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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.

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.

Background Women with acute uncomplicated urine infection are usually treated with antibiotics. One trial has demonstrated that delayed antibiotic treatment offered without symptom relief results in a modest reduction in antibiotic use. There is some evidence that ibuprofen provides symptom relief and reduces antibiotic use. Uva-ursi, a herbal product, has a traditional use for urinary infection symptom relief. We set out to test: in adult women with suspected UTI who accept the delayed prescription strategy: Do NSAIDs or uva-ursi (a herbal product) provide relief from urinary symptoms and reduce antibiotic use. Methods/design Adult women with suspected urinary tract infection presenting to primary care will be randomised using a factorial trial design in which patients will be randomised to one of two interventions as below: Group 1 – Uva-ursi + advice to take ibuprofen Group 2 – Placebo + advice to take ibuprofen Group 3 – Uva-ursi + no advice to take ibuprofen Group 4 – Placebo + no advice to take ibuprofen Patients and physicians will be blinded to the randomised group for the herb. The main outcome is symptom severity at days 2–4 recorded in a validated, self-report diary used in previous studies. Secondary outcomes include antibiotic use and symptom duration. In total the trial will require 328 patients in order to achieve at least 90% power for the primary endpoint and 80% for the secondary endpoint. In accordance with CONSORT guidelines all comparative analyses will be conducted on an intention-to-treat basis using SPSS or similar package. Discussion The outcomes from this trial have the potential to modify the current approach to the management of acute urinary symptoms with less dependence on the use of antibiotics. Trial registration ISRCTN registry, ID: ISRCTN43397016 . Registered on 11 February 2015.

ObjectivesTo explore patient views and perspectives of current management of chronic rhinosinusitis (CRS) in primary and secondary care.DesignSemistructured qualitative telephone interviews as part of the MACRO programme (Defining best Management for Adults with Chronic RhinOsinusitis).SettingPrimary care and secondary care ear, nose and throat outpatient clinics in the UK.ParticipantsTwenty-five patients consented to in-depth telephone interviews. Transcribed recordings were managed using NVivo software and analysed using inductive thematic analysis.ResultsCRS 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.ConclusionsPatients 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.

Objective To quantitatively determine the prevalence of anxiety and depression in men on active surveillance (AS). Design Cross-sectional questionnaire survey. Setting Secondary care prostate cancer (PCa) clinics across South, Central and Western England. Participants 313 men from a total sample of 426 with a histological diagnosis of PCa currently managed with AS were identified from seven UK urology departments. The mean age of respondents was 70 (51–86) years with the majority (76%) being married or in civil partnerships. 94% of responders were of white British ethnicity. Primary outcome measures The prevalence of clinically meaningful depression and anxiety as assessed by the Hospital Anxiety and Depression Scale (HADS; score ≥8/21). Secondary outcome measures Patient demographic data (age, employment, relationship, ethnic and educational status). Each demographic variable was cross-tabulated against patients identified as depressed or anxious to allow for the identification of variables that were significantly associated with depression and anxiety. In order to determine predictors for depression and anxiety among the demographic variables, logistic regression analyses were conducted, with p<0.05 considered as indicating statistical significance. Results The prevalence of clinical anxiety and depression as determined via the HADS (HADS ≥8) was 23% (n=73) and 12.5% (n=39), respectively. Published data from men in the general population of similar age has shown prevalence rates of 8% and 6%, respectively, indicating a twofold increase in depression and a threefold increase in anxiety among AS patients. Our findings also suggest that AS patients experience substantially greater levels of anxiety than patients with PCa treated radically. The only demographic predictor for anxiety or depression was divorce. Conclusions Patients with PCa managed with AS experienced substantially higher rates of anxiety and depression than that expected in the general population. Strategies to address this are needed to improve the management of this population and their quality of life.

Defined as the co-occurrence of more than two chronic conditions, multi-morbidity has been described as a significant health care problem: a trend linked to a rise in non-communicable disease and an ageing population. Evidence on the experiences of living with multi-morbidity in middle-income countries (MICs) is limited. In high-income countries (HICs), multi-morbidity has a complex impact on health outcomes, including functional status, disability and quality of life, complexity of health care and burden of treatment. Previous evidence also shows that multi-morbidity is consistently higher amongst women. This study aimed to explore the perceptions and experiences of women living with multi-morbidity in the Greater Accra Region, Ghana: to understand the complexity of their health needs due to multi-morbidity, and to document how the health system has responded. Guided by the Cumulative Complexity Model, and using stratified purposive sampling, 20 in-depth interviews were conducted between May and September 2015 across three polyclinics in the Greater Accra Region. The data were analysed using the six phases of Thematic Analysis. Overall four themes emerged: 1) the influences on patients’ health experience; 2) seeking care and the responsiveness of the health care system; 3) how patients manage health care demands; and 4) outcomes due to health. Spirituality and the stigmatization caused by specific conditions, such as HIV, impacted their overall health experience. Women depended on the care and treatment provided through the health care system despite inconsistent coverage and a lack of choice thereof, although their experiences varied by chronic condition. Women depended on their family and community to offset the financial burden of treatment costs, which was exacerbated by having many conditions. The implications are that integrated health and social support, such as streamlining procedures and professional training on managing complexity, would benefit and reduce the burden of multi-morbidity experienced by women with multi-morbidity in Ghana.

