Background/Objective: To test the feasibility of a mixed-phase, pilot, placebo-controlled, double-blind trial of mistletoe therapy (MT) with an embedded qualitative study in the UK National Health Service (NHS) setting. Methods: The aim was to recruit 45 patients via an NHS oncology centre with a diagnosis of early or locally advanced breast cancer. Participants were allocated to Iscador® Malus, Iscador® Pinus, or physiological saline (placebo). Diaries and quality-of-life questionnaires were administered. Qualitative interviews were conducted with participants, oncologists, and nurses. Feasibility was assessed by recruitment, retention, adherence, blinding, and safety. Results: Sixty-seven patients were approached between August 2019 and March 2020, 15 gave consent, 14 participants were randomised, and 2 withdrew during the trial. Ten participants and five staff were interviewed. Barriers to recruitment were the additional treatments/time, extra injections, and the possibility of placebo allocation. Adherence was very good whilst the participants were on the study therapy. Diaries and interviews indicated that 11/14 participants struggled with injections and skin reactions. There were 22 adverse events due to the MT, related to the injections or skin reactions. Conclusion: This pilot study examined the feasibility of conducting a randomised placebo-controlled, double-blind trial of mistletoe therapy for breast cancer patients within the UK NHS. The results describe the challenges and achievements of recruitment, retention, adherence, blinding, and safety in this context.

We were greatly disappointed when, in February, NHS England announced that preference informed allocation (PIA) will be used to allocate Specialised Foundation Programme (SFP) posts in England henceforth, starting in 2024.1 The responsible bodies in the devolved nations have indicated that they will follow suit. This decision has been taken despite numerous attempts over the past year to engage with NHS England and the UK Foundation Programme Office to discuss alternative approaches. Warnings from across academia, including from medical students, doctors in training, clinical academics in training, the Integrated Academic Training Advisory Committee, the British Medical Association, Specialised Foundation School leads, senior clinical academics, the National Institute for Health and Care Research (NIHR), the Academy of Medical Sciences, and the Clinical Academic Training Forum (CATF) that the introduction of PIA for SFPs would be unwelcome have gone unheeded.

Aims With over 20% of children in the UK living with obesity, our study aimed to map child weight management services provided by acute NHS trusts across England. The primary objectives were to identify the proportion of NHS trusts providing a weight management service and to determine whether there were any geographical disparities in the distribution of these services. The secondary objective was to understand the format of services provided. Our final objective was to explore whether the catchment population for acute NHS trusts providing a service differed in terms of ethnicity and deprivation, compared to those that did not provide a service. Methods A survey was sent to each acute NHS trust in England (n=148) through a Freedom of Information (FOI) request. The survey comprised eight questions seeking to collect data on: the proportion of NHS trusts providing weight management services for children living with obesity, service’s eligibility criteria, source of funding, key personnel involved, number of new patients seen per year, intervention duration, length of follow up and the outcomes collected. Results The survey response rate was 94% (n=139/148). Thirty-two (23%) acute NHS trusts provided a weight management service for children living with obesity. The proportion of NHS trusts providing a child weight management service was greatest in London (36%, n=9/32) and the North-East and Yorkshire (32%, n=7/32) and lowest within the Midlands (4% n=1/32). There were inconsistencies in eligibility criteria and characteristics of weight management services as demonstrated in figure 1. 61% of existing services saw fewer than 100 new patients per year and there was no standardisation of intervention duration, follow-up period or outcome measures as demonstrated in figure 2. Conclusion There are inequalities in the geographical distribution of child weight management services across England, provided by acute NHS trusts. The NHS long term plan for tackling the current inequalities in service provision aims to treat a further 1000 children per year with severe complications of obesity through the ‘complication of excess weight’ (CEW) clinics.

