This Viewpoint discusses the need to quantify the long-term adverse effects of immune checkpoint inhibitors, particularly immune-related adverse effects, which are not universally dose dependent, limiting the value of conventional adverse event grading systems.
Risultati per: Long COVID: principali risultati, meccanismi e raccomandazioni
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Buprenorphine, Pain, and Opioid Use in Patients Taking High-Dose Long-Term Opioids
This randomized clinical trial evaluates optionally switching to buprenorphine as a strategy for improving pain and reducing opioids among patients prescribed high-dose, full agonist long-term opioid therapy.
Lepodisiran — A Long-Duration Small Interfering RNA Targeting Lipoprotein(a)
New England Journal of Medicine, Ahead of Print.
[Articles] Adipose cellularity as a measurement of long-term changes in body weight: a Swedish cohort study spanning 1988–2016
Adipose cellularity is associated with long-term changes in body weight, following interventions to decrease body weight. Patients with a high number of large fat cells experienced the most pronounced weight reduction.
Social, personal and medical factors influencing treatment delay for patients with primary glaucoma during the COVID-19 pandemic: a qualitative interview study
Background
Primary glaucoma patients faced many difficulties that affected their treatment during the COVID-19 pandemic. Glaucoma treatment often starts with prescription eye-drops. However, delays in ophthalmic therapy often occur due to poor awareness of the dangers of glaucoma, which subsequently leads to irreversible visual field defects and eventual blindness.
Objective
This study aimed to explore the social, personal and medical factors that contributed to barriers in the treatment of primary glaucoma during the COVID-19 pandemic, with the overarching goal of providing insights to develop measures that can identify the barriers of the treatment process and prevent consequent adverse outcomes.
Methods
We adopted a phenomenological approach and used purposive sampling to recruit 122 patients into our study. Face-to-face, semistructured, one-on-one interviews were conducted in a private office. The data were analysed using Colaizzi’s seven-step method. In cases where classification was difficult, consensus was reached among the three researchers who formed the core assessment team.
Results
A total of 122 glaucoma patients experienced delayed pharmaceutical treatment during the outbreak. Delays were longer among females and patients over 75 years old, highlighting that treatment delays were a significant issue for glaucoma patients during the COVID-19 pandemic, particularly for older females. Coding of the transcripts yielded three themes (eight subthemes): (1) the impact of social support on glaucoma pharmaceutical treatment: (a) the inability to seek pharmaceutical treatment alone and (b) online reservation and payment requirements; (2) the impact of personal reasons on glaucoma pharmaceutical treatment: (c) fear of being infected with COVID-19, (d) being infected with COVID-19 or coming into contact with COVID-19 patients, (e) being busy with work or life; (3) the impact of medical resources on glaucoma pharmaceutical treatment: (f) abnormal diagnosis and treatment processes, (g) insufficient medical manpower and (h) insufficient communication from medical staff.
Conclusions
To prevent medication delays and potential irreversible damage to the visual field in primary glaucoma patients during health crises, it is essential to further explore personalised strategies for coping with the impact of pandemics. Special attention should be given to glaucoma patients facing significant life burdens, such as the elderly and females, and efforts should be made to increase their awareness of the risks of glaucoma. Future studies could explore the feasibility of providing more support to glaucoma patients, such as online payment and appointment scheduling options, to reduce delays and alleviate patient anxiety.
Allerta dei microbiologici, 'boom di infezioni dopo il Covid'
‘Registrato un incremento dalle 4 alle 10 volte’
Does Prone Positioning Save Lives in Nonintubated Patients with COVID-19?
A meta-analysis offers compelling evidence that awake prone positioning improves outcomes in patients with acute hypoxemic respiratory failure.
Impact of COVID-19 infection on mortality, diabetic complications and haematological parameters in patients with diabetes mellitus: a systematic review and meta-analysis
Objectives
SARS-CoV-2 poses significant challenges to people living with diabetes (PLWD). This systematic review aimed to explore the impact of COVID-19 on mortality, complications associated with diabetes and haematological parameters among PLWD.
Design
Systematic review and meta-analysis using the Grading of Recommendations Assessment, Development and Evaluation (GRADE).
