Talking in primary care (TIP): protocol for a cluster-randomised controlled trial in UK primary care to assess clinical and cost-effectiveness of communication skills e-learning for practitioners on patients' musculoskeletal pain and enablement.

INTRODUCTION: Effective communication can help optimise healthcare interactions and patient outcomes. However, few interventions have been tested clinically, subjected to cost-effectiveness analysis or are sufficiently brief and well-described for implementation in primary care. This paper presents the protocol for determining the effectiveness and cost-effectiveness of a rigorously developed brief eLearning tool, EMPathicO, among patients with and without musculoskeletal pain. METHODS AND ANALYSIS: A cluster randomised controlled trial in general practitioner (GP) surgeries in England and Wales serving patients from diverse geographic, socioeconomic and ethnic backgrounds. GP surgeries are randomised (1:1) to receive EMPathicO e-learning immediately, or at trial end. Eligible practitioners (eg, GPs, physiotherapists and nurse practitioners) are involved in managing primary care patients with musculoskeletal pain. Patient recruitment is managed by practice staff and researchers. Target recruitment is 840 adults with and 840 without musculoskeletal pain consulting face-to-face, by telephone or video. Patients complete web-based questionnaires at preconsultation baseline, 1 week and 1, 3 and 6 months later. There are two patient-reported primary outcomes: pain intensity and patient enablement. Cost-effectiveness is considered from the National Health Service and societal perspectives. Secondary and process measures include practitioner patterns of use of EMPathicO, practitioner-reported self-efficacy and intentions, patient-reported symptom severity, quality of life, satisfaction, perceptions of practitioner empathy and optimism, treatment expectancies, anxiety, depression and continuity of care. Purposive subsamples of patients, practitioners and practice staff take part in up to two qualitative, semistructured interviews. ETHICS APPROVAL AND DISSEMINATION: Approved by the South Central Hampshire B Research Ethics Committee on 1 July 2022 and the Health Research Authority and Health and Care Research Wales on 6 July 2022 (REC reference 22/SC/0145; IRAS project ID 312208). Results will be disseminated via peer-reviewed academic publications, conference presentations and patient and practitioner outlets. If successful, EMPathicO could quickly be made available at a low cost to primary care practices across the country. TRIAL REGISTRATION NUMBER: ISRCTN18010240.

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.

Patient perceptions of empathy in primary care telephone consultations: A mixed methods study.

OBJECTIVE: Clinical empathy can enhance patient outcomes. This study examined patients' perceptions of empathy in primary care consultations delivered by telephone. METHODS: A mixed methods study was nested in a larger feasibility study conducted May-October 2020. Adults reporting a UK primary care consultation in the previous 2 weeks completed an online survey. A sample of survey respondents participated in a semi-structured qualitative interview. Interviews were analysed thematically. RESULTS: Survey respondents (n = 359) rated practitioners as between 'good' and 'very good' at established patient-reported indicators of clinical empathy. Telephone consultations were rated slightly lower than face-to-face or other consultations. 30 survey respondents were interviewed. Three qualitative themes identified how telephone consultations can shape clinical empathy: setting for an empathic encounter; feeling connected; being acknowledged. CONCLUSION: Primary care patients typically perceive good levels of clinical empathy in telephone consultations; specific features of telephone consultations may facilitate and/or hinder clinical empathy. PRACTICE IMPLICATIONS: To ensure patients feel listened to, acknowledged and understood, practitioners may need to increase their empathic verbalisations in telephone consultations. By using verbal responses to demonstrate active listening and by clearly describing and/or implementing next steps in management, practitioners may be able to enhance clinical empathy in telephone consultations.

How to improve discussions about osteoarthritis in primary care.

The studyVennik J, Hughes S, Smith KA, et al. Patient and practitioner priorities and concerns about primary healthcare interactions for osteoarthritis: a meta-ethnography. Patient Educ Couns 2022;105:1865-77.To read the full NIHR Alert, go to: https://evidence.nihr.ac.uk/alert/discussions-about-osteoarthritis-in-primary-care/.

