Abstract Background Localised renal cell carcinoma is treated with radical nephrectomy (RN) or partial nephrectomy (PN). Nephron-sparing PN increases preservation of renal function, reducing incidence of end stage renal failure and associated cardiovascular events. In patients with exophytic T1a (≤ 4 cm) tumours and normal contralateral kidney, PN is standard of care. In patients with T1b (> 4–7 cm) or endophytic T1a tumours and normal contralateral kidney, the benefits of PN over RN are less clear as there are increased surgical complications and more tissue may be excised reducing the preservation of renal function. There are no high-quality studies to address if PN is superior to RN in these more complex cases. Methods PARTIAL is a pragmatic randomised controlled parallel group unblinded superiority trial with embedded internal pilot and economic and process evaluation. A total of 420 participants will be recruited in UK NHS centres with expertise in minimally invasive nephrectomy techniques. Eligible consenting adults with a single T1 renal cell carcinoma, normal contralateral kidney and equipoise within the multidisciplinary team confirming suitability to receive both interventions by minimally invasive approaches are randomised 1:1 to PN or RN. Patients with metastatic disease, existing chronic kidney disease, solitary functioning kidney, congenital renal abnormality, inherited kidney cancer syndrome, who lack capacity to consent or are pregnant or breast feeding are excluded. Primary outcomes are gains in preservation of renal function at 2 years and surgical complications over the peri-operative period. Secondary outcomes are quality of life and recovery, cost and cost-effectiveness, rates of positive surgical margin, recurrence and cardiovascular events, overall survival, progression to chronic kidney disease and end stage renal failure, operative conversion and patient acceptability. Participants are followed up for 2 years with outcomes collected from medical records and participant questionnaires. Discussion PARTIAL will determine if gains from PN are superior to RN and offset the potential harms and costs in complex T1 renal tumours suitable for either approach. If PN is not found to provide clinically significant gains and excess complications are confirmed, then a practice-changing case for RN as standard of care could be made. Trial registration ISRCTN 11293415. Registered prospectively on 19 January 2023.

Background:People with multiple and persistent physical symptoms have impaired quality of life and poor experiences of health care. We aimed to evaluate the effectiveness of a community-based Symptoms Clinic intervention in people with multiple and persistent physical symptoms. Trial design:Pragmatic multicentre individually randomised parallel group clinical trial. Methods:Participants: Recruitment was between December 2018 and December 2021 in four areas of the UK. Eligibility was based on electronic health records, healthcare use and multiple physical symptoms (PHQ-15 between 10 and 20) which were not due to other medical conditions. Intervention delivery changed from face to face to online in 2020 in response to the pandemic. Interventions: Participants were randomised to receive the Symptoms Clinic plus usual care (intervention) or usual care alone (control). The Symptoms Clinic is a short-term extended medical consultation-based intervention delivered over approximately 8 weeks. Objective: To test the clinical and cost-effectiveness of an extended-role general practitioner 'Symptoms Clinic' for people with persistent physical symptoms. Outcome: The primary outcome measure was the PHQ-15 at 52 weeks post randomisation. Randomisation: Participants were randomised 1 : 1 using a centralised web-based system, stratified by study centre with random permuted blocks of varying sizes. Masking: It was not possible to mask participants to their allocation. Outcome assessors who handled patient-reported questionnaires were masked to allocation. Results:Numbers randomised: 354 participants were randomised into the trial: 176 to the usual care group and 178 to the intervention group. Numbers analysed: 132 participants in the usual care group and 144 participants in the intervention group were included in the analysis representing 77.8% retention. Outcome: Mean (SD) PHQ-15 at baseline was 14.9 (3.0) in the control group and 15.0 (2.9) in the intervention group. At 52 weeks it was 14.1 (3.7) in the control group and 12.2 (4.5) in the intervention group. The between-group difference, adjusted for age, sex, baseline PHQ-15 and clinician effect was -1.82 (95% CI -2.67 to -0.97; p < 0.001) favouring the intervention. Harms: There were no significant between-group differences in the proportions of patients experiencing non-serious (-0.03, 95% CI -0.11 to 0.05) or serious (0.02, 95% CI -0.02 to 0.07) adverse events. All serious adverse events were deemed unrelated to trial interventions. Economic evaluation: Cost-effectiveness analysis indicated an incremental cost-effectiveness ratio of £15,751/QALY. Process evaluation: The intervention was delivered with high fidelity and was acceptable to patients. The intervention appeared to act through the hypothesised mechanism of explanation as a bridge from uncertainty about the cause to actions to manage symptoms. Limitations and further research: The intervention was delivered by a small number of GPs in long consultations. Further research should examine wider implementation and how to integrate elements of the intervention into shorter consultations. Conclusions:The Symptoms Clinic delivered by specially trained GPs leads to a clinically meaningful improvement in physical symptoms at 52 weeks and is likely to be a cost-effective addition to current care. Funding:This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme as award number 15/136/07.

