Methodological reflections on the recruitment and engagement of people for cancer screening research in Wales.

Cancer is a major threat to public health and the second leading cause of death globally. Population-based cancer screening is an effective way to improve the early detection of a cancer and reduce mortality. Factors associated with participation in cancer screening have been increasingly explored in research. The challenges to undertaking such research are evident, but there is little discussion about how to address such challenges. This article discusses methodological issues associated with the recruitment and engagement of participants in research, drawing upon our experience of undertaking research exploring the support needs of people residing in Newport West, Wales, to participate in breast, bowel, and cervical screening programs. Four key areas were addressed: sampling issues, language barriers, IT issues, and time demand for participation. The paper highlights the importance of ongoing community engagement, the provision of appropriate study materials, and the adaption to different data collection modes to meet participants' needs to participate in research, thus enabling people who are usually excluded from research to have a voice and make a significant contribution to research.

Impact of prior SARS-CoV-2 infection and COVID-19 vaccination on the subsequent incidence of COVID-19: a multicentre prospective cohort study among UK healthcare workers - the SIREN (Sarscov2 Immunity & REinfection EvaluatioN) study protocol.

INTRODUCTION: Understanding the effectiveness and durability of protection against SARS-CoV-2 infection conferred by previous infection and COVID-19 is essential to inform ongoing management of the pandemic. This study aims to determine whether prior SARS-CoV-2 infection or COVID-19 vaccination in healthcare workers protects against future infection. METHODS AND ANALYSIS: This is a prospective cohort study design in staff members working in hospitals in the UK. At enrolment, participants are allocated into cohorts, positive or naïve, dependent on their prior SARS-CoV-2 infection status, as measured by standardised SARS-CoV-2 antibody testing on all baseline serum samples and previous SARS-CoV-2 test results. Participants undergo monthly antibody testing and fortnightly viral RNA testing during follow-up and based on these results may move between cohorts. Any results from testing undertaken for other reasons (eg, symptoms, contact tracing) or prior to study entry will also be captured. Individuals complete enrolment and fortnightly questionnaires on exposures, symptoms and vaccination. Follow-up is 12 months from study entry, with an option to extend follow-up to 24 months.The primary outcome of interest is infection with SARS-CoV-2 after previous SARS-CoV-2 infection or COVID-19 vaccination during the study period. Secondary outcomes include incidence and prevalence (both RNA and antibody) of SARS-CoV-2, viral genomics, viral culture, symptom history and antibody/neutralising antibody titres. ETHICS AND DISSEMINATION: The study was approved by the Berkshire Research Ethics Committee, Health Research Authority (IRAS ID 284460, REC reference 20/SC/0230) on 22 May 2020; the vaccine amendment was approved on 12 January 2021. Participants gave informed consent before taking part in the study.Regular reports to national and international expert advisory groups and peer-reviewed publications ensure timely dissemination of findings to inform decision making. TRIAL REGISTRATION NUMBER: ISRCTN11041050.

An International Commentary on Dysphagia and Dysphonia During the COVID-19 Pandemic.

COVID-19 has had an impact globally with millions infected, high mortality, significant economic ramifications, travel restrictions, national lockdowns, overloaded healthcare systems, effects on healthcare workers' health and well-being, and large amounts of funding diverted into rapid vaccine development and implementation. Patients with COVID-19, especially those who become severely ill, have frequently developed dysphagia and dysphonia. Health professionals working in the field have needed to learn about this new disease while managing these patients with enhanced personal protective equipment. Emerging research suggests differences in the clinical symptoms and journey to recovery for patients with COVID-19 in comparison to other intensive care populations. New insights from outpatient clinics also suggest distinct presentations of dysphagia and dysphonia in people after COVID-19 who were not hospitalized or severely ill. This international expert panel provides commentary on the impact of the pandemic on speech pathologists and our current understanding of dysphagia and dysphonia in patients with COVID-19, from acute illness to long-term recovery. This narrative review provides a unique, comprehensive critical appraisal of published peer-reviewed primary data as well as emerging previously unpublished, original primary data from across the globe, including clinical symptoms, trajectory, and prognosis. We conclude with our international expert opinion on what we have learnt and where we need to go next as this pandemic continues across the globe.

Multidisciplinary management of laryngeal pathology identified in patients with COVID-19 following trans-laryngeal intubation and tracheostomy.