Data sources
EMBASE, MEDLINE, Cochrane Central Register of Controlled Trials and LILACS were searched between 1 December 2019 and 14 January 2025.
Eligibility criteria for selecting studies
Eligible studies included case-control and cohort studies involving PLWD categorised into two groups: those with confirmed SARS-CoV-2 infection and those without.
Data extraction and synthesis
Meta-analyses estimated the odds ratios (ORs) and mean differences (MDs) of outcomes including mortality, intensive care unit (ICU) admission, diabetic ketoacidosis (DKA), acute kidney injury, hospitalisation length and haematological parameters. We pooled results using random-effects models and assessed study quality with the Newcastle-Ottawa Scale. A funnel plot was used to detect potential publication bias. The overall certainty of evidence was assessed using GRADE.
Results
25 of 7266 unique studies were eligible, including 1 154674 PLWD (561 558 with COVID-19 and 593 116 without COVID-19). SARS-CoV-2 infection in PLWD was associated with significantly increased mortality (OR 2.52, 95% CI 1.45 to 4.36, I2=99%), acute kidney injury (3.69, 95% CI 2.75 to 4.94, I2=0%), random plasma glucose in subjects with type 1 diabetes (MD 20.38 mg/dL, 95% CI 7.39 to 33.36, I2=0%), haemoglobin A1C in subjects with type 2 diabetes (0.21%, 95% CI 0.05 to 0.38, I2=13%), creatinine (0.12 mg/dL, 95% CI 0.04 to 0.19, I2=0%), C reactive protein (38.30 mg/L, 95% CI 4.79 to 71.82, I2=82%) and D-dimer (1.52 µg/mL, 95% CI 0.73 to 2.31, I2=0%). No significant differences were observed in the incidence of ICU admission and DKA, hospitalisation length, haemoglobin, leucocyte, lymphocyte, neutrophil to lymphocyte ratio, platelet, blood urea nitrogen, estimated glomerular filtration rate, procalcitonin, albumin, ferritin and bilirubin among PLWD with and without SARS-CoV-2 infection.
Conclusions
SARS-CoV-2 infection is associated with elevated risks of mortality and acute kidney injury and poor glycaemic control in PLWD, alongside increased levels of inflammatory and coagulation biomarkers. These findings underscore the urgent need for tailored clinical management strategies for PLWD with COVID-19.
PROSPERO registration number
CRD42023418039.
Impact of COVID-19 infection on mortality, diabetic complications and haematological parameters in patients with diabetes mellitus: a systematic review and meta-analysis
Objectives
SARS-CoV-2 poses significant challenges to people living with diabetes (PLWD). This systematic review aimed to explore the impact of COVID-19 on mortality, complications associated with diabetes and haematological parameters among PLWD.
Design
Systematic review and meta-analysis using the Grading of Recommendations Assessment, Development and Evaluation (GRADE).
Data sources
EMBASE, MEDLINE, Cochrane Central Register of Controlled Trials and LILACS were searched between 1 December 2019 and 14 January 2025.
Eligibility criteria for selecting studies
Eligible studies included case-control and cohort studies involving PLWD categorised into two groups: those with confirmed SARS-CoV-2 infection and those without.
Data extraction and synthesis
Meta-analyses estimated the odds ratios (ORs) and mean differences (MDs) of outcomes including mortality, intensive care unit (ICU) admission, diabetic ketoacidosis (DKA), acute kidney injury, hospitalisation length and haematological parameters. We pooled results using random-effects models and assessed study quality with the Newcastle-Ottawa Scale. A funnel plot was used to detect potential publication bias. The overall certainty of evidence was assessed using GRADE.
