BMJ Open

Shimoni, Zvi; Cohen, Regev; Avdiaev, Ruslan; Froom, Paul

doi: 10.1136/bmjopen-2016-013696pmid: 27986743

PurposeTo determine the consequences of treating febrile geriatric patients with a suspected urinary tract infection (UTI) with antibiotics that have high resistance rates due primarily to extended-spectrum β-lactamase (ESBL) producing bacteria.MethodsIn this cohort study, we selected 257 consecutive hospitalised patients aged ≥70 years with a chief symptom of fever, possibly due to a UTI and initially treated with antibiotics with rates in our hospital of urinary culture resistance >20%. Patients with severe sepsis were excluded. The main outcomes measures were in vitro bacterial resistance to initial antibiotic therapy (BRIAT), response to therapy, hospitalisation days and mortality.ResultsUrine cultures were positive in 64.2% (165 of 257) of the patients and BRIAT occurred in 28.0% (72 of 257). Response rates were 100% (93 of 93) in those with bacteria sensitive to initial antibiotic therapy, 95.7% (88 of 92) in the culture negative patients, and 66.7% (48 of 72) in those with BRIAT (p<0.001). There were no deaths due to deterioration during the initial treatment period because of BRIAT. In the patients with BRIAT, the median length of hospitalisation was 3 days longer than that in the other patients (7 and 4 days, respectively, p<0.001).ConclusionsWe conclude that initial broad spectrum antibiotic treatment could potentially lower the median length of hospitalisation by 3 days in many hospitalised geriatric patients without an extra-urinary tract source for their fever. This benefit needs to be balanced against the risk to the individual patient and to the general public of increasing bacterial resistance rates to broader spectrum antibiotics often held in reserve.

Hagiwara, Akiyoshi; Tanaka, Noriko; Uemura, Tatsuki; Matsuda, Wataru; Kimura, Akio

doi: 10.1136/bmjopen-2016-012850pmid: 28039291

ObjectiveTo determine whether treatment with recombinant human thrombomodulin (rhTM) increases survival among patients with severe septic-induced disseminated intravascular coagulation (DIC).DesignSingle-centre, open-label, randomised controlled trial.SettingSingle tertiary hospital.Participant92 patients with severe septic-induced DIC.InterventionsPatients with DIC scores ≥4, as defined by the Japanese Association of Acute Medicine, were diagnosed with DIC. The envelope method was used for randomisation. The treatment group (rhTM group, n=47) was intravenously treated with rhTM within 24 hours of admission (day 0), and the control group (n=45) did not receive any anticoagulants, except in cases of deep venous thrombosis and pulmonary embolism.Primary and secondary measurementsData were collected on days 0 (admission), 1, 2, 3, 5, 7 and 10. The primary outcome was survival at 28 and 90 days. The secondary end points comprised changes in DIC scores, platelet counts, d-dimer, antithrombin III and C reactive protein levels, and Sequential Organ Failure Assessment (SOFA) scores. All analyses were conducted on an intent-to-treat basis.Main resultsThe 28-day survival rates were 84% and 83% in the control and rhTM groups, respectively (p=0.745, log-rank test). The 90-day survival rates were 73% and 72% in the control and rhTM groups, respectively (p=0.94, log-rank test). Meanwhile, the rates of recovery from DIC (<4) were significantly higher in the rhTM group than in the control group (p=0.001, log-rank test). Relative change from baseline of d-dimer levels was significantly lower in the rhTM group than in the control group, on days 3 and 5.ConclusionsrhTM treatment decreased d-dimer levels and facilitated DIC recovery in patients with severe septic-induced DIC. However, the treatment did not improve survival in this cohort.Trial registration numberUMIN000008339.

