Primary care preparedness for the SARS-CoV-2 pandemic: a survey of NHS GPs.

BACKGROUND: Primary care manages a significant proportion of healthcare in the United Kingdom and should be a key part of the SARS-CoV-2 pandemic response. AIM: To assess preparedness for the SARS-CoV-2 pandemic by understanding GPs' perception of their ability to manage current and future service demand, set-up of triage processes, and training in Covid-19 infection prevention and control procedures. DESIGN AND SETTING: Cross-sectional survey of practicing GPs in the United Kingdom, with 2 rounds of data collection early in the pandemic. METHODS: Online survey, scripted and hosted by medeConnect Healthcare, comprising 6 closed prompts on 7-point Likert scales, and an optional free-text component. Quantitative data were analysed using descriptive statistics. Free-text data were analysed thematically. RESULTS: One thousand two GPs completed each round; 51 GPs completed free-text responses in March, and 64 in April. Quantitative data showed greatest confidence in triage of Covid-19 patients, and GPs were more confident managing current than future Covid-19 demand. GPs' responses were more optimistic and aligned in April than March. Free-text data highlighted that GPs were concerned about lack of appropriate personal protective equipment and personal risk of Covid-19 infection in March, and unmet needs of non-Covid-19 patients in April. In both rounds, GPs expressed feeling overlooked by government and public health bodies. CONCLUSION: Guidance to support general practice clinicians to manage future waves of Covid-19 or other health emergencies must be tailored to general practice from the outset, to support clinicians to manage competing health demands, and mitigate impacts on primary care providers' wellbeing.

The SARS-CoV-2 pandemic has posed significant challenges for the health services in the United Kingdom and abroad. A Doctors Association UK poll published in early March 2020 found that only 1% of 800 GPs believed the NHS was well prepared for the SARS-CoV-2 pandemic. We surveyed 1,002 GPs across the United Kingdom to gauge how well prepared they felt to cope with the challenges posed by Covid-19. We conducted surveys in March and April 2020, an important time early in the pandemic with rapid changes and uncertainty. We found that GPs were more confident about their ability to manage Covid-19 patients, and do so safely, in April. GPs were most confident that they would be able to triage Covid-19 patients but were concerned about future Covid-19 demand. GPs expressed frustration about a lack of personal protective equipment in March. In April, GPs' primary concern was that patients with other health concerns were not being seen. In both samples, GPs expressed feelings of being overlooked by the government. Primary care needs tailored guidance from as early as possible in a health crisis to support clinicians to manage the competing demands of responding to emergency situations, maintain usual care and their own wellbeing.

How do Healthcare Workers 'Do' Guidelines? Exploring How Policy Decisions Impacted UK Healthcare Workers During the First Phase of the COVID-19 Pandemic.

We describe how COVID-19-related policy decisions and guidelines impacted healthcare workers (HCWs) during the UK's first COVID-19 pandemic phase. Guidelines in healthcare aim to streamline processes, improve quality and manage risk. However, we argue that during this time the guidelines we studied often fell short of these goals in practice. We analysed 74 remote interviews with 14 UK HCWs over 6 months (February-August 2020). Reframing guidelines through Mol's lens of 'enactment', we reveal embodied, relational and material impacts that some guidelines had for HCWs. Beyond guideline 'adherence', we show that enacting guidelines is an ongoing, complex process of negotiating and balancing multilevel tensions. Overall, guidelines: (1) were inconsistently communicated; (2) did not sufficiently accommodate contextual considerations; and (3) were at times in tension with HCWs' values. Healthcare policymakers should produce more agile, acceptable guidelines that frontline HCWs can enact in ways which make sense and are effective in their contexts.

Canadian critical care nurses experiences on the front lines of the COVID-19 pandemic: a qualitative descriptive study.

