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Mixed-methods non-randomised single-arm feasibility study assessing delivery of a remote vocational rehabilitation intervention for patients with serious injury: the ROWTATE study

Por: Kellezi · B. · Holmes · J. · Kettlewell · J. · Lindley · R. · Radford · K. · Patel · P. · Bridger · K. · Lannin · N. A. · Andrews · I. · Blackburn · L. · Brooks · A. · das Nair · R. · Fallon · S. · Farrin · A. · Hoffman · K. · Jones · T. · Morriss · R. · Timmons · S. · Kendrick · D.
Objectives

This study aimed to evaluate the feasibility of delivering a vocational rehabilitation intervention (Return to Work After Trauma—ROWTATE), remotely to individuals recovering from traumatic injuries. The primary objectives were to assess therapists’ training and competence, adapt the intervention and training for remote delivery and assess the feasibility and fidelity of remote delivery to inform a definitive randomised controlled trial.

Design

A mixed-methods feasibility study incorporating (1) telerehabilitation qualitative literature review, (2) qualitative interviews preintervention and postintervention with therapists and patients, (3) a team objective structured clinical examination to assess competency, (4) usefulness of training, attitudes towards (15-item Evidence-Based Practice Attitude Scale) and confidence in (4-item Evidence Based Practice Confidence Scale) evidence-based practice, intervention delivery confidence (8-bespoke questions) and intervention behaviour determinants (51-items Theoretical Domains Framework) and (5) single-arm intervention delivery feasibility study.

Setting

The study was conducted in two UK Major Trauma Centres. The intervention and training were adapted for remote delivery due to the COVID-19 pandemic.

Participants

Therapists: Seven occupational therapists (OTs) and clinical psychologists (CPs) were trained, and six participated in competency assessment. Seven OTs and CPs participated in preintervention interviews and surveys; six completed post-intervention interviews and four completed post-training surveys. Patients: 10 patients were enrolled in the single-arm feasibility study and 4 of these participated in postintervention qualitative interviews. Inclusion criteria included therapists involved in vocational rehabilitation delivery and patients admitted to major trauma centres. Exclusion criteria included participation in other vocational rehabilitation trials or those who had returned to work or education for at least 80% of preinjury hours. Intervention: The ROWTATE vocational rehabilitation intervention was delivered remotely by trained OTs and CPs. Training included competency assessments, mentoring and adaptation for telerehabilitation. The intervention was delivered over multiple sessions, with content tailored to individual patient needs.

Results

Therapists found the training useful, reported positive attitudes (Evidence-Based Practice Attitude Scale mean=2.9 (SD 0.9)) and high levels of confidence in delivering evidence-based practice (range 75%–100%) and the ROWTATE intervention (range 80%–100%). Intervention barriers identified pretraining became facilitators post-training. Half the therapists needed additional support post-training through mentoring or additional training. The intervention and training were successfully adapted for remote delivery. High levels of fidelity (intervention components delivered: OTs=84.5%, CPs=92.9%) and session attendance rates were found (median: OT=97%, CP=100%). Virtually all sessions were delivered remotely (OT=98%, CP=100%). The intervention was acceptable to patients and therapists; both considered face-to-face delivery where necessary was important.

Conclusions

The ROWTATE intervention was delivered remotely with high fidelity and attendance and was acceptable to patients and therapists. Definitive trial key changes include modifying therapist training, competency assessment, face-to-face intervention delivery where necessary and addressing lower fidelity intervention components.

Trial registration number

ISRCTN74668529.

Integrated knowledge translation (iKT) in preclinical research: A scoping review protocol

by Georgia Black, Reena Besa, Daniel Blumberger, Heather Brooks, Graham Collingridge, John Georgiou, Evelyn K. Lambe, Clement Ma, Bernadette Mdawar, Tarek K. Rajji, Sanjeev Sockalingam, Cara Sullivan, Quincy Vaz, Zhengbang Yao, Branka Agic

Introduction

Integrated knowledge translation (iKT) is a collaborative research approach that emphasizes the meaningful and active participation of knowledge users throughout the research process. Evidence suggests that integrated knowledge translation has the potential to increase the relevance, applicability, and use of research findings. This approach has been increasingly utilized in health research in recent years. However, the extent to which it has been applied in preclinical research and its effectiveness are unknown. To address this gap, we will conduct a scoping review to map the current use, potential benefits, and challenges of iKT in preclinical research.

