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Qualitative study exploring the design of a patient-reported symptom-based risk stratification system for suspected head and neck cancer referrals: protocol for work packages 1 and 2 within the EVEREST-HN programme

Por: Albutt · A. · Hardman · J. · McVey · L. · Odo · C. · Paleri · V. · Patterson · J. · Webb · S. · Rousseau · N. · Kellar · I. · Randell · R.
Introduction

Between 2009/2010 and 2019/2020, England witnessed an increase in suspected head and neck cancer (sHNC) referrals from 140 to 404 patients per 100 000 population. 1 in 10 patients are not seen within the 2-week target, contributing to patient anxiety. We will develop a pathway for sHNC referrals, based on the Head and Neck Cancer Risk Calculator. The evolution of a patient-reported symptom-based risk stratification system to redesign the sHNC referral pathway (EVEREST-HN) Programme comprises six work packages (WPs). This protocol describes WP1 and WP2. WP1 will obtain an understanding of language to optimise the SYmptom iNput Clinical (SYNC) system patient-reported symptom questionnaire for sHNC referrals and outline requirements for the SYNC system. WP2 will codesign key elements of the SYNC system, including the SYNC Questionnaire, and accompanying behaviour change materials.

Methods and analysis

WP1 will be conducted at three acute National Health Service (NHS) trusts with variation in service delivery models and ensuring a broad mixture of social, economic and cultural backgrounds of participants. Up to 150 patients with sHNC (n=50 per site) and 15 clinicians (n=5 per site) will be recruited. WP1 will use qualitative methods including interviews, observation and recordings of consultations. Rapid qualitative analysis and inductive thematic analysis will be used to analyse the data. WP2 will recruit lay patient representatives to participate in online focus groups (n=8 per focus group), think-aloud technique and experience-based codesign and will be analysed using qualitative and quantitative approaches.

Ethics and dissemination

The committee for clinical research at The Royal Marsden, a research ethics committee and the Health Research Authority approved this protocol. All participants will give informed consent. Ethical issues of working with patients on an urgent cancer diagnostic pathway have been considered. Findings will be disseminated via journal publications, conference presentations and public engagement activities.

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.

The experiences of gender and sexually diverse parents using support and services for their young children: An integrative review

Abstract

Aim

To address: What are the experiences of 2SLGBTQQIA+ parents using parenting supports and services to meet their children's early childhood development needs (<5 years of age)?

Design

Whittemore and Knafl's (2005) integrative review methodology.

Methods

Electronic databases were searched from 2000 to October 14, 2022 for empirical studies or reviews addressing the research question. The title and abstract of 12,158 articles were screened for inclusion in the review by two independent researchers; 175 of these articles underwent full-text review. Studies selected were critically appraised using a Joanna Briggs Institute Critical Appraisal tool. Relevant key findings were extracted from each study and entered into N-VIVO-12. Thematic content analysis was employed and PRISMA guidelines were adhered to.

Results

A total of 18 articles (15 qualitative and three multi-method studies) met the inclusion criteria and were selected for the review. Seven themes were revealed from analysis of the studies: (1) 2SLGBTQQIA+ Status kept a secret; (2) Forced to come out; (3) Heteronormative messaging; (4) Feeling excluded; (5) Stigmatised; (6) Parents act as educators; and (7) Positive experiences.

Conclusion

This integrative review provides nurses with insight into the experiences of 2SLGBTQQIA+ parents using health care services for their young child.

Implications for the Profession

This article highlights what changes nurses need to make to their practice to ensure appropriate, inclusive care for clients of diverse sexual and gender identities and their families.

Impact

Health care providers, especially nurses, have an opportunity to improve the experiences of these families and positively impact their health and well-being. Additionally, there is a need for research with the 2SLGBTQQIA+ parent community and the use of rigorous methodological techniques, including clearly linking participants' gender and sexual identities with study findings, to improve our understanding of 2SLGBTQQIA+ parent experiences.