Background: Subgrouping methods have the potential to support treatment decision making for patients with depression. Such approaches have not been used to study the continued course of depression or likelihood of relapse following treatment. Method: Data from individual participants of seven randomised controlled trials were analysed. Latent profile analysis was used to identify subgroups based on baseline characteristics. Associations between profiles and odds of both continued chronic depression and relapse up to one year post-treatment were explored. Differences in outcomes were investigated within profiles for those treated with antidepressants, psychological therapy, and usual care. Results: Seven profiles were identified; profiles with higher symptom severity and long durations of both anxiety and depression at baseline were at higher risk of relapse and of chronic depression. Members of profile five (likely long durations of depression and anxiety, moderately-severe symptoms, and past antidepressant use) appeared to have better outcomes with psychological therapies: antidepressants vs. psychological therapies (OR (95% CI) for relapse = 2.92 (1.24–6.87), chronic course = 2.27 (1.27–4.06)) and usual care vs. psychological therapies (relapse = 2.51 (1.16–5.40), chronic course = 1.98 (1.16–3.37)). Conclusions: Profiles at greater risk of poor outcomes could benefit from more intensive treatment and frequent monitoring. Patients in profile five may benefit more from psychological therapies than other treatments.

Background This paper aims to explore change in BMI z-score through childhood and the association between parent BMI and child BMI z-score. This is important to understand for the development of effective obesity interventions. Methods Data from the longitudinal B-ProAct1v study (1837 participants) were analysed. A paired sample t-test examined changes in child BMI z-score between Year 1 and 4. Multivariable linear regression models examined the cross-sectional associations between child BMI z-score and parent BMI in Year 1 and 4. The influence of change in parental BMI between Year 1 and Year 4 on child BMI z-score in Year 4 was explored through regression analyses, adjusted for baseline BMI z-score. Results There was a strong association between child BMI z-score at Year 1 and 4. Child mean BMI z-score score increased from 0.198 to 0.330 ( p = < 0.005) between these timepoints. For every unit increase in parent BMI, there was an increase in child BMI z-score of 0.047 in Year 1 ( p = < 0.005) and of 0.059 in Year 4 ( p = < 0.005). Parental BMI change was not significantly associated with Year 4 child BMI z-score. Conclusion The key indicator of higher child BMI at Year 4 is high BMI at Year 1. Further studies are needed to explore the impact of parental weight change on child BMI z-score and whether interventions targeted at overweight or obese parents, can improve their child’s BMI z-score.