Methods

Guided by a modified Arksey and O’Malley’s scoping review framework, we will systematically search reference lists and key research databases including Medline, Embase, PsycINFO, Cochrane CENTRAL, Cochrane Database of Systematic Reviews, and Web of Science. Peer-reviewed articles written or translated in English that focus on iKT or approaches that align with iKT within the context of preclinical research will be included. This review will be conducted as part of the Improving Neuroplasticity through Spaced Prefrontal intermittent-Theta-Beta-Stimulation REfinement in Depression (INSPiRE-D) project, which features preclinical research from mouse models to human work (Grant number CAMH File No.22-060). The project’s multidisciplinary team and knowledge user advisory committee will be consulted at key points throughout the scoping review process. A person with lived experience co-chairs the project advisory committee, co-authored this manuscript, and will be routinely included in the decision-making process of the scoping review.

Online randomised e-hypnotherapy for chronic pelvic pain study (REST): comparing e-hypnotherapy with relaxation and waitlist to improve pain, cost-effectiveness and biopsychosocial outcomes

Por: Evans · S. · Naude · C. · Coitinho Biurra · Y. · Bowring · J. · Knowles · S. · Brooks · T. · Skvarc · D. · Esterman · A. · Fuller-Tyszkiewicz · M. · Klas · A. · Van Niekerk · L. · McCaffrey · N. · Stanley · K. · Druitt · M. · Andrews · J. · Vancaillie · T. · Cheah · S. · Ciccia · D. · Blak
Background

Chronic pelvic pain, defined as persistent pain in the structures of the pelvis, is a condition that significantly impacts the health-related quality of life (HRQoL) of up to one-third of people worldwide, with substantial associated costs to both the individual and healthcare system/s. The present trial aims to establish the efficacy of e-hypnotherapy over relaxation and waitlist controls on pain, HRQoL and biopsychosocial outcomes, and evaluate cost-effectiveness.

Methods

A parallel-group, investigator-blinded, randomised controlled trial will be conducted. Eligible participants will be randomly allocated to either a 7-week online personalised e-hypnotherapy programme (n=44), a 7-week online personalised relaxation control (n=44) or waitlist control (n=44). The primary outcome will be self-reported pain level, and secondary outcomes will include psychological distress, QoL, pain catastrophising, self-efficacy, central sensitisation, somatic symptoms, fatigue and sleep. Cost-effectiveness will also be examined. Longitudinal qualitative interviews will be conducted with participants in the e-hypnotherapy (n=20) and relaxation (n=20) groups to understand meaningful change and barriers/facilitators for ongoing use.

Ethics and dissemination

This protocol has received ethics approval in Australia from the Deakin University Research Ethics Committee (DUREC ref. 2024-080). Findings will be disseminated through peer-reviewed publications and presentations at national and international conferences related to chronic pelvic pain and mind–body interventions.

Trial registration number

Australian New Zealand Clinical Trials Registry ACTRN12623000368639p.

Distal Radius Interventions for Fracture Treatment (DRIFT) trial: study protocol for a multicentre randomised clinical trial of completely translated distal radius fractures at paediatric hospitals in North America

Por: Balmert Bonner · L. · Janicki · J. · Georgiadis · A. · Truong · W. · Harris Beauvais · D. · Belthur · M. · Daley · E. L. · Franzone · J. · Howard · A. · May · C. · Rockhold · F. · Schulz · J. · Bailey · M. · Chiswell · K. · DeLaRosa · J. · Brooks · J. T. · Cantanzano · A. A. · Chan · A.
Introduction

Distal radius fractures are the most common fractures seen in the emergency department in children in the USA. However, no established or standardised guidelines exist for the optimal management of completely displaced fractures in younger children. The proposed multicentre randomised trial will compare functional outcomes between children treated with fracture reduction under sedation versus children treated with simple immobilisation.

Methods and analysis

Participants aged 4–10 years presenting to the emergency department with 100% dorsally translated metaphyseal fractures of the radius less than 5 cm from the distal radial physis will be recruited for the study. Those patients with open fractures, other ipsilateral arm fractures (excluding ulna), pathologic fractures, bone diseases, or neuromuscular or metabolic conditions will be excluded. Participants who agree to enrol in the trial will be randomly assigned via a minimal sufficient balance algorithm to either sedated reduction or in situ immobilisation. A sample size of 167 participants per arm will provide at least 90% power to detect a difference in the primary outcome of Patient-Reported Outcomes Measurement Information System Upper Extremity computer adaptive test scores of 4 points at 1 year from treatment. Primary analyses will employ a linear mixed model to estimate the treatment effect at 1 year. Secondary outcomes include additional measures of perceived pain, complications, radiographic angulation, satisfaction and additional procedures (revisions, refractures, reductions and reoperations).