Results
25 of 7266 unique studies were eligible, including 1 154674 PLWD (561 558 with COVID-19 and 593 116 without COVID-19). SARS-CoV-2 infection in PLWD was associated with significantly increased mortality (OR 2.52, 95% CI 1.45 to 4.36, I2=99%), acute kidney injury (3.69, 95% CI 2.75 to 4.94, I2=0%), random plasma glucose in subjects with type 1 diabetes (MD 20.38 mg/dL, 95% CI 7.39 to 33.36, I2=0%), haemoglobin A1C in subjects with type 2 diabetes (0.21%, 95% CI 0.05 to 0.38, I2=13%), creatinine (0.12 mg/dL, 95% CI 0.04 to 0.19, I2=0%), C reactive protein (38.30 mg/L, 95% CI 4.79 to 71.82, I2=82%) and D-dimer (1.52 µg/mL, 95% CI 0.73 to 2.31, I2=0%). No significant differences were observed in the incidence of ICU admission and DKA, hospitalisation length, haemoglobin, leucocyte, lymphocyte, neutrophil to lymphocyte ratio, platelet, blood urea nitrogen, estimated glomerular filtration rate, procalcitonin, albumin, ferritin and bilirubin among PLWD with and without SARS-CoV-2 infection.
Conclusions
SARS-CoV-2 infection is associated with elevated risks of mortality and acute kidney injury and poor glycaemic control in PLWD, alongside increased levels of inflammatory and coagulation biomarkers. These findings underscore the urgent need for tailored clinical management strategies for PLWD with COVID-19.
PROSPERO registration number
CRD42023418039.
Vitamin D supplementation for managing COVID-19 in patients with vitamin D deficiency: a systematic review and meta-analysis of randomised controlled trials
Objectives
Vitamin D deficiency is prevalent among the population. Previous studies have shown that vitamin D supplementation might be useful for treating COVID-19 infection. Therefore, we performed a meta-analysis to explore vitamin D supplementation efficacy in treating COVID-19 patients with vitamin D deficiency.
Design
Systematic review and meta-analysis
Data sources
PubMed, Cochrane Library, Embase and Web of Science.
Eligibility criteria
Randomised controlled trials exploring vitamin D supplementation for patients with COVID-19 and vitamin D deficiency.
Data extraction and synthesis
Two independent reviewers employed standardised methods to search, screen and code the included studies. The primary outcomes included mortality during follow-up, 28-day mortality, need for mechanical ventilation and intensive care unit (ICU). The secondary outcome included length of stay in hospital and ICU. The risk of bias was assessed using the Risk of Bias 2 tool. Depending on the level of heterogeneity, either a random-effects model or a fixed-effects model was applied. The findings were summarised using Grading of Recommendations Assessment, Development and Evaluation (GRADE) evidence profiles and synthesised qualitatively.
Results
A total of nine studies, comprising 870 participants, were included in the analysis. The pooled results indicated that vitamin D supplementation was associated with a lower risk of mortality (risk ratio 0.76; 95% CI 0.60 to 0.97). However, this apparent benefit was not robust when examined through the leave-one-out method and trial sequential analysis. Regarding other outcomes, there was no statistically significant difference between vitamin D supplementation and no supplementation in terms of 28-day mortality, the need for mechanical ventilation and ICU admission. Vitamin D supplementation was associated with a 0.41 day shorter length of stay in the ICU (mean difference –0.41; 95% CI –1.09 to 0.28) and a 0.07 day shorter length of stay in the hospital (mean difference –0.07; 95% CI –0.61 to 0.46) compared with no supplementation; however, neither difference was statistically significant.
Conclusion
Based on evidence of low to moderate quality, vitamin D supplementation reduced the mortality rate during follow-up in COVID-19 patients with vitamin D deficiency. However, it did not improve 28-day mortality, nor did it reduce the need for mechanical ventilation and ICU admission, or the length of stay in the ICU and hospital.
PROSPERO registration number
CRD42024573791.
Consequences of loneliness/isolation and visitation restrictions on the mood of long-term care residents without severe dementia pre-COVID-19 and during COVID-19: a scoping review
Background
Mental health disorders are common among residents of long-term care (LTC). Despite depression being the most common type of mental illness, it is often undiagnosed in LTC. Due to its prevalence, chronicity and associated morbidity, depression poses a considerable service use burden. The COVID-19 pandemic has brought needed attention to the mental health challenges faced by older adults in LTC.
Objectives
To explore the effects of isolation on the mood of LTC residents and compare between both the pre-COVID-19 and COVID-19 periods.
Design
A scoping review.
