The Risk Perception of the Chinese Diaspora during the COVID-19 Pandemic: Targeting Cognitive Dissonance through Storytelling.

The global COVID-19 pandemic in 2020 required risk communications to mitigate the virus' spread. However, social media not only conveyed health information to minimize the contagion, but also distracted from the threat by linking it to an externalized 'other'-primarily those appearing to be of Chinese descent. This disinformation caused the attribution of blame to Chinese people worldwide. In Canada's Greater Toronto Area, Chinese individuals reported widespread public stigma that compounded their risk of contagion; to the degree that it was driven by cognitive dissonance, it generated experiences of social and cultural vulnerability. In this paper, we draw on the aforementioned study's findings to explain how the risk perception and threat appraisal of Chinese diaspora individuals were impacted by different cognitive dissonance pathways. These findings explore how storytelling is a viable intervention with which to target and mitigate cognitive dissonance. Indeed, the mechanisms of cognitive dissonance can modify risk perception and mitigate social and cultural vulnerability, thereby averting potential long-term negative consequences for one's mental health and well-being. We hope our guidance, training educators to target pathways of cognitive dissonance by drawing on storytelling (with humour), can assist them to better convey information in ways that are more inclusive during public health emergencies.

Safety and efficacy of losmapimod in facioscapulohumeral muscular dystrophy (ReDUX4): a randomised, double-blind, placebo-controlled phase 2b trial.

BACKGROUND: Facioscapulohumeral muscular dystrophy is a hereditary progressive myopathy caused by aberrant expression of the transcription factor DUX4 in skeletal muscle. No approved disease-modifying treatments are available for this disorder. We aimed to assess the safety and efficacy of losmapimod (a small molecule that inhibits p38α MAPK, a regulator of DUX4 expression, and p38ß MAPK) for the treatment of facioscapulohumeral muscular dystrophy. METHODS: We did a randomised, double-blind, placebo-controlled phase 2b trial at 17 neurology centres in Canada, France, Spain, and the USA. We included adults aged 18-65 years with type 1 facioscapulohumeral muscular dystrophy (ie, with loss of repression of DUX4 expression, as ascertained by genotyping), a Ricci clinical severity score of 2-4, and at least one skeletal muscle judged using MRI to be suitable for biopsy. Participants were randomly allocated (1:1) to either oral losmapimod (15 mg twice a day) or matching placebo for 48 weeks, via an interactive response technology system. The investigator, study staff, participants, sponsor, primary outcome assessors, and study monitor were masked to the treatment allocation until study closure. The primary endpoint was change from baseline to either week 16 or 36 in DUX4-driven gene expression in skeletal muscle biopsy samples, as measured by quantitative RT-PCR. The primary efficacy analysis was done in all participants who were randomly assigned and who had available data for assessment, according to the modified intention-to-treat principle. Safety and tolerability were assessed as secondary endpoints. This study is registered at ClinicalTrials.gov, number NCT04003974. The phase 2b trial is complete; an open-label extension is ongoing. FINDINGS: Between Aug 27, 2019, and Feb 27, 2020, 80 people were enrolled. 40 were randomly allocated to losmapimod and 40 to placebo. 54 (68%) participants were male and 26 (33%) were female, 70 (88%) were White, and mean age was 45·7 (SD 12·5) years. Least squares mean changes from baseline in DUX4-driven gene expression did not differ significantly between the losmapimod (0·83 [SE 0·61]) and placebo (0·40 [0·65]) groups (difference 0·43 [SE 0·56; 95% CI -1·04 to 1·89]; p=0·56). Losmapimod was well tolerated. 29 treatment-emergent adverse events (nine drug-related) were reported in the losmapimod group compared with 23 (two drug-related) in the placebo group. Two participants in the losmapimod group had serious adverse events that were deemed unrelated to losmapimod by the investigators (alcohol poisoning and suicide attempt; postoperative wound infection) compared with none in the placebo group. No treatment discontinuations due to adverse events occurred and no participants died during the study. INTERPRETATION: Although losmapimod did not significantly change DUX4-driven gene expression, it was associated with potential improvements in prespecified structural outcomes (muscle fat infiltration), functional outcomes (reachable workspace, a measure of shoulder girdle function), and patient-reported global impression of change compared with placebo. These findings have informed the design and choice of efficacy endpoints for a phase 3 study of losmapimod in adults with facioscapulohumeral muscular dystrophy. FUNDING: Fulcrum Therapeutics.