BACKGROUND: Recent pandemics have provided important lessons to inform planning for public health emergencies. Despite these lessons, gaps in implementation during the COVID-19 pandemic are evident. Additionally, research to inform interventions to support the needs of front-line nurses during a prolonged pandemic are lacking. We aimed to gain an understanding of critical care nurses' perspectives of the ongoing pandemic, including their opinions of their organization and governments response to the pandemic, to inform interventions to improve the response to the current and future pandemics. METHODS: This sub-study is part of a cross-sectional online survey distributed to Canadian critical care nurses at two time points during the pandemic (March-May 2020; April-May 2021). We employed a qualitative descriptive design comprised of three open-ended questions to provide an opportunity for participants to share perspectives not specifically addressed in the main survey. Responses were analyzed using conventional content analysis. RESULTS: One hundred nine of the 168 (64.9%) participants in the second survey responded to the open-ended questions. While perspectives about effectiveness of both their organization's and the government's responses to the pandemic were mixed, most noted that inconsistent and unclear communication made it difficult to trust the information provided. Several participants who had worked during previous pandemics noted that their organization's COVID-19 response failed to incorporate lessons from these past experiences. Many respondents reported high levels of burnout and moral distress that negatively affected both their professional and personal lives. Despite these experiences, several respondents noted that support from co-workers had helped them to cope with the stress and challenges. CONCLUSION: One year into the pandemic, critical care nurses' lived experiences continue to reflect previously identified challenges and opportunities for improvement in pandemic preparedness and response. These findings suggest that lessons from the current and prior pandemics have been inadequately considered in the COVID-19 response. Incorporation of these perspectives into interventions to improve the health system response, and support the needs of critical care nurses is essential to fostering a resilient health workforce. Research to understand the experience of other front-line workers and to learn from more and less successful interventions, and leaders, is needed.

Risk Communication and Community Engagement During the Migrant Worker COVID-19 Outbreak in Singapore.

In early phases of the COVID-19 pandemic in Singapore, Risk Communication and Community Engagement (RCCE) with large, diverse communities of migrant workers living in high-density accommodation was slow to develop. By August 2020, Singapore had reported 55,661 cases of COVID-19, with migrant workers comprising 94.6% of the cases. A system of RCCE among migrant worker communities in Singapore was developed to maximize synergy in RCCE. Proactive stakeholder engagement and participatory approaches with affected communities were key to effective dissemination of scientific information about COVID-19 and its prevention.

Immunity certification for COVID-19: ethical considerations.

Restrictive measures imposed because of the coronavirus disease 2019 (COVID-19) pandemic have resulted in severe social, economic and health effects. Some countries have considered the use of immunity certification as a strategy to relax these measures for people who have recovered from the infection by issuing these individuals a document, commonly called an immunity passport. This document certifies them as having protective immunity against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the virus that causes COVID-19. The World Health Organization has advised against the implementation of immunity certification at present because of uncertainty about whether long-term immunity truly exists for those who have recovered from COVID-19 and concerns over the reliability of the proposed serological test method for determining immunity. Immunity certification can only be considered if scientific thresholds for assuring immunity are met, whether based on antibodies or other criteria. However, even if immunity certification became well supported by science, it has many ethical issues in terms of different restrictions on individual liberties and its implementation process. We examine the main considerations for the ethical acceptability of immunity certification to exempt individuals from restrictive measures during the COVID-19 pandemic. As well as needing to meet robust scientific criteria, the ethical acceptability of immunity certification depends on its uses and policy objectives and the measures in place to reduce potential harms, and prevent disproportionate burdens on non-certified individuals and violation of individual liberties and rights.

Les restrictions imposées dans le cadre de la lutte contre la pandémie de maladie à coronavirus 2019 (COVID-19) ont eu de lourdes conséquences économiques, sociales et sanitaires. Certains pays ont envisagé la mise en place d'une stratégie visant à alléger ces restrictions pour les individus guéris en leur octroyant un document communément appelé «passeport d'immunité¼. Ce document atteste qu'ils ont développé une immunité protectrice contre le coronavirus 2 du syndrome respiratoire aigu sévère (SARS-CoV-2), le virus à l'origine de la COVID-19. L'Organisation mondiale de la Santé a déconseillé l'usage du certificat d'immunité pour l'instant, car l'incertitude demeure quant à l'existence réelle d'une immunité à long terme pour ceux qui se sont remis de la COVID-19. En outre, la fiabilité des tests sérologiques censés déterminer si l'individu est immunisé n'est pas avérée. Un tel certificat ne peut être instauré que si les seuils scientifiques en matière d'immunité sont respectés, qu'ils soient fondés sur les anticorps ou sur d'autres critères. Néanmoins, même si le certificat d'immunité est désormais bien accepté par la science, il s'accompagne de nombreuses questions d'ordre éthique en ce qui concerne la limitation des libertés individuelles et la mise en œuvre. Dans le présent document, nous examinons les principales considérations à prendre en compte pour garantir l'acceptabilité éthique du certificat d'immunité visant à lever les mesures de restriction pour certaines personnes durant la pandémie de COVID-19. Cette acceptabilité éthique dépend non seulement de son degré de conformité à des critères scientifiques stricts, mais aussi de son usage, des objectifs politiques ainsi que des mesures mises en place pour atténuer les préjudices potentiels et éviter d'imposer une charge disproportionnée sur les individus dépourvus de certificat, ou de bafouer les droits et libertés de tout un chacun.