Ethics and dissemination

Ethical approval was obtained from the following local Institutional Review Boards: Advarra, serving as the single Institutional Review Board, approved the study (Pro00062090) in April 2022. The Hospital for Sick Children (Toronto, ON, Canada) did not rely on Advarra and received separate approval from their local Research Ethics Board (REB; REB number: 1000079992) on 19 July 2023. Results will be disseminated through publication in peer-reviewed journals and presentations at international conference meetings.

Trial registration number

NCT05131685.

New onset autoimmune disease following a SARS-CoV-2 infection: A systematic review protocol

by Alicia A. Grima, Linda T. Hiraki, Shelly Bolotin, Andrew D. Paterson, Jennifer D. Brooks

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has infected millions of people worldwide. While most infected individuals who survive do so with no long-term consequences, approximately 10 to 70% develop long-term sequelae. Of particular concern has been the development of autoimmune diseases. Viral triggers for autoimmune disease have been thoroughly studied for previous viral infections and several recent studies have sought to investigate the link between SARS-CoV-2 and new onset autoimmune disease. Several reviews have also been conducted on the topic, however, many of these reviews are limited in focus, emphasizing biological mechanisms and case reports, as opposed to estimates of risk. Further, these reviews do not capture more recent cohort studies that have been published investigating the association between SARS-CoV-2 and new onset autoimmune disease. Therefore, there is a need for a more comprehensive and temporally updated systematically conducted review of the literature to address the question What is the risk of incident (i.e., new onset) autoimmune disease following a SARS-CoV-2 infection among adults (≥18 years)?. A systematic search of MEDLINE, EMBASE, CINAHL, and grey literature will be conducted, with results screened in duplicate in two stages: 1) Title and abstract screening and 2) Full text screening. A standardized data extraction sheet will be used on any studies passing through both stages of screening to extract details on publication, study population, exposure, and outcomes. Narrative and tabular synthesis of overall findings will be conducted, with diversity and heterogeneity of included studies discussed. If possible, a meta-analysis will also be conducted to combine findings of risk across the included studies. This protocol has been registered to PROSPERO (registration number: CRD42024594446).

Assessing tuberculosis infection prevalence and test concordance in high-risk groups: a cross-sectional study in Mexicali, Baja California

Por: Brumwell · A. · Herrera · R. · Contreras · K. · Lee · M. · Becerra · E. · Estrada-Guzman · J. · Nicholson · T. · Machado Contreras · R. · Brooks · M. B.
Background

Despite low sensitivity and implementation challenges, the tuberculin skin test (TST) remains the standard-of-care tuberculosis (TB) infection test in Mexico. Interferon gamma release assays (IGRA) may overcome TST-related challenges. Within the confines of the local programmatic setting, this cross-sectional study evaluated the prevalence of TB infection (TBI) and concordance of TST and IGRA in three high-risk populations in Mexicali, Baja California, Mexico.

Methods

Household contacts (HHC) of individuals with TB, people who use drugs (PWUD), people deprived of liberty (PDL) and prison employees underwent evaluation for TBI using TST and QIAreach, a novel IGRA. Prevalence of infection, concordance of test results and reactivity trends of time-to-results (TTR) by TST-induration size were assessed.

Results

In total, 214 of 411 (52.07%) people who had TST and 269 of 460 (58.48%) people who had IGRA tested positive for TBI. Frequency of infection varied across risk groups (HHC 29 (29.6%); PWUD 67 (70.53%); PDL 111 (56.06%) and prison employees 7 (35.0%), p20 mm, p=0.05).

Conclusion

All risk groups had a high frequency of TBI, necessitating locally tailored guidelines for screening, treatment and management of TBI to optimise care for vulnerable populations.

Association of childhood socioeconomic status and health with depressive symptoms in later life: a cross-sectional latent class analysis of the 2014/2015 Indonesia Family Life Survey

Por: Isnuwardana · R. · Gibson · J. · Maharani · A. · Susanti · H. · Brooks · H. · Bee · P. · Anselmi · L.
Objectives

While childhood circumstances predict mental health outcomes in high-income countries, evidence from low-income and middle-income countries (LMICs) like Indonesia remains scarce. This study examines the long-term association between childhood socioeconomic status (SES), health and depressive symptoms in adulthood, testing the hypothesis that early-life disadvantages increase the odds of depressive symptoms later in life.

Design

Cross-sectional analysis using latent class analysis to cluster childhood SES/health and logistic regression to assess associations with depressive symptoms.