Asthma affects over 1 million children across the UK, and preventative treatment is guided subjectively by patient symptoms. Spirometry is an objective test of lung function and can be used in children to guide treatment. However, current guidelines do not indicate how asthma treatment should change in the context of changing spirometry results. This study will evaluate how spirometry can be used to guide asthma treatment and reduce the risk for asthma attacks in children. This is a multi-centre, randomised controlled trial. Children aged 6–15 years, who have a diagnosis of asthma and have had an exacerbation requiring oral or intravenous corticosteroids in the previous 12 months, will be eligible. Exclusion criteria include being unable to provide spirometry measurement at baseline assessment, having another chronic respiratory condition and being currently treated with maintenance oral steroids or biologicals. Participants will be recruited in both primary and secondary care settings and will be randomised to either receive asthma treatment guided by spirometry plus symptoms (intervention group) or asthma treatment guided by symptoms only (standard care group). Within the spirometry group, treatment recommendations will be dependent on changes in spirometry measurements. Participants will attend assessments 3, 6, 9 and 12 months post-randomisation, where treatment recommendations will be made. The primary outcome is the number of asthma attacks per participant requiring treatment with 1–7 days of oral or intravenous corticosteroid over 12 months, as recorded by the participant or parent. Secondary outcomes include time to first attack, any asthma attack, adverse events, dose of inhaled corticosteroids, asthma control and quality of life. Adherence to inhaled corticosteroid treatment is measured by an electronic logging device. This study will evaluate whether asthma treatment guided by spirometry will reduce future asthma attacks in children. Our findings may be relevant to national and international asthma guidelines. ISRCTN, ISRCTN31849868. Registered on 01.07.2022. Prospectively registered.

BACKGROUND:People with multiple and persistent physical symptoms have impaired quality of life and poor experiences of health care. We aimed to evaluate the effectiveness of a community-based symptom-clinic intervention in people with multiple and persistent physical symptoms, hypothesising that this symptoms clinic plus usual care would be superior to usual care only. METHODS:The Multiple Symptoms Study 3 was a pragmatic, multicentre, parallel-group, individually randomised controlled trial conducted in 108 general practices in the UK National Health Service in four regions of England between Dec 6, 2018, and June 30, 2023. Participants were individually randomised (1:1) to the symptom-clinic intervention plus usual care or to usual care only via a computer-generated, pseudo-random list stratified by trial centre. Allocation was done by the trial statistician and concealed with a centralised, web-based randomisation system; masking participants was not possible due to the nature of the intervention. The symptom-clinic intervention was a sequence of up to four medical consultations that aimed to elicit a detailed clinical history, fully hear and validate the participant, offer rational explanations for symptoms, and assist the participant to develop ways of managing their symptoms; it was delivered by general practitioners with an extended role. The primary outcome was Patient Health Questionnaire-15 (PHQ-15) score 52 weeks after randomisation, analysed by intention to treat. The trial is registered on the ISRCTN registry (ISRCTN57050216). FINDINGS:354 participants were randomly assigned; 178 (50%) were assigned to receive the community-based symptoms clinic plus usual care and 176 (50%) were assigned to receive usual care only. At the primary-outcome point of 52 weeks, PHQ-15 scores were 14·1 (SD 3·7) in the group receiving usual care and 12·2 (4·5) in the group receiving the intervention. The adjusted between-group difference of -1·82 (95% CI -2·67 to -0·97) was statistically significantly in favour of the intervention group (p<0·0001). There were 39 adverse events in the group receiving usual care and 36 adverse events in the group receiving the intervention. There were no statistically significant between-group differences in the proportion of participants who had non-serious adverse events (-0·03, 95% CI -0·11 to 0·05) or serious adverse events (0·02, -0·02 to 0·07). No serious adverse event was deemed to be related to the trial intervention. INTERPRETATION:Our symptom-clinic intervention, which focused on explaining persistent symptoms to participants in order to support self-management, led to sustained improvement in multiple and persistent physical symptoms. FUNDING:UK National Institute for Health and Care Research.

