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Protocol for a cluster randomised trial of a goal-oriented care approach for multimorbidity patients supported by a digital platform

Por: Gil Conde · M. · Peyroteo · M. · Maria · A. · Maia · M. R. · Gregorio · J. · Paulo · M. S. · Alves · M. · Papoila · A. L. · Lapao · L. V. · Heleno · B.
Introduction

Health information systems represent an opportunity to improve the care provided to people with multimorbidity. There is a pressing need to assess their impact on clinical outcomes to validate this intervention. Our study will determine whether using a digital platform (Multimorbidity Management Health Information System, METHIS) to manage multimorbidity improves health-related quality of life (HR-QoL).

Methods and analysis

A superiority, cluster randomised trial will be conducted at primary healthcare practices (1:1 allocation ratio). All public practices in the Lisbon and Tagus Valley (LVT) Region, Portugal, not involved in a previous pilot trial, will be eligible. At the participant level, eligible patients will be people with complex multimorbidity, aged 50 years or older, with access to an internet connection and a communication technology device. Participants who cannot sign/read/write and who do not have access to an email account will not be included in the study. The intervention combines a training programme and a customised information system (METHIS). Both are designed to help clinicians adopt a goal-oriented care model approach and to encourage patients and carers to play a more active role in autonomous healthcare. The primary outcome is HR-QoL, measured at 12 months with the physical component scale of the 12-item Short Form questionnaire (SF-12). Secondary outcomes will also be measured at 12 months and include mental health (mental component Scale SF-12, Hospital Anxiety and Depression Scale). We will also assess serious adverse events during the trial, including hospitalisation and emergency services. Finally, at 18 months, we will ask the general practitioners for any potentially missed diagnoses.

Ethics and dissemination

The Research and Ethics Committee (LVT Region) approved the trial protocol. Clinicians and patients will sign an informed consent. A data management officer will handle all data, and the publication of several scientific papers and presentations at relevant conferences/workshops is envisaged.

Trial registration number

NCT05593835.

Dynamic changes in methadone utilisation for opioid use disorder treatment: a retrospective observational study during the COVID-19 pandemic

Por: Kennalley · A. L. · Fanelli · J. L. · Furst · J. A. · Mynarski · N. J. · Jarvis · M. A. · Nichols · S. D. · McCall · K. L. · Piper · B. J.
Objectives

Opioid use disorder (OUD) is a major public health concern in the USA, resulting in high rates of overdose and other negative outcomes. Methadone, an OUD treatment, has been shown to be effective in reducing the risk of overdose and improving overall health and quality of life. This study analysed the distribution of methadone for the treatment of OUD across the USA over the past decade and through the COVID-19 pandemic.

Design

Retrospective observational study using secondary data analysis of the Drug Enforcement Administration and Medicaid Databases.

Setting

USA.

Participants

Patients who were dispensed methadone at US opioid treatment programmes (OTPs).

Primary and secondary outcome measures

The primary outcomes were the overall pattern in methadone distribution and the number of OTPs in the USA per year. The secondary outcome was Medicaid prescriptions for methadone.

Results

Methadone distribution for OUD has expanded significantly over the past decade, with an average state increase of +96.96% from 2010 to 2020. There was a significant increase in overall distribution of methadone to OTP from 2010 to 2020 (+61.00%, p

Conclusions

There have been dynamic changes in methadone distribution for OUD. Furthermore, pronounced variation in methadone distribution among states was observed, with some states having no OTPs or Medicaid coverage. New policies are urgently needed to increase access to methadone treatment, address the opioid epidemic in the USA and reduce overdose deaths.

Experience and impact of gender-based violence in Honiara, Solomon Islands: a cross-sectional study recording violence over a 12-month period

Por: Chadwick · V. · Kluckow · H. · Mapstone · K. · Whiffin · V. · Ryder · B. · Rimon · M. · Hebala · H. · Hill · S. · Martiniuk · A. L.
Objective

This study aims to collect data on the experience and impact of gender-based violence experienced by women attending health clinics in Honiara, Solomon Islands.

Method

Any woman over the age of 18 who attended a local health clinic in Honiara, Solomon Islands during the time of recruitment (ten consecutive weekdays in May 2015) was eligible to participate in an interviewer administered, in-person survey, gathering data on gender-based violence over the past 12 months.

