Complications of vasectomy: results from a prospective audit of 105 393 procedures.

OBJECTIVES: To provide up-to-date complication rates for vasectomy in the UK using 15 years of data collected by the Association of Surgeons in Primary Care (ASPC). PATIENTS AND METHODS: Data were collected between 2007 and March 2022. A patient questionnaire was completed on the day of surgery and at 4 months postoperatively. Rates of early and late failure, infection, hospital admission or re-admission, haematoma and post-vasectomy pain syndrome (PVPS) were recorded. There were no specific exclusion criteria. Complication rates were compared to those published by major urological organisations. Descriptive statistics were utilised, without formal statistical analysis. RESULTS: Over the 15-year study period, data from 105 393 vasectomies were collected, performed by >150 surgeons. In 2022, 94.4% of surgeons used one test to prove sterility. In all, 65% of patients used a postal sperm test after vasectomy to confirm sterility. Early failure rates were available for 69 500 patients. Early failure occurred in 648 patients (0.93%). Of 99 124 patients, late failure occurred in 41 (0.04%). Of 102 549 vasectomies, postoperative infection was reported in 1250 patients (1.22%), haematoma in 1599 patients (1.56%), and PVPS was reported in 139 patients (0.14%). CONCLUSIONS: Vasectomy remains a safe and reliable contraceptive method. The rates of complication were generally lower than those published by major urological organisations. This large, prospective audit provides accurate, contemporaneous complication rates that can form the basis for pre-vasectomy counselling.

A phase 2 study of AZD4635 in combination with durvalumab or oleclumab in patients with metastatic castration-resistant prostate cancer.

BACKGROUND: Inhibition of the adenosine 2A receptor (A2AR) diminishes the immunosuppressive effects of adenosine and may complement immune-targeting drugs. This phase 2 study evaluated the A2AR antagonist AZD4635 in combination with durvalumab or oleclumab in patients with metastatic castration-resistant prostate cancer. METHODS: Patients with histologically/cytologically confirmed disease progressing within 6 months on ≥ 2 therapy lines were randomly assigned to either Module 1 (AZD4635 + durvalumab) or Module 2 (AZD4635 + oleclumab). Primary endpoints were objective response rate per RECIST v1.1 and prostate-specific antigen (PSA) response rate. Secondary endpoints included radiological progression-free survival (rPFS), overall survival, safety, and pharmacokinetics. RESULTS: Fifty-nine patients were treated (Module 1, n = 29; Module 2, n = 30). Median number of prior therapies was 4. One confirmed complete response by RECIST (Module 1) and 2 confirmed PSA responses (1 per module) were observed. The most frequent adverse events (AEs) possibly related to AZD4635 were nausea (37.9%), fatigue (20.7%), and decreased appetite (17.2%) in Module 1; nausea (50%), fatigue (30%), and vomiting (23.3%) in Module 2. No dose-limiting toxicities or treatment-related serious AEs were observed. In Module 1, AZD4635 geometric mean trough concentration was 124.9 ng/mL (geometric CV% 69.84; n = 22); exposures were similar in Module 2. In Modules 1 and 2, median (95% CI) rPFS was 2.3 (1.6 -3.8) and 1.5 (1.3- 4.0) months, respectively. Median PFS was 1.7 versus 2.3 months for patients with high versus low blood-based adenosine signature. CONCLUSION: In this heavily pretreated population, AZD4635 with durvalumab or oleclumab demonstrated minimal antitumor activity with a manageable safety profile. CLINICAL TRIAL: gov identifier: NCT04089553.

