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1.
Breast Cancer Res Treat ; 206(3): 443-463, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38837086

ABSTRACT

PURPOSE: Beta blockers (BBs) are commonly used cardiovascular medications, and their association with breast cancer outcomes has been examined in several previous observational studies and meta-analyses. In this study, an updated meta-analysis was undertaken to ascertain the association between BBs and both breast cancer death (BCD) and breast cancer recurrence (BCR). METHODS: Articles were sourced from various databases up until the 14th of August 2023. Effect estimates were pooled using the random effects model, and the Higgins I2 statistic was computed to ascertain heterogeneity. Subgroup analyses were conducted by the potential for immortal time bias (ITB), the exposure period (prediagnosis vs postdiagnosis), and type of BB (selective vs non-selective). Publication bias was assessed using funnel plots and Egger's regression tests. RESULTS: Twenty-four studies were included. Pooled results showed that there was no statistically significant association between BB use and both BCD (19 studies, hazard ratio = 0.90, 95% CI 0.78-1.04) and BCR (16 studies, HR = 0.87, 95% CI 0.71-1.08). After removing studies with ITB, the associations were attenuated towards the null. There was no effect modification for either outcome when stratifying by the exposure period or type of BB. There was clear evidence of publication bias for both outcomes. CONCLUSION: In this meta-analysis, we found no evidence of an association between BB use and both BCD and BCR. Removing studies with ITB attenuated the associations towards the null, but there was no effect modification by the exposure period or type of BB.


Subject(s)
Adrenergic beta-Antagonists , Breast Neoplasms , Humans , Breast Neoplasms/drug therapy , Breast Neoplasms/pathology , Female , Adrenergic beta-Antagonists/therapeutic use , Neoplasm Recurrence, Local/epidemiology
2.
JMIR Aging ; 7: e53020, 2024 Jun 04.
Article in English | MEDLINE | ID: mdl-38842168

ABSTRACT

Background: Walking is important for maintaining physical and mental well-being in aged residential care (ARC). Walking behaviors are not well characterized in ARC due to inconsistencies in assessment methods and metrics as well as limited research regarding the impact of care environment, cognition, or physical function on these behaviors. It is recommended that walking behaviors in ARC are assessed using validated digital methods that can capture low volumes of walking activity. Objective: This study aims to characterize and compare accelerometry-derived walking behaviors in ARC residents across different care levels, cognitive abilities, and physical capacities. Methods: A total of 306 ARC residents were recruited from the Staying UpRight randomized controlled trial from 3 care levels: rest home (n=164), hospital (n=117), and dementia care (n=25). Participants' cognitive status was classified as mild (n=87), moderate (n=128), or severe impairment (n=61); physical function was classified as high-moderate (n=74) and low-very low (n=222) using the Montreal Cognitive Assessment and the Short Physical Performance Battery cutoff scores, respectively. To assess walking, participants wore an accelerometer (Axivity AX3; dimensions: 23×32.5×7.6 mm; weight: 11 g; sampling rate: 100 Hz; range: ±8 g; and memory: 512 MB) on their lower back for 7 days. Outcomes included volume (ie, daily time spent walking, steps, and bouts), pattern (ie, mean walking bout duration and alpha), and variability (of bout length) of walking. Analysis of covariance was used to assess differences in walking behaviors between groups categorized by level of care, cognition, or physical function while controlling for age and sex. Tukey honest significant difference tests for multiple comparisons were used to determine where significant differences occurred. The effect sizes of group differences were calculated using Hedges g (0.2-0.4: small, 0.5-0.7: medium, and 0.8: large). Results: Dementia care residents showed greater volumes of walking (P<.001; Hedges g=1.0-2.0), with longer (P<.001; Hedges g=0.7-0.8), more variable (P=.008 vs hospital; P<.001 vs rest home; Hedges g=0.6-0.9) bouts compared to other care levels with a lower alpha score (vs hospital: P<.001; Hedges g=0.9, vs rest home: P=.004; Hedges g=0.8). Residents with severe cognitive impairment took longer (P<.001; Hedges g=0.5-0.6), more variable (P<.001; Hedges g=0.4-0.6) bouts, compared to those with mild and moderate cognitive impairment. Residents with low-very low physical function had lower walking volumes (total walk time and bouts per day: P<.001; steps per day: P=.005; Hedges g=0.4-0.5) and higher variability (P=.04; Hedges g=0.2) compared to those with high-moderate capacity. Conclusions: ARC residents across different levels of care, cognition, and physical function demonstrate different walking behaviors. However, ARC residents often present with varying levels of both cognitive and physical abilities, reflecting their complex multimorbid nature, which should be considered in further work. This work has demonstrated the importance of considering a nuanced framework of digital outcomes relating to volume, pattern, and variability of walking behaviors among ARC residents.


