Chronic rhinosinusitis:a qualitative study of patient views and experiences of current management in primary and secondary care

OBJECTIVES: To explore patient views and perspectives of current management of chronic rhinosinusitis (CRS) in primary and secondary care. DESIGN: Semistructured qualitative telephone interviews as part of the MACRO programme (Defining best Management for Adults with Chronic RhinOsinusitis). SETTING: Primary care and secondary care ear, nose and throat outpatient clinics in the UK. PARTICIPANTS: Twenty-five patients consented to in-depth telephone interviews. Transcribed recordings were managed using NVivo software and analysed using inductive thematic analysis. RESULTS: CRS has a significant impact on patients' quality of life, affecting their ability to work effectively, their social interactions and daily living. Patients seek help when symptoms become unmanageable, but can become frustrated with the primary care system with difficulties obtaining an appointment, and lack of continuity of care. Patients perceive that general practitioners can be dismissive of CRS symptoms, and patients often prioritise other concerns when they consult. Health system barriers and poor communication can result in delays in accessing appropriate treatment and referral. Adherence to intranasal steroids is a problem and patients are uncertain about correct technique. Nasal irrigation can be time-consuming and difficult for patients to use. Secondary care consultations can appear rushed, and patients would like specialists to take a more 'holistic' approach to their management. Surgery is often considered a temporary solution, appropriate when medical options have been explored. CONCLUSIONS: Patients are frustrated with the management of their CRS, and poor communication can result in delays in receiving appropriate treatment and timely referral. Patients seek better understanding of their condition and guidance to support treatments decisions in light of uncertainties around the different medical and surgical options. Better coordinated care between general practice and specialist settings and consistency of advice has the potential to increase patient satisfaction and improve outcomes

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.</p

Clarithromycin and endoscopic sinus surgery for adults with chronic rhinosinusitis with and without nasal polyps: study protocol for the MACRO randomised controlled trial.

BACKGROUND: Chronic rhinosinusitis (CRS) is a common source of ill health; 11% of UK adults reported CRS symptoms in a worldwide population study. Guidelines are conflicting regarding whether antibiotics should be included in primary medical management, reflecting the lack of evidence in systematic reviews. Insufficient evidence to inform the role of surgery contributes to a fivefold variation in UK intervention rates. The objective of this trial is to establish the comparative effectiveness of endoscopic sinus surgery (ESS) or a prolonged course of antibiotics (clarithromycin) in adult patients with CRS in terms of symptomatic improvement and costs to the National Health Service compared with standard medical care (intranasal medication) at 6 months. METHODS/DESIGN: A three-arm parallel-group trial will be conducted with patients who remain symptomatic after receiving appropriate medical therapy (either in primary or secondary care). They will be randomised to receive: (1) intranasal medication plus ESS, (2) intranasal medication plus clarithromycin (250 mg) or (3) intranasal medication plus a placebo. Intranasal medication (current standard medical care) is defined as a spray or drops of intranasal corticosteroids and saline irrigations. The primary outcome measure is the SNOT-22 questionnaire, which assesses disease-specific health-related quality of life. The study sample size is 600. Principal analyses will be according to the randomised groups irrespective of compliance. The trial will be conducted in at least 16 secondary or tertiary care centres with an internal pilot at six sites for 6 months. DISCUSSION: The potential cardiovascular side effects of macrolide antibiotics have been recently highlighted. The effectiveness of antibiotics will be established through this trial, which may help to reduce unnecessary usage and potential morbidity. If ESS is shown to be clinically effective and cost-effective, the trial may encourage earlier intervention. In contrast, if it is shown to be ineffective, then there should be a significant reduction in surgery rates. The trial results will feed into the other components of the MACRO research programme to establish best practice for the management of adults with CRS and design the ideal patient pathway across primary and secondary care. TRIAL REGISTRATION: ISRCTN36962030 . Registered on 17 October 2018

Maximising recruitment to a randomised controlled trial for chronic rhinosinusitis using qualitative research methods: the MACRO conversation study

