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

The management of acute infective conjunctivitis in general practice

Acute infective conjunctivitis (AlC) is a common self-limiting condition presenting to general practice. However, evidence is limited on GPs current management of AlC, patients' understanding of conjunctivitis or the most appropriate management strategy for AlC in general practice.The aims of this thesis where to: 1) To determine GPs' current management strategies for AlC 2) To gain an understanding of patients concerns and beliefs about AlC and develop a patient information leaflet (PIL). 3) To assess the effect of common management strategies for AlC on symptom resolution and patients belief in antibiotics.Three complementary studies were used: 1) A postal survey of 300 GPs regarding their diagnosis and management of AlC. 2) A qualitative study involving interviews with 25 patients to explore conjunctivitis from the patients' perspective. 3) An open randomised controlled tria~ with 307 recruits, to assess the effect of different management strategies (immediate, delayed or no offer of antibiotics; a patient information leaflet and an eye swab) for AlC in general practice.The results were: 1) Survey: 95% of responding GPs usually prescribe topical antibiotics for AlC despite 58% stating that they thought at least half of the cases they see are viral in origin. Only 36% of GPs believed they could discriminate between viral and bacterial infection 2) Qualitative study: patients regarded conjunctivitis as a minor illness although some considered it might become more serious if not treated. They stated a preference not to take medication but believed that conjunctivitis would not clear without treatment. However, they were open to alternative management approaches (e.g. delayed prescription approach) because they trusted their GPs judgement. Once aware of the self-limiting nature of conjunctivitis, patients felt they would prefer to wait a few days to see if it improved before seeking medical advice even if this resulted in a few more days of symptoms. 3) Randomised trial: different prescribing strategies did not affect symptom severity in the ftrst 3 days, but duration of moderately bad symptoms was less with antibiotics (control 4.83 days, immediate 3.26 days (p=0.001), delayed 3.86 days (p=0.002)). Compared with no initial offer of antibiotics, antibiotic use was higher in the immediate group (control 30%, immediate 99% (p=0.001), delayed 53% (p=0.004)) as was belief in the effectiveness of antibiotics (control 47%, immediate 67% (p=0.03); delayed 55% (p=0.35)) and intention to re-consult (control 40%, immediate 68% (p=0.001), delayed 41 % (p=0.98)). A patient information leaflet or an eye swab had no affect on the main outcomes, but an eye swab seemed to increase patient worry about AlC and a PIL seemed to increase satisfaction with the consultation and the amount of information received. Re-attendance in the next two weeks was less in the delayed group (delayed OR 0.33 (0.11;0.98); immediate OR 0.65 (0.26; 1.63)).In conclusion: Most general practitioners prescribe topical antibiotics for most cases of acute infective conjunctivitis -a self-limiting condition. Most patients are unaware of the self-limiting nature of AlC. A delayed prescribing approach is probably the most appropriate strategy to use for the management of acute conjunctivitis in primary care - it reduces antibiotic use by nearly 50%, shows no evidence of 'medicalisation', provides similar symptom duration and severity to immediate prescribing and reduces re-attendance in the short term compared with no offer of antibiotics

A randomised controlled trial of management strategies for acute infective conjunctivitis in general practice