Background: COVID-19 disease often requires invasive ventilatory support. Trans-laryngeal intubation of the trachea may cause laryngeal injury, possibly compounded by coronavirus infection. Fibreoptic Endoscopic Evaluation of Swallowing (FEES) provides anatomical and functional assessment of the larynx, guiding multidisciplinary management. Our aims were to observe the nature of laryngeal abnormalities in patients with COVID-19 following prolonged trans-laryngeal intubation and tracheostomy, and to describe their impact on functional laryngeal outcomes, such as tracheostomy weaning. Methods: A retrospective observational cohort analysis was undertaken between March and December 2020, at a UK tertiary hospital. The Speech and Language Therapy team assessed patients recovering from COVID-19 with voice/swallowing problems identified following trans-laryngeal intubation or tracheostomy using FEES. Laryngeal pathology, treatments, and outcomes relating to tracheostomy and oral feeding were noted. Results: Twenty-five FEES performed on 16 patients identified a median of 3 (IQR 2-4) laryngeal abnormalities, with 63% considered clinically significant. Most common pathologies were: oedema (n = 12, 75%); abnormal movement (n = 12, 75%); atypical lesions (n = 11, 69%); and erythema (n = 6, 38%). FEES influenced management: identifying silent aspiration (88% of patients who aspirated (n = 8)), airway patency issues impacting tracheostomy weaning (n = 8, 50%), targeted dysphagia therapy (n = 7, 44%); ENT referral (n = 6, 38%) and reflux management (n = 5, 31%). Conclusions: FEES is beneficial in identifying occult pathologies and guiding management for laryngeal recovery. In our cohort, the incidence of laryngeal pathology was higher than a non-COVID-19 cohort with similar characteristics. We recommend multidisciplinary investigation and management of patients recovering from COVID-19 who required prolonged trans-laryngeal intubation and/or tracheostomy to optimise laryngeal recovery.

SARS-CoV-2 infection rates of antibody-positive compared with antibody-negative health-care workers in England: a large, multicentre, prospective cohort study (SIREN).

BACKGROUND: Increased understanding of whether individuals who have recovered from COVID-19 are protected from future SARS-CoV-2 infection is an urgent requirement. We aimed to investigate whether antibodies against SARS-CoV-2 were associated with a decreased risk of symptomatic and asymptomatic reinfection. METHODS: A large, multicentre, prospective cohort study was done, with participants recruited from publicly funded hospitals in all regions of England. All health-care workers, support staff, and administrative staff working at hospitals who could remain engaged in follow-up for 12 months were eligible to join The SARS-CoV-2 Immunity and Reinfection Evaluation study. Participants were excluded if they had no PCR tests after enrolment, enrolled after Dec 31, 2020, or had insufficient PCR and antibody data for cohort assignment. Participants attended regular SARS-CoV-2 PCR and antibody testing (every 2-4 weeks) and completed questionnaires every 2 weeks on symptoms and exposures. At enrolment, participants were assigned to either the positive cohort (antibody positive, or previous positive PCR or antibody test) or negative cohort (antibody negative, no previous positive PCR or antibody test). The primary outcome was a reinfection in the positive cohort or a primary infection in the negative cohort, determined by PCR tests. Potential reinfections were clinically reviewed and classified according to case definitions (confirmed, probable, or possible) and symptom-status, depending on the hierarchy of evidence. Primary infections in the negative cohort were defined as a first positive PCR test and seroconversions were excluded when not associated with a positive PCR test. A proportional hazards frailty model using a Poisson distribution was used to estimate incidence rate ratios (IRR) to compare infection rates in the two cohorts. FINDINGS: From June 18, 2020, to Dec 31, 2020, 30 625 participants were enrolled into the study. 51 participants withdrew from the study, 4913 were excluded, and 25 661 participants (with linked data on antibody and PCR testing) were included in the analysis. Data were extracted from all sources on Feb 5, 2021, and include data up to and including Jan 11, 2021. 155 infections were detected in the baseline positive cohort of 8278 participants, collectively contributing 2 047 113 person-days of follow-up. This compares with 1704 new PCR positive infections in the negative cohort of 17 383 participants, contributing 2 971 436 person-days of follow-up. The incidence density was 7·6 reinfections per 100 000 person-days in the positive cohort, compared with 57·3 primary infections per 100 000 person-days in the negative cohort, between June, 2020, and January, 2021. The adjusted IRR was 0·159 for all reinfections (95% CI 0·13-0·19) compared with PCR-confirmed primary infections. The median interval between primary infection and reinfection was more than 200 days. INTERPRETATION: A previous history of SARS-CoV-2 infection was associated with an 84% lower risk of infection, with median protective effect observed 7 months following primary infection. This time period is the minimum probable effect because seroconversions were not included. This study shows that previous infection with SARS-CoV-2 induces effective immunity to future infections in most individuals. FUNDING: Department of Health and Social Care of the UK Government, Public Health England, The National Institute for Health Research, with contributions from the Scottish, Welsh and Northern Irish governments.