Patient or Public Contribution

Although there was no direct patient contribution to the work since it was an integrative review of the literature, indirectly patient contributions are incorporated from the original research results of studies incorporated into this review.

“High blood pressure comes from thinking too much”: Understandings of illness among couples living with cardiometabolic disorders and HIV in Malawi

by Jane Jere, Allison Ruark, Julie T. Bidwell, Rita M. Butterfield, Torsten B. Neilands, Sheri D. Weiser, Nancy Mulauzi, James Mkandawire, Amy A. Conroy

Cardiometabolic disorders (CMD) such as hypertension and diabetes are increasingly prevalent in sub-Saharan Africa, placing people living with HIV at risk for cardiovascular disease and threatening the success of HIV care. Spouses are often the primary caregivers for people living with CMD, and understanding patients’ and partners’ conceptions of CMD could inform care. We conducted semi-structured interviews with 25 couples having a partner living with HIV and either hypertension or diabetes. Couples were recruited from HIV clinics in Malawi and were interviewed on beliefs around symptoms, causation, prevention, and treatment for CMD. Data were analyzed at the individual and dyadic levels using framework analysis and Kleinman’s theory of explanatory models as a lens. On average, participants were 51 years old and married for 21 years. Approximately 57%, 14%, and 80% had hypertension, diabetes, and HIV. Couples endorsed a combination of biomedical explanatory models (beliefs around physical and mental health) and traditional explanatory models (beliefs around religion and natural remedies), although tended to emphasize the biomedical model. Half of couples believed stress was the main cause of hypertension. For diabetes, diet was believed to be a common cause. In terms of prevention, dietary changes and physical activity were most frequently mentioned. For disease management, medication adherence and diet modifications were emphasized, with some couples also supporting herbal remedies, stress reduction, and faith in God as strategies. Participants were generally more concerned about CMD than HIV due to poor access to CMD medications and beliefs that CMD could lead to sudden death. Within couples, partners often held many of the same beliefs but diverged around which etiological or preventive factors were most important (e.g., stress versus diet) and the best diet for CMD. Health education programs should involve primary partners to build knowledge of CMD and address overlap with HIV, and reinforce accurate information on lifestyle factors for the prevention and treatment of CMD.

Cohort profile: evaluation of immune response and household transmission of SARS-CoV-2 in Costa Rica: the RESPIRA study

Por: Loria · V. · Aparicio · A. · Hildesheim · A. · Cortes · B. · Barrientos · G. · Retana · D. · Sun · K. · Ocampo · R. · Prevots · D. R. · Zuniga · M. · Waterboer · T. · Wong-McClure · R. · Morera · M. · Butt · J. · Binder · M. · Abdelnour · A. · Calderon · A. · Gail · M. H. · Pfeiffer · R. M.
Purpose

The RESPIRA cohort aims to describe the nature, magnitude, time course and efficacy of the immune response to SARS-CoV-2 infection and vaccination, population prevalence, and household transmission of COVID-19.

Participants

From November 2020, we selected age-stratified random samples of COVID-19 cases from Costa Rica confirmed by PCR. For each case, two population-based controls, matched on age, sex and census tract were recruited, supplemented with hospitalised cases and household contacts. Participants were interviewed and blood and saliva collected for antibodies and PCR tests. Participants will be followed for 2 years to assess antibody response and infection incidence.

Findings to date

Recruitment included 3860 individuals: 1150 COVID-19 cases, 1999 population controls and 719 household contacts from 304 index cases. The age and regional distribution of cases was as planned, including four age strata, 30% rural and 70% urban. The control cohort had similar sex, age and regional distribution as the cases according to the study design. Among the 1999 controls recruited, 6.8% reported at enrolment having had COVID-19 and an additional 12.5% had antibodies against SARS-CoV-2. Compliance with visits and specimens has been close to 70% during the first 18 months of follow-up. During the study, national vaccination was implemented and nearly 90% of our cohort participants were vaccinated during follow-up.

