Proton pump inhibitor utilisation and potentially inappropriate prescribing analysis: insights from a single-centred retrospective study

alkiviadis.1961 shared this article with you from Inoreader Proton pump inhibitor utilisation and potentially inappropriate prescribing analysis: insights from a single-centred retrospective study Via BMJ Open Current Issue Objectives This study aimed to characterise the prescribing patterns and evaluate the appropriateness of the prescribed proton pump inhibitors (PPIs) in adult patients via a review of electronic medical records in a single-centred hospital. Design All patients admitted to the outpatient department of Jinshan Hospital, Fudan University, Shanghai, between 1 January 2018 and 31 December 2018 were evaluated. Individuals aged 18 years or above and with at least one dispensing for PPIs were identified as PPI users. New PPI users were defined as a subject who did not receive any dispensing for PPIs in the year prior to the index date. Baseline characteristics of PPI users and their therapies were described by treatment indication, economic indicators and co-prescription, overall and separately. Setting The prescription database was retrieved from the hospital information system of Jinshan Hospital, Fudan University. Results Among 18 435 identified PPI users in 2018, 14 219 patients (aged 18 years or above) who had at least one dispensing PPIs were new users (77%), and among them, men accounted for 47%. The mean treatment duration was 23 days. Omeprazole was the most commonly prescribed drug. PPIs are inappropriately prescribed in 50% (13 589/25 850) of prescriptions. Prescription appropriateness analysis indicated that the unapproved indications for PPI new users accounted for 47%; among them, the proportion of gastritis diagnosis was 34%. The proportion of PPI new users with co-prescription of glucocorticosteroids (GCs) who have risk factors accounted for 24% and lower than other co-prescription. A majority of PPI users (73%) reported high-dose PPI prescription. The defined daily dose of oral pantoprazole was the highest, and injectable omeprazole had the highest defined daily cost. In contrast, only the drug utilisation index value of oral esomeprazole was less than 1.0. Conclusion The results indicate the challenge of PPI use was accompanied by unapproved indications, frequent inappropriate co-prescription with GCs and excessive dosages. Efforts should be paid to promote rational use and ensure the choice of suitable PPI therapy in the future. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Assessing the safety and pharmacokinetics of the anti-HIV monoclonal antibody CAP256V2LS alone and in combination with VRC07-523LS and PGT121 in South African women: study protocol for the first-in-human CAPRISA 012B phase I clinical trial

alkiviadis.1961 shared this article with you from Inoreader Assessing the safety and pharmacokinetics of the anti-HIV monoclonal antibody CAP256V2LS alone and in combination with VRC07-523LS and PGT121 in South African women: study protocol for the first-in-human CAPRISA 012B phase I clinical trial Via BMJ Open Current Issue Introduction New HIV prevention strategies are urgently required. The discovery of broadly neutralising antibodies (bNAbs) has provided the opportunity to evaluate passive immunisation as a potential prevention strategy and facilitate vaccine development. Since 2014, several bNAbs have been isolated from a clade C-infected South African donor, CAPRISA 256. One particular bNAb, CAP256-VRC26.25, was found to be extremely potent, with good coverage against clade C viruses, the dominant HIV clade in sub-Saharan Africa. Challenge studies in non-human primates demonstrated that this antibody was fully protective even at extremely low doses. This bNAb was subsequently structurally engineered and the clinical variant is now referred to as CAP256V2LS. Methods and analysis CAPRISA 012B is the second of three trials in the CAPRISA 012 bNAb trial programme. It is a first-in-human, phase I study to assess the safety and pharmacokinetics of CAP256V2LS. The study is divided into four groups. Group 1 is a dose escalation of CAP256V2LS administered intravenously to HIV-negative and HIV-positive women. Group 2 is a dose escalation of CAP256V2LS administered subcutaneously (SC), with and without the dispersing agent recombinant human hyaluronidase (rHuPH20) as single or repeat doses in HIV-negative women. Groups 3 and 4 are randomised placebo controlled to assess two (CAP256V2LS+VRC07-523LS; CAP256V2LS+PGT121) and three (CAP256V2LS+VRC07-523LS+PGT121) bNAb combinations administered SC to HIV-negative women. Safety will be assessed by the frequency of reactogenicity and adverse events related to the study product. Pharmacokinetic disposition of CAP256V2LS alone and in combination with VRC07-523LS and PGT121 will be assessed via dose subgroups and route of adm inistration. Ethics and dissemination The University of KwaZulu-Natal Biomedical Research Ethics Committee (BREC) and the South African Health Products Regulatory Authority (SAHPRA) have granted regulatory approval (trial reference numbers: BREC00000857/2019 and SAHPRA 20200123). Trial results will be disseminated through conference presentations, peer-reviewed publications and the clinical trial registry. Trial registration number PACTR202003767867253; Pre-results. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Longitudinal cohort study of the impact of specialist cancer services for teenagers and young adults on quality of life: outcomes from the BRIGHTLIGHT study

