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N-acetyl cysteine for the treatment of alcohol use disorder: study protocol for a multi-site, double-blind randomised controlled trial (NAC-AUD study)

Por: Morley · K. · Arunogiri · S. · Connor · J. P. · Clark · P. J. · Chatterton · M. L. · Baillie · A. · Slade · T. · Berk · M. · Lubman · D. · Haber · P. S.
Introduction

Current treatments for alcohol use disorders (AUD) have limited efficacy. A previous 28-day pilot trial of N-acetyl cysteine (NAC) vs placebo found NAC to be feasible and safe, with evidence of improvement on some measures of alcohol consumption. Thus, the primary aim of the NAC-AUD study is to examine the therapeutic and cost-effectiveness of NAC vs placebo in improving treatment outcomes for AUD. We will also examine the (i) effect of NAC vs placebo on mood, markers of liver injury, cognition and hangover symptoms; and (ii) predictors of any response.

Methods and analysis

This double-blind trial will randomise participants with AUD to a 12-week regimen of either NAC (2400 mg/day) or placebo. All participants will receive medical management. The primary drinking outcome will be the number of heavy drinking days (HDDs) per week, validated by phosphatidylethanol (PEth). Secondary alcohol-related outcomes will include standard drinks per drinking day (SDDD) per week and absence of any HDDs. Other secondary outcomes will include markers of liver injury, depression, anxiety, craving, hangover symptoms, cognition and blood oxidative stress markers. We will also examine the cost-efficacy of NAC vs placebo.

Ethics and dissemination

Ethics approval for the study has been granted by The Sydney Local Health District Ethics Review Committee (X21-0342& HREC2021/ETH11614). There are no restrictions on publication from the sponsor or other parties.

Trial registration number

NCT05408247.

Multifaceted analysis of presenteeism: contributions of pain, psychological factors and daily functioning - a cross-sectional study in Japan

Por: Yoshino · A. · Ushio · K. · Nakamura · R. · Shiota · S. · Katagiri · T. · Nishihara · K. · Moriwaki · K. · Anno · K. · Mikami · Y. · Tsutsumi · Y.
Objective

Presenteeism, defined as reduced work efficiency due to health issues despite attending work, accounts for a substantial proportion of labour productivity loss. Although pain significantly impacts presenteeism, the relationship between pain and presenteeism remains poorly understood due to the multifaceted nature of pain, encompassing psychosocial factors and daily functioning. This study aimed to identify which of these factors are significantly associated with presenteeism among employees.

Design

Cross-sectional study using self-administered questionnaires and generalised additive model analysis.

Setting

Multiple workplaces (including a university and hospitals) in Japan.

Participants

Employed individuals (n=212, age range: 20–65 years; 59 males and 153 females) participated. They were recruited through workplace bulletin boards, email announcements and direct invitations. Participants with and without chronic pain were included.

Primary and secondary outcome measures

Participants completed self-report measures, including the Health and Work Performance Questionnaire (HPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Pain Catastrophising Scale (PCS), Beck Depression Inventory-second edition (BDI-II), State-Trait Anxiety Inventory (STAI) and WHO Disability Assessment Schedule 2.0 (WHODAS 2.0).

Results

The results indicated that absolute HPQ was significantly associated with BDI-II scores (F=4.51, p=0.035). On the other hand, relative HPQ was influenced by SF-MPQ (F=3.76, p=0.005), PCS (F=4.16, p=0.014), STAI (F=5.62, p=0.019) and limited daily activities (F=13.25, p=0.00035).

Conclusions

These findings suggest that presenteeism is multifactorial, with pain, psychosocial factors and daily functioning playing critical roles. Moreover, the impact of depression on presenteeism differs from that of pain and anxiety. Therefore, tailored intervention approaches may be required for each factor, ultimately improving workplace productivity.

Trial registration number

This study was preregistered at UMIN-CTR (UMIN000054797).

Outcomes of patient and public involvement in the development of the Cognitive Decline after Brain Radiosurgery (CoDe B-Rad) study: refining the research question and methodology

Por: Bangiri · A. · Horobin · A. · Baker · J. · Pszczolkowski · S. · Thust · S. · Morgan · P. S.
Objectives

Patient and public involvement (PPI) was sought in the development of the protocol for the Cognitive Decline after Brain Radiosurgery (CoDe B-Rad) study, which aims to identify potential side effects of stereotactic radiosurgery (SRS). PPI served to refine the research question and methodology.

Design

PPI.

Setting

PPI conducted online with people based in the UK. The CoDe B-Rad study is running in regional National Health Service tertiary care in the UK and is currently nearing recruitment completion.

Participants

Patients and carers with lived experiences of brain radiotherapy. Contributors were identified through national charities.

Procedures

Initial focus groups were planned, but participation proved challenging. Instead, online questionnaires, one-to-one discussions and participation in support groups were completed.

Results

All contributors experienced changes to their cognition and/or quality of life (QoL) after radiotherapy. Quantifying the side effects of SRS and minimising them were identified as a research gap. Discussion group participation proved challenging. PPI plans were altered to accommodate the physical and mental needs of contributors. It was decided to combine the Montreal Cognitive Assessment along with European Organisation for Research and Treatment in Cancer QLQ-C30 and BN20 to capture cognitive status and QoL of patients with brain metastases and meningiomas after SRS. Patients/carers recommended for sessions to be restricted to 30 min and testing to be offered face-to-face, online, in hospital or at patients’ homes. Coproduction was not achievable with our patient population but that did not diminish the input of contributors nor the impact it had on designing the study protocol.