Background Despite a growing number of prescriptions for antidepressants (over 70 million in 2018), there is uncertainty about when people with depression might benefit from antidepressant medication and concern that antidepressants are prescribed unnecessarily. Objectives The main objective of the PANDA (What are the indications for Prescribing ANtiDepressAnts that will lead to a clinical benefit?) research programme was to provide more guidance about when antidepressants are likely to benefit people with depression. We aimed to estimate the minimal clinically important difference for commonly used self-administered scales for depression and anxiety, and to understand more about how patients respond to such assessments. We carried out an observational study of patients with depressive symptoms and a placebo-controlled randomised controlled trial of sertraline versus placebo to estimate the treatment effect in UK primary care. The hypothesis was that the severity and duration of symptoms were related to treatment response. Design The programme consisted of three phases. The first phase relied on the secondary analysis of existing data extracted from published trials. The second phase was the PANDA cohort study of patients with depressive symptoms who presented to primary care and were followed up 2, 4 and 6 weeks after a baseline assessment. Both quantitative and qualitative methods were used in the analysis. The third phase was a multicentre randomised placebo-controlled double-blind trial of sertraline versus placebo in patients presenting to primary care with depressive symptoms. Setting UK primary care in Bristol, London, Liverpool and York. Participants Patients aged 18–74 years who were experiencing depressive symptoms in primary care. Eligibility for the PANDA randomised controlled trial included that there was uncertainty about the benefits about treatment with an antidepressant. Interventions In the PANDA randomised controlled trial, patients were individually randomised to 100 mg daily of sertraline or an identical placebo. The PANDA cohort study was an observational study. Main outcome measures Depressive symptoms measured using the Patient Health Questionnaire were the primary outcome for the randomised controlled trial. Other outcomes included anxiety symptoms using the Generalised Anxiety Disorder-7; depressive symptoms using the Beck Depression Inventory, version 2; health-related quality of life; self-reported improvement; and cost-effectiveness. Results The secondary analysis of existing randomised controlled trials [GENetic and clinical Predictors Of treatment response in Depression (GenPod), TREAting Depression with physical activity (TREAD) and Clinical effectiveness and cost-effectiveness of cognitive Behavioural Therapy as an adjunct to pharmacotherapy for treatment-resistant depression in primary care (CoBalT)] found evidence that the minimal clinically important difference increased as the initial severity of depressive symptoms rose. Our estimates of minimal clinically important difference were a 17% and 18% reduction in Beck Depression Inventory scores for GenPod and TREAD, respectively. In CoBalT, a 32% reduction corresponded to the minimal clinically important difference but the participants in this study had depression that had not responded to antidepressants. In the PANDA study cohort, and from our analyses in existing data, we found that the minimal clinically important difference varies considerably with the initial severity of depressive and anxiety symptoms. Expressing the minimal clinically important difference as a percentage reduction reduces this variation at higher scores, but at low scores the percentage reduction increased substantially. The results from the qualitative studies pointed out many limitations of the Patient Health Questionnaire-9 items in assessing change and recovery from depression. In the PANDA randomised controlled trial, there was no evidence that sertraline resulted in a reduction in depressive symptoms within 6 weeks of randomisation, but there was some evidence of a reduction by 12 weeks. However, sertraline led to a reduction in anxiety symptoms, an improvement of mental health-related quality of life and an increased likelihood of reporting improvement. The mean Patient Health Questionnaire-9 items score at 6 weeks was 7.98 (standard deviation 5.63) in the sertraline group and 8.76 (standard deviation 5.86) in the placebo group (5% relative reduction, 95% confidence interval –7% to 15%; p = 0.41). Of the secondary outcomes, there was strong evidence that sertraline reduced anxiety symptoms (Generalised Anxiety Disorder-7 score reduced by 17% (95% confidence interval 9% to 25%; p = 0.00005). Sertraline had a high probability (> 90%) of being cost-effective at 12 weeks. The PANDA randomised controlled trial found no evidence that treatment response or cost-effectiveness was related to severity or duration of depressive symptoms. The minimal clinically important difference estimates suggested that sertraline’s effect on anxiety, but not on depression, was likely to be clinically important. Limitations The results from the randomised controlled trial and the estimates of minimal clinically important difference were not sufficiently precise to provide specific clinical guidance for individuals. We had low power in testing whether or not initial severity and duration of depressive symptoms are related to treatment response. Conclusions The results of the trial support the use of sertraline and probably other selective serotonin reuptake inhibitors because of their action in reducing anxiety symptoms and the likelihood of longer-term benefit on depressive symptoms. Sertraline could be prescribed for anxiety symptoms that commonly occur with depression and many patients will experience a clinical benefit. The Patient Health Questionnaire-9 items and similar self-administered scales should not be used on their own to assess clinical outcome, but should be supplemented with further clinical assessment. Future work We need to examine the longer-term effects of antidepressant treatment. We need more precise estimates of the treatment effects and minimal clinically important difference at different severities to provide more specific guidance for individuals. However, the methods we have developed provide an approach towards providing such detailed guidance. Trial registration Current Controlled Trials ISRCTN84544741 and EudraCT number 2013-003440-22. Funding This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research ; Vol. 7, No. 10. See the NIHR Journals Library website for further project information.

