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Brain Re-Irradiation Or Chemotherapy: a phase II randomised trial of re-irradiation and chemotherapy in patients with recurrent glioblastoma (BRIOChe) - protocol for a multi-centre open-label randomised trial

Por: Hudson · E. M. · Noutch · S. · Webster · J. · Brown · S. R. · Boele · F. W. · Al-Salihi · O. · Baines · H. · Bulbeck · H. · Currie · S. · Fernandez · S. · Hughes · J. · Lilley · J. · Smith · A. · Parbutt · C. · Slevin · F. · Short · S. · Sebag-Montefiore · D. · Murray · L.
Introduction

Glioblastoma (GBM) is the most common adult primary malignant brain tumour. The condition is incurable and, despite aggressive treatment at first presentation, almost all tumours recur after a median of 7 months. The aim of treatment at recurrence is to prolong survival and maintain health-related quality of life (HRQoL). Chemotherapy is typically employed for recurrent GBM, often using nitrosourea-based regimens. However, efficacy is limited, with reported median survivals between 5 and 9 months from recurrence. Although less commonly used in the UK, there is growing evidence that re-irradiation may produce survival outcomes at least similar to nitrosourea-based chemotherapy. However, there remains uncertainty as to the optimum approach and there is a paucity of available data, especially with regards to HRQoL. Brain Re-Irradiation Or Chemotherapy (BRIOChe) aims to assess re-irradiation, as an acceptable treatment option for recurrent IDH-wild-type GBM.

Methods and analysis

BRIOChe is a phase II, multi-centre, open-label, randomised trial in patients with recurrent GBM. The trial uses Sargent’s three-outcome design and will recruit approximately 55 participants from 10 to 15 UK radiotherapy sites, allocated (2:1) to receive re-irradiation (35 Gy in 10 daily fractions) or nitrosourea-based chemotherapy (up to six, 6-weekly cycles). The primary endpoint is overall survival rate for re-irradiation patients at 9 months. There will be no formal statistical comparison between treatment arms for the decision-making primary analysis. The chemotherapy arm will be used for calibration purposes, to collect concurrent data to aid interpretation of results. Secondary outcomes include HRQoL, dexamethasone requirement, anti-epileptic drug requirement, radiological response, treatment compliance, acute and late toxicities, progression-free survival.

Ethics and dissemination

BRIOChe obtained ethical approval from Office for Research Ethics Committees Northern Ireland (reference no. 20/NI/0070). Final trial results will be published in peer-reviewed journals and adhere to the ICMJE guidelines.

Trial registration number

ISRCTN60524.

Strategies for treating acute pain in patients with opioid dependence: a scoping review protocol

Por: Levine · S. · Andrews · M. · Saracco · B. · Salzman · M.
Introduction

People who are dependent on opioids experience acute pain similar to other individuals. However, treating acute pain in these patients renders unique challenges such as opioid-induced hyperalgesia, opioid tolerance, withdrawal and stigma from healthcare providers. Thus, it is crucial to identify effective strategies for treating acute pain in this population and to highlight gaps in knowledge to create a high standard of care. The main objective of the proposed scoping review is to identify current strategies for treating the acute pain in individuals with opioid dependence or use disorder.

Methods and analysis

MEDLINE via the PubMed interface, Embase and Cochrane Central, Web of Science: Conference Proceedings Citation Index and Google Scholar will be searched. Forward and backward citation searching of the final included studies will also be conducted. Two independent reviewers will screen the titles and abstracts of sources, review and assess relevant full-text studies and extract data. Data will be presented in a diagram and will contribute to a qualitative thematic analysis.

Ethics and dissemination

Data will be gathered from publicly accessible sources, so ethics approval is not necessary. The results will be disseminated through a peer-reviewed journal and reported at conferences related to addiction medicine.

Trial registration number

10.17605/OSF.IO/BG6SJ.

Snoring Survivors: the impact of obstructive sleep apnoea and continuous positive airway pressure use on in-hospital mortality, length of stay and costs among patients hospitalised with acute cardiovascular disease - A retrospective analysis of 2016-2019

Por: Ogbu · I. · Hakobyan · B. · Sossou · C. · Levisman · J. · Obiagwu · C. · Danielian · A.
Background

The routine administration of supplemental oxygen to non-hypoxic patients with acute myocardial infarction (AMI) has been abandoned for lack of mortality benefit. However, the benefits of continuous positive airway pressure (CPAP) use in patients hospitalised with acute cardiovascular disease and concomitant obstructive sleep apnoea (OSA) remain to be elucidated.