Understanding the Risk of Social Vulnerability for the Chinese Diaspora during the COVID-19 Pandemic: A Model Driving Risk Perception and Threat Appraisal of Risk Communication-A Qualitative Study.

During the first wave of the COVID-19 pandemic, immigrants were among the most socially vulnerable in Western countries. The Chinese diaspora in Canada were one such group due to the widespread cultural stigma surrounding their purported greater susceptibility to transmit and become infected by COVID-19. This paper aims to understand the social vulnerability of the Chinese diaspora in the Greater Toronto Area, Canada, during the first wave of COVID-19 from an explanation of their risk perception and threat appraisal of risk communication. We conducted secondary data analysis of 36 interviews using critical realism. The participants self-identified as being of Chinese descent. The results were used to develop a model of how social vulnerability occurred. In brief, cognitive dissonance was discovered to generate conflicts of one's cultural identity, shaped by social structures of (i) stigma of contagion, (ii) ethnic stigma, and (iii) public sentiment, and mediated by participants' threat appraisal and (iv) self-reliance. We assert that risk communicators need to consider their audiences' diverse socialization in crafting messages to modify behaviors, create a sense of responsibility, and mitigate public health threats. A lack of awareness of one's cognitive dissonance driven by cultural vulnerability may heighten their social vulnerability and prevent them from taking action to protect themself from high-risk events.

A longitudinal study on the change in sleep across three waves of the COVID-19 outbreaks in Hong Kong.

In the year 2020, Hong Kong experienced four COVID-19 epidemic waves. The present study aimed to examine the transition of sleep disturbances and explore its associated factors across the later three epidemic waves. Among the 1138 respondents who participated in an online survey at the second wave (T1, April 2020), 338 and 378 participants also completed a follow-up at the third (T2, August 2020) and fourth waves (T3, December 2020), respectively. Participants completed the Insomnia Severity Index and an investigator-designed questionnaire regarding potential factors associated with sleep change such as perceived risk of being infected, economic stress, and confidence in the government and health care professional. Sample of this study were mainly female (67.7%), married (50.3%), young adults (54.2%) with tertiary education (81.6%). Maintaining normal sleep was the most prevalent trajectory of sleep of all three waves (50.5%), followed by persistent insomnia (17.2%) and remitted insomnia (9.0%). Besides female, older-age and lower education level, the results showed that increment in worry about family being infected (adjusted risk ratio, RR = 1.28), perceived interference of daily lives (adjusted RR = 1.19), and economic distress (adjusted RR = 1.24) were significantly associated with the development of clinical insomnia during the three epidemic waves. These factors were also associated with worsening of other sleep parameters. Insomnia being persistent across the three waves of COVID-19 outbreaks was common. Increasing economic distress, daily interference, and worry about family members being infected were associated with an increasing risk of clinical insomnia across the three COVID-19 outbreaks. Supplementary Information: The online version contains supplementary material available at 10.1007/s41105-023-00486-w.

Nurse-led self-management education and support programme on self-management behaviour and quality of life among adults with type 2 diabetes: A pilot randomized controlled trial.