Background: Randomised controlled trials (RCTs) are considered the ‘gold standard’ of medical evidence; however, recruitment can be challenging. The MACRO trial is a NIHR-funded RCT for chronic rhinosinusitis (CRS) addressing the challenge of comparing surgery, antibiotics and placebo. The embedded MACRO conversation study (MCS) used qualitative research techniques pioneered by the University of Bristol QuinteT team to explore recruitment issues during the pilot phase, to maximise recruitment in the main trial. Methods: Setting: Five outpatient Ear Nose and Throat (ENT) departments recruiting for the pilot phase of the MACRO trial (ISRCTN Number: 36962030, prospectively registered 17 October 2018). We conducted a thematic analysis of telephone interviews with 18 recruiters and 19 patients and 61 audio-recordings of recruitment conversations. We reviewed screening and recruitment data and mapped patient pathways at participating sites. We presented preliminary findings to individual site teams. Group discussions enabled further exploration of issues, evolving strategies and potential solutions. Findings were reported back to the funder and used together with recruitment data to justify progression to the main trial. Results: Recruitment in the MACRO pilot trial began slowly but accelerated in time to progress successfully to the main trial. Research nurse involvement was pivotal to successful recruitment. Engaging the wider network of clinical colleagues emerged as an important factor, ensuring the patient pathway through primary and secondary care did not inadvertently affect trial eligibility. The most common reason for patients declining participation was treatment preference. Good patient-clinician relationships engendered trust and supported patient decision-making. Overall, trial involvement appeared clearly presented by recruiters, possibly influenced by pre-trial training. The weakest area of understanding for patients appeared to be trial medications. A clear presentation of medical and surgical treatment options, together with checking patient understanding, had the potential to allay patient concerns. Conclusion: The MACRO conversation study contributed to the learning process of optimising recruitment by helping to identify and address recruitment issues. Although some issues were trial-specific, others have applicability to many clinical trial situations. Using qualitative research techniques to identify/explore barriers and facilitators to recruitment may be valuable during the pilot phase of many RCTs including those with complex designs

Expert panel process to optimise the design of a randomised controlled trial in chronic rhinosinusitis (the MACRO programme).

BACKGROUND: MACRO (Defining best Management for Adults with Chronic RhinOsinusitis) is an NIHR-funded programme of work designed to establish best practice for adults with chronic rhinosinusitis (CRS). The 7-year programme comprises three consecutive workstreams, designed to explore NHS care pathways through analysis of primary and secondary data sources, and to undertake a randomised controlled trial to evaluate a longer-term course of macrolide antibiotics and endoscopic sinus surgery for patients with CRS. A number of outstanding elements still required clarification at the funding stage. This paper reports an expert panel review process designed to agree and finalise the MACRO trial design, ensuring relevance to patients and clinicians whilst maximising trial recruitment and retention. METHODS: An expert panel, consisting of the MACRO Programme Management Group, independent advisors, and patient contributors, was convened to review current evidence and the mixed-method data collected as part of the programme, and reach agreement on MACRO trial design. Specifically, agreement was sought for selection of macrolide antibiotic, use of orally administered steroids, inclusion of CRS phenotypes (with/without nasal polyps), and overall trial design. RESULTS: A 12-week course of clarithromycin was agreed as the main trial comparator due to its increasing use as a first- and second-line treatment for patients with CRS, and the perceived need to establish its role in CRS management. Orally administered steroids will be used as a rescue medication during the trial, rather than routinely either pre or post trial randomisation, to limit any potential effects on surgical outcomes and better reflect current UK prescribing habits. Both CRS phenotypes will be included in a single trial to ensure that the MACRO trial is both pragmatic and generalisable to primary care. A modified, three-arm trial design was agreed after intense discussions and further exploratory work. Inclusion criteria were amended to ensure that the patients recruited would be considered eligible for the treatment offered in the trial due to having already received appropriate medical therapy as deemed suitable by their ENT surgeon. A proposed 6-week run-in period prior to randomisation was removed due to the new criteria prior to randomisation. CONCLUSION: The expert panel review process resulted in agreement on key elements and an optimal design for the MACRO trial, considered most likely to be successful in terms of both recruitment potential and ability to establish best management of patients with CRS

Harnessing Placebo Effects in Primary Care: Using the Person-Based Approach to Develop an Online Intervention to Enhance Practitioners' Communication of Clinical Empathy and Realistic Optimism During Consultations.