Methods

In this retrospective case–control analysis, using 10th International Classification of Diseases, Clinical Modification (ICD-10) codes, we searched the 2016–2019 Nationwide Inpatient Sample for patients diagnosed with unstable angina (UA), AMI, acute decompensated heart failure (ADHF) and atrial fibrillation with rapid ventricular response (AFRVR), who also carried a diagnosis of OSA. We identified in-hospital CPAP use with ICD-10-Procedure Coding System codes. In-hospital death, length of stay (LOS) and hospital charges were compared between patients with and without OSA, and between OSA patients with and without CPAP use.

Results

Our sample included 2 959 991 patients, of which 1.5% were diagnosed with UA, 30.3% with AMI, 37.5% with ADHF and 45.8% with AFRVR. OSA was present in 12.3%. Patients with OSA were more likely to be younger, male, smokers, obese and have chronic obstructive pulmonary disease, renal failure and heart failure (p

Conclusion

Our study showed that patients with recognised OSA hospitalised for AMI, ADHF and AFRVR had significantly lower mortality regardless of CPAP use, while CPAP treatment among these patients was associated with significantly higher in-hospital mortality and resource utilisation. The routine use of CPAP during acute cardiovascular encounters could neutralise the impact of chronic intermittent ischaemic preconditioning.

Intraorbital pressure–volume characteristics in a piglet model: In vivo pilot study

by Yasin Hamarat, Laimonas Bartusis, Vilma Putnynaite, Rolandas Zakelis, Mantas Deimantavicius, Vilma Zigmantaite, Ramunė Grigaleviciute, Audrius Kucinskas, Evaldas Kalvaitis, Arminas Ragauskas

Intracranial pressure measurement is frequently used for diagnosis in neurocritical care but cannot always accurately predict neurological deterioration. Intracranial compliance plays a significant role in maintaining cerebral blood flow, cerebral perfusion pressure, and intracranial pressure. This study’s objective was to investigate the feasibility of transferring external pressure into the eye orbit in a large-animal model while maintaining a clinically acceptable pressure gradient between intraorbital and external pressures. The experimental system comprised a specifically designed pressure applicator that can be placed and tightly fastened onto the eye. A pressure chamber made from thin, elastic, non-allergenic film was attached to the lower part of the applicator and placed in contact with the eyelid and surrounding tissues of piglets’ eyeballs. External pressure was increased from 0 to 20 mmHg with steps of 1 mmHg, from 20 to 30 mmHg with steps of 2 mmHg, and from 30 to 50 mmHg with steps of 5 mmHg. An invasive pressure sensor was used to measure intraorbital pressure directly. An equation was derived from measured intraorbital and external pressures (intraorbital pressure = 0.82 × external pressure + 3.12) and demonstrated that external pressure can be linearly transferred to orbit tissues with a bias (systematic error) of 3.12 mmHg. This is close to the initial intraorbital pressure within the range of pressures tested. We determined the relationship between intraorbital compliance and externally applied pressure. Our findings indicate that intraorbital compliance can be controlled across a wide range of 1.55 to 0.15 ml/mmHg. We observed that external pressure transfer into the orbit can be achieved while maintaining a clinically acceptable pressure gradient between intraorbital and external pressures.

Integrated health system intervention aimed at reducing type 2 diabetes risk in women after gestational diabetes in South Africa (IINDIAGO): a randomised controlled trial protocol

Por: Norris · S. A. · Zarowsky · C. · Murphy · K. · Ware · L. J. · Lombard · C. · Matjila · M. · Chivese · T. · Muhwava · L. S. · Mutabazi · J. C. · Harbron · J. · Fairall · L. R. · Lambert · E. · Levitt · N.
Introduction

South Africa has a high prevalence of gestational diabetes mellitus (GDM; 15%) and many of these women (48%) progress to type 2 diabetes mellitus (T2DM) within 5 years post partum. A significant proportion (47%) of the women are not aware of their diabetes status after the index pregnancy, which may be in part to low postnatal diabetes screening rates. Therefore, we aim to evaluate a intervention that reduces the subsequent risk of developing T2DM among women with recent GDM. Our objectives are fourfold: (1) compare the completion of the nationally recommended 6-week postpartum oral glucose tolerance test (OGTT) between intervention and control groups; (2) compare the diabetes risk reduction between control and intervention groups at 12 months’ post partum; (3) assess the process of implementation; and (4) assess the cost-effectiveness of the proposed intervention package.