Setting

A nationally representative household survey was conducted across 13 provinces in urban and rural areas of Indonesia.

Participants

32 085 adults aged 18 years and older from the 2014–2015 Indonesia Family Life Survey. Participants with missing data on childhood circumstances or depressive symptoms were excluded, resulting in a final analytic sample of 29 140 individuals.

Outcome measures

The primary outcome was depressive symptoms measured using the 10-item Centre for Epidemiologic Studies Depression Scale, with scores ≥10 indicating clinically significant symptoms. Secondary exposures included latent classes of childhood SES and health (high, moderate and low disadvantage). Analyses adjusted for adult SES, health behaviours, social capital and demographic characteristics.

Results

Three latent classes emerged: low (64.85%), moderate (5.73%) and high (29.42%) early-life disadvantage. Adjusted logistic regression showed higher odds of depressive symptoms for high (OR 1.39, 95% CI 1.28 to 1.50) and moderate disadvantage (OR 1.66, 95% CI 1.48 to 1.87) versus low. Significant covariates included age, education, wealth and social capital (all p

Conclusions

Early-life disadvantages predict depressive symptoms in adulthood in Indonesia, underscoring the need for child-focused interventions (health, education and poverty reduction) to mitigate long-term mental health risks in LMICs. Further research should explore longitudinal mechanisms.

Enhancing cognitive function in breast cancer survivors through community-based aerobic exercise training: protocol for a Hybrid Type I effectiveness-implementation study employing a randomised controlled design

Por: Ehlers · D. K. · Austin · J. D. · Ernst · B. · Page · L. L. · Ofori · E. · Porter · G. C. · Fanning · J. · Hickman · G. · McKim · P. · Cole · M. · Donaldson · M. · Braden · B. B. · Kunze · K. L. · Butterfield · R. J. · Baxter · L. C. · Ahles · T. A. · Estabrooks · P.
Introduction

Despite growing evidence to characterise cancer-associated cognitive decline (CACD) in women with breast cancer, interventions to mitigate CACD are limited. Emerging evidence suggests aerobic exercise may enhance cognition after breast cancer diagnosis and treatment; yet, CACD remains an understudied outcome of exercise, and few high-quality studies have been conducted. In addition to knowledge gaps in effectiveness, the translation of exercise interventions to community settings remains challenging. The Breast cancer Reasoning and Activity INtervention (BRAIN) investigates the effectiveness of aerobic exercise training, delivered in a community-based setting, for improving cognitive function in women with breast cancer and gathers information on the implementation success of the intervention.

Methods and analysis

This Hybrid Type I effectiveness–implementation study is conducted at an academic medical centre in the southwestern United States in partnership with a non-profit, community health and wellness organisation. The study enrols 160 women diagnosed with stage I–IIIa breast cancer and within 3–36 months of treatment completion into a 1:1 randomised controlled trial. Individuals randomised to the exercise group receive a 6-month, individually tailored aerobic exercise programme delivered by exercise trainers employed at local community fitness centres. The programme is progressive in nature and designed to help participants achieve aerobic exercise levels consistent with guidelines for cancer survivors. Individuals randomise to the control group receive a 6-month health education control intervention delivered virtually by hospital-based health educators. Cognitive performance (primary), self-reported cognition, patient-reported outcomes, physical activity and cardiorespiratory fitness are measured at baseline, 6 months (postintervention) and 12 months (follow-up). Brain structure and function are measured via magnetic resonance imaging (MRI) at baseline and 6 months. Implementation outcomes are defined by the RE-AIM framework, which includes reach, effectiveness, adoption, implementation and maintenance. RE-AIM outcomes are measured at baseline, 6 months, 12 months and ongoing during the study.

Ethics and dissemination

This study was approved by the Mayo Clinic Institutional Review Board (#23-000020). All participants provide informed consent prior to participation. Findings will be disseminated to scientific, clinical and community audiences through manuscripts, presentations and newsletters.

Trial registration number

NCT04816006.

