Low-Dose vs Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Trial.

BACKGROUND: Current guidelines recommend a target international normalized ratio (INR) range of 2.5 to 3.5 in patients with a mechanical mitral prosthesis. The Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT) Mitral randomized controlled noninferiority trial assessed safety and efficacy of warfarin at doses lower than currently recommended in patients with an On-X (Artivion, Inc) mechanical mitral valve. METHODS: After On-X mechanical mitral valve replacement, followed by at least 3 months of standard anticoagulation, 401 patients at 44 North American centers were randomized to low-dose warfarin (target INR, 2.0-2.5) or standard-dose warfarin (target INR, 2.5-3.5). All patients were prescribed aspirin, 81 mg daily, and encouraged to use home INR testing. The primary end point was the sum of the linearized rates of thromboembolism, valve thrombosis, and bleeding events. The design was based on an expected 7.3% event rate and 1.5% noninferiority margin. RESULTS: Mean patient follow-up was 4.1 years. Mean INR was 2.47 and 2.92 (P <.001) in the low-dose and standard-dose warfarin groups, respectively. Primary end point rates were 11.9% per patient-year in the low-dose group and 12.0% per patient-year in the standard-dose group (difference, -0.07%; 95% CI, -3.40% to 3.26%). The CI >1.5%, thus noninferiority was not achieved. Rates (percentage per patient-year) of the individual components of the primary end point were 2.3% vs 2.5% for thromboembolism, 0.5% vs 0.5% for valve thrombosis, and 9.13% vs 9.04% for bleeding. CONCLUSIONS: Compared with standard-dose warfarin, low-dose warfarin did not achieve noninferiority for the composite primary end point. (PROACT Clinicaltrials.gov number, NCT00291525).

WITHDRAWN: Low-Dose Versus Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Controlled Trial.

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Scholarship, teaching practice and educational responsibility: Issues in designing and implementing a quality improvement and evidence-based practice module in the undergraduate curriculum.

As part of a review of the undergraduate medical curriculum at King's College London, a module preparing students to undertake a quality improvement project (QIP) was developed. Using an illuminative evaluation method, the successes and challenges of the module were identified. The student experience lay along a continuum. At one end, QIPs enabled some significant improvements within trusts and primary care. Projects were presented in their clinical settings and at national and international conferences, and were published. At the other end of the continuum, students struggled to find an actionable project or have early and regular communication with their supervisors. Poor implementation of the module created challenges. These included misunderstanding of module requirements by students and supervisors, lack of clarity about what a feasible undergraduate project comprised and logistical problems when students moved from their QIP site to their next rotation. Travel back to the QIP site to complete projects involved missing scheduled teaching in their current rotation. Supervisors were unsure how to assess group projects. Key successes included students feeling better prepared to undertake QIPs, students developing a better understanding of the dynamics of clinical settings and teams, and how to manage these to progress projects.

United Kingdom British association for sexual health and HIV national guideline for the management of epididymo-orchitis, 2020.

The British Association for Sexual Health and HIV (BASHH) UK guideline for the management of epididymo-orchitis has been updated in 2020. It offers advice on diagnostic tests, treatment and health promotion principles in the effective management of epididymo-orchitis. Empirical treatment should be started in patients with objective swelling and tenderness on testicular examination. First-line empirical treatment for sexually acquired epididymo-orchitis has changed to ceftriaxone 1g intramuscularly and doxycycline. Higher dose of ceftriaxone in line with the BASHH 2018 gonorrhoea guideline ensures effective treatment of strains with reduced susceptibility. Ofloxacin or doxycycline is recommended in patients with epididymo-orchitis probably due to non-gonococcal organisms (e.g. negative microscopy for gram-negative intracellular diplococci or no risk factors for gonorrhoea identified). Where Mycoplasma genitalium is tested and identified, treatment should include an appropriate antibiotic (e.g. moxifloxacin). If enteric pathogens are a likely cause (e.g. older patient, not sexually active, recent instrumentation, men who practice insertive anal intercourse, men with known abnormalities of the urinary tract or a positive urine dipstick for leucocytes and nitrites), ofloxacin and levofloxacin are recommended. A clinical care pathway has been produced to simplify the management of epididymo-orchitis. A patient information leaflet has been developed.

Improving the quality of clinical coding and payments through student doctor-coder collaboration in a tertiary haematology department.