Methods
PubMed, CINAHL, PsycINFO, SCOPUS, Google Scholar and medRxiv were searched for studies that met the eligibility criteria: (1) articles assessing mood or mental health status of LTC residents; (2) mood disturbance resulting from visitation restrictions/isolation or loneliness; (3) residents were without severe dementia or moderate/severe cognitive impairment and (4) studies were available in English. Studies were excluded if their entire sample was residents with severe cognitive impairment or severe dementia. A total of 31 studies were included in this review. The total number of articles retrieved from the databases searched was 3652 articles, of which 409 duplicates were removed. 3242 article titles and abstracts were screened for eligibility, of which 3063 were excluded. The remaining 180 full-text studies were reviewed for eligibility, where an additional 149 studies were excluded. Data were then extracted from all full-length pieces for analysis, and findings were summarised.
Results
The review identified contradictory views with a diversity of findings highlighting the complexity of factors influencing residents’ mood during a global health crisis such as that of COVID-19. Studies highlighted the importance of quality interactions with others for the well-being of LTC residents. Significant correlations were found between social isolation, loneliness and depression. During COVID-19, visitation restrictions led to increased loneliness, depression and mood problems, especially among residents without cognitive impairment. However, some studies reported no significant adverse effects or even a decrease in depression symptoms during COVID-19 restrictions, possibly due to implemented strategies to maintain social engagement.
Conclusion
The COVID-19 pandemic had a substantial impact on LTC homes, influencing the physical and mental well-being of residents. This highlighted pre-existing challenges in the LTC system, emphasising the importance of comprehensive strategies to safeguard resident mental health. It is important to combine measures to ensure both physical safety and mental well-being.
Ecdc, con vaccinazione -27% di rischio di long-Covid
“Vaccini aiutano a ridurre effetti a lungo termine”
Long-term lived experiences of patients with chronic pain or angina pectoris treated with spinal cord stimulation: a qualitative study
Objective
To explore the short-term and long-term lived experiences of patients with chronic pain and angina pectoris with spinal cord stimulation.
Design
An interpretive qualitative study with thematic analysis of one-off, semistructured interviews, following Braun and Clarke (2006).
Setting
A multidisciplinary, publicly funded pain service in Auckland, New Zealand. Patients usually undergo a comprehensive medical, psychological and functional assessment and an in-house pain management programme before proceeding to spinal cord stimulator implantation.
Participants
Participants implanted with a spinal cord stimulator between 1998 and 2019 who had their stimulator for ≥1 year, purposively sampled to increase the range of ethnicities.
Main outcome
The themes identified from the interviews.
Results
24 participants with chronic pain of varied aetiology and a median (range) of 5.2 (2.4–23.2) years since stimulator implantation participated. 22 participants had the device in situ, and 2 had been explanted. Five main themes were identified: (1) embodiment: stimulator and body as one; (2) technical factors: batteries and type of stimulation; (3) improved well-being; (4) social connection and (5) healthcare system interaction. Most participants reported pain relief, but many had experienced complications and discomfort. They emphasised the importance of ongoing support from the pain service. Acceptance of pain, coping and embodiment emerged as common motifs across these themes. 21 participants were satisfied with their treatment.
Conclusion
Within the context of a multidisciplinary pain clinic, despite some discomfort and various complications, most participants valued the ongoing reduction of pain achieved with spinal cord stimulation. Timely access to support from the pain service influenced their experience and satisfaction with their stimulators. Acceptance of pain and embodiment of the stimulator helped participants adapt to living with their stimulator, often over many years.
Retrospective cohort study of long-acting injectable (LAI) antipsychotic initiation in the inpatient setting: impact of LAI characteristics on transition and continuation of care among patients with schizophrenia in the USA
Objectives
To investigate long-acting injectable (LAI) antipsychotic prescribing patterns and their associations with transition and continuation of care and healthcare resource utilisation (HCRU) for patients with schizophrenia in the USA.
Design
A retrospective cohort study.
Setting
Electronic health record data from adults in the USA with schizophrenia were extracted from the NeuroBlu Database V.21R2.
Participants
Adults (aged ≥18 years) with a schizophrenia diagnosis who initiated LAI antipsychotic treatment during psychiatric inpatient admission. The index date was the date of LAI initiation. Patients who had ≥1 primary, secondary or tertiary ICD-9/10 (International Classification of Diseases) diagnosis of schizophrenia at clinical sites that had both inpatient and outpatient facilities were included.