Methods and analyses

Convergent parallel mixed-methods study with the main component being a pragmatic, 2-arm individually randomised controlled trial, which will be carried out at five major referral centres and up to 26 well-baby clinics in the Western Cape and Gauteng provinces of South Africa. Participants (n=370) with GDM (with no prior history of either type 1 or type 2 diabetes) will be recruited into the study at 24–36 weeks’ gestational age, at which stage first data collection will take place. Subsequent data collection will take place at 6–8 weeks after delivery and again at 12 months. The primary outcome for the trial is twofold: first, the completion of the recommended 2-hour OGTT at the well-baby clinics 6–8 weeks post partum, and second, a composite diabetes risk reduction indicator at 12 months. Process evaluation will assess fidelity, acceptability, and dose of the intervention.

Ethics and dissemination

Ethics approval has been granted from University of Cape Town (829/2016), University of the Witwatersrand, Johannesburg (M170228), University of Stellenbosch (N17/04/032) and the University of Montreal (2019-794). The results of the trial will be disseminated through publication in peer-reviewed journals and presentations to key South African Government stakeholders and health service providers.

Protocol version

1 December 2022 (version #2). Any protocol amendments will be communicated to investigators, Human Ethics Research Committees, trial participants, and trial registries.

Trial registration number

PAN African Clinical Trials Registry (https://pactr.samrc.ac.za) on 11 June 2018 (identifier PACTR201805003336174).

Cannabis for medical use versus opioids for chronic non-cancer pain: a systematic review and network meta-analysis of randomised clinical trials

Por: Jeddi · H. M. · Busse · J. W. · Sadeghirad · B. · Levine · M. · Zoratti · M. J. · Wang · L. · Noori · A. · Couban · R. J. · Tarride · J.-E.
Objective

The objective of this study is to evaluate the comparative benefits and harms of opioids and cannabis for medical use for chronic non-cancer pain.

Design

Systematic review and network meta-analysis.

Data sources

EMBASE, MEDLINE, CINAHL, AMED, PsycINFO, PubMed, Web of Science, Cannabis-Med, Epistemonikos and the Cochrane Library (CENTRAL) from inception to March 2021.

Study selection

Randomised trials comparing any type of cannabis for medical use or opioids, against each other or placebo, with patient follow-up ≥4 weeks.

Data extraction and synthesis

Paired reviewers independently extracted data. We used Bayesian random-effects network meta-analyses to summarise the evidence and the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach to evaluate the certainty of evidence and communicate our findings.

Results

Ninety trials involving 22 028 patients were eligible for review, among which the length of follow-up ranged from 28 to 180 days. Moderate certainty evidence showed that opioids provide small improvements in pain, physical functioning and sleep quality versus placebo; low to moderate certainty evidence supported similar effects for cannabis versus placebo. Neither was more effective than placebo for role, social or emotional functioning (all high to moderate certainty evidence). Moderate certainty evidence showed there is probably little to no difference between cannabis for medical use and opioids for physical functioning (weighted mean difference (WMD) 0.47 on the 100-point 36-item Short Form Survey physical component summary score, 95% credible interval (CrI) –1.97 to 2.99), and cannabis resulted in fewer discontinuations due to adverse events versus opioids (OR 0.55, 95% CrI 0.36 to 0.83). Low certainty evidence suggested little to no difference between cannabis and opioids for pain relief (WMD 0.23 cm on a 10 cm Visual Analogue Scale (VAS), 95% CrI –0.06 to 0.53) or sleep quality (WMD 0.49 mm on a 100 mm VAS, 95% CrI –4.72 to 5.59).

Conclusions

Cannabis for medical use may be similarly effective and result in fewer discontinuations than opioids for chronic non-cancer pain.

PROSPERO registration number

CRD42020185184.

Examining age, period and cohort effects in attitude change to childhood vaccinations in a representative New Zealand survey: a multiyear cohort-sequential growth modelling study

Por: Hayes · E. · Yogeeswaran · K. · Zubielevitch · E. · Lee · C. H. J. · Cording · J. · Sibley · C. G.
Objectives

Vaccinations are an important preventative measure in reducing the spread of infectious diseases worldwide. However, concerns of undervaccination during childhood have become increasingly common. The current study aims to investigate changes in attitudes towards childhood vaccinations prior to the COVID-19 pandemic using a national sample from New Zealand.