The post-ICU presentation screen (PICUPS) and rehabilitation prescription (RP) for intensive care survivors part I: Development and preliminary clinimetric evaluation.

Background: Patients who have had prolonged stays in intensive care have ongoing rehabilitation needs. This is especially true of COVID-19 ICU patients, who can suffer diverse long-term ill effects. Currently there is no systematic data collection to guide the needs for therapy input for either of these groups nor to inform planning and development of rehabilitation services. These issues could be resolved in part by the systematic use of a clinical tool to support decision-making as patients progress from the Intensive Care Unit (ICU), through acute hospital care and onwards into rehabilitation. We describe (i) the development of such a tool (the Post-ICU Presentation Screen (PICUPS)) and (ii) the subsequent preparation of a person-centred Rehabilitation Prescription (RP) to travel with the patient as they continue down the care pathway. Methods: PICUPS development was led by a core group of experienced clinicians representing the various disciplines involved in post-ICU rehabilitation. Key constructs and item-level descriptors were identified by group consensus. Piloting was performed as part of wider clinical engagement in 26 acute hospitals across England. Development and validation of such a tool requires clinimetric analysis, and this was based on classical test theory. Teams also provided feedback about the feasibility and utility of the tool. Results: Initial PICUPS design yielded a 24-item tool. In piloting, a total of 552 records were collated from 314 patients, of which 121 (38.5%) had COVID-19. No obvious floor or ceiling effects were apparent. Exploratory factor analysis provided evidence of uni-dimensionality with strong loading on the first principal component accounting for 51% of the variance and Cronbach's alpha for the full-scale score 0.95 - although a 3-factor solution accounted for a further 21%. The PICUPS was responsive to change both at full scale- and item-level. In general, positive responses were seen regarding the tool's ability to describe the patients during their clinical course, engage and flag the relevant professionals needed, and to inform what should be included in an RP. Conclusions: The PICUPS tool has robust scaling properties as a clinical measure and is potentially useful as a tool for identifying rehabilitation needs as patients step down from ICU and acute hospital care.

The Post-ICU presentation screen (PICUPS) and rehabilitation prescription (RP) for intensive care survivors part II: Clinical engagement and future directions for the national Post-Intensive care Rehabilitation Collaborative.

Background: Many Intensive Care Unit (ICU) survivors suffer from a multi- system disability, termed the post-intensive care syndrome. There is no current national coordination of either rehabilitation pathways or related data collection for them. In the last year, the need for tools to systematically identify the multidisciplinary rehabilitation needs of severely affected COVID-19 survivors has become clear. Such tools offer the opportunity to improve rehabilitation for all critical illness survivors through provision of a personalised Rehabilitation Prescription (RP). The initial development and secondary refinement of such an assessment and data tools is described in the linked paper. We report here the clinical and workforce data that was generated as a result. Methods: Prospective service evaluation of 26 acute hospitals in England using the Post-ICU Presentation Screen (PICUPS) tool and the RP. The PICUPS tool comprised items in domains of a) Medical and essential care, b) Breathing and nutrition; c) Physical movement and d) Communication, cognition and behaviour. Results: No difference was seen in total PICUPS scores between patients with or without COVID-19 (77 (IQR 60-92) vs. 84 (IQR 68-97); Mann-Whitney z = -1.46, p = 0.144. A network analysis demonstrated that requirements for physiotherapy, occupational therapy, speech and language therapy, dietetics and clinical psychology were closely related and unaffected by COVID-19 infection status. A greater proportion of COVID-19 patients were referred for inpatient rehabilitation (13% vs. 7%) and community-based rehabilitation (36% vs.15%). The RP informed by the PICUPS tool generally specified a greater need for multi-professional input when compared to rehabilitation plans instituted. Conclusions: The PICUPS tool is feasible to implement as a screening mechanism for post-intensive care syndrome. No differences are seen in the rehabilitation needs of patients with and without COVID-19 infection. The RP could be the vehicle that drives the professional interventions across the transitions from acute to community care. No single discipline dominates the rehabilitation requirements of these patients, reinforcing the need for a personalised RP for critical illness survivors.

Swallowing and Communication Management of Tracheostomy and Laryngectomy in the Context of COVID-19: A Review.

