Improving equity in access to early diagnosis of cancer in different healthcare systems of Latin America: protocol for the EquityCancer-LA implementation-effectiveness hybrid study

Introduction
Healthcare fragmentation, a main cause for delay in cancer diagnosis and treatment, contributes to high mortality in Latin America (LA), particularly among disadvantaged populations. This research focuses on integrated care interventions, which have been limitedly implemented in the region. The objective is to evaluate the contextual effectiveness of scaling-up an integrated care intervention to improve early diagnosis of frequent cancers in healthcare networks of Chile, Colombia and Ecuador.

Methods and analysis
This research is two pronged: (A) quasi-experimental design (controlled before and after) with an intervention and a control healthcare network in each LA country, using an implementation-effectiveness hybrid approach to assess the intervention process, effectiveness and costs; and (B) case study design to analyse access to diagnosis of most frequent cancers. Focusing on the most vulnerable socioeconomic population, it develops in four phases: (1) analysis of delays and barriers to early diagnosis (baseline); (2) intervention adaptation and implementation (primary care training, fast-track referral pathway and patient information); (3) intracountry evaluation of intervention and (4) cross-country analysis. Baseline and evaluation studies adopt mixed-methods qualitative (semistructured individual interviews) and quantitative (patient questionnaire survey) methods. For the latter, a sample size of 174 patients with cancer diagnosis per healthcare network and year was calculated to detect a proportions difference of 15%, before and after intervention (α=0.05; β=0.2) in a two-sided test. A participatory approach will be used to tailor the intervention to each context, led by a local steering committee (professionals, managers, policy makers, patients and researchers).

Ethics and dissemination
This study complies with international and national legal stipulations on ethics. It was approved by each country’s ethical committee and informed consent will be obtained from participants. Besides the coproduction of knowledge with key stakeholders, it will be disseminated through strategies such as policy briefs, workshops, e-tools and scientific papers.

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Dicembre 2022

Understanding the barriers and facilitators that influence access to quality cardiovascular care for rural Indigenous peoples: protocol for a scoping review

Introduction
Māori (the Indigenous peoples of New Zealand) are disproportionately represented in cardiovascular disease (CVD) prevalence, morbidity and mortality rates, and are less likely to receive evidence-based CVD healthcare. Rural Māori experience additional barriers to treatment access, poorer health outcomes and a more significant burden of CVD risk factors compared with non-Māori and Māori living in urban areas. Importantly, these inequities are similarly experienced by Indigenous peoples in other nations impacted by colonisation. Given the scarcity of available literature, we are conducting a scoping review of literature exploring barriers and facilitators in accessing quality CVD healthcare for rural Māori and other Indigenous peoples in nations impacted by colonisation.

Methods and analysis
A scoping review will be conducted to identify and map the extent of research available and identify any gaps in the literature. This review will be underpinned by Kaupapa Māori Research methodology and will be conducted using Arksey and O’Malley’s (2005) methodological framework. A database search of MEDLINE (OVID), PubMed, Embase, SCOPUS, CINAHL Plus, Australia/New Zealand Reference Centre and NZResearch.org will be used to explore empirical research literature. A grey literature search will also be conducted. Two authors will independently review and screen search results in an iterative manner. The New Zealand Ministry of Health Te Tiriti o Waitangi (Treaty of Waitangi) Framework principles will be used as a framework to summarise and construct a narrative of existing literature. Existing literature will also be appraised using the CONSolIDated critERia for strengthening the reporting of health research involving Indigenous Peoples (CONSIDER) statement.

Ethics and dissemination
Ethical approval has not been sought for this review as we are using publicly available data. We will publish this protocol and the findings of our review in an open-access peer-reviewed journal. This protocol has been registered on Open Science Framework (DOI:10.17605/osf.io/xruhy).

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Dicembre 2022

Access to medicine among asylum seekers, refugees and undocumented migrants across the migratory cycle: a scoping review protocol

Introduction
Migration creates new health vulnerabilities and exacerbates pre-existing medical conditions. Migrants often face legal, system-related, administrative, language and financial barriers to healthcare, but little is known about factors that specifically influence migrants’ access to medicines and vaccines. This scoping review aims to map existing evidence on access to essential medicines and vaccines among asylum seekers, refugees and undocumented migrants who aim to reach Europe. We will consolidate existing information and analyse the barriers that limit access at the different stages of the migratory phases, as well as policies and practices undertaken to address them.

Methods
We follow the Arksey and O’Malley framework for knowledge synthesis of research, as updated by Levac et al. For reporting the results of our search and to synthetise evidence, we will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extended reporting guideline for scoping reviews. This scoping review consists of five iterative stages. Bibliographic databases (PubMed, CINAHL, Cochrane Database of Systematic Reviews and Scopus) and grey literature databases (Open Grey, Grey Literature Report and Google Scholar, Web of Science Conference Proceedings, non-governmental organisations and United Nations agency websites) will be searched for relevant studies.