Vuik, Sabine I; Mayer, Erik; Darzi, Ara

doi: 10.1136/bmjopen-2016-012903pmid: 27993905

ObjectiveTo show how segmentation can enhance risk stratification tools for integrated care, by providing insight into different care usage patterns within the high-risk population.DesignA retrospective cohort study. A risk score was calculated for each person using a logistic regression, which was then used to select the top 5% high-risk individuals. This population was segmented based on the usage of different care settings using a k-means cluster analysis. Data from 2008 to 2011 were used to create the risk score and segments, while 2012 data were used to understand the predictive abilities of the models.Setting and participantsData were collected from administrative data sets covering primary and secondary care for a random sample of 300 000 English patients.Main measuresThe high-risk population was segmented based on their usage of 4 different care settings: emergency acute care, elective acute care, outpatient care and GP care.ResultsWhile the risk strata predicted care usage at a high level, within the high-risk population, usage varied significantly. 4 different groups of high-risk patients could be identified. These 4 segments had distinct usage patterns across care settings, reflecting different levels and types of care needs. The 2008–2011 usage patterns of the 4 segments were consistent with the 2012 patterns.DiscussionCluster analyses revealed that the high-risk population is not homogeneous, as there exist 4 groups of patients with different needs across the care continuum. Since the patterns were predictive of future care use, they can be used to develop integrated care programmes tailored to these different groups.ConclusionsUsage-based segmentation augments risk stratification by identifying patient groups with different care needs, around which integrated care programmes can be designed.

Kerckhove, Nicolas; Mallet, Christophe; Pereira, Bruno; Chenaf, Chouki; Duale, Christian; Dubray, Claude; Eschalier, Alain

doi: 10.1136/bmjopen-2016-013530pmid: 27986742

IntroductionCurrently available analgesics are ineffective in 30–50% of patients suffering from neuropathic pain and often induce deleterious side effects. T-type calcium channel blockers (mibefradil, ethosuximide, NNC 55-0396) are of great interest for the development of new symptomatic treatments of neuropathic pain, due to their various effects on pain perception. Interestingly, ethosuximide, which has already been approved for treating epilepsy, is available on the European market for clinical use. Despite numerous preclinical data demonstrating an antinociceptive effect of ethosuximide in various animal models of neuropathic pain, no clinical studies have been published to date on the analgesic efficacy of ethosuximide in patients with neuropathic pain.Methods and analysisThe Ethosuximide in the Treatment of non-Diabetic Peripheral Neuropathic Pain (EDONOT) trial is a randomised, parallel, controlled, double-blinded, multicentre clinical study. It is the first clinical trial to evaluate the efficacy and safety of ethosuximide in the treatment of non-diabetic peripheral neuropathic pain. Adult patients exhibiting peripheral neuropathic pain (Numeric Rating Scale (NRS) ≥4 and Douleur Neuropathique 4 (DN4)≥4) for at least 3 months and under stable analgesic treatment for at least 1 month will be included. Patients (n=220) will be randomly assigned to receive either ethosuximide or control treatment for 6 weeks following a 1 week run-in period. The primary end point is the intensity of neuropathic pain, assessed by NRS (0–10) before and after 6 weeks of treatment. The secondary end points are safety (adverse events are collected during the study: daily by the patient on the logbook and during planned phone calls by investigators), the intensity and features of neuropathic pain (assessed by Brief Pain Inventory (BPI) and Neuropathic Pain Symptom Inventory (NPSI) questionnaires) and health-related quality of life (assessed by Medical Outcome Study Short Form 12 (MOS SF-12) and Leeds questionnaires).Ethics and communicationThe study was approved by an independent ethics committee (CPP Sud-Est VI, France, IRB00008526) and registered by the French competent authority (Agence nationale de sécurité du médicament (ANSM)).Trial registration numberNCT02100046, Recruiting.