Objectives Psychological dysfunction (such as anxiety) is common in people with difficult asthma and is associated with poor outcomes. Asthma guidelines increasingly emphasise the need to recognise and address co-morbidities, and it is plausible that appropriately targeted psychological interventions may be clinically and cost-effective. We hypothesised that mindfulness—facilitating adaptive responses to mental and emotional stress—would be acceptable and feasible for people with difficult asthma and undertook a pilot uncontrolled observational study. Methods We offered a 4-week mindfulness intervention (four group sessions with 10–20 min of daily home practice) to adult patients attending difficult asthma clinics. Seventeen patients provided informed consent. Before and 3 months after the intervention, self-report questionnaires assessed asthma control, asthma-related quality of life, anxiety, depression, medication adherence and dysfunctional breathing symptoms. We conducted a focus group and follow-up telephone interviews with patients and collected routine clinic data including lung function. Results Three-month follow-up patients had lower self-reported anxiety scores, but there were no significant changes in other self-report measures including asthma control and asthma quality of life—though numerical trends generally indicated improvement. Intervention adherence and study retention varied. Thematic analysis exploring qualitative data found overarching themes highlighting the acceptability of mindfulness treatments, and identified some practical challenges to attending the course. Conclusions Patients consenting to the mindfulness intervention found it acceptable. Self-report measures suggest potential for positive impact on their wellbeing. Patients successfully integrated mindfulness with their existing treatment, although practical barriers prevented some from attending the face-to-face group course.

ObjectivesTo 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.DesignSemi-structured qualitative telephone interviews as part of the MACRO programme (Defining best Management for Adults with Chronic Rhinosinusitis)SettingPrimary care and secondary care ENT outpatient clinics in the UK.ParticipantsTwelve 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 measuresHealthcare professional views of management options and care pathways for CRS.ResultsGPs 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.ConclusionsClinicians 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.

Research into the homeopathic consultation has largely focused on patients’ experiences, although the practitioner is a crucial component of the therapeutic context and may have an important part in optimizing health outcomes. Therefore the aim of this qualitative research was to gain an in-depth understanding of homeopathic practitioners’ perceptions and experiences of the consultation. Medical and non-medical homeopaths were sampled from the registers of the Faculty and Society of Homeopaths. Two phases of data collection were employed. Phase 1 used in depth face-to-face interviews enabling the development of an initial model of the homeopathic consultation. Phase 2 involved observations of homeopathic consultations and practitioner reflective diaries in order to confirm, refute, or enlarge the model. Using the constant comparative method of grounded theory five main categories emerged, exploring the journey, finding the level, responding therapeutically, understanding self, and connecting, forming a model entitled “a theoretical model of a UK classical homeopathic consultation” which describes how homeopaths view and enact the consultation process. This study suggests that the process of identifying and prescribing the remedy is embedded in the consultation, highlighting the interconnectedness of the whole homeopathic consultation and aspects of the consultation that are unique and specific to homeopathy.

Lung cancer is a common malignancy that occurs worldwide and generally has a poor prognosis. Its diagnosis presents significant physical and emotional challenges for patients and their family, friends and caregivers (FFCs). This study aimed to gain insights into patients and FFCs perspectives regarding lung cancer and its treatment, as well as physicians perceptions of patients thoughts about their illness. An international online survey was conducted, assessing 113 patients diagnosed with non-small-cell lung cancer, 70 corresponding FFCs and 188 treating physicians. Data were collected using an interactive internet-based tool, in order to establish respondents priorities. Interesting differences between patients , FFCs and physicians perspectives on lung cancer were revealed. For all respondents, the primary feeling about lung cancer was described as \"sadness\". Patients were more likely to express a determination to be positive, whereas fear was a common response for FFCs and was a perspective also reported by physicians. Physicians views on how they had communicated disease information were more positive than those of the patients, with many patients detecting physician hesitancy to communicate negative news. This study provides important insights into the self-reported thoughts and feelings of patients with lung cancer, their personal networks of FFCs and the physicians who care for them.