Search Results for: Short Acting Opioid

The Teachable Moment titled “Opioid-Induced Adrenal Insufficiency,” published online on May 13, 2024, and in the July 2024 issue, was corrected to fix an error in the unit of measurement for serum cortisol values. Where it previously read “6.6, 17.2, and 19.2 μg/mL,” it now correctly reads “6.6, 17.2, and 19.2 μg/dL.” This article was corrected online.

This cross-sectional study examines prescription claims for contraceptives and medications for opioid use disorder among commercially insured women in the US from 2016 to 2021.

Introduction
Remimazolam is a novel short-acting benzodiazepine that exhibits sedative and hypnotic properties without compromising respiratory function and while maintaining haemodynamic stability. Its safety and efficacy have been demonstrated to be non-inferior to those of propofol in the context of general anaesthesia. Nevertheless, the non-inferiority in terms of postoperative recovery quality in obese patients has not been established. Thus, we conducted a prospective, randomised, parallel-group, non-inferiority study to compare remimazolam-based general anaesthesia with propofol-based general anaesthesia on the postoperative quality of recovery (QoR) in patients undergoing laparoscopic sleeve gastrectomy.

Methods and analysis
All participants meeting the included criteria will be enrolled after signing an informed consent form. Patients will be randomly allocated to either the propofol group (n=63; induction and maintenance with propofol) or the remimazolam group (n=63; induction and maintenance with remimazolam). The primary endpoint of the study is the 15-item QoR Scale assessed at 24 hours postoperatively. Secondary endpoints include the doses of anaesthetic required for loss of consciousness (LOC), the time to LOC, the time to recovery of consciousness, the total amount of anaesthetic administered during the surgery and the incidence of hypotension and bradycardia. Additionally, postoperative profiles of pain, nausea and vomiting, delirium, intraoperative awareness, adverse events and patient satisfaction will be collected. Statistical analyses will be performed using IBM SPSS Statistics V.26.0 and GraphPad Prism V.5.01. Statistical significance is set at two-sided p values

Introduction
Children having surgery, and their parents, commonly have anxiety in the preoperative period, and this may impact longer-term health and quality of life. Psychological preparation can be expensive and time-consuming, and the type and effectiveness of preparatory interventions are variable. The aim of this randomised controlled trial (RCT) is to evaluate the clinical effectiveness of a preoperative smartphone psychological preparation application with virtual reality (VR) capability (the ‘Little Journey app’ (LJ)), at reducing anxiety and its sequelae in children and their carers.

Methods and analysis
Multicentre, assessor-blinded, two-armed, parallel group, RCT in children aged between 3 and 12 years, undergoing ambulatory surgery and receiving their first general anaesthetic. Randomisation is one-to-one between an intervention and a control arm. Participants in the intervention arm are provided with access to the LJ app and a low-cost cardboard VR headset (to be used with a smartphone) to use in the weeks leading up to their operation. Children in the control arm receive the same VR headset and suggestions of unrelated VR games to play, but no access to the LJ app. To improve accessibility, smart devices are provided to children whose families do not have a smart phone, and the app content has been translated from English into multiple languages. Both groups receive standard perioperative care at the hospital where they are having treatment. The primary outcome measure is the modified Yale Preoperative Anxiety Scale-Short Form applied by independent blinded observers, immediately before induction of general anaesthesia. Secondary outcomes include process measures, psychological and socioeconomic outcomes for both children and parents/carers. The planned sample size was 304 participants, including an anticipated 15% attrition rate. An interim analysis was conducted when the trial was temporarily paused because of the COVID-19 pandemic, at which point 119 participants had been recruited. The trial steering committee and data monitoring committee recommended continuation of the trial, but the sample size was increased to 596 to account for differences between the previously anticipated and actual outcomes of recruited participants.

Ethics and dissemination
The study was approved by Surrey Borders—Research Ethics Committee 251219, and all participating sites were in England. Results will be presented in academic manuscripts and presentations and summarised for diverse audiences (including clinicians and patients/public) in podcasts, infographics and other multimedia formats.

