Commentary on: Er S, Murat M, Ata EE, Kose S, Buzlu S. Nursing student’s mental health: How does eco-anxiety effect? Int J Mental Health Nurs. 2024;00:1-12.
Implications for practice and research Nurse educators should be aware of eco-anxiety and think about the impact of climate change on nursing students. Nurse researchers should investigate ways of supporting nursing students affected by eco-anxiety and develop strategies to promote student learning during a climate emergency.
Climate change is causing a global climate emergency, which is increasingly seen as a major problem for global health concern.
Commentary on: Kearns, RJ, Kyzayeva, A, Halliday, LO, et al. Epidural analgesia during labour and severe maternal morbidity: population based study. BMJ 2024;385.
Implications for practice and research Health research, policy and information should emphasise the advantages of intrapartum epidurals beyond pain relief, especially for women with pre-existing conditions and preterm labour. Health services must provide access to a 24-hour epidural service within their maternity care.
The use of intrapartum epidurals to manage pain during labour and birth has been globally accepted for decades.
Health research aims to improve people’s health by understanding the best ways to diagnose and treat conditions, and understand people’s responses to health problems and health promotion initiatives. Quantitative research, and more specifically randomised controlled trials (RCTs), aims to establish if an intervention works, for example testing the effectiveness of a new drug, using statistical analysis. In contrast, qualitative research focuses on understanding a situation, for example people’s experiences, perspectives and behaviours. Qualitative research can enhance RCTs by ensuring a more complete understanding of the factors that influence the acceptability of a new intervention and how it might be implemented in practice. A previous article in this series outlined how process evaluation embedded within RCTs can help understand how and why an intervention works.
by Zihang Zhao, Xiang Zhang, Xi Hou, Zihan Liu, Zhiyong Hou, Lianxin Song, Ruipeng Zhang
Percutaneous Bunnell repair and open modified Kessler repair remain debated options for acute Achilles tendon rupture (AATR). We retrospectively compared a minimally invasive percutaneous Bunnell technique (Group A) with an open modified Kessler repair (Group B) within a standardized early functional rehabilitation (EFR) protocol at a single center. Fifty-five adults with closed AATR treated between January 2021 and December 2022 were analyzed (Group A, n = 25; Group B, n = 30). Between-group comparisons used Welch t tests for continuous variables and χ² or Fisher exact tests for categorical variables; American Orthopaedic Foot & Ankle Society (AOFAS) and Achilles Tendon Total Rupture Score (ATRS) were assessed at 12 and 24 weeks, with Holm adjustment applied within each scale. Compared with Group B, Group A had shorter operative time (56.6 ± 15.1 vs 68.2 ± 23.2 minutes; mean difference −11.6; 95% CI −22.05 to −1.15; P = 0.030), less intraoperative blood loss (28.4 ± 8.4 vs 74.7 ± 19.4 mL; −46.3; 95% CI −54.22 to −38.38; PTo examine how clinicians’ scepticism regarding patients’ self-reports of subjective symptoms can be internalised, leading to psychosocial and medical harms.
In-depth, semi-structured qualitative interviews with the resulting data analysed using reflexive thematic analysis.
43 individuals with Ehlers-Danlos syndrome (EDS) from Europe and North America completed a pre-survey, and 39 of those participants completed interviews for this study. Purposive sampling was used to obtain approximately equal numbers of participants with hypermobile EDS and the molecularly defined types of EDS.
Patients with both hypermobile and molecularly defined types of EDS reported high levels of self-doubt, with 73% of survey respondents questioning the extent—and even reality—of their private experiences of pain. Participants attributed much of their self-doubt to repeated dismissal and minimisation of their symptoms in healthcare settings, especially during childhood. Ultimately, self-doubt transformed not merely how they communicated their symptoms but also how they recognised, evaluated and even experienced them at a phenomenological level. While some participants developed coping strategies, others withdrew from the conventional medical system altogether.