Risk of post-vasectomy infections in 133,044 vasectomies from four international vasectomy practices

ABSTRACT Objectives: To estimate the risk of post-vasectomy infections in various settings and across various surgical techniques and sanitization practices. Patients and Methods: Retrospective review of the records of 133,044 vasectomized patients from four large practices/network of practices using the no-scalpel vasectomy (NSV) technique in Canada (2011-2021), Colombia (2015-2020), New Zealand (2018-2021), and the United Kingdom (2006-2019). We defined infection as any mention in medical records of any antibiotics prescribed for a genital or urinary condition following vasectomy. Results: Post-vasectomy infection risks were 0.8% (219 infections/26,809 procedures), 2.1% (390/18,490), 1.0% (100/10,506), and 1.3% (1,007/77,239) in Canada, Colombia, New Zealand, and the UK, respectively. Audit period comparison suggests a limited effect on the risk of infection of excising a short vas segment, applying topical antibiotic on scrotal opening, wearing a surgical mask in Canada, type of skin disinfectant, and use of non-sterile gloves in New Zealand. Risk of infection was lower in Colombia when mucosal cautery and fascial interposition [FI] were used for vas occlusion compared to ligation, excision, and FI (0.9% vs. 2.1%, p<0.00001). Low level of infection certainty in 56% to 60% of patients who received antibiotics indicates that the true risk might be overestimated. Lack of information in medical records and patients not consulting their vasectomy providers might have led to underestimation of the risk. Conclusion: Risk of infection after vasectomy is low, about 1%, among international high-volume vasectomy practices performing NSV and various occlusion techniques. Apart from vasectomy occlusion technique, no other factor modified the risk of post-vasectomy infection.

Risk of post-vasectomy infections in 133,044 vasectomies from four international vasectomy practices.

OBJECTIVES: To estimate the risk of post-vasectomy infections in various settings and across various surgical techniques and sanitization practices. PATIENTS AND METHODS: Retrospective review of the records of 133,044 vasectomized patients from four large practices/network of practices using the no-scalpel vasectomy (NSV) technique in Canada (2011-2021), Colombia (2015-2020), New Zealand (2018-2021), and the United Kingdom (2006-2019). We defined infection as any mention in medical records of any antibiotics prescribed for a genital or urinary condition following vasectomy. RESULTS: Post-vasectomy infection risks were 0.8% (219 infections/26,809 procedures), 2.1% (390/18,490), 1.0% (100/10,506), and 1.3% (1,007/77,239) in Canada, Colombia, New Zealand, and the UK, respectively. Audit period comparison suggests a limited effect on the risk of infection of excising a short vas segment, applying topical antibiotic on scrotal opening, wearing a surgical mask in Canada, type of skin disinfectant, and use of non-sterile gloves in New Zealand. Risk of infection was lower in Colombia when mucosal cautery and fascial interposition [FI] were used for vas occlusion compared to ligation, excision, and FI (0.9% vs. 2.1%, p<0.00001). Low level of infection certainty in 56% to 60% of patients who received antibiotics indicates that the true risk might be overestimated. Lack of information in medical records and patients not consulting their vasectomy providers might have led to underestimation of the risk. CONCLUSION: Risk of infection after vasectomy is low, about 1%, among international high-volume vasectomy practices performing NSV and various occlusion techniques. Apart from vasectomy occlusion technique, no other factor modified the risk of post-vasectomy infection.

Global variation in early epidemic growth rates and reproduction number of seasonal influenza.

BACKGROUND: Little is known about global variation in early epidemic growth rates and effective reproduction numbers (Re) of seasonal influenza. We aimed to estimate global variation in Re of influenza type A and B during a single period. METHODS: Country influenza detection time series from September 2017 through January 2019 were obtained from an international database. Type A and B epidemics by country were selected on the basis of Re estimates for a five-week moving window, advanced by week. Associations of Re with absolute latitude, human development index, percent of the population aged <15 years, and percent of those living in rural areas in each country were assessed. RESULTS: Time series were included for 119 of 169 available countries. There were 100 countries with influenza A and 79 with B epidemics. Median Re for both influenza A and B epidemics was 1.23 (ranges: A 1.10, 1.60; B 1.06, 1.58). Re of influenza B but not A was independently associated with absolute latitude, increasing by 0.022 (95% confidence interval 0.002, 0.043) per 10 degrees. CONCLUSION: The Re of influenza A and B were similar. Only the Re of influenza B was associated with country characteristics, which was increasing with distance from the equator. The approach may be suitable for continuous Re surveillance.

Pharmacokinetics, safety, and tolerability of intravenous brivaracetam in pediatric patients with epilepsy: An open-label trial.