Trial registration number
NCT03797716.

Objectives
The Victorian Healthy Homes Program investigated the impact of thermal home upgrades on energy and health outcomes in vulnerable, older individuals over winter in Victoria, Australia.

Design
A staggered parallel-group randomised control trial design of 984 (764 per protocol (PP)) vulnerable households and 1313 (1015 PP) individuals. The intervention group received their upgrade prior to their winter of recruitment, and the control group received their upgrade after the winter of their recruitment.

Setting
Western Melbourne (metropolitan) and the Goulburn Valley (regional) in Victoria, Australia.

Participants
1000 households were recruited: 800 from western Melbourne (metropolitan) and 200 from the Goulburn Valley (regional).

Intervention
A thermal comfort and home energy efficiency upgrade of up to $AUD3500 per household.

Primary and secondary outcome measures
The primary outcome was the change in indoor temperature over winter and the secondary outcomes were changes in quality of life, healthcare use and costs, self-reported health measures, energy use and costs and humidity.

Results
A relatively low-cost and simple home upgrade (average cost $A2809) resulted in reduced gas consumption (–25.5 MJ/day) and increased indoor winter temperatures (average daily increase of 0.33°C), and a reduction of exposure to cold conditions (

Introduction
Rapid changes in technology, communication and transportation prompted challenges in achieving the recommended level of physical activity. Although the students are returning for in-campus classes to promote more interaction and socialisation, the youth still fall short of living up to the desired level of physical activity. The mode of transportation plays a pivotal role in physical activity, yet its relationship is poorly elucidated. The aim of the study is to explore the relationship between the types of transportation and the level of physical activity among senior high school students aged 16–18 from the University of Santo Tomas.

Methods and analysis
This will be an observational, cross-sectional, analytical study design. Participants’ demographics and anthropometric measurements such as height, weight and hip and waist circumferences will be collected. To measure the variables of interest, the International Physical Activity Questionnaire and Global Physical Activity Questionnaire will be used. Descriptive statistics will be used to characterise the samples using frequency, mean, median and SD, while inferential statistics such as analysis of variance for comparison and Pearson’s and Spearman for correlation will be used. All analysis will be done using IBM Statistical Packages for Social Sciences V.23 with the significant level set at alpha 0.05.

Ethics and dissemination
Ethical approval was obtained from the University of Santo Tomas—College of Rehabilitation Sciences Ethics Review Committee with the protocol number SI-2023–029. The study will comply with the principles of the Declaration of Helsinki, Ethical Guidelines on Health-Related Social Research of the Philippine Health Research Ethics Board and the Data Privacy Act 2012. All results, regardless of outcome, whether positive or negative, will be accessible through publication and by reporting to the participant through email and other relevant authorities.

Objectives
This objectives of this study were to determine the effectiveness of clinical healthcare interventions designed for improving the work participation of patients with various health conditions and identify promising elements within these interventions.

Design
A systematic literature search was conducted, and a synthesis of systematic reviews (SRs) was performed.

Data sources
MEDLINE, Embase, Cochrane Library and CINAHL were searched for articles published from January 2012 to December 2023.

Eligibility criteria
SRs of randomised controlled trials evaluating the effectiveness of interventions that aimed at improving work participation initiated within clinical healthcare in patients being treated for various health conditions were included.

Data extraction and synthesis
Two authors independently used standardised methods to search and select SRs, and extract data. Our primary outcome was work participation, which could include return-to-work rate or sick leave duration. We were interested in both short-, medium-, as well as long-term outcomes. Risk of bias was assessed using the AMSTAR-2 tool. We used Grading of Recommendations Assessment, Development, and Evaluation (GRADE) to evaluate the certainty of the evidence and findings were summarised in GRADE evidence profiles. We used a deductive synthesis to identify promising intervention elements.