Background: Empathic communication and positive messages are important components of "placebo" effects and can improve patient outcomes, including pain. Communicating empathy and optimism to patients within consultations may also enhance the effects of verum, i.e., non-placebo, treatments. This is particularly relevant for osteoarthritis, which is common, costly and difficult to manage. Digital interventions can be effective tools for changing practitioner behavior. This paper describes the systematic planning, development and optimization of an online intervention-"Empathico"-to help primary healthcare practitioners enhance their communication of clinical empathy and realistic optimism during consultations. Methods: The Person-Based Approach to intervention development was used. This entailed integrating insights from placebo and behavior change theory and evidence, and conducting primary and secondary qualitative research. Systematic literature reviews identified barriers, facilitators, and promising methods for enhancing clinical empathy and realistic optimism. Qualitative studies explored practitioners' and patients' perspectives, initially on the communication of clinical empathy and realistic optimism and subsequently on different iterations of the Empathico intervention. Insights from the literature reviews, qualitative studies and public contributor input were integrated into a logic model, behavioral analysis and principles that guided intervention development and optimization. Results: The Empathico intervention comprises 7 sections: Introduction, Empathy, Optimism, Application of Empathico for Osteoarthritis, Reflection on my Consultations, Setting Goals and Further Resources. Iterative refinement of Empathico, using feedback from patients and practitioners, resulted in highly positive feedback and helped to (1) contextualize evidence-based recommendations from placebo studies within the complexities of primary healthcare consultations and (2) ensure the intervention addressed practitioners' and patients' concerns and priorities. Conclusions: We have developed an evidence-based, theoretically-grounded intervention that should enable practitioners to better harness placebo effects of communication in consultations. The extensive use of qualitative research throughout the development and optimization process ensured that Empathico is highly acceptable and meaningful to practitioners. This means that practitioners are more likely to engage with Empathico and make changes to enhance their communication of clinical empathy and realistic optimism in clinical practice. Empathico is now ready to be evaluated in a large-scale randomized trial to explore its impact on patient outcomes

Development of an educational intervention to support implementation of nasal balloon autoinflation for glue ear: a mixed methods approach

Nasal balloon autoinflation has been found in clinical trials to be an effective, nonsurgical treatment for otitis media with effusion (OME) that is applicable to primary care where most affected children initially present. Research findings suggest that it is a feasible and safe treatment which has the potential to improve ear-related quality of life for children and families, whilst enhancing primary care management and adherence to the NICE recommended 3 month active monitoring period. However, implementing new research findings into routine clinical practice can be challenging. Whilst nasal balloon autoinflation may be effective in the context of a clinical trial, it is not clear how generaliseable it is to the normal primary care setting.The main aim of this PhD is to facilitate wider implementation of the nasal balloon using the Normalization Process Theory to help understand how the treatment can become routinised and embedded in every day primary care practice.A qualitative study of GPs views and experiences of primary care management of children with OME provided important information about the context for implementation. A secondary analysis of qualitative data from multiple stakeholders (GPs, nurses and parents) then identified that a high quality demonstration video would promote engagement and uptake of the nasal balloon, and thus minimize the potential burden on the GP consultation. A theory-based educational intervention (LittleEARS) was then developed, guided by the medical literature, qualitative enquiry, multi-expert knowledge, and end-user feedback. Additionally, to help facilitate better active monitoring for OME, the Two Alternative Auditory Disability and Speech Reception Test (TADAST) was further developed, evaluated and embedded within the educational intervention. A feasibility study was then conducted to assess acceptability, demand, practicality and implementation of the educational intervention in families of children with OME.The qualitative work has provided a valuable insight into the potential barriers and facilitators for implementation of the nasal balloon for OME in child in primary care. The LittleEARS educational intervention appears to be both appropriate and potentially useful to families of children with OME during the recommended 3 month active monitoring period. However, further work is required to confirm acceptability and feasibility to the wider primary care population.The use of Normalization Process Theory (NPT) helped towards a better understanding of the processes for implementation, and provided an appropriate theoretical framework for my research