You have accessJournal of UrologyStone Disease: Surgical Therapy (Including ESWL) IV (PD47)1 May 2024PD47-01 PURE RCT 1: CLINICAL AND COST-EFFECTIVENESS OF FLEXIBLE URETERORENOSCOPY AND EXTRACORPOREAL SHOCKWAVE LITHOTRIPSY FOR LOWER POLE STONES ≤10 MM Oliver Wiseman, Daron Smith, Kathryn Starr, Lorna Aucott, Rodolfo Hernández, Ruth Thomas, Steven MacLennan, Charles Clark, Graeme MacLennan, Dawn McRae, Victoria Bell, Seonaidh Cotton, Zara Gall, Ben Turney, and Sam McClinton Oliver WisemanOliver Wiseman , Daron SmithDaron Smith , Kathryn StarrKathryn Starr , Lorna AucottLorna Aucott , Rodolfo HernándezRodolfo Hernández , Ruth ThomasRuth Thomas , Steven MacLennanSteven MacLennan , Charles ClarkCharles Clark , Graeme MacLennanGraeme MacLennan , Dawn McRaeDawn McRae , Victoria BellVictoria Bell , Seonaidh CottonSeonaidh Cotton , Zara GallZara Gall , Ben TurneyBen Turney , and Sam McClintonSam McClinton View All Author Informationhttps://doi.org/10.1097/01.JU.0001008652.62443.0a.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Renal tract stone disease is common. The EAU guidelines recommend that lithotripsy (ESWL) and flexible ureteroscopic stone treatment (FURS) are equally appropriate first line treatment options including stones in the lower pole. A pragmatic multicentre, open-label, superiority randomised controlled trial was undertaken to determine which of ESWL or FURS offer the best outcomes in terms of quality of life, clinical effectiveness and cost-effectiveness for people with lower pole kidney stones ≤10 mm. This RCT received ethical approval from the North of Scotland National Health Service (NHS) Research Ethics Committee. METHODS: Eligible adults with stones ≤10 mm were randomised to ESWL or FURS across participating National Health Service (NHS) Urology departments. 461 patients were randomised; 231 to FURS; 230 to ESWL. The primary outcome measure was health status Area Under the Curve (AUC), measured weekly until 12 weeks post-intervention with EQ-5D-5L. The primary economic outcome was the incremental cost per quality-adjusted life year (ICER; QALYs) gained at twelve months from randomisation. RESULTS: Mean health status during these twelve weeks was 0.807 (SD 0.205) in the FURS group (n=164) and 0.826 (0.207) in the ESWL group (n=188), the between-group difference was 0.024 (95% CI -0.004, 0.053), a small difference in favour FURS after correcting for an initial baseline imbalance. Complete stone clearance was higher with FURS (72%) than ESWL (36%). ICER was £65,163 per QALY gained by FURS. At a threshold value of £20,000 per QALY, ESWL has a 99.9% chance of being cost effective. Limitations of the study were that blinding of participants and health care providers was not possible. There were differential waiting times between interventions, however, adjusting for this gave similar treatment effect estimates. CONCLUSIONS: The PUrE study found that ESWL was more cost-effective than FURS for lower pole stones ≤10 mm, with no meaningful difference in patient health status despite the higher complete stone free rates with FURS. Source of Funding: The PUrE RCT was funded by the UK National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (project number 13/152/02). This abstract presents independent research commissioned by the National Institute for Health and Care Research (NIHR). The views and opinions expressed by authors in this abstract are those of the authors and do not necessarily reflect those of the NHS, the NIHR, Evaluation Trials and Studies Coordination Centre, the Health Technology Assessment programme or the UK Department of Health. The Health Services Research Unit (HSRU) and the Health Economics Research Unit (HERU), University of Aberdeen receives core funding from the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. The views and opinions expressed by authors in this abstract are those of the authors.*Oliver Wiseman and Daron Smith are joint first authors © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e980 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Oliver Wiseman More articles by this author Daron Smith More articles by this author Kathryn Starr More articles by this author Lorna Aucott More articles by this author Rodolfo Hernández More articles by this author Ruth Thomas More articles by this author Steven MacLennan More articles by this author Charles Clark More articles by this author Graeme MacLennan More articles by this author Dawn McRae More articles by this author Victoria Bell More articles by this author Seonaidh Cotton More articles by this author Zara Gall More articles by this author Ben Turney More articles by this author Sam McClinton More articles by this author Expand All Advertisement PDF downloadLoading ...