OBJECTIVE: To evaluate the pharmacokinetics, safety, and tolerability of brivaracetam (BRV) as 15-min intravenous (IV) infusion and bolus (≤2-min injection). METHODS: EP0065 (ClinicalTrials.gov: NCT03405714) was a Phase 2, multicenter, open-label trial in patients ≥1 month to <16 years of age with epilepsy. Patients received up to 5 mg/kg/day BRV (not exceeding 200 mg/day). Enrollment was sequential by descending age, depending on safety review. Outcomes included BRV plasma concentrations before and after IV administration, treatment-emergent adverse events (TEAEs), and discontinuations due to TEAEs. RESULTS: Fifty patients were enrolled, received BRV, and completed the trial. Twenty-six patients (52.0%) received 15-min infusions and 24 (48.0%) received bolus injections. Most patients (80.0%) received one IV dose. In the 15-min infusion group, geometric mean (GeoMean) BRV concentrations 15 (±2) min (n = 21) and 3 h (±15 min) (n = 21) post dose were 1903.0 ng/mL (geometric coefficient of variation [GeoCV]: 60.7%) and 1130.3 ng/mL (58.8%), respectively. In the bolus group, GeoMean BRV concentrations 15 (±2) min (n = 19) and 3 h (±15 min) (n = 21) post dose were 1704.8 ng/mL (GeoCV: 74.5%) and 1383.9 ng/mL (85.0%), respectively. Overall, 14 patients (28.0%) had TEAEs (15-min infusion: 8 [30.8%]; bolus: 6 [25.0%]), most commonly (≥5% of patients) somnolence (3 [6.0%]). Ten patients (20.0%) had drug-related TEAEs (15-min infusion: 6 [23.1%]; bolus: 4 [16.7%]). No patients discontinued due to TEAEs, and no deaths occurred. SIGNIFICANCE: IV BRV (up to 200 mg/day) was well tolerated in patients ≥1 month to <16 years of age, regardless of whether BRV was administered as 15-min infusion or bolus. No unexpected safety or pharmacokinetic differences were observed between patients receiving 15-min infusions or bolus, and plasma concentrations were in the expected range. Safety results were consistent with the known safety profile of oral BRV, with no new safety concerns identified.

Do carers of adolescents at first episode psychosis have distinctive psychological needs? A pilot exploration.

BACKGROUND: Carers of patients experiencing first episode psychosis (FEP) are at an increased risk of mental and physical health problems themselves. However, little is known about how the psychological needs of carers may differ between those caring for an adolescent versus an adult who has FEP. AIMS: This pilot study aimed to explore any differences in the psychological needs of carers caring for adolescents versus adults with FEP. METHODS: We surveyed 254 carers of 198 FEP patients (34 carers of adolescents of 24 FEP adolescent patients). Carers completed self-report measures of anxiety, depression, burnout, subjective burden, coping, and key illness beliefs. The sample was divided according to whether the patient was under (adolescent) or over (adult) age 18, and analysed using mixed model logistic regressions. RESULTS: Compared to the carers of adult patients, carers of adolescents were more than twice as likely (12% vs. 30%) to experience overall burnout syndrome (all three domains), and to develop it much quicker (19.4 vs. 10.1 months). They were also more likely to adopt behavioural disengagement avoidance as a form of coping. However, there was no difference between carers in terms of anxiety, depression, beliefs and subjective burden. For carers of adolescents, burnout was independently predicted by: a negative belief about the consequences of psychosis for the adolescent patient and an incoherent understanding of the patient's mental health. CONCLUSIONS: If our findings can be replicated in a larger sample, then Rapid-Onset-Burnout-Syndrome (ROBS) is a particular problem in carers of adolescents at FEP, suggesting a need for routine screening and possible prophylactic intervention. Carers of adolescent's use of behavioural escape coping maybe also require early intervention. Theoretically, consideration could be given to the development of an adolescent sub-branch to the cognitive model of caregiving.

