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Data from: Adjunctive clindamycin for cellulitis: clinical trial comparing flucloxacillin with or without clindamycin for the treatment of limb cellulitis
Objective: To compare flucloxacillin with clindamycin to flucloxacillin alone for the treatment of limb cellulitis. Design: Parallel, double-blinded, randomised controlled trial. Setting: Emergency department attendances and general practice referrals within 20 hospitals in England. Interventions: Flucloxacillin, at a minimum of 500 mg 4 times per day for 5 days, with clindamycin 300 mg 4 times per day for 2 days given orally versus flucloxacillin given alone. Main outcome measures: The primary outcome was improvement at day 5. This was defined as being afebrile with either a reduction in affected skin surface temperature or a reduction in the circumference of the affected area. Secondary outcomes included resolution of systemic features, resolution of inflammatory markers, recovery of renal function, reduction in the affected area, decrease in pain, return to work or normal activities and the absence of increased side effects. Results: 410 patients were included in the trial. No significant difference was seen in improvement at day 5 for flucloxacillin with clindamycin (136/156, 87%) versus flucloxacillin alone (140/172, 81%)—OR 1.55 (95% CI 0.81 to 3.01), p=0.174. There was a significant difference in the number of patients with diarrhoea at day 5 in the flucloxacillin with clindamycin allocation (34/160, 22%) versus flucloxacillin alone (16/176, 9%)—OR 2.7 (95% CI 1.41 to 5.07), p=0.002. There was no clinically significant difference in any secondary outcome measures. There was no significant difference in the number of patients stating that they had returned to normal activities at the day 30 interview in the flucloxacillin with clindamycin allocation (99/121, 82%) versus flucloxacillin alone (104/129, 81%)—adjusted OR 0.90 (95% CI 0.44 to 1.84). Conclusions: The addition of a short course of clindamycin to flucloxacillin early on in limb cellulitis does not improve outcome. The addition of clindamycin doubles the likelihood of diarrhoea within the first few days.
Data from: Salivary gland ultrasonography as a predictor of clinical activity in Sjögren's syndrome
Purpose: Primary Sjögren's syndrome is a multisystem autoimmune disease characterized by hypofunction of salivary and lacrimal glands and possible multi-organ system manifestations. Over the past 15 years, three sets of diagnostic criteria have been proposed, but none has included salivary gland ultrasonography. However, recent studies support its role in the diagnosis and prognostic evaluation of patients with Sjögren's syndrome. This study aimed to determine the value of salivary gland ultrasonography in the diagnosis and prognosis of Sjögren's syndrome by relating ultrasonography severity scores to clinical and laboratory data. Methods: Seventy patients who fulfilled the 2002 American-European Consensus Group diagnostic criteria for primary Sjögren's syndrome were selected from 84 patients receiving care in specialized outpatient clinics at our institution from November 2013 to May 2016. Their serology, European League Against Rheumatism Sjögren's syndrome disease activity index (ESSDAI), salivary flow rate, immunoglobulin G, and salivary and serum beta-2 microglobulin levels were measured. Salivary gland ultrasonography was performed by an experienced radiologist, using scores of 1-4 to classify salivary gland impairment. Results: Salivary gland ultrasonography scores of 1 or 2 were associated with an ESSDAI < 5. Ultrasonography scores of 3 or 4 were associated with an ESSDAI ≥ 5 (p=0.064), a positive antinuclear antibody test (p=0.006), positive anti-Ro/SSA antibodies (p=0.003), positive anti-La/SSB antibodies (p=0.077), positive rheumatoid factor (p=0.034), and immunoglobulin G levels > 1600 mg/dL (p=0.077). Salivary flow rate was lower in patients with scores 3 or 4 (p=0.001). Conclusion: This study provides further evidence that salivary gland ultrasonography can be used not only for diagnosis but also for prognostic evaluation of primary Sjögren's syndrome. These findings confirm what has been reported in the literature. However, further analyses involving larger matched samples are required to support this finding and include salivary gland ultrasonography as part of the diagnostic criteria for Sjögren's syndrome.