alkiviadis.1961 shared this article with you from Inoreader Longitudinal cohort study of the impact of specialist cancer services for teenagers and young adults on quality of life: outcomes from the BRIGHTLIGHT study Via BMJ Open Current Issue Objectives In England, healthcare policy advocates specialised age-appropriate services for teenagers and young adults (TYA), those aged 13 to 24 years at diagnosis. Specialist Principal Treatment Centres (PTC) provide enhanced TYA age-specific care, although many still receive care in adult or children's cancer services. We present the first prospective structured analysis of quality of life (QOL) associated with the amount of care received in a TYA-PTC Design Longitudinal cohort study. Setting Hospitals delivering inpatient cancer care in England. Participants 1114 young people aged 13 to 24 years newly diagnosed with cancer. Intervention Exposure to the TYA-PTC defined as patients receiving NO-TYA-PTC care with those receiving ALL-TYA-PTC and SOME-TYA-PTC care. Primary outcome Quality of life measured at five time points: 6, 12, 18, 24 and 36 months after diagnosis. Results Group mean total QOL improved over time for all patients, but for those receiving NO-TYA-PTC was an average of 5.63 points higher (95% CI 2.77 to 8.49) than in young people receiving SOME-TYA-PTC care, and 4·17 points higher (95% CI 1.07 to 7.28) compared with ALL-TYA-PTC care. Differences were greatest 6 months after diagnosis, reduced over time and did not meet the 8-point level that is proposed to be clinically significant. Young people receiving NO-TYA-PTC care were more likely to have been offered a choice of place of care, be older, from more deprived areas, in work and have less severe disease. However, analyses adjusting for confounding factors did not explain the differences between TYA groups. Conclusions Receipt of some or all care in a TYA-PTC was associated with lower QOL shortly after cancer diagnosis. The NO-TYA-PTC group had higher QOL 3 years after diagnosis, however those receiving all or some care in a TYA-PTC experienced more rapid QOL improvements. Receipt of some care in a TYA-PTC requires further study. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Individualised physical exercise training and enhanced protein intake in older citizens during municipality-based rehabilitation: protocol for a randomised controlled trial

alkiviadis.1961 shared this article with you from Inoreader Individualised physical exercise training and enhanced protein intake in older citizens during municipality-based rehabilitation: protocol for a randomised controlled trial Via BMJ Open Current Issue Introduction Successful rehabilitation of the growing number of older citizens receiving healthcare services can lead to preservation of functional independence and improvement in quality of life. Adequate intake of dietary protein and physical training are key factors in counteracting the age-related decline in strength performance and physical function. However, during rehabilitation, many older people/persons have insufficient protein intake, and difficulties in performing exercise training with sufficient intensity and volume. The primary aim of this trial is to investigate if individualised physical exercise training programmes combined with increased protein intake (IPET+P) can improve measures on all International Classification of Functioning, Disability and Health levels, such as strength, gait speed and health-related quality of life, when compared with care as usual in municipality-based rehabilitation alone (usual care, UC) or care as usual in combination with increased protein int ake (UC+P). Further, the trial investigates whether UC+P will potentiate more significant improvements in outcome measures than UC. Methods and analysis The trial is a three-armed multicentre, block-randomised controlled trial consisting of a 12-week intervention period with a 1-year follow-up. Citizens above 65 years referred to rehabilitation in the municipality without restricting comorbidities are eligible. Participants are randomised to either a UC group, a UC group with protein supplementation receiving 27.5 g protein/day (UC+P), or an IPET+P supplementation of 27.5 g protein/day. The Short Musculoskeletal Function Assessment questionnaire is the primary outcome. Ethics and dissemination Approvals from The Ethics Committee in Region Zealand, Denmark (SJ-758), and the General Data Protection Regulation at the University of Southern Denmark, Odense (10.330) have been obtained. Trial registration number NCT04091308 View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Prompt closure versus gradual weaning of external ventricular drainage for hydrocephalus in adult patients with aneurysmal subarachnoid haemorrhage: a systematic review