Hospitals within the UK are paid for services provided by 'Payment-by-Results'. In a system that rewards productivity, effective collaboration between coders and clinicians is crucial. However, clinical coding is frequently error prone and has been shown to impact negatively on departmental revenue. Our aim was to increase the median number of diagnostic codes per sickle cell inpatient admission at Guy's Hospital by 3. Three interventions were implemented using the Plan, Do, Study, Act structure. This consisted of student doctors searching for diagnoses along with comorbidities that clinical coders had missed, distributing laminated cards with common clinical codes and implementing discharge pro formas. Through auditing, student doctors generated a total of £58 813 over 16 weeks. We observed an increase in the median number of codes by ≥2 additional codes. We improved coding accuracy where we identified errors in an average of 32.5% of admissions each month, improving the quality of patient documentation. We have demonstrated student doctor involvement in clinical coding as a potentially sustainable means of achieving accurate payment for services provided; increasing departmental revenue. We are the first to report the efficacy of student-coder collaboration in improving the accuracy of clinical coding.

Implementing undergraduate quality improvement.

BACKGROUND: All clinicians need to have knowledge and expertise to undertake quality improvement (QI). In 2016, a London medical school initiated a core QI and evidence-based practice module for fourth-year students. We describe the structure and content of the module and analyse QI projects (QIPs) and student feedback. METHODS: We collected data on QIPs, including number and location, adherence to QI methodology and level of improvement achieved. We also examined end-of-module feedback with free text analysis of the written comments. RESULTS: A total of 398 students completed 99 QIPs: 90% were based in secondary care and 10% were based in primary care. A total of 72 projects (72%) led to improvements in clinical care, with 14% achieving their stated aim. Adherence to methodology was high: 75% had a 'SMART (specific, measurable, achievable, realistic and timely)' aim; 96% implemented at least one plan-do-study-act (PDSA) cycle (range 1-4), and appropriate run charts for measures occurred in 80% of projects. QIPs were categorised based on their outcome: self-help and self-care, 12%; efficiency, 16%; prevention and early detection, 14%; drug safety, 11%; improvement to pathways and protocols, 44%; and improving patient experience 3%. The implementation challenges encountered were: suboptimal supervisor preparedness; student time limitations; and difficulties with the virtual learning platform. However, the experiences that QIPs offered in preparation for postgraduate training were appreciated by students. CONCLUSIONS: We have demonstrated that students are able to robustly apply QI methodologies, equipping them to act as agents for change, learning as they do, and meaningfully improving QI capacity and capability in local health systems.

Identifying Pathways Mediating Obstructive Sleep Apnea and Obesity in Indian Children.

OBJECTIVE: Overweight and obesity in children is associated with several metabolic and cardiovascular impairments, including obstructive sleep apnea (OSA). However, the causal pathway from OSA to obesity is not fully known yet. The aim of this study was to explore the association between OSA and obesity-related metabolic outcomes in obese Indian children. METHODS: An observational, cross-sectional study was conducted. Obese children referred to the Otorhinolaryngology Department at the Maulana Azad Medical College (New Delhi, India) for suspicion of OSA were consecutively enrolled. OSA was diagnosed by polysomnographic parameters. Homeostasis model assessment (HOMA) was calculated to measure insulin sensitivity and HOMA > 4.39 was considered as a threshold for insulin resistance. The association between various polysomnographic measures and HOMA, adiponectin and various urinary catecholamines was assessed. RESULTS: Complete polysomnographic parameters were available for 45 children; of these 29 were found to suffer from OSA. OSA children had significantly higher glucose concentrations compared to non-OSA ones (p value = 0.012) but no differences were found in insulin resistance and urinary catecholamines levels. Older age was significantly associated to lower levels of catecholamines. No significant associations were found between polysomnographic parameters and both HOMA and adiponectin. Only age was found to be significantly associated with HOMA (p = 0.03) and adiponectin (p = 0.01). CONCLUSIONS: A better understanding of the role played by OSA on obese children's metabolic functions is crucial to implement specific prevention strategies to reduce the public health burden of non-communicable diseases.

Detection of immunoglobulin M and immunoglobulin G antibodies to Mycoplasma pneumoniae in children with community-acquired lower respiratory tract infections.