AIM: This study examined the preliminary effects of a nurse-led self-management education and support programme on the self-management behaviours and quality of life among people with type 2 diabetes in Western Ethiopia. METHODS: A pilot randomized controlled trial was conducted between January and August 2021. Participants were recruited in the hospital and randomly assigned to the control arm to continue usual care (n = 38) or the intervention arm to receive usual care and the diabetes self-management education and support programme (n = 38) in the community. Self-management behaviours and quality of life were assessed using a 10-item summary of diabetes self-care activity (expanded) scale and a 34-item diabetes quality of life measure, respectively, at baseline and 2 months after follow-up. Generalized estimating equation models were used to examine the preliminary effects of the programme on the outcomes. RESULTS: Preliminary results indicated that the programme outperformed usual care in self-management practise, with large effect sizes immediately postintervention and at 2 months after the intervention, and quality of life at 2 months after the intervention. CONCLUSION: A nurse-led diabetes self-management education and support intervention, including the families of people with diabetes, may be an option to boost the self-management practise and quality of life of patients with diabetes.

Effects of family-based diabetes self-management education and support programme on support behaviour amongst adults with type 2 diabetes in Western Ethiopia.

Support from family and peers may enhance the outcomes of diabetes management. This study reported the preliminary effect of a family-based diabetes self-management education and support (DSMES) programme on the perceived support status of people with diabetes and the family's caregiver support behaviour amongst dyads living in Western Ethiopia. A 1:1 two-armed pilot randomised controlled trial (RCT) was conducted. A total of 76 dyads were recruited using the convenience sampling method and randomly assigned to either intervention or control groups. The control group continued the usual care, whereas the intervention group continued the usual care and additionally received a 12-h social cognitive theory (SCT)-guided, family-supported DSMES programme in the community. Generalised estimating equations models were computed to test the preliminary effects of the DSMES programme on the outcomes. P-value < 0.05 was set as statistically significant. The pilot RCT shows a statistically significant between-group difference in the changes in support needed at T1 (d = 0.88) and T2 (d = 1.35) and support received at T1 (d = 0.88) and T2 (d = 1.44). The DSMES programme has outperformed usual care with a medium effect size at T1 (d = 0.54) and a large effect size at T2 (d = 0.97) on the family's supportive behaviour. Although the intervention group was not statistically significant at T1 (d = 0.43), a large effect size was obtained at T2 (d = 0.97) on the family's non-supportive behaviour. A SCT-guided, family-supported DSMES programme produced a promising positive effect on enhancing the support needed and support received from their family/friends, and it also improved the family's supportive behaviour. Thus, family support could be incorporated into DSMES programmes for diabetes management in Western Ethiopia. The trial was registered by the Chinese Clinical Trial Registry ( http://www.chictr.org.cn ); Registration number: ChiCTR2000040292.

An integrated smoking cessation and alcohol intervention among Hong Kong Chinese young people: Study protocol for a feasibility randomized controlled trial.

INTRODUCTION: Young smokers always partake in both smoking and drinking. However, drinking undermines their likelihood to attempt quitting smoking or to successfully abstain from smoking. Hence, this trial will examine the feasibility of implementing an integrated smoking cessation and alcohol intervention in young Hong Kong Chinese people. Effect sizes of the integrated intervention (II) on self-reported and biochemically validated quit rates will also be calculated. METHODS: The study will be a three-arm randomized controlled trial in a convenience sample of 150 smokers aged 18-25 years with alcohol drinking. Participants will be randomized into a standard treatment (ST), II, or control arm. The ST group will receive a brief smoking cessation intervention based on the 5A (Ask, Assess, Advice, Assist, Arrange) and 5R (Relevance, Risks, Rewards, Roadblocks, Repetition) models. The II group will receive brief advice on alcohol use based on the FRAMES (Feedback, Responsibility, Advice, Menu, Empathy, Efficacy) model in addition to the brief smoking cessation intervention. Both the ST and II groups will receive booster interventions at 1-week, 1-month, 3-month, and 6-month follow-up. The control group will receive leaflets on smoking cessation and alcohol reduction. Self-reported quitters at 6-month follow-up will be invited for biochemical validation. The primary outcomes are feasibility measures. The secondary outcomes are effect size of II on self-reported and biochemically validated quit rates at 6 months relative to control and ST. Outcomes will be assessed at baseline and at 1-week, 1-month, 3-month, and 6-month follow-ups. ANALYSIS: Descriptive statistics will be used to calculate the feasibility measures. The three arms will be compared using analysis of variance for continuous variables and chi-square test for categorical variables. Effect sizes of II for self-reported and biochemically validated quit rates at 6 months will be determined using the generalized estimating equation model.