Results
The health conditions included in the selected SRs were cancer, chronic low back and musculoskeletal pain, coronary heart disease, inflammatory arthritis, complaints of the lumbopelvic region during pregnancy, stroke and traumatic brain injury. Across health conditions, many interventions trended towards small, favourable effects. Moderately certain evidence showed that multidisciplinary and physical interventions enhance work participation at 12 months for people with cancer (risk ratio (RR) 1.23, 95% CI 1.09 to 1.33 and RR 1.23, 95% CI 1.08 to 1.39, respectively), and that multidisciplinary interventions reduce the days of return to work compared with usual care for people with coronary heart disease (40.77 days lower than control, 95% CI –67.19 to –14.35). Low-certainty evidence suggested that multidisciplinary interventions may enhance work participation at 12 months for people with coronary heart disease (RR 1.56, 95% CI 1.23 to 1.98) and reduce the number of sick leave days at 12 months for people with chronic low back pain (82, IQR 51 to 164 vs 175, IQR 91 to 365; p=0.003). Promising elements included (psycho)education, cognitive-behavioural therapy, psychosocial support, group and vocational counselling and physical training.

Conclusions
There is considerable overlap in clinical healthcare interventions that aim to enhance work participation for patients across health conditions. Although their effects on work participation vary, some conditions show favourable response to multidisciplinary interventions. More evidence is needed on developing tailored interventions and evaluating their cost-effectiveness.

PROSPERO registration number
CRD42022346552.

Introduction
Despite the current opioid crisis resulting in tens of thousands of deaths every year, buprenorphine, a medication that can reduce opioid-related mortality, withdrawal, drug use and craving, is still underprescribed in the emergency department (ED) for treatment of opioid use disorder (OUD). The EMergency department-initiated BuprenorphinE for opioid use Disorder (EMBED) trial introduced a clinical decision support (CDS) tool that improved the proportion of ED physicians prescribing buprenorphine but did not affect patient-level rates of buprenorphine initiation. The present trial aims to build on these findings by optimising CDS use through iterative improvements, refined interventions and clinician feedback to enhance OUD treatment initiation in EDs.

Methods and analysis
The Adaptive Decision support for Addiction Treatment (ADAPT) trial employs the Multiphase Optimization Strategy (MOST) framework to refine a multicomponent CDS tool designed to facilitate buprenorphine initiation for OUD in ED settings. Using a pragmatic, learning health system approach in three phases, the trial applies plan–do–study–act cycles for continuous CDS refinement. The CDS will be updated in the preparation phase to reflect new evidence. The optimisation phase will include a 2x2x2 factorial trial, testing the impact of various intervention components, followed by rapid, serial randomised usability testing to reduce user errors and enhance CDS workflow efficiency. In the evaluation phase, the optimised CDS package will be tested in a randomised trial to assess its effectiveness in increasing ED initiation of buprenorphine compared with the original EMBED CDS.

Ethics and dissemination
The protocol has received approval from our institution’s institutional review board (protocol #2000038624) with a waiver of informed consent for collecting non-identifiable information only. Given the minimal risk involved in implementing established best practices, an independent study monitor will oversee the study instead of a Data Safety Monitoring Board. Findings will be submitted to ClinicalTrials.gov, published in open-access, peer-reviewed journals, presented at national conferences and shared with clinicians at participating sites through email notification.

Trial registration number
NCT06799117.

Introduction
Acute pain levels following orthopaedic injury (eg, fracture) are a predictor of the onset of chronic pain, which affects nearly 50% of fracture patients and impairs functional recovery. Among current pharmacological treatments for acute pain, non-steroidal anti-inflammatory drugs have been associated with delayed bone healing, while opioids inhibit effective bone remodelling, increase the risk of pseudarthrosis and carry a high risk of addiction. In light of this, the development of new pain treatments is essential. Cannabidiol (CBD), a non-addictive and non-psychotropic cannabis component stands out as a potential therapeutic agent, given its analgesic and anti-inflammatory properties as well as its potential benefits for bone healing. This randomised controlled trial aims to investigate the effect of acute CBD treatment, compared with placebo, on patients’ self-reported pain, inflammation and well-being following a fracture injury.