Comparison of postal and non-postal post-vasectomy semen sample submission strategies on compliance and failures: an 11-year analysis of the audit database of the Association of Surgeons in Primary Care of the UK.

BACKGROUND: Vasectomy occlusive success is defined by the recommendation of 'clearance' to stop other contraception, and is elicited by post-vasectomy semen analysis (PVSA). We evaluated how the choice of either a postal or non-postal PVSA submission strategy was associated with compliance to PVSA and effectiveness of vasectomy. METHODS: We studied vasectomies performed in the UK from 2008 to 2019, reported in annual audits by Association of Surgeons in Primary Care members. We calculated the difference between the two strategies for compliance with PVSA, and early and late vasectomy failure. We determined compliance by adding the numbers of men with early failure and those given clearance. We performed stratified analyses by the number of test guidance for clearance (one-test/two-test) and the study period (2008-2013/2014-2019). RESULTS: Among 58 900 vasectomised men, 32 708 (56%) and 26 192 (44%) were advised submission by postal and non-postal strategies, respectively. Compliance with postal (79.5%) was significantly greater than with non-postal strategy (59.1%), the difference being 20.4% (95% CI 19.7% to 21.2%). In compliant patients, overall early failure detection was lower with postal (0.73%) than with non-postal (0.94%) strategy (-0.22%, 95% CI -0.41% to -0.04%), but this difference was neither clinically nor statistically significant with one-test guidance in 2014-2019. There was no difference in late failure rates. CONCLUSIONS: Postal strategy significantly increased compliance to PVSA with similar failure detection rates. This resulted in more individuals receiving clearance or early failure because of the greater percentage of postal samples submitted. Postal strategy warrants inclusion in any future guidelines as a reliable and convenient option.

Carer subjective burden after first-episode psychosis: Types and predictors. A multilevel statistical approach.

BACKGROUND: Carer burden at first-episode psychosis is common and adds to the multiple other psychiatric and psychological problems that beset new carers; yet, knowledge of the factors that predict carer burden is limited. AIM: This study sought to investigate the types and predictors of carer burden at first-episode psychosis in the largest, most ethnically diverse and comprehensively characterised sample to date. METHOD: This study involved a cross-sectional survey of carers of people with first-episode psychosis presenting to Harrow and Hillingdon Early Intervention in Psychosis service between 2011 and 2017. Carers completed self-report measures assessing their illness beliefs, coping styles and caregiving experiences (i.e. burden). Thirty carer and patient sociodemographic and clinical factors were also collected. Mixed effects linear regression modelling was conducted to account for clustering of carers by patient, with carer burden (and its 8 subtypes) investigated as dependent variables. RESULTS: The sample included data on 254 carers (aged 18-74 years) and 198 patients (aged 14-36 years). Regression modelling identified 35 significant predictors of carer burden and its subtypes at first-episode psychosis. Higher total burden was independently predicted by perceiving greater negative consequences of the illness for the patient (B = .014, p < .001, 95% CI: [.010-.018]) and the carer (B = .008, p = .002, 95% CI: [.003-.013]), and engaging in avoidant-focussed coping (B = .010, p = .006, 95% CI: [.003-.016]). Lower burden was independently predicted by patients being in a relationship (B = -.075, p = .047, 95% CI: [-.149 to -.001]). Predictors of the eight burden subtypes (difficult behaviours, negative symptoms, stigma, problems with services, effects on family, dependency, loss and need to backup) are also included in the article. CONCLUSION: Findings can be used to inform the identification of carers 'at-risk' of experiencing burden and highlight potential targets for theraputic intervention to lower carer buden.

First episode psychosis: A comparison of caregiving appraisals in parents caring for the same child.