These findings have important implications for clinicians, who may inadvertently reinforce self-doubt through discussion of diagnostic uncertainty. Doubt need not be delegitamising. Recognising and mitigating these potential harms requires epistemic humility and attention to the psychosocial dynamics of patient-provider interaction.
by Federica Biassoni, Giulia Vismara, Martina Gnerre
The objective of this study was to examine whether different types of mental-imagery training focused on the vocal apparatus can enhance awareness of the vocal tract and diaphragm (vocal awareness) in non-professional singers.Sixty participants with no singing education received one of three training conditions: following instructions based on 1) a description of the physiological changes that take place during phonation (physiological description), 2) imitating an action using the vocal apparatus (imitative action), and 3) a metaphorical narration. Imitative action and metaphorical narration were conceptualized as more imaginative forms of training. Vocal awareness was assessed with a questionnaire that participants completed before and after the training. The questionnaire measured three indices: vocal apparatus representation, vocal apparatus interoceptive awareness, and vocal self-regulation. Results showed that all three types of training program significantly enhanced vocal awareness, but imitative action and metaphorical narration were more effective for interoceptive awareness, and metaphorical narration was more effective for self-regulation. In conclusion, the two imaginative forms of training were more effective than physiological description for improving vocal awareness.by Allison Anbari, Zachary Massey, Abigail Adediran, Na Wang, LaRissa Lawrie, Priscilla Martinez, Denis McCarthy
Alcohol consumption increases breast cancer risk. We evaluated the responses of 748 United States female participants ages 21–29 to health warning messages addressing the relationship between alcohol consumption and increased breast cancer risk. In an online experiment, participants were randomly assigned to view standalone health warning messages about alcohol, breast cancer, and breast cancer health effects with varying picture and text attributes. Participants then completed post-message exposure assessments that included an immediate open-ended response to the message prompt. We conducted a qualitative content analysis of the responses and coded deductively based on constructs from the Message Impact Framework including message reactions, attitudes and beliefs, and behavioral intentions. These constructs and corresponding variables were present in participants’ responses. Response type did not vary by participants’ demographics or the attributes of the health warning message they viewed. The code new information was applied to 20% of the responses, indicating that those participants had no prior knowledge of alcohol and breast cancer risk. Alcohol and breast cancer messaging could impact drinking behaviors. Given the frequency of responses indicating a lack of awareness, more work in cancer prevention and population health messaging is warranted.by Natthakul Akarapredee, Chalirmporn Atasilp, Chonlaphat Sukasem, Pimonpan Jinda, Rattanaporn Sukprasong, Jiraporn Jensuriyarkun, Soravit Wongjitjanyong, Patompong Satapornpong, Natchaya Vanwong
IntroductionIrinotecan is a chemotherapy agent commonly prescribed for metastatic colorectal cancer but often leads to neutropenia. Variations in genes encoding drug-metabolizing enzymes and transporters may affect the toxicity and effectiveness of irinotecan. This study aimed to examine the impact of these genetic polymorphisms on irinotecan outcomes in Thai colorectal cancer patients.
MethodsThe study retrospectively analyzed 41 metastatic colorectal cancer patients treated with irinotecan-based chemotherapy. Genotyping was conducted for 23 single nucleotide polymorphisms in genes including UGT1A1, CYP3A4, CYP3A5, CES1, ABCB1, ABCC2, ABCC5, ABCG1, ABCG2, and SLCO1B1.Toxicity and efficacy were assessed, with statistical significance set at a Bonferroni-corrected P value Results
In terms of toxicity, UGT1A1*6 was significantly associated with both all-grade and severe neutropenia in the first cycle (p p p ABCC2 -24C > T variant was linked to all-grade neutropenia in the second cycle (p = 0.001). For efficacy, patients with the wild-type UGT1A1*6 had longer progression-free survival (PFS) (p SLCO1B1 521T > C variant was associated with improved PFS (p Conclusion
UGT1A1*6 and ABCC2 -24C > T variants emerge as potential predictors of irinotecan-induced neutropenia, while UGT1A1*6 and SLCO1B1 521T > C may serve as markers of prolonged PFS in Thai patients. Validation through larger prospective studies is essential to confirm and refine these genetic associations.
