Patient-reported outcome measures for monitoring primary care patients with depression: the PROMDEP cluster RCT and economic evaluation.

Background: Guidelines on the management of depression recommend that practitioners use patient-reported outcome measures for the follow-up monitoring of symptoms, but there is a lack of evidence of benefit in terms of patient outcomes. Objective: To test using the Patient Health Questionnaire-9 questionnaire as a patient-reported outcome measure for monitoring depression, training practitioners in interpreting scores and giving patients feedback. Design: Parallel-group, cluster-randomised superiority trial; 1 : 1 allocation to intervention and control. Setting: UK primary care (141 group general practices in England and Wales). Inclusion criteria: Patients aged ≥ 18 years with a new episode of depressive disorder or symptoms, recruited mainly through medical record searches, plus opportunistically in consultations. Exclusions: Current depression treatment, dementia, psychosis, substance misuse and risk of suicide. Intervention: Administration of the Patient Health Questionnaire-9 questionnaire with patient feedback soon after diagnosis, and at follow-up 10-35 days later, compared with usual care. Primary outcome: Beck Depression Inventory, 2nd edition, symptom scores at 12 weeks. Secondary outcomes: Beck Depression Inventory, 2nd edition, scores at 26 weeks; antidepressant drug treatment and mental health service contacts; social functioning (Work and Social Adjustment Scale) and quality of life (EuroQol 5-Dimension, five-level) at 12 and 26 weeks; service use over 26 weeks to calculate NHS costs; patient satisfaction at 26 weeks (Medical Informant Satisfaction Scale); and adverse events. Sample size: The original target sample of 676 patients recruited was reduced to 554 due to finding a significant correlation between baseline and follow-up values for the primary outcome measure. Randomisation: Remote computerised randomisation with minimisation by recruiting university, small/large practice and urban/rural location. Blinding: Blinding of participants was impossible given the open cluster design, but self-report outcome measures prevented observer bias. Analysis was blind to allocation. Analysis: Linear mixed models were used, adjusted for baseline depression, baseline anxiety, sociodemographic factors, and clustering including practice as random effect. Quality of life and costs were analysed over 26 weeks. Qualitative interviews: Practitioner and patient interviews were conducted to reflect on trial processes and use of the Patient Health Questionnaire-9 using the Normalization Process Theory framework. Results: Three hundred and two patients were recruited in intervention arm practices and 227 patients were recruited in control practices. Primary outcome data were collected for 252 (83.4%) and 195 (85.9%), respectively. No significant difference in Beck Depression Inventory, 2nd edition, score was found at 12 weeks (adjusted mean difference -0.46, 95% confidence interval -2.16 to 1.26). Nor were significant differences found in Beck Depression Inventory, 2nd Edition, score at 26 weeks, social functioning, patient satisfaction or adverse events. EuroQol-5 Dimensions, five-level version, quality-of-life scores favoured the intervention arm at 26 weeks (adjusted mean difference 0.053, 95% confidence interval 0.013 to 0.093). However, quality-adjusted life-years over 26 weeks were not significantly greater (difference 0.0013, 95% confidence interval -0.0157 to 0.0182). Costs were lower in the intervention arm but, again, not significantly (-£163, 95% confidence interval -£349 to £28). Cost-effectiveness and cost-utility analyses, therefore, suggested that the intervention was dominant over usual care, but with considerable uncertainty around the point estimates. Patients valued using the Patient Health Questionnaire-9 to compare scores at baseline and follow-up, whereas practitioner views were more mixed, with some considering it too time-consuming. Conclusions: We found no evidence of improved depression management or outcome at 12 weeks from using the Patient Health Questionnaire-9, but patients' quality of life was better at 26 weeks, perhaps because feedback of Patient Health Questionnaire-9 scores increased their awareness of improvement in their depression and reduced their anxiety. Further research in primary care should evaluate patient-reported outcome measures including anxiety symptoms, administered remotely, with algorithms delivering clear recommendations for changes in treatment. Study registration: This study is registered as IRAS250225 and ISRCTN17299295. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 17/42/02) and is published in full in Health Technology Assessment; Vol. 28, No. 17. See the NIHR Funding and Awards website for further award information.

