketamine as a psychedelic-like agent, with an evidence-informed CoP program, serves HCPs facing depression and PTSD. The program was a registered quality improvement project. The community based, evidence and equity informed framework is designed to minimize safety risks and to support and maintain recovery. The team's guiding principles include holistic, trauma-informed care, inclusivity, cultural/personal safety and constant quality improvement. Aligned with Canada's Strategy for Patient-Oriented Research led by the Canadian Institutes of Health Research our program is about engaging HCPs in the research process. This engagement helps to ensure that studies focus on HCP-identified priorities, which ultimately lead to better treatments and patient outcomes. The treatment program is 12-weeks in length  and runs through Vancouver Island University.The team includes medical doctors, researchers, HCPs with lived experience of depression and PTSD, nurses, clinical counselors, spiritual health practitioners, Indigenous Elders and Knowledge Holders, Somatic Energy Practitioners, Functional Medicine Experts, Sleep Experts, Aromatherapy experts, and Physical Movement Experts. This style of team is rare in the Western Medical Model, necessitating apprenticeship/mentoring to build the team and orient new members.Alongside Indigenous knowledge holders and cultural safety experts, the team engages in ongoing training and practices that promote equity and trauma informed care. The team models the program's guiding principles, including the adoption of shared intentions and agreements. These include, honesty, authenticity, vulnerability, and the mirroring of unconditional positive regard. The realization of these practices and principles bring forth a remarkable real humanity and palpable caring within the team. This, in turn, creates an environment of safety and trust that is often espoused, but rarely realized in mainstream health care settings.Those wishing to join the team are encouraged to first go through the program as participants in the CoP program, and if eligible, in the KaT portion as well. Once participants transition to alumni, they can apply to be a mentee on the team, working closely with a mentor before they become a full facilitating team member.HCPs with depression and PTSD were the priority population. Prior to acceptance into the program, participants first undergo a thorough three step intake process. The initial intake is completed by a registered psychiatric nurse who introduces participants to the program concepts through regulation practices, inner attunement, and authentic expression. For instance, the intake begins with a breathing technique that promotes relaxation, encouraging them to listen to what is arising in their physical awareness, and to speak to their fears and hopes of the process.If determined a good fit by the participant-candidate and the team member, they proceed to meet with the team psychiatrist. If cleared by the team's psychiatrist, they then proceed to a meeting with a medical doctor who specializes in psychedelic-assisted therapy, ensuring no contraindications to ketamine use.AND history of previous treatment failure AND diagnosis of treatment resistant depression  pression , 13, chrpression , obsessipression , suicidapression , PTSD  first meets in a large group format, then they move to the same breakout group each week for sharing. Each small group contains between six and nine participants and is facilitated by a clinician and therapist dyad. Except for the psychedelic medicine-assisted component of the 12-week program, all patient provider interactions are completed virtually. Additional sessions are provided by a Functional Medicine Practitioner, an Emotional Freedom Technique (EFT/Tapping) Practitioner, a Body Movement Practitioner (such as Yoga), and one to one support as needed from a variety of specialists on the team.Coming To Know teaching, which cultivates the understanding, meaning, confidence, and engagement necessary for the deeper work (at the level of the body) to unfold. All then engage in a Pause Practice (guided meditation or somatic self-regulation practice), which encourages transition from “figuring it out” at the level of the mind to a somatic or felt sense, honoring the inner healing intelligence within the body.Each week, participants meet in a large group format for 30–40 min beginning with an opening message by the program's Indigenous Elder, followed by Program Logistics. A team member provides an evidence-informed Buddy, to connect and integrate with once a week, using a structured conversational format promoting authentic and embodied sharing.Within the breakout groups at the first meeting, each small group adopts a set of intentions and agreements. Members are accountable to one another, which is important for developing accountability, trust and a sense of relational