Kwon, David Soonil; Kim, Kyuwoong; Park, Sang Min

doi: 10.1136/bmjopen-2016-012618pmid: 28031209

ObjectiveThe annual outbreak of influenza is one of the major causes of morbidity and mortality among the elderly population around the world. While there is an annual vaccine available to prevent or reduce the incidence of disease, not all older people in Korea choose to be vaccinated. There have been few previous studies to examine the factors influencing influenza vaccination in Korea. Thus, this study identifies nationwide factors that affect influenza vaccination rates in elderly Koreans.MethodsWe obtained data from the Fourth Korean National Health and Nutrition Examination Survey 2007–2009 (KNHANES IV), a nationwide health survey in Korea. To assess influenza vaccination status, we analysed answers to a single question from the survey. From the respondents, we selected 3567 elderly population aged 65 years or older, to analyse the effects of variables including sociodemographic, health behavioural risk, health status and psychological factors on vaccination coverage. We identified factors that affect vaccination status using a multiple logistic regression analysis.ResultsThe rate of influenza vaccination in this elderly population was 75.8%. Overall, the most significant determinants for choosing influenza vaccination were a recent history of health screening (adjusted OR (aOR) 2.26, 95% CI 1.92 to 2.66) and smoking (aOR 0.78, 95% CI 0.62 to 0.98). Other contributing factors were age, household income, marital status, alcohol consumption, physical activity level, self-reported health status and a limitation in daily activities. In contrast, psychological factors, including self-perceived quality of life, stress and depressive mood, did not show close association with vaccination coverage.ConclusionsTo boost influenza vaccination rates in the elderly, an influenza campaign should focus on under-represented groups, especially smokers. Additionally, promoting routine health screening for the elderly may be an efficient way to help achieve higher vaccination rates. Our results highlight the need for a new strategy for the vaccination campaign.

Harding, Seeromanie; Silva, Maria João; Molaodi, Oarabile R; Enayat, Zinat E; Cassidy, Aidan; Karamanos, Alexis; Read, Ursula M; Cruickshank, J Kennedy

doi: 10.1136/bmjopen-2016-013221pmid: 27979836

ObjectiveTo examine influences of adiposity from early adolescence to early 20s on cardiovascular disease (CVD) risk in the multiethnic Determinants of young Adult Social well-being and Health (DASH) longitudinal study.MethodsIn 2002–2003, 6643 11–13-year-olds from 51 London schools participated at baseline, and 4785 were seen again at 14–16 years. Recently, 665 (97% of invited) participated in pilot follow-up at 21–23 years, with biological and psychosocial measures and blood biomarkers (only at 21–23 years). Regression models examined interplay between ethnicity, adiposity and CVD.ResultsAt 21–23 years, ∼30–40% were overweight. About half of the sample had completed a degree with little ethnic variation despite more socioeconomic disadvantage in adolescence among ethnic minorities. Regardless of ethnicity, overweight increased more steeply between 14–16 years and 21–23 years than between 11–13 years and 14–16 years. More overweight among Black Caribbean and Black African females, lower systolic blood pressure (sBP) among Indian females and Pakistani/Bangladeshi males compared with White UK peers, persisted from 11–13 years. At 21–23 years, glycated haemoglobin (HbA1c) was higher among Black Caribbean females, total cholesterol higher and high-density lipoprotein (HDL) cholesterol lower among Pakistani/Bangladeshis. Overweight was associated with a ∼+2 mm Hg rise in sBP between 11–13 years and 21–23 years. Adiposity measures at 11–13 years were related to allostatic load (a cluster of several risk markers), HbA1c and HDL cholesterol at 21–23 years. Ethnic patterns in CVD biomarkers remained after adjustments.ConclusionsAdolescent adiposity posed significant risks at 21–23 years, a period in the lifespan generally ignored in cardiovascular studies, when ethnic/gender variations in CVD are already apparent.

Räsänen, Tiina; Lintonen, Tomi; Tolvanen, Asko; Konu, Anne

doi: 10.1136/bmjopen-2016-012468pmid: 28007707

BackgroundDuring the adolescent period, risk-taking behaviour increases. These behaviours can compromise the successful transition from adolescence to adulthood. The purpose of this study was to examine social support as a mediator of the relation between problem behaviour and gambling frequency among Finnish adolescents.MethodsData were obtained from the national School Health Promotion Study (SHPS) from the years 2010 and 2011 (N=102 545). Adolescents were classified in the most homogeneous groups based on their problem behaviour via latent class analysis.ResultsPath analysis indicated that social support was negatively associated with problem behaviour, and problem behaviour and social support were negatively related (except for social support from friends among boys) to gambling. Social support from parents and school mediated, albeit weakly, the relations between problem behaviour and gambling among girls and boys.ConclusionsProblem behaviour may affect gambling through social support from school and parents. Thus prevention and intervention strategies should focus on strengthening adolescents' social support. In addition, because of the clustering of different problem behaviours instead of concentrating on a single form of problem behaviour multiple-behaviour interventions may have a much greater impact on public health.

