The clinical and cost-effectiveness of elective primary total knee replacement with PAtellar Resurfacing compared to selective patellar resurfacing: a pragmatic multicentre randomized controlled Trial (PART).

Aims: During total knee replacement (TKR), surgeons can choose whether or not to resurface the patella, with advantages and disadvantages of each approach. Recently, the National Institute for Health and Care Excellence (NICE) recommended always resurfacing the patella, rather than never doing so. NICE found insufficient evidence on selective resurfacing (surgeon's decision based on intraoperative findings and symptoms) to make recommendations. If effective, selective resurfacing could result in optimal individualized patient care. This protocol describes a randomized controlled trial to evaluate the clinical and cost-effectiveness of primary TKR with always patellar resurfacing compared to selective patellar resurfacing. Methods: The PAtellar Resurfacing Trial (PART) is a patient- and assessor-blinded multicentre, pragmatic parallel two-arm randomized superiority trial of adults undergoing elective primary TKR for primary osteoarthritis at NHS hospitals in England, with an embedded internal pilot phase (ISRCTN 33276681). Participants will be randomly allocated intraoperatively on a 1:1 basis (stratified by centre and implant type (cruciate-retaining vs cruciate-sacrificing)) to always resurface or selectively resurface the patella, once the surgeon has confirmed sufficient patellar thickness for resurfacing and that constrained implants are not required. The primary analysis will compare the Oxford Knee Score (OKS) one year after surgery. Secondary outcomes include patient-reported outcome measures at three months, six months, and one year (Knee injury and Osteoarthritis Outcome Score, OKS, EuroQol five-dimension five-level questionnaire, patient satisfaction, postoperative complications, need for further surgery, resource use, and costs). Cost-effectiveness will be measured for the lifetime of the patient. Overall, 530 patients will be recruited to obtain 90% power to detect a four-point difference in OKS between the groups one year after surgery, assuming up to 40% resurfacing in the selective group. Conclusion: The trial findings will provide evidence about the clinical and cost-effectiveness of always patellar resurfacing compared to selective patellar resurfacing. This will inform future NICE guidelines on primary TKR and the role of selective patellar resurfacing.

Lower urinary tract symptoms in men: the TRIUMPH cluster RCT.

Background: Conservative therapies are recommended as initial treatment for male lower urinary tract symptoms. However, there is a lack of evidence on effectiveness and uncertainty regarding approaches to delivery. Objective: The objective was to determine whether or not a standardised and manualised care intervention delivered in primary care achieves superior symptomatic outcome for lower urinary tract symptoms to usual care. Design: This was a two-arm cluster randomised controlled trial. Setting: The trial was set in 30 NHS general practice sites in England. Participants: Participants were adult men (aged ≥ 18 years) with bothersome lower urinary tract symptoms. Interventions: Sites were randomised 1 : 1 to deliver the TReatIng Urinary symptoms in Men in Primary Health care using non-pharmacological and non-surgical interventions trial intervention or usual care to all participants. The TReatIng Urinary symptoms in Men in Primary Health care using non-pharmacological and non-surgical interventions intervention comprised a standardised advice booklet developed for the trial from the British Association of Urological Surgeons' patient information sheets, with patient and expert input. Patients were directed to relevant sections by general practice or research nurses/healthcare assistants following urinary symptom assessment, providing the manualised element. The healthcare professional provided follow-up contacts over 12 weeks to support adherence to the intervention. Main outcome measures: The primary outcome was the validated patient-reported International Prostate Symptom Score 12 months post consent. Rather than the minimal clinically important difference of 3.0 points for overall International Prostate Symptom Score, the sample size aimed to detect a difference of 2.0 points, owing to the recognised clinical impact of individual symptoms. Results: A total of 1077 men consented to the study: 524 in sites randomised to the intervention arm (n = 17) and 553 in sites randomised to the control arm (n = 13). A difference in mean International Prostate Symptom Score at 12 months was found (adjusted mean difference of -1.81 points, 95% confidence interval -2.66 to -0.95 points), with a lower score in the intervention arm, indicating less severe symptoms. Secondary outcomes of patient-reported urinary symptoms, quality of life specific to lower urinary tract symptoms and perception of lower urinary tract symptoms all showed evidence of a difference between the arms favouring the intervention. No difference was seen between the arms in the proportion of urology referrals or adverse events. In qualitative interviews, participants welcomed the intervention, describing positive effects on their symptoms, as well as on their understanding of conservative care and their attitude towards the experience of lower urinary tract symptoms. The interviews highlighted that structured, in-depth self-management is insufficiently embedded within general practitioner consultations. From an NHS perspective, mean costs and quality-adjusted life-years were similar between trial arms. The intervention arm had slightly lower mean costs (adjusted mean difference of -£29.99, 95% confidence interval -£109.84 to £22.63) than the usual-care arm, and a small gain in quality-adjusted life-years (adjusted mean difference of 0.001, 95% confidence interval -0.011 to 0.014). Conclusions: The intervention showed a small, sustained benefit for men's lower urinary tract symptoms and quality of life across a range of outcome measures in a UK primary care setting. Qualitative data showed that men highly valued the intervention. Intervention costs were marginally lower than usual-care costs. Limitations of the study included that trial participants were unmasked, with limited diversity in ethnicity and deprivation level. Additional research is needed to assess the applicability of the intervention for a more ethnically diverse population.. Trial registration: This trial is registered as ISRCTN11669964. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/90/03) and is published in full in Health Technology Assessment; Vol. 28, No. 13. See the NIHR Funding and Awards website for further award information.