Design

Age-based, period-based, and cohort-based changes were assessed using cohort-sequential latent growth modelling in 11 overlapping birth cohorts, which spanned the ages of 23–79 years.

Setting and participants

Data were taken from the New Zealand Attitudes and Values Study where 58 654 adults completed at least one wave across a 7-year period (2013 and 2015–2019).

Results

The period-based and cohort-based models fit the data equally well (2(282)=8547.93, p2(273)=8514.87, p

Conclusion

Overall, both the cohort-based and period-based models reveal changes in vaccination attitudes suggesting that even prior to the COVID-19 pandemic, societal influences had an impact on attitudes towards childhood vaccination.

An Evaluation of the Multifactorial Model of Cancer-Related Cognitive Impairment

imageBackground Up to 45% of patients report cancer-related cognitive impairment (CRCI). A variety of characteristics are associated with the occurrence and/or severity of CRCI. However, an important gap in knowledge of risk factors for CRCI is the relative contribution of each factor. The multifactorial model of cancer-related cognitive impairment (MMCRCI) is a conceptual model of CRCI that can be used to evaluate the strength of relationships between various factors and CRCI. Objectives The purpose of this study was to use structural regression methods to evaluate the MMCRCI using data from a large sample of outpatients receiving chemotherapy (n = 1,343). Specifically, the relationships between self-reported CRCI and four MMCRCI concepts (i.e., social determinants of health, patient-specific factors, treatment factors, and co-occurring symptoms) were examined. The goals were to determine how well the four concepts predicted CRCI and determine the relative contribution of each concept to deficits in perceived cognitive function. Methods This study is part of a larger, longitudinal study that evaluated the symptom experience of oncology outpatients receiving chemotherapy. Adult patients were diagnosed with breast, gastrointestinal, gynecological, or lung cancer; had received chemotherapy within the preceding 4 weeks; were scheduled to receive at least two additional cycles of chemotherapy; were able to read, write, and understand English; and gave written informed consent. Self-reported CRCI was assessed using the attentional function index. Available study data were used to define the latent variables. Results On average, patients were 57 years of age, college educated, and with a mean Karnofsky Performance Status score of 80. Of the four concepts evaluated, whereas co-occurring symptoms explained the largest amount of variance in CRCI, treatment factors explained the smallest amount of variance. A simultaneous structural regression model that estimated the joint effect of the four exogenous latent variables on the CRCI latent variable was not significant. Discussion These findings suggest that testing individual components of the MMCRCI may provide useful information on the relationships among various risk factors, as well as refinements of the model. In terms of risk factors for CRCI, co-occurring symptoms may be more significant than treatment factors, patient-specific factors, and/or social determinants of health in patients receiving chemotherapy.

Distinct Profiles of Morning and Evening Fatigue Co-Occurrence in Patients During Chemotherapy

imageBackground Morning and evening fatigue are distinct and distressing symptoms experienced during chemotherapy that demonstrate a large amount of interindividual variability. Objectives The objectives of this study were to identify subgroups of patients with distinct morning and evening fatigue co-occurrence profiles and evaluate for differences among these subgroups in demographic, clinical, and symptom characteristics and quality of life. Methods Oncology patients (n = 1,334) completed the Lee Fatigue Scale to self-report morning and evening fatigue, six times over two cycles of chemotherapy. Latent profile analysis was used to identify subgroups of patients with distinct morning and evening physical fatigue profiles. Results Four distinct morning and evening fatigue profiles were identified (i.e., Both Low, Low Morning + Moderate Evening, Both Moderate, and Both High). Compared to the Both Low profile, the Both High profile was significantly younger, less likely to be married or partnered, more likely to live alone, had a higher comorbidity burden, and lower functional status. The Both High profile had higher levels of anxiety, depressive symptoms, sleep disturbance, and pain and lower levels of quality of life. Discussion The variability in the morning and evening severity scores among the four profiles supports the hypothesis that morning and evening fatigue are distinct but related symptoms. Clinically meaningful levels of both morning and evening fatigue were reported by 50.4% of our sample, which suggests that the co-occurrence of these two symptoms is relatively common. Patients in Both Moderate and Both High profiles experienced an extremely high symptom burden that warrants ongoing assessments and aggressive symptom management interventions.

The initiation of Dutch newly qualified hospital-based midwives in practice, a qualitative study

In the Netherlands, a percentage of newly qualified midwives start work in maternity care as a hospital-based midwife, although prepared particularly for working autonomously in the community.
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