Subject(s)
Accelerometry , Cognition , Walking , Humans , Male , Female , Cross-Sectional Studies , Walking/physiology , Aged, 80 and over , Cognition/physiology , Aged , Homes for the Aged
3.
Inj Prev ; 2024 May 20.
Article in English | MEDLINE | ID: mdl-38768980

ABSTRACT

BACKGROUND: Maori (the Indigenous people of Aotearoa New Zealand (NZ)) are more likely to experience injury than non-Maori, but less likely to have effective access to publicly funded injury care services. It is unknown if this pattern extends into older age. This retrospective study analysed Accident Compensation Corporation (ACC; national no-fault injury compensation scheme) claims data to investigate ethnic variation in unintentional injury claims and related costs for older adults (≥50 years). METHODS: Injury claims data for older adults residing in two regions of NZ between January 2014 and December 2018 were reviewed. Age-standardised claims rates (per person year) standardised rate ratios were calculated and compared between Maori and non-Maori. ACC claim costs (medical treatment; earning-related compensation) were estimated, with total and average costs per claim compared between the two groups. RESULTS: There were 149 275 ACC claims (18 369 Maori; 130 906 non-Maori) among 64 238 individuals (9284 Maori; 54 954 non-Maori). The age-standardised rate of ACC claims for unintentional injury was 46% higher among non-Maori (95% CI 44% to 48%) than Maori. The ACC spend for non-Maori was NZ$155 277 962 compared with NZ$30 446 673 for Maori. Maori had a significantly higher average cost per claim (NZ$1658 vs NZ$1186, p<0.001). CONCLUSIONS: Results of this study highlight differences in the manner in which different groups of older adults access injury compensation in NZ, indicating the need to invest in injury prevention initiatives that target older Maori, as well as initiatives supporting improved ACC access for older Maori.

4.
BMJ Open Respir Res ; 11(1)2024 May 22.
Article in English | MEDLINE | ID: mdl-38777583

ABSTRACT

INTRODUCTION: Asthma attacks are a leading cause of morbidity and mortality but are preventable in most if detected and treated promptly. However, the changes that occur physiologically and behaviourally in the days and weeks preceding an attack are not always recognised, highlighting a potential role for technology. The aim of this study 'DIGIPREDICT' is to identify early digital markers of asthma attacks using sensors embedded in smart devices including watches and inhalers, and leverage health and environmental datasets and artificial intelligence, to develop a risk prediction model to provide an early, personalised warning of asthma attacks. METHODS AND ANALYSIS: A prospective sample of 300 people, 12 years or older, with a history of a moderate or severe asthma attack in the last 12 months will be recruited in New Zealand. Each participant will be given a smart watch (to assess physiological measures such as heart and respiratory rate), peak flow meter, smart inhaler (to assess adherence and inhalation) and a cough monitoring application to use regularly over 6 months with fortnightly questionnaires on asthma control and well-being. Data on sociodemographics, asthma control, lung function, dietary intake, medical history and technology acceptance will be collected at baseline and at 6 months. Asthma attacks will be measured by self-report and confirmed with clinical records. The collected data, along with environmental data on weather and air quality, will be analysed using machine learning to develop a risk prediction model for asthma attacks. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the New Zealand Health and Disability Ethics Committee (2023 FULL 13541). Enrolment began in August 2023. Results will be presented at local, national and international meetings, including dissemination via community groups, and submission for publication to peer-reviewed journals. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry ACTRN12623000764639; Australian New Zealand Clinical Trials Registry.


Subject(s)
Artificial Intelligence , Asthma , Humans , Prospective Studies , New Zealand , Male , Adult , Female , Child , Observational Studies as Topic , Nebulizers and Vaporizers , Adolescent
5.
Environ Health ; 23(1): 39, 2024 Apr 13.
Article in English | MEDLINE | ID: mdl-38609941

ABSTRACT

BACKGROUND: Physical inactivity is a global public health problem. A practical solution would be to build physical activity into the daily routine by using active modes of transport. Choice of transport mode can influence cancer risk through their effects on levels of physical activity, sedentary time, and environmental pollution. This review synthesizes existing evidence on the associations of specific transport modes with risks of site-specific cancers. METHODS: Relevant literature was searched in PubMed, Embase, and Scopus from 1914 to 17th February 2023. For cancer sites with effect measures available for a specific transport mode from two or more studies, random effects meta-analyses were performed to pool relative risks (RR) comparing the highest vs. lowest activity group as well as per 10 Metabolic Equivalent of Task (MET) hour increment in transport-related physical activity per week (∼150 min of walking or 90 min of cycling). RESULTS: 27 eligible studies (11 cohort, 15 case-control, and 1 case-cohort) were identified, which reported the associations of transport modes with 10 site-specific cancers. In the meta-analysis, 10 MET hour increment in transport-related physical activity per week was associated with a reduction in risk for endometrial cancer (RR: 0.91, 95% CI: 0.83-0.997), colorectal cancer (RR: 0.95, 95% CI: 0.91-0.99) and breast cancer (RR: 0.99, 95% CI: 0.89-0.996). The highest level of walking only or walking and cycling combined modes, compared to the lowest level, were significantly associated with a 12% and 30% reduced risk of breast and endometrial cancers respectively. Cycling, compared to motorized modes, was associated with a lower risk of overall cancer incidence and mortality. CONCLUSION: Active transport appears to reduce cancer risk, but evidence for cancer sites other than colorectum, breast, and endometrium is currently limited.