Data from: A critical appraisal of clinical trials conducted and subsequent drug approvals in India and South Africa
Objectives: To assess the relation between the number of clinical trials conducted and respective new drug approvals in India and South Africa. Design: Construction and analysis of a comprehensive database of completed randomised controlled clinical trials based on clinicaltrials.gov from 1 January 2005 to 31 December 2010 and drug approval data from 2006 until 2013 for India and South Africa. Setting: USA, the EU, India and South Africa. Main outcome measures: Percentage of completed randomised clinical trials for an Investigational Medicinal Product (IMP) leading to new drug approval in India and South Africa. Results: A total of 622 eligible randomised controlled trials were identified as per search criteria for India and South Africa. Clustering them for the same sponsor and the same Investigational New Drug (IND) resulted in 453 eligible trials, that is, 224 for India and 229 for South Africa. The distribution of the market application approvals between the EU/USA as well as India and South Africa revealed that out of clinical trials with the participation of test centres in India and/or South Africa, 39.6% (India) clinical trials and 60.1% (South Africa) clinical trials led to market authorisation in the EU/USA without a New Drug Application (NDA) approval in India or South Africa. Conclusions: Despite an increase in clinical trial activities, there is a clear gap between the number of trials conducted and market availability of these new drugs in India and South Africa. Drug regulatory authorities, investigators, institutional review boards and patient groups should direct their efforts to ensuring availability of new drugs in the market that have been tested and researched on their population.
Data from: Quantifying patient preferences for symptomatic breast clinic referral: a decision analysis study
Objectives: Decision analysis study that incorporates patient preferences and probability estimates to investigate the impact of women's preferences for referral or an alternative strategy of watchful waiting if faced with symptoms that could be due to breast cancer. Setting: Community-based study. Participants: Asymptomatic women aged 30-60 years. Interventions: Participants were presented with 11 health scenarios that represent the possible consequences of symptomatic breast problems. Participants were asked the risk of death that they were willing to take in order to avoid the health scenario using the standard gamble (SG) utility method. This process was repeated for all 11 health scenarios. Formal decision analysis for the preferred individual decision was then estimated for each participant. Primary outcome measure: The preferred diagnostic strategy, either watchful waiting or referral to a breast clinic. Sensitivity analysis was used to examine how each varied according to changes in the probabilities of the health scenarios. Results: A total of 35 participants completed the interviews, with median age 41 years (Interquartile range 35 to 47 years). The majority of the study sample were employed (n=32, 91.4%), with a third-level (university) education (n=32, 91.4%) and with knowledge of someone with breast cancer (n=30, 85.7%). When individual preferences were accounted for, 25 (71.4%) patients preferred watchful waiting to referral for triple assessment as their preferred initial diagnostic strategy. Sensitivity analysis shows that referral for triple assessment becomes the dominant strategy at the upper probability estimate (18%) of breast cancer in the community. Conclusions: Watchful waiting is an acceptable strategy for most women who present to their GP with breast symptoms. These findings suggest that current referral guidelines should take more explicit account of women's preferences in relation in terms of the initial diagnostic strategy for symptomatic breast problems.