Urinary problems among men become more common with age. Nearly one-third of all men aged > 65 years experience some urinary symptoms, which can have a substantial effect on their daily lives. Symptoms include needing to pass urine more often, urgently or during the night, and difficulties in passing urine. Men are usually diagnosed and treated by their general practitioner, and should be offered advice on controlling their symptoms themselves (e.g. lifestyle changes and exercises) before trying tablets or surgery. However, it is not known how helpful such advice is, and how general practices can effectively provide it. Thirty general practices in the West of England and Wessex took part in the study. Practices were split into two groups, with each practice providing either the TReatIng Urinary symptoms in Men in Primary Health care using non-pharmacological and non-surgical interventions care package or the practice's usual care to all of its patients in the trial. The TReatIng Urinary symptoms in Men in Primary Healthcare using nonpharmacological and non-surgical interventions care package included a booklet of advice to help control urinary symptoms, with a nurse or healthcare assistant directing men to relevant sections according to their symptoms, and providing follow-up contacts. We mainly assessed the benefits of the TReatIng Urinary symptoms in Men in Primary Healthcare using nonpharmacological and non-surgical interventions care package, compared with usual care, by using a questionnaire on urinary symptoms completed by participants. A total of 1077 men with urinary symptoms that bothered them joined the study. The main result was that men reported greater improvement in urinary symptoms with the TRIUMPH care package than with usual care, 12 months after joining the study. We also found that men receiving the TRIUMPH care package had a slight improvement in quality of life and outlook on their urinary symptoms. There was no difference between the two groups in the number of patients referred to hospital for treatment, the type, number and severity of side effects or cost to the NHS. Overall, the TRIUMPH care package was more effective in treating men with urinary symptoms than usual care by their general practice.

Cost-effectiveness of a primary healthcare intervention to treat male lower urinary tract symptoms: the TRIUMPH cluster randomised controlled trial.

OBJECTIVES: To estimate the cost-effectiveness of a primary care intervention for male lower urinary tract symptoms (LUTS) compared with usual care. DESIGN: Economic evaluation alongside a cluster randomised controlled trial from a UK National Health Service (NHS) perspective with a 12-month time horizon. SETTING: Thirty NHS general practice sites in England. PARTICIPANTS: 1077 men aged 18 or older identified in primary care with bothersome LUTS. INTERVENTIONS: A standardised and manualised intervention for the treatment of bothersome LUTS was compared with usual care. The intervention group (n=524) received a standardised information booklet with guidance on conservative treatment for LUTS, urinary symptom assessment and follow-up contacts for 12 weeks. The usual care group (n=553) followed local guidelines between general practice sites. MEASURES: Resource use was obtained from electronic health records, trial staff and participants, and valued using UK reference costs. Quality-adjusted life-years (QALYs) were calculated from the EQ-5D-5L questionnaire. Adjusted mean differences in costs and QALYs and incremental net monetary benefit were estimated. RESULTS: 866 of 1077 (80.4%) participants had complete data and were included in the base-case analysis. Over the 12-month follow-up period, intervention and usual care arms had similar mean adjusted costs and QALYs. Mean differences were lower in the intervention arm for adjusted costs -£29.99 (95% CI -£109.84 to £22.63) while higher in the intervention arm for adjusted QALYs 0.001 (95% CI -0.011 to 0.014). The incremental net monetary benefit statistic was £48.01 (95% CI -£225.83 to £321.85) at the National Institute for Health and Care Excellence UK threshold of £20 000 per QALY. The cost-effectiveness acceptability curve showed a 63% probability of the intervention arm being cost-effective at this threshold. CONCLUSIONS: Costs and QALYs were similar between the two arms at 12 months follow-up. This indicates that the intervention can be implemented in general practice at neutral cost. TRIAL REGISTRATION NUMBER: ISRCTN11669964.