security. Participants are paired with a Short Check-In, where they name one to two physical sensations and emotions they feel in that moment. They then transition to a Long Check-In, where they speak to an open-ended reflective question that encourages contemplation, somatic reflection, and emotional expression. Participants receive an Integration Practice to incorporate over the following week, ending in a Short Check-Out, where they again name one to two physical sensations and emotions that they are experiencing in that moment.During the small group break-out session, participants begin with a All members are encouraged to engage according to their own comfort level, working within their unique window of tolerance for vulnerability. With practice, participants gain trust and confidence in the process and their small group. The mechanisms of healing in the CoP structure include co-regulation of the nervous system, somatic awareness, authentic expression, expanding one's window of tolerance for vulnerability and stress, and the giving and receiving of unconditional positive regard through compassionate witnessing .I am already experiencing moments of sadness when I think of these 12 sessions ending and I hope for it to continue in some form past the formal end of the program. I see that for integration to truly take place, I would need for the process to last longer than 12 weeks.”“Upon completion of the program, participants receive an exit interview to reflect on the process and for continuity of care. For those wanting ongoing support after the 12-weeks, participants are invited to join an Alumni CoP Program, enabling ongoing peer and team support and additional access to KaT.I truly believe them when they tell me to ‘reach out anytime,' ‘we are always here for you' – the words, actions and energies all align leaving me with a deep sense of trust, and a willingness to open further in the safety of the container. I feel truly seen.”“The delicate and thoughtful way in which the container of the group was developed was helpful and satisfying. I was amazed at how quickly I felt safe and willing to share my vulnerable pieces with the group. I have appreciated the offerings of various tools for my tool box.”“The KaT component of the 12-week program brings CoP members together to receive ketamine in a group format, with a skilled therapist-clinician dyad per six participants. In addition, floating cultural and spiritual safety experts and knowledge holders, somatic energy practitioners, medical doctors, and a psychiatrist oversee all of the group administrations, attending where needed.KaT is typically provided at week 4, 5, and 7. The short window of time between sessions provides a liminal space that magnifies the psychedelic mechanism, which could also be described as a loosening of the mind/ego structures that lead to the sense of stuckness that characterizes many mental health conditions.KaT sessions include at least one or more one-to-one preparatory sessions. Participants plan for the ketamine sessions to take 4 h. Participants arrive at the healthcare center and are welcomed by the medical team for check-in and vital signs. They are then invited to settle into the room where the session will take place. Each room is set up with mats on the floor in a circular formation. A ceremonial process takes place, similar to the CoP structure, while also honoring local Indigenous and cultural traditions and participant preferences. Consent forms are collectively reviewed and signed. Ketamine is administered as either oral lozenges for the first session and intramuscularly for the second and third sessions. Participants are provided with eye coverings and synchronized headphones, ensuring that they are all listening to the same uniquely constructed, ketamine-specific playlist. When the effects of the ketamine begin to wane around the 90-min mark, the initial sharing begins. Upon completion and ceremonial close, vital signs are repeated, and participants are escorted to the person driving them home.Post-KaT, to facilitate integration within the first 36 h where neuroplasticity is most pronounced , particiAlthough nervous at first of the unknown, I have found the sessions absolutely mind shifting. The work that I have done in these sessions have made me able to process my trauma and move forward in a way that I never thought would be possible. It brought forward things that I didn't know were affecting me. The days after the KaT sessions, I processed the experience even further.”