Cost-effectiveness of methenamine hippurate compared with antibiotic prophylaxis for the management of recurrent urinary tract infections in secondary care: a multicentre, open-label, randomised, non-inferiority trial

Objectives
To estimate the cost-effectiveness of methenamine hippurate compared with antibiotic prophylaxis in the management of recurrent urinary tract infections.

Design
Multicentre, open-label, randomised, non-inferiority trial.

Setting
Eight centres in the UK, recruiting from June 2016 to June 2018.

Participants
Women aged ≥18 years with recurrent urinary tract infections, requiring prophylactic treatment.

Interventions
Women were randomised to receive once-daily antibiotic prophylaxis or twice-daily methenamine hippurate for 12 months. Treatment allocation was not masked and crossover between arms was allowed.

Primary and secondary outcome measures
The primary economic outcome was the incremental cost per quality-adjusted life year (QALY) gained at 18 months. All costs were collected from a UK National Health Service perspective. QALYs were estimated based on responses to the EQ-5D-5L administered at baseline, 3, 6, 9, 12 and 18 months. Incremental costs and QALYs were estimated using an adjusted analysis which controlled for observed and unobserved characteristics. Stochastic sensitivity analysis was used to illustrate uncertainty on a cost-effectiveness plane and a cost-effectiveness acceptability curve. A sensitivity analysis, not specified in the protocol, considered the costs associated with antibiotic resistance.

Results
Data on 205 participants were included in the economic analysis. On average, methenamine hippurate was less costly (–£40; 95% CI: –684 to 603) and more effective (0.014 QALYs; 95% CI: –0.05 to 0.07) than antibiotic prophylaxis. Over the range of values considered for an additional QALY, the probability of methenamine hippurate being considered cost-effective ranged from 51% to 67%.

Conclusions
On average, methenamine hippurate was less costly and more effective than antibiotic prophylaxis but these results are subject to uncertainty. Methenamine hippurate is more likely to be considered cost-effective when the benefits of reduced antibiotic use were included in the analysis.

Trial registration number
ISRCTN70219762.

Leggi
Aprile 2024

Access to innovative anticancer medicines in China: a national survey on availability, price and affordability

Objectives
This study aimed to investigate the availability, price, and affordability of nationally negotiated innovative anticancer medicines in China.

Design
Retrospective observational study based on data from a nationwide medical database.

Data sources/setting
Quarterly data about the use of innovative anticancer medicines from 2020 to 2022 were collected from the Chinese Medicine Economic Information Network. This study covered 895 public general hospitals in 30 provincial administrative regions in China. Of the total hospitals, 299 (33.41%) were secondary and 596 (66.59%) were tertiary.

Main outcome measures
The adjusted WHO and Health Action International methodology was used to calculate the availability and affordability of 33 nationally negotiated innovative anticancer medicines in the investigated hospitals. Price is expressed as the defined daily dose cost.

Results
On average, the total availability of 33 innovative anticancer medicines increased annually from 2020 to 2022. The median availability of all investigated medicines in tertiary hospitals from 2020 to 2022 was 24.04%, 33.60% and 37.61%, respectively, while the indicators in secondary hospitals were 4.90%, 12.54% and 16.48%, respectively. The adjusted prices of the medicines newly put in Medicare (in March 2021) decreased noticeably, with the decline rate ranging from 39.98% to 82.45% in 2021 compared with those in 2020. Most generic brands were priced much lower than the originator brands. The affordability of anticancer medicines has improved year by year from 2020 to 2022. In comparison, rural residents had lower affordability than urban residents.

Conclusions
The overall accessibility of 33 nationally negotiated innovative anticancer medicines improved from 2020 to 2022. However, the overall availability of most anticancer medicines in China remained at a low level (less than 50%). Further efforts should be made to sufficiently and equally benefit patients with cancer.