A comprehensive study of skeletal muscle imaging in FHL1-related reducing body myopathy.

OBJECTIVE: FHL1-related reducing body myopathy is an ultra-rare, X-linked dominant myopathy. In this cross-sectional study, we characterize skeletal muscle ultrasound, muscle MRI, and cardiac MRI findings in FHL1-related reducing body myopathy patients. METHODS: Seventeen patients (11 male, mean age 35.4, range 12-76 years) from nine independent families with FHL1-related reducing body myopathy underwent clinical evaluation, muscle ultrasound (n = 11/17), and lower extremity muscle MRI (n = 14/17), including Dixon MRI (n = 6/17). Muscle ultrasound echogenicity was graded using a modified Heckmatt scale. T1 and STIR axial images of the lower extremity muscles were evaluated for pattern and distribution of abnormalities. Quantitative analysis of intramuscular fat fraction was performed using the Dixon MRI images. Cardiac studies included electrocardiogram (n = 15/17), echocardiogram (n = 17/17), and cardiac MRI (n = 6/17). Cardiac muscle function, T1 maps, T2-weighted black blood images, and late gadolinium enhancement patterns were analyzed. RESULTS: Muscle ultrasound showed a distinct pattern of increased echointensity in skeletal muscles with a nonuniform, multifocal, and "geographical" distribution, selectively involving the deeper fascicles of muscles such as biceps and tibialis anterior. Lower extremity muscle MRI showed relative sparing of gluteus maximus, rectus femoris, gracilis, and lateral gastrocnemius muscles and an asymmetric and multifocal, "geographical" pattern of T1 hyperintensity within affected muscles. Cardiac studies revealed mild and nonspecific abnormalities on electrocardiogram and echocardiogram with unremarkable cardiac MRI studies. INTERPRETATION: Skeletal muscle ultrasound and muscle MRI reflect the multifocal aggregate formation in muscle in FHL1-related reducing body myopathy and are practical and informative tools that can aid in diagnosis and monitoring of disease progression.

Lean tissue mass measurements by dual-energy X-ray absorptiometry and associations with strength and functional outcome measures in facioscapulohumeral muscular dystrophy.

Facioscapulohumeral muscular dystrophy (FSHD) is a slowly progressive disease of skeletal muscle. Dual energy X-ray absorptiometry (DEXA) is a widely available, cost-effective and sensitive technique for measuring whole body and regional lean tissue mass and has been used in prior clinical trials in neuromuscular diseases. The Clinical Trial Readiness to Solve Barriers to Drug Development in FSHD (ReSolve) study is a prospective, longitudinal, observational multisite study. We obtained concurrent DEXA scans and functional outcome measurements in 185 patients with FSHD at the baseline visit. We determined the associations between lean tissue mass in the upper and lower extremities and corresponding clinical outcome measures. There were moderate correlations between upper and lower extremity lean tissue mass and their corresponding strengths and function. Lean tissue mass obtained by DEXA scan may be useful as a biomarker in future clinical trials in FSHD.

Factors associated with severe depressive symptoms among Chinese secondary school students in Hong Kong: a large cross-sectional survey.