BACKGROUND:Experience of domestic violence and abuse (DVA) is associated with mental illness. Advocacy has little effect on mental health outcomes of female DVA survivors and there is uncertainty about the effectiveness of psychological interventions for this population. OBJECTIVE:To test effectiveness of a psychological intervention delivered by advocates to DVA survivors. DESIGN, MASKING, SETTING, PARTICIPANTS:Pragmatic parallel group individually randomized controlled trial of normal DVA advocacy vs. advocacy + psychological intervention. Statistician and researchers blinded to group assignment. Setting: specialist DVA agencies; two UK cities. Participants: Women aged 16 years and older accessing DVA services. INTERVENTION:Eight specialist psychological advocacy (SPA) sessions with two follow up sessions. MEASUREMENTS:Primary outcomes at 12 months: depression symptoms (PHQ-9) and psychological distress (CORE-OM). Primary analysis: intention to treat linear (logistic) regression model for continuous (binary) outcomes. RESULTS:263 women recruited (78 in shelter/refuge, 185 in community), 2 withdrew (1 community, control group; 1 intervention, refuge group), 1 was excluded from the study for protocol violation (community, control group), 130 in intervention and 130 in control groups. Recruitment ended June 2013. 12-month follow up: 64%. At 12-month follow up greater improvement in mental health of women in the intervention group. Difference in average CORE-OM score between intervention and control groups: -3.3 points (95% CI -5.5 to -1.2). Difference in average PHQ-9 score between intervention and control group: -2.2 (95% CI -4.1 to -0.3). At 12 months, 35% of the intervention group and 55% of the control group were above the CORE-OM -2clinical threshold (OR 0.32, 95% CI 0.16 to 0.64); 29% of the intervention group and 46% of the control group were above the PHQ-9 clinical threshold (OR 0.41, 95% CI 0.21 to 0.81). LIMITATIONS:64% retention at 12 months. CONCLUSIONS:An eight-session psychological intervention delivered by DVA advocates produced clinically relevant improvement in mental health outcomes compared with normal advocacy care. TRIAL REGISTRATION:ISRCTN registry ISRCTN58561170 Original Research 3675/3750.

BACKGROUND:In 2005,12% of the English population visited a complementary and alternative medicine (CAM) practitioner.AIM:To obtain up-to-date general population figures for practitioner-led CAM use in England, and to discover people's views and experiences regarding access.DESIGN & SETTING:A face-to-face questionnaire survey was commissioned. A nationally representative adult quota sample (aged ≥15 years) was used.METHOD:Ten questions were included within Ipsos MORI's weekly population-based survey. The questions explored 12-month practitioner-led CAM use, reasons for non-use, views on NHS-provided CAM, and willingness to pay.RESULTS:Of 4862 adults surveyed, 766 (16%) had seen a CAM practitioner. People most commonly visited CAM practitioners for manual therapies (massage, osteopathy, chiropractic) and acupuncture, as well as yoga, pilates, reflexology, and mindfulness or meditation. Women, people with higher socioeconomic status (SES) and those in south England were more likely to access CAM. Musculoskeletal conditions (mainly back pain) accounted for 68% of use, and mental health 12%. Most was through self-referral (70%) and self-financing. GPs (17%) or NHS professionals (4%) referred and/or recommended CAM to users. These CAM users were more often unemployed, with lower income and social grade, and receiving NHS-funded CAM. Responders were willing to pay varying amounts for CAM; 22% would not pay anything. Almost two in five responders felt NHS funding and GP referral and/or endorsement would increase their CAM use.CONCLUSION:CAM use in England is common for musculoskeletal and mental health problems, but varies by sex, geography, and SES. It is mainly self-referred and self-financed; some is GP-endorsed and/or referred, especially for individuals of lower SES. Researchers, patients, and commissioners should collaborate to research the effectiveness and cost-effectiveness of CAM and consider its availability on the NHS.

The NHS is a key election issue.1 Patient demand for primary care rose by 10.5% between 2007 and 2014,2 while recruiting and retaining GPs is ever more challenging. The Royal College of General Practitioners’ election manifesto for NHS England includes a call to meet the health secretary’s pledge of an additional 5000 GPs by …