Leggi
Aprile 2024

Swissped-RECOVERY: masked independent adjudication for the interpretation of non-randomised treatment in a two-arm open-label randomised controlled trial (methylprednisolone vs immunoglobulins) in Paediatric Inflammatory Multisystem Syndrome Temporally Associated with SARS-CoV-2 (PIMS-TS) involving 10 secondary and tertiary paediatric hospitals in Switzerland

Objectives
In trials of acute severe infections or inflammations frequent administration of non-randomised treatment (ie, intercurrent event) in response to clinical events is expected. These events may affect the interpretation of trial findings. Swissped-RECOVERY was set up as one of the first randomised controlled trials worldwide, investigating the comparative effectiveness of anti-inflammatory treatment with intravenous methylprednisolone or intravenous immunoglobulins in children and adolescents with Paediatric Inflammatory Multisystem Syndrome Temporally Associated with SARS-CoV-2 (PIMS-TS). We present one approach towards improving the interpretation of non-randomised treatment in a randomised controlled trial.

Design
This is a pre-planned ancillary analysis of the Swissped-RECOVERY trial, a randomised multicentre open-label two-arm trial.

Setting
10 Swiss paediatric hospitals (secondary and tertiary care) participated.

Participants
Paediatric patients hospitalised with PIMS-TS.

Interventions
All patient-first intercurrent events, if applicable, were presented to an independent adjudication committee consisting of four international paediatric COVID-19 experts to provide independent clinical adjudication to a set of standardised questions relating to whether additional non-randomised treatments were clinically indicated and disease classification at the time of the intercurrent event.

Results
Of 41 treatments in 75 participants (24/41 (59%) and 17/41 (41%) in the intravenous methylprednisolone and immunoglobulin arms of the trial, respectively), two-thirds were considered indicated. The most common treatment (oral glucocorticoids, 14/41, 35%) was mostly considered not indicated (11/14, 79%), although in line with local guidelines. Intercurrent events among patients with Shock-like PIMS-TS at baseline were mostly considered indicated. A significant proportion of patients with undifferentiated PIMS-TS at baseline were not attributed to the same group at the time of the intercurrent event (6/12 unchanged, 4/12 Kawasaki disease-like, 2/12 Shock-like).

Conclusion
The masked adjudication of intercurrent events contributes to the interpretation of results in open-label trials and should be incorporated in the future.

Trial registration numbers
SNCTP000004720 and NCT 04826588.

Leggi
Aprile 2024

Is a smartphone application (BlueIce) acceptable and safe for university students who self-harm: an open study

Background
Many university students self-harm but few receive support. Smartphone apps have been identified as acceptable sources of support for students who self-harm, but the use of supportive self-harm apps is yet to be explored in this population.

Objective
This study sought to explore the acceptability and safety of a specific app (BlueIce) for university students who self-harm.

Methods
This was an exploratory, mixed methods study with 15 university students attending university well-being services with self-harming thoughts and/or behaviours. BlueIce was offered alongside the face-to-face support provided by the well-being service. Self-harming thoughts and behaviours, coping self-efficacy, and symptoms of anxiety and depression were measured before and after using BlueIce for 6 weeks. Follow-up interviews were also undertaken to explore how students perceived BlueIce in more depth.

Results
Following app use, there were statistically significant reductions in symptoms of anxiety (baseline M 12.47, SD 4.42; follow-up M 10, SD 4.16) t(14)=2.26, p=0.040, d=0.58 and depression (baseline M 16.5, SD 5.17, follow-up M 12.27, SD 3.66) t(13)=5.50, p

Leggi
Aprile 2024

Is Equity Being Traded for Access to Heart Transplant?

Disparities in care and outcomes are common, complex problems and are well illustrated by heart failure, from the initial diagnosis to the treatment of advanced disease. In the US, Black individuals develop heart failure at a much younger age than individuals of other races, and the incidence for Black individuals is 50% higher than that for White individuals. Although the age-adjusted hospitalization rate for Black patients with heart failure in the US has decreased over the past 20 years, it was still approximately 2.2 times the rate for White patients in 2018. There is also a concern for disparities in unrecognized heart failure among Black patients and among female patients, as they are more likely to be diagnosed in the acute care setting despite having symptoms for months before diagnosis. The increased risk extends to those with end-stage heart failure, with Black patients accounting for 26.5% of hospitalizations coded as end-stage heart failure (2017-2020), which is double their 12.1% share of the overall US population in the 2020 US census.