Treatment of lower urinary tract symptoms in men in primary care using a conservative intervention: cluster randomised controlled trial.

OBJECTIVE: To determine whether a standardised and manualised care intervention in men in primary care could achieve superior improvement of lower urinary tract symptoms (LUTS) compared with usual care. DESIGN: Cluster randomised controlled trial. SETTING: 30 National Health Service general practice sites in England. PARTICIPANTS: Sites were randomised 1:1 to the intervention and control arms. 1077 men (≥18 years) with bothersome LUTS recruited between June 2018 and August 2019: 524 were assigned to the intervention arm (n=17 sites) and 553 were assigned to the usual care arm (n=13 sites). INTERVENTION: Standardised information booklet developed with patient and expert input, providing guidance on conservative and lifestyle interventions for LUTS in men. After assessment of urinary symptoms (manualised element), general practice nurses and healthcare assistants or research nurses directed participants to relevant sections of the manual and provided contact over 12 weeks to assist with adherence. MAIN OUTCOME MEASURES: The primary outcome was patient reported International Prostate Symptom Score (IPSS) measured 12 months after participants had consented to take part in the study. The target reduction of 2.0 points on which the study was powered reflects the minimal clinically important difference where baseline IPSS is <20. Secondary outcomes were patient reported quality of life, urinary symptoms and perception of LUTS, hospital referrals, and adverse events. The primary intention-to-treat analysis included 887 participants (82% of those recruited) and used a mixed effects multilevel linear regression model adjusted for site level variables used in the randomisation and baseline scores. RESULTS: Participants in the intervention arm had a lower mean IPSS at 12 months (adjusted mean difference -1.81 points, 95% confidence interval -2.66 to -0.95) indicating less severe urinary symptoms than those in the usual care arm. LUTS specific quality of life, incontinence, and perception of LUTS also improved more in the intervention arm than usual care arm at 12 months. The proportion of urology referrals (intervention 7.3%, usual care 7.9%) and adverse events (intervention seven events, usual care eight events) were comparable between the arms. CONCLUSIONS: A standardised and manualised intervention in primary care showed a sustained reduction in LUTS in men at 12 months. The mean difference of -1.81 points (95% confidence interval -0.95 to -2.66) on the IPSS was less than the predefined target reduction of 2.0 points. TRIAL REGISTRATION: ISRCTN Registry ISRCTN11669964.

Readability of online monkeypox patient education materials: Improved recognition of health literacy is needed for dissemination of infectious disease information.

BACKGROUND: Health literacy is key to navigating the current global epidemic of misinformation and inaccuracy relating to healthcare. The American Medical Association (AMA) suggests health information should be written at the level of American sixth grade. With the monkeypox outbreak being declared a Public Health Emergency of International Concern (PHEIC) in July 2022, we sought to assess the readability of online patient education materials (PEMs) relating to monkeypox to see if they are at the target level of readability. METHODS: A search was conducted on Google.com using the search term 'Monkeypox'. The top 50 English language webpages with patient education materials (PEMs) relating to monkeypox were compiled and categorised by country of publication and URL domain. Readability was assessed using five readability tools: Flesch Reading Ease Score (FRES), Flesch-Kincaid Grade Level (FKGL), Gunning Fog Index (GFI), Coleman-Liau Index (CLI), and, Simple Measure of Gobbledygook Index (SMOG). Unpaired t-test for URL domain, and one-way ANOVA for country were performed to determine influence on readability. RESULTS: Three of the five tools (FRES, GFI, CLI) identified no webpages that met the target readability score. The FKGL and SMOG tools identified one (2%) and two (4%) webpages respectively that met the target level. County and URL domain demonstrated no influence on readability. CONCLUSION: Online PEMs relating to monkeypox are written above the recommended reading level. Based on the previously established effect of health literacy, this is likely exacerbating health inequalities. This study highlights the need for readability to be considered when publishing online PEMs.