Depression is common, can be disabling and costs the nation billions. The National Health Service recommends general practitioners who treat people with depression use symptom questionnaires to help assess whether those people are getting better over time. A symptom questionnaire is one type of patient-reported outcome measure. Patient-reported outcome measures appear to benefit people having therapy and mental health care, but this approach has not been tested thoroughly in general practice. Most people with depression are treated in general practice, so it is important to test patient-reported outcome measures there, too. In this study, we tested whether using a patient-reported outcome measure helps people with depression get better more quickly. The study was a 'randomised controlled trial' in general practices, split into two groups. In one group, people with depression completed the Patient Health Questionnaire, or 'PHQ-9', patient-reported outcome measure, which measures nine symptoms of depression. In the other group, people with depression were treated as usual without the Patient Health Questionnaire-9. We fed the results of the Patient Health Questionnaire-9 back to the people with depression themselves to show them how severe their depression was and asked them to discuss the results with the practitioners looking after them. We found no differences between the patient-reported outcome measure group and the control group in their level of depression; their work or social life; their satisfaction with care from their practice; or their use of medicines, therapy or specialist care for depression. However, we did find that their quality of life was improved at 6 months, and the costs of the National Health Service services they used were lower. Using the Patient Health Questionnaire-9 can improve patients' quality of life, perhaps by making them more aware of improvement in their depression symptoms, and less anxious as a result. Future research should test using a patient-reported outcome measure that includes anxiety and processing the answers through a computer to give practitioners clearer advice on possible changes to treatment for depression.

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.

Depression follow-up monitoring with the PHQ-9: open cluster-randomised controlled trial.

BACKGROUND: Outcome monitoring of depression is recommended but lacks evidence of patient benefit in primary care. AIM: To test monitoring depression using the PHQ-9 questionnaire with patient feedback. DESIGN AND SETTING: Open cluster-randomised controlled trial in 141 group practices. METHOD: Adults with new depressive episodes were recruited through records searches and opportunistically. EXCLUSION CRITERIA: dementia, psychosis, substance misuse, suicide risk. The PHQ-9 questionnaire was to be administered soon after diagnosis, and 10-35 days later. PRIMARY OUTCOME: Beck Depression Inventory (BDI-II) score at 12 weeks. SECONDARY OUTCOMES: BDI-II at 26 weeks; Work and Social Adjustment Scale and EuroQol EQ-5D-5L quality of life at 12 and 26 weeks; antidepressant treatment, mental health service use, adverse events, and Medical Informant Satisfaction Scale over 26 weeks. RESULTS: 302 intervention arm patients were recruited and 227 controls. At 12 weeks 252 (83.4%) and 195 (85.9%) were followed-up respectively. Only 41% of intervention arm patients had a GP follow-up PHQ-9 recorded. There was no significant difference in BDI-II score at 12 weeks (mean difference -0.46; 95% CI -2.16,1.26), adjusted for baseline depression, baseline anxiety, sociodemographic factors, and clustering by practice). EQ-5D-5L quality of life scores were higher in the intervention arm at 26 weeks (adjusted mean difference 0.053; 95% CI 0.093,0.013). A clinically significant difference in depression at 26 weeks could not be ruled out. No significant differences were found in social functioning, adverse events, or satisfaction. In a per-protocol analysis, antidepressant use and mental health contacts were significantly greater in intervention arm patients with a recorded follow-up PHQ-9. CONCLUSIONS: No evidence was found of improved depression outcome at 12 weeks from monitoring. The findings of possible benefits over 26 weeks warrant replication, investigating possible mechanisms, preferably with automated delivery of monitoring and more instructive feedback.

Antibiotics for lower respiratory tract infection in children presenting in primary care: ARTIC-PC RCT.