BACKGROUND: The first onset of psychosis can be a traumatic event for diagnosed individuals but can also impact negatively on their families. Little is known about how parents of the same child make sense of the illness. In mothers and fathers caring for the same child with early psychosis, the current study assessed their similarities and differences in key areas of their caregiving role. METHODS: Using a cross-sectional design, parental pairs caring for the same child treated within an early intervention in psychosis service, completed self-report measures on their caregiving experiences, illness beliefs, coping styles and affect. RESULTS: Data from 44 mothers and fathers were analysed. Analyses confirmed that parents reported similar levels of emotional dysfunction and conceptualized the illness in broadly similar ways with regard to what they understood the illness to be, their emotional reactions to the illness, perceived illness consequences and beliefs about treatment. Significant differences were identified in their beliefs about the timeline of the illness and reported approaches to coping. CONCLUSIONS: With exception of beliefs about illness timeline and an expressed preference for use of emotion-based coping, parent caregivers of the same child in early psychosis services are likely to report similar illness beliefs and caregiving reactions. Efforts to ensure staff awareness of the potential areas of divergence in parental caregiving appraisals and exploring the implications of the divergence for the caregiving relationship and patient outcomes are indicated.

Understanding the experience of "burnout" in first-episode psychosis carers.

BACKGROUND: The first onset of psychosis can exert a significant negative impact on the functioning and positive wellbeing of family carers. Carer reports of "burnout" have recently been recorded in early psychosis carers, though the literature is scarce detailing our understanding of how burnout relates to the primary experience of caregiving. The current study investigated reports of burnout and its relationship with beliefs about caregiving and wellbeing in a large group of early psychosis carers who were routinely assessed within an early intervention team. METHODS AND MATERIALS: Using a cross-sectional design, 169 early psychosis carers completed the Maslach Burnout Inventory alongside measures of caregiving experiences, affect and wellbeing. RESULTS: The mean illness length for patients with psychosis was 18 months. Their mean age was 24.4 years and most was male (65%). The majority of carer participants were parental caregivers and living with their relative with psychosis. Across the three key burnout dimensions, 58% of the sample reported high levels of emotional exhaustion; 31% endorsed high levels of depersonalization; and 43% reported low levels personal accomplishment. The most severe level of burnout, reflecting elevated rates across all three dimensions, was observed in 16% of the sample. Carer burnout was positively associated with negative caregiving experiences (i.e. burden), poor affect, and reduced levels of positive wellbeing and perception of being in good health. CONCLUSIONS: Reports by early psychosis carers of exhaustion, feeling inadequate and expressing negativity towards the relative they care for is not uncommon and are closely associated with their overall negative appraisals of caregiving. The results underscore the importance of developing targeted interventions during the early phase, which are designed to reduce the development and entrenchment of burnout responses in carers, but to also mitigate its negative sequelae.

Modifying illness beliefs in recent onset psychosis carers: Evaluating the impact of a cognitively focused brief group intervention in a routine service.

AIMS: At first-episode psychosis (FEP), many patients will be routed within familial networks and supported by informal carers who are predominately close family members such as parents. Carer burden, distress and poorer coping styles are associated with different illness beliefs. The current study sought to examine the impact and acceptability of a 3 session, cognitively informed, group intervention targeting illness beliefs previously linked to distress and poorer caregiving experiences in FEP carers. METHODS: Carers attending a routine FEP service were invited to attend the group intervention and completed a measure of illness beliefs at baseline and post intervention. RESULTS: Data on 68 carers with complete datasets are presented. Carers were predominately females (64.2%). Group attendance was linked to positive improvements in carer baseline beliefs about the negative consequences of the illness for the patient and themselves, attributions of blame about the illness to the patient and themselves and their overall understanding about the illness. Significant improvements in their understanding of the illness timeline and course, and confidence in dealing with difficulties were also identified. CONCLUSIONS: A cognitively informed group approach to targeting the less adaptive illness beliefs reported by FEP carers may offer an effective and acceptable pathway to facilitate their understanding of the illness and adjustment. Further studies using controlled designs are required.

Burnout in early course psychosis caregivers: the role of illness beliefs and coping styles.