Qualitative Assessment of the Conservative Management of Nocturia with Standardised Written Materials for Lower Urinary Tract Symptoms in Men Treated in Primary Care.

BACKGROUND: Many men prefer conservative treatment of lower urinary tract symptoms (LUTS) but education and self-help guidance are limited in primary care. OBJECTIVE: To report qualitative interview findings for men reporting nocturia in a primary care setting for LUTS. DESIGN, SETTING, AND PARTICIPANTS: TRIUMPH (Treating Urinary Symptoms in Men in Primary Healthcare) is a multicentre cluster randomised trial of standardised manualised care (a booklet delivered by a health care professional) versus usual care for LUTS. The participants (524 in the intervention arm and 553 in the usual care arm) were men presenting for primary care for LUTS at 30 general practice (GP) sites in the UK. INTERVENTION: Delivery of a LUTS self-management booklet by health care staff in comparison to usual care for men with LUTS. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The qualitative component included 58 early-stage (0-3 mo after study enrolment) and 33 late-stage (3-9 mo later) interviews with participants to assess their experience of LUTS and conservative treatment in primary care. Purposive sampling was used to select participants for interview. RESULTS AND LIMITATIONS: Nocturia is a common driver for seeking health care and is perceived by men as relatively acceptable to discuss. Information and self-help guidance were largely absent from descriptions of GP consultations, other than reducing evening caffeine and fluid intake. The TRIUMPH LUTS intervention booklet offers explanations and self-management guidance. Men with long-term disruptive symptoms, a perception that the booklet content was novel or worthwhile, and a belief that self-management might help, were more receptive to the intervention. In follow-up, improvements in nocturia were related to successful implementation of several aspects of the guidance. Most men were willing to complete a bladder diary, but some found it inconvenient, especially men in employment. The characteristics of the trial population mean that the findings may not apply to all men. CONCLUSIONS: Reassuring men that nocturia is part of ageing without offering them information and support risks reinforcing the tendency to discount problematic LUTS. The trial booklet and the training of health care professionals support guidance on nocturia self-management, which is most effective for men receptive to this approach. However, the nature of the trial population means that the findings may not apply to all men. PATIENT SUMMARY: Men are more comfortable in discussing waking at night to urinate than talking about other urinary symptoms with their GP. This problem should lead to a detailed discussion of all urinary symptoms rather than being thought of as a sign of ageing. An information booklet and nurse consultation helped many men to improve this symptom.

Access to maternity and prenatal care services in rural Michigan.

BACKGROUND: The United States physician shortages affect rural health care access, including maternity care. Project aims were to identify and characterize prenatal and delivery care in Michigan's rural counties and to explore access to trial of labor after cesarean (TOLAC) services for women in rural Michigan. METHODS: Descriptive, cross-sectional design used 2015 Medicaid claims data and public health plan information to identify maternity care services provided within Michigan's rural counties. Publicly available health plan information was used to identify rural maternity hospitals and prenatal care practitioners; findings were verified by Internet searches and telephone interviews. Medicaid claims data were used to determine services provided. High-risk geographic areas were defined as those where women needed to travel >30 miles for maternity-related care. Expected TOLAC rate was determined based on published national birth data; rural hospitals were stratified based on whether they met the expected TOLAC rate, delivered 20%-60% of expected rate, or billed ≤1 TOLAC birth to Medicaid in 2015. RESULTS: In Michigan's 57 rural counties, only 29 hospitals provide maternity care. Geographic high-risk areas were identified in the Upper Peninsula and northeast Lower Peninsula of Michigan. Only two rural hospitals billed for the expected rate of TOLAC births; six delivered at a lower rate, and the remaining 21 hospitals provided no TOLAC services, resulting in large areas of the state where women were not offered this option locally. CONCLUSIONS: Maternity care services are limited for many rural Michigan women. Findings can be used to target specific strategies to improve access to care for these women. Similar analyses, exploring patterns of maternity care delivery in other rural regions worldwide, may uncover similar or additional inequities.

'Food for thought': The importance of nutrition to patient care and the role of the junior doctor.