Objective: to assess different management strategies for acute infective conjunctivitis.Design: open, factorial, randomised controlled trial.Setting: 30 general practices in southern England.Participants: 307 adults and children with acute infective conjunctivitis.Intervention: one of three antibiotic prescribing strategies--immediate antibiotics (chloramphenicol eye drops; n=104), no antibiotics (controls; n=94), or delayed antibiotics (n=109); a patient information leaflet or not; and an eye swab or not.Main outcome measures: severity of symptoms on days 1-3 after consultation, duration of symptoms, and belief in the effectiveness of antibiotics for eye infections.Results: prescribing strategies did not affect the severity of symptoms but duration of moderate symptoms was less with antibiotics: no antibiotics (controls) 4.8 days, immediate antibiotics 3.3 days (risk ratio 0.7, 95% confidence interval 0.6 to 0.8), delayed antibiotics 3.9 days (0.8, 0.7 to 0.9). Compared with no initial offer of antibiotics, antibiotic use was higher in the immediate antibiotic group: controls 30%, immediate antibiotics 99% (odds ratio 185.4, 23.9 to 1439.2), delayed antibiotics 53% (2.9, 1.4 to 5.7), as was belief in the effectiveness of antibiotics: controls 47%, immediate antibiotics 67% (odds ratio 2.4, 1.1 to 5.0), delayed antibiotics 55% (1.4, 0.7 to 3.0), and intention to reattend for eye infections: controls 40%, immediate antibiotics 68% (3.2, 1.6 to 6.4), delayed antibiotics 41% (1.0, 0.5 to 2.0). A patient information leaflet or eye swab had no effect on the main outcomes. Reattendance within two weeks was less in the delayed compared with immediate antibiotic group: 0.3 (0.1 to 1.0) v 0.7 (0.3 to 1.6).Conclusions: delayed prescribing of antibiotics is probably the most appropriate strategy for managing acute conjunctivitis in primary care. It reduces antibiotic use, shows no evidence of medicalisation, provides similar duration and severity of symptoms to immediate prescribing, and reduces reattendance for eye infections.Trial registration: current controlled trials ISRCTN32956955

Weaning oxygen in infants with bronchopulmonary dysplasia

Bronchopulmonary dysplasia (BPD) is a form of chronic lung disease commonly seen in preterm infants as the sequelae following respiratory distress syndrome. The management of evolving BPD aims to minimise lung injury and prevent the impact of hypoxia and hyperoxia. Proposed morbidities include respiratory instability, pulmonary hypertension, suboptimal growth, altered cerebral oxygenation and long-term neurodevelopmental impairment. The ongoing management and associated morbidity present a significant burden for carers and healthcare systems. Long-term oxygen therapy may be required for variable duration, though there is a lack of consensus and wide variation in practise when weaning supplemental oxygen. Furthermore, a shift in care towards earlier discharge and community care underlines the importance of a structured discharge and weaning process that eliminates the potential risks associated with hypoxia and hyperoxia. This review article describes recent evidence outlining oxygen saturation reference ranges in young infants, on which structured guidance can be based

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

peer reviewedObjectives: 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

Management of irritable bowel syndrome in primary care: feasibility randomised controlled trial of mebeverine, methylcellulose, placebo and a patient self-management cognitive behavioural therapy website (MIBS trial)

Background: IBS affects 10-22% of the UK population. Abdominal pain, bloating and altered bowel habit affectquality of life, social functioning and time off work. Current GP treatment relies on a positive diagnosis, reassurance,lifestyle advice and drug therapies, but many suffer ongoing symptoms. A recent Cochrane review highlighted the lack of research evidence for IBS drugs. Neither GPs, nor patients have good evidence to inform prescribing decisions. However, IBS drugs are widely used: In 2005 the NHS costs were nearly £10 million for mebeverine and over £8 million for fibre-based bulking agents. CBT and self-management can be helpful, but poor availability in the NHS restricts their use. We have developed a web-based CBT selfmanagement programme, Regul8, based on an existing evidence based self-management manual and in partnership with patients. This could increase access with minimal increased costs.Methods/Design: The aim is to undertake a feasibility factorial RCT to assess the effectiveness of the commonlyprescribed medications in UK general practice for IBS: mebeverine (anti-spasmodic) and methylcellulose(bulkingagent)and Regul8, the CBT based self-management website. 135 patients aged 16 to 60 years with IBS symptoms fulfilling Rome III criteria, recruited via GP practices, will be randomised to 1 of 3 levels of the drug condition: mebeverine, methylcellulose or placebo for 6 weeks and to 1 of 3 levels of the website condition, Regul8 with a nurse telephone session and email support, Regul8 with minimalemail support, or no website, thus creating 9 groups.Outcomes: Irritable bowel symptom severity scale and IBS-QOL will be measured at baseline, 6 and 12 weeks asthe primary outcomes. An intention to treat analysis will be undertaken by ANCOVA for a factorial trial.Discussion: This pilot will provide valuable information for a larger trial. Determining the effectiveness ofcommonly used drug treatments will help patients and doctors make informed treatment decisions regarding drugmanagement of IBS symptoms, enabling better targeting of treatment. A web-based self-management CBT programme for IBS developed in partnership with patients has the potential to benefit large numbers of patients with low cost to the NHS. Assessment of the amount of email or therapist support required for the website willenable economic analysis to be undertaken.Trial Registration: ClinicalTrials.gov Identifier (NCT number): NCT00934973