Leggi
Aprile 2024

Correction for 'multicentre, open-label, randomised, controlled trial to compare early intervention with calcimimetics and conventional therapy in preventing coronary artery calcification in patients with secondary hyperparathyroidism (UPCOMING): a study protocol

This article has been corrected since it was published online. The authors wish to add a statement about the sharing of data for this trial, in line with BMJ Open’s policy on data sharing.
The jRCT registry (the registry where information for this trial is listed) provides a section on data sharing, which is titled “Plan to share IPD” (individual participant data), and the authors had already filled out this section when initially registering the study. The jRCT system only makes this section publicly available after the study is complete. Data generated from our study and any other necessary materials will be made available on reasonable request to the corresponding author.

Leggi
Aprile 2024

Impact of an ICU bed capacity optimisation method on the average length of stay and average cost of hospitalisation following implementation of Chinas open policy with respect to COVID-19: a difference-in-differences analysis based on information management system data from a tertiary hospital in southwest China

Objectives
Following the implementation of China’s open policy with respect to COVID-19 on 7 December 2022, the influx of patients with infectious diseases has surged rapidly, necessitating hospitals to adopt temporary requisition and modification of ward beds to optimise hospital bed capacity and alleviate the burden of overcrowded patients. This study aims to investigate the effect of an intensive care unit (ICU) bed capacity optimisation method on the average length of stay (ALS) and average cost of hospitalisation (ACH) after the open policy of COVID-19 in China.

Design and setting
A difference-in-differences (DID) approach is employed to analyse and compare the ALS and ACH of patients in four modified ICUs and eight non-modified ICUs within a tertiary hospital located in southwest China. The analysis spans 2 months before and after the open policy, specifically from 5 October 2022 to 6 December 2022, and 7 December 2022 to 6 February 2023.

Participants
We used the daily data extracted from the hospital’s information management system for a total of 5944 patients admitted by the outpatient and emergency access during the 2-month periods before and after the release of the open policy in China.

Results
The findings indicate that the ICU bed optimisation method implemented by the tertiary hospital led to a significant reduction in ALS (HR –0.6764, 95% CI –1.0328 to –0.3201, p=0.000) and ACH (HR –0.2336, 95% CI –0.4741 to –0.0068, p=0.057) among ICU patients after implementation of the open policy. These results were robust across various sensitivity analyses. However, the effect of the optimisation method exhibits heterogeneity among patients admitted through the outpatient and emergency channels.

Conclusions
This study corroborates a significant positive impact of ICU bed optimisation in mitigating the shortage of medical resources following an epidemic outbreak. The findings hold theoretical and practical implications for identifying effective emergency coordination strategies in managing hospital bed resources during sudden public health emergency events. These insights contribute to the advancement of resource management practices and the promotion of experiences in dealing with public health emergencies.

Leggi
Aprile 2024

Restrictive use of Restraints and Delirium Duration in the Intensive Care Unit (R2D2-ICU): protocol for a French multicentre parallel-group open-label randomised controlled trial

Introduction
Physical restraint (PR) is prescribed in patients receiving invasive mechanical ventilation in the intensive care unit (ICU) to avoid unplanned removal of medical devices. However, it is associated with an increased risk of delirium. We hypothesise that a restrictive use of PR, as compared with a systematic use, could reduce the duration of delirium in ICU patients receiving invasive mechanical ventilation.