To assess the feasibility of conducting a cluster randomised controlled trial comparing the effects of Advanced Trauma Life Support (ATLS) and Primary Trauma Care (PTC) with standard care on patient outcomes.
This was a pilot pragmatic three-armed parallel, cluster randomised, controlled trial conducted between April 2022 and February 2023. Patients were followed up for 30 days.
Tertiary care hospitals across metropolitan areas in India.
Adult trauma patients and residents managing these patients were included.
ATLS or PTC training was provided for residents in the intervention arms.
The outcomes were the consent rate, loss to follow-up rate, missing data rates, differences in the distribution between observed data and data extracted from medical records, and the resident pass rate.
Two hospitals were randomised to the ATLS arm, two to the PTC arm and three to the standard care arm. We included 376 patients and 22 residents. The percentage of patients who consented to follow-up was 77% and the percentage of residents who consented to receive training was 100%. The loss to follow-up rate was 14%. The pass rate was 100%. Overall, the amount of missing data for key variables was low. The data collected through observations were similar to data extracted from medical records, but there were more missing values in the extracted data.
Conducting a full-scale cluster randomised controlled trial comparing the effects of ATLS, PTC and standard care on patient outcomes appears feasible, especially if such a trial would use data and outcomes available in medical records.
Cognitive behavioural therapy (CBT) and interpersonal psychotherapy (IPT) are both efficacious treatments for depression, but it is less clear how both compare on outcome domains other than depression and in the longer term. Moreover, it is unclear which of these two psychotherapies works better for whom. This article describes the protocol for a systematic review and individual participant data (IPD) meta-analysis that aims to compare the efficacy of CBT and IPT for adults with depression on a range of outcomes in both the short and long term, and to explore moderators of the treatment effect. This study can enhance our understanding of treatments for depression and inform treatment personalisation.
Systematic literature searches will be conducted in PubMed, PsycINFO, EMBASE and the Cochrane Library from inception to 1 January 2026, to identify randomised clinical trials (RCTs) comparing CBT and IPT for adult depression. Researchers of eligible studies will be invited to contribute their participant-level data. One-stage IPD meta-analyses will be conducted with mixed-effects models to examine (a) treatment efficacy on all outcome measures that are assessed at post-treatment or follow-up in at least two studies, and (b) various baseline participant characteristics as potential moderators of depressive symptom level at treatment completion.
Ethical approval is not required for this study since it will be based on anonymised data from RCTs that have already been completed. The findings of the present study will be disseminated through a peer-reviewed journal or conference presentation.
Prescribing high-dose antipsychotics is typically reserved for individuals with treatment-resistant severe mental illnesses, such as schizophrenia, bipolar disorder and psychotic depression. It carries an increased risk of adverse drug effects, necessitating regular monitoring. Non-mental health specialist clinicians may not always be aware when the maximum recommended dose of antipsychotics is exceeded, leading to unintentional high-dose prescribing without recognising the need for additional monitoring or understanding the associated risks. Therefore, providing clinical decision support (CDS) tools to support clinicians and improve the appropriate prescribing of antipsychotics is important. The aim of this study is to understand current prescribing practices and assess the impact of high-dose antipsychotic prescribing on clinical outcomes among hospitalised patients. The findings from this study will shape a future project focused on developing an integrated computerised CDS tool.
This retrospective cohort study will examine antipsychotic prescribing among hospitalised patients using Hospital Electronic Prescribing and Medicines Administration data in Scotland from 2019 to 2023, in linkage with hospital records, Scottish Morbidity Records and primary care prescribing (Prescribing Information System). Patients will be grouped into those prescribed high-dose (exposed), defined as exceeding the 100% maximum recommended British National Formulary dose and normal-dose (unexposed) antipsychotics, followed from their first ever antipsychotic prescription date (index date) until the end of the study, study outcomes or death, whichever happens first. We will quantify high-dose antipsychotic prescribing, profile patient characteristics and use machine learning techniques to assess associations of high-dose antipsychotic prescribing with clinical outcomes, including harms and benefits, but will not attempt to establish causality.