Background: Many adolescents were reported to have severe depressive symptoms, and a careful assessment of its correlates is essential for prevention and intervention programs. This study aimed to gain insight into the prevalence of severe depressive symptoms and its association with factors at four levels (individual, relationship, school and society) in a large sample of Hong Kong Chinese secondary school students. Methods: Secondary school students from Secondary 1 through 7 were selected as participants using a cluster random sampling method. A questionnaire including inventories measuring 24 factors at the four levels (six individual factors, 11 relationship factors, three school factors, and four society factors) was completed by 8,963 participants (56.3% female) with a mean age of 15.1 (SD = 1.8) years. Students with a score of ≥15 on the Patient Health Questionnaire were defined as having severe depressive symptoms. The association between severe depressive symptoms and correlates were examined by t-test and χ2 test. Logistic regression models using a hierarchical approach then examined the individual contribution of these 24 factors to severe depressive symptoms with the control of other factors in the model. Results: 7.4% of the students have severe depressive symptoms. Twenty-two of the 24 factors were significantly associated with severe depressive symptoms in bivariate analyses. In the logistic regression, 11 factors (three individual factors: age, self-esteem and self-mastery; six relationship factors: tobacco use, alcohol drinking, drug use, paternal psychological control, dinner with parents, and perceived social support from friends; one school factor: felt pressure from homework; and one society factor: number of sibling) were statistically significant. Felt pressure from homework, alcohol drinking, and perceived social support from friends were the strongest correlates of severe depressive symptoms. Conclusion: The prevalence of self-reported severe depressive symptoms in Hong Kong Chinese secondary school students was high, and the identification of multiple associated factors at the four levels simultaneously provides a knowledge basis for the development of a comprehensive, multivariate model of factors influencing severe depressive symptoms in Chinese secondary school students. The factors identified in the present study may be helpful when designing and implementing preventive intervention programs.

Effects of a culturally tailored, family-supported, community-based self management education and support programme on clinical outcomes among adults with type 2 diabetes in Western Ethiopia: A pilot randomised controlled trial.

AIM: To examine the preliminary effects of a culturally tailored, family-supported, community-based diabetes self management education and support (DSMES) programme for Ethiopian people with type 2 diabetes on glycosylated haemoglobulin (HbA1c ), blood pressure, body mass index and lipid profiles. METHODS: A two-arm pilot randomised controlled trial (RCT) was conducted involving 76 participant-caregiver dyads from Western Ethiopia, which were randomly allocated to the intervention arm to receive 12 h of DSMES intervention guided by social cognitive theory on top of usual care, or to the control group, which received usual care. While HbA1c was a primary outcome, the blood pressure, body mass index and lipid profiles were secondary outcomes. Primary outcome was the change in HbA1c between baseline and 2-month follow-up between the groups. Generalised estimating equations was used to test the preliminary effect of the DSMES programme on the outcomes at baseline, post-intervention and at 2-month follow-up for secondary outcomes. Cohen's d was used to estimate the between-group effect sizes of the intervention. RESULTS: The DSMES produced significant improvement in HbA1c with large effect size (ß = -1.667, p < 0.001, d = -0.81) and triglycerides with medium effect size (d = -0.50). HbA1c in the intervention group was decreased by 12 mmol/mol (1.1%). Although nonsignificant, the DSMES also had small to moderate effects (d = -0.123 to 0.34) on blood pressure, body mass index, total cholesterol, low-density and high-density lipoproteins when compared with usual care. CONCLUSION: A culturally tailored, social cognitive theory-guided, family-supported, community-based DSME programme could have a benefit on HbA1c and triglycerides. A full RCT is warranted to test the effectiveness of the DSMES programme.

The effect of a lifestyle intervention program using a mobile application versus the effect of a program using a booklet for adults with metabolic syndrome: A three-arm randomized controlled trial.