Methods and analysis
This is a triple-blind, randomised, placebo-controlled clinical trial. A total of 225 adults aged 18–70 years, who have suffered a long bone fracture and were treated at the Hôpital du Sacré-Coeur de Montréal, will be randomly assigned within 1 week to one of three treatment arms (25 mg or 50 mg of CBD or placebo) for 1 month. The primary outcome will be the difference in the pain score between groups at 1-month follow-up. Secondary outcomes will include measures of persistent pain, inflammation, opioid usage, quality of life, sleep quality, depression, anxiety, cognition and orthopaedic function. Data will be collected at baseline, 1-month and 3-month follow-ups.

Ethics and dissemination
This study obtained a Health Canada licence for use of cannabis products. It has also been approved by Health Canada and the Research Ethics Board of the CIUSSS du Nord-de-l’Île-de-Montréal (Project ID 2025-2105). The findings will be published in a peer-reviewed journal and presented at local, national and international conferences. The trial’s results will be made publicly available on the ClinicalTrials.gov database.

Trial registration number
NCT06448923.

Introduction
Adolescents and young people aged 10–24 years comprise 32% of the total population of Pakistan. Adolescents and young people are a heterogeneous group—in different stages of development, living in different circumstances and with differing and changing needs. Neglect of specific adolescents’ sexual and reproductive health (SRH) needs can pose serious challenges and affect physical and mental health, future employment, economic well-being and adolescents’ ability to reach their full potential. Evidence suggests that adolescents in Pakistan have poor access to SRH services, including access to contraception and limited knowledge of SRH and rights (SRHR), contributing to unplanned pregnancies, very early childbearing, short birth intervals, pregnancy complications, maternal death and disability. Despite recognising adolescence as an important developmental period, research on SRHR needs and access to SRH information among adolescents in Pakistan is scarce. This project will use a participatory action research (PAR) approach based on the principles of public engagement in science and innovation to develop a national SRHR and Family Planning Advocacy Toolkit for adolescents in Pakistan.

Methods and analysis
We will use the PAR framework to guide our study. This research project will be conducted in three stages with cyclical recurring activities involving planning, acting, observing and reflecting, as informed by the PAR framework. The three stages are: (1) establishment of youth advisory groups and identification and prioritisation of SRHR concerns, (2) planning and co-designing an appropriate intervention (ie, SRHR and Family Planning Advocacy Toolkit) and (3) implementation and usability testing of advocacy Toolkit. This project leverages strong, well-established partnerships among researchers, clinicians, lady health workers (LHWs) and adolescent communities living in rural parts of Pakistan.

Ethics and dissemination
This study has received ethics approval from the University of Alberta Research Ethics Board (Pro00129101_REN1) and the Ethics Review Committee at Aga Khan University (2023-8671-26021). We will actively engage adolescent advisory group members, youth partners and LHWs in the dissemination of the Toolkit to ensure that it will reach end users in the rural community. In collaboration with governmental platforms, community non-governmental organisations and educational campaigns, the Toolkit will be disseminated to ensure SRH knowledge is readily available to young adolescents. We will also publish our study findings for peer-reviewed publications, digital stories and conference presentations.

Objectives
Advances in the treatment of opioid use disorder (OUD) have seen the development of long-acting injectable opioid substitutes which could improve outcomes for people with OUD. However, comparative quantitative analysis of individual outcomes is lacking. The present study sought to investigate factors associated with prescribing long-acting injectable buprenorphine (LAIB), and changes in outcome variables compared with oral medication for OUD.

Design
Cross-sectional retrospective analysis of electronic health records.

Setting
Community substance use treatment service Via. Six sites shared their data between 15 August 2022 and 15 August 2023.

