Determining the clinical and cost-effectiveness of nasal sprays and a physical activity and stress management intervention to reduce respiratory tract infections in primary care: A protocol for the 'Immune Defence' randomised controlled trial.

BACKGROUND: Most adults in the UK experience at least one viral respiratory tract infection (RTI) per year. Individuals with comorbidities and those with recurrent RTIs are at higher risk of infections. This can lead to more severe illness, worse quality of life and more days off work. There is promising evidence that using common nasal sprays or improving immune function through increasing physical activity and managing stress, may reduce the incidence and severity of RTIs. METHODS AND DESIGN: Immune Defence is an open, parallel group, randomised controlled trial. Up to 15000 adults from UK general practices, with a comorbidity or risk factor for infection and/or recurrent infections (3 or more infections per year) will be randomly allocated to i) a gel-based nasal spray designed to inhibit viral respiratory infections; ii) a saline nasal spray, iii) a digital intervention promoting physical activity and stress management, or iv) usual care with brief advice for managing infections, for 12 months. Participants will complete monthly questionnaires online. The primary outcome is the total number of days of illness due to RTIs over 6 months. Key secondary outcomes include: days with symptoms moderately bad or worse; days where work/normal activities were impaired; incidence of RTI; incidence of COVID-19; health service contacts; antibiotic usage; beliefs about antibiotics; intention to consult; number of days of illness in total due to respiratory tract infections over 12 months. Economic evaluation from an NHS perspective will compare the interventions, expressed as incremental cost effectiveness ratios. A nested mixed methods process evaluation will examine uptake and engagement with the interventions and trial procedures. TRIAL STATUS: Recruitment commenced in December 2020 and the last participant is expected to complete the trial in April 2024. DISCUSSION: Common nasal sprays and digital interventions to promote physical activity and stress management are low cost, accessible interventions applicable to primary care. If effective, they have the potential to reduce the individual and societal impact of RTIs. TRIAL REGISTRATION: Prospectively registered with ISRCTN registry (17936080) on 30/10/2020. SPONSOR: This RCT is sponsored by University of Southampton. The sponsors had no role in the study design, decision to publish, or preparation of the manuscript.

Using nasal sprays to prevent respiratory tract infections: a qualitative study of online consumer reviews and primary care patient interviews.

OBJECTIVES: Nasal sprays could be a promising approach to preventing respiratory tract infections (RTIs). This study explored lay people's perceptions and experiences of using nasal sprays to prevent RTIs to identify barriers and facilitators to their adoption and continued use. DESIGN: Qualitative research. Study 1 thematically analysed online consumer reviews of an RTI prevention nasal spray. Study 2 interviewed patients about their reactions to and experiences of a digital intervention that promotes and supports nasal spray use for RTI prevention (reactively: at 'first signs' of infection and preventatively: following possible/probable exposure to infection). Interview transcripts were analysed using thematic analysis. SETTING: Primary care, UK. PARTICIPANTS: 407 online customer reviews. 13 purposively recruited primary care patients who had experienced recurrent infections and/or had risk factors for severe infections. RESULTS: Both studies identified various factors that might influence nasal spray use including: high motivation to avoid RTIs, particularly during the COVID-19 pandemic; fatalistic views about RTIs; beliefs about alternative prevention methods; the importance of personal recommendation; perceived complexity and familiarity of nasal sprays; personal experiences of spray success or failure; tolerable and off-putting side effects; concerns about medicines; and the nose as unpleasant and unhygienic. CONCLUSIONS: People who suffer disruptive, frequent or severe RTIs or who are vulnerable to RTIs are interested in using a nasal spray for prevention. They also have doubts and concerns and may encounter problems. Some of these may be reduced or eliminated by providing nasal spray users with information and advice that addresses these concerns or helps people overcome difficulties.

Patient perceptions of vulnerability to recurrent respiratory tract infections and prevention strategies: a qualitative study.

