Immunoglobulin Replacement Therapy During COVID-19 Pandemic: Practical and Psychological Impact in Patients with Antibody Deficiency.

PURPOSE: The COVID-19 pandemic has impacted on how health services deliver care and the mental health of the population. Due to their clinical vulnerability, to reduce in-hospital attendances during the COVID-19 pandemic, modifications in immunoglobulin treatment regimens were made for patients with antibody deficiency. These patients were also likely to experience social isolation due to shielding measure that were advised. We aimed to investigate the impact of modifying immunoglobulin treatment regimen on infection and mental health burden during shielding restrictions. METHOD: Patients on immunoglobulin replacement therapy (IGRT) responded to a standardised questionnaire examining self-reported infection frequency, anxiety (GAD-7), depression (PHQ-8), fatigue (FACIT), and quality of life during the pandemic. Infection frequency and immunoglobulin trough levels were compared to pre-pandemic levels. RESULTS: Patients who did not change treatment modality or those who received immunoglobulin replacement at home during the pandemic reported fewer infections. In patients who received less frequent hospital infusions, there was no significant increase in infections whilst immunoglobulin trough levels remained stable. There was no significant difference in anxiety, or depression scores between the treatment modality groups. Patients reported higher fatigue scores compared to the pre-COVID general population and in those discharged following hospitalisation for COVID. CONCLUSION: Changing immunoglobulin treatment regimen did not negatively impact infection rates or psychological wellbeing. However, psychological welfare should be prioritised for this group particularly given uncertainties around COVID-19 vaccination responsiveness and continued social isolation for many.

Alcohol identification and intervention in English emergency departments.

AIMS: In the ED, alcohol identification and brief advice is an effective method of reducing consumption and related harms. Our objective was to conduct a national survey of English EDs to determine current practice regarding alcohol identification and provision of brief advice and to compare changes in activity to a previous National Survey conducted in 2011. METHODS: This was a cross-sectional survey of all consultant-led EDs in England. RESULTS: Of 180 departments, 147 (81.6%) responded. All departments may question adult patients about their alcohol consumption, with many (63.6%) asking all patients aged over 18 years as part routine care and using a formal screening tool (61.4%). The majority of departments asked young people (aged 11-17 years) about their consumption (83.8%), but only 11.6% did so as a part of routine practice. Compared with the 2011 survey, there have been significant increases in routine screening among adults (15.9%, CI 4.16% to 27.18%; p=0.006), general practitioners being informed about patients'alcohol-related presentations (10.2%, CI 0.64% to 19.58%; p=0.028) and access to an alcohol health worker or a clinical nurse specialist (13.4%, CI 3.64% to 22.91%, p=0.005). Modest (non-significant) changes were also found in access to training on brief advice (9.7%) and the use of formal screening questions on adult patients (9.7%). CONCLUSION: Alcohol screening together with referral or intervention is becoming part of routine practice in England. Compared with our previous national survey, increases in alcohol screening and intervention activity are demonstrated, with improvements in routine questioning (among adults), the number of general practitioners being informed about alcohol-related attendances, provision of training, access to specialist services and the use of formal screening tools.

Bifeprunox versus placebo for schizophrenia.

BACKGROUND: Bifeprunox is a novel antipsychotic drug designed to treat schizophrenia. However, research into the drug was ceased in 2009 due to rejection of licence to go to market by the US Food and Drug Administration (FDA), who could not approve the drug for acute or long-term symptoms of schizophrenia because more research was required to demonstrate convincing effects "beyond those already achieved" with currently licenced drugs. There were also concerns expressed over one death of a person whilst on the drug. OBJECTIVES: To investigate the clinical and adverse effects of bifeprunox for people with schizophrenia. SEARCH METHODS: We searched the Cochrane Schizophrenia Group's Trials Register on 23 October 2015, which is based on regular searches of MEDLINE, EMBASE, CINAHL, BIOSIS, AMED, PubMed, PsycINFO, and clinical trials registries. There are no language, date, document type, or publication status limitations for inclusion of records in the register. SELECTION CRITERIA: All randomised clinical trials focusing on bifeprunox versus placebo for schizophrenia. DATA COLLECTION AND ANALYSIS: We extracted data independently. For binary outcomes, we calculated risk ratio (RR) and its 95% confidence interval (CI), on an intention-to-treat basis. For continuous data, we estimated the mean difference (MD) between groups and its 95% CI. We employed a random-effects model for analyses. We assessed risk of bias for included studies and created 'Summary of findings' tables using GRADE. MAIN RESULTS: We included four randomised controlled trials (RCTs). We found evidence of missing data and poor reporting. When bifeprunox 20 mg was compared with placebo for schizophrenia, the drug resulted in a reduction of the Positive and Negative Syndrome Scale (PANSS) positive subscale score regarding positive symptoms (n = 549, 2 RCTs, MD -1.89, 95% CI -2.85 to -0.92, low-quality evidence) and the PANSS negative subscale regarding negative symptoms (n = 549, 2 RCTs, MD -1.53, 95% CI -2.37 to -0.69, low-quality evidence). There was a clear improvement regarding deterioration in the bifeprunox 20 mg group (n = 231, 1 RCT, RR 0.71 95% CI, 0.54 to 0.93, very low-quality evidence). The total number of participants with equal to or greater than 7% weight increase was similar between bifeprunox and placebo (n = 483, 1 RCT, RR 1.02 95% CI 0.31 to 3.33 moderate-quality evidence). There were no useable data for quality of life, economic outcomes, and service use. AUTHORS' CONCLUSIONS: Our results showed some positive effects and a favourable adverse effect profile for bifeprunox, although there were few data overall and none were of high quality. It would seem that these data alone would not have been enough for the FDA to decide to halt progress of the drug to market. We can only assume that we are missing important data. Both the FDA and the relevant pharmaceutical companies have not made all relevant data accessible. As some of these trials also involved an additional haloperidol, olanzapine, quetiapine, or risperidone arm, these data are not only relevant to evaluation of bifeprunox. In not making all data accessible, it is hard to see how the FDA and the drug companies have fulfilled their full obligations to people with schizophrenia or their clinicians.