Missed opportunities in hospital quality measurement during the COVID-19 pandemic: a retrospective investigation of US hospitals CMS Star Ratings and 30-day mortality during the early pandemic

Objectives
In the USA and UK, pandemic-era outcome data have been excluded from hospital rankings and pay-for-performance programmes. We assessed the relationship between US hospitals’ pre-pandemic Centers for Medicare and Medicaid Services (CMS) Overall Hospital Star ratings and early pandemic 30-day mortality among both patients with COVID and non-COVID to understand whether pre-existing structures, processes and outcomes related to quality enabled greater pandemic resiliency.

Design and data source
A retrospective, claim-based data study using the 100% Inpatient Standard Analytic File and Medicare Beneficiary Summary File including all US Medicare Fee-for-Service inpatient encounters from 1 April 2020 to 30 November 2020 linked with the CMS Hospital Star Ratings using six-digit CMS provider IDs.

Outcome measure
The outcome was risk-adjusted 30-day mortality. We used multivariate logistic regression adjusting for age, sex, Elixhauser mortality index, US Census Region, month, hospital-specific January 2020 CMS Star rating (1–5 stars), COVID diagnosis (U07.1) and COVID diagnosisxCMS Star Rating interaction.

Results
We included 4 473 390 Medicare encounters from 2533 hospitals, with 92 896 (28.2%) mortalities among COVID-19 encounters and 387 029 (9.3%) mortalities among non-COVID encounters. There was significantly greater odds of mortality as CMS Star Ratings decreased, with 18% (95% CI 15% to 22%; p

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Beating the empty pelvis syndrome: the PelvEx Collaborative core outcome set study protocol

Introduction
The empty pelvis syndrome is a significant source of morbidity following pelvic exenteration surgery. It remains poorly defined with research in this field being heterogeneous and of low quality. Furthermore, there has been minimal engagement with patient representatives following pelvic exenteration with respect to the empty pelvic syndrome. ‘PelvEx—Beating the empty pelvis syndrome’ aims to engage both patient representatives and healthcare professionals to achieve an international consensus on a core outcome set, pathophysiology and mitigation of the empty pelvis syndrome.

Methods and analysis
A modified-Delphi approach will be followed with a three-stage study design. First, statements will be longlisted using a recent systematic review, healthcare professional event, patient and public engagement, and Delphi piloting. Second, statements will be shortlisted using up to three rounds of online modified Delphi. Third, statements will be confirmed and instruments for measurable statements selected using a virtual patient-representative consensus meeting, and finally a face-to-face healthcare professional consensus meeting.

Ethics and dissemination
The University of Southampton Faculty of Medicine ethics committee has approved this protocol, which is registered as a study with the Core Outcome Measures in Effectiveness Trials Initiative. Publication of this study will increase the potential for comparative research to further understanding and prevent the empty pelvis syndrome.

Trial registration number
NCT05683795.

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Efficacy and safety of autologous haematopoietic stem cell transplantation versus alemtuzumab, ocrelizumab, ofatumumab or cladribine in relapsing remitting multiple sclerosis (StarMS): protocol for a randomised controlled trial

Introduction
Autologous haematopoietic stem cell transplantation (aHSCT) is increasingly used as treatment for patients with active multiple sclerosis (MS), typically after failure of disease-modifying therapies (DMTs). A recent phase III trial, ‘Multiple Sclerosis International Stem Cell Transplant, MIST’, showed that aHSCT resulted in prolonged time to disability progression compared with DMTs in patients with relapsing remitting MS (RRMS). However, the MIST trial did not include many of the current high-efficacy DMTs (alemtuzumab, ocrelizumab, ofatumumab or cladribine) in use in the UK within the control arm, which are now offered to patients with rapidly evolving severe MS (RES-MS) who are treatment naïve. There remain, therefore, unanswered questions about the relative efficacy and safety of aHSCT over these high-efficacy DMTs in these patient groups. The StarMS trial (Autologous Stem Cell Transplantation versus Alemtuzumab, Ocrelizumab, Ofatumumab or Cladribine in Relapsing Remitting Multiple Sclerosis) will assess the efficacy, safety and long-term impact of aHSCT compared with high-efficacy DMTs in patients with highly active RRMS despite the use of standard DMTs or in patients with treatment naïve RES-MS.

Methods and analysis
StarMS is a multicentre parallel-group rater-blinded randomised controlled trial with two arms. A total of 198 participants will be recruited from 19 regional neurology secondary care centres in the UK. Participants will be randomly allocated to the aHSCT arm or DMT arm in a 1:1 ratio. Participants will remain in the study for 2 years with follow-up visits at 3, 6, 9, 12, 18 and 24 months postrandomisation. The primary outcome is the proportion of patients who achieve ‘no evidence of disease activity’ during the 2-year postrandomisation follow-up period in an intention to treat analysis. Secondary outcomes include efficacy, safety, cost-effectiveness and immune reconstitution of aHSCT and the four high-efficacy DMTs.