AIMS: In occupational settings, burnout is a common response to chronic exposure stressors and has been frequently documented in formal caregivers (i.e. paid psychiatric staff). However, the literature is limited on reports of burnout among informal caregivers and particularly within early psychosis groups. The current study sought to investigate reports of burnout in carers of young adults treated within a specialist early psychosis service and links with key appraisals reported about the illness and coping. METHODS: Seventy-two carers completed the Maslach Burnout Inventory along with self-report measures of coping styles and illness beliefs. RESULTS: Seventy-eight per cent of carers reported high burnout in at least one of the three key burnout markers (i.e. emotional exhaustion, depersonalization or low personal accomplishment). Seven per cent of carers met full criteria for high burnout across all the three domains. A carer's belief about the negative consequences of the illness for themselves was a significant predictor of emotional exhaustion and depersonalization. Low personal accomplishment was linked to a carer's less optimistic beliefs about the illness timeline and fewer reports of adaptive coping. CONCLUSIONS: The results provide preliminary support for the importance of asking carers in the early illness phase about their experiences of caregiving. Targeted assessment may serve as a helpful tool to identify and intervene with carers in need of additional support with stress management, use of adaptive coping strategies, and balanced recovery focused information about psychosis.

Unilateral absence of vas deferens: prevalence among 23, 013 men seeking vasectomy

ABSTRACT Purpose: To determine the prevalence of unilateral absence of vas deferens (UAVD) in men with both testes seeking vasectomy. Materials and Methods: Computerized charts of 23,013 patients encountered between January 1994 and December 2013 in one university hospital and two community clinics of Quebec City, Canada, were searched. Pre-vasectomy consultation, operative reports and semen analysis results were reviewed to identify cases of UAVD. Cases were categorized as confirmed (unilateral vasectomy and success confirmed by semen analysis) or possible congenital UAVD further sub-categorized according to whether or not a scrotal anomaly was present. Results: Among 159 men identified as potentially having UAVD, chart review revealed that 47 had only one testicle, 26 had bilateral vasa, and four were misdiagnosed (post-vasectomy semen analysis [PVSA] showing motile sperm after unilateral vasectomy) leaving 82 men deemed cases of UAVD (0.36%, 95% confidence interval 0.28% to 0.43%). These were classified as confirmed (n=48, 0.21%) and possible (n=34, 0.15%; 22 without and 12 with scrotal anomalies) congenital UAVD. The misdiagnosis ratio of UAVD was low when scrotal content was otherwise normal (1:48), but higher if anomalies were present (3:12). Conclusions: Most surgeons who perform vasectomy will encounter cases of UAVD. In most suspected cases, it is safe and effective to proceed with unilateral vasectomy under local anesthesia while stressing the need for PVSA. Further studies or scrotal exploration may be considered in patient with prior scrotal surgery.

Continual reassessment method for dose escalation clinical trials in oncology: a comparison of prior skeleton approaches using AZD3514 data.

BACKGROUND: The continual reassessment method (CRM) requires an underlying model of the dose-toxicity relationship ("prior skeleton") and there is limited guidance of what this should be when little is known about this association. In this manuscript the impact of applying the CRM with different prior skeleton approaches and the 3 + 3 method are compared in terms of ability to determine the true maximum tolerated dose (MTD) and number of patients allocated to sub-optimal and toxic doses. METHODS: Post-hoc dose-escalation analyses on real-life clinical trial data on an early oncology compound (AZD3514), using the 3 + 3 method and CRM using six different prior skeleton approaches. RESULTS: All methods correctly identified the true MTD. The 3 + 3 method allocated six patients to both sub-optimal and toxic doses. All CRM approaches allocated four patients to sub-optimal doses. No patients were allocated to toxic doses from sigmoidal, two from conservative and five from other approaches. CONCLUSIONS: Prior skeletons for the CRM for phase 1 clinical trials are proposed in this manuscript and applied to a real clinical trial dataset. Highly accurate initial skeleton estimates may not be essential to determine the true MTD, and, as expected, all CRM methods out-performed the 3 + 3 method. There were differences in performance between skeletons. The choice of skeleton should depend on whether minimizing the number of patients allocated to suboptimal or toxic doses is more important. TRIAL REGISTRATION: NCT01162395 , Trial date of first registration: July 13, 2010.

Unilateral absence of vas deferens: prevalence among 23.013 men seeking vasectomy.