Conclusions

In cancer research, diligent considerations are required to ensure the suitability of involvement methods for this vulnerable population. Flexibility and adaptability of draft PPI plans are essential to achieve meaningful contributions. The protocol of the ongoing CoDe B-Rad study was positively shaped by people with lived experiences of brain radiotherapy.

Trial registration number

NCT06466720 (CoDe B-Rad study).

Randomised controlled trial to compare the efficacy of integrated cognitive-behavioural therapy (COPE-A) for substance use and traumatic stress among adolescents and young adults delivered via telehealth versus in person: trial protocol

Por: Mills · K. · Winter · V. · Cobham · V. · Peach · N. · Arunogiri · S. · Chatterton · M. L. · Bendall · S. · Back · S. E. · Perrin · S. · Brady · K. · COPE-A Trial Team · Barrett · Teesson · Slade · Hamilton · Rickwood · Reid · Leicester · Milne · Curtis · Harvey · Kay-Lambkin
Introduction

Emerging research indicates that integrated treatment of co-occurring post-traumatic stress disorder (PTSD) and substance use disorder can be effective among adolescents and young people. However, various barriers exist to young people accessing evidence-based treatments. Telehealth offers an opportunity to address these barriers and provide a scalable and accessible alternative to inperson treatment. This paper describes the study protocol for a randomised controlled trial (RCT) examining the efficacy, safety and cost-effectiveness of an integrated trauma-focused cognitive-behavioural treatment for traumatic stress and substance use among adolescents and young adults (Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure – Adolescent and Young Adult version (COPE-A)) when delivered in person compared with via telehealth.

Methods and analysis

A two-arm, parallel group, single-blind, non-inferiority RCT with follow-up at 4 months and 12 months post study entry will be conducted in Sydney, Australia. Participants (170 adolescents and young adults aged 12–25 years) will be allocated to receive COPE-A either in person or via telehealth (allocation ratio 1:1) using minimisation. Project psychologists will administer treatment via both modes of delivery over a maximum of 16 sessions of 60–90 min. The primary outcome will be between-group differences in change in the severity of PTSD symptoms from baseline to 4-month follow-up, as measured by the Clinician-Administered PTSD Scale for Children and Adolescents for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.

Ethics and dissemination

This study has been approved by the Sydney Children’s Hospitals Network Human Research Ethics Committee (2024/ETH01050). Research findings will be published in peer-reviewed journals and presented at scientific conferences.

Trial registration number

ACTRN12624000776505.

Protocol version

V.2.3, 20 March 2025.

Impacts on quality of care following electronic health record implementation within a large Canadian community hospital: a qualitative study

Por: Vanderhout · S. · Taneja · S. · Heidebrecht · C. L. · Nie · J. X. · Seuren · L. · Giri · R. · Tang · T. · Mansfield · E. · Kuluski · K. · Wodchis · W. P.
Objective

This study aimed to describe how healthcare providers perceived the impacts of implementing and using an electronic health record (EHR) on quality, safety and person-centredness of care.

Design

A qualitative descriptive design using semistructured interviews.

Setting

In October 2020, a large Canadian community hospital implemented a new EHR system (Epic) across three sites, transitioning from a previously fragmented (combination of paper-based and electronic) system.

Participants

Sixty-two healthcare providers and clinical leaders.

Results

Participants shared their experiences regarding the impact of EHR implementation on quality of care, which were analysed into common themes including task efficiency, information management, patient interactions and patient safety. While the system significantly altered their routines and introduced new responsibilities like additional documentation requirements, it also facilitated adherence to clinical guidelines, improved information visibility and enhanced documentation, benefiting overall quality of care and patient safety. Participants reported that EHR implementation led to increased efficiency, freeing up time for patient care and improving communication with patients and other providers.

Conclusion

EHRs have the potential to improve quality of care and patient safety, but this depends on their perceived value and how well healthcare providers can integrate their various features into clinical routines.

Barriers to uptake of referral services from secondary eye care to tertiary eye care and its associated determinants in L V Prasad Eye Institute network in Southern India: A cross-sectional study-Report II

by Debananda Padhy, Giridhar Pyda, Srinivas Marmamula, Rohit C. Khanna

Aim

To investigate the barriers to the uptake of referral services from secondary care centers (SC) to a higher-level tertiary care center (TC) in Southern India.

Methods

A cross-sectional study was conducted in the Mahabubnagar district of Telangana, India, between February 1, 2018 to January 31, 2019 and all those referred from SC to TC between January 1, 2013 to December 30, 2016 were identified for interview. Based on inclusion criteria, of the 960 participants identified, 681 (70.9%) participated in the study. A validated study questionnaire was administered to all participants. Information collected were the demographic details, details related to their referral and barriers to referral. The participants that presented at TC were considered compliant and who did not, were non-compliant. Reasons for non-compliance was also collected.

Results

The mean age those interviewed was 46.1 years (SD: 17.3 years) and 429 (63%) were males and 252 (37%) were females. Overall, 516 (75.8%) were compliant, and 165 (24.2%) were non-compliant. The major factors for non-compliance were economic (16.4%) and attitudinal (44.2%) barriers. Within the attitudinal barrier category, the most prevalent individual attitudinal barriers were ‘too busy to go to the eye center for treatment (16.4%)’and ‘able to manage routine daily activities with current vision (12.1%)’. The multivariable analysis showed that the non-compliant participants had only visited the SC once prior to the referral (odds ratio: 2.82; 95% CI: 1.43–5.57) (p = 0.003).

Conclusions

Participants with only one SC visit, were less likely to comply with referrals and the major barriers to compliance were economical and attitudinal. It is important to address these specific barriers to provide proper counseling to participants during referrals.

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