Subject(s)
Breast Neoplasms , Endometrial Neoplasms , Female , Humans , Exercise , Bicycling , Environmental Pollution
6.
Contemp Clin Trials ; 140: 107519, 2024 05.
Article in English | MEDLINE | ID: mdl-38547962

ABSTRACT

BACKGROUND: Parents with babies in the neonatal intensive care unit (NICU) experience high levels of stress, anxiety, and depression. The NICU experience may also lead to impaired parenting and early childhood socio-emotional problems. Psychosocial interventions can reduce NICU parent distress. Yet many are time-intensive and costly to deliver. Acceptance and Commitment Therapy (ACT), an evidence-based psychological therapy, may address these needs. ACT has been shown to be effective in reducing distress of parents of children with chronic illnesses, particularly when combined with parent education. Therefore, the primary aim of this study is to determine if a digital intervention that uses a brief form of ACT plus parent education will reduce the stress of primary caregivers with preterm babies in the NICU more than a digital education-only intervention or standard care control group. METHODS: In a randomised controlled cluster trial design, participants will be randomly assigned to one of three groups: ACT plus education; education-only; or standard care control. The primary outcome will be parental/caregiver stress levels, measured on the Parental Stress Scale: Neonatal Intensive Care Unit. Secondary outcomes include overall stress, anxiety, and depression. Outcome measures will be evaluated at baseline, two weeks after enrolment, discharge to home, and 3-months post-discharge. CONCLUSION: This study will explore the efficacy of a digital ACT plus education intervention on parental stress levels. While position papers have advocated for the use of ACT with NICU parents, this study will be the first to test ACT as a stand-alone intervention with this population. TRIAL REGISTRATION: This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry on 14 June 2023 (ACTRN12623000641695p).


Subject(s)
Acceptance and Commitment Therapy , Caregivers , Depression , Infant, Premature , Intensive Care Units, Neonatal , Parents , Stress, Psychological , Female , Humans , Infant, Newborn , Male , Acceptance and Commitment Therapy/methods , Anxiety/therapy , Caregivers/psychology , Caregivers/education , Depression/therapy , Parents/psychology , Parents/education , Stress, Psychological/therapy , Randomized Controlled Trials as Topic
7.
Pilot Feasibility Stud ; 10(1): 29, 2024 Feb 12.
Article in English | MEDLINE | ID: mdl-38347582

ABSTRACT

BACKGROUND: An advanced cancer diagnosis can be associated with a significant profile of distress. Psychedelic compounds have shown clinically significant effects in the treatment of psychological distress in patients with advanced-stage cancer. Given the challenges of delivering timely and effective intervention in the advanced cancer context, it is possible that an alternative, more pragmatic, approach lies in psychedelic 'microdosing'. Microdosing refers to repeated administration of psychedelics in sub-hallucinogenic doses. The purpose of this study is to evaluate the feasibility of conducting a full-scale randomised controlled trial comparing psychedelic microdose-assisted-meaning-centred psychotherapy (PA-MCP) to standard meaning-centred psychotherapy (MCP) in New Zealand indigenous (Maori) and non-indigenous people with advanced cancer and symptoms of anxiety and/or depression. Although MCP is a well-established psychotherapeutic treatment in advanced cancer populations, the potential efficacy and effectiveness of this therapy when delivered alongside a standardised microdose regimen of a psychedelic compound have not been investigated. METHODS: Participants with advanced-stage cancer and symptoms of anxiety and/or depression (N = 40; 20 Maori, 20 non-Maori) will be randomised under double-blind conditions to receive 7 sessions of MCP alongside 13 doses of either an LSD microdose (4-20 µg) (PA-MCP) or inactive placebo (placebo-MCP). The feasibility, acceptability, and safety of this intervention and physiological and psychological measures will be recorded at baseline, at each session of MCP, and at a 1-month and 6-month follow-up. DISCUSSION: Our findings will evaluate the feasibility, acceptability, and safety of a larger randomised controlled trial and provide an initial indication of the potential benefits of psychedelic microdosing for psychological distress in advanced-stage indigenous and non-indigenous cancer patients. TRIAL REGISTRATION: NZCTR, ACTRN12623000478617. Registered 11 May 2023.  https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385810&isReview=true .