You have accessJournal of UrologyStone Disease: Surgical Therapy (Including ESWL) IV (PD47)1 May 2024PD47-02 PURE RCT 2: CLINICAL AND COST-EFFECTIVENESS OF FURS AND PERCUTANEOUS NEPHROLITHOTOMY FOR LOWER POLE STONES 10-25MM Daron Smith, Oliver Wiseman, Kathryn Starr, Lorna Aucott, Rodolfo Hernández, Ruth Thomas, Steven MacLennan, Charles Clark, Graeme MacLennan, Dawn McRae, Victoria Bell, Seonaidh Cotton, Zara Gall, Ben Turney, and Sam McClinton Daron SmithDaron Smith , Oliver WisemanOliver Wiseman , Kathryn StarrKathryn Starr , Lorna AucottLorna Aucott , Rodolfo HernándezRodolfo Hernández , Ruth ThomasRuth Thomas , Steven MacLennanSteven MacLennan , Charles ClarkCharles Clark , Graeme MacLennanGraeme MacLennan , Dawn McRaeDawn McRae , Victoria BellVictoria Bell , Seonaidh CottonSeonaidh Cotton , Zara GallZara Gall , Ben TurneyBen Turney , and Sam McClintonSam McClinton View All Author Informationhttps://doi.org/10.1097/01.JU.0001008652.62443.0a.02AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Renal tract stone disease is common. The EAU guidelines recommend that PCNL be the treatment of choice for stones over 20mm. For lower pole stones between 10 and 20mm flexible ureteroscopic stone treatment (FURS) or PCNL are recommended over ESWL if the anatomy is unfavourable; if the anatomy is favourable then ESWL, FURS or PCNL can be chosen. We report the results of a pragmatic multicentre, open-label, superiority randomised controlled trial undertaken to determine whether FURS or PCNL offers the better outcome in terms of quality of life, clinical effectiveness and cost-effectiveness for people with lower pole kidney stones 10-25 mm. This RCT received ethical approval from the North of Scotland National Health Service (NHS) Research Ethics Committee. METHODS: Eligible adults with stones 10-25 mm were randomised to FURS or PCNL across participating National Health Service (NHS) Urology departments. 159 patients were randomised: 73 to FURS, 86 to PCNL. The primary outcome measure was health status Area Under the Curve (AUC), measured weekly with EQ-5D-5L until 12 weeks post-intervention. The primary economic outcome was the incremental cost per quality-adjusted life year (QALYs) gained at twelve months from randomisation. RESULTS: Complete stone clearance was higher with PCNL (71%) than FURS (48%). Mean health status was slightly in favour of PCNL during the 12 weeks post intervention at 0.818 (0.217) in the PCNL group (N=86) compared to 0.794 (0.198) in the FURS group, equivalent to a between-group difference of 0.06 (95% CI 0.11, 0.02), favouring PCNL. At a threshold value of £20,000 per QALY, PCNL has an 87% chance of being cost-effective. Limitations of the study were that blinding of participants and health care providers was not possible, and that the study did not recruit to target, partly due to effect of COVID on operative waiting times. CONCLUSIONS: This study found that PCNL was more clinically effective for complete stone free status and more cost-effective than FURS based on a micro-costing basis, which is the effective cost of treatment to the NHS. Source of Funding: The PUrE RCT was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (project number 13/152/02). This abstract presents independent research commissioned by the National Institute for Health and Care Research (NIHR). The views and opinions expressed by authors in this abstract are those of the authors and do not necessarily reflect those of the NHS, the NIHR, Evaluation Trials and Studies Coordination Centre, the Health Technology Assessment programme or the UK Department of Health. The Health Services Research Unit (HSRU) and the Health Economics Research Unit (HERU), University of Aberdeen receives core funding from the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. The views and opinions expressed by authors in this abstract are those of the authors. *Daron Smith and Oliver Wiseman are joint first authors © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e980 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Daron Smith More articles by this author Oliver Wiseman More articles by this author Kathryn Starr More articles by this author Lorna Aucott More articles by this author Rodolfo Hernández More articles by this author Ruth Thomas More articles by this author Steven MacLennan More articles by this author Charles Clark More articles by this author Graeme MacLennan More articles by this author Dawn McRae More articles by this author Victoria Bell More articles by this author Seonaidh Cotton More articles by this author Zara Gall More articles by this author Ben Turney More articles by this author Sam McClinton More articles by this author Expand All Advertisement PDF downloadLoading ...