CONTEXT: Mycoplasma pneumoniae (M. pneumoniae) causes up to 40% of community-acquired pneumonia in children. It is impossible to identify M. pneumoniae infection on the basis of clinical signs, symptoms, and radiological features. Therefore, correct etiological diagnosis strongly depends on laboratory diagnosis. AIMS: This study aims to investigate the role of M. pneumonia e in pediatric lower respiratory tract infections (LRTIs) employing enzyme-linked immunosorbent assays (ELISA) and particle agglutination (PA) test. SETTINGS AND DESIGN: Two hundred and eighty children, age 6 months to 12 years with community-acquired LRTIs were investigated for M. pneumoniae etiology. MATERIALS AND METHODS: We investigated 280 children hospitalized for community-acquired LRTIs, using ELISA and PA test for detecting M. pneumoniae immunoglobulin M (IgM) and immunoglobulin G antibodies. STATISTICAL ANALYSIS USED: The difference of proportion between the qualitative variables was tested using the Chi-square test and Fischer exact test. P ≤ 0.05 was considered as statistically significant. Kappa value was used to assess agreement between ELISA and PA test. RESULTS: M. pneumoniae was positive in 51 (23.2%) <5 years and 33 (54.0%) children in ≥5 years of age group, and this difference was statistically significant (P < 0.001). Clinical and radiological findings in M. pneumoniae positive and negative groups were comparable. ELISA detected M. pneumoniae in 78 (27.8%) and PA test 39 (13.9%) patients; 33 (84.6%) ELISA positive and 6 (15.4%) ELISA negative. ELISA/PA test together detected M. pneumoniae infection in 84 (30%) children. CONCLUSIONS: Our data underline that M. pneumoniae plays an important role in children with community-acquired LRTIs and more particularly in children >5 years of age.

Rapid detection of respiratory syncytial virus in community-acquired lower respiratory tract infections in children by chromatographic assay.

Respiratory syncytial virus (RSV) is the single most important viral agent causing pediatric lower respiratory tract infections (LRTIs) worldwide. To evaluate the role of RSV in pediatric LRTIs, we studied 85 children <2 years of age hospitalized for community-acquired LRTIs. Nasopharyngeal aspirates were obtained on admission for the detection of RSV antigen by immunochromatographic assay. Demographic, clinical, and radiological findings for RSV antigen were compared. Data analysis was performed by Chi-square test. A relatively higher number of RSV-infected children 32 (60.4%) were below 6 months of age. Clinical and radiological findings in both RSV-positive and RSV-negative groups were comparable. RSV antigen was positive in 53 (62.4%) with immunochromatography. Our study confirms that RSV plays a significant role in community-acquired LRTIs in children.

Higher specialty training in genitourinary medicine: A curriculum competencies-based approach.

Specialty trainees in genitourinary medicine (GUM) are required to attain competencies described in the GUM higher specialty training curriculum by the end of their training, but learning opportunities available may conflict with service delivery needs. In response to poor feedback on trainee satisfaction surveys, a four-year modular training programme was developed to achieve a curriculum competencies-based approach to training. We evaluated the clinical opportunities of the new programme to determine: (1) Whether opportunity cost of training to service delivery is justifiable; (2) Which competencies are inadequately addressed by direct clinical opportunities alone and (3) Trainee satisfaction. Local faculty and trainees assessed the 'usefulness' of the new modular programme to meet each curriculum competence. The annual General Medical Council (GMC) national training survey assessed trainee satisfaction. The clinical opportunities provided by the modular training programme were sufficiently useful for attaining many competencies. Trainee satisfaction as captured by the GMC survey improved from two reds pre- to nine greens post-intervention on a background of rising clinical activity in the department. The curriculum competencies-based approach to training offers an objective way to balance training with service provision and led to an improvement in GMC survey satisfaction.

Mycoplasma pneumoniae in Community-Acquired Lower Respiratory Tract Infections.