Participants
Anonymised data were extracted for 235 people receiving LAIB and 266 people receiving oral medication for OUD.

Primary and secondary outcomes
Prescribing data, sociodemographic information (age, sex, indices of multiple deprivation decile of individual’s residence, primary and secondary substance, number of previous treatment episodes, employment and ethnicity) and treatment outcome profiles (substance use, physical and mental health, quality of life, employment) were extracted and analysed. To examine predictors of receiving LAIB (vs medication for OUD), we conducted logistic regression including the demographic predictors. Psychological health, physical health and quality of life scores were analysed using Welch’s t-tests.

Results
LAIB was associated with positive changes in quality of life between the first and last assessments. Demographic and situational factors were predictors of LAIB initiation, indicating the potential for increasing health inequalities in substance use treatment.

Conclusions
LAIB is associated with changes in quality of life over a 1-year period. Further research is needed to investigate the aetiology of improved well-being and outcomes over time.

Introduction
Human milk plays a crucial role in infants’ nutrition and immunity, with its composition being influenced by different factors. The role of maternal diet on human milk fatty acid composition, especially eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), is well studied. Higher fish intake is associated with higher DHA levels in human milk, while fewer associations have been reported for EPA. Yet, maternal diet’s impact on human milk composition for other nutrients is understudied, and variations in sampling protocols and study quality hinder definitive conclusions on its overall impact. Ethnicity may also impact milk composition, with different dietary habits intertwined with different genetic backgrounds, but also here research lacks standardised protocols. Our study aims to investigate maternal diet, ethnicity, and their association with human milk composition, along with their potential short-term associations with infant health and development, through detailed dietary assessment and by recruiting participants from diverse backgrounds. Understanding these associations could inform the development of tailored nutritional guidelines for mothers and infants, ultimately promoting optimal health and well-being for both. The study design, with its strict sampling procedure, can guide and inspire future studies.

Methods and analysis
We will conduct an observational study involving 120 healthy mothers from three ethnic backgrounds (Chinese, Caucasian and Turkish), exclusively breastfeeding their 2-month-old infants. We will collect human milk samples at two time points and assess maternal dietary intake over 4 days. Additionally, we will collect data on various maternal and child characteristics, including maternal stress, socioeconomic status and health, and infant feeding, sleeping, crying, gastrointestinal health and developmental status.

Ethics and dissemination
The study has been approved by the Medical Ethical Committee Oost-Nederland (NL79447.091.21), and all participants provided written informed consent before entering the study. Findings will be widely disseminated at international conferences and meetings including the annual Nutrition & Growth conference, ESPGHAN, and through publication in scientific peer-reviewed journals.

Trial registration number
ISRCTN registry (ISRCTN35735283).

Introduction
Efforts have focused in recent decades on developing anaesthetic strategies that limit the use of morphine because of its known side effects. This study aims to compare postoperative morphine consumption between opioid-free anaesthesia (OFA) and conventional opioid-based general anaesthesia.

Methods and analysis
Phase III, multicentre, randomised controlled study comparing morphine consumption in the immediate postoperative period (first 48 hours) between OFA and conventional general anaesthesia (CGA). The study is conducted across three French academic cancer centres, with a planned enrolment of 158 patients, randomly assigned (1:1) to the OFA and CGA. The primary outcome is morphine consumption during the first 48 hours postoperatively.

Ethics and dissemination
The study has been approved by the National Research Ethics Committee (CPP, reference number 1-22–036/22.01675.000085) and the French National Agency for Medicines and Health Products Safety (ANSM, reference number MEDAECNAT-2022-04-0057). Written, informed consent to participate will be obtained from all participants. Results will be published in international peer-reviewed journals.

Trial registration number
This trial has been registered in the Clinical Trials in the European Union database (CTIS number: 2024-513308-32-00) and in ClinicalTrials.gov (NCT05439005).