PURPOSE: The research aimed to examine the effect of a lifestyle intervention program using mobile application versus booklet for adults with metabolic syndrome in Hong Kong. The outcomes comprised body weight (primary outcome), exercise amount, improvement of cardiometabolic risk factors, cardiovascular endurance, perceived stress scale, and exercise self-efficacy. DESIGN: A three-arm randomized controlled trial namely App group, Booklet group, and control group was adopted. METHODS: Two hundred sixty-four adults with metabolic syndrome were recruited from community centers from 2019 to December 2021. Inclusion criteria are those adults with metabolic syndrome, able to use a smart phone. All participants received a 30-min health talk. App group additionally received a mobile application, while Booklet group received a booklet, and the control group received a placebo booklet. Data were collected at baseline, Weeks 4, 12, and 24. SPSS and generalized estimating equations (GEE) model were employed for data analysis. FINDINGS: Attrition rates were minimal, ranged from 2.65% to 6.44%. Both app and booklet group showed significant improvement in outcomes (exercise amount, waist circumference) when compared to control group. However, statistically significant and superior results were observed in app group, including body weight, exercise amount, waist circumference, body mass index, and systolic blood pressure when compared to booklet group. CONCLUSION: The lifestyle intervention supported with app was found to be superior to the booklet support for reducing body weight and maintaining exercise. CLINICAL RELEVANCE: The lifestyle intervention program using mobile application support could be used widely for adults with metabolic syndrome in the community. Suggest nurses may incorporate this program in their health promotion strategies focusing on a healthy lifestyle to reduce the risk of progression to metabolic syndrome.

Experiences of seeking and accessing medical care among persons with major depression: A qualitative descriptive study of persons with depression in China.

Introduction: A large number of people in China are affected by depression, yet tend to delay seeking treatment. This study aims to explore persons living with depression and their journey of diagnoses and seeking professional medical help in China. Methods: Semi-structured interviews were conducted with 20 persons who visiting physicians to be diagnosed and receive professional help from a large mental health center in Guangzhou, Guangdong province, China. Individual interviews were conducted and data were analyzed using content analysis. Results: Three themes were identified from the findings: (1) "noticed something was wrong"; (2) negotiated decisions with their own narratives and the personal suggestions of others; and (3) gave new meaning to their experiences of depression, whereby they sought medical treatment. Discussion: The findings of the study indicated that the impact of progressive depressive symptoms on the participants' daily lives was a strong motivation for them to seek professional help. The obligation to care for and support their family prevented them from initially disclosing their depressive symptoms to family members, but eventually prompted them to seek professional help and persist in follow-up treatment. Some participants experienced unexpected benefits (e.g., relief at no longer feeling "alone") during their first visit to the hospital for depression or when they were diagnosed with depression. The results suggest a need to continue to actively screen for depression and provide more public education to prevent negative assumptions and reduce public and personal stigmatization of those with mental health problems.

Factors predicted quality of life of people with type 2 diabetes in western Ethiopia.

BACKGROUND: Multiple factors predict the quality of life of adults with diabetes. However, the relationships of demographics, self-management practice, and support status with the quality of life of people with diabetes are unknown. Therefore, the study aimed to assess factors related with the quality of life of adults with type 2 diabetes in western Ethiopia. METHODS: A hospital-based cross-sectional study involving adults with type 2 diabetes was conducted in western Ethiopia from June 02, 2020, to August 31, 2020. Convenience sampling technique was used in selecting subjects. The translated and psychometrically tested summary of diabetes self-management activities (expanded), diabetes quality of life, and diabetes care profile support scales were used in measuring self-management practice, quality of life, and support status, respectively. Data were collected via face-to-face interviews. Factors related with quality of life were examined through bivariate analysis and multivariable linear regression. In all statistical tests, P value <0.05 and confidence level that excluded zero were considered statistically significant. RESULTS: A total of 417 adults with type 2 diabetes participated in the study. In a multivariable linear regression, seven factors including age, male, homemakers, those separated/divorced, number of years since diabetes diagnosis, self-management practice and support needed were related with quality of life. Male patients (ß = 2.786, 95% CI = 1.285 to 4.287, p < 0.001), homemakers (ß = 0.366, 95% CI = 0.056; 0.677, p = 0.021), self-management practice (ß = 4.528, 95% CI = 3.851 to 5.205, p < 0.001) and those who needed support from their families or peers (ß = 1.623, 95% CI = 0.458; 2.788, p = 0.006) were related positively with quality of life whereas those who separated or divorced (ß = -1.698, 95% CI = -3.371 to -0.025, p = 0.047), older age (ß = -0.195, 95% CI = -0.269 to -0.121, p < 0.001) and those who lived with diabetes for a longer duration (ß = -2.206, 95% CI = -4.151 to -0.261, p = 0.026) were related negatively with quality of life. CONCLUSION: Quality of life of people with type 2 diabetes living in western Ethiopia was predicted positively by being male, homemakers, having self-management practice, and support needed, whereas negatively influenced by old age, separation or divorce, and long diabetes life. Thus, encouraging self-management practice, and continuous family or friend support are necessary to enhance quality of life of people with type 2 diabetes. Further study should employ random sampling techniques and involve participants from multiple study settings to increase representativeness of the samples.