Racial and Ethnic Disparities in Emergency Department Use Among Older Adults With Asthma and Primary Care Nurse Practitioner Work Environments

imageBackground Older adults from specific racial and ethnic minoritized groups experience disproportionately higher asthma prevalence, morbidity, and mortality. They also often use emergency departments (EDs) to manage their asthma. High-quality primary care can improve asthma control and prevent ED use. Nurse practitioners (NPs) provide an increasing proportion of primary care to minoritized patients, yet often, they work in poor work environments that strain NP care. Objectives We examined whether racial and ethnic health disparities in ED visits among older adults with asthma are moderated by the NP work environment in primary care practices. Methods In 2018–2019, we used a cross-sectional design to collect survey data on NP work environments from 1,244 NPs in six geographically diverse states (i.e., Arizona, California, New Jersey, Pennsylvania, Texas, and Washington). We merged the survey data with 2018 Medicare claims data from 46,658 patients with asthma to assess the associations of all-cause and ambulatory care-sensitive conditions, ED visits with NPs’ work environment, and race and ethnicity using logistic regression. Results More than one third of patients with asthma visited the ED in 1 year, and a quarter of them had an ambulatory care-sensitive condition ED visit. Black and Hispanic patients were more likely than White patients to have all-cause and ambulatory care-sensitive condition ED visits. NP work environment moderated the association of race with all-cause and ambulatory care-sensitive condition ED visits among patients with asthma. Greater standardized NP work environment scores were associated with lower odds of all-cause and ambulatory care-sensitive condition ED visits between Black and White patients. Discussion Disparities in ED visits between Black and White patients with asthma decrease when these patients receive care in care clinics with more favorable NP work environments. Preventing unnecessary ED visits among older adults with asthma is a likely benefit of favorable NP work environments. As the NP workforce grows, creating favorable work environments for NPs in primary care is vital for narrowing the health disparity gap.

Effect of the Nurse Work Environment on Older Hispanic Surgical Patient Readmissions

imageBackground Readmissions following hospitalization for common surgical procedures are prevalent among older adults and are disproportionally experienced by Hispanic patients. One potential explanation for these disparities is that Hispanic patients may receive care in hospitals with lower-quality nursing care. Objectives The objective of this study was to evaluate the relationship between the hospital-level work environment of nurses and hospital readmissions among older Hispanic patients. Methods Using linked data sources from 2014 to 2016, we conducted a cross-sectional analysis of 522 hospitals and 732,035 general, orthopedic, and vascular surgical patients (80,978 Hispanic patients and 651,057 non-Hispanic White patients) in four states. Multivariable logistic regression models were employed to determine the relationship between the work environment and older Hispanic patient readmissions at multiple time periods (7, 30, and 90 days). Results In final adjusted models that included an interaction between work environment and ethnicity, an increase in the quality of the work environment resulted in a decrease in the odds of readmission that was greater for older Hispanic surgical patients at all time periods. Specifically, an increase in three of the five work environment subscales (Nurse Participation in Hospital Affairs, Nursing Foundations for Quality of Care, and Staffing and Resource Adequacy) was associated with a reduction in the odds of readmission that was greater for Hispanic patients than their non-Hispanic White counterparts. Discussion System-level investments in the work environment may reduce Hispanic patient readmission disparities. This study’s findings may be used to inform the development of targeted interventions to prevent hospital readmissions for Hispanic patients.

Cut‐off scores of the Depression Anxiety Stress Scale‐8: Implications for improving the management of chronic pain

Abstract

Aim

Mental distress, non-specific symptoms of depression and anxiety, is common in chronic pelvic pain (CPP). It contributes to poor recovery. Women's health nurses operate in multidisciplinary teams to facilitate the assessment and treatment of CPP. However, valid cut-off points for identifying highly distressed patients are lacking, entailing a gap in CPP management.

Design

This instrumental cross-sectional study identified a statistically derived cut-off score for the Depression Anxiety Stress Scale-8 (DASS-8) among 214 Australian women with CPP (mean age = 33.3, SD = 12.4, range = 13–71 years).

Methods

Receiver operator characteristic curve, decision trees and K-means clustering techniques were used to examine the predictive capacity of the DASS-8 for psychiatric comorbidity, pain severity, any medication intake, analgesic intake and sexual abuse. The study is prepared according to the STROBE checklist.

Results

Cut-off points resulting from the analysis were ordered ascendingly. The median (13.0) was chosen as an optimal cut-off score for predicting key outcomes. Women with DASS-8 scores below 15.5 had higher analgesic intake.

Conclusion

CPP women with a DASS-8 score above 13.0 express greater pain severity, psychiatric comorbidity and polypharmacy. Thus, they may be a specific target for nursing interventions dedicated to alleviating pain through the management of associated co-morbidities.

Implications for patient care

At a cut-off point of 13.0, the DASS-8 may be a practical instrument for recommending a thorough clinician-based examination for psychiatric comorbidity to facilitate adequate CPP management. It may be useful for evaluating patients' response to nursing pain management efforts. Replications of the study in different populations/countries are warranted.

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