PURPOSE: To determine the prevalence of unilateral absence of vas deferens (UAVD) in men with both testes seeking vasectomy. MATERIALS AND METHODS: Computerized charts of 23.013 patients encountered between January 1994 and December 2013 in one university hospital and two community clinics of Quebec City, Canada, were searched. Pre-vasectomy consultation, operative reports and semen analysis results were reviewed to identify cases of UAVD. Cases were categorized as confirmed (unilateral vasectomy and success confirmed by semen analysis) or possible congenital UAVD further sub-categorized according to whether or not a scrotal anomaly was present. RESULTS: Among 159 men identified as potentially having UAVD, chart review revealed that 47 had only one testicle, 26 had bilateral vasa, and four were misdiagnosed (post-vasectomy semen analysis [PVSA] showing motile sperm after unilateral vasectomy) leaving 82 men deemed cases of UAVD (0.36%, 95% confidence interval 0.28% to 0.43%). These were classified as confirmed (n=48, 0.21%) and possible (n=34, 0.15%; 22 without and 12 with scrotal anomalies) congenital UAVD. The misdiagnosis ratio of UAVD was low when scrotal content was otherwise normal (1:48), but higher if anomalies were present (3:12). CONCLUSIONS: Most surgeons who perform vasectomy will encounter cases of UAVD. In most suspected cases, it is safe and effective to proceed with unilateral vasectomy under local anesthesia while stressing the need for PVSA. Further studies or scrotal exploration may be considered in patient with prior scrotal surgery.

Trends in management and outcomes of COPD patients in primary care, 2000-2009: a retrospective cohort study.

BACKGROUND: Since the introduction of the Quality and Outcomes framework, there has been some evidence of improvement in the management of chronic obstructive pulmonary disease (COPD) patients in the United Kingdom through increasing rates of smoking cessation advice and immunisations against influenza. However, it is unknown whether disease-specific management criteria, disease outcomes and diagnosis have improved. AIMS: To describe changes in the management and outcomes of patients with COPD in UK general practice between 2000 and 2009. METHODS: The study was done on a retrospective cohort using data from The Health Improvement Network UK primary care database. We calculated age at diagnosis of COPD and death, total number of short-term oral corticosteroid courses and consultations, and proportion of patients with very severe COPD and on triple inhaled therapy for each year between 2000 and 2009. RESULTS: We identified 92,576 patients with COPD. The mean age at COPD diagnosis decreased from 68.1 years in 2000 to 66.7 years in 2009. The mean age at death increased from 78.2 years in 2000 to 78.8 years in 2009. The number of prescribed courses of oral corticosteroids increased from 0.6 in 2000 to 0.8 in 2009. The number of consultations increased from 9.4 in 2004 to 11.3 in 2009. The risk of having very severe COPD decreased from 9.4% in 2004 to 6.8% in 2009. The likelihood of patients with very severe COPD receiving triple therapy increased from 25% in 2004 to 59% in 2009. CONCLUSIONS: The trends suggest that management and outcomes observed in patients with COPD may have improved since the year 2000.

Improving lactose digestion and symptoms of lactose intolerance with a novel galacto-oligosaccharide (RP-G28): a randomized, double-blind clinical trial.

BACKGROUND: Lactose intolerance (LI) is a common medical problem with limited treatment options. The primary symptoms are abdominal pain, diarrhea, bloating, flatulence, and cramping. Limiting dairy foods to reduce symptoms contributes to low calcium intake and the risk for chronic disease. Adaptation of the colon bacteria to effectively metabolize lactose is a novel and potentially useful approach to improve lactose digestion and tolerance. RP-G28 is novel galacto-oligosaccharide (GOS) being investigated to improve lactose digestion and the symptoms of lactose intolerance in affected patients. METHODS: A randomized, double-blind, parallel group, placebo-controlled study was conducted at 2 sites in the United States. RP-G28 or placebo was administered to 85 patients with LI for 35 days. Post-treatment, subjects reintroduced dairy into their daily diets and were followed for 30 additional days to evaluate lactose digestion as measured by hydrogen production and symptom improvements via a patient-reported symptom assessment instrument. RESULTS: Lactose digestion and symptoms of LI trended toward improvement on RP-G28 at the end of treatment and 30 days post-treatment. A reduction in abdominal pain was also demonstrated in the study results. Fifty percent of RP-G28 subjects with abdominal pain at baseline reported no abdominal pain at the end of treatment and 30 days post treatment (p = 0.0190). RP-G28 subjects were also six times more likely to claim lactose tolerance post-treatment once dairy foods had been re-introduced into their diets (p = 0.0389). CONCLUSIONS: Efficacy trends and favorable safety/tolerability findings suggest that RP-G28 appears to be a potentially useful approach for improving lactose digestion and LI symptoms. The concurrent reduction in abdominal pain and improved overall tolerance could be a meaningful benefit to lactose intolerant individuals.