The Health and Social Care Public Benefit and Privacy Policy Panel (HSC-PBPP) has granted ethical approval (ref. 2024-0239) following a Data Protection Impact Assessment, with data securely held and accessed in the National Safe Haven. The results will be published in international peer-reviewed journals and will be shared with clinicians.
The purpose of this article is to present the Gothenland Millennium Cohort, describe the data collection process, present key measures used and summarise some of the key findings to date in order to stimulate collaboration and use of the cohort data. This research programme was originally established to study pathways to alcohol and drug use, behavioural problems, mental health issues, and the factors that promote or prevent these outcomes. The Cohort aims to support scientific research and doctoral education through a longitudinal study that tracks individuals from early adolescence through adulthood. This programme is multidisciplinary (social work, psychology, disability research) with the goal of producing high-quality research that deepens our understanding of how early-life vulnerabilities, risks and protective factors influence long-term wellbeing, including health and welfare, in diverse populations.
In 2013, all school-registered adolescents, in grades 6 and 7 (aged 12 and 13), in four municipalities in Gothenland region (ie, southern Sweden) born in year 2000 or 2001, were invited to participate. Of 2150 invited adolescents, 1885 (88%) accepted participation in the programme and 1760 (93.4%) participated in at least one of the annual data collection waves up to grade 9 (Wave 4), with participation rates ranging from 70% to 85% per wave. Wave 5 questionnaires were collected during the second year of upper secondary school (grade 11). In Wave 5, half (50.4 %; n = 949) of the adolescents participated. In Wave 6, interviews were conducted with a selection of participants in their last year of upper secondary school (grade 12). Parents were surveyed in Waves 1 and 2 by self-report questionnaires (response rate = 32%; 41%). Data were also gathered from teachers (attrition
Over 240 publications have been produced as of September 2025 in the areas of disability and everyday functioning, child-parent relationships, child welfare, substance use and criminal behaviour, mental health, trauma, harassment, and sexuality.
These include continued investigation of wellbeing and its related indicators during adolescence as well as in emerging adulthood, continued efforts to secure funding and an age 25 expansion of the cohort data.
Pneumonia remains a leading cause of under-5 mortality in sub-Saharan Africa, accounting for approximately 14% of deaths in this age group. In Malawi, pneumonia accounts for 12% of under-5 deaths, with recent data revealing a concerning trend of over 110 000 new cases reported in 6 months. The Malawi government has made significant strides in reducing childhood mortality through the Integrated Community Case Management (iCCM) strategy, resulting in an 11% reduction in under-5 mortality over a 5-year period. However, the current iCCM strategy does not include the management of chest indrawing pneumonia in children aged 2–59 months and fast-breathing pneumonia in infants aged up to 2 months. This implementation research aims to increase pneumonia treatment coverage for under-5 year-old children in Kasungu District, Malawi, by expanding the community-based management of pneumonia by the iCCM-trained Health Surveillance Assistants (HSAs).
The current implementation research using both qualitative and quantitative data collection methods will assess the feasibility and acceptability of iCCM-trained HSAs managing chest indrawing pneumonia and fast-breathing pneumonia in children under 5 with oral amoxicillin at the community level in district Kasungu using the existing district health system. The study will employ a district health system model, leveraging existing trained iCCM HSAs to enrol and manage infants aged 7–59 days with fast-breathing pneumonia and 2–59-month-old children with chest indrawing pneumonia in the community with 7-day and 5-day oral amoxicillin, respectively. HSAs will also use pulse oximetry to identify hypoxaemic children for prompt referral to a hospital for further care. Sociodemographic features of enrolled children will be documented. Enrolled children will be followed up on treatment compliance using follow-up forms. The pneumonia treatment coverage will be assessed using baseline, midline and end-line surveys using both qualitative and quantitative data collection methods.