OBJECTIVES: Respiratory tract infections (RTIs) are extremely common, usually self-limiting, but responsible for considerable work sickness absence, reduced quality of life, inappropriate antibiotic prescribing and healthcare costs. Patients who experience recurrent RTIs and those with certain comorbid conditions have higher personal impact and healthcare costs and may be more likely to suffer disease exacerbations, hospitalisation and death. We explored how these patients experience and perceive their RTIs to understand how best to engage them in prevention behaviours. DESIGN: A qualitative interview study. SETTING: Primary care, UK. METHODS: 23 participants who reported recurrent RTIs and/or had relevant comorbid health conditions were interviewed about their experiences of RTIs. Interviews took place as the COVID-19 pandemic began. Data were analysed using inductive thematic analysis. RESULTS: Three themes were developed: Understanding causes and vulnerability, Attempting to prevent RTIs, Uncertainty and ambivalence about prevention, along with an overarching theme; Changing experiences because of COVID-19. Participants' understandings of their susceptibility to RTIs were multifactorial and included both transmission via others and personal vulnerabilities. They engaged in various approaches to try to prevent infections or alter their progression yet perceived they had limited personal control. The COVID-19 pandemic had improved their understanding of transmission, heightened their concern and motivation to avoid RTIs and extended their repertoire of protective behaviours. CONCLUSIONS: Patients who experience frequent or severe RTIs are likely to welcome and benefit from advice and support regarding RTI prevention. To engage people effectively, those developing interventions or delivering health services must consider their beliefs and concerns about susceptibility and prevention.

Factors associated with attendance at screening for breast cancer: a systematic review and meta-analysis.

OBJECTIVE: Attendance at population-based breast cancer (mammographic) screening varies. This comprehensive systematic review and meta-analysis assesses all identified patient-level factors associated with routine population breast screening attendance. DESIGN: CINAHL, Cochrane Library, Embase, Medline, OVID, PsycINFO and Web of Science were searched for studies of any design, published January 1987-June 2019, and reporting attendance in relation to at least one patient-level factor. DATA SYNTHESIS: Independent reviewers performed screening, data extraction and quality appraisal. OR and 95% CIs were calculated for attendance for each factor and random-effects meta-analysis was undertaken where possible. RESULTS: Of 19 776 studies, 335 were assessed at full text and 66 studies (n=22 150 922) were included. Risk of bias was generally low. In meta-analysis, increased attendance was associated with higher socioeconomic status (SES) (n=11 studies; OR 1.45, 95% CI: 1.20 to 1.75); higher income (n=5 studies; OR 1.96, 95% CI: 1.68 to 2.29); home ownership (n=3 studies; OR 2.16, 95% CI: 2.08 to 2.23); being non-immigrant (n=7 studies; OR 2.23, 95% CI: 2.00 to 2.48); being married/cohabiting (n=7 studies; OR 1.86, 95% CI: 1.58 to 2.19) and medium (vs low) level of education (n=6 studies; OR 1.24, 95% CI: 1.09 to 1.41). Women with previous false-positive results were less likely to reattend (n=6 studies; OR 0.77, 95% CI: 0.68 to 0.88). There were no differences by age group or by rural versus urban residence. CONCLUSIONS: Attendance was lower in women with lower SES, those who were immigrants, non-homeowners and those with previous false-positive results. Variations in service delivery, screening programmes and study populations may influence findings. Our findings are of univariable associations. Underlying causes of lower uptake such as practical, physical, psychological or financial barriers should be investigated. TRIAL REGISTRATION NUMBER: CRD42016051597.

Communicating biopsy results from breast screening assessment: current practice in English breast screening centres and staff perspectives of telephoning results.

OBJECTIVE: To record how breast screening centres in England deliver all biopsy results (cancer/non-cancer) from the breast assessment visit. DESIGN: Online survey of 63 of 79 breast screening centres in England from all regions (East Midlands, East of England, London, North East Yorkshire & Humber, North West, South East, South West, West Midlands). The survey contained quantitative measures of frequency for telephoning biopsy results (routinely, occasionally or never) and optional qualitative free-text responses. Surveys were completed by a staff member from each centre. RESULTS: There were no regional trends in the use of telephone results services, (X² (14, n=63)=11.55, p=0.64), Centres who telephoned results routinely did not deliver results sooner than centres who deliver results in-person (X² (16, n=63)=12.76, p=0.69).When delivering cancer results, 76.2% of centres never telephone results and 23.8% of centres occasionally telephone results. No centres reported delivering cancer results routinely by telephone. Qualitative content analysis suggests that cancer results are only telephoned at the patient request and under exceptional circumstances.When delivering non-cancer results, 12.7% of centres never telephoned results, 38.1% occasionally telephoned results and 49.2% routinely telephoned results. Qualitative content analysis revealed different processes for delivering telephone results, including patient choice and scheduling an in-person results appointment for all women attending breast assessment, then ringing non-cancer results unexpectedly ahead of this prebooked appointment. CONCLUSIONS: In the National Health Service Breast Screening Programme, breast assessment results that are cancer are routinely delivered in-person. However, non-cancer breast assessment results are often routinely delivered by telephone, despite breast screening policy recommendations. More research is needed to understand the impact of telephoning results on women attending breast assessment, particularly women who receive a non-cancer result. Future research should also consider how women themselves might prefer to receive their results.