Data from: Outcome of breast cancer in Moroccan young women correlated to clinic-pathological features, risk factors and treatment: a comparative study of 716 cases in a single institution
Background: Breast cancer in young women is quite uncommon and shows more aggressive characteristics with major disparities between worldwide populations. Prognosis and outcome of breast cancer in young patients are widely studied, but still no consensus is available. Methods: We retrospectively included 716 cases of breast cancer women diagnosed in 2009 at the National Institute of Oncology of Rabat. Patients were divided into two groups according to their age: women aged ≤40 years (Group 1) and women aged >40 years (Group 2). Data were recorded from patients' medical files and analyzed using SPSS 13.0 software (IBM). Results: Young patients represent 24.9% of all patients with breast cancer. The comparison between the two groups displayed significant differences regarding nulliparity (p = 0.001) and progesterone receptor negativity (p = 0.01). Moreover, more progression (Metastases/Relapse) was registered in young women as compared to older women with breast cancer (p = 0.03). The estimated median follow-up period was 31 months. The 5-years Event-Free Survival (EFS) of patients with local disease was 64.6% in young women and 71.5% in older women with breast cancer (p = 0.04). Multivariate analysis in young women showed that nulliparity (HR: 7.2; 95%CI: 1.16–44.54; p = 0.03), T3 tumors (HR: 17.39; 95%CI: 1.74–173.34; p = 0.01) and negative PgR status (HR: 19.85; 95%CI: 1.07–366.54; p = 0.04) can be considered as risk factors for poorer event free survival while hormone therapy was associated with better EFS (HR: 0.11; 95%CI: 0.00–0.75; p = 0.03). In Group 2, multivariate analysis showed that patients with inflammatory breast cancer, N+ status, absence of radiotherapy, absence of chemotherapy, and absence of hormone therapy are at increased risk of recurrence. Conclusions: In Morocco, breast cancer is more frequent in young women as compared to western countries. Breast cancer in young women is more aggressive and is diagnosed late, leading to an intensive treatment. Moreover, the main factors associated with breast cancer development in young women would be hormonal and reproductive status. Analysis of other genetic biomarkers is needed to explain the high prevalence of breast cancer in young women to improve breast cancer management in Morocco
Data from: Identification of biomarkers for Barcelona Clinic Liver Cancer staging and overall survival of patients with hepatocellular carcinoma
The aim of the current study was to identify biomarkers that correlate with the Barcelona Clinic Liver Cancer (BCLC) staging system and prognosis of patients with hepatocellular carcinoma (HCC). We downloaded 4 gene expression datasets from the Gene Expression Omnibus database (http://www.ncbi.nlm.nih.gov/geo), and screened for genes that were differentially expressed between HCC and normal liver tissues, using significance analysis of the microarray algorithm. We used a weighted gene co-expression network analysis (WGCNA) to identify hub genes that correlate with BCLC staging, functional enrichment analysis to associate hub genes with their functions, protein-protein interaction network analysis to identify interactions among hub genes, UALCAN analysis to assess gene expression levels based on tumour stage, and survival analyses to clarify the effects of hub genes on patients' overall survival (OS). We identified 50 relevant hub genes using WGCNA; among them, 13 genes (including TIGD5, C8ORF33, NUDCD1, INSB8, and STIP1) correlated with OS and BCLC staging. Significantly enriched gene ontology biological process terms included RNA processing, non-coding RNA processing and phosphodiester bond hydrolysis, and 6 genes were found to interact with 10 or more hub genes. We identified several candidate biomarkers that correlate with BCLC staging and OS of HCC. These genes might be used for prognostic assessment and selection of HCC patients for surgery, especially those with intermediate or advanced disease.