Ethical approval was obtained from the National Health Research Sciences Committee and the WHO Ethics Committee. The implementation research findings will be disseminated to national-level stakeholders and specifically targeted at District Health Offices, which are responsible for implementing the interventions.
Polysubstance use (PSU), particularly opioid-involved and stimulant-involved PSU, is a growing issue in the USA. PSU increases the risk of negative health consequences, including infectious diseases, worsening physical and mental health conditions, and overdose-related deaths. These consequences occur in the context of varying health risk behaviours, substance-related preferences, and treatment engagements among people with PSU. To inform improvements in prevention, harm reduction, and substance use disorder (SUD) treatment, additional research is needed to comprehensively understand the current context and drivers of PSU preferences, motivations, and behaviours.
Herein, we describe the protocol for a prospective cohort study designed to capture detailed patterns, profiles, and trajectories of PSU, with the aim of comprehensively examining the drivers of PSU behaviours and SUD treatment utilisation. Adults (ages 18–75; n=400) who engage in PSU will be recruited from healthcare institutions, an established participant database maintained by an adjacent SUD research team, and online advertisements. Study assessments will capture dynamic patterns, choice preferences, and motivators of PSU via behavioural economic (BE) measures, detailed Timeline Follow-Back (TLFB) interviews, and self-administered surveys. The assessment timeline will include a baseline survey and TLFB interview, weekly TLFB interviews for 4 weeks post-baseline, and follow-up surveys and TLFB interviews at 4-, 8-, and 12-months post-baseline.
The study is funded through the National Institutes of Health Helping to End Addiction Long-term (HEAL) initiative and was approved by the University of Michigan Medical Institutional Review Board. Findings will be disseminated to academic, clinical, and community partners through the Michigan Innovations in Addiction Care through Research and Education programme. Results from this study will inform actionable and practical insights relevant to the delivery of personalised care in the context of PSU.
Selective dorsal rhizotomy (SDR) is one of the treatment options available for spasticity management in ambulatory children and young people with cerebral palsy (CYPwCP). Although improvements in gross motor function one to two years after surgery have been established, evidence of longer-term benefit requires further investigation. Given the irreversible nature of SDR and the increased rehabilitation commitments required from families and clinicians, providing evidence of longer-term benefits is essential to support their decision-making. This study aims to investigate medium (3–5 years) and long-term (6–10 years) SDR outcomes in ambulatory children with CP and how SDR affects families’ lives over time.
This is a convergent parallel mixed-methods study using the International Classification of Functioning, Disability and Health as a theoretical framework. The study aims to recruit 90 CYPwCP participants, who had SDR at a tertiary hospital in the UK when aged between 3 and 14 years. Participants (parents and CYPwCP) will be invited to complete an online survey and attend the hospital for one follow-up visit 3 or more years after SDR. Comparisons will be made with existing data on objective measures and parent-reported outcomes collected in clinical practice at baseline, 6, 12 and 24 months to understand the trajectory of changes. Semistructured interviews will be conducted with 18–20 parents/carers and 25–30 CYPwCP to understand their perspectives on the outcomes of SDR compared with their prior expectations. The Framework Method will be used to analyse qualitative data both inductively and deductively. Qualitative and quantitative study data will be integrated using joint displays.
Ethical approval has been obtained through the Coventry and Warwick Research and Ethics Committee (24/WM/0078). Findings will be shared through international conferences, peer-reviewed journals, social media and dissemination events for families and CYP.
Osteogenesis imperfecta (OI) is the most common inherited cause of bone fragility (approximately 1 in 16 000). People with OI suffer bone fragility causing fractures, pain and deformity; sarcopenia causing fatigue and poor endurance; aortic root dilatation and hearing loss. No drug currently has market authorisation to treat OI in Europe. Current standard-of-care is multidisciplinary, with pharmacological interventions—primarily bisphosphonates—directed at increasing bone mass; however, such interventions are of equivocal efficacy. The structural damage that can accumulate as a result of repeated fractures over time may not be reversible. The lack of a treatment with clearly defined efficacy in terms of reducing fracture frequency or the sarcopenia, that is increasingly recognised in this condition, leads to the consideration of alternatives based on what is known about the molecular pathophysiology of the condition. For reasons that are currently unclear, transforming growth factor beta (TGFβ) pathway signalling is increased in OI, and both studies in mouse models and more recently also in humans suggest that reducing TGFβ pathway signalling could be of benefit in OI. This demonstrator project tests the hypothesis that losartan, an antihypertensive agent known to reduce circulating TGFβ, will reduce bone turnover and bone loss and have a positive effect on muscle function and quality of life in adults and older adolescents with OI.
