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Effectiveness of photobiomodulation therapy on pain intensity in postpartum women with nipple or perineal trauma: protocol for a multicentre, double-blinded, parallel-group, randomised controlled trial

Por: Gondim · E. J. L. · Nascimento · S. L. · Gaitero · M. V. C. · Mira · T. A. A. d. · Goncalves · A. d. V. · Surita · F. G.
Introduction

Photobiomodulation (PBM) using low-level laser can affect tissue repair mechanisms and seems promising in reducing pain intensity. However, few studies support the effectiveness of PBM on postpartum period complications, such as nipple and/or perineal trauma and pain, probably due to the low doses used. The primary objective of this study is to analyse the effectiveness of PBM on pain intensity in the nipple and perineal trauma in women in the immediate postpartum period. Secondary objectives are to evaluate the effect on tissue healing and the women’s satisfaction.

Methods and analysis

A double-blind, multicentre, parallel-group, randomised controlled trial will be performed in two public referral maternity hospitals in Brazil with 120 participants, divided into two arms: 60 participants in the nipple trauma arm and 60 participants in the perineal trauma arm. Participants will be women in the immediate postpartum period, who present with nipple trauma or perineal trauma and report pain intensity greater than or equal to 4 points on the Numerical Rating Scale for Pain. Block randomisation will be performed, followed by blinding allocation. In the experimental group, one application of PBM will be performed between 6 hours and 36 hours after birth. For the sham group, the simulation will be carried out without triggering energy. Both participants and the research evaluator will be blinded to the allocation group. Intention-to-treat method and the between-group and within-group outcome measures analysis will be performed.

Ethics and dissemination

This research protocol was approved by the Research Ethics Committees of the University of Campinas, Brazil, and of the School Maternity Assis Chateaubriand, Brazil (numbers CAAE: 59400922.1.1001.5404; 59400922.1.3001.5050). Participants will be required to sign the informed consent form to participate. Results will be disseminated to the health science community.

Trial registration number

Brazilian Registry of Clinical Trials (RBR-2qm8jrp).

Advancing Suicide Intervention Strategies for Teens (ASSIST): study protocol for a multisite randomised controlled trial

Por: Adrian · M. · McCauley · E. · Gallop · R. · Stevens · J. · Jobes · D. A. · Crumlish · J. · Stanley · B. · Brown · G. K. · Green · K. L. · Hughes · J. L. · Bridge · J. A.
Introduction

Brief interventions that reduce suicide risk following youth’s experience with acute care due to suicidality are needed.

Methods and analysis

The study will use a three-arm randomised controlled trial designed to test the effectiveness of the Safety Planning Intervention with structured follow-up (SPI+) and the Collaborative Assessment and Management of Suicidality (CAMS) compared with enhanced usual care. The primary outcomes measure will be suicidal events, defined as death by suicide, attempted suicide, preparatory acts toward imminent suicidal behaviour or suicidal ideation resulting in a change in emergency evaluation or inpatient admission. Secondary measures will be the number of suicide attempts and severity of suicidal ideation. The experimental interventions, SPI+ and CAMS, consist of up to eight sessions over approximately 8 weeks that are designed to manage (SPI+) or treat (CAMS) patient-identified ‘drivers’ of suicidal thoughts and behaviours. Mechanisms and moderators of change will be evaluated to understand treatment impacts.

Ethics and dissemination

This study has been approved by the Seattle Children’s Institutional Review Board and is monitored by external agencies including the University of Washington Institute for Translational Health Sciences, and a National Institute of Mental Health (NIMH)-appointed Data Safety and Monitoring Board. Trial results will help establish evidence towards safe and effective treatment strategies for youth transitioning from acute to outpatient care due to a suicidal crisis. The data will be shared with the NIMH Data Archives and disseminated through publications and conferences.

Trial registration number

NCT05078970.

Eliciting preferences of persons with dementia and informal caregivers to support ageing in place in the Netherlands: a protocol for a discrete choice experiment

Por: Vullings · I. · Wammes · J. · Uysal-Bozkir · O. · Smits · C. · Labrie · N. H. M. · Swait · J. D. · de Bekker-Grob · E. · Macneil-Vroomen · J. L.
Introduction

Ageing in place (AIP) for persons with dementia is encouraged by European governments and societies. Healthcare packages may need reassessment to account for the preferences of care funders, patients and informal caregivers. By providing insight into people’s preferences, discrete choice experiments (DCEs) can help develop consensus between stakeholders. This protocol paper outlines the development of a Dutch national study to cocreate a healthcare package design methodology built on DCEs that is person-centred and helps support informal caregivers and persons with dementia to AIP. A subpopulation analysis of persons with dementia with a migration background is planned due to their high risk for dementia and under-representation in research and care.

Methods and analysis

The DCE is designed to understand how persons with dementia and informal caregivers choose between different healthcare packages. Qualitative methods are used to identify and prioritise important care components for persons with dementia to AIP. This will provide a list of care components that will be included in the DCE, to quantify the care needs and preferences of persons with dementia and informal caregivers. The DCE will identify individual and joint preferences to AIP. The relative importance of each attribute will be calculated. The DCE data will be analysed with the use of a random parameters logit model.

Ethics and dissemination

Ethics approval was waived by the Amsterdam University Medical Center (W23_112 #23.137). A study summary will be available on the websites of Alzheimer Nederland, Pharos and Amsterdam Public Health institute. Results are expected to be presented at (inter)national conferences, peer-reviewed papers will be submitted, and a dissemination meeting will be held to bring stakeholders together. The study results will help improve healthcare package design for all stakeholders.

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.

Systematic review of the effect of metabolic syndrome on outcomes due to acute respiratory distress syndrome: a protocol

Por: Stone · G. · Sisk · A. · Brown · M. · Corder · A. · Tea · K. · Zu · Y. · Shaffer · J. · Kashyap · R. · Qadir · N. · Denson · J. L.
Introduction

Acute respiratory distress syndrome (ARDS) is a life-threatening condition commonly seen in the intensive care unit. COVID-19 has dramatically increased the incidence of ARDS—with this rise in cases comes the ability to detect predisposing factors perhaps not recognised before, such as metabolic syndrome (MetS) and its associated conditions (hypertension, obesity, dyslipidaemia and type 2 diabetes mellitus). In this systematic review, we seek to describe the complex relationship between MetS, its associated conditions and ARDS (including COVID-19 ARDS).

Methods and analysis

A systematic search of PubMed, Embase, Cochrane Central Register of Controlled Trials, CINAHL and Web of Science will be conducted. The population of interest is adults with ARDS and MetS (as defined according to the study author recognising that MetS definitions vary) or any MetS-associated condition. The control group will be adult patients with ARDS without MetS or any individual MetS-associated condition. We will search studies published in English, with a date restriction from the year 2000 to June 2023 and employ the search phrases ‘metabolic syndrome’, ‘acute respiratory distress syndrome’ and related terms. Search terms including ‘dyslipidaemia’, ‘hypertension’, ‘diabetes mellitus’ and ‘obesity’ will also be utilised. Outcomes of interest will include mortality (in-hospital, ICU, 28-day, 60-day and 90-day), days requiring mechanical ventilation and hospital and/or ICU length of stay. Study bias will be assessed using the NIH Bias Scale.

Ethics and dissemination

Ethical approval is not required because this study includes previously published and publicly accessible data. Findings from this review will be disseminated via publication in a peer-reviewed journal.

PROSPERO registration number

CRD42023405816.

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