Good nutrition is an integral component of patient care. Not only does eating correctly provide substantial physical benefits, it also ensures psychological comfort throughout admission. Nevertheless, our formative years as medical students, and now as junior doctors, have shown us that patient nutrition is frequently neglected both in the clinical setting and in the subject matter of our education.Amid the coronavirus pandemic, this is especially problematic; older, frailer patients, with multiple comorbidities and higher rates of malnutrition, are faring much worse with the virus. Combined with the fact that 40% of patients admitted to hospital are malnourished to some degree, we are looking at a huge population of potential COVID-19 patients facing a further decline in nutritional status and higher mortality as a result of this, making attention to nutrition more important than ever.As junior doctors, we have a role in the nutritional assessment of and support for our patients by ensuring that all patients are suitably assessed using a scoring tool with the appropriate ensuing actions taken. We must also ensure that our knowledge regarding nutritional assessment and support is adequate and aim to supplement this via additional learning to meet the minimum requirements for our curriculum.

Long-term persistence of structured habitats: seagrass meadows as enduring hotspots of biodiversity and faunal stability.

Ecological studies indicate that structurally complex habitats support elevated biodiversity, stability and resilience. The long-term persistence of structured habitats and their importance in maintaining biodiverse hotspots remain underexplored. We combined geohistorical data (dead mollusc assemblages, 'DA') and contemporary surveys (live mollusc assemblages, 'LA') to assess the persistence of local seagrass habitats over multi-centennial timescales and to evaluate whether they acted as long-term drivers of biodiversity, stability and resilience of associated fauna. We sampled structured seagrass meadows and open sandy bottoms along Florida's Gulf Coast. Results indicated that: (i) LA composition differed significantly between the two habitat types, (ii) LA from seagrass sites were characterized by significantly elevated local biodiversity and significantly higher spatial stability, (iii) DA composition differed significantly between the two habitat types, and (iv) fidelity between LA and DA was significantly greater for seagrass habitats. Contemporary results support the hypotheses that local biodiversity and spatial stability of marine benthos are both elevated in structured seagrass habitats. Geohistorical results suggest that structured habitats persist as local hotspots of elevated biodiversity and faunal stability over centennial-to-millennial timescales; indicating that habitat degradation and concomitant loss within structurally complex marine systems is a key driver of declining biodiversity and resilience.

TReatIng Urinary symptoms in Men in Primary Healthcare using non-pharmacological and non-surgical interventions (TRIUMPH) compared with usual care: study protocol for a cluster randomised controlled trial.

BACKGROUND: Lower urinary tract symptoms (LUTS) can relate to urinary storage or voiding. In men, the prevalence and severity of LUTS increases with age, with a significant impact on quality of life. The majority of men presenting with LUTS are managed by their general practitioner (GP) in the first instance, with conservative therapies recommended as the initial treatment. However, the provision of conservative therapies in primary care is variable and can be time and resource limited. GPs require practical resources to enhance patient engagement with such interventions. TRIUMPH aims to determine whether a standardised and manualised care intervention delivered in primary care achieves superior symptomatic outcome for LUTS versus usual care. METHODS/DESIGN: TRIUMPH is a two-arm, cluster randomised controlled trial (RCT) being conducted in 30 National Health Service (NHS) general practices in England. The TRIUMPH intervention comprises a standardised LUTS advice booklet developed for the trial with patient and healthcare professional (HCP) consultation. The booklet is delivered to patients by nurses/healthcare assistants following assessment of their urinary symptoms. Patients are directed to relevant sections of the booklet, providing the manualised element of the intervention. To encourage adherence, HCPs provide follow-up contacts over 12 weeks. Practices are randomised 1:1 to either deliver the TRIUMPH intervention or a usual care pathway. The patient-reported International Prostate Symptom Score (IPSS) at 12 months post consent is the primary outcome. Secondary outcomes include cost-effectiveness, patient-reported outcomes on LUTS, quality of life, and patient and HCP acceptability and experience of the intervention. Primary analyses will be conducted on an intention-to-treat basis. DISCUSSION: It is unclear whether conservative therapies for male LUTS are effectively delivered in primary care using current approaches. This can lead to men being inappropriately referred to secondary care or experiencing persistent symptoms. Primary care, therefore, holds the key to effective treatment for these men. The TRIUMPH intervention, through its standardised and manualised approach, has been developed to support GP practices in delivering effective conservative care. This pragmatic, cluster RCT should provide robust evidence in a primary-care setting to inform future guidelines. TRIAL REGISTRATION: ISCRTN registry, ID: ISRCTN11669964 . Registered on 12 April 2018.