Empathy in patient-clinician interactions when using telecommunication: A rapid review of the evidence.

Objectives: The COVID-19 pandemic accelerated the replacement of many face-to-face healthcare consultations with telephone consultations. Little is known about the extent to which empathy can be expressed in telephone consultations. Our objective is to review evidence related to empathy in telephone consultations including clinical outcomes, and patient/practitioner experiences. Methods: Searches of Medline/Ovid and PsycINFO/Ovid were undertaken. Titles and abstract screening, data extraction, and risk of bias were undertaken by two reviewers. Discrepancies were resolved in discussion with additional reviewers. Included studies were specific to tele-communications with empirical data on empathy related to patient outcomes/views, published (in English), 2010-2021. Studies that did not mention empathy explicitly were excluded. Results: Our search yielded 740 individual records and 8 studies (527 patients, 20 practitioners) met inclusion criteria: Some barriers to expression of empathy were noted, but no major obstacles were reported. However, data was sparse and most studies had a high risk of bias. Conclusion: Empathy in telephone consultations is possible, (though the loss of non-verbal cues and touch can present barriers) however the research does not yet identify how. Innovation: It is possible to establish and display empathy in telephone consultations, but future research needs to identify how this can be optimized. Funding: This work was supported by a National Institute for Health Research (NIHR) School for Primary Care Research grant (project number 389). The University of Southampton's Primary Care Department is a member of the NIHR School for Primary Care Research and supported by NIHR Research funds. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. Protocol registration. PROSPERO (CRD42021238087).

Clinician views on optimism and empathy in primary care consultations: a qualitative interview study.

BACKGROUND: Practitioner expressions of optimism and empathy may improve treatment engagement, adherence, and patient satisfaction but are not delivered consistently amid the challenges of everyday clinical practice. AIM: To explore primary care practitioner (PCP) views about optimistic and empathic communication in consultations; and to identify behavioural, attitudinal, and/or contextual issues likely to encourage or deter PCPs from practising such communication. DESIGN & SETTING: Qualitative interview study with 20 PCPs (GPs, practice nurses, and primary care physiotherapists). METHOD: Semi-structured telephone interviews with 20 PCPs. Data were analysed thematically. RESULTS: A conceptual mismatch between optimism and patient expectations became apparent; when asked how PCPs communicate about the likely effects of a treatment, answers were focussed around managing patient expectations. When prompted, it became clear PCPs were open to communicating optimistically with patients, but emphasised the need for realism. Concerns arose that patients may not be receptive to optimistic messages, especially when holding negative expectations. PCPs felt that expressing empathy is fundamental to all clinical consultations, noting that it can be challenging. Some PCPs worried that increasing expressions of empathy might increase their risk of clinician burnout and felt guilty about (appropriately) communicating empathy while maintaining some emotional distance. CONCLUSION: PCPs agreed expressing realistic optimism during consultations could aid communication and would constitute a novel change to practice. PCPs strive for clinical empathy but can struggle to manage emotional self-protection. Specific training to help PCPs express realistic optimism and empathy, and better utilise efficient non-verbal skills could help these issues.

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.

Patient and practitioner priorities and concerns about primary healthcare interactions for osteoarthritis: A meta-ethnography.

OBJECTIVE: To explore primary care practitioners' (PCPs) and patients' priorities and concerns for healthcare interactions for osteoarthritis (OA) in primary care. METHODS: We searched Embase, CINAHL, Medline, PsychInfo (1990 to present) for primary qualitative and mixed methods studies with findings concerning healthcare interactions for OA symptoms. Patient and PCP perceptions were analysed separately then inter-related using a 'line of argument' synthesis. RESULTS: Twenty-six studies reporting qualitative data from 557 patients and 199 PCPs were synthesised. Our findings suggest that therapeutic interactions for OA can be based on discordant priorities and concerns; some patients perceive that PCPs hold negative attitudes about OA and feel their concerns about impact are not appreciated; some PCPs feel patients have misconceptions about prognosis, and hold pessimistic views about outcomes; and both tend to de-prioritise OA within consultations. CONCLUSION: Greater working in partnership could build mutual trust, facilitate tailored provision of information, and foster a shared understanding of OA upon which to build realistic goals for management. PRACTICE IMPLICATIONS: Developing a better shared understanding of OA has the potential to improve the quality of healthcare interactions for both patients and PCPs. The significant impact of OA on everyday life means it should be given higher priority in primary care consultations.