Background: Antimicrobial resistance is a global health threat. Antibiotics are commonly prescribed for children with uncomplicated lower respiratory tract infections, but there is little randomised evidence to support the effectiveness of antibiotics in treating these infections, either overall or relating to key clinical subgroups in which antibiotic prescribing is common (chest signs; fever; physician rating of unwell; sputum/rattly chest; shortness of breath). Objectives: To estimate the clinical effectiveness and cost-effectiveness of amoxicillin for uncomplicated lower respiratory tract infections in children both overall and in clinical subgroups. Design: Placebo-controlled trial with qualitative, observational and cost-effectiveness studies. Setting: UK general practices. Participants: Children aged 1-12 years with acute uncomplicated lower respiratory tract infections. Outcomes: The primary outcome was the duration in days of symptoms rated moderately bad or worse (measured using a validated diary). Secondary outcomes were symptom severity on days 2-4 (0 = no problem to 6 = as bad as it could be); symptom duration until very little/no problem; reconsultations for new or worsening symptoms; complications; side effects; and resource use. Methods: Children were randomised to receive 50 mg/kg/day of oral amoxicillin in divided doses for 7 days, or placebo using pre-prepared packs, using computer-generated random numbers by an independent statistician. Children who were not randomised could participate in a parallel observational study. Semistructured telephone interviews explored the views of 16 parents and 14 clinicians, and the data were analysed using thematic analysis. Throat swabs were analysed using multiplex polymerase chain reaction. Results: A total of 432 children were randomised (antibiotics, n = 221; placebo, n = 211). The primary analysis imputed missing data for 115 children. The duration of moderately bad symptoms was similar in the antibiotic and placebo groups overall (median of 5 and 6 days, respectively; hazard ratio 1.13, 95% confidence interval 0.90 to 1.42), with similar results for subgroups, and when including antibiotic prescription data from the 326 children in the observational study. Reconsultations for new or worsening symptoms (29.7% and 38.2%, respectively; risk ratio 0.80, 95% confidence interval 0.58 to 1.05), illness progression requiring hospital assessment or admission (2.4% vs. 2.0%) and side effects (38% vs. 34%) were similar in the two groups. Complete-case (n = 317) and per-protocol (n = 185) analyses were similar, and the presence of bacteria did not mediate antibiotic effectiveness. NHS costs per child were slightly higher (antibiotics, £29; placebo, £26), with no difference in non-NHS costs (antibiotics, £33; placebo, £33). A model predicting complications (with seven variables: baseline severity, difference in respiratory rate from normal for age, duration of prior illness, oxygen saturation, sputum/rattly chest, passing urine less often, and diarrhoea) had good discrimination (bootstrapped area under the receiver operator curve 0.83) and calibration. Parents found it difficult to interpret symptoms and signs, used the sounds of the child's cough to judge the severity of illness, and commonly consulted to receive a clinical examination and reassurance. Parents acknowledged that antibiotics should be used only when 'necessary', and clinicians noted a reduction in parents' expectations for antibiotics. Limitations: The study was underpowered to detect small benefits in key subgroups. Conclusion: Amoxicillin for uncomplicated lower respiratory tract infections in children is unlikely to be clinically effective or to reduce health or societal costs. Parents need better access to information, as well as clear communication about the self-management of their child's illness and safety-netting. Future work: The data can be incorporated in the Cochrane review and individual patient data meta-analysis. Trial registration: This trial is registered as ISRCTN79914298. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 9. See the NIHR Journals Library website for further project information.

Children are commonly prescribed antibiotics for chest infections, but such infections are becoming resistant to antibiotics, and it is not clear if antibiotics work in treating them. A total of 432 children who saw their general practitioner with a chest infection were given either an antibiotic (amoxicillin) or a placebo (no antibiotic) for 7 days. Symptom diaries documented the infection's duration and its side effects. Children not in the placebo study were able to participate in another study that documented the same outcomes (an 'observational study'). We interviewed parents, doctors and nurses about their observations and concerns. Our patient and public involvement and engagement work with parents indicated that a 3-day symptom reduction was required to justify giving antibiotics. After seeing the doctor, parents whose children received antibiotics rated infective symptoms as moderately bad or worse for 5 days, and parents whose children received the placebo rated these for 6 days. Side effects and complications were similar in the two groups. Findings were similar when including the results of the observational study, and for children in whose chest the doctor could hear wheeze or rattles; who had fever; who were rated by the doctor as more unwell, who were short of breath, or who had had bacteria detected in the throat. The costs to the NHS per child were similar (antibiotics, £29; placebo, £26), and the wider costs to society were the same (antibiotics, £33; placebo, £33). Parents found it difficult to interpret their child's symptoms, and commonly used the sound of the cough to judge severity. Parents commonly consulted to receive an examination and reassurance, and accepted that antibiotics should be used only when 'necessary'. Clinicians noted a reduction in parents' expectations for antibiotics. Amoxicillin for chest infections in children is unlikely to be effective. General practitioners should support parents to self-manage at home and give clear communication about when and how to seek medical help if they continue to be concerned.