alkiviadis.1961 shared this article with you from Inoreader Prompt closure versus gradual weaning of external ventricular drainage for hydrocephalus in adult patients with aneurysmal subarachnoid haemorrhage: a systematic review Via BMJ Open Current Issue Objectives To summarise the evidence on benefits and harms of prompt closure versus gradual weaning of external ventricular drainage (EVD) in patients with hydrocephalus following aneurysmal subarachnoid haemorrhage (aSAH) based on randomised clinical trials (RCTs) in humans. Setting RCTs comparing prompt closure versus gradual weaning of EVD in adult patients with hydrocephalus following aSAH were included. Participants Patients aged equal to or greater than 18 years with an EVD due to hydrocephalus following aSAH were eligible for inclusion. Primary and secondary outcome measures Primary outcomes were all-cause mortality, any serious adverse event, rate of ventriculoperitoneal (VP) shunt placement and quality of life. Secondary outcomes were patients with shunt failure, hospital and neuro intensive care unit (NICU) length of stay (LOS) and complications related to treatment with an EVD. Data permitted report of rate of VP shunt placement, and hospital and NICU LOS. Results Six studies were assessed in full text. One RCT with 81 patients was included. Rate of VP shunt placement was 63.4% in the rapid weaning group (ie, prompt closure of the EVD; 41 patients) and 62.5% in the gradual weaning group (40 patients; p=0.932). LOS in hospital and NICU was significantly shorter in the rapidly weaned group compared with the gradually weaned group (mean 19.1 vs 21.5 days in hospital (p=0.03); and mean 14.1 vs 16.9 days in NICU (p=0.0002)). Data were insufficient to conduct meta-analysis, trial sequential analysis or subgroup analysis of heterogeneity and sensitivity. One RCT is currently ongoing. Conclusions We found insufficient evidence to favour any of the two strategies for EVD discontinuation in patients with hydrocephalus following aSAH. PROSPERO registration number CRD42018108801. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Nurse-led, screening-triggered, early specialised palliative care intervention programme for patients with advanced lung cancer: study protocol for a multicentre randomised controlled trial

alkiviadis.1961 shared this article with you from Inoreader Nurse-led, screening-triggered, early specialised palliative care intervention programme for patients with advanced lung cancer: study protocol for a multicentre randomised controlled trial Via BMJ Open Current Issue Introduction It has been suggested that palliative care integrated into standard cancer treatment from the early phase of the disease can improve the quality of life of patients with cancer. In this paper, we present the protocol for a multicentre randomised controlled trial to examine the effectiveness of a nurse-led, screening-triggered, early specialised palliative care intervention programme for patients with advanced lung cancer. Methods and analysis A total of 206 patients will be randomised (1:1) to the intervention group or the control group (usual care). The intervention, triggered with a brief self-administered screening tool, comprises comprehensive need assessments, counselling and service coordination by advanced-level nurses. The primary outcome is the Trial Outcome Index of the Functional Assessment of Cancer Therapy (FACT) at 12 weeks. The secondary outcomes include participants' quality of life (FACT-Lung), depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder-7), illness perception (Prognosis and Treatment Perceptions Questionnaire), medical service use and survival. A mixed-method approach is expected to provide an insight about how this intervention works. Ethics and dissemination This study has been approved by the Institutional Review Board of the National Cancer Center Japan (approval number: 2016-235). The findings will be disseminated through peer-reviewed publications and conference presentations and will be reflected on to the national healthcare policy. Trial registration number UMIN000025491. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Clinical and economic impact of intensive care unit-acquired bloodstream infections