Antisense oligonucleotide targeting DMPK in patients with myotonic dystrophy type 1: a multicentre, randomised, dose-escalation, placebo-controlled, phase 1/2a trial.

BACKGROUND: Myotonic dystrophy type 1 results from an RNA gain-of-function mutation, in which DM1 protein kinase (DMPK) transcripts carrying expanded trinucleotide repeats exert deleterious effects. Antisense oligonucleotides (ASOs) provide a promising approach to treatment of myotonic dystrophy type 1 because they reduce toxic RNA levels. We aimed to investigate the safety of baliforsen (ISIS 598769), an ASO targeting DMPK mRNA. METHODS: In this dose-escalation phase 1/2a trial, adults aged 20-55 years with myotonic dystrophy type 1 were enrolled at seven tertiary referral centres in the USA and randomly assigned via an interactive web or phone response system to subcutaneous injections of baliforsen 100 mg, 200 mg, or 300 mg, or placebo (6:2 randomisation at each dose level), or to baliforsen 400 mg or 600 mg, or placebo (10:2 randomisation at each dose level), on days 1, 3, 5, 8, 15, 22, 29, and 36. Sponsor personnel directly involved with the trial, participants, and all study personnel were masked to treatment assignments. The primary outcome measure was safety in all participants who received at least one dose of study drug up to day 134. This trial is registered with ClinicalTrials.gov (NCT02312011), and is complete. FINDINGS: Between Dec 12, 2014, and Feb 22, 2016, 49 participants were enrolled and randomly assigned to baliforsen 100 mg (n=7, one patient not dosed), 200 mg (n=6), 300 mg (n=6), 400 mg (n=10), 600 mg (n=10), or placebo (n=10). The safety population comprised 48 participants who received at least one dose of study drug. Treatment-emergent adverse events were reported for 36 (95%) of 38 participants assigned to baliforsen and nine (90%) of ten participants assigned to placebo. Aside from injection-site reactions, common treatment-emergent adverse events were headache (baliforsen: ten [26%] of 38 participants; placebo: four [40%] of ten participants), contusion (baliforsen: seven [18%] of 38; placebo: one [10%] of ten), and nausea (baliforsen: six [16%] of 38; placebo: two [20%] of ten). Most adverse events (baliforsen: 425 [86%] of 494; placebo: 62 [85%] of 73) were mild in severity. One participant (baliforsen 600 mg) developed transient thrombocytopenia considered potentially treatment related. Baliforsen concentrations in skeletal muscle increased with dose. INTERPRETATION: Baliforsen was generally well tolerated. However, skeletal muscle drug concentrations were below levels predicted to achieve substantial target reduction. These results support the further investigation of ASOs as a therapeutic approach for myotonic dystrophy type 1, but suggest improved drug delivery to muscle is needed. FUNDING: Ionis Pharmaceuticals, Biogen.

Mediating role of self-efficacy between unmet needs and quality of life in palliative cancer caregivers.