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.

A randomised controlled trial of a digital intervention (Renewed) to support symptom management, wellbeing and quality of life in cancer survivors.

BACKGROUND: Many cancer survivors following primary treatment have prolonged poor quality of life. AIM: To determine the effectiveness of a bespoke digital intervention to support cancer survivors. DESIGN: Pragmatic parallel open randomised trial. SETTING: UK general practices. METHODS: People having finished primary treatment (<= 10 years previously) for colo-rectal, breast or prostate cancers, with European-Organization-for-Research-and-Treatment-of-Cancer QLQ-C30 score <85, were randomised by online software to: 1)detailed 'generic' digital NHS support ('LiveWell';n=906), 2) a bespoke complex digital intervention ('Renewed';n=903) addressing symptom management, physical activity, diet, weight loss, distress, or 3) 'Renewed-with-support' (n=903): 'Renewed' with additional brief email and telephone support. RESULTS: Mixed linear regression provided estimates of the differences between each intervention group and generic advice: at 6 months (primary time point: n's respectively 806;749;705) all groups improved, with no significant between-group differences for EORTC QLQ-C30, but global health improved more in both intervention groups. By 12 months there were: small improvements in EORTC QLQ-C30 for Renewed-with-support (versus generic advice: 1.42, 95% CIs 0.33-2.51); both groups improved global health (12 months: renewed: 3.06, 1.39-4.74; renewed-with-support: 2.78, 1.08-4.48), dyspnoea, constipation, and enablement, and lower NHS costs (generic advice £265: in comparison respectively £141 (153-128) and £77 (90-65) lower); and for Renewed-with-support improvement in several other symptom subscales. No harms were identified. CONCLUSION: Cancer survivors quality of life improved with detailed generic online support. Robustly developed bespoke digital support provides limited additional short term benefit, but additional longer term improvement in global health enablement and symptom management, with substantially lower NHS costs.

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 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.

Antibiotics for lower respiratory tract infection in children presenting in primary care in England (ARTIC PC): a double-blind, randomised, placebo-controlled trial.

BACKGROUND: Antibiotic resistance is a global public health threat. Antibiotics are very commonly prescribed for children presenting with uncomplicated lower respiratory tract infections (LRTIs), but there is little evidence from randomised controlled trials of the effectiveness of antibiotics, both overall or among key clinical subgroups. In ARTIC PC, we assessed whether amoxicillin reduces the duration of moderately bad symptoms in children presenting with uncomplicated (non-pneumonic) LRTI in primary care, overall and in key clinical subgroups. METHODS: ARTIC PC was a double-blind, randomised, placebo-controlled trial done at 56 general practices in England. Eligible children were those aged 6 months to 12 years presenting in primary care with acute uncomplicated LRTI judged to be infective in origin, where pneumonia was not suspected clinically, with symptoms for less than 21 days. Patients were randomly assigned in a 1:1 ratio to receive amoxicillin 50 mg/kg per day or placebo oral suspension, in three divided doses orally for 7 days. Patients and investigators were masked to treatment assignment. The primary outcome was the duration of symptoms rated moderately bad or worse (measured using a validated diary) for up to 28 days or until symptoms resolved. The primary outcome and safety were assessed in the intention-to-treat population. The trial is registered with the ISRCTN Registry (ISRCTN79914298). FINDINGS: Between Nov 9, 2016, and March 17, 2020, 432 children (not including six who withdrew permission for use of their data after randomisation) were randomly assigned to the antibiotics group (n=221) or the placebo group (n=211). Complete data for symptom duration were available for 317 (73%) patients; missing data were imputed for the primary analysis. Median durations of moderately bad or worse symptoms were similar between the groups (5 days [IQR 4-11] in the antibiotics group vs 6 days [4-15] in the placebo group; hazard ratio [HR] 1·13 [95% CI 0·90-1·42]). No differences were seen for the primary outcome between the treatment groups in the five prespecified clinical subgroups (patients with chest signs, fever, physician rating of unwell, sputum or chest rattle, and short of breath). Estimates from complete-case analysis and a per-protocol analysis were similar to the imputed data analysis. INTERPRETATION: Amoxicillin for uncomplicated chest infections in children is unlikely to be clinically effective either overall or for key subgroups in whom antibiotics are commonly prescribed. Unless pneumonia is suspected, clinicians should provide safety-netting advice but not prescribe antibiotics for most children presenting with chest infections. FUNDING: National Institute for Health Research.