IMPORTANCE: The care of patients with a surgically modified airway, such as tracheostomy or laryngectomy, represents a challenge for speech-language pathologists (SLPs) in the context of the coronavirus disease 2019 (COVID-19) pandemic. The objective was to review available publications and practice guidelines on management of tracheostomy and laryngectomy in the context of COVID-19. This study performed a review and synthesis of information available in the PubMed database and from national SLP organizations across 6 countries. OBSERVATIONS: From the search, 22 publications on tracheostomy and 3 referring to laryngectomy were identified. After analysis of titles and abstracts followed by full-text review, 4 publications were identified as presenting guidelines for specific approaches to tracheostomy and were selected; all 3 publications on laryngectomy were selected. The main guidelines on tracheostomy described considerations during management (eg, cuff manipulation, suctioning, valve placement) owing to the increased risk of aerosol generation and transmission during swallowing and communication interventions in this population. Regarding laryngectomy, the guidelines focused on the care and protection of both the professional and the patient, offering recommendations on the management of adverse events and leakage of the tracheoesophageal prosthesis. CONCLUSIONS AND RELEVANCE: Frequent guideline updates for SLPs are necessary to inform best practice and ensure patient and health care worker protection and safety while providing high-quality care and rehabilitation.

Assessment, Diagnosis, and Treatment of Dysphagia in Patients Infected With SARS-CoV-2: A Review of the Literature and International Guidelines.

Purpose Speech-language pathologists are playing a crucial role in the assessment and management of patients infected with severe acute respiratory syndrome coronavirus 2. Our goal was to synthesize peer-reviewed literature and association guidelines from around the world regarding dysphagia assessment and management for this specific population. Method A review of publications available in the PubMed database and official guidelines of international groups was performed on May 23, 2020. The information was synthesized and categorized into three content areas for swallowing: clinical evaluation, instrumental assessment, and rehabilitation. Results Five publications were identified in the PubMed database. Following title, abstract, and full-text review, only three publications met inclusion criteria: two reviews and one narrative report. Additionally, 19 international guidelines were reviewed. To assess swallowing, a modified clinical evaluation was recommended and only following a risk assessment. Instrumental assessments were often considered aerosol generating, especially transnasal procedures such as endoscopy and manometry. For this reason, many associations recommended that these examinations be performed only when essential and with appropriate personal protective equipment. Guidelines recommended that intervention should focus on compensatory strategies, including bolus modification, maneuvers/postural changes, and therapeutic exercises that can be conducted with physical distancing. Respiratory training devices were not recommended during rehabilitation. Conclusions International associations have provided extensive guidance regarding the level of risk related to the management of dysphagia in this population. To date, there are no scientific papers offering disease and/or recovery profiling for patients with dysphagia and coronavirus disease 2019. As a result, research in this area is urgently needed.

Speech-Language Pathology Guidance for Tracheostomy During the COVID-19 Pandemic: An International Multidisciplinary Perspective.

Purpose As the COVID-19 pandemic has unfolded, there has been growing recognition of risks to frontline health care workers. When caring for patients with tracheostomy, speech-language pathologists have significant exposure to mucosal surfaces, secretions, and aerosols that may harbor the SARS-CoV-2 virus. This tutorial provides guidance on practices for safely performing patient evaluation and procedures, thereby reducing risk of infection. Method Data were collated through review of literature, guidelines, and consensus statements relating to COVID-19 and similar high-consequent infections, with a focus on mitigating risk of transmission to health care workers. Particular emphasis was placed on speech-language pathologists, nurses, and other allied health professionals. A multinational interdisciplinary team then analyzed findings, arriving at recommendations through consensus via electronic communications and video conference. Results Reports of transmission of infection to health care workers in the current COVID-19 pandemic and previous outbreaks substantiate the need for safe practices. Many procedures routinely performed by speech-language pathologists have a significant risk of infection due to aerosol generation. COVID-19 testing can inform level of protective equipment, and meticulous hygiene can stem spread of nosocomial infection. Modifications to standard clinical practice in tracheostomy are often required. Personal protective equipment, including either powered air-purifying respirator or N95 mask, gloves, goggles, and gown, are needed when performing aerosol-generating procedures in patients with known or suspected COVID-19 infection. Conclusions Speech-language pathologists are often called on to assist in the care of patients with tracheostomy and known or suspected COVID-19 infection. Appropriate care of these patients is predicated on maintaining the health and safety of the health care team. Careful adherence to best practices can significantly reduce risk of infectious transmission.