Optimising trial outcomes and patient retention for the MACRO trial for chronic rhinosinusitis

Background The MACRO Trial, part of the MACRO Programme (defining best Management for Adults with Chronic RhinOsinusitis), has been funded by the National Institute of Health Research to compare longer-term antibiotics, matched placebo and sinus surgery in 600 adult CRS patients across 16 hospitals, with the SNOT-22 as the main outcome measure. The study reported here aimed to evaluate current subjective and objective outcome assessments for nasal syndromes and identify any assessments that are redundant. The study also aimed to work with patient representatives and include their perspectives on the outcomes work undertaken during their experience of a ‘MACRO trial visit’ to determine acceptability and final choice of the chosen assessments for the trial. Methods Adults diagnosed with CRS and meeting the provisional eligibility criteria for the MACRO trial were recruited to take part in this mixed-method study from 2 tertiary centre ENT clinics to undergo all of the proposed objective outcome measures and the SNOT-22 questionnaire. Correlations between objective tests and SNOT-22 item scores were evaluated. Purposively selected participants were also invited to take part in a semi-structured telephone interview to explore their experiences and views of undergoing the proposed outcome measures in a simulated trial visit. Results A total of 70 patients were recruited, 36 had CRS without nasal polyps, 34 had CRS with nasal polyps and 37% of patients were male. There was a weak inverse correlation between the SNOT-22 “Blockage” ratings and Peak Nasal Inspiratory Flow (PNIF) readings. There was a moderate inverse correlation between the SNOT-22 “Smell” ratings and Sniffin’ Sticks scores. There was no significant correlation between the SNOT-22 item ratings (runny, post nasal drip, thick nasal discharge) and Saccharin test results. The participants’ experience of the trial visit was generally positive and the duration of the simulated trial visit of <1.5 hours was deemed acceptable. The majority of the proposed outcome measures were valued by the participants by providing a way of quantifying their symptoms, with the exception of the Saccharin test. Discussion The Sniffin’ Sticks test and PNIF correlate with their respective component SNOT-22 scores but are considered important by patients and PNIF remains a simple cheap test to perform. The Saccharin test will be removed as participants did not value it and was not highly rated in parallel work on a core outcome set for CRS. To our knowledge, our study is the first to assess acceptibility of proposed objective outcome measures for a CRS trial using a combined approach of considering both statistical analysis of outcome data and participants’ perspectives. Whilst this study was designed specifically for the MACRO trial, it demonstrated a good mixed methods research model to select the most appropriate objective tools for a large Randomised Control Trial (RCT). We propose that future studies in CRS should adopt the same methodology to assess their outcome measures to reduce patient and research burden

Nasal balloon autoinflation for glue ear in primary care: a qualitative interview study

Background:Nasal balloon autoinflation is an effective, non-surgical treatment for symptomatic children with glue ear, although uptake is variable and evidence about acceptability and feasibility is limited. Aim:To explore parent and healthcare professional views and experiences of nasal balloon autoinflation for children with glue ear in primary care. Design and settingQualitative study using semi-structured interviews with a maximum variety sample of parents, GPs and practice nurses.Method:Semi-structured face-to-face and telephone interviews were audio-recorded, transcribed verbatim and analysed using inductive thematic analysis. Results:14 parents, 31 GPs and 19 nurses were included in the study. Parents described the nasal balloon as a natural, ‘holistic’ treatment that was both acceptable and appealing to children. GPs and nurses perceived the method to be a low cost, low risk strategy, applicable to the primary care setting. Good instruction and demonstration ensured children mastered the technique and engaged with the treatment, but uncertainties were raised about training provision and potential impact on the GP consultation. Making nasal balloon autoinflation part of a child’s daily routine enhances compliance, but difficulties can arise if children are unwell or refuse to cooperate. Conclusions:Nasal balloon autoinflation is an acceptable, low cost treatment option for children with glue ear in primary care. Provision of educational materials and demonstration of the method are likely to promote uptake and compliance. Wider use of the nasal balloon has the potential to enhance early management, and may help to fill the management gap arising from forthcoming changes to care pathways.<br/