Las medidas restrictivas impuestas a causa de la pandemia de la enfermedad coronavirus de 2019 (COVID-19) han tenido graves efectos sociales, económicos y sanitarios. Algunos países han considerado la posibilidad de utilizar la certificación de inmunidad como estrategia para flexibilizar dichas medidas para las personas que se han recuperado de la infección mediante la expedición a dichas personas de un documento, comúnmente denominado pasaporte de inmunidad. Este documento certifica que han desarrollado inmunidad protectora contra el coronavirus-2 del síndrome respiratorio agudo severo (SARS-CoV-2), el virus que causa la COVID-19. La Organización Mundial de la Salud ha desaconsejado la aplicación de la certificación de la inmunidad en la actualidad debido a la incertidumbre sobre si existe realmente una inmunidad a largo plazo para quienes se han recuperado de la COVID-19 y a las preocupaciones sobre la fiabilidad del método de prueba serológica propuesto para determinar la inmunidad. La certificación de la inmunidad solo puede considerarse si se cumplen los umbrales científicos para asegurar la inmunidad, ya sea que se basen en anticuerpos o en otros criterios. Sin embargo, incluso si la certificación de la inmunidad llegara a estar bien respaldada por la ciencia, tiene muchas cuestiones éticas en cuanto a las diferentes restricciones de las libertades individuales y su proceso de aplicación. Examinamos las principales consideraciones sobre la aceptabilidad ética de la certificación de la inmunidad para eximir a los individuos de las medidas restrictivas durante la pandemia de la COVID-19. Además de necesitar cumplir criterios científicos sólidos, la aceptabilidad ética de la certificación de inmunidad depende de sus usos y objetivos de política y de las medidas que se apliquen para reducir los posibles daños y evitar que se impongan cargas desproporcionadas a las personas que no cuenten con dicha certificación y se violen las libertades y derechos individuales.

Developing a whole-school mental health and wellbeing intervention through pragmatic formative process evaluation: a case-study of innovative local practice within The School Health Research network.

BACKGROUND: The evidence-base for whole school approaches aimed at improving student mental health and wellbeing remains limited. This may be due to a focus on developing and evaluating de-novo, research-led interventions, while neglecting the potential of local, contextually-relevant innovation that has demonstrated acceptability and feasibility. This study reports a novel approach to modelling and refining the programme theory of a whole-school restorative approach, alongside plans to scale up through a national educational infrastructure in order to support robust scientific evaluation. METHODS: A pragmatic formative process evaluation was conducted of a routinized whole-school restorative approach aimed at improving student mental health and wellbeing in Wales. RESULTS: The study reports the six phases of the pragmatic formative process evaluation. These are: 1) identification of innovative local practice; 2) scoping review of evidence-base to identify potential programme theory; outcomes; and contextual characteristics that influence implementation; 3) establishment of a Transdisciplinary Action Research (TDAR) group; 4) co-production and confirmation of an initial programme theory with stakeholders; 5) planning to optimise intervention delivery in local contexts; and 6) planning for feasibility and outcome evaluation. The phases of this model may be iterative and not necessarily sequential. CONCLUSIONS: Formative, pragmatic process evaluations can support researchers, policy-makers and practitioners in developing robust scientific evidence-bases for acceptable and feasible local innovations that do not already have a clear evidence base. The case of a whole-school restorative approach provides a case example of how such an evaluation may be undertaken.

Perspectives on COVID-19 testing policies and practices: a qualitative study with scientific advisors and NHS health care workers in England.

BACKGROUND: As COVID-19 death rates have risen and health-care systems have experienced increased demand, national testing strategies have come under scrutiny. Utilising qualitative interview data from a larger COVID-19 study, this paper provides insights into influences on and the enactment of national COVID-19 testing strategies for health care workers (HCWs) in English NHS settings during wave one of the COVID-19 pandemic (March-August 2020). Through the findings we aim to inform learning about COVID-19 testing policies and practices; and to inform future pandemic diagnostic preparedness. METHODS: A remote qualitative, semi-structured longitudinal interview method was employed with a purposive snowball sample of senior scientific advisors to the UK Government on COVID-19, and HCWs employed in NHS primary and secondary health care settings in England. Twenty-four interviews from 13 participants were selected from the larger project dataset using a key term search, as not all of the transcripts contained references to testing. Framework analysis was informed by the non-adoption, abandonment, scale-up, spread, and sustainability of patient-facing health and care technologies implementation framework (NASSS) and by normalisation process theory (NPT). RESULTS: Our account highlights tensions between the communication and implementation of national testing developments; scientific advisor and HCW perceptions about infectiousness; and uncertainties about the responsibility for testing and its implications at the local level. CONCLUSIONS: Consideration must be given to the implications of mass NHS staff testing, including the accuracy of information communicated to HCWs; how HCWs interpret, manage, and act on testing guidance; and the influence these have on health care organisations and services.