Circulation, Volume 151, Issue 7, Page 490-507, February 18, 2025. Hypertension in pregnancy contributes substantially to maternal morbidity and mortality, persistent hypertension, and rehospitalization. Hypertensive disorders of pregnancy are also associated with a heightened risk of cardiovascular disease, and timely recognition and modification of associated risk factors is crucial in optimizing long-term maternal health. During pregnancy, there are expected physiologic alterations in blood pressure (BP); however, pathophysiologic alterations may also occur, leading to preeclampsia and gestational hypertension. The diagnosis and effective management of hypertension during pregnancy is essential to mitigate maternal risks, such as acute kidney injury, stroke, and heart failure, while balancing potential fetal risks, such as growth restriction and preterm birth due to altered uteroplacental perfusion. In the postpartum period, innovative and multidisciplinary care solutions that include postpartum maternal health clinics can help optimize short- and long-term care through enhanced BP management, screening of cardiovascular risk factors, and discussion of lifestyle modifications for cardiovascular disease prevention. As an adjunct to or distinct from postpartum clinics, home BP monitoring programs have been shown to improve BP ascertainment across diverse populations and to lower BP in the months after delivery. Because of concerns about pregnant patients being a vulnerable population for research, there is little evidence from trials examining the diagnosis and treatment of hypertension in pregnant and postpartum individuals. As a result, national and international guidelines differ in their recommendations, and more studies are needed to bolster future guidelines and establish best practices to achieve optimal cardiovascular health during and after pregnancy. Future research should focus on refining treatment thresholds and optimal BP range peripartum and postpartum and evaluating interventions to improve postpartum and long-term maternal cardiovascular outcomes that would advance evidence-based care and improve outcomes worldwide for people with hypertensive disorders of pregnancy.

Introduction
Glaucoma is one of the most common causes of blindness and affects more than 70 million people worldwide. The disease is characterised by the loss of retinal ganglion cells associated with a progressive optic neuropathy, resulting in an impairment of visual functions, for example, visual field loss. Nowadays, the only modifiable risk factor is the increase in intraocular pressure, and its treatment is to lower this pressure by medication, laser treatment or surgery to avoid disease progression. New methods for preventing and reversing vision loss are thus urgently needed. Several small and two multicentre studies have presented evidence that repetitive transorbital alternating current stimulation (rtACS) can lead to long-lasting visual field improvement. This could open a new and inexpensive therapeutic option for optic atrophy. However, the level of evidence for this method is still fairly rather poor, and further trials are needed. Therefore, this clinical trial aims to prove the effectiveness of rtACS compared with sham stimulation in patients with primary open-angle glaucoma (POAG).

Methods and analysis
VIRON (Vision Restoration in Optic Neuropathy) is a national, multicentre, prospective, randomised, placebo-controlled, double-blind trial with three arms. The primary objective is to assess the effectiveness of rtACS in patients with POAG compared with sham stimulation. The primary outcome is the change in mean defect (MD) in the visual field immediately after 10 sessions of rtACS (days 9, 16 and 23) compared with the values of initial perimetry (days –21 to –14 and 0) after applying electrical stimulation with a classical montage, compared with sham and electrical stimulation using individualised montage. Secondary outcome measures comprise a long-term effect with changes in MD at 24 weeks after stimulation, and data from the National Eye Institute Visual Function-25 and quality of life (Short Form 36) questionnaires. The target population are patients with glaucomatous optic atrophy and significant glaucomatous visual field defects (MD of 5–22 dB) due to POAG.
After randomisation, patients received either classical rtACS (group 1), individual rtACS (group 2) or sham stimulation (group 3) in daily 25 min stimulation sessions in two series of five consecutive days separated by a weekend interval. In group 1, active stimulation will be via the routinely applied montage using two electrodes affixed on the right and left side of the head, next to the eyes, with straightforward fixation. In group 2, the current flow will be individually modelled (MRI-based) to target areas of partial visual field defects by optimising electrode positions in conjunction with an optimised visual fixation direction. Group 3 with sham stimulation will serve as control.
The calculated sample size required to achieve a statistical power of 80% for a relevant effect size and allow for dropouts was 300 (100 per group). The trial has already begun with the first patient in July 2023. The planned recruitment period is 24 months with an estimated end of the study in November 2025 (last patient out). An adjusted extension of the study period is planned.