Objectives: This study aimed to evaluate the cost-effectiveness of an extended-role general practitioner symptoms clinic (SC), added to usual care (UC) for patients with multiple persistent physical symptoms (sometimes known as medically unexplained symptoms). Methods: This was a 52-week within-trial cost-utility analysis of a pragmatic multicenter randomized controlled trial comparing SC + UC (n = 178) with UC alone (n = 176), conducted from the primary perspective of the UK National Health Service and personal and social services (PSS). Base-case quality-adjusted life-years (QALYs) were measured using EQ-5D-5L. Missing data were imputed using multiple imputation. Cost-effectiveness results were presented as incremental cost-effectiveness ratios and incremental net monetary benefits. Uncertainty was explored using cost-effectiveness acceptability curves (using 1000 nonparametric bootstrapped samples) and sensitivity analysis (including societal costs, using SF-6D and ICECAP-A capability measure for adults outcomes to estimate QALYs and years of full capability, respectively, varying intervention costs, missing data mechanism assumptions). Results: Multiple imputation analysis showed that compared with UC alone, SC + UC was more expensive (adjusted mean cost difference: 704; 95% CI 605- pound 807) pound and more effective (adjusted mean QALY difference: 0.0447; 95% CI 0.0067-0.0826), yielding an incremental cost-effectiveness ratio of 15 pound 765/QALY, incremental net monetary benefit of 189.22 pound (95% CI 2 573.62 pound to 948.28) pound and a 69% probability of the SC + UC intervention arm being cost-effective at a threshold of 20 pound 000 per QALY. Results were robust to most sensitivity analyses but sensitive to missing data assumptions (2 of the 8 scenarios investigated), SF-6D, and ICECAP_A capability measure for adults quality-of-life outcomes. Conclusions: A symptoms clinic is likely to be a potentially cost-effective treatment for patients with persistent physical symptoms.

This ATLAANZ 2022 conference presentation was based on the experiences of an interviewee in the author’s research on students’ experiences and perceptions of learning support services at Toi Ohomai Te Pūkenga (Toi Ohomai). The interviewee had graduated from a Kura Kaupapa Māori (KKM) in a small town, where they had studied science in te reo Māori. At Toi Ohomai, they felt unable to disclose to the tutor of their English-medium, science-based course that they were not familiar with the vocabulary being used. The tutor, meanwhile, assumed all their learners knew the English terms. The interviewee described how in class they “felt dumb”. At the same time, they were trying to adjust to life in a city which was very different. I reflected on how KKM graduates could be better supported. I concluded that if Toi Ohomai tutors and staff had a way to identify KKM graduates, they could proactively offer them support and resources. I explored options for identifying ākonga from Māori-medium education in the Toi Ohomai learning management system. I then spoke with the Head of Māori Success at Toi Ohomai, who discussed the idea with colleagues. An alternative approach was agreed upon, based on the core practice of knowing the learner.

Following the merger of Bay of Plenty Polytechnic and Waiariki Institute of Technology to become Toi Ohomai Te Pūkenga, the newly formed Te Ranga Eke Panuku / Learning Success and Engagement (LSE) team combined and redeveloped their services. In this article the author reflects on her ATLAANZ 2022 conference presentation, which shared distance students’ perspectives from her master’s research on the revised services. The author’s study explored whether and how the LSE services were meeting student needs and how the services could be further improved. Analysis of the survey (n=278) and interview (n=12) data revealed gaps in awareness of support services across all learner groups. However, distance students were less connected to the support services than on-campus learners, and the researcher found unmet academic and pastoral needs among distance participants. In addition, participants stated that they had been looking for ways to express their opinions and saw the research survey as an opportunity to ‘have their say’ to make improvements. As per the Pastoral Education (Pastoral Care of Tertiary and International Learners) Code of Practice 2021, the LSE team has increased promotion of services for distance learners, and developed more resources. A booking system now gives ākonga agency in accessing the services, and tutors can similarly book in-class support. The research illustrates that all Te Pūkenga students, whether distance, campus-based, or work-based, require access to online services during flexible hours. Further, every distance and work-based learner, should be able to access face-to-face support at their nearest campus, alongside their campus-based peers, within and beyond regular hours.