OBJECTIVE: To determine the role of Mycoplasma pneumoniae (M. pneumoniae) in pediatric lower respiratory tract infections (LRTIs) employing serological tests and polymerase chain reaction (PCR) analysis. METHODS: In this prospective study, 200 children aged 6 mo to 12 y hospitalized with acute LRTIs were investigated for M. pneumoniae. Serum samples were collected for serological analysis of M. pneumoniae. Throat swab samples were obtained on admission to amplify 277-base pair region of 16S rDNA gene of M. pneumoniae by PCR. RESULTS: In the present study, 40(26.1%) children <5 y and 28(59.5%) children ≥5 y age group were positive for M. pneumoniae infection and this difference was statistically significant (P < 0.001). M. pneumoniae was positive in 32(41%) female and 36(29.5%) male children though this difference was statistically insignificant (P = 0.12). The clinical profile across M. pneumoniae positive and negative cases were comparable except for presence of chest pain which was statistically significant (P = 0.023). None of the radiological findings was statistically associated with incidence of M. pneumoniae infection. Serological evidence of acute M. pneumoniae infection was observed in 64(32%) patients with sensitivity 66.6% and specificity 70.1% while PCR positivity in 12(6%) patients with sensitivity 12.5% and specificity 97%. Together, serology and PCR detected M.pneumoniae infection in 68(34%) patients. CONCLUSIONS: The present study underlines the role of M. pneumoniae in children with community- acquired LRTIs and more particularly in ≥5 y of age.

Mantoux test revisited: Variability in reading tuberculin test in pediatric population.

INTRODUCTION: Mantoux test aids in the diagnosis of tuberculosis (TB), however its application and interpretation are dependent on multiple factors. METHODOLOGY: A prospective study enrolling 400 children (aged 2-12) suspected to have tuberculosis. All participants received Mantoux test with two different strengths (1 TU and 5 TU) of Purified Protein Derivative (PPD) on different forearms. The test was read by two readers after 48 ± 2 and 72 ± 2 hours. Primary outcome was difference in the size of induration when read by two readers (interobserver variability). Secondary outcomes were difference in the size of induration at different intervals, with different strengths of PPD and percentage positivity of Mantoux test in TB patients. RESULTS: Statistically significant difference was seen in the size of induration when read by two different readers, with fair to moderate agreement when read at 48 and 72 hours (1 TU: p = 0.002, k = 0.52 and p = 0.1, k = 0.73 respectively, 5 TU: p = 0.001, k = 0.39 and p = 0.0009, k = 0.33 respectively). Tendency of under-reading occurred when size of induration was close to significant level (10-14 mm). Size of induration was similar when read at 48 or 72 hours (1 TU: p = 0.9, 5 TU: p = 1.0). Mantoux positivity rate in patients with TB was more with 5 TU as compared to 1 TU (61.2% vs. 16.3%). CONCLUSIONS: There is significant interobserver variability with a tendency to under-read around the cutoff point. The use of 5 TU PPD at 48 hours by a trained physician can aid in early and more reliable diagnosis of TB.

Application of serology and nested polymerase chain reaction for identifying Chlamydophila pneumoniae in community-acquired lower respiratory tract infections in children.

CONTEXT: Chlamydophila pneumoniae is a common cause of community-acquired respiratory infections, including pneumonia, bronchitis, and upper respiratory tract infections. Since it is difficult to detect C. pneumoniae in clinical practice, specific etiological diagnosis is established only in a minority of cases. AIMS: To investigate the role of C. pneumoniae in community-acquired lower respiratory tract infections (LRTIs) in children, with the use of serological tests and nested polymerase chain reaction (PCR) analysis. SETTINGS AND DESIGN: One hundred children, age of 2 months to 12 years, hospitalized for community-acquired LRTIs were investigated for C. pneumoniae etiology. MATERIALS AND METHODS: We investigated 100 children hospitalized for community-acquired LRTIs, using enzyme-linked immunosorbent assay for detecting anti-C. pneumoniae immunoglobulin M, and immunoglobulin G antibodies and nasopharyngeal aspirates for analysis of C. pneumoniae PCR. The demographic, clinical, and radiological findings for C. pneumoniae antibody positive and C. pneumoniae antibody negative cases were compared. STATISTICAL ANALYSIS USED: Data analysis was performed by Chi-square test and Fisher's exact tests using Epi Info (2002). RESULTS: Clinical and radiological findings in both the groups were comparable. A relatively higher rate of C. pneumoniae infection in children was observed below 5 years of age. Serological evidence of C. pneumoniae infection was observed in 12 (12%) patients and nested PCR was positive in 5 (5%) children. Thirteen (13%) patients were diagnosed with C. pneumoniae infection by serology and/or nested PCR. CONCLUSIONS: Our study confirms that C. pneumoniae plays a significant role in community-acquired LRTIs in children of all ages, even in children aged <5 years.