Ethics and dissemination
VIRON was approved by the Central Ethics Committee of the University Medical Center Göttingen (19 October 2022) and those of the individual participating centres (Bonn: 446/23-EP, Hamburg: 2023-200889-BO-bet, Cologne: 23-1487 and Mainz: 2023-17399-§23b). The study protocol complies with the Declaration of Helsinki, the national medicine device regulation (MDR) laws and the international standards of good clinical practice (GCP).
The study protocol (V.5, 24 November 2023) was designed following the Standard Protocol Items: Recommendations for Interventional Trials guidelines and is registered on https://drks.de/search/de/trial/DRKS00029129.
As study initiatior the University Medical Center Göttingen (UMG) is responsible for data ownership and data management of the VIRON study. The study data will be published within 6 months of the study being completed. After the publication of the primary results, all data are anonymised and published in an open-access journal to ensure access to the data for third parties.

Trial registration number
https://drks.de/search/de/trial/DRKS00029129.

Introduction
The treatment of patients with cardiogenic shock (CS) has been focused historically on single interventions (medical treatments, percutaneous and surgical interventions and, more recently, various temporary mechanical circulatory supports). However, none of these interventions has significantly changed the short-term prognosis of CS. Moreover, considerable interest in interventions applied in the acute setting has not been matched with comprehensive assessment of patients’ long-term follow-up, not only for survival and rehospitalisation but also for quality of life and functional status, recovery from critical illness and its destructive sequelae, and a global evaluation of the overall sustainability of pathways of care. To fill this knowledge gap, the ENIGMA study will be conducted.

Methods and analysis
This is a prospective and retrospective multicentre registry conducted under the scientific coordination of the IRCCS Fondazione Don Gnocchi and funded by the Italian Ministry of Health (PNRR-MCNT2-2023-12377767). Data referring to 2000 patients included in the Altshock registry, the largest multicentre CS registry in Italy, will be analysed. A standardised protocol of high-intensity cardiac rehabilitation has been defined and will be followed by the involved institutions after the inclusion of the first 1000 patients. Where feasible, this new pathway will be implemented in every institution. All the patients enrolled will be evaluated according to the Long-Term Conditions Questionnaire, the Kansas City Cardiomyopathy Questionnaire and a questionnaire on the patient experience at 6-month follow-up, to evaluate real-life comparative effects on patient outcomes and experiences. In conclusion, a health technology assessment (HTA) analysis, grounded in the EUnetHTA Core Model, will be conducted to define the potential multidimensional benefits and effects with regard to the overall economic, organisational and social sustainability of the innovative dedicated pathway. Various data sources will be used to conduct the HTA: (1) literature evidence, to define the evidence-based comparative indicators considering both surgical approaches; (2) real-world anonymised data from the hospitals included in the study, to enable costing of the rehabilitative pathways; and (3) healthcare professionals’ perceptions, defining the perceived added value of the innovative pathway versus the historical one, based on an evaluation scale ranging from –3 to +3.

Ethics and dissemination
The study was approved by the ethical committee (EC) of Lombardy Region (CET 44/24), on 28 May 2024, and is under evaluation by the EC of three other centres. The study protocol will be evaluated for ethics by 10 more centres in January 2025. Study results will be published in peer-reviewed publications and disseminated through conference presentations. The Associazione Nazionale Scompensati Cardiaci (AISC; ‘National Association of Patients with Heart Failure’), the Progetto Vita initiative and the non-profit organisation ‘Heart Helps Heart’ have endorsed the project and will be involved in disseminating information about the project and its outcomes to the general public.

Clinical trial registration number
The ENIGMA-shock study has been registered at ClincialTrials.gov: NCT06572826.