Barasinski, Chloé; Vendittelli, Françoise

doi: 10.1136/bmjopen-2016-012290pmid: 27998899

IntroductionThe scientific data currently available do not allow any definitive conclusion to be reached about what type of pushing should be recommended to women during the second stage of labour. The objective of this trial is to assess and compare the effectiveness of directed open-glottis pushing versus directed closed-glottis pushing. Secondary objectives are to assess, according to the type of pushing: immediate maternal and neonatal morbidity, intermediate-term maternal pelvic floor morbidity, uncomplicated birth, and women's satisfaction at 4 weeks post partum.Methods and analysisThis multicentre randomised clinical trial compares directed closed-glottis pushing (Valsalva) versus directed open-glottis pushing during the second stage of labour in 4 hospitals of France. The study population includes pregnant women who received instruction in both types of pushing, have no previous caesarean delivery, are at term and have a vaginal delivery planned. Randomisation takes place during labour once cervical dilation ≥7 cm. The principal end point is assessed by a composite criterion: spontaneous delivery without perineal lesion (no episiotomy or spontaneous second-degree, third-degree or fourth-degree lacerations). We will need to recruit 125 women per group. The primary analysis will be by intention-to-treat analysis, with the principal results reported as crude relative risks (RRs) with their 95% CIs. A multivariate analysis will be performed to take prognostic and confounding factors into account to obtain adjusted RRs.Ethics and disseminationThis study was approved by a French Institutional Review Board (Comité de Protection des Personnes Sud Est 6:N°AU1168). Results will be reported in peer-reviewed journals and at scientific meetings. This study will make it possible to assess the effectiveness of 2 types of directed pushing used in French practice and to assess their potential maternal, fetal and neonatal effects. Findings from the study will be useful for counselling pregnant women before and during labour.Trial registration numberAgence national de sécurité du médicament et des produits de santé (ANSM): 150099B-22 and IDRCB: 2014-A01920-47. ClinicalTrials.gov: NCT02474745. Pre-result stage.

doi: 10.1136/bmjopen-2015-010756corr1pmid: 27974374

Palser, Sally C; Rayner, Oliver C; Leighton, Paul A; Smyth, Alan R

doi: 10.1136/bmjopen-2016-012303pmid: 28031208

BackgroundPeople with cystic fibrosis (CF) are susceptible to respiratory infection with Pseudomonas aeruginosa (PA), which may become chronic if initial eradication fails. Environmental acquisition and person-to-person transmission can occur. Respiratory PA infection is associated with increased mortality and more hospitalisations. This may cause patients and families anxiety and lead them to adopt preventive measures which may be ineffectual and intrusive. It is not possible to hold a conventional focus group to explore these issues because people with CF cannot meet together due to the risk of cross-infection.ObjectiveTo explore the perceptions of first respiratory infection with PA in people with CF and those close to them.DesignWe designed an online survey, to maximise accessibility and avoid the risk of cross-infection. This established the respondent's relationship with CF, asked 3 open questions about perceptions of PA and a final question about the prioritisation of research. Responses were analysed using a structured, iterative process. We identified keywords, analysed these incontext and derived key themes.SettingPromotion through social media allowed respondents from any country to participate.ParticipantsPeople with CF and those close to them.ResultsResponses were received from 393 people, including 266 parents and 97 people with CF. The key themes were the emotional burden of PA (fear in particular); the burden of treatment PA entails and the need for accurate knowledge about PA.ConclusionsLack of knowledge and the health beliefs of individuals may promote fear of infection and inappropriate avoidance measures. Uncertainty about the implications of PA infection and the treatment required may cause anxiety. Healthcare professionals should provide clear information about how PA might be acquired and the treatment necessary, making clear the limitations of current understanding and acknowledging health beliefs.