BACKGROUND:Various washout policies are widely used in adults living with long-term catheters (LTC). There is currently insufficient evidence on the benefits and potential harms of prophylactic LTC washout policies in the prevention of blockages and other LTC-related adverse events, such as urinary tract infections. CATHETER II tests the hypothesis that weekly prophylactic LTC washouts (normal saline or citric acid) in addition to standard LTC care reduce the incidence of catheter blockage requiring intervention compared to standard LTC care only in adults living with LTC. METHODS:CATHETER II is a pragmatic three-arm open multi-centre superiority randomised controlled trial with an internal pilot, economic analysis, and embedded qualitative study. Eligible participants are adults aged ≥ 18 years, who have had a LTC in use for ≥ 28 days, have no plans to discontinue the use of the catheter, are able to undertake the catheter washouts, and complete trial documentation or have a carer able to help them. Participants are identified from general practitioner practices, secondary/tertiary care, community healthcare, care homes, and via public advertising strategies. Participants are randomised 1:1:1 to receive a weekly saline (0.9%) washout in addition to standard LTC care, a weekly citric acid (3.23%) washout in addition to standard LTC care or standard LTC care only. Participants and/or carers will receive training to administer the washouts. Patient-reported outcomes are collected at baseline and for 24 months post-randomisation. The primary clinical outcome is catheter blockage requiring intervention up to 24 months post-randomisation expressed per 1000 catheter days. Secondary outcomes include symptomatic catheter-associated urinary tract infection requiring antibiotics, catheter change, adverse events, NHS/ healthcare use, and impact on quality of life. DISCUSSION:This study will guide treatment decision-making and clinical practice guidelines regarding the effectiveness of various prophylactic catheter washout policies in men and women living with LTC. This research has received ethical approval from Wales Research Ethics Committee 6 (19/WA/0015). TRIAL REGISTRATION:ISRCTN ISRCTN17116445 . Registered prospectively on 06 November 2019.

Introduction Persistent physical symptoms (which cannot be adequately attributed to physical disease) affect around 1 million people (2% of adults) in the UK. They affect patients' quality of life and account for at least one third of referrals from General Practitioners (GPs) to specialists. These referrals give patients little benefit but have a real cost to health services time and diagnostic resources. The symptoms clinic has been designed to help people make sense of persistent physical symptoms (especially if medical tests have been negative) and to reduce the impact of symptoms on daily life. Methods and analysis This pragmatic, multicentre, randomised controlled trial will assess the clinical and cost-effectiveness of the symptoms clinic intervention plus usual care compared with usual care alone. Patients were identified through GP searches and mail-outs and recruited by the central research team. 354 participants were recruited and individually randomised (1:1). The primary outcome is the self-reported Physical Health Questionnaire-15 at 52 weeks postrandomisation. Secondary outcome measures include the EuroQol 5 dimension 5 level and healthcare resource use. Outcome measures will also be collected at 13 and 26 weeks postrandomisation. A process evaluation will be conducted including consultation content analysis and interviews with participants and key stakeholders. Ethics and dissemination Ethics approval has been obtained via Greater Manchester Central Research Ethics Committee (Reference 18/NW/0422). The results of the trial will be submitted for publication in peer-reviewed journals, presented at relevant conferences and disseminated to trial participants and patient interest groups.