Results

A total of 100 women were recruited into this study. Of these women, 47% of women reported experiencing physical or sexual violence in the past 12 months. The most common perpetrators were the woman’s husband or boyfriend. There are low rates of reporting, particularly through formal avenues such as to police or village leaders. Alcohol was involved in more than half the cases of reported violence.

Conclusion

Women in this study report high rates of gender-based violence. To our knowledge, this is the only study examining women’s personal experience of gender-based violence in the Solomon Islands, with self-reported data on the frequency and nature of the violence, and the impact on women, including physical and mental, utilisation of healthcare services, police and legal involvement. Efforts to reduce gender-based violence should aim to reduce intimate partner violence, increase reporting and address wider social attitudes towards gender equality.

Effects of a laboratory-based aerobic exercise intervention on brain volume and cardiovascular health markers: protocol for a randomised clinical trial

Por: Molina Hidalgo · C. · Collins · A. M. · Crisafio · M. E. · Grove · G. · Kamarck · T. W. · Kang · C. · Leckie · R. L. · MacDonald · M. · Manuck · S. B. · Marsland · A. L. · Muldoon · M. F. · Rasero · J. · Scudder · M. R. · Velazquez-Diaz · D. · Verstynen · T. · Wan · L. · Gianaros · P. J
Introduction

Physical activity (PA) has beneficial effects on brain health and cardiovascular disease (CVD) risk. Yet, we know little about whether PA-induced changes to physiological mediators of CVD risk influence brain health and whether benefits to brain health may also explain PA-induced improvements to CVD risk. This study combines neurobiological and peripheral physiological methods in the context of a randomised clinical trial to better understand the links between exercise, brain health and CVD risk.

Methods and analysis

In this 12-month trial, 130 healthy individuals between the ages of 26 and 58 will be randomly assigned to either: (1) moderate-intensity aerobic PA for 150 min/week or (2) a health information control group. Cardiovascular, neuroimaging and PA measurements will occur for both groups before and after the intervention. Primary outcomes include changes in (1) brain structural areas (ie, hippocampal volume); (2) systolic blood pressure (SBP) responses to functional MRI cognitive stressor tasks and (3) heart rate variability. The main secondary outcomes include changes in (1) brain activity, resting state connectivity, cortical thickness and cortical volume; (2) daily life SBP stress reactivity; (3) negative and positive affect; (4) baroreflex sensitivity; (5) pulse wave velocity; (6) endothelial function and (7) daily life positive and negative affect. Our results are expected to have both mechanistic and public health implications regarding brain–body interactions in the context of cardiovascular health.

Ethics and dissemination

Ethical approval has been obtained from the University of Pittsburgh Institutional Review Board (IRB ID: 19020218). This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule.

Trial registration number

NCT03841669.

Relationship between Framingham Cardiovascular Risk Score and cognitive performance among ageing rural Indian participants: a cross-sectional analysis

Por: Mensegere · A. L. · Sundarakumar · J. S. · Diwakar · L. · Issac · T. G. · SANSCOG Study Team · Gangadhar · Rao · Rao · Sivakumar
Objective

The burden of cardiovascular risk factors is increasing in India, which, in turn, can adversely impact cognition. Our objective was to examine the effect of cardiovascular risk factors measured by Framingham Risk Score (FRS) on cognitive performance among a cohort of healthy, ageing individuals (n=3609) aged ≥45 years from rural India.

Design

A cross-sectional analysis.

Setting

A rural community setting in southern India.

Participants

Healthy, ageing, dementia-free participants, aged 45 years and above, belonging to the villages of Srinivaspura (a rural community located around 100 km from Bangalore, India), were recruited.

Primary outcome measures

Using a locally adapted, validated, computerised cognitive test battery, we assessed cognitive performance across multiple cognitive domains: attention, memory, language, executive functioning and visuospatial ability.

Results

The median (IQR) age of the sample was 57 (50.65) and 50.5% were women. Multiple linear regression analysis showed that participants with higher FRS performed poorly in attention (visual attention (β=–0.018, p=0.041)), executive functioning (categorical fluency (β=–0.064, p

Conclusion

Increased cardiovascular risk as evidenced by FRS was associated with poorer cognitive performance in all cognitive domains among dementia-free middle-aged and older rural Indians. It is imperative to design and implement appropriate interventions (pharmacological and lifestyle-based) for cardiovascular risk reduction and thereby, prevent or mitigate accelerated cognitive impairment in ageing individuals.

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