Ethics and dissemination
The study was approved by the Yorkshire and Humber—Leeds West Research Ethics Committee (20/YH/0061). Participants will provide written informed consent prior to any study specific procedures. The study results will be submitted to a peer-reviewed journal and abstracts will be submitted to relevant national and international conferences.

Trial registration number
ISRCTN88667898.

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Errors in Percentage Calculations

In the Original Investigation titled “Prone Positioning During Extracorporeal Membrane Oxygenation in Patients With Severe ARDS: The PRONECMO Randomized Clinical Trial,” published in the December 26, 2023, issue of JAMA, errors in percentages occurred. In the Results of the Abstract and in the Results, Secondary Outcomes, section of the text, the risk difference for 90-day mortality should have been 3.5% with a 95% CI of −12.7% to 19.7%. In Table 1, the numbers of female participants reported were correct but the percentages should have been 27.9% and 42.8% for the prone ECMO and supine ECMO groups, respectively; the number of patients with COVID-19 pneumonia in the supine ECMO group was correct but the percentage should have been 94.0%. This article was corrected online.

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Rh Sensitization and Induced Abortion

To the Editor A recent study posited that analysis of fRBCs in pregnant individuals who had previous induced abortions at less than 12 weeks’ gestational age could be used to recommend discontinuation of Rh immunoglobulin prophylaxis in a subset of patients. While this research provides valuable insights into the complex issue of maternal alloimmunization, it does not establish a clear link between fRBC levels and the most important outcome—hemolytic disease of the fetus and newborn (HDFN). First, the study’s premise relied on the establishment of a specific threshold of fRBC transfer required to induce alloimmunization. While the authors set a “conservative” threshold of 125 fRBCs per 5 million total RBCs, there is uncertainty regarding the exact fRBC concentration necessary to trigger alloimmunization. The 0.1-mL blood volume used as the basis for their development of the threshold of 125 fRBCs per 5 million RBCs was originally derived in a study performed in 1965, in which 0.1 mL of fRBCs was injected every 6 weeks into 15 antibody-free female participants until antibodies were detected. However, subsequent studies showed that alloimmunization occurred after exposure to fewer fRBCs. Notably, sensitization has been reported following apheresis platelets that typically contain 0.0005 mL of fRBCs or less.

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CDC Warns of Low Vaccination Rates Amid Spike in Respiratory Diseases

From November to December 2023, US hospitalization rates increased by 200% for influenza, 51% for COVID-19, and 60% for respiratory syncytial virus (RSV) among all age groups, according to a Centers for Disease Control and Prevention (CDC) advisory. Amid growing concern, the CDC issued the advisory about the low vaccination rates for all 3 respiratory illnesses and developed a vaccination conversation guide with talking points to help clinicians encourage uptake.

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Association of Long COVID with mental health disorders: a retrospective cohort study using real-world data from the USA

Objectives
Mental health disorders (MHD) rank third for US adult hospitalisations. Given the substantial prevalence of ‘Long COVID’ in SARS-CoV-2 survivors, this study aims to assess its association with increased MHD risk using extensive real-world data.

Design
A retrospective cohort study with propensity score matching was conducted. We used the International Classification of Diseases, 10th Revision codes to identify individuals with Long COVID status and COVID-19 histories. Multivariable stratified Cox proportional hazards regression analysis was conducted to determine the association of Long COVID status with MHD.

Setting
Data were sourced from the TriNetX database, spanning records from 1 October 2021 to 16 April 2023.

Participants
Two distinct cohorts were established: one comprising individuals diagnosed with Long COVID and another comprising individuals with no history of Long COVID or COVID-19. At the start of the study, none of the participants had a recorded MHD.

Primary and secondary outcome measures
The main outcome of interest was a composite diagnosis of MHD. Secondary outcomes were individual mental health conditions.

Results
The study included 43 060 control participants without Long COVID and 4306 Long COVID participants, demonstrating well-balanced distribution across all covariates. After adjusting for 4 demographic factors and 10 comorbidities, Long COVID was associated with MHD (adjusted HR, aHR 2.60; 95% CI 2.37 to 2.85). In subgroup analysis, Long COVID was associated with major depression disorder (aHR 3.36; 95% CI 2.82 to 4.00) and generalised anxiety disorder (aHR 3.44; 95% CI 2.99 to 3.96).

Conclusions
In this retrospective large real-world cohort study, Long COVID was associated with an increased risk of incident MHD. The MHD impact is significant considering the vast number of patients with Long COVID. Enhanced MHD screening among COVID-19 survivors should be a priority.

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Correction notice: Depression in older adults during the COVID-19 pandemic: a systematic review protocol

Silva C, Fonseca C, Ferreira R, et al Depression in older adults during the COVID-19 pandemic: a systematic review protocol BMJ Open 2022;12:e065610. doi: 10.1136/bmjopen-2022-065610.
Above mentioned article is revised since it was published as Funding statement is now updated as given below:
The present publication was funded by Fundacão Ciência e Tecnologia, IP national support through CHRC (UIDP/04923/2020)”.

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