alkiviadis.1961 shared this article with you from Inoreader Clinical and economic impact of intensive care unit-acquired bloodstream infections in Taiwan: a nationwide population-based retrospective cohort study Via BMJ Open Current Issue Objectives To estimate the clinical and economic impact of intensive care unit-acquired bloodstream infections in Taiwan. Design Retrospective cohort study. Setting Nationwide Taiwanese population in the National Health Insurance Research Database and the Taiwan Nosocomial Infections Surveillance (2007–2015) dataset. Participants The first episodes of intensive care unit-acquired bloodstream infections in patients ≥20 years of age in the datasets. Propensity score-matching (1:2) of demographic data, comorbidities and disease severity was performed to select a comparison cohort from a pool of intensive care unit patients without intensive care unit-acquired infections from the same datasets. Primary and secondary outcome measures The mortality rate, length of hospitalisation and healthcare cost. Results After matching, the in-hospital mortality of 14 234 patients with intensive care unit-acquired bloodstream infections was 44.23%, compared with 33.48% for 28 468 intensive care unit patients without infections. The 14-day mortality rate was also higher in the bloodstream infections cohort (4323, 30.37% vs 6766 deaths, 23.77%, respectively; p<0.001). Furthermore, the patients with intensive care unit-acquired bloodstream infections had a prolonged length of hospitalisation after their index date (18 days (IQR 7–39) vs 10 days (IQR 4–21), respectively; p<0.001) and a higher healthcare cost (US$16 038 (IQR 9667–25 946) vs US$10 372 (IQR 6289–16 932), respectively; p<0.001). The excessive hospital stay and healthcare cost per case were 12.69 days and US$7669, respectively. Similar results were observed in subgroup analyses of various WHO's priority pathogens and Candida spp. Conclusions Intensive care unit-acquired bloodstream infections in critically ill patients were associated with increased mortality, longer hospital stays and higher healthcare costs. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Is long-bout sedentary behaviour associated with long-term glucose levels 3 months after acute ischaemic stroke? A prospective observational cohort study

alkiviadis.1961 shared this article with you from Inoreader Is long-bout sedentary behaviour associated with long-term glucose levels 3 months after acute ischaemic stroke? A prospective observational cohort study Via BMJ Open Current Issue Background and purpose Sedentary behaviour is a risk factor for vascular disease and stroke patients are more sedentary than their age-matched peers. The association with glucose levels, as a potential mediator, is unclear, and we have investigated the association between long-bout sedentary behaviour and long-term glucose levels in stroke survivors. Methods This study uses data from the Norwegian Cognitive Impairment After Stroke study, a multicentre cohort study. The patients were recruited at hospital admission for acute stroke, and the follow-up was done at the outpatient clinic. Sedentary behaviour—being in a sitting or reclining position—was registered 3 months after stroke using position transition data from the body-worn sensor activPAL attached to the unaffected thigh. A MATLAB script was developed to extract activity data from 08:00 to 10:00 for 4 days and to categorise the data into four bout-length categories. The primary outcome was glycated haemoglobin (HbA1c), analysed at 3 months. Regression models were used to analyse the association between HbA1c and sedentary behaviour in the whole population and stratified based on a diagnosis of diabetes mellitus (DM). Age, body mass index and the use of antidiabetic drugs were added as covariates into the models. Results From a total of 815 included patients, 379 patients fulfilled the inclusion criteria for this study. We found no association between time in sedentary behaviour and HbA1c in the whole stroke population. We found time in sedentary behaviour in bouts of ≥90 min to be associated with a higher HbA1c in patients with DM. Conclusion Long-bout sedentary time is associated with a higher HbA1c in patients with DM 3 months after ischaemic stroke. Future research should investigate the benefit of breaking up sedentary time as a secondary preventive measure. Trial registration number NCT02650531, https://clinicaltrials.gov/ct2/show/NCT02650531 View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Impact of the zero-mark-up drug policy on drug-related expenditures and use in public hospitals, 2016-2018: an interrupted time series study in Shaanxi

alkiviadis.1961 shared this article with you from Inoreader Impact of the zero-mark-up drug policy on drug-related expenditures and use in public hospitals, 2016-2018: an interrupted time series study in Shaanxi Via BMJ Open Current Issue Objective The aim of this study was to measure the impact of zero-mark-up drug policy (ZMDP) on drug-related expenditures and use in urban hospitals. Design This was a retrospective observational study of trends in drug expenses and use in the context of the ZMDP using an interrupted time series analysis. Setting Twelve hospitals (three tertiary hospitals and nine secondary hospitals) in Xi'an, which is the capital of Shaanxi Province in Western China. Data and participants The prescription information for all outpatients and inpatients in the study hospitals from January 2016 to April 2018 was used in this study. Interventions The Chinese government announced the policy intervention measure of the ZMDP, which was implemented in all public hospitals as of 1 April 2017. Primary measures Monthly drug expenditures, monthly medical expenditures, the percentage of drug expenditures among total medical expenditures, the average outpatient drug expenditure per visit, the percentage of prescriptions that include an injection and the percentage of prescriptions that include an antibiotic. Results Monthly total medical expenses increased in both tertiary and secondary hospitals after the ZMDP was implemented. In tertiary hospitals, the average outpatient drug expenditures per visit showed a slow decreasing trend before the intervention and an increasing trend after the intervention, with statistically significant changes in both the level (p<0.001) and the trend (p=0.02). Secondary hospitals showed a slow increasing trend both before and after the policy implementation, with no significant change in the trend (p=0.205). The proportion of prescriptions, including injections, was over 20% in secondary hospitals and less than 20% in tertiary hospitals, with no significant changes to this indicator observed after implementation of ZMDP. Conclusions The effect of the ZMDP on drug-related expenditures and use in Chinese public hospitals was not substantially evident. Future pharmaceutical reform measures should give more consideration to physician prescription behaviours. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Laryngopharyngeal reflux