8.
Australas J Ageing ; 43(2): 359-368, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38268323

ABSTRACT

OBJECTIVES: To characterise unintentional injury-related hospitalisation and mortality amongst older adults (aged 50+ years) in the Lakes and Bay of Plenty District Health Boards of Aotearoa New Zealand and to examine whether hospitalisation patterns differed by ethnicity. METHODS: This observational study analysed unintentional injury-related hospitalisations and deaths among older adults between 2014 and 2018. Routinely collected national data sets were used to calculate annualised, age-standardised injury rates. The independent variable of interest was ethnicity (Maori or non-Maori). RESULTS: There were 11,834 unintentional injury-related hospitalisations in the study period (n = 1444 for Maori). Overall, there was no significant difference in the age-standardised hospitalisation rate between Maori and non-Maori (Standardised Rate Ratio [SRR] = 0.96 [95% CI 0.90, 1.02]). Falls were the most common mechanism of injury among Maori and non-Maori overall (50% and 71%) and relative risks of falls increased with age. Non-Maori were 57% less likely to be hospitalised for unintentional poisoning than Maori (SRR = 0.43, [0.34, 0.59]). CONCLUSIONS: The mechanisms of injury, and variation in unintentional injury-related hospitalisation rates between Maori and non-Maori, change throughout older age, and incidence increase0073 with age. Falls cause significant injury-related hospitalisations for older Maori and responsive injury prevention and rehabilitation efforts are warranted to achieve equitable health outcomes.


Subject(s)
Hospitalization , Native Hawaiian or Other Pacific Islander , Humans , New Zealand/epidemiology , Aged , Male , Female , Hospitalization/statistics & numerical data , Middle Aged , Native Hawaiian or Other Pacific Islander/statistics & numerical data , Aged, 80 and over , Accidental Falls/statistics & numerical data , Risk Factors , Age Factors , Accidental Injuries/mortality , Accidental Injuries/ethnology , Wounds and Injuries/mortality , Wounds and Injuries/ethnology , Cause of Death
9.
ANZ J Surg ; 94(3): 299-308, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38263368

ABSTRACT

OBJECTIVE: The experience of stress is common among surgeons while working in the operating theatre (OT). Understanding and finding ways to mitigate this stress is important for optimizing surgical quality and maintaining clinician wellbeing. In this pilot study, we tested the feasibility and reported the outcomes of measuring the effect of background music on intra-operative surgeon stress in the clinical environment. METHODS: The effect of Music on the Operating Surgeon: A pilot Randomized crossover Trial (the MOSART study) was conducted over a 9-month period in a single-centre. Vascular and general surgeons acting as primary operators (POs) performing elective, general anaesthetic operations were included. The intervention was surgeon-selected music, and the control was the absence of music. Outcome measures were feasibility (recruitment rate, practicability, and completeness of data), heart rate variability (HRV) indices, the Six-Item State-Trait Anxiety Inventory (STAI-6), and the Surgical Task-load Index (SURG-TLX). RESULTS: Five POs performed 74 eligible randomized cases. The protocol was well tolerated, and no cases were abandoned. Data was incomplete in 8% of cases. The overall mean (SD) operative SURG-TLX score was 48 (±22). Mean HR increased and RMSSD decreased significantly from baseline, suggesting reduced parasympathetic activity while operating. The presence of intra-operative music was not found to affect the psychological or physiological outcomes. CONCLUSIONS: A music interventional study of this nature is feasible in the operating theatre environment, though no difference was found between in the music and non-music conditions. Follow-up research in a simulated environment with intensive physiological monitoring could be considered.


Subject(s)
Music , Surgeons , Humans , Music/psychology , Pilot Projects , Cross-Over Studies , Anxiety/etiology , Anxiety/prevention & control , Anxiety/psychology , Surgeons/psychology
10.
Br J Health Psychol ; 29(1): 37-58, 2024 02.
Article in English | MEDLINE | ID: mdl-37544883

ABSTRACT

INTRODUCTION: Weight loss is hard to achieve and even harder to maintain. Engaging in effortful behavioural change to manage body weight can sometimes result in feelings of guilt and shame. Self-compassion, the tendency to find kindness for oneself in times of struggle, may facilitate coping with the unique challenges of weight management. This study assessed whether a remotely delivered self-compassion intervention improved weight management outcomes when delivered as a supplement to an existing digital behavioural weight management programme, Weight Watchers (WW). METHOD: Using a mixed-method study design, 249 adults seeking to manage weight were randomized to either the WW programme or WW supplemented with the self-compassion for weight management intervention (SC4WM). Participants completed measures of self-compassion, eating behaviour, physical activity, body weight and emotional well-being along with potential moderators, including weight self-stigma, eating restraint, psychological coping and perceived stress at baseline, post-intervention (4 weeks) and follow-up (12 weeks). RESULTS: There was no evidence that the SC4WM intervention had a significantly different effect than WW alone. Other than body weight, all outcomes improved over time in both groups. Self-compassion was slightly higher overall in the SC4WM group (p = .05), with this group reporting higher self-kindness at 4 weeks (p = .014) and lower self-judgement at 12 weeks (p = .023) compared to the control group. CONCLUSIONS: Although the SC4WM intervention group did show a small increase in self-kindness and reduction in self-judgement, weight management outcomes were not improved over and above the existing WW programme. Recommendations for adapting the SC4WM intervention to improve efficacy to augment weight management outcomes are provided.