Data from: A single session of hyperbaric oxygen therapy demonstrates acute and long-lasting neuroplasticity effects in humans: a replicated, randomized controlled clinical trial
Purpose: Animal studies have demonstrated anti-inflammatory, and anti-nociceptive properties of hyperbaric oxygen therapy (HBOT). However, physiological data are scarce in humans. In a recent experimental study, the authors used the burn injury (BI) model observing a decrease in secondary hyperalgesia area (SHA) in the HBOT-group compared to a control-group.Surprisingly, a long-lasting neuroplasticity effect mitigating the BI-induced SHA-response was seen in the HBOT-preconditioned group. The objective of the present study, therefore, was to confirm our previous findings using an examiner-blinded, block-randomized, controlled, crossover study design. Patients and methods: Nineteen healthy subjects attended two BI-sessions with an inter-session interval of ≥28 days. The BIs were induced on the lower legs by a contact thermode (12.5 cm2, 47C°, 420 s). The subjects were block-randomized to receive HBOT (2.4 ATA, 100% O2, 90 min) or ambient conditions ([AC]; 1 ATA, 21% O2), dividing cohorts equally into two sequence allocations: HBOT-AC or AC-HBOT. All sensory assessments performed during baseline, BI, and post-intervention phases were at homologous time points irrespective of sequence allocation. The primary outcome was SHA, comparing interventions and sequence allocations. Data are mean (95% CI). Results: During HBOT-sessions a mitigating effect on SHAs was demonstrated compared to AC-sessions, ie, 18.8 (10.5–27.0) cm2 vs 32.0 (20.1–43.9) cm2 (P=0.021), respectively. In subjects allocated to the sequence AC-HBOT a significantly larger mean difference in SHA in the AC-session vs the HBOT-session was seen 25.0 (5.4–44.7) cm2 (P=0.019). In subjects allocated to the reverse sequence, HBOT-AC, no difference in SHA between sessions was observed (P=0.55), confirming a preconditioning, long-lasting (≥28 days) effect of HBOT. Conclusion: Our data demonstrate that a single HBOT-session compared to control is associated with both acute and long-lasting mitigating effects on BI-induced SHA, confirming central anti-inflammatory, neuroplasticity effects of hyperbaric oxygen therapy.
Data from: A clinical decision support system learned from data to personalize treatment recommendations towards preventing breast cancer metastasis
Objective: A Clinical Decision Support System (CDSS) that can amass Electronic Health Record (EHR) and other patient data holds promise to provide accurate classification and guide treatment choices. Our objective is to develop the Decision Support System for Making Personalized Assessments and Recommendations Concerning Breast Cancer Patients (DPAC), which is a CDSS learned from data that recommends the optimal treatment decisions based on a patient's features. Method: We developed a Bayesian network architecture called Causal Modeling with Internal Layers (CAMIL), and an algorithm called Treatment Feature Interactions (TFI), which learns from data the interactions needed in a CAMIL model. Using the TFI algorithm, we learned interactions for six treatments from the Lynn Sage Data Set (LSDS). We created a CAMIL model using these interactions, resulting in a DPAC which recommends treatments towards preventing 5-year breast cancer metastasis. Results: In a 5-fold cross-validation analysis, we compared the probability of being metastasis free in 5 years for patients who made decisions recommended by DPAC to those who did not. These probabilities are (the probability for those making the decisions appears first): chemotherapy (.938, .872); breast/chest wall radiation (.939, .902); nodal field radiation (.940, .784); antihormone (.941, .906); HER2 inhibitors (.934, .880); neadjuvant therapy (.931, .837). In an application of DPAC to the independent METABRIC dataset, the probabilities for chemotherapy were (.845, .788). Discussion: Patients who took the advice of DPAC had, as a group, notably better outcomes than those who did not. We conclude that DPAC is effective at amassing and analyzing data towards treatment recommendations. Some of the findings in DPAC are controversial. For example, DPAC says that chemotherapy increases the chances of metastasis for many node negative patients. This controversy shows the importance of developing a conclusive version of DPAC to ensure we provide patients with the best patient-specific treatment recommendations.
Data from: Sharing of clinical trial data and results reporting practices among large pharmaceutical companies: cross sectional descriptive study and pilot of a tool to improve company practices
Objectives: To develop and pilot a tool to measure and improve pharmaceutical companies' clinical trial data sharing policies and practices. Design: Cross sectional descriptive analysis. Setting: Large pharmaceutical companies with novel drugs approved by the US Food and Drug Administration in 2015. Data sources: Data sharing measures were adapted from 10 prominent data sharing guidelines from expert bodies and refined through a multi-stakeholder deliberative process engaging patients, industry, academics, regulators, and others. Data sharing practices and policies were assessed using data from ClinicalTrials.gov