BACKGROUND:Children who do not attend (DNA) their hospital outpatient appointments are a concern because this potentially compromises the child's health and incurs financial cost. Little is known about children who DNA or the views of GPs to non-attendance.AIM:To describe the characteristics of children who DNA hospital paediatric outpatient appointments, and explore how GPs view and respond to DNAs.DESIGN AND SETTING:A mixed methods study of data from all new referrals to a children's hospital in the South West of England between 1 September and 31 October 2012.METHOD:Data were extracted from patients' hospital and GP records, and Stata was used to analyse the data quantitatively. Analysis focused on describing the characteristics of children who DNA, and the process of care that followed. Practices that had either the highest or lowest number of DNAs were purposefully sampled for GPs who had referred children to secondary care at the study hospital within the previous year. Interviews were held between May 2014 and July 2015, and were analysed thematically.RESULTS:Children who DNA are more likely to be from an area of greater deprivation (adjusted odds ratio [AOR] 1.02, 95% confidence interval [CI] = 1.00 to 1.02, P = 0.04), and with a child protection alert in their hospital notes (AOR 2.72, 95% CI = 1.26 to 5.88, P = 0.01). Non-attendance is communicated poorly to GPs, rarely coded in patients' GP records, and few GP practices have a formal policy regarding paediatric DNAs.CONCLUSION:Non-attendance at hospital outpatient appointments may indicate a child's welfare is at risk. Communication between primary and secondary care needs to be improved, and guidelines developed to encourage GPs to monitor children who DNA.

AimsTo present a methodological exemplar of integrating findings from a quantitative and qualitative review on the same topic to provide insight into components of care that contribute to supportive care that is acceptable to men with prostate cancer.BackgroundMen with prostate cancer are likely to live a long time with the disease, experience side effects from treatment and therefore have ongoing supportive care needs. Quantitative and qualitative reviews have been published but the findings have yet to be integrated.DesignIntegration of quantitative and qualitative synthesized evidence.Data sourceTwo previously published systematic reviews.Review methodsSynthesized evidence on supportive care for men with prostate cancer was integrated from two previously published systematic reviews: a narrative quantitative review and a qualitative review with thematic synthesis. These two streams of synthesized evidence were synthesized using concurrent narrative summary. Data from both reviews were used to develop a set of propositions from which a summary of components of care that likely to contribute to supportive care acceptable to men with prostate cancer were identified.ResultsNine propositions were developed which covered men's supportive care focusing on the role of health professionals. These propositions were used to compose nine components of care likely to lead to supportive care that is acceptable to men with prostate cancer. Some of these components are no/low cost such as developing a more empathic personalized approach, but more specific approaches need further investigation in randomized controlled trials, for example, online support.ConclusionThis methodological exemplar demonstrates the integration of quantitative and qualitative synthesized data to determine components of care likely to lead to provision of supportive care acceptable to men with prostate cancer.

Background Depressive symptoms are usually managed within primary care and antidepressant medication constitutes the first-line treatment. It remains unclear at present which people are more likely to benefit from antidepressant medication. This paper describes the protocol for a randomised controlled trial (PANDA) to investigate the severity and duration of depressive symptoms that are associated with a clinically significant response to sertraline compared to placebo, in people presenting to primary care with depression. Methods/design PANDA is a randomised, double blind, placebo controlled trial in which participants are individually randomised to sertraline or placebo. Eligible participants are those who are between the ages of 18 to 74; have presented to primary care with depression or low mood during the past 2 years; have not received antidepressant or anti-anxiety medication in the 8 weeks prior to enrolment in the trial and there is clinical equipoise about the benefits of selective serotonin reuptake inhibitor (SSRI) medication. Participants who consent to participate in the trial are randomised to receive either sertraline or matching placebo, starting at 50 mg daily for 1 week, increasing to 100 mg daily for up to 11 weeks (with the option of increasing to 150 mg if required). Participants, general practitioners (GPs) and the research team will be blind to treatment allocation. The primary outcome will be depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9) at 6 weeks post randomisation, measured as a continuous outcome. Secondary outcomes include depressive symptoms measured with the PHQ-9 at 2 and 12 weeks as a continuous outcome and at 2, 6 and 12 weeks as a binary outcome; follow-up scores on depressive symptoms measured with the Beck Depression Inventory-II, anxiety symptoms measured by the Generalized Anxiety Disorder-7 and quality of life measured with the Euroqol-5D-5L and Short Form-12; emotional processing task scores measured at baseline, 2 and 6 weeks; and costs associated with healthcare use, time off work and personal costs. Discussion The PANDA trial uses a simple self-administered measure to establish the severity and duration of depressive symptoms associated with a clinically significant response to sertraline. The evidence from the trial will inform primary care prescribing practice by identifying which patients are more likely to benefit from antidepressants. Trial registration Controlled Trials ISRCTN Registry, ISRCTN84544741 . Registered on 20 March 2014. EudraCT Number: 2013-003440-22; Protocol Number: 13/0413 (version 6.1).

Background Chlamydia and gonorrhoea are common causes of urethritis. Management is often based on an enhanced syndromic approach while awaiting results. This can necessitate prescribing to cover a range of potential pathogens, and result in uncertainty for patients. Point of care testing (POCT) for chlamydia and gonorrhoea in men with symptoms of urethritis could alter care pathways and reduce reattendance. Aims To measure reattendance rates in men presenting with symptoms of urethritis. To identify reasons for reattendance including those that could be mitigated by POCT. Methods All men with urethritis symptoms presenting over a three month period were identified using electronic patient records. Urethritis was defined as ≥5 pmnls/hpf on a Gram stained urethral smear. Reattendances within 30 days of initial clinic visit and reasons for reattendance were recorded for both microscopy-positive and negative groups. Results 431 men with urethritis symptoms were identified in a 3 month period. 192 had confirmed urethritis on initial microscopy. 31% of microscopy-positive men and 42% of microscopy-negative men reattended at least once within 30 days of initial visit. Common reasons for reattendance were early morning smear (20%), persistent symptoms (18%), results (16%) and gonorrhoea test of cure (9%). Discussion This service evaluation has identified high reattendance rates in men with urethritis symptoms. POCT could impact on reattendance rates in a number of ways. Pathogen-guided treatment may reduce antimicrobial failure and persistent symptoms. Same-day results could reduce results visits. Reassurance from negative same-day results may also have a role in reducing persistent symptoms.

You have accessJournal of UrologyProstate Cancer: Advanced I1 Apr 2015MP73-14 PROSTATE CANCER AND ANDROGEN DEPRIVATION THERAPY-IS IT THE RIGHT MANAGEMENT? Sanchia Goonewardene, Debbie Sharp, and Raj Persad Sanchia GoonewardeneSanchia Goonewardene More articles by this author , Debbie SharpDebbie Sharp More articles by this author , and Raj PersadRaj Persad More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.2690AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Prostate cancer is a large and important clinical challenge. By 2030, prostate cancer is estimated to be the most common cancer overall (Prostate Cancer UK, 2014). NICE guidance (2008) specifies considering intermittent therapy for men having long-term androgen deprivation therapy (ADT). We aim to review if we are compliant with this. METHODS A retrospective audit over 10 years reviewing patients' electronic records, at a large urban general practice was conducted. The following data were collected: stage and grade of prostate cancer, risk stratification and length of androgen deprivation therapy. If ADT was prescribed, case notes were examined for progression to metastases, whether intermittent therapy was offered, side effects of ADT such as fatigue, cardiac risk, sexual dysfunction, and documentation of discussions along the lines of what is written in NICE guidance to combat these risks, and requirement for conversion to ‘full’ ADT. RESULTS The practice was studied had 10,610 patients registered, of whom 47 patients were found to be on ADT. Four cases were low risk disease (PSA <10, Gleason score 6, T2b or less on MRI and clinical examination). 16 cases were intermediate risk (PSA 10-20, Gleason score 7, T2c on MRI / clinical examination), the rest were high risk disease (PSA 20 or greater, Gleason score 8, T3a or above). The average length of time on ADT was 7 years. Continuous ADT was given in all cases. There were no patients who had been noted to progress to metastases. All PSAs on ADT therapy remained stable, with no obvious disease progression. No side effects were recorded. CONCLUSIONS This cohort again are one that could be easily targeted for intermittent ADT. Whilst ADT therapy, is currently being used, a better mode to consider would be intermittent ADT therapy. This has both a health and cost utility benefit. © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e935 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Sanchia Goonewardene More articles by this author Debbie Sharp More articles by this author Raj Persad More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...