A Digital Intervention for Primary Care Practitioners to Support Antidepressant Discontinuation (Advisor for Health Professionals): Development Study.

BACKGROUND: The number of people receiving antidepressants has increased in the past 3 decades, mainly because of people staying on them longer. However, in many cases long-term treatment is not evidence based and risks increasing side effects. Additionally, prompting general practitioners (GPs) to review medication does not improve the rate of appropriate discontinuation. Therefore, GPs and other health professionals may need help to support patients discontinuing antidepressants in primary care. OBJECTIVE: This study aims to develop a digital intervention to support practitioners in helping patients discontinue inappropriate long-term antidepressants (as part of a wider intervention package including a patient digital intervention and patient telephone support). METHODS: A prototype digital intervention called Advisor for Health Professionals (ADvisor HP) was planned and developed using theory, evidence, and a person-based approach. The following elements informed development: a literature review and qualitative synthesis, an in-depth qualitative study, the development of guiding principles for design elements, and theoretical behavioral analyses. The intervention was then optimized through think-aloud qualitative interviews with health professionals while they were using the prototype intervention. RESULTS: Think-aloud qualitative interviews with 19 health professionals suggested that the digital intervention contained useful information and was readily accessible to practitioners. The development work highlighted a need for further guidance on drug tapering schedules for practitioners and clarity about who is responsible for broaching the subject of discontinuation. Practitioners highlighted the need to have information in easily and quickly accessible formats because of time constraints in day-to-day practice. Some GPs felt that some information was already known to them but understood why this was included. Practitioners differed in their ideas about how they would use ADvisor HP in practice, with some preferring to read the resource in its entirety and others wanting to dip in and out as needed. Changes were made to the wording and structure of the intervention in response to the feedback provided. CONCLUSIONS: ADvisor HP is a digital intervention that has been developed using theory, evidence, and a person-based approach. The optimization work suggests that practitioners may find this tool to be useful in supporting the reduction of long-term antidepressant use. Further quantitative and qualitative evaluation through a randomized controlled trial is needed to examine the feasibility, effectiveness, and cost-effectiveness of the intervention.

Understanding GPs' views and experiences of using clinical prediction rules in the management of respiratory infections: a qualitative study.

BACKGROUND: Respiratory tract infections (RTIs) account for 60% of antibiotic prescribing in primary care. Several clinical prediction rules (CPRs) have been developed to help reduce unnecessary prescribing for RTIs, but there is a lack of studies exploring whether or how these CPRs are being used in UK general practice. AIM: To explore UK GPs' views and experiences with regards to RTI CPRs, and to identify barriers and facilitators to their use in practice. DESIGN & SETTING: A qualitative analysis of interviews with in-hours GPs working in the South and South West of England. METHOD: Semi-structured qualitative telephone interviews were conducted, digitally recorded, transcribed verbatim, and analysed using an inductive thematic approach. Patient and public involvement representatives contributed to study design and interpretation of findings. RESULTS: Thirty-two GPs were interviewed. Some CPRs were more commonly used than others. Participants used CPRs to facilitate patient-clinician discussion, confirm and support their decision, and document the consultation. GPs also highlighted concerns including lack of time, inability of CPRs to incorporate patient complexity, a shift in focus from the patient during consultations, and limited use in remote consultation (during the COVID-19 pandemic). CONCLUSION: This study highlights the need for user-friendly CPRs that are readily integrated into computer systems, and easily embedded into routine practice to complement clinical decision-making. Existing CPRs need to be validated for other populations where demographics and clinical characteristics may differ, as well different settings including remote consultations and self-assessment.

