JRSM Open最新文献

Objectives: Investigate the additional therapeutic value compared to existing medicines of new oncology drugs given a conditional approval (Notice of Compliance with conditions, NOC/c) by Health Canada using therapeutic ratings from four independent organisations.

Design: A list of all new oncology drugs with an NOC/c from the start of the programme in 1998 to the end of 2023 was constructed. First-in-class and orphan drug status was determined for all drugs. Therapeutic ratings were obtained from the Canadian Patented Medicine Prices Review Board, the French drug bulletin Prescrire International, the French agency Haute Autorité de Santé and the German Institute for Quality and Efficiency in Health Care. If more than one organisation rated the drug, the highest rating was used.

Setting: Canada.

Participants: Oncology drugs with a conditional approval.

Main outcome measures: Additional therapeutic gain compared to existing products.

Results: Fifty-four oncology drugs were approved. Conditions were fulfilled for 29, fulfilment was still pending for 22 and 3 drugs were either discontinued by the manufacturer or placed on restricted access. Eighteen drugs had both orphan drug and first-in-class status. Therapeutic evaluations were available for 50 drugs, and the distribution of additional therapeutic value was examined for the entire group of 50 drugs, for 29 drugs that had fulfilled their conditions and for 18 drugs with both orphan drug and first-in-class status. In the three groups, 8.0%, 10.3% and 11.7%, respectively, offered major therapeutic improvement.

Conclusions: Few new oncology drugs approved through the NOC/c pathway offer major therapeutic improvements over existing drugs.

Objectives: To investigate the drugs and indications that have passed through the UK's Early Access to Medicines Scheme (EAMS) to date, the type of evidence the regulator considers when accepting a drug into the EAMS, and potential risks to patients.

Design: Analysis of publicly available data: MHRA Public Assessment Reports; Electronic Medicines Compendium database; interactive Drug Analysis Profiles database; Eudravigilance database.

Setting: United Kingdom.

Participants: The 51 'scientific opinions' available on the MHRA website in June 2024.

Main outcome measures: Public Assessment Reports, pharmacovigilance data.

Results: After exclusions, there were 48 EAMS submissions, consisting of 48 indications and 32 drugs. 60% of indications were for cancer. Only 7% of EAMS submissions were based on double-blind, placebo-controlled randomised trials. The average sample size of studies conducted for the EAMS was 654. Most studies used surrogate (76%) and/or survival (57%) outcomes. Only 17% used subjective outcomes. For 17% of the indications, no ongoing studies were being conducted. Animal studies were conducted preclinically for all drugs and 35% also conducted in vitro studies. 47% of the drugs had elevated rates of suspected adverse reaction reports according to pharmacovigilance data.

Conclusions: We recommend that the EAMS drugs with elevated reporting rates are reviewed, that future studies of EAMS drugs use patient-centred outcomes, that preclinical studies make greater use of human biology-based approaches, that post-approval trials are conducted, and that future reviews of the EAMS centre the experience of patients.

The delayed onset of thyroid eye disease is well recognised but less commonly perceived in routine clinical practice and this case report serves as a reminder for a high index of suspicion in at-risk patients.

Objective: To explore the psychopathology of the victims of the UK Post Office scandal and the extent to which this can be adequately described by current classification of traumatic stress symptoms.

Design: Standard clinical interviews for the purposes of preparing medico-legal reports.

Setting: Face to face and virtual interviews.

Participants: Victims of the Post Office Scandal, postmaster's and postmistress's wrongly accused of theft.

Main outcome measures: ICD-10 diagnostic criteria.

Results: All the subjects had experienced life changing traumatic reactions which were inadequately captured by current diagnostic criteria.

Conclusions: The current taxonomy of trauma fails to capture the diversity of symptoms experienced by the postmasters and we argue that a formulation based approach should be employed, especially in the court room. There remains inadequate research exploring the impact of wrongful conviction on the mental state of victims.

Chest pain is a symptom that is potentially life-threatening and requires quick and accurate evaluations. This article describes the quality of guidelines related to the evaluation and diagnosis of acute, undifferentiated chest pain. After systematically evaluating existing guidelines, we found that there exists a wide variety of quality in these documents. Future documents that provide recommendations should utilize guideline evaluation tools during the creation process to ensure a high-quality product, regardless of document type.

Objectives: Evaluating the outcomes of enhanced case management (ECM) for patients with tuberculosis (TB) in the North Central London TB Service (NCLTBS).

Design: Retrospective cohort study.

Setting: The NCLTBS provides care for persons diagnosed with TB across north and central London. Management involves both medical and psychosocial support, leading to the implementation ECM to provide additional non-clinical assistance to patients at risk of treatment non-completion. However, there has been limited evaluation of its outcomes.

Participants: All adults with TB notified to NCLTBS between January 2013 and June 2021.

Main outcome measures: Descriptive socio-economic and clinical characteristics grouped by binary ECM status (yes/no) and level (0-3). Clinical outcomes at 12 months (completed treatment, death, lost-to-follow-up, continuing on treatment) were compared using multivariable logistic regression.

Results: Totally, 2437 patients were included (57.2% male, 79.1% born outside the UK). Overall, 82.3% completed treatment and 4.1% died. Factors associated with mortality included older age (over 70 years odds ratio (OR) 3.3), inpatient diagnosis (OR 4.4), and mental health issues (OR 2.2). 52.8% received ECM, with the proportion increasing over time, and 76% of this group successfully competed treatment.