OBJECTIVE: Although unmet support needs are associated with health-related quality of life (HRQOL) in cancer caregivers, little is known about the mechanism underlying the relationship between two variables. The self-efficacy (SE) theory and literature suggest that caregiving SE is important in the perception of and reaction to caregiving demands, which in turn affects HRQOL. The aim of this study was to examine whether caregiving SE mediates the relationship between unmet support needs and HRQOL in family caregivers of palliative cancer patients. METHODS: This secondary analysis used the data from 125 family caregivers of palliative cancer patients who were recruited from two public hospitals in Hong Kong. The caregivers completed a survey questionnaire that covered socio-demographic characteristics, unmet support needs, caregiving SE, and HRQOL. Parallel mediation analyses were conducted via SPSS PROCESS macro (Model 4) to test the hypothesized models. RESULTS: The direct effect of unmet support needs on mental HRQOL was significant (effect = -0.49, 95% CI = -0.06 to -0.92). For the indirect effect, only caregiving SE in the domain of 'care for the care recipient' mediated the relationship between unmet support needs and mental HRQOL (effect = -0.32, 95% CI = -0.08 to -0.59). CONCLUSION: The findings suggest that caregiving SE may function as a mechanism through which unmet support needs influence mental HRQOL in family caregivers of palliative cancer patients. Healthcare providers should consider developing supportive care interventions to improve caregivers' HRQOL by incorporating effective strategies to enhance SE and reduce unmet needs for this population.

Immigrants' and refugees' experiences of access to health and social services during the COVID-19 pandemic in Toronto, Canada.

OBJECTIVE: In 2020, the World Health Organization reported that immigrants were the most vulnerable to contracting COVID, due to a confluence of personal and structural barriers. This study explored how immigrants and refugees experienced access to health and social services during the first wave of COVID-19 in Toronto, Canada. METHODS: This study analyzed secondary data from a qualitative study that was conducted between May and September 2020 in Toronto that involved semi-structured interviews with 72 immigrants and refugees from 21 different countries. The secondary data analysis was informed by critical realism. RESULTS: The vast majority of participants experienced fear and anxiety during the COVID-19 outbreak but through a combination of self-reliance and community support came to terms with the realities of the pandemic. Some even found the lifestyle changes engendered by the pandemic a positive experience. CONCLUSIONS: Self-reliance may hinder help-seeking and augment the threat of COVID-19. This is particularly a concern for the most vulnerable immigrants, who experience multiple disruptions in their health care, have limited material resources and social supports, and perhaps are still dealing with the challenges of settling in the new country.

The Nature and Types of Community Palliative and end-of-Life Care Services: A Content Analysis of Service Provider Websites in Hong Kong.

OBJECTIVE: To analyze the nature and types of community palliative and end-of-life care (PEoLC) services in Hong Kong in order to inform future service development. METHODS: This cross-sectional descriptive study systematically searched the eligible websites of service providers concerning community PEoLC services for patients and their family caregivers using the Hong Kong version of the Google Search engine in August 2021. Search terms included different traditional Chinese translations of palliative care, end-of- lifecare, and hospice care. For the included websites, information regarding the characteristics and types of PEoLC services were extracted and coded using content analysis. RESULTS: Sixteen websites providing community PEoLC services were included in this analysis, which were almost all provided by non-governmental organizations (NGOs). Around half of the service providers targeted the geriatric group and served the population in some major geographic areas and districts only. Ten types of services were identified, including (1) information and advice; (2) psychological support; (3) dying and bereavement care; (4) spiritual support; (5) medical and nursing care; (6) leisure and social well-being activities; (7) support with household and other practical tasks; (8) referral resources; (9) financial support; and (10) caregiving skills training. CONCLUSION: Existing community PEoLC services in Hong Kong are provided mainly by NGOs, with a focus on comprehensive care for patients in some areas and districts but few support services for caregivers. There is a need for continued efforts to optimize the PEoLC services to support patients and caregivers locally.