“Participants are given a dose of between 1 and 1.5 mg/kg by intramuscular injection. The dosing range promotes a psychedelic mechanism and is determined in conversation with the participant, based on their goals, intentions, and comfort with non-ordinary states of consciousness. In session two and three, the dosing is adjusted to remain aligned with participant's goals and comfort level. Dissociation is a normal (and often helpful) side effect for many. Some also experienced nausea, vomiting, and/or hypertension, which was resolved through pharmaceutical and non-pharmaceutical approaches.Over 1 year, three cohorts totaling 94 participants completed the 12-week treatment program. With each cohort, quality improvement results were directly translated to the frontline of care and to ongoing program development efforts. As illustrated in Of those who screened positive for generalized anxiety disorder symptoms (GAD), such as feeling on edge, not being able to stop worrying, trouble relaxing, unable to sit still, irritability, a sense of impending doom, 91% had reduced scores, dropping into a milder category or had significant clinical improvements.Of those who screened positive for symptoms of depression, such as feeling hopeless, little interest in doing things, sleeping too much or too little, loss of appetite and energy, trouble concentrating, feeling like a failure, and thoughts of being better off dead, 79% had reduced scores that dropped them into a milder category or had significant clinical improvements.Of those who screened positive for PTSD, such as re-experiencing past, emotional numbness, avoidance of people and activities that remind them of past trauma, difficulty sleeping, jumpy, easily irritated and angered, 86% left the program screening negative for PTSD.Of those who screened positive for Life/Work Impairments in romantic relationships, family relationships, work, friendships and socializing, parenting, education, and self-care, 92% had significant clinical improvements.Upon Completion in response to “What are you noticing about yourself and your relationships?”:I have been led through some of my fears while experiencing a new found deep sense of love for life. I am able to connect with my partner from a more intimate authentic place. I am also noticing a greater depth of connection with those I work with and for.”“I've stopped using Edibles [Cannabis]. I've felt more empowered, like I have my voice. I'm more connected to myself. I am quicker to reach out. I find love easier in connection. I'm less anxious at work and have more ease as I enjoy my colleagues more and trust they enjoy me. I'm noticing more space within myself. I'm not engaging in the push-pull in my relationships as much.”“This cohort-based case study was completed within a registered quality improvement project with the local health authority, which was exempt from REB review. Running through a program of research with a control group  will promote further understanding of impact factors.Access to ketamine assisted therapy is limited, the cost of treatment, and durability of results are common challenges. Using a group/CoP model reduces cost, enhances capacity and thereby access, accelerates recovery and may reduce relapse by providing ongoing integration support over the 12 weeks of the program and beyond. Based on the learnings and positive outcomes of this program, we anticipate that the demand for communities of practice as a treatment and supportive integration mechanism will become a gold standard in the delivery of psychedelic-assisted therapies. Finally, we would like to recognize the HCPs that courageously stepped forward to co-develop this program in the process of navigating their own healing journeys.The original contributions presented in the study are included in the article/supplementary material, further inquiries can be directed to the corresponding author/s.The project was registered as a Quality Improvement Project with the local health authority, exempt from formal ethical review under TCPS 2 (2018), Article 2.5. The patients provided their written consent to participate in the program.All authors provided substantial contributions to the conception or design of the work, or the acquisition, analysis or interpretation of data for the work, drafted the work or revising it critically for important intellectual content, provided approval for publication of the content, and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.The project was supported by Vancouver Island University, a Canadian Institutes of Health Research Knowledge Synthesis grant, a British Columbia Ministry of Health COVID-19 Research grant, the Regional Initiatives Fund, in-kind support from Island Health, the British Columbia Nurses Union, First Nations Health Authority, and philanthropic funds.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.