COVID-19 infection prevention and control procedures and institutional trust: Perceptions of Canadian intensive care and emergency department nurses.

PURPOSE: Healthcare workers must ensure effective infection prevention and control (IPC) to prevent nosocomial spread of SARS-CoV-2, the virus that causes COVID-19. This questionnaire study aims to evaluate Canadian critical care and emergency department nurses' readiness to follow IPC guidelines in their workplace, and to understand their perceptions of trust in organizational preparedness, communication, and infection risk. METHODS: We adapted an internationally distributed survey for the Canadian context. This cross-sectional questionnaire, incorporating validated scales for items including institutional trust, was distributed by email to nurses via the Canadian Association of Critical Care Nurses and the Canadian Association of Emergency Physicians networks between 16 March and 25 May 2020. We evaluated intensive care unit and emergency department nurses' adherence to IPC protocols, barriers and facilitators to IPC guideline adherence, and their level of institutitonal trust. RESULTS: Three hundred and nineteen nurses responded to the survey. There was higher trust in organizational preparedness among nurses who were older (B = 0.31, P < 0.001) and more experienced (F = 18.09, P < 0.001), and particularly among those with previous experience working in outbreak settings (F = 7.87, P = 0.005). Compared with those without experience working in outbreak settings, respondents with this experience reported higher levels of fear of becoming ill and fear of providing care for COVID-19 patients (χ2 = 21.48, P = 0.002 and χ2 = 12.61, P = 0.05, respectively). Older and more experienced nurses reported greater comfort with IPC skills and easier access to personal protective equipment. While the vast majority (96%) of respondents reported using masks and gloves, only 83% had access to isolation facilities for suspected or confirmed COVID-19 cases. CONCLUSION: Canadian nurses had strong self-reported adherence to IPC measures and personal protective equipment use. There were high levels of trust in health system leadership to ensure protective measures are present and reliable. Trust was particularly high among older and more experienced nurses despite these populations reporting higher levels of fear of personal illness.

RéSUMé: OBJECTIF: Les travailleurs de la santé doivent assurer l'efficacité de la prévention et du contrôle des infections (PCI) pour prévenir la propagation nosocomiale du SRAS-CoV-2, le virus qui cause la COVID-19. Cette étude sous forme de questionnaire vise à évaluer le degré de préparation des infirmières et infirmiers des services d'urgence et de soins intensifs canadiens à suivre les lignes directrices de la PCI sur leur lieu de travail, ainsi qu'à comprendre leur degré de confiance dans la préparation, la communication et le risque d'infection au niveau de l'organisation. MéTHODE: Nous avons adapté un sondage distribué à l'échelle internationale au contexte canadien. Ce questionnaire sectoriel, incorporant des échelles validées pour des éléments tels que la confiance institutionnelle, a été distribué par courriel aux infirmières et infirmiers par l'entremise de l'Association canadienne des infirmiers/infirmières en soins intensifs et des réseaux de l'Association canadienne des médecins d'urgence entre le 16 mars et le 25 mai 2020. Nous avons évalué l'adhésion du personnel infirmier des unités de soins intensifs et des services d'urgence aux protocoles de la PCI, les obstacles et les facilitateurs à l'observance des lignes directrices de la PCI, ainsi que leur niveau de confiance institutionnelle. RéSULTATS: Trois cent dix-neuf infirmières et infirmiers ont répondu au questionnaire. Il y avait une plus grande confiance dans la préparation organisationnelle chez les infirmières et infirmiers plus âgés (B = 0,31, P < 0,001) et plus expérimentés (F = 18,09, P < 0,001), et en particulier parmi celles et ceux qui avaient déjà travaillé dans des contextes d'éclosion (F = 7,87, P = 0,005). Comparativement à celles et ceux qui n'ont pas d'expérience dans des contextes d'éclosion, les répondant(e)s avec expérience ont signalé des niveaux plus élevés de peur de tomber malade et de peur de fournir des soins aux patients atteints de la COVID-19 (χ2 = 21,48, P = 0,002 et χ2 = 12,61, P = 0,05, respectivement). Les infirmières et infirmiers plus âgés et plus expérimentés ont déclaré être plus à l'aise avec leurs compétences en PCI et avoir un meilleur accès aux équipements de protection individuelle. Alors que la grande majorité (96 %) des répondant(e)s ont déclaré avoir utilisé des masques et des gants, seulement 83 % avaient accès à des zones d'isolement pour les cas présumés ou confirmés de COVID-19. CONCLUSION: Les infirmières et infirmiers canadiens ont rapporté une forte adhésion aux mesures de la PCI et à l'utilisation des équipements de protection individuelle. Il y avait un niveau élevé de confiance dans le leadership du système de santé pour s'assurer que les mesures de protection étaient présentes et fiables. La confiance était particulièrement élevée chez le personnel infirmier plus âgé et plus expérimenté, bien les niveaux de peur d'être personnellement atteint de la maladie étaient plus élevés pour ces infirmières et infirmiers.