Conclusions: This comprehensive evaluation of ECM in a diverse London population indicates high treatment completion rates even among those with multiple social risk factors. However, ECM needs of patients has increased over time, with a particular rise in patients requiring the highest support level. Given the small difference between standard care and ECM categories 1 and 2, there may be scope to simplify the system.

Objectives: To assess how ethnicity, migration status and occupation are associated with healthcare workers (HCW) redeployment experiences during COVID-19 in a nationwide ethnically diverse sample.

Design: A cross-sectional analysis using data from the nationwide United Kingdom Research Study into Ethnicity And COVID-19 outcomes in Healthcare workers (UK-REACH) cohort study.

Setting: Healthcare settings.

Participants: Healthcare workers (HCW).

Main outcome measures: Outcome measures included redeployment, provision of training and supervision during redeployment, change in patient contact and interaction with COVID-19 patients.

Methods: We used logistic regression to examine associations of ethnicity, migration status, and occupation with redeployment experiences of HCWs.

Results: Of the 10,889 HCWs included, 20.4% reported being redeployed during the first UK national lockdown in March 2020. Those in nursing roles (Odds Ratio (OR) 1.22, 95% Confidence Interval (CI) 1.04-1.42, p = 0.009) (compared to medical roles) had higher likelihood of being redeployed as did migrants compared to those born in the UK (OR 1.26, 95% CI 1.06-1.49, p = 0.01) (in a subcohort of HCWs on the agenda for change (AfC) pay scales). Asian HCWs were less likely to report receiving training (OR 0.66, 95% CI 0.50-0.88, p = 0.005) and Black HCWs (OR 2.02, 95% CI 1.14-3.57, p = 0.02) were more likely to report receiving supervision, compared to White colleagues. Finally, redeployed Black (OR 1.33, 95% CI 1.07-1.66, p = 0.009) and Asian HCWs (OR 1.30, 95% CI 1.14-1.48, p < 0.001) were more likely to report face-to-face interaction with COVID-19 patients than White HCWs.

Conclusions: Our findings highlight disparities in HCWs' redeployment experiences by ethnicity, migration, and job role which are potentially related to structural inequalities in healthcare.

Post-stroke spasticity and contracture remain prevalent and pose significant challenges in stroke rehabilitation. While non-surgical management is the mainstay, surgical reconstruction offers a valuable adjunct when conservative measures are exhausted. This clinical review article provides an overview of surgical reconstruction for limb spasticity and contracture following adult stroke, encompassing the rationale and specifics of these interventions. It highlights the underutilization of surgical reconstruction in rehabilitation of adult stroke patients with spasticity and contracture, and the importance of multidisciplinary collaboration including surgeons in stroke rehabilitation to optimize functional outcomes.

Objectives: To investigate long COVID (LC) symptoms self-reported via a digital application. Explore associations between various demographic factors and intensity of LC symptoms.

Design: A retrospective case series study. We analysed self-reported symptoms from 1008 individuals with LC between November 30, 2020, and March 23, 2022.

Setting: England and Wales.

Participants: Individuals with LC using the healthcare application in 31 post-COVID-19 clinics and self-reporting LC symptoms.

Main outcome measures: Highest reported LC symptoms, associations with demographic factors and intensity of symptoms.

Results: 109 symptom categories were identified, with pain (26.5%), neuropsychological issues (18.4%), fatigue (14.3%) and dyspnoea (7.4%) the most prevalent. The intensity of reported symptoms increased by 3.3% per month since registration. Age groups 68-77 and 78-87 experienced higher symptom intensity (32.8% and 86% higher, respectively) compared to the 18-27 age group. Women reported 9.2% more intense symptoms than men, and non-white individuals with LC reported 23.5% more intense symptoms than white individuals with LC. Higher education levels (national vocational qualification (NVQ) 3 to NVQ 5) were associated with less symptom intensity (27.7%, 62.8% and 44.7% less, respectively) compared to the least educated (NVQ 1-2). People in less deprived areas had less intense symptoms than those in the most deprived area. No significant association was found between index of multiple deprivation (IMD) decile and number of symptoms.

Conclusion: Treatment plans must prioritise addressing prevalent LC symptoms; we recommend sustained support for LC clinics. Demographic factors significantly influence symptom severity, underlining the need for targeted interventions. These findings can inform healthcare policies to better manage LC.

Racial microaggressions are subtle and everyday actions that communicate derogatory messages or assumptions based on an individual's race. These seemingly minor acts, often unintended, can accumulate to undermine patient well-being and contribute to healthcare disparities. They are the unnoticed comments, gestures, or attitudes that carry significant impact. Through a systematic analysis of the literature, we highlight the insidious nature of racial microaggressions and their impact on healthcare outcomes. The objectives of this paper are to: • Present real-life instances from research to showcase the tangible effects of racial microaggressions. • Identify the everyday scenarios within healthcare interactions where racial microaggressions often occur. • Emphasise the need for recognition and understanding of these biases for fostering better patient-provider relationships. Also, by analysing the fundamental elements underpinning racial microaggressions such as systems, interactions, vulnerabilities and consequences, we explore the implications it has on healthcare policy and management. Most importantly, we address the importance of identifying and tackling racial microaggressions in order to create a more inclusive healthcare environment.