Subject(s)
Self-Compassion , Weight Loss , Adult , Humans , Empathy , Coping Skills
11.
Br J Health Psychol ; 29(1): 59-79, 2024 02.
Article in English | MEDLINE | ID: mdl-37648902

ABSTRACT

OBJECTIVES: To experimentally investigate whether more urgent patient presentations elicit greater compassion from health care professionals than less urgent, facilitating future research and thinking to address systemic barriers to compassion in health care. DESIGN: This is a pre-registered online study with an experimental, within-subjects repeated-measure study design. Two clinical vignettes that systematically varied the urgency of patient presentation were utilized. Both vignettes depicted a patient with difficult behaviours typically associated with lower compassion. METHODS: Health care professionals (doctors, nurses and allied health practitioners) recruited from all 20 District Health Boards across Aotearoa/New Zealand completed two vignettes in a counterbalanced order. Paired-sample t-tests were used to test the effect of the presentation urgency on indices of compassion. RESULTS: A total of 939 participants completed the vignettes (20% doctors, 47%, nurses and 33% allied health professionals). As expected, participants reported greater care and motivation to help the more urgent patient. However, the more urgent patient was also perceived as less difficult, and exploratory analyses showed that perceived patient difficulty was associated with lower caring and motivation to help, particularly in the less urgent patient. CONCLUSIONS: This is the first work to experimentally test the relationship between the urgency of patient presentation and compassion in health care. Although the association between urgency and difficulty is complex, our findings are consonant with evolutionary views in which urgent distress elicits greater compassion. A system-wide orientation towards efficiency and urgency may exacerbate this 'bias' which must be addressed to ensure more equitable compassion in health care.


Subject(s)
Empathy , Physicians , Humans , Health Personnel , Attitude of Health Personnel , New Zealand
12.
J Am Med Dir Assoc ; 25(2): 201-208.e6, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38042173

ABSTRACT

OBJECTIVES: To investigate the effect of an exercise program on falls in intermediate and high-level long-term care (LTC) residents and to determine whether adherence, physical capacity, and cognition modified outcomes. DESIGN: Randomized controlled trial. SETTING AND PARTICIPANTS: Residents (n = 520, aged 84 ± 8 years) from 25 LTC facilities in New Zealand. METHODS: Individually randomized to Staying UpRight, a physical therapist-led, balance and strength group exercise program delivered for 1 hour, twice weekly over 12 months. The control arm was dose-matched and used seated activities with no resistance. Falls were collected using routinely collected incident reports. RESULTS: Baseline fall rates were 4.1 and 3.3 falls per person-year (ppy) for intervention and control groups. Fall rates over the trial period were 4.1 and 4.3 falls ppy respectively [P = .89, incidence rate ratio (IRR) 0.98, 95% CI 0.76, 1.27]. Over the 12-month trial period, 74% fell, with 63% of intervention and 61% of the control group falling more than once. Risk of falls (P = .56, hazard ratio 1.08, 95% CI 0.85, 1.36) and repeat falling or fallers sustaining an injury at trial completion were similar between groups. Fall rates per 100 hours walked did not differ between groups (P = .42, IRR 1.15, 95% CI 0.81, 1.63). Program delivery was suspended several times because of COVID-19, reducing average attendance to 26 hours over 12 months. Subgroup analyses of falls outcomes for those with the highest attendance (≥50% of classes), better physical capacity (Short Physical Performance Battery scores ≥8/12), or cognition (Montreal Cognitive Assessment scores ≥ 18/30) showed no significant impact of the program. CONCLUSIONS/IMPLICATIONS: In intermediate and high-level care residents, the Staying UpRight program did not reduce fall rates or risk compared with a control activity, independent of age, sex, or care level. Inadequate exercise dose because of COVID-19-related interruptions to intervention delivery likely contributed to the null result.


Subject(s)
Accidental Falls , COVID-19 , Aged , Humans , Accidental Falls/prevention & control , Exercise , Exercise Therapy , Long-Term Care , Aged, 80 and over
13.
Pilot Feasibility Stud ; 9(1): 169, 2023 Oct 05.
Article in English | MEDLINE | ID: mdl-37798662