Acute kidney injury in a child: A case of Munchausen syndrome by proxy.

Renal and urologic problems in pediatric condition falsification (PCF) or Munchausen by proxy (MSP) can result in serious diagnostic dilemma. Symptoms of hematuria, pyuria and recurrent urinary tract infections have occasionally been described. However, MSP presenting as azotemia has not been previously reported. We describe the case of an unfortunate boy who had to undergo unnecessary hemodialysis for persistent hyperkalemia and azotemia before a final diagnosis of the falsification of investigations by the parents was made.

Piloting Upfront Xpert MTB/RIF Testing on Various Specimens under Programmatic Conditions for Diagnosis of TB & DR-TB in Paediatric Population.

BACKGROUND: India accounts for one-fifth of the global TB incidence. While the exact burden of childhood TB is not known, TB remains one of the leading causes of childhood mortality in India. Bacteriological confirmation of TB in children is challenging due to difficulty in obtaining quality specimens, in the absence of which diagnosis is largely based on clinical judgement. While testing multiple specimens can potentially contribute to higher proportion of laboratory confirmed paediatric TB cases, lack of high sensitivity tests adds to the diagnostic challenge. We describe here our experiences in piloting upfront Xpert MTB/RIF testing, for diagnosis of TB in paediatric population in respiratory and extra pulmonary specimens, as recently recommended by WHO. METHOD: Xpert MTB/RIF testing was offered to all paediatric (0-14 years) presumptive TB cases (both pulmonary and extra-pulmonary) seeking care at public and private health facilities in the project areas covering 4 cities of India. RESULTS: Under this pilot project, 8,370 paediatric presumptive TB & presumptive DR-TB cases were tested between April and-November 2014. Overall, 9,149 specimens were tested, of which 4,445 (48.6%) were non-sputum specimens. Xpert MTB/RIF gave 9,083 (99.2%, CI 99.0-99.4) valid results. Of the 8,143 presumptive TB cases enrolled, 517 (6.3%, CI 5.8-6.9) were bacteriologically confirmed. TB detection rates were two fold higher with Xpert MTB/RIF as compared to smear microscopy. Further, a total of 60 rifampicin resistant TB cases were detected, of which 38 were detected among 512 presumptive TB cases while 22 were detected amongst 227 presumptive DR-TB cases tested under the project. CONCLUSION: Xpert MTB/RIF with advantages of quick turnaround testing-time, high proportion of interpretable results and feasibility of rapid rollout, substantially improved the diagnosis of bacteriologically confirmed TB in children, while simultaneously detecting rifampicin resistance.

Barriers and facilitators to development of standard treatment guidelines in India.

This paper describes 15 years' experience of the development process of the first set of comprehensive standard treatment guidelines (STGs) for India and their adoption or adaptation by various state governments. The aim is to shorten the learning curve for those embarking on a similar exercise, given the key role of high-quality STGs that are accepted by the clinical community in furthering universal health coverage. The main overall obstacles to STG development are: (i) weak understanding of the concept; (ii) lack of time, enthusiasm and availability of local expertise; and (iii) managing consensus between specialists and generalists. Major concerns to prescribers are: encroachment on professional autonomy, loss of treating the patient as an individual and applying the same standards at all levels of health care. Processes to address these challenges are described. At the policy level, major threats to successful completion and focused implementation are: frequent changes in governance, shifts in priorities and discontinuity. In the authors' experience, compared with each state developing their own STGs afresh, adaptation of pre-existing valid guidelines after an active adaptation process involving local clinical leaders is not only simpler and quicker but also establishes local ownership and facilitates acceptance of a quality document. Executive orders and in-service sensitization programmes to introduce STGs further enhance their adoption in clinical practice.

Multi-detector computed tomography imaging of large airway pathology: A pictorial review.

The tracheobronchial tree is a musculo-cartilagenous framework which acts as a conduit to aerate the lungs and consequently the entire body. A large spectrum of pathological conditions can involve the trachea and bronchial airways. These may be congenital anomalies, infections, post-intubation airway injuries, foreign body aspiration or neoplasms involving the airway. Appropriate management of airway disease requires an early and accurate diagnosis. In this pictorial essay review, we will comprehensively describe the various airway pathologies and their imaging findings by multi-detector computed tomography.