"Chiropractic is manual therapy, not talk therapy": a qualitative analysis exploring perceived barriers to remote consultations by chiropractors.

BACKGROUND: Remote consultations (RCs) enable clinicians to continue to support patients when face-to-face appointments are not possible. Restrictions to face-to-face care during the COVID-19 pandemic has accelerated a pre-existing trend for their adoption. This is true for many health professionals including some chiropractors. Whilst most chiropractors in the UK have used RCs in some form during the pandemic, others have not. This study seeks to understand the views of chiropractors not using RCs and to explore perceived potential barriers. METHODS: A national online survey was completed by 534 registered practicing UK chiropractors on the use of RCs. Respondents had the opportunity of providing open-ended responses concerning lack of engagement in RCs during the COVID-19 pandemic. Textual responses obtained from 137 respondents were coded and analysed using thematic analysis. RESULTS: The use of RCs provided an opportunity for chiropractors to deliver ongoing care during the COVID-19 pandemic. However, many chiropractors expressed concern that RCs misaligned with their strong professional identity of providing 'hands-on' care. Some chiropractors also perceived that patients expected physical interventions during chiropractic care and thus considered a lack of demand when direct contact is not possible. In the absence of a physical examination, some chiropractors had concerns about potential misdiagnosis, and perceived lack of diagnostic information with which to guide treatment. Clinic closures and change in working environment led to practical difficulties of providing remote care for a few chiropractors. CONCLUSIONS: The COVID-19 pandemic may have accelerated changes in the way healthcare is provided with RCs becoming more commonplace in primary healthcare provision. This paper highlights perceived barriers which may lead to reduced utilisation of RCs by chiropractors, some of which appear fundamental to their perceived identity, whilst others are likely amenable to change with training and experience.

Exploring patient views of empathic optimistic communication for osteoarthritis in primary care: a qualitative interview study using vignettes.

BACKGROUND: Osteoarthritis (OA) causes pain and disability. An empathic optimistic consultation approach can improve patient quality of life, satisfaction with care, and reduce pain. However, expressing empathic optimism may be overlooked in busy primary care consultations and there is limited understanding of patients' views about this approach. AIM: To explore patients' perspectives on clinician communication of empathy and optimism in primary care OA consultations. DESIGN & SETTING: Vignette study with qualitative semi-structured interviews. Purposefully sampled patients (n = 33) aged >45 years with hip or knee OA from GP practices in Wessex (Hampshire, Dorest, Wiltshire, and Somerset). METHOD: Fifteen participants watched two filmed OA consultations with a GP, and 18 participants read two case vignettes. In both formats, one GP depicted an empathic optimistic approach and one GP had a 'neutral' approach. Semi-structured interviews were conducted with all participants and analysed using thematic analysis. RESULTS: Patients recognised that empathic communication enhanced interactions, helping to engender a sense of trust in their clinician. They felt it was acceptable for GPs to convey optimism only if it was realistic, personalised, and embedded within an empathic consultation. Discussing patients' experiences and views with them, and conveying an accurate understanding of these experiences improves the credibility of optimistic messages. CONCLUSION: Patients value communication with empathy and optimism, but it requires a fine balance to ensure messages remain realistic and trustworthy. Increased use of a realistic optimistic approach within an empathic consultation could enhance consultations for OA and other chronic conditions, and improve patient outcomes. Digital training to help GPs implement these findings is being developed.

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.

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.

Improving Empathy in Healthcare Consultations-a Secondary Analysis of Interventions.