Parent and Clinician Views of Managing Children with Symptoms of a Lower Respiratory Tract Infection and Their Influence upon Decisions to Take Part in a Placebo-Controlled Randomised Control Trial.

Children presenting with uncomplicated lower respiratory tract infections (LRTIs) commonly receive antibiotics despite public campaigns on antibiotic resistance. Qualitative interview studies were nested in a placebo-controlled trial of amoxicillin for LRTI in children. Thirty semi-structured telephone interviews were conducted with sixteen parents and fourteen clinicians to explore views of management and decisions to participate in the trial. All interviews were audio-recorded, transcribed and analysed using thematic analysis. Parents found it difficult to interpret symptoms and signs, and commonly used the type of cough (based on sound) to judge severity, highlighting the importance of better information to support parents. Provision of a clinical examination and reassurance regarding illness severity were key motivations for consulting. Many parents now acknowledge that antibiotics should only be used when 'necessary', and clinicians reported noticing a shift in parent attitudes with less demand for antibiotics and greater satisfaction with clinical assessment, reassurance and advice. Decisions to take part in the trial were influenced by the perceived risks associated with allocation to a placebo, and concerns about unnecessary use of antibiotics. Clear communication about self-management and safety-netting were identified as important when implementing 'no antibiotic' prescribing strategies to reassure parents and to support prescribing decisions.

Qualitative study: patients' enduring concerns about discussing internet use in general practice consultations.

OBJECTIVES: To examine patients' accounts of their use of the internet before seeing a general practitioner (GP) using thematic analysis of semistructured interviews. DESIGN: Qualitative semistructured interview study with transcripts analysed thematically. SETTING: Primary care patients consulting with 10 GPs working at 7 GP practices of varying sizes and at a range of locations around London and the Southeast of England. PARTICIPANTS: 28 adult patients: 16 women and 12 men ranging in age from 18 to 75 from a range of self-defined ethnic backgrounds. Participants were selected based on instances when the patients reported having used the internet before the consultation, when patients referred to the internet in the consultation or when the physician used the internet or made reference to it during the consultation. RESULTS: Patients report that they can find health information online that they believe is reliable and helpful for both themselves and their GP. However, they report uncertainty about how to share internet-based findings and reluctance to disclose their efforts at researching health issues online for fear of appearing disrespectful or interfering with the flow of the consultation. CONCLUSIONS: Despite the democratisation of access to information about health due via the internet, patients continue to experience their use of the internet for health information as a sensitive and potentially problematic topic. The onus may well be on GPs to raise the likelihood (without judgement) that patients will have looked things up before consulting and invite them to talk about what they found.

Antibiotic prescribing in UK out-of-hours primary care services: a realist-informed scoping review of training and guidelines for healthcare professionals.