This is a phase 2/pilot, open-label, dose-escalating study. This study aims to identify the effective dose for losartan in this population to inform the design of a pivotal phase III study. The study aims to recruit 30 adolescents and adults aged 16 years and above with OI across secondary care study sites in the UK and Italy. Participants will be recruited from the patient populations attending for treatment of OI at the participating hospital sites or referred by clinicians at the Participant Identification Centres (PIC sites). Participants will be randomised to one of three ‘final doses’—25, 50 or 75 mg losartan once daily. All participants will start on 25 mg once daily. Those assigned to higher ‘final doses’ will increase in 25 mg once daily increments on day 8 and day 15 following safety assessments. The primary outcome measures are to establish the effective dose of losartan in OI patients, based on maximal reduction in the bone resorption marker carboxy-terminal crosslink of type I collagen telopeptide (CTX) over the 24-week period of the study.
Secondary outcome measures are to determine the changes in proxy efficacy outcomes for bone (turnover, mass, architecture and strength) using blood tests, high-resolution peripheral quantitative CT (HRpQCT), dual-energy X-ray absorptiometry (DXA) and muscle (strength) using the ‘Timed Up and Go’ test. In addition, the changes in quality of life, including pain and fatigue, will be evaluated by using a disease-specific tool (OI-QOL) and a validated generic tool (EQ-5D-5L-VAS).
In the UK, the study protocol and amendments have been approved by the London Bridge Research Ethics Committee (REC reference: 23/LO/015) and by the Medicines and Healthcare products Regulatory Agency (MHRA). In Italy, the study protocol and amendments have been approved by the Italian and European ethics and regulatory authorities (Clinical Trials Information System European Union (CTIS EU) portal according to EU Regulation 536/2014). Final version of study protocol: Version 3.2, 05.03.2025. Final results will be disseminated in peer-reviewed journals through local OI, orthopaedic and other relevant clinical networks and at national and international meetings. Sheffield Children’s National Health Service Foundation Trust (UK) and Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Ortopedico Rizzoli (Italy) are the joint study sponsors.
ISRCTN (ISRCTN13317811).
Self-care plays a pivotal role in the management of heart failure (HF). Health literacy and empowerment are considered the prerequisites of effective self-care. This project aims to improve self-management in people with HF by describing, analysing and enhancing the communication practices of clinicians and patients to support people with HF to increase their health literacy skills and participate in shared decision-making.
A multimethod research design incorporating an interview component, a concurrent mixed-methods component and a pilot intervention study is used. The study is currently being conducted at two Australian hospitals in metropolitan areas (one public and one private). The interview component involves semistructured interviews with healthcare providers and hospital executives and managers at the participating sites to explore perceived barriers and facilitators to HF self-management and understand the institutional context of HF care. The concurrent mixed-methods components include: (a) tracking and audio recording the clinical interactions of patients with HF (n=30) during their hospitalisation and up to 6 months after discharge and semistructured interviews with the patient (and the carer) and the participating clinician after each clinical interaction and (b) collecting longitudinal survey data (n=180, patients) to track patients’ health literacy, empowerment and self-management over 6 months. The pilot feasibility study includes developing a complex intervention for clinicians and patients and evaluating its acceptability and potential in improving health literacy and reducing readmissions, length of stay and costs.
This study was approved by the Australian Capital Territory Health (2023.ETH.00007) and Edith Cowan University (023–04314-SAUNDERS) Human Research Ethics Committees. Informed consent was obtained and will continue to be sought from all participants. Study results will be disseminated in peer-reviewed journals.