Addressing challenges for clinical research responses to emerging epidemics and pandemics: a scoping review.

BACKGROUND: Major infectious disease outbreaks are a constant threat to human health. Clinical research responses to outbreaks generate evidence to improve outcomes and outbreak control. Experiences from previous epidemics have identified multiple challenges to undertaking timely clinical research responses. This scoping review is a systematic appraisal of political, economic, administrative, regulatory, logistical, ethical and social (PEARLES) challenges to clinical research responses to emergency epidemics and solutions identified to address these. METHODS: A scoping review. We searched six databases (MEDLINE, Embase, Global Health, PsycINFO, Scopus and Epistemonikos) for articles published from 2008 to July 2018. We included publications reporting PEARLES challenges to clinical research responses to emerging epidemics and pandemics and solutions identified to address these. Two reviewers screened articles for inclusion, extracted and analysed the data. RESULTS: Of 2678 articles screened, 76 were included. Most presented data relating to the 2014-2016 Ebola virus outbreak or the H1N1 outbreak in 2009. The articles related to clinical research responses in Africa (n = 37), Europe (n = 8), North America (n = 5), Latin America and the Caribbean (n = 3) and Asia (n = 1) and/or globally (n = 22). A wide range of solutions to PEARLES challenges was presented, including a need to strengthen global collaborations and coordination at all levels and develop pre-approved protocols and equitable frameworks, protocols and standards for emergencies. Clinical trial networks and expedited funding and approvals were some solutions implemented. National ownership and community engagement from the outset were a key enabler for delivery. Despite the wide range of recommended solutions, none had been formally evaluated. CONCLUSIONS: To strengthen global preparedness and response to the COVID-19 pandemic and future epidemics, identified solutions for rapid clinical research deployment, delivery, and dissemination must be implemented. Improvements are urgently needed to strengthen collaborations, funding mechanisms, global and national research capacity and capability, targeting regions vulnerable to epidemics and pandemics. Solutions need to be flexible to allow timely adaptations to context, and research led by governments of affected regions. Research communities globally need to evaluate their activities and incorporate lessons learnt to refine and rehearse collaborative outbreak response plans in between epidemics.

Implementation of the Family Nurse Partnership programme in England: experiences of key health professionals explored through trial parallel process evaluation.

BACKGROUND: The Family Nurse Partnership (FNP) programme was introduced to support young first-time mothers. A randomised trial found FNP added little short-term benefit compared to usual care. The study included a comprehensive parallel process evaluation, including focus groups, conducted to aid understanding of the introduction of the programme into a new service and social context. The aim of the focus groups was to investigate views of key health professionals towards the integration and delivery of FNP programme in England. METHODS: Focus groups were conducted separately with Family Nurses, Health Visitors and Midwives at trial sites during 2011-2012. Transcripts from audio-recordings were analysed thematically. RESULTS: A total of 122 professionals participated in one of 19 focus groups. Family Nurses were confident in the effectiveness of FNP, although they experienced practical difficulties meeting programme fidelity targets and considered that programme goals did not sufficiently reflect client or community priorities. Health Visitors and Midwives regarded FNP as well-resourced and beneficial to clients, describing their own services as undervalued and struggling. They wished to work closely with Family Nurses, but felt excluded from doing so by practical barriers and programme protection. CONCLUSION: FNP was described as well-resourced and delivered by highly motivated and well supported Family Nurses. FNP eligibility, content and outcomes conflicted with individual client and community priorities. These factors may have restricted the potential effectiveness of a programme developed and previously tested in a different social milieu. Building Blocks ISRCTN23019866 Registered 20/04/2009.

Feasibility and acceptability of a motivational interviewing breastfeeding peer support intervention.