BACKGROUND: Antibiotic overuse has contributed to antimicrobial resistance, which is a global public health problem. In the UK, despite the fall in rates of antibiotic prescription since 2013, prescribing levels remain high in comparison with other European countries. Prescribing in out-of-hours (OOH) care provides unique challenges for prudent prescribing, for which professionals may not be prepared. AIM: To explore the guidance available to professionals on prescribing antibiotics for common infections in OOH primary care within the UK, with a focus on training resources, guidelines, and clinical recommendations. DESIGN & SETTING: A realist-informed scoping review of peer-reviewed articles and grey literature. METHOD: The review focused on antibiotic prescribing OOH (for example, clinical guidelines and training videos). General prescribing guidance was searched whenever OOH-focused resources were unavailable. Electronic databases and websites of national agencies and professional societies were searched following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) standards. Findings were organised according to realist review components, that is, mechanisms, contexts, and outcomes. RESULTS: In total, 46 clinical guidelines and eight training resources were identified. Clinical guidelines targeted adults and children, and included recommendations on prescription strategy, spectrum of the antibiotic prescribed, communication with patients, treatment duration, and decision-making processes. No clinical guidelines or training resources focusing specifically on OOH were found. CONCLUSION: The results highlight a lack of knowledge about whether existing resources address the challenges faced by OOH antibiotic prescribers. Further research is needed to explore the training needs of OOH health professionals, and whether further OOH-focused resources need to be developed given the rates of antibiotic prescribing in this setting.

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.

Pelargonium sidoides root extract for the treatment of acute cough due to lower respiratory tract infection in adults: a feasibility double-blind, placebo-controlled randomised trial.

BACKGROUND: Pelargonium sidoides DC (Geraniaceae) root extract, EPs®7630 or "Kaloba®", is a widely used herbal remedy for respiratory infections, with some evidence of effectiveness for acute bronchitis. However, it is not yet widely recommended by medical professionals in the UK. There is a need to undertake appropriately designed randomised trials to test its use as an alternative to antibiotics. The aim was to assess the feasibility of conducting a double-blind randomised controlled trial of Pelargonium sidoides root extract for treatment of acute bronchitis in UK primary care, investigating intervention compliance, patient preference for dosage form and acceptability of patient diaries. STUDY DESIGN: Feasibility double-blind randomised placebo-controlled clinical trial. METHODS: We aimed to recruit 160 patients with cough (≤ 21 days) caused by acute bronchitis from UK general practices. Practices were cluster-randomised to liquid or tablet preparations and patients were individually randomised to Kaloba® or placebo. We followed participants up for 28 days through self-reported patient diaries with telephone support and reviewed medical records at one month. Outcomes included recruitment, withdrawal, safety, reconsultation and symptom diary completion rates. We also assessed treatment adherence, antibiotic prescribing and consumption, mean symptom severity (at days 2-4 after randomisation) and time to symptom resolution. We interviewed 29 patients and 11 health professionals to identify barriers and facilitators to running such a randomised trial. RESULTS: Of 543 patients screened, 261 were eligible, of whom 134 (51%) were recruited and 103 (77%) returned a completed diary. Overall, 41% (41/100) of patients took antibiotics (Kaloba® liquid group: 48% [15/31]; placebo liquid group: 23% [6/26]; Kaloba® tablet group: 48% [9/21]; placebo tablet group: 50% [11/22]). Most patients adhered to the study medication (median 19 out of 21 doses taken in week 1, IQR 18-21 - all arms combined). There were no serious adverse events relating to treatment. Most patients interviewed found study recruitment to be straightforward, but some found the diary too complex. CONCLUSIONS: It was feasible and acceptable to recruit patients from UK primary care to a double-blind placebo-controlled trial of herbal medicine (Kaloba®) for the treatment of acute bronchitis, with good retention and low data attrition. TRIAL REGISTRATION: HATRIC was registered on the ISRCTN registry ( ISRCTN17672884 ) on 16 August 2018, retrospectively registered. The record can be found at http://www.isrctn.com/ISRCTN17672884 .

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.

Patients' and kidney care team's perspectives of treatment burden and capacity in older people with chronic kidney disease: a qualitative study.