BCR–ABL1 as accurately and precisely as possible. In this context, the droplet digital PCR (ddPCR) presents an alternative methodology for such quantification. To hypothesize the introduction of this technology in routine practice, we performed a multicentric study that compares ddPCR with the standard methodology currently used. Our results demonstrate that the use of ddPCR in clinical practice is feasible and could be beneficial.The introduction to clinical practice of a treatment-free remission approach in chronic myeloid leukemia patients with a stable deep molecular response highlighted how crucial it is to monitor the molecular levels of BCR–ABL1 mRNA levels represent the key molecular marker for the evaluation of minimal residual disease (MRD) in chronic myeloid leukemia (CML) patients and real-time quantitative PCR (RT-qPCR) is currently the standard method to monitor it. In the era of tyrosine kinase inhibitors (TKIs) discontinuation, droplet digital PCR (ddPCR) has emerged to provide a more precise detection of MRD. To hypothesize the use of ddPCR in clinical practice, we designed a multicentric study to evaluate the potential value of ddPCR in the diagnostic routine. Thirty-seven RNA samples from CML patients and five from healthy donors were analyzed using both ddPCR QXDxTMBCR-ABL %IS Kit and LabNet-approved RT-qPCR methodologies in three different Italian laboratories. Our results show that ddPCR has a good agreement with RT-qPCR, but it is more precise to quantify BCR–ABL1 transcript levels. Furthermore, we did not find differences between duplicate or quadruplicate analysis in terms of BCR–ABL1% IS values. Droplet digital PCR could be confidently introduced into the diagnostic routine as a complement to the RT-qPCR. BCR–ABL1 fusion gene encoding for the homonym protein with hyper tyrosine kinase activity. The BCR–ABL1 rearrangement occurs in about 95% of CML patients with two major (e13a2 and e14a2), one minor (e1a2), and some rare variants [BCR–ABL1 isoform while real-time quantitative polymerase chain reaction (RT-qPCR) in necessary to assess the response to tyrosine kinase inhibitors (TKIs) therapy [Chronic myeloid leukemia (CML) is a clonal hematopoietic disorder characterized by increased and unregulated growth of differentiated myeloid cells that accumulate in the blood . The recBCR–ABL1 mRNA levels represent the key molecular marker for the evaluation of minimal residual disease (MRD), defining the depth of molecular remission and guiding clinical decisions such as a change in TKI or, more recently, discontinuation of therapy [BCR–ABL1 follow the recommendation described by the Europe Against Cancer (EAC) program and successively revised especially for the DMR scoring [mBCR–ABL1 quantification and (ii) properly coordinates quality control rounds in order to monitor and eventually improve the network laboratories’ performances. The first point has been improved over the years thanks to the introduction of the use of a laboratory-specific conversion factor [BCR–ABL1 levels monitoring is necessary. In this context, droplet digital PCR (ddPCR) represents an innovative evolution of RT-qPCR with many practical advantages. This technology is based on a massive partition of the sample into thousands of droplets in which single end-point PCR reactions are performed. Being independent of calibrators and standard reference curves [BCR–ABL1 levels in CML patients by assessing the agreement between the measures obtained, the repeatability (intra-laboratory variability), and the reproducibility (inter-laboratory variability) of the two methods. Furthermore, we investigated the Limit of Blank (LoB) of ddPCR QXDx™ BCR-ABL %IS Kit in our cohort of CML samples.For this reason,  therapy . The cri scoring ,6. In adn factor . Furthern factor , a highle curves ,9 and ove curves , ddPCR ae curves ,12,13,14n = 10; group 2, MR 3, n = 9; group 3, MR 4, n = 8; group 4, MR 4.5 and 5, n = 10, and group 5, healthy donors, n = 5.Peripheral blood (PB) leukocytes were isolated by Buffy Coat procedure from 37 CML patients, according to LabNet recommendations, and 5 healthy donors. Total RNA was extracted using Maxwell 16 LEV simplyRNA Blood kit , following the manufacturer’s instructions. RNA samples were then quantified by NanoDrop™ One/OneC Microvolume UV-Vis Spectrophotometer  and aliquoted for RT-qPCR and ddPCR experiments. CML samples were divided into 5 groups based on the MR levels [BCR–ABL1 p210 was quantified by RT-qPCR in 3 different Italian laboratories, namely: Lab 1 , Lab 2 , and Lab 3 . Lab 2 and 3 performed 1 amplification session each, while Lab 1 performed 3 independent sessions. BCR–ABL1 p210 was quantified with three different methods: by using the One-Step BCR-ABL P210 ELITe MGB Kit , according to manufacturer’s protocol (Lab 1); by using the One-Step Philadelphia SensiQuant Kit , according to the manufacturer’s instructions (Lab 2); and as described by Gabert et al. [BCR–ABL1/ABL1 %IS.t et al.  (Lab 3).BCR–ABL1 p210 was also quantified by ddPCR. Lab 2 and 3 performed 1 amplification session each, while Lab 1 performed 3 independent sessions. The BCR–ABL1 fusion and ABL1 transcripts were tested in multiplex in the same well. All ddPCR experiments were performed using QXDx™ BCR-ABL %IS Kit  on the QX200 system (Bio-Rad), according to the manufacturer’s instructions. Samples were tested in quadruplicate. Each replicate was partitioned into about 20,000 droplets by a droplet generator and amplified by PCR. Plates were then loaded onto the QX200 droplet reader (Bio-Rad) and analyzed by QuantaSoftTM software . The target quantification for each sample was expressed as BCR–ABL1/ABL1 %IS.TM BCR-ABL %IS. All analyses were stratified by the level of disease.The Bland–Altman analysis was performed and the bias with the 95% Limits of Agreement (95% LoA), the measurement errors, and the coefficients of reproducibility and repeatability were reported for the measurement of the agreement between the two techniques. Furthermore, the Limit of Blank (LoB) was evaluated for the Kit QXDxd ± 1.96 × s, where d and s are the mean and the standard deviation of the differences, respectively. Only data from Lab 1 were considered. The coefficient of repeatability is defined as the upper limits of a prediction interval for the absolute difference between two measurements by the same method on the same item under identical circumstances .The bias was estimated by the mean difference between the measurements of the two methods. An LoA of 95% represents the prediction limits of the differences between the methods and was estimated as The coefficient of reproducibility is defined as the upper limits of a prediction interval for the absolute difference between two measurements by the same method on the same item under different circumstances, normally referring to different laboratories. To estimate measurement errors, coefficients of repeatability, and reproducibility, a variance component model was fitted with replicate measurements in each method by item stratum. Restricted-Maximum Likelihood (REML) estimates of the relevant variance component were returned. For the coefficient of repeatability, only data from Lab 1, with replicates, were considered. For the coefficient of reproducibility, data from Lab 1, without replicates, Lab 2, and Lab 3 were considered. Healthy donors were excluded.t-test did not reveal significant differences between the mean values of BCR–ABL1 obtained with the two techniques , including the heterogeneity of the different samples, the replicates on the same sample, and the intrinsic variability of the methods. If we isolate the latter component, we notice that the measurement error is higher when using RT-qPCR for all levels of disease .To assess the intra-laboratory variability, we calculated the coefficient of repeatability of ddPCR and RT-qPCR on data obtained in Lab 1 in three independent sessions with the same experimental conditions. Results are reported in To assess the inter-laboratory reproducibility, we compared ddPCR and RT-qPCR results obtained in all the laboratories, without replicates. A total of 252 measurements were included in this analysis, 126 for the ddPCR and 126 for the RT-qPCR, divided as follows: 60 for group 1, 54 for group 2, 48 for group 3, 60 for group 4, and 30 for group 5. We calculated the reproducibility coefficient and we observed that the values obtained with ddPCR were smaller than qRT-PCR for all the levels of disease .BCR–ABL1/ABL1 %IS values obtained from duplicate or quadruplicate analysis for all the levels of disease were observed . The three independent runs performed in Lab 1 returned 15 BCR–ABL1/ABL1 %IS values  calculated from 60 replicates. Among five samples from healthy subjects, we found four samples with a detectable analyte concentration in one out of four replicates. LoB was determined by calculating the 95th percentile of the blank values using a quantile multilevel regression model to take into account the three independent runs of each sample.To estimate the Limit of Blank (LoB) of the ddPCR BioRad assay, we considered results obtained in Lab 1 for BCR–ABL1/ABL1 %IS. Instead, we obtained a LoB of 0.002, considering four positive replicates out of 60.If we considered four positive samples out of 15 measurements—defining a sample as positive when at least one out of four replicates had detectable analyte concentration—then we obtained a LoB of 0.0007 BCR–ABL1 breakpoints in CML patients [PML/RARA in acute promyelocytic leukemia (APL) [BCR–ABL1 canonical transcripts, a variant-specific discrepancy in the evaluation of BCR–ABL1 e13a2 and e14a2 mRNA was observed when EAC assay was used in RT-qPCR. In 2019, Bernardi et al. demonstrated that ddPCR can correctly quantify both variants, confirming that the ddPCR results are less affected than RT-qPCR by primer efficiency [BCR–ABL1 molecular levels in CML patients treated with TKIs. In our experiments, we used a multiplex ddPCR assay for p210 BCR–ABL1 Major translocations in the peripheral blood of CML patients, which can quantify the target (BCR–ABL1 Major translocations) and the housekeeping (ABL1) genes in the same well, returning an absolute quantification. The results obtained are expressed