A recent systematic review of randomised trials suggested that empathic communication improves patient health outcomes. However, the methods for training healthcare practitioners (medical professionals; HCPs) in empathy and the empathic behaviours demonstrated within the trials were heterogeneous, making the evidence difficult to implement in routine clinical practice. In this secondary analysis of seven trials in the review, we aimed to identify (1) the methods used to train HCPs, (2) the empathy behaviours they were trained to perform and (3) behaviour change techniques (BCTs) used to encourage the adoption of those behaviours. This detailed understanding of interventions is necessary to inform implementation in clinical practice. We conducted a content analysis of intervention descriptions, using an inductive approach to identify training methods and empathy behaviours and a deductive approach to describe the BCTs used. The most commonly used methods to train HCPs to enhance empathy were face-to-face training (n = 5), role-playing (n = 3) and videos (self or model; n = 3). Duration of training was varied, with both long and short training having high effect sizes. The most frequently targeted empathy behaviours were providing explanations of treatment (n = 5), providing non-specific empathic responses (e.g. expressing understanding) and displaying a friendly manner and using non-verbal behaviours (e.g. nodding, leaning forward, n = 4). The BCT most used to encourage HCPs to adopt empathy behaviours was "Instruction on how to perform behaviour" (e.g. a video demonstration, n = 5), followed by "Credible source" (e.g. delivered by a psychologist, n = 4) and "Behavioural practice" (n = 3 e.g. role-playing). We compared the effect sizes of studies but could not extrapolate meaningful conclusions due to high levels of variation in training methods, empathy skills and BCTs. Moreover, the methods used to train HCPs were often poorly described which limits study replication and clinical implementation. This analysis of empathy training can inform future research, intervention reporting standards and clinical practice.

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.

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.

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.

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 SETTING: Qualitative study using semi-structured interviews with a maximum-variety sample of parents, GPs, and practice nurses. The study took place between February 2013 and September 2014. METHOD: Semi-structured face-to-face and telephone interviews were audiorecorded, transcribed verbatim, and analysed using inductive thematic analysis. RESULTS: In all, 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. CONCLUSION: 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.

Management strategies for chronic rhinosinusitis: a qualitative study of GP and ENT specialist views of current practice in the UK.

OBJECTIVES: To explore general practitioner (GP) and ears, nose and throat (ENT) specialist perspectives of current treatment strategies for chronic rhinosinusitis (CRS) and care pathways through primary and secondary care. DESIGN: Semi-structured qualitative telephone interviews as part of the MACRO programme (Defining best Management for Adults with Chronic Rhinosinusitis) SETTING: Primary care and secondary care ENT outpatient clinics in the UK. PARTICIPANTS: Twelve GPs and 9 ENT specialists consented to in-depth telephone interviews. Transcribed recordings were managed using NVivo software and analysed using inductive thematic analysis. MAIN OUTCOME MEASURES: Healthcare professional views of management options and care pathways for CRS. RESULTS: GPs describe themselves as confident in recognising CRS, with the exception of assessing nasal polyps. In contrast, specialists report common missed diagnoses (eg, allergy; chronic headache) when patients are referred to ENT clinics, and attribute this to the limited ENT training of GPs. Steroid nasal sprays provide the foundation of treatment in primary care, although local prescribing restrictions can affect treatment choice and poor adherence is perceived to be the causes of inadequate symptom control. Symptom severity, poor response to medical treatment and patient pressure drive referral, although there is uncertainty about optimal timing. Treatment decisions in secondary care are based on disease severity, polyp status, prior medical treatment and patient choice, but there is major uncertainty about the place of longer courses of antibiotics and the use of oral steroids. Surgery is regarded as an important treatment option for patients with severe symptoms or with nasal polyps, although timing of surgery remains unclear, and the uncertainty about net long-term benefits of surgery makes balancing of benefits and risks more difficult. CONCLUSIONS: Clinicians are uncertain about best management of patients with CRS in both primary and secondary care and practice is varied. An integrated care pathway for CRS is needed to improve patient management and timely referral.

An open randomised study of autoinflation in 4- to 11-year-old school children with otitis media with effusion in primary care.