OBJECTIVE: Chronic kidney disease (CKD) is often a multimorbid condition and progression to more severe disease is commonly associated with increased management requirements, including lifestyle change, more medication and greater clinician involvement. This study explored patients' and kidney care team's perspectives of the nature and extent of this workload (treatment burden) and factors that support capacity (the ability to manage health) for older individuals with CKD. DESIGN: Qualitative semistructured interview and focus group study. SETTING AND PARTICIPANTS: Adults (aged 60+) with predialysis CKD stages G3-5 (identified in two general practitioner surgeries and two renal clinics) and a multiprofessional secondary kidney care team in the UK. RESULTS: 29 individuals and 10 kidney team members were recruited. Treatment burden themes were: (1) understanding CKD, its treatment and consequences, (2) adhering to treatments and management and (3) interacting with others (eg, clinicians) in the management of CKD. Capacity themes were: (1) personal attributes (eg, optimism, pragmatism), (2) support network (family/friends, service providers), (3) financial capacity, environment (eg, geographical distance to unit) and life responsibilities (eg, caring for others). Patients reported poor provision of CKD information and lack of choice in treatment, whereas kidney care team members discussed health literacy issues. Patients reported having to withdraw from social activities and loss of employment due to CKD, which further impacted their capacity. CONCLUSION: Improved understanding of and measures to reduce the treatment burden (eg, clear information, simplified medication, joined up care, free parking) associated with CKD in individuals as well as assessment of their capacity and interventions to improve capacity (social care, psychological support) will likely improve patient experience and their engagement with kidney care services.

Herbal medicine for acute bronchitis: A qualitative interview study of patients' and health professionals' views.

BACKGROUND: Antibiotics are widely prescribed for acute bronchitis in the UK. Herbal medicine could be used instead to provide symptom relief. AIM: To explore the views of patients and health professionals on using herbal medicine for acute bronchitis instead of antibiotics. DESIGN AND SETTING: This was a nested qualitative study, conducted alongside a feasibility randomised clinical trial which ran from July 2018 to May 2019 in 20 GP practices in Wessex, UK. METHOD: We conducted telephone semi-structured interviews with patients and with health professionals. The interview data were transcribed and analysed thematically. RESULTS: Overall, 40 interviews were conducted with 29 patients, six GPs and five nurses. While some patients believed antibiotics are more effective, most were aware of resistance and were keen to try an alternative, including herbal medicine. Several patients believed herbals would be "less intrusive" than antibiotics, whereas a few disliked the taste or experienced side-effects after taking a herbal. Professionals were concerned about potential interactions with conventional medicines. Many patients trusted herbals because of their long history of use, while some did not understand them. Availability of herbals without a prescription enables patients to use them for self-care, but their cost was a barrier for some. Many patients were willing to take a herbal if advised by their GP. Most GPs were happy to recommend a herbal, if endorsed by evidence-based guidelines. CONCLUSION: Many patients and health professionals would consider using herbal medicine for acute bronchitis, if based on trustworthy advice and evidence-based guidelines respectively.

A feasibility study of a psycho-educational support intervention for men with prostate cancer on active surveillance.

BACKGROUND: PROACTIVE is a psycho-educational support intervention for prostate cancer patients managed on Active Surveillance. PROACTIVE is composed of two interdependent components: group workshops and internet-delivered information modules. AIMS: We conducted a feasibility study to determine the practicality of delivering PROACTIVE at two prostate cancer centres. METHODS AND RESULTS: The feasibility study was a mixed-methods randomized parallel-group exploratory trial. Participants were randomised using a ratio of 3:1 PROACTIVE group to treatment as usual. Qualitative semi-structured interviews and quantitative measures were completed at baseline, intervention completion (week 6), and at 6-month follow-up. Interview transcripts were analysed thematically using Framework analysis. Descriptive statistics were used to examine recruitment and retention rates and changing trends in outcome measures. Most aspects of the research design and PROACTIVE intervention were acceptable to those participating in the study. In particular, participants valued the opportunity to share and discuss experiences with other prostate cancer patients on Active Surveillance and receive detailed authoritative information. However, three issues were identified: (a) a low response rate (13 participants recruited, response rate 16%), (b) low utilisation of internet delivered information modules, (c) self-perceived low levels of anxiety amongst participants with the majority perceiving their cancer as not impacting on their day-to-day life or causing anxiety. CONCLUSIONS: Due to these significant research design issues, it is not recommended PROACTIVE be evaluated in a large-scale randomised controlled trial. Further research is required to explore the impact of Active Surveillance on anxiety amongst men with localized prostate cancer managed by Active Surveillance.