Dissemination and ethics
This review will be disseminated through a peer-reviewed article in a scientific open-access journal and conference presentations. Furthermore, findings will be shared at workshops of research and operational stakeholders for facilitating translation into research and operational practices. Since it consists of reviewing and collecting data from publicly available materials, this scoping review does not require ethics approval.

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Dicembre 2022

Standardised treatment and monitoring protocol to assess safety and tolerability of bacteriophage therapy for adult and paediatric patients (STAMP study): protocol for an open-label, single-arm trial

Introduction
There has been renewed interest in the therapeutic use of bacteriophages (phages); however, standardised therapeutic protocols are lacking, and there is a paucity of rigorous clinical trial data assessing efficacy.

Methods and analysis
We propose an open-label, single-arm trial investigating a standardised treatment and monitoring protocol for phage therapy. Patients included will have exhausted other therapeutic options for control of their infection and phage therapy will be administered under Australia’s Therapeutic Goods Administration Special Access Scheme. A phage product with high in vitro activity against the targeted pathogen(s) must be available in line with relevant regulatory requirements. We aim to recruit 50–100 patients over 5 years, from any public or private hospitals in Australia. The standardised protocol will specify clinical assessments and biological sampling at scheduled time points. The primary outcome is safety at day 29, assessed by the frequency of adverse events, and overseen by an independent Data Safety Monitoring Board. Secondary outcomes include long-term safety (frequency of adverse events until at least 6 months following phage therapy), and feasibility, measured as the proportion of participants with >80% of minimum data available for analysis. Additional endpoints assessed include clinical response, patient/guardian reported quality of life measures, phage pharmacokinetics, human host immune responses and microbiome analysis. All trial outcomes will be summarised and presented using standard descriptive statistics.

Ethics and dissemination
Participant inclusion will be dependent on obtaining written informed consent from the patient or guardian. The trial protocol was approved by the Sydney Children’s Hospitals Network Human Research Ethics Committee in December 2021 (Reference 2021/ETH11861). In addition to publication in a peer-reviewed scientific journal, a lay summary of study outcomes will be made available for participants and the public on the Phage Australia website (https://www.phageaustralia.org/).

Trial registration number
Registered on ANZCTR, 10 November 2021 (ACTRN12621001526864; WHO Universal Trial Number: U1111-1269-6000).

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Dicembre 2022

Practical suggestions for harms reporting in exercise oncology: the Exercise Harms Reporting Method (ExHaRM)

The volume of high-quality evidence supporting exercise as beneficial to cancer survivors has grown exponentially; however, the potential harms of exercise remain understudied. Consequently, the trade-off between desirable and undesirable outcomes of engaging in exercise remains unclear to clinicians and people with cancer. Practical guidance on collecting and reporting harms in exercise oncology is lacking. We present a harms reporting protocol developed and refined through exercise oncology trials since 2015.
Development of the Exercise Harms Reporting Method (ExHaRM) was informed by national and international guidelines for harms reporting in clinical trials involving therapeutic goods or medical devices, with adaptations to enhance applicability to exercise. The protocol has been adjusted via an iterative process of implementation and adjustment through use in multiple exercise oncology trials involving varied cancer diagnoses (types: breast, brain, gynaecological; stages at diagnosis I–IV; primary/recurrent), and heterogeneous exercise intervention characteristics (face to face/telehealth delivery; supervised/unsupervised exercise). It has also involved the development of terms (such as, adverse outcomes, which capture all undesirable physical, psychological, social and economic outcomes) that facilitate the harms assessment process in exercise.
ExHaRM involves: step 1: Monitor occurrence of adverse outcomes through systematic and non-systematic surveillance; step 2: Assess and record adverse outcomes, including severity, causality, impact on intervention and type; step 3: Review of causality by harms panel (and revise as necessary); and step 4: Analyse and report frequencies, rates and clinically meaningful details of all-cause and exercise-related adverse outcomes.
ExHaRM provides guidance to improve the quality of harms assessment and reporting immediately, while concurrently providing a framework for future refinement. Future directions include, but are not limited to, standardising exercise-specific nomenclature and methods of assessing causality.

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Dicembre 2022

Change of Article Status to Open Access

The Original Investigation titled “Pooled Analysis of Meningioma Risk Following Treatment for Childhood Cancer,” which published online October 6, 2022, has changed license status to open access (CC-BY license). This article was updated online.

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Dicembre 2022

JAMA Oncology

JAMA Oncology is committed to publishing influential original research, opinions, and reviews that advance the science of oncology and improve the clinical care of patients with cancer.

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Dicembre 2022