ABSTRACT

BACKGROUND: Globally, an estimated 260 million people suffer from depression [1], and there is a clear need for the development of new, alternative antidepressant therapies. In light of problems with the tolerability and efficacy of available treatments [2], a global trend is emerging for patients to self-treat depression with microdoses of psychedelic drugs such as lysergic acid diethylamide (LSD) and psilocybin [3]. Beyond anecdotal reports from those who self-medicate in this way, few clinical trials have evaluated this practice. In our recently published phase 1 study in healthy volunteers [4], we determined that LSD microdosing was relatively safe and well tolerated in that cohort. Furthermore, the data demonstrated that conducting such microdosing trials is broadly feasible, with excellent adherence and compliance to the regimen observed. In this open-label pilot trial of patients with major depressive disorder (LSDDEP1), we will test the tolerability and feasibility of an 8-week regimen of LSD microdosing in this patient group prior to a larger subsequent randomised controlled trial (LSDDEP2). METHODS: Twenty patients meeting the DSM-5 criteria for major depressive disorder will receive an 8-week LSD microdosing treatment regimen. The treatment protocol will use a sublingual formulation of LSD (MB-22001) delivered twice per week under a titration schedule using a dose of 5-15 µg. Tolerability will be assessed by quantifying the percentage of participants who withdraw from the trial due to adverse events attributable to the treatment regimen, while feasibility will be assessed by quantifying the percentage of attended clinic visits once enrolled. To determine whether there is any antidepressant response to the LSD microdosing regimen, MADRS scores will be assessed at baseline and 2, 4, 6, and 8 weeks after the commencement of the regimen. DISCUSSION: The results of LSDDEP1 will provide valuable information regarding the tolerability and feasibility of a proposed LSD microdosing regimen in patients with MDD. Such information is critically important to optimise trial design prior to commencing a subsequent and more resource-intensive randomised controlled trial. TRIAL REGISTRATION: ANZCTR, ACTRN12623000486628. Registered on 12 May 2023.

14.
N Z Med J ; 136(1579): 70-85, 2023 Jul 21.
Article in English | MEDLINE | ID: mdl-37501246

ABSTRACT

AIM: To describe the incidence, characteristics, and ethnic variation of hospitalisations for treatment injury and complications of medical or surgical care in older adults in two regions of Aotearoa New Zealand. METHODS: This observational study analysed treatment-related hospital admissions (<24 hours; index injury from primary or secondary care) among older adults (<50 years) between 2014-2018 in Lakes and Bay of Plenty District Health Boards. Among all admissions due to a treatment injury (n=296) or a complication of healthcare (n=13,850), age-standardised incidence rates per 100,000 were determined by ethnicity and age group. RESULTS: The rates of admissions for treatment injuries were 30% lower among non-Maori than among Maori (New Zealand's Indigenous population). Complications of healthcare admissions rates were 43% lower among non-Maori than in Maori. Medications were the most common cause (54%) of healthcare complications. Rates of treatment injury and healthcare complications increased with age for both Maori and non-Maori, until the age of 80 years. CONCLUSION: Ethnic variation in treatment injuries and complications of healthcare between Maori and non-Maori provide further evidence of the existence of inequities in access to quality healthcare in New Zealand. Transparent, publicly available national monitoring of treatment injuries and complications, disaggregated by age and ethnicity, is recommended.


Subject(s)
Ethnicity , Population Groups , Humans , Aged , Aged, 80 and over , New Zealand/epidemiology , Delivery of Health Care , Hospitalization
15.
Asia Pac J Ophthalmol (Phila) ; 12(4): 384-391, 2023.
Article in English | MEDLINE | ID: mdl-37523430

ABSTRACT

PURPOSE: The burden of uveal melanoma (UM) in Aotearoa-New Zealand (NZ), a country with the highest global burden of cutaneous melanoma, is unknown. This first, large-scale study of UM in NZ investigates survival and risks of mortality in histologically confirmed UM. METHODS: Deidentified epidemiological data on histologically confirmed UM between January 1, 2000, and December 31, 2020, were extracted from the NZ Cancer Registry. The main outcome measures were patient demographics, tumor characteristics, all-cause versus disease-specific survival, and risks of mortality. RESULTS: Histologically confirmed UM constituted 1.5% (n=703) of all-body site melanomas in NZ (n=47,997). UM predominantly affected Europeans (95%), followed by NZ indigenous Maori (4%), Asians (<1%), and Pacific Peoples (<1%), with no eye or sex predilection. Three hundred eighteen (45%) were deceased at follow-up. Of the deceased, 50% died from UM. The 1-, 5-, and 10-year survival from all-cause mortality was 94%, 68%, and 51%, and disease-specific survival was 97%, 79%, and 71%, respectively. Increasing age at UM diagnosis (>60 y), UM arising from nonspecified sites, and mixed cell UM were associated with an increased risk of disease-specific mortality. No difference in disease-specific mortality was found between sex and ethnicity on multivariate and competing risks analysis. CONCLUSIONS: Despite the government-funded public eye care and increasing research and awareness on UM globally, the burden of UM in the 21st century in NZ remains comparable to global studies. We continue to observe an earlier presentation of UM in non-European cohorts, particularly in our Maori population, and further studies on UM in NZ are warranted.