An uncontrolled study with process evaluation was conducted in three U.K. community maternity sites to establish the feasibility and acceptability of delivering a novel breastfeeding peer-support intervention informed by motivational interviewing (MI; Mam-Kind). Peer-supporters were trained to deliver the Mam-Kind intervention that provided intensive one-to-one peer-support, including (a) antenatal contact, (b) face-to-face contact within 48 hr of birth, (c) proactive (peer-supporter led) alternate day contact for 2 weeks after birth, and (d) mother-led contact for a further 6 weeks. Peer-supporters completed structured diaries and audio-recorded face-to-face sessions with mothers. Semistructured interviews were conducted with a purposive sample of mothers, health professionals, and all peer-supporters. Interview data were analysed thematically to assess intervention acceptability. Audio-recorded peer-support sessions were assessed for intervention fidelity and the use of MI techniques, using the MITI 4.2 tool. Eight peer-supporters delivered the Mam-Kind intervention to 70 mothers in three National Health Service maternity services. Qualitative interviews with mothers (n = 28), peer-supporters (n = 8), and health professionals (n = 12) indicated that the intervention was acceptable, and health professionals felt it could be integrated with existing services. There was high fidelity to intervention content; 93% of intervention objectives were met during sessions. However, peer-supporters reported difficulties in adapting from an expert-by-experience role to a collaborative role. We have established the feasibility and acceptability of providing breastfeeding peer-support using a MI-informed approach. Refinement of the intervention is needed to further develop peer-supporters' skills in providing mother-centred support. The refined intervention should be tested for effectiveness in a randomised controlled trial.

Development of a novel motivational interviewing (MI) informed peer-support intervention to support mothers to breastfeed for longer.

BACKGROUND: Many women in the UK stop breastfeeding before they would like to, and earlier than is recommended by the World Health Organization (WHO). Given the potential health benefits for mother and baby, new ways of supporting women to breastfeed for longer are required. The purpose of this study was to develop and characterise a novel Motivational Interviewing (MI) informed breastfeeding peer-support intervention. METHODS: Qualitative interviews with health professionals and service providers (n = 14), and focus groups with mothers (n = 14), fathers (n = 3), and breastfeeding peer-supporters (n = 15) were carried out to understand experiences of breastfeeding peer-support and identify intervention options. Data were audio-recorded, transcribed, and analysed thematically. Consultation took place with a combined professional and lay Stakeholder Group (n = 23). The Behaviour Change Wheel (BCW) guided intervention development process used the findings of the qualitative research and stakeholder consultation, alongside evidence from existing literature, to identify: the target behaviour to be changed; sources of this behaviour based on the Capability, Opportunity and Motivation (COM-B) model; intervention functions that could alter this behaviour; and; mode of delivery for the intervention. Behaviour change techniques included in the intervention were categorised using the Behaviour Change Technique Taxonomy Version 1 (BCTTv1). RESULTS: Building knowledge, skills, confidence, and providing social support were perceived to be key functions of breastfeeding peer-support interventions that aim to decrease early discontinuation of breastfeeding. These features of breastfeeding peer-support mapped onto the BCW education, training, modelling and environmental restructuring intervention functions. Behaviour change techniques (BCTTv1) included social support, problem solving, and goal setting. The intervention included important inter-personal relational features (e.g. trust, honesty, kindness), and the BCTTv1 needed adaptation to incorporate this. CONCLUSIONS: The MI-informed breastfeeding peer-support intervention developed using this systematic and user-informed approach has a clear theoretical basis and well-described behaviour change techniques. The process described could be useful in developing other complex interventions that incorporate peer-support and/or MI.

Talking to the people that really matter about their participation in pandemic clinical research: A qualitative study in four European countries.

BACKGROUND: Pandemics of new and emerging infectious diseases are unpredictable, recurrent events that rapidly threaten global health and security. We aimed to identify public views regarding provision of information and consent to participate in primary and critical care clinical research during a future influenza-like illness pandemic. METHODS: Descriptive-interpretive qualitative study, using focus groups (n = 10) and semi-structured interviews (n = 16), with 80 members of the public (>18 years) in Belgium, Spain, Poland and the UK. Local qualitative researchers followed a scenario-based topic guide to collect data. Data were transcribed verbatim, translated into English and subject to framework analysis. RESULTS: Public understandings of pandemics were shaped by personal factors (illness during the previous H1N1 pandemic, experience of life-threatening illness) and social factors (historical references, media, public health information). Informants appreciated safeguards provided by ethically robust research procedures, but current enrolment procedures were seen as a barrier. They proposed simplified enrolment processes for higher risk research and consent waiver for certain types of low-risk research. Decision making about research participation was influenced by contextual, research and personal factors. Informants generally either carefully weighed up various approaches to research participation or responded instinctively. They supported the principle of using routinely collected, anonymized clinical biological samples for research without explicit consent, but regarded this as less acceptable if researchers were motivated primarily by commercial gain. CONCLUSIONS: This bottom-up approach to ascertaining public views on pandemic clinical research has identified support for more proportionate research protection procedures for publically funded, low-risk studies.