as a percentage of BCR–ABL1/ABL1 in the International Scale (IS) . Indeed, each kit contains two IS calibrator checks, traceable to the First WHO international Genetic Reference Panel (09/138) [BCR–ABL1/ABL1 %IS values determined by ddPCR and RT-qPCR are superimposable. Although we were able to demonstrate that ddPCR has a good agreement with RT-qPCR, ddPCR resulted in greater precision (higher repeatability) than RT-qPCR for all the levels of disease. Moreover, the ddPCR was found to be more reproducible than RT-qPCR in all the disease levels, meeting the efforts made by the CML community to standardize the results [BCR–ABL1 positive cell out of 107 cells, predicting relapse in CML patients after imatinib discontinuation [BCR–ABL1 [Droplet digital PCR represents an innovative evolution of RT-qPCR. According to the “divide et impera” principle, each sample is partitioned into several thousand up to 20,000) single end-point PCR reactions and is not affected by the inhibitors present, primer efficiency, or calibrators, nor does it require standard reference curves. The last two issues allow to overcome the RT-qPCR limitations in monitoring several fusion transcripts, such as both canonical and atypical patients  and PML/ia (APL) , guidingficiency . The rec09/138) , that al/138 , th,000 sing results ,7,15. Th results ,23,24,25BCR–ABL1 . Our datBCR–ABL1 . MoreoveBCR–ABL1 . This prFinally, data obtained about LoB underline how it is necessary to identify guidelines for the interpretation of the positivity of a sample and, therefore, to define a cut-off to distinguish a sample as true-positive or true-negative. An example comes from the MRD monitoring of other hematological diseases, such as multiple myeloma, mantle cell lymphoma, and follicular lymphoma ,30, wherBCR–ABL1/ABL1 results obtained by ddPCR and RT-qPCR. The performance of the ddPCR assay makes it a promising tool for routine MRD monitoring in CML patients.Our data indicated a good correlation between the


We evaluated the performance of the new Abbott SARS-CoV-2 IgM assay on the Architect immunoassay analyser and compared it to the Architect IgG/Roche Cobas total antibody assays in both SARS-CoV-2 RT-PCR positive cases and healthy controls.200 healthy control samples and 48 individuals with other antibody-positive disorders (18 hepatitis/18 dengue/11 ANA/1 dsDNA) served to assess for potential cross-reactivity. Anonymised residual leftover sera positive for SARS-CoV-2 on RT-PCR were recruited as cases (N = 133). The sensitivity/specificity/cross-reactivity of the Architect IgM assay were assessed. Concordance between the 3 assays were also analysed.There was no cross-reactivity with controls and other antibody positive samples. The Architect IgM assay was 100% specific (95% CI 98.5 to 100) and sensitivity was 77.8% (95% CI 60.8 to 89.9) ≥14 days post-first positive RT-PCR (POS). Sensitivity of the combined Architect IgM and IgG results (30.8%) was significantly better than the Cobas total antibodies (15.4%) in early disease (p = 0.04). While the Architect IgM assay had moderate agreement with the Cobas total antibody result (Cohen’s kappa 0.72), a combined Architect IgM and IgG result had better agreement (Cohen’s kappa 0.83).The Architect IgM assay has good specificity and no cross-reactivity with other antibody positive cases. A combined Architect IgM and IgG result has better sensitivity than the individual assays for early COVID-19. The Architect IgM assay is not comparable to the Cobas total antibody assay, but the Architect IgM and IgG combined result has good agreement with the Cobas assay. •IgM/IgG may not develop in some cases of COVID-19, even ≥14 days post infection.•The sensitivity/PPV of the combined Architect IgG/IgM assays improves ≥14 days POS.•The Architect IgM/IgG combined result has good agreement with the Cobas assay.•The Architect IgM and IgG combined results slightly outperforms the Cobas assay. SARS-CoV-2Novel severe acute respiratory syndrome coronavirus 2COVID-19Coronavirus disease 2019RT-PCRReverse-transcriptase polymerase chain reactionPOSPost-first positive RT-PCRHShealth screeningANAanti-nuclear antibodyds-DNAdouble-stranded DNA antibodyCOICut-off indexPPVPositive predictive valueNPVNegative predictive value1Although reverse-transcriptase polymerase chain reaction (RT-PCR) testing remains the recommended diagnostic test for novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, up to 13% of patients can have low viral loads with negative RT-PCR tests  and in sWe have previously evaluated the Abbott SARS-CoV-2 IgG antibody  and the 2Participants: Residual leftover sera were used in this study. Two-hundred pre-pandemic samples from a staff health screening (HS) program in 2018 served as controls. In addition, 48 pre-pandemic/current antibody positive samples , 18 dengue (taken in 2020), 11 anti-nuclear antibody [ANA] and 1 double-stranded-DNA antibody [dsDNA] (pre-pandemic)) were used to assess for potential cross-reactivity. All pre-pandemic samples were non-reactive on the Architect IgG and Cobas assays, and all cross-reactivity samples taken in 2020 had COIs comparable to pre-pandemic samples, establishing that they were likely to be free of COVID-19. Residual de-identified sera from other routine laboratory testing  in subjects who tested positive for SARS-CoV-2 on RT-PCR from April to June 2020 were recruited as cases (N = 133) (see 133) see . 