Subject(s)
Melanoma , Skin Neoplasms , Humans , Melanoma/epidemiology , Melanoma/pathology , New Zealand/epidemiology , Maori People , Registries
16.
Nutrients ; 15(12)2023 Jun 07.
Article in English | MEDLINE | ID: mdl-37375568

ABSTRACT

There is increasing evidence that adherence to a Mediterranean dietary pattern reduces the incidence of diet-related diseases. To date, the habitual dietary intake of New Zealand (NZ) adults has not been examined in relation to its alignment with a Mediterranean-style dietary pattern. This study aimed to define the habitual dietary patterns, nutrient intakes, and adherence to the Mediterranean Diet in a sample of 1012 NZ adults (86% female, mean age 48 ± 16 years) who had their diabetes risk defined by the Australian Type 2 Diabetes Risk Assessment Tool (AUSDRISK). Dietary intakes were collected using a validated semi-quantitative NZ food frequency questionnaire, and dietary patterns were identified using principal component analysis. Reported intakes from the FFQ were used in conjunction with the Mediterranean-Style Dietary Pattern Score (MSDPS) to determine adherence to a Mediterranean dietary pattern. Mixed linear models were used to analyze the association between dietary patterns and MSDPS with demographics, health factors, and nutrient intakes. Two distinct dietary patterns were identified: Discretionary (positive loadings on processed meat, meat/poultry, fast food, sweet drinks, and sugar, sweets, and baked good) and Guideline (positive loadings on vegetables, eggs/beans, and fruits). Adherence to dietary patterns and diet quality was associated with age and ethnicity. Dietary patterns were also associated with sex. Adherence to a Mediterranean dietary pattern defined by the MSDPS was low, indicating that a significant shift in food choices will be required if the Mediterranean Diet is to be adopted in the NZ population.


Subject(s)
Diabetes Mellitus, Type 2 , Diet, Mediterranean , Adult , Humans , Female , Middle Aged , Male , Cross-Sectional Studies , Feeding Behavior , New Zealand/epidemiology , Australia , Diet , Eating
17.
Asia Pac J Ophthalmol (Phila) ; 12(3): 273-278, 2023.
Article in English | MEDLINE | ID: mdl-37042461

ABSTRACT

PURPOSE: Conjunctival melanoma (CM) is a rare and aggressive malignancy. Global studies demonstrate increased burden of disease in countries with high rates of cutaneous melanoma. There are currently no reports on CM incidence, trends, or survival within Aotearoa-New Zealand (NZ), a country with the highest global rates of cutaneous melanoma, which this study aims to address. DESIGN: This was a retrospective review using the national cancer registry. METHODS: Data on histologically confirmed CM diagnosed between January 1, 2000, and December 31, 2020, were obtained from the NZ Cancer Registry. Cases were identified using the International Classification of Disease, 10th edition (ICD-10) codes. Primary outcome measures were age-standardized incidence, trends, and survival. RESULTS: A total of 68 CM cases were identified. There was a preponderance for females (n=40, 58.8%) and CM predominantly affected European patients (n=63, 92.6%). Median follow-up was 5.0 years [interquartile range (IQR)=2.4-9.9 y] and the median age at diagnosis was 68.5 years (IQR=57.0-79.0 y), with non-Europeans presenting at a significantly younger age [-17.3 y (95% CI: -31.3 to -3.2), P =0.019] than Europeans. The annual age-adjusted incidence(±SD) was 0.6±0.2 cases per million population per year with a stable incidence trend over 21 years. All-cause mortality was found in 28 cases (41.2%) and the median time to death was 3.76 years (IQR=2.1-5.7 y). Five-year all-cause survival and disease-specific survival was 69% and 90%, respectively. CONCLUSIONS: This is the first report on CM incidence, trends, and mortality in NZ. The CM burden is in line with European and North American data, despite NZ having the highest rate of cutaneous melanoma. The incidence remained stable over 2 decades.


Subject(s)
Conjunctival Neoplasms , Melanoma , Skin Neoplasms , Female , Humans , Middle Aged , Aged , Infant , Melanoma/epidemiology , Melanoma/pathology , Skin Neoplasms/epidemiology , Skin Neoplasms/pathology , Incidence , New Zealand/epidemiology , Conjunctival Neoplasms/epidemiology , Registries , Melanoma, Cutaneous Malignant
18.
J Endovasc Ther ; : 15266028231165723, 2023 Apr 19.
Article in English | MEDLINE | ID: mdl-37073512