Use of long-term antibiotic treatment in COPD patients in the UK: a retrospective cohort study.

BACKGROUND: Exacerbations of chronic obstructive pulmonary disease (COPD) are a burden to patients and impose a major cost on health services. Long-term antibiotic therapy may prevent exacerbations, but at present it is not recommended by management guidelines. AIMS: To identify the type and prevalence of long-term oral antibiotic treatments prescribed to patients with COPD and to assess the patient characteristics associated with long-term antibiotic use. METHODS: A retrospective cohort using all eligible practices in The Health Improvement Network (THIN) UK primary care database between 2000 and 2009 was studied. We identified patients with COPD and then those who received a course of long-term antibiotics. Long-term courses were defined as >6 months in duration with <50% concomitant oral corticosteroid treatment. RESULTS: We identified 92,576 patients with COPD, but only 567 patients (0.61%) who received 998 long-term antibiotic courses. Mean follow-up time was 3 years and 10 months. The median long-term antibiotic course length was 280 days (interquartile range 224, 394) and 58 patients (0.06%) were continuously prescribed antibiotics for >2 years. The most commonly used long-term antibiotics were oxytetracycline, doxycycline, and penicillin. Azithromycin, erythromycin, and clarithromycin were less frequently used. There was little evidence of the use of rotating courses of antibiotics. Men, people aged 50-79 years, non-smokers, and patients with poorer lung function were more likely to receive long-term antibiotic treatment. CONCLUSIONS: Relatively few COPD patients are currently prescribed long-term antibiotics. Further clinical trials are required to determine the efficacy of this therapy. If beneficial, the use of such treatments should be incorporated into clinical guidelines.

Type 2 diabetes: a cohort study of treatment, ethnic and social group influences on glycated haemoglobin.

OBJECTIVES: To assess whether in people with poorly controlled type 2 diabetes (HbA1c>7.5%) improvement in HbA1c varies by ethnic and social group. DESIGN: Prospective 2-year cohort of type 2 diabetes treated in general practice. SETTING AND PARTICIPANTS: All patients with type 2 diabetes in 100 of the 101 general practices in two London boroughs. The sample consisted of an ethnically diverse group with uncontrolled type 2 diabetes aged 37-71 years in 2007 and with HbA1c recording in 2008-2009. OUTCOME MEASURE: Change from baseline HbA1c in 2007 and achievement of HbA1c control in 2008 and 2009 were estimated for each ethnic, social and treatment group using multilevel modelling. RESULTS: The sample consisted of 6104 people; 18% were white, 63% south Asian, 16% black African/Caribbean and 3% other ethnic groups. HbA1c was lower after 1 and 2 years in all ethnic groups but south Asian people received significantly less benefit from each diabetes treatment. After adjustment, south Asian people were found to have 0.14% less reduction in HbA1c compared to white people (95% CI 0.04% to 0.24%) and white people were 1.6 (95% CI 1.2 to 2.0) times more likely to achieve HbA1c controlled to 7.5% or less relative to south Asian people. HbA1c reduction and control in black African/Caribbean and white people did not differ significantly. There was no evidence that social deprivation influenced HbA1c reduction or control in this cohort. CONCLUSIONS: In all treatment groups, south Asian people with poorly controlled diabetes are less likely to achieve controlled HbA1c, with less reduction in mean HbA1c than white or black African/Caribbean people.