Primary outcome measures
Transition-of-care (eg, risk of rehospitalisation, number of hospital readmissions, number of outpatient visits post discharge), continuation-of-care (eg, first treatment path after discharge, time to index LAI discontinuation and number of patients who restarted LAIs after discontinuation) and HCRU endpoints (eg, length of stay of index hospitalisation and estimated cost for psychiatric outpatient visits pre-index and post-index) were the primary outcome measures.
Results
A total of 1197 patients were included who initiated an LAI in an inpatient setting. Of 339 patients with ≥3 months pre-index and post-index data, median time to rehospitalisation was 135 days. Patients discharged taking an LAI alone had lower frequency of rehospitalisation (incidence rate ratio (IRR)=0.62 (95% CI, 0.46 to 0.84)), lower risk of longer hospital stays (IRR=0.60 (95% CI, 0.43 to 0.84)), lower risk of becoming rehospitalised (HR=0.49 (95% CI, 0.35 to 0.69)) and lower risk of outpatient visits (IRR=0.50 (95% CI, 0.36 to 0.70)) versus patients co-prescribed an oral antipsychotic (LAI+OA). Patients discharged taking an LAI dosed once every 1–2 months or once every 2 weeks had lower frequency of rehospitalisation (IRR=0.85 (95% CI, 0.64 to 1.14)), lower risk of longer hospital stays (IRR=0.90 (95% CI, 0.70 to 1.15)) and lower risk of becoming rehospitalised versus an LAI dosed once every 2 weeks; risk of becoming rehospitalised was no different (HR=1.00 (95% CI, 0.76 to 1.32)) and risk of outpatient visits was greater (IRR=1.25 (95% CI, 0.96 to 1.63)). During hospitalisation, 73.4% of patients were co-prescribed an OA, most frequently risperidone, with their index LAI. From pre-admission to post-discharge, psychiatric clinic costs significantly increased (US$14 231, p
Investigation of ethics approval as part of a research integrity assessment of randomised controlled trials in COVID-19 evidence syntheses: a meta-epidemiological study
Objectives
Ethical compliance of randomised controlled trials (RCTs) documented as ethics committee (EC) approval is vital for participant protection but is often overlooked by evidence synthesis producers despite regulatory mandates. We aimed to systematically assess reporting of ethics approval and informed consent (IC) in RCTs included in evidence syntheses and examined its potential impact on the study pool as part of a research integrity assessment (RIA).
Design
Meta-epidemiological study.
Setting
Assessment of ethics approval; domain 3 of the RIA tool developed for evidence syntheses.
Participants/subjects
COVID-19 RCTs included in evidence syntheses.
Primary outcomes
We extracted ethical items from study reports, that is, ethics approval statements, EC details, ethics approval numbers (ENs), IC and verified national recognition of ECs. RCTs were assessed regarding ethics approval and categorised as ‘no concern’, ‘awaiting classification’ or ‘exclude’ from the study pool. We also examined the impact of study settings on ethics approval reporting and discussed assessment reliability.
Results
We included 188 RCTs. 93% of primary study reports contained an ethics statement, 70% provided EC details, 44% reported EN and 91% mentioned IC. Trial registration records identified the EC in 8 RCTs and EN in 25 RCTs. Overall, 41% of RCTs reported all ethical items. Authors of 95 RCTs were contacted for missing information, yielding 22 satisfactory responses. Of the 151 RCTs with identified ECs, 88% were nationally recognised. Overall, 53% of RCTs were classified as ‘no concern’, 47% as ‘awaiting classification’ and none were excluded. Most were ‘awaiting classification’ due to reporting-related reasons. No significant differences in ethics approval reporting were observed across study settings, countries, or sample sizes.
Conclusions
Reporting of ethical items in RCTs remains inadequate. Including ethics approval details in reporting guidelines such as Consolidated Standards of Reporting Trials could improve this. Current under-reporting issues limit the reliability of the RIA tool’s ethics approval assessment.
Protocol registration
The protocol is available on OSF (https://osf.io/3bzeg).
Selecting a Venous Catheter for Medium- to Long-Term Use
This JAMA Insights discusses selection of catheters for medium- or long-term use in 4 clinical settings.