ABSTRACT

INTRODUCTION: This physician-initiated study provides 5-year (i.e., long-term) treatment durability data from 3 top recruitment sites that participated in the prospective, multicenter, nonrandomized, single-arm VBX FLEX clinical study (ClinicalTrials.gov identifier: NCT02080871). It evaluates the long-term treatment durability of the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (VBX Stent-Graft) in the treatment of subjects with de novo or restenotic aortoiliac lesions. MATERIALS AND METHODS: A total of 59 subjects with 94 treated lesions were enrolled at the 3 participating sites from the original 140 intent-to-treat subjects in the VBX FLEX study. The primary durability endpoint was long-term primary patency. Secondary long-term outcomes included freedom from target lesion revascularization (TLR), freedom from target vessel revascularization (TVR), as well as resting ankle-brachial index (ABI), Rutherford category, EuroQol 5 Dimensions, and Walking Impairment status. RESULTS: Fifty-nine subjects participated and twenty-eight (47.5%) were available through the end of the study at 5-year follow-up (the median follow-up time was 6.6 years due to complications resulting from COVID-19 precautions). At 3 and 5 years, the Kaplan-Meier estimates for freedom from all-cause mortality were 94.5% and 81.7%, respectively. The Kaplan-Meier estimates for primary patency at 3 and 5 years were 94.0% and 89.5% (by lesion) and 91.7% and 84.4% (by subject). Primary assisted patency at 3 and 5 years were 93.3% and 93.3%. Kaplan-Meier estimate for freedom from TLR at 5 years was 89.1%. The majority of subjects were asymptomatic (Rutherford category 0) at 3 years (29/59; 72%), and at 5-year follow-up (18/28; 64%). The 5-year mean resting ankle-brachial index was 0.95±0.18, an improvement of 0.15±0.26 from the baseline (p<0.001). Quality of life measures also showed sustained improvement through long-term follow-up. CONCLUSION: The 5-year long-term follow-up data underscore the robustness and durability of the Viabahn Balloon-Expandable Endoprosthesis for treating aortoiliac occlusive disease. CLINICAL IMPACT: Durable improvement after endovascular treatment of iliac occlusive disease is clinically important because many of these patients are claudicants with significant life expectancy. This study is the first to evaluate the long-term outcomes in patients with iliac occlusive disease treated with the Viabahn VBX balloon-expandable endopirostheses. The study reports excellent long-term patency outcomes with prolonged clinical benefit. These durable results are likely to be an important consideration for clinicians undertaking iliac artery revascularization procedures.

19.
Biol Psychiatry ; 94(6): 511-521, 2023 09 15.
Article in English | MEDLINE | ID: mdl-36997080

ABSTRACT

BACKGROUND: Microdosing psychedelic drugs is a widespread social phenomenon with diverse benefits claimed for mood and cognition. Randomized controlled trials have failed to support these claims, but the laboratory-based dosing in trials conducted to date may have limited ecological validity. METHODS: Healthy male volunteers were randomized into lysergic acid diethylamide (LSD) (n = 40) and placebo (n = 40) groups and received 14 doses of either 10 µg LSD or an inactive placebo every 3 days for 6 weeks. First doses were given in a supervised laboratory setting, with other doses self-administered in a naturalistic setting. Results of safety data, blinding, daily questionnaires, expectancy, and pre-/postintervention psychometrics and cognitive tasks are presented here. RESULTS: The most notable reported adverse event was treatment-related anxiety, which prompted the withdrawal of 4 participants from the LSD group. Daily questionnaires showed credible evidence (>99% posterior probability) of improved ratings of creativity, connectedness, energy, happiness, irritability, and wellness on dose days compared with nondose days, and these effects remained when controlling for preintervention expectancy. No questionnaire or cognitive task showed a credible change between baseline and 6-week assessment time points. CONCLUSIONS: Microdosing LSD appears to be relatively safe in healthy adult men, notwithstanding a risk of anxiety. While microdosing elicited transient increases in scales associated with mood-elevating effects, it was not sufficient to promote enduring changes to overall mood or cognition in healthy adults. Future microdosing trials in clinical populations will require the use of active placebos to control for placebo effects and dose titration to adjust for interindividual variability in drug response.


Subject(s)
Hallucinogens , Lysergic Acid Diethylamide , Adult , Humans , Male , Affect , Anxiety/drug therapy , Cognition , Hallucinogens/adverse effects , Healthy Volunteers
20.
Eat Disord ; 31(1): 33-63, 2023.
Article in English | MEDLINE | ID: mdl-35400300

ABSTRACT

Intuitive eating (IE) is an approach to health promotion that fosters a positive relationship with food and the body. The objective of this review was to aggregate and analyse the literature on IE interventions, thereby offering an early investigation of methodological approaches to intervention. This review was conducted in accordance with the preferred reporting items for systematic review and meta-analysis protocols (PRISMA) guidelines. Searching was conducted in four electronic databases. Studies were eligible for inclusion if they delivered an IE intervention and used the Intuitive Eating Scale (IES). Nine studies were included in this review. Six were eligible for meta-analysis, though only outcomes on the IES were examined; all other measures were examined individually. All interventions led to improvements on measures of IE, with a large pooled effect size (1.50 [1.15, 1.85]) and positive changes on a variety of other outcomes relating to health. This pattern preliminarily suggests that IE interventions change psychological processes as intended and can be useful in promoting health behaviour. The present review offers a synthesis of existing approaches to IE interventions and an evaluation of which specific variants appear to be more effective. This paper provides a basis upon which future interventions can be developed to improve approaches to psychoeducation.Clinical ImplicationsInterventions contributed to improvements in measures of IE lasting up to 6 months.Interventions contributed to positive changes on outcomes such as quality of life, body image, and body appreciation.Self-management through IE-based interventions may be feasible and effective.


Subject(s)
Health Behavior , Quality of Life , Humans , Health Promotion/methods
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