Gram negative bloodstream infections (GN BSI) are a leading cause of mortality worldwide, and antibiotic treatment approaches remain understudied. BALANCE+ is a perpetual Bayesian adaptive platform trial to test multiple treatment questions for hospitalised patients with GN BSI. The vanguard phase objective was to test the feasibility of the main trial.
Adaptive platform trial with five initial domains of investigation, each with open label 1:1 randomisation.
Ten hospitals across four Canadian provinces.
Individuals admitted to hospital with blood cultures yielding Gram negative bacteria.
The five initial domains of investigation included: antibiotic de-escalation versus no de-escalation; oral transition to beta-lactam versus non-beta-lactam treatment; routine versus no routine follow-up blood cultures (FUBCs); central vascular catheter replacement versus retention; and, ceftriaxone versus carbapenem treatment for low risk AmpC organisms.
Domain-specific recruitment rates and protocol adherence.
During the vanguard phase, 719 patients were screened, of whom 563 (78.3%) were eligible, with 179 (31.8%) enrolled into the platform. The platform recruitment rate was 1.37 patients/site-week. Recruitment varied by domain: routine versus no FUBC domain 1.23 patients/site-week; oral beta-lactam versus non-beta-lactam domain 0.48; de-escalation versus no de-escalation domain 0.28; low risk AmpC domain 0.02; catheter replacement versus retention domain 0.01. Domain specific protocol adherence rates were 145/158 (91.8%) for routine versus no routine FUBC, 53/60 (88.3%) for oral beta-lactam versus non-beta-lactam, 26/33 (78.8%) for de-escalation versus no de-escalation, 3/3 (100%) for low risk AmpC, and 0/1 (0%) for line replacement versus retention. There was complete ascertainment of all study outcomes in hospital 170/170 (100%) and near complete ascertainment at 90 days 162/170 (95.3%).
The vanguard phase demonstrated overall trial feasibility by recruitment rate and protocol adherence, with differences across interventions, leading to a transition to the main BALANCE+ platform trial with minimal protocol modifications.
The treatment of tobacco dependence in patients admitted to hospital is a priority for the National Health Service in England. We aimed to conduct an economic analysis of a pilot ‘opt-out’ tobacco dependence treatment intervention adapted from the Ottawa Model of Smoking Cessation.
Observational cost analysis of an inpatient tobacco dependence treatment intervention, and matched cohort study comparing readmission costs between patients who received the intervention and benchmarked equivalents who did not.
11 acute inpatient wards in a major teaching hospital in London, England.
673 patients who smoked, admitted between 1 July 2020 and 30 June 2021.
The intervention consisted of the systematic identification of smoking status, automatic referral to tobacco dependence advisors, provision of pharmacotherapy and behavioural support throughout the hospital stay and telephone support for 6 months after discharge.
The primary outcomes were cost-per-patient, cost-per-quit and incremental cost effectiveness ratio among patients who received the intervention. The secondary outcomes were patient-level readmission costs and bed-days from 6 months after discharge, compared between the intervention group and a group of matched benchmark patients who smoked but did not receive the intervention.
The total cost of the intervention was £178 105. On the basis of 104 patients who reported not smoking at 6 months, the cost-per-quit was £1712.55, equating to an estimated age-adjusted incremental cost per life year gained of £3325. Among 611 patients who were successfully matched to a benchmark cohort, readmissions for patients in the intervention group cost £492 k less than their benchmark equivalents over 21 months from 1 January 2021 to 30 September 2022 (£266 k vs £758 k), incurred 414 fewer bed days (303 vs 717) and readmitted at a lower rate (5% vs 11%). There were reduced readmission rates and costs among all patients who received the intervention compared with their benchmarked equivalents, regardless of smoking status at 6 months, except among those who opted out.
A pilot ‘opt-out’ tobacco dependence treatment intervention implemented in an acute hospital setting in London demonstrated value for money through reduced readmission rates and costs among all patients who received it.