British Society of Gastroenterology guidelines on the management of irritable bowel syndrome

Irritable bowel syndrome (IBS) remains one of the most common gastrointestinal disorders seen by clinicians in both primary and secondary care. Since publication of the last British Society of Gastroenterology guideline in 2007, substantial advances have been made in understanding its complex pathophysiology, resulting in its re-classification as a disorder of gut-brain interaction, rather than a functional gastrointestinal disorder. Moreover, there has been a considerable amount of new evidence published concerning the diagnosis, investigation, and management of IBS. The primary aim of this guideline, commissioned by the BSG, is to review and summarise the current evidence to inform and guide clinical practice, by providing a practical framework for evidence-based management of patients. One of the strengths of this guideline is that the recommendations for treatment are based upon evidence derived from a comprehensive search of the medical literature, which was used to inform an update of a series of trial-based and network meta-analyses assessing the efficacy of dietary, pharmacological, and psychological therapies in treating IBS. Specific recommendations have been made according to the Grading of Recommendations Assessment, Development and Evaluation system, summarising both the strength of the recommendations and the overall quality of evidence. Finally, this guideline identifies novel treatments that are in development, as well as highlighting areas of unmet need for future research

Effect of brain-gut behavioral treatments on abdominal pain in irritable bowel syndrome: systematic review and network meta-analysis

Background and aims: some brain-gut behavioral treatments (BGBTs) are beneficial for global symptoms in irritable bowel syndrome (IBS). US management guidelines suggest their use in patients with persistent abdominal pain but their specific effect on this symptom has not been assessed systematically.Methods: we searched the literature through 16th December 2023 for randomized controlled trials (RCTs) assessing efficacy of BGBTs for adults with IBS, compared with each other, or a control intervention. Trials provided an assessment of abdominal pain resolution or improvement at treatment completion. We extracted data as intention-to-treat analyses, assuming dropouts to be treatment failures and reporting pooled relative risks (RRs) of abdominal pain not improving with 95% confidence intervals (CIs), ranking therapies according to P-score.Results: we identified 42 eligible RCTs, containing 5220 participants. After treatment completion, the BGBTs with the largest numbers of trials, and patients recruited, demonstrating efficacy for abdominal pain, specifically, included self-guided/minimal contact cognitive behavioral therapy (CBT) (RR = 0.71; 95% CI 0.54-0.95, P-score 0.58), face-to-face multicomponent behavioral therapy (RR = 0.72; 95% CI 0.54-0.97, P score 0.56), and face-to-face gut-directed hypnotherapy (RR = 0.77; 95% CI 0.61-0.96, P-score 0.49). Among trials recruiting only patients with refractory global IBS symptoms, group CBT was more efficacious than routine care for abdominal pain, but no other significant differences were detected. No trials were low risk of bias across all domains and there was evidence of funnel plot asymmetry.Conclusions: several BGBTs, including self-guided/minimal contact CBT, face-to-face multicomponent behavioral therapy, and face-to-face gut-directed hypnotherapy may be efficacious for abdominal pain in IBS, although none were superior to another