Methods and analysis
The Restrictive use of Restraints and Delirium Duration in ICU (R2D2-ICU) study is a national multicentric, parallel-group, randomised (1:1) open-label, controlled, superiority trial, which will be conducted in 10 ICUs. A total of 422 adult patients requiring invasive mechanical ventilation for an expected duration of at least 48 hours and eligible for prescription of PR will be randomly allocated within 6 hours from intubation to either the restrictive PR use group or the systematic PR use group, until day 14, ICU discharge or death, whichever comes first. In both groups, PR will consist of the use of wrist straps. The primary endpoint will be delirium or coma-free days, defined as the number of days spent alive in the ICU without coma or delirium within the first 14 days after randomisation. Delirium will be assessed using the Confusion Assessment Method-ICU twice daily. Key secondary endpoints will encompass agitation episodes, opioid, propofol, benzodiazepine and antipsychotic drug exposure during the 14-day intervention period, along with a core outcome set of measures evaluated 90 days postrandomisation.

Ethics and dissemination
The R2D2-ICU study has been approved by the Comité de Protection des Personnes (CPP) ILE DE FRANCE III—PARIS (CPP19.09.06.37521) on June 10th, 2019). Participant recruitment started on 25 January 2021. Results will be published in international peer-reviewed medical journals and presented at conferences.

Trial registration number
NCT04273360.

Leggi
Aprile 2024

Systematic RADaR analysis of responses to the open-ended question in the Culture of Care Barometer survey of a Dutch hospital

Objectives
Systematically measuring the work environment of healthcare employees is key to continuously improving the quality of care and addressing staff shortages. In this study, we systematically analyse the responses to the one open-ended question posed in the Dutch version of the Culture of Care Barometer (CoCB-NL) to examine (1) if the responses offered new insights into healthcare employees’ perceptions of their work environment and (2) if the original CoCB had any themes missing.

Design
Retrospective text analysis using Rigorous and Accelerated Data Reduction technique.

Setting
University hospital in the Netherlands using the CoCB-NL as part of the annual employee survey.

Participants
All hospital employees were invited to participate in the study (N=14 671). In total, 2287 employees responded to the open-ended question.

Results
2287 comments were analysed. Comments that contained more than one topic were split according to topic, adding to the total (n=2915). Of this total, 372 comments were excluded because they lacked content or respondents indicated they had nothing to add. Subsequently, 2543 comments were allocated to 33 themes. Most comments (n=2113) addressed the 24 themes related to the close-ended questions in the CoCB-NL. The themes most commented on concerned questions on ‘organisational support’. The remaining 430 comments covered nine additional themes that addressed concerns about work environment factors (team connectedness, team effectiveness, corporate vision, administrative burden and performance pressure) and themes (diversity and inclusion, legal frameworks and collective bargaining, resilience and work–life balance, and personal matters).

Conclusions
Analysing responses to the open-ended question in the CoCB-NL led to new insights into relevant elements of the work environment and missing themes in the COCB-NL. Moreover, the analysis revealed important themes that not only require attention from healthcare organisations to ensure adequate improvements in their employees’ work environment but should also be considered to further develop the CoCB-NL.

Leggi
Aprile 2024

Impact of pandemic-related movement restriction on public access defibrillation in Japan: a retrospective cohort study

Objectives
To analyse monthly changes in public access defibrillation (PAD) incidence and outcomes of out-of-hospital cardiac arrest (OHCA) during the 2020–2021 COVID-19 pandemic compared with those during the 2016–2019 prepandemic period with consideration of pandemic-related movement restriction.

Design
Retrospective cohort study.

Setting
An extended database was created by combining and reconciling the nationwide Utstein-style OHCA and the emergency medical service (EMS) transportation databases in Japan.

Participants
We analysed 226 182 EMS-witnessed, non-newborn and out-of-home OHCA cases in Japan.

Primary and secondary outcome measures
The primary outcomes were the PAD incidence and neurologically favourable 1-month survival rate. The secondary outcomes were bystander cardiopulmonary resuscitation (CPR) provision and dispatcher-assisted CPR attempts.

Results
The proportion of out-of-home OHCA cases slightly decreased during the pandemic (from 33.7% to 31.9%). Although the pandemic was associated with a decreased PAD incidence, 2-year trend analyses by an interaction test showed that the PAD incidence was lower during the first nationwide declaration of a state of emergency (p

Leggi
Aprile 2024