Is a motivational interviewing based lifestyle intervention for obese pregnant women across Europe implemented as planned? Process evaluation of the DALI study.

BACKGROUND: Process evaluation is an essential part of designing and assessing complex interventions. The vitamin D and lifestyle intervention study (DALI) study is testing different strategies to prevent development of gestational diabetes mellitus among European obese pregnant women with a body mass index ≥29 kg/m2. The intervention includes guidance on physical activity and/or healthy eating by a lifestyle coach trained in motivational interviewing (MI). The aim of this study was to assess the process elements: reach, dose delivered, fidelity and satisfaction and to investigate whether these process elements were associated with changes in gestational weight gain (GWG). METHODS: Data on reach, dose delivered, fidelity, and satisfaction among 144 participants were collected. Weekly recruitment reports, notes from meetings, coach logs and evaluation questionnaires (n = 110) were consulted. Fidelity of eight (out of twelve) lifestyle coach practitioners was assessed by analysing audio recorded counselling sessions using the MI treatment integrity scale. Furthermore, associations between process elements and GWG were assessed with linear regression analyses. RESULTS: A total of 20% of the possible study population (reach) was included in this analysis. On average 4.0 (of the intended 5) face-to-face sessions were delivered. Mean MI fidelity almost reached 'expert opinion' threshold for the global scores, but was below 'beginning proficiency' for the behavioural counts. High variability in quality of MI between practitioners was identified. Participants were highly satisfied with the intervention, the lifestyle coach and the intervention materials. No significant associations were found between process elements and GWG. CONCLUSION: Overall, the intervention was well delivered and received by the study population, but did not comply with all the principles of MI. Ensuring audio recording of lifestyle sessions throughout the study would facilitate provision of individualized feedback to improve MI skills. A larger sample size is needed to confirm the lack of association between process elements and GWG. TRIAL REGISTRATION: ISRCTN registry: ISRCTN70595832 ; Registered 12 December 2011.

Development and Delivery of a Physical Activity Intervention for People With Huntington Disease: Facilitating Translation to Clinical Practice.

BACKGROUND AND PURPOSE: We studied the development and delivery of a 14-week complex physical activity intervention for people with Huntington disease, where detailed information about the intervention was fully embedded in the trial design process. METHODS: Intervention Development: The intervention was developed through a series of focus groups. The findings from the focus groups informed the development of a logic model for the physical activity intervention that was broadly consistent with the framework of self-determination theory. Intervention Delivery: Key components underpinning the delivery of the intervention were implemented including a defined coach training program and intervention fidelity assessment methods. Training of coaches (physical therapists, occupational therapists, research nurses, and exercise trainers) was delivered via group and 1:1 training sessions using a detailed coach's manual, and with ongoing support via video calls, and e-mail communication as needed. Detailed documentation was provided to determine costs of intervention development and coach training. RESULTS: Intervention delivery coaches at 8 sites across the United Kingdom participated in the face-to-face training. Self-report checklists completed by each of the coaches indicated that all components of the intervention were delivered in accordance with the protocol. Mean (standard deviation) intervention fidelity scores (n = 15), as measured using a purpose-developed rating scale, was 11 (2.4) (out of 16 possible points). Coaches' perceptions of intervention fidelity were similarly high. The total cost of developing the intervention and providing training was £30,773 ($47,042 USD). DISCUSSION AND CONCLUSIONS: An important consideration in promoting translation of clinical research into practice is the ability to convey the detailed components of how the intervention was delivered to facilitate replication if the results are favorable. This report presents an illustrative example of a physical activity intervention, including the development and the training required to deliver it. This approach has the potential to facilitate reproducibility, evidence synthesis, and implementation in clinical practice.Video Abstract available for more insights from the authors (see Supplemental Digital Content 1, http://links.lww.com/JNPT/A122).

A rapid review of community engagement and informed consent processes for adaptive platform trials and alternative design trials for public health emergencies.