BACKGROUND: Otitis media with effusion (OME) is a very common problem in primary care, but one that lacks an evidence-based non-surgical treatment. OBJECTIVE: To determine the clinical effectiveness of nasal balloon autoinflation for the treatment of OME in children. DESIGN: A pragmatic, two-arm, open randomised controlled trial. SETTING: Forty-three general practices from 17 UK primary care trusts recruited between January 2012 and February 2013. PARTICIPANTS: School children aged 4-11 years with a history of OME symptoms or related concerns in the previous 3 months, and a type B tympanogram, diagnostic of a middle ear effusion, in one or both ears. INTERVENTION: Three hundred and twenty children were randomised, 160 to each group, using independent web-based computer-generated randomisation (with minimisation based on age, sex and baseline severity of OME) to either nasal balloon autoinflation performed three times per day for 1-3 months plus usual care, or usual care alone. MAIN OUTCOME MEASURES: The proportion of children demonstrating clearance of middle ear fluid in at least one ear (with normal tympanograms) at 1 and 3 months, assessed blind to treatment. An ear-related measure of quality of life (QoL) [a 14-point questionnaire on the impact of OME (OMQ-14)], weekly diary recorded symptoms, compliance and adverse events were all secondary outcomes. RESULTS: At 1 month, the proportion of children with normal tympanograms was 47.3% (62/131) in those allocated to autoinflation and 35.6% (47/132) in those receiving usual care [adjusted relative risk (RR) 1.36, 95% confidence interval (CI) 0.99 to 1.88]. At 3 months, the proportions were 49.6% (62/125) and 38.3% (46/120), respectively (adjusted RR 1.37, 95% CI 1.03 to 1.83; number needed to treat = 9). The change in OMQ-14 also favoured the intervention arm (adjusted global score difference -0.42; p = 0.001). Reported compliance was good: 89% in the first month and 80% in months 2 and 3. Adverse events included otalgia in 4% of treated children compared with 1% in the control group. Minor nosebleeds (14% vs. 15%) and respiratory tract infections (18% vs. 13%) were noted. CONCLUSION: We found the use of autoinflation in young children with OME to be feasible in primary care and effective in both clearing effusions and improving child and parent ear-related QoL and symptoms. This method has scope to be used more widely. Further research is needed for very young children, and to inform prudent use in different health settings.

Effect of nasal balloon autoinflation in children with otitis media with effusion in primary care: an open randomized controlled trial.

BACKGROUND: Otitis media with effusion is a common problem that lacks an evidence-based nonsurgical treatment option. We assessed the clinical effectiveness of treatment with a nasal balloon device in a primary care setting. METHODS: We conducted an open, pragmatic randomized controlled trial set in 43 family practices in the United Kingdom. Children aged 4-11 years with a recent history of ear symptoms and otitis media with effusion in 1 or both ears, confirmed by tympanometry, were allocated to receive either autoinflation 3 times daily for 1-3 months plus usual care or usual care alone. Clearance of middle-ear fluid at 1 and 3 months was assessed by experts masked to allocation. RESULTS: Of 320 children enrolled, those receiving autoinflation were more likely than controls to have normal tympanograms at 1 month (47.3% [62/131] v. 35.6% [47/132]; adjusted relative risk [RR] 1.36, 95% confidence interval [CI] 0.99 to 1.88) and at 3 months (49.6% [62/125] v. 38.3% [46/120]; adjusted RR 1.37, 95% CI 1.03 to 1.83; number needed to treat = 9). Autoinflation produced greater improvements in ear-related quality of life (adjusted between-group difference in change from baseline in OMQ-14 [an ear-related measure of quality of life] score -0.42, 95% CI -0.63 to -0.22). Compliance was 89% at 1 month and 80% at 3 months. Adverse events were mild, infrequent and comparable between groups. INTERPRETATION: Autoinflation in children aged 4-11 years with otitis media with effusion is feasible in primary care and effective both in clearing effusions and improving symptoms and ear-related child and parent quality of life. TRIAL REGISTRATION: ISRCTN, No. 55208702.