Communicating benign biopsy results by telephone in the NHS Breast Screening Programme: a protocol for a cluster randomised crossover trial.

INTRODUCTION: One of the main harms from breast cancer screening is the anxiety caused by false positive results. Various factors may be associated with false-positive anxiety. One modifiable factor may be the method of communication used to deliver results. The aim of this study is to measure the effect on anxiety of receiving benign biopsy results in-person or by telephone. METHODS AND ANALYSIS: This is a multi-centre cluster randomised crossover trial in the English National Health Service Breast Screening Programme (NHSBSP) involving repeated survey measures at four time points. Participants will be women of screening age who have a biopsy following a suspicious mammography result, who ultimately receive a benign or normal (B1) result. Centres will trial both telephone and in-person results on a month-by-month basis, being randomised to which communication method will be trialled first. Women will be blinded to the method of communication they will receive. The analysis will compare women who have received telephone results and women who have received in-person results. The primary outcome measure will be anxiety (measured by the Psychological Consequences Questionnaire) after receiving results, while controlling for baseline anxiety. Secondary outcome measures will include anxiety at 3 and 6 months post-results, understanding of results and patient preferences for how results are communicated. Qualitative telephone interviews will also be conducted to further explore women's reasons for communication preferences. Qualitative and quantitative data will be integrated after initial separate analysis using the pillar integration process. ETHICS AND DISSEMINATION: This study has been approved by the Public Health England Breast Screening Programme Research Advisory Committee, (BSPRAC_0013, ODR1718_040) and the National Health Service Health Research Authority (HRA) West Midlands-Coventry & Warwickshire Research Ethics Committee (17/WM/0313). The findings from this study will be disseminated to key stakeholders within the NHSBSP and via academic publications. TRIAL REGISTRATION NUMBER: ISRCTN36997684 TRIAL SPONSOR: This research is part of a PhD award and is funded by the Economic and Social Research Council Doctoral Training Centre at the University of Warwick and Public Health England. The sponsor for this research is Jane Prewett (sponsorship@warwick.ac.uk).

Communication of cancer screening results by letter, telephone or in person: A mixed methods systematic review of the effect on attendee anxiety, understanding and preferences.

Attending and receiving a result from screening can be an anxious process. Using an appropriate method to deliver screening results could improve communication and reduce negative outcomes for screening attendees. Screening programmes are increasingly communicating results by letter or telephone rather than in-person. We investigated the impact of communication methods on attendees. We systematically reviewed the literature on the communication methods used to deliver results in cancer screening programmes for women, focusing on screening attendee anxiety, understanding of results and preferences for results communication. We included qualitative and quantitative research. We searched MEDLINE, PsycINFO, CINAHL, Cochrane Library and Embase. Results were analysed using framework synthesis. 10,558 papers were identified with seven studies meeting the inclusion criteria. Several key ideas emerged from the synthesis including speed, accuracy of results, visual support, ability to ask questions, privacy of results location and managing expectations. Verbal communication methods (telephone and in-person) were preferred and facilitated greater understanding than written methods, although there was considerable variability in attendee preferences. Findings for anxiety were mixed, with no clear consensus on which method of communication might minimise attendee anxiety. The low number of identified studies and generally low quality evidence suggest we do not know the most appropriate communication methods in the delivery of cancer screening results. More research is needed to directly compare methods of results communication, focusing on what impact each method may have on screening attendees.

Ultra-brief non-expert-delivered defusion and acceptance exercises for food cravings: A partial replication study.

Food cravings are a common barrier to losing weight. This article presents a randomised comparison of non-expert group-delivered ultra-brief defusion and acceptance interventions against a distraction control. A total of 63 participants were asked to carry a bag of chocolates for a week while trying to resist the temptation to eat them. A behavioural rebound measure was administered. Each intervention out-performed control in respect of consumption, but not cravings. These techniques may have a place in the clinical management of food cravings. We provide tentative evidence that the mechanism of action is through decreased reactivity to cravings, not through reduced frequency of cravings.