Background : Public Health Emergencies (PHE) demand expeditious research responses to evaluate new or repurposed therapies and prevention strategies. Alternative Design Trials (ADTs) and Adaptive Platform Trials (APTs) have enabled efficient large-scale testing of biomedical interventions during recent PHEs. Design features of these trials may have implications for engagement and/or informed consent processes. We aimed to rapidly review evidence on engagement and informed consent for ADTs and APTs during PHE to consider what (if any) recommendations can inform practice. Method : In 2022, we searched 8 prominent databases for relevant peer reviewed publications and guidelines for ADTs/APTs in PHE contexts. Articles were selected based on pre-identified inclusion and exclusion criteria. We reviewed protocols and informed consent documents for a sample of large platform trials and consulted with key informants from ADTs/APT trial teams. Data were extracted and summarised using narrative synthesis. Results : Of the 49 articles included, 10 were guidance documents, 14 discussed engagement, 10 discussed informed consent, and 15 discussed both. Included articles addressed ADTs delivered during the West African Ebola epidemic and APTs delivered during COVID-19. PHE clinical research guidance documents highlight the value of ADTs/APTs and the importance of community engagement, but do not provide practice-specific guidance for engagement or informed consent. Engagement and consent practice for ADTs conducted during the West African Ebola epidemic have been well-documented. For COVID-19, engagement and consent practice was described for APTs primarily delivered in high income countries with well-developed health service structures. A key consideration is strong communication of the complexity of trial design in clear, accessible ways. Conclusion: We highlight key considerations for best practice in community engagement and informed consent relevant to ADTs and APTs for PHEs which may helpfully be included in future guidance. Protocol: The review protocol is published online at Prospero on 15/06/2022: registration number CRD42022334170.

A rapid qualitative methods assessment and reporting tool for epidemic response as the outcome of a rapid review and expert consultation.

During the first year of the COVID-19 pandemic, the Methods Sub-Group of the WHO COVID-19 Social Science Research Roadmap Working Group conducted a rapid evidence review of rapid qualitative methods (RQMs) used during epidemics. The rapid review objectives were to (1) synthesize the development, implementation, and uses of RQMs, including the data collection tools, research questions, research capacities, analytical approaches, and strategies used to speed up data collection and analysis in their specific epidemic and institutional contexts; and (2) propose a tool for assessing and reporting RQMs in epidemics emergencies. The rapid review covered published RQMs used in articles and unpublished reports produced between 2015 and 2021 in five languages (English, Mandarin, French, Portuguese, and Spanish). We searched multiple databases in these five languages between December 2020 and January 31, 2021. Sources employing "rapid" (under 6 months from conception to reporting of results) qualitative methods for research related to epidemic emergencies were included. We included 126 published and unpublished sources, which were reviewed, coded, and classified by the research team. Intercoder reliability was found to be acceptable (Krippendorff's α = 0.709). We employed thematic analysis to identify categories characterizing RQMs in epidemic emergencies. The review protocol was registered at PROSPERO (no. CRD42020223283) and Research Registry (no. reviewregistry1044). We developed an assessment and reporting tool of 13 criteria in three domains, to document RQMs used in response to epidemic emergencies. These include I. Design and Development (i. time frame, ii. Training, iii. Applicability to other populations, iv. Applicability to low resource settings, v. community engagement, vi. Available resources, vii. Ethical approvals, viii. Vulnerability, ix. Tool selection); II. Data Collection and Analysis (x. concurrent data collection and analysis, xi. Targeted populations and recruitment procedures); III. Restitution and Dissemination (xii. Restitution and dissemination of findings, xiii. Impact). Our rapid review and evaluation found a wide range of feasible and highly effective tools, analytical approaches and timely operational insights and recommendations during epidemic emergencies.

The experiences of patients ill with COVID-19-like symptoms and the role of testing for SARS-CoV-2 in supporting them: A qualitative study in eight European countries during the first wave of the pandemic.

BACKGROUND: Access to testing during the first wave of the COVID-19 pandemic was limited, impacting patients with COVID-19-like symptoms. Current qualitative studies have been limited to one country or were conducted outside Europe. OBJECTIVES: To explore - in eight European countries - the experiences of patients consulting in primary care with COVID-19-like symptoms during the first wave of the pandemic. METHODS: Sixty-six semi-structured interviews, informed by a topic guide, were conducted by telephone or in person between April and July 2020. Patients with COVID-19-like symptoms were purposively recruited in primary care sites in eight countries and sampled based on age, gender, and symptom presentation. Deductive and inductive thematic analysis techniques were used to develop a framework representing data across settings. Data adequacy was attained by collecting rich data. RESULTS: Seven themes were identified, which described the experiences of patients consulting. Two themes are reported in this manuscript describing the role of COVID-19 testing in this experience. Patients described significant distress due to their symptoms, especially those at higher risk of complications from COVID-19, and those with severe symptoms. Patients wanted access to testing to identify the cause of their illness and minimise the burden of managing uncertainty. Some patients testing positive for COVID-19 assumed they would be immune from future infection. CONCLUSION: Patients experiencing novel and severe symptoms, particularly those with comorbidities, experienced a significant emotional and psychological burden due to concerns about COVID-19. Testing provided reassurance over health status and helped patients identify which guidance to follow. Testing positive for SARS-CoV-2 led to some patients thinking they were immune from future infection, thus influencing subsequent behaviour.