alkiviadis.1961 shared this article with you from Inoreader Laryngopharyngeal reflux in war-torn Syria and its association with smoking and other risks: an online cross-sectional population study Via BMJ Open Current Issue Objectives To demonstrate the burden of laryngopharyngeal reflux (LPR) in Syria and its associated variables. Design This is a cross-sectional study that used online questionnaires that included demographics, smoking, war-related questions and reflux symptom index (RSI). Setting This research was conducted online across Syria and included the general population. Participants Participants who lived in Syria, agreed to participate, and responded to all the RSI questions were included. This research comprised 734 participants, with 94.6% response rate, 75.5% being females, and a mean age of 24 years. Results Overall, 31.9% of subjects had symptoms suggestive of LPR. Participants who were 30 years and younger had fewer symptoms suggestive of LPR compared with the older group p=0.012 (OR 0.534; 95% CI 0.325 to 0.877). While having an epigastric burning sensation, chest pain and indigestion were the most common symptoms, having a sore throat was the least common. Being distressed from war noises was associated with more symptoms p=0.009 (OR 1.562; 95% CI 1.117 to 2.183). However, losing someone or changing place of living due to war were not significantly associated with these symptoms p>0.05. RSI scores were associated with cigarette and/or shisha smoking p<0.05. Finally, asthma, allergic disorders and having a job were associated with having LPR symptoms p<0.05. No significant findings were observed in consanguinity, marital status, educational level and socioeconomic status. Conclusions War, smoking, asthma, allergies, respiratory conditions and having a job were associated with LPR symptoms. However, they may be associated with these symptoms independently from LPR; for instance, similar symptoms can be caused by the mental disorders from war, the unique environment and irritant substances of the laryngeal mucosa. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Cáncer de Hürthle

alkiviadis.1961 shared this article with you from Inoreader Cáncer de Hürthle Via Cuida tu tiroides Los tumores de Células de Hürthle están compuestos de células oncocíticas y generalmente son lesiones encapsuladas. Para demostrar que nos encontramos ante un Carcinoma de Células de Hürthle es necesario mostrar que existe invasión de la cápsula y/o invasión vascular. Si esto no se demuestra nos encontraríamos ante un adenoma de Células Hürthle y por tanto ante una lesión benigna. El Carcinoma de Células de Hürthle se ha reclasificado recientemente (WHO 2017) como un tumor diferente del Carcinoma Folicular de Tiroides. Debido a múltiples cambios en su clasificación las ultimas décadas los estudios publicados hasta la fecha en términos de pronóstico y supervivencia muestran discrepancias por lo que los datos referidos a este tumor no son consistentes. Epidemiología: Los estudios publicados hasta la fecha referentes a este tumor muestran que son tumores más frecuentes en el hombre y con una tendencia a aparecer en etapas más tardías de la vida comparado con otros tumores del tiroides como el carcinoma papilar. Una de las series más amplias y con mayor seguimiento a largo plazo publicadas sobre CCH muestra que en el momento del diagnóstico la media de edad es de 57 años, suelen ser tumores de gran tamaño y con un estadio tumoral al diagnóstico avanzado. La supervivencia es menor que en otros tumores como el carcinoma folicular y el pupilar de tiroides  Etiología: En la actualidad se desconoce qué factores exógenos predisponen al desarrollo de este cáncer. Presentación Clínica La presentación clínica habitual es como incidentaloma o nódulo tiroideo solitario o en seno de un bocio multinodular. El diagnóstico es generalmente citológico y precisa la diferenciación del tumor folicular (adenoma o carcinoma). Pronóstico y supervivencia: Al igual que el carcinoma folicular se considera que este tumor presenta peor pronóstico a mayor grado de invasión vascular.  Las mayores tasas de mortalidad se muestran en los tumores ampliamente invasivos con una extensa invasión vascular  Las opciones de tratamiento en estos tumores son más limitadas que en el carcinoma folicular y en el carcinoma papilar por ser en ocasiones yodo resistentes.   La entrada Cáncer de Hürthle se publicó primero en Cuida tu tiroides. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.