78 RT-PInstrumentation and materials: The Abbott SARS-CoV-2 IgG assay is a qualitative chemiluminescent microparticle immunoassay run on the ARCHITECT i2000 System, as described previously , as appropriate. 95% confidence intervals for sensitivity and specificity were calculated according to Clopper and Pearson exact method with standard logit confidence intervals for predictive values. Between-test agreements were assessed by interpretation of Cohen’s Kappa-statistics. Statistical analyses were performed using MedCalc® Statistical Software version 19.5.3 . For the 95% confidence interval in groups with 100% PPV, we used Stata 14 software . Compliance with STARD guidelines is enclosed see .3Precision: For precision analysis, negative and positive Abbott control material was run 10 times each. For negative controls the within run CV was 21.0% (at COI 0.02), and for positive controls the within run CV was 2.4% (at COI 2.99); between run CV was 15.5% (at COI 0.03) and 3.7% (at COI 2.30) respectively.Cross-reactivity and specificity: All 48 samples positive for hepatitis, dengue, ANA and dsDNA antibodies showed no cross-reactivity with the Architect IgM assay. All 248 controls and cross-reactivity samples tested negative on the Architect IgM assay, with a specificity of 100% (95% CI 98.5 to 100).Sensitivity: The Architect IgM assay sensitivity increased with days POS. However, the sensitivity remained at 77.8% even after 14 days POS  of cases were negative after 14 days see . The comConcordance: Agreement between assays were studied in a pairwise fashion by applying inter-rater agreement statistics (Cohen Kappa). Individually, the Architect IgG had good agreement with the Cobas assay . The agreement between Architect IgM and Cobas assays was moderate  but improved when combining the Architect IgM and IgG assays , with 94.5% (n = 360) concordant cases.4On its own, the Architect IgM assay has moderate sensitivity (26.2%) for antibody detection within the first week of infection, increasing in the second week to 71.9% and peaks at 77.8% thereafter. This is in keeping with other studies , where IThe sensitivity of the Architect IgM in early disease is further improved by combining it with the Architect IgG results. For cases at 0–6 days POS, this combined result increases the sensitivity of antibody detection from 26.2% to 30.8%, exceeding that of the Cobas total antibody 15.4%) and Abbott IgG (10.8%) assays. The sensitivity of the Cobas total antibody assay was marginally higher than the individual Architect IgG and IgM results in the total population. Furthermore, the sensitivity of the combined Architect IgM and IgG results exceeded 95% after 14 days POS. Other studies .4% and A.There is a clear concordance between the Architect IgG and Cobas total antibody assays. One study  comparinSome studies show that IgG can be more sensitive in early disease than IgM (IgG 64.7% vs IgM 38.2% sensitivity in days 5–10 after disease onset) . Others The strengths of our study are that we have assessed the sensitivity performance of the Architect IgM assay stratified by groups of days POS. We also confirm that dengue antibodies have no cross-reactivity with the Architect IgM antibody assay, as some studies  have shoOne limitation of our study is that it is comprised of a hospital population. The serological status was compared to the timing of RT-PCR positivity and not relative to timing of symptom onset. We are thus unable to account for any delays between start of infection and RT-PCR. However, the use of RT-PCR as a surrogate for disease onset would include subjects who are possibly asymptomatic . The proportion of males is substantially higher in our cases, as this reflects the real-world male preponderance of more severe COVID-19 . The hig5In summary, we report some new findings for the new Architect IgM assay. The IgM or IgG may not develop in some cases of COVID-19 infection, even after 14 days POS. The Abbott IgG and IgM results should be interpreted together. Either IgG and/or IgM positivity should be considered as positive for seroconversion. A negative IgM or IgG result does not exclude COVID-19 infection. The sensitivity and PPV of the combined Architect IgG and IgM assays improve after 14 days POS, and even outperforms the Cobas total antibody assay.All co-authors have contributed to the study and manuscript.The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.