Future plans

RESPIRA will enable multiple analyses, including population prevalence of infection, clinical, behavioural, immunological and genetic risk factors for SARS-CoV-2 acquisition and severity, and determinants of household transmission. We are conducting retrospective and prospective assessment of antibody levels, their determinants and their protective efficacy after infection and vaccination, the impact of long-COVID and a series of ancillary studies. Follow-up continues with bimonthly saliva collection for PCR testing and biannual blood collection for immune response analyses. Follow-up will be completed in early 2024.

Trial registration number

NCT04537338.

Comparing estimates of psychological distress using 7-day and 30-day recall periods: Does it make a difference?

by Miranda R. Chilver, Richard A. Burns, Ferdi Botha, Peter Butterworth

Self-report measures are widely used in mental health research and may use different recall periods depending on the purpose of the assessment. A range of studies aiming to monitor changes in mental health over the course of the COVID-19 pandemic opted to shorten recall periods to increase sensitivity to change over time compared to standard, longer recall periods. However, many of these studies lack pre-pandemic data using the same recall period and may rely on pre-existing data using standard recall periods as a reference point for assessing the impact of the pandemic on mental health. The aim of this study was to assess whether comparing scores on the same questionnaire with a different recall period is valid. A nationally representative sample of 327 participants in Australia completed a 7-day and 30-day version of the six-item Kessler Psychological Distress Scale (K6) and a single-item measure of psychological distress (TTPN item) developed for the Taking the Pulse of the Nation survey. Linear mixed models and mixed logistic regression models were used to assess whether altering the recall period systematically changed response patterns within subjects. No substantive recall period effects were found for the K6 or the TTPN, although there was a trend towards higher K6 scores when asked about the past 30 days compared to the past 7 days (b = 1.00, 95% CI: -0.18, 2.17). This may have been driven by the “feeling nervous” item which was rated higher using the 30-day compared to the 7-day recall period. Neither the K6 nor the TTPN item were significantly affected by the recall period when reduced to a binary variable of likely severe mental illness. The results indicate that altering the recall period of psychological distress measures does not substantively alter the score distribution in the general population of Australian adults.

Metabolic profiling of <i>Mytilus coruscus</i> mantle in response of shell repairing under acute acidification

by Xiaojun Fan, Ying Wang, Changsheng Tang, Xiaolin Zhang, Jianyu He, Isabella Buttino, Xiaojun Yan, Zhi Liao

Mytilus coruscus is an economically important marine bivalve mollusk found in the Yangtze River estuary, which experiences dramatic pH fluctuations due to seasonal freshwater input and suffer from shell fracture or injury in the natural environment. In this study, we used intact-shell and damaged-shell M. coruscus and performed metabolomic analysis, free amino acids analysis, calcium-positive staining, and intracellular calcium level tests in the mantle to investigate whether the mantle-specific metabolites can be induced by acute sea-water acidification and understand how the mantle responds to acute acidification during the shell repair process. We observed that both shell damage and acute acidification induced alterations in phospholipids, amino acids, nucleotides, organic acids, benzenoids, and their analogs and derivatives. Glycylproline, spicamycin, and 2-aminoheptanoic acid (2-AHA) are explicitly induced by shell damage. Betaine, aspartate, and oxidized glutathione are specifically induced by acute acidification. Our results show different metabolic patterns in the mussel mantle in response to different stressors, which can help elucidate the shell repair process under ocean acidification. furthermore, metabolic processes related to energy supply, cell function, signal transduction, and amino acid synthesis are disturbed by shell damage and/or acute acidification, indicating that both shell damage and acute acidification increased energy consumption, and disturb phospholipid synthesis, osmotic regulation, and redox balance. Free amino acid analysis and enzymatic activity assays partially confirmed our findings, highlighting the adaptation of M. coruscus to dramatic pH fluctuations in the Yangtze River estuary.
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