Background Urinary stone disease affects 2–3% of the general population. Ureteric stones are associated with severe pain and can have a significant impact on a patient’s quality of life. Most ureteric stones are expected to pass spontaneously with supportive care; however, between one-fifth and one-third of patients require an active intervention. The two standard interventions are shockwave lithotripsy and ureteroscopic stone treatment. Both treatments are effective, but they differ in terms of invasiveness, anaesthetic requirement, treatment setting, number of procedures, complications, patient-reported outcomes and cost. There is uncertainty around which is the more clinically effective and cost-effective treatment. Objectives To determine if shockwave lithotripsy is clinically effective and cost-effective compared with ureteroscopic stone treatment in adults with ureteric stones who are judged to require active intervention. Design A pragmatic, multicentre, non-inferiority, randomised controlled trial of shockwave lithotripsy as a first-line treatment option compared with primary ureteroscopic stone treatment for ureteric stones. Setting Urology departments in 25 NHS hospitals in the UK. Participants Adults aged ≥ 16 years presenting with a single ureteric stone in any segment of the ureter, confirmed by computerised tomography, who were able to undergo either shockwave lithotripsy or ureteroscopic stone treatment and to complete trial procedures. Intervention Eligible participants were randomised 1 : 1 to shockwave lithotripsy (up to two sessions) or ureteroscopic stone treatment. Main outcome measures The primary clinical outcome measure was resolution of the stone episode (stone clearance), which was operationally defined as ‘no further intervention required to facilitate stone clearance’ up to 6 months from randomisation. This was determined from 8-week and 6-month case report forms and any additional hospital visit case report form that was completed by research staff. The primary economic outcome measure was the incremental cost per quality-adjusted life-year gained at 6 months from randomisation. We estimated costs from NHS resources and calculated quality-adjusted life-years from participant completion of the EuroQol-5 Dimensions, three-level version, at baseline, pre intervention, 1 week post intervention and 8 weeks and 6 months post randomisation. Results In the shockwave lithotripsy arm, 67 out of 302 (22.2%) participants needed further treatment. In the ureteroscopic stone treatment arm, 31 out of 302 (10.3%) participants needed further treatment. The absolute risk difference was 11.4% (95% confidence interval 5.0% to 17.8%); the upper bound of the 95% confidence interval ruled out the prespecified margin of non-inferiority (which was 20%). The mean quality-adjusted life-year difference (shockwave lithotripsy vs. ureteroscopic stone treatment) was –0.021 (95% confidence interval 0.033 to –0.010) and the mean cost difference was –£809 (95% confidence interval –£1061 to –£551). The probability that shockwave lithotripsy is cost-effective is 79% at a threshold of society’s willingness to pay for a quality-adjusted life-year of £30,000. The CEAC is derived from the joint distribution of incremental costs and incremental effects. Most of the results fall in the south-west quadrant of the cost effectiveness plane as SWL always costs less but is less effective. Limitations A limitation of the trial was low return and completion rates of patient questionnaires. The study was initially powered for 500 patients in each arm; however, the total number of patients recruited was only 307 and 306 patients in the ureteroscopic stone treatment and shockwave lithotripsy arms, respectively. Conclusions Patients receiving shockwave lithotripsy needed more further interventions than those receiving primary ureteroscopic retrieval, although the overall costs for those receiving the shockwave treatment were lower. The absolute risk difference between the two clinical pathways (11.4%) was lower than expected and at a level that is acceptable to clinicians and patients. The shockwave lithotripsy pathway is more cost-effective in an NHS setting, but results in lower quality of life. Future work (1) The generic health-related quality-of-life tools used in this study do not fully capture the impact of the various treatment pathways on patients. A condition-specific health-related quality-of-life tool should be developed. (2) Reporting of ureteric stone trials would benefit from agreement on a core outcome set that would ensure that future trials are easier to compare. Trial registration This trial is registered as ISRCTN92289221. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 26, No. 19. See the NIHR Journals Library website for further project information.

ObjectivesTo assess the cost‐effectiveness, resource use implications, quality‐adjusted life‐years (QALYs) and cost per QALY of care pathways starting with either extracorporeal shockwave lithotripsy (SWL) or with ureteroscopic retrieval (ureteroscopy [URS]) for the management of ureteric stones.Patients and MethodsData on quality of life and resource use for 613 patients, collected prospectively in the Therapeutic Interventions for Stones of the Ureter (TISU) randomized controlled trial (ISRCTN 92289221), were used to assess the cost‐effectiveness of two care pathways, SWL and URS. A health provider (UK National Health Service) perspective was adopted to estimate the costs of the interventions and subsequent resource use. Quality‐of‐life data were calculated using a generic instrument, the EuroQol EQ‐5D‐3L. Results are expressed as incremental cost‐effectiveness ratios and cost‐effectiveness acceptability curves.ResultsThe mean QALY difference (SWL vs URS) was −0.021 (95% confidence interval [CI] −0.033 to −0.010) and the mean cost difference was −£809 (95% CI −£1061 to −£551). The QALY difference translated into approximately 10 more healthy days over the 6‐month period for the patients on the URS care pathway. The probabaility that SWL is cost‐effective is 79% at a society's willingness to pay (WTP) threshold for 1 QALY of £30,000 and 98% at a WTP threshold of £20,000.ConclusionThe SWL pathway results in lower QALYs than URS but costs less. The incremental cost per QALY is £39 118 cost saving per QALY lost, with a 79% probability that SWL would be considered cost‐effective at a WTP threshold for 1 QALY of £30 000 and 98% at a WTP threshold of £20 000. Decision‐makers need to determine if costs saved justify the loss in QALYs.

It is not only crucial to provide patients with information, but also to communicate this information in a way to enable patient participation in health decisions. Experimental studies investigating the association between the communication style of health professionals and patients' health decisions are rare, which limits causal conclusions. This study investigated the effect of a doctor's patient-centered communication style on the likelihood to take a medication.Healthy women (N = 120) were randomly allocated to one of three groups. They either received a medical consultation characterized by a patient-centered communication style (PC group) or by a doctor-centered communication style (DC group) or they received no consultation at all (control group). All participants were told that the study would investigate the effects of a 'concentration-enhancing medication'. Voluntary intake of the medication (a placebo pill) served as behavioral outcome. Participants' self-rated intention to take the medication was measured at three assessment points. Data were analyzed using a Chi-square-test and a mixed analysis of covariance.In each group, 40 participants were analyzed. Following the consultation, groups did not differ regarding the behavioral outcome, but participants' intention to take the medication was higher in the PC group compared with the control group.Our results indicate that patient-centered communication has a beneficial influence on participants' intention to take medication. Future studies should investigate the role of communication in individuals with health conditions that require a specified treatment plan and taking medication over the long-term.

Background: Renal stone disease is common and can cause emergency presentation with acute pain due to ureteric colic. International guidelines have stated the need for a multicentre randomised controlled trial (RCT) to determine whether a non-invasive outpatient (shockwave lithotripsy [SWL]) or surgical (ureteroscopy [URS]) intervention should be the first-line treatment for those needing active intervention. This has implications for shaping clinical pathways. Objective: To report a pragmatic multicentre non-inferiority RCT comparing SWL with URS. Design, setting, and participants: This trial tested for non-inferiority of up to two sessions of SWL compared with URS as initial treatment for ureteric stones requiring intervention. Outcome measurements and statistical analysis: The primary outcome was whether further intervention was required to clear the stone, and secondary outcomes included quality of life assessment, severity of pain, and serious complications; these were based on questionnaires at baseline, 8 wk, and 6 mo. We included patients over 16 yr with a single ureteric stone clinically deemed to require intervention. Intention-to-treat and per-protocol analyses were planned. Results and limitations: The study recruited between July 1, 2013 and June 30, 2017. We recruited 613 participants from a total of 1291 eligible patients, randomising 306 to SWL and 307 to URS. Sixty-seven patients (22.1%) in the SWL arm needed further treatment compared with 31 patients (10.3%) in the URS arm. The absolute risk difference was 11.7% (95% confidence interval 5.6%, 17.8%) in favour of URS, which was inside the 20% threshold we set for demonstrating noninferiority of SWL. Conclusions: This RCT was designed to test whether SWL is non-inferior to URS and confirmed this; although SWL is an outpatient noninvasive treatment with potential advantages both for patients and for reducing the use of inpatient health care resources, the trial showed a benefit in overall clinical outcomes with URS compared with SWL, reflecting contemporary practice. The Therapeutic Interventions for Stones of the Ureter (TISU) study provides new evidence to help guide the choice of modality for this common health condition. Patient summary: We present the largest trial comparing ureteroscopy versus extracorporeal shockwave lithotripsy for ureteric stones. While ureteroscopy had marginally improved outcome in terms of stone clearance, as expected, shockwave lithotripsy had better results in terms of health care costs. These results should enable patients and health care providers to optimise treatment pathways for this common urological condition. (C) 2021 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Metacognitive skills are important for effective learning, with literature suggesting these skills are particularly difficult to acquire for those with a diagnosis of ADHD. This action research project investigated how best to support adolescents with a diagnosis of ADHD to develop their metacognition, specifically around planning, monitoring, and evaluating. It sought to encourage them to self-reflect on independent work completed during English lessons in an intervention session with the researcher. There were four participants from Year 9 (age 13 to 14 years) at a secondary school in the West Midlands and they were in the same English class; three of them had a diagnosis of ADHD. Data was collected from recordings of the intervention sessions, the participants’ self-reflections, questionnaires, and a reflective journal. There were four cycles of action research. Template analysis was performed on this data which produced a thematic map representing the whole data and individual thematic maps for each participant. The main findings were that each participant had an individual profile of metacognitive strengths and needs which included their motivation for changing their behaviour and knowledge of metacognitive strategies. They required an individual approach to support, whether that be the explicit modelling of a strategy or requiring a prompt to use one. The consideration of group dynamics was an important factor for the intervention to work. This action research project offers further discussion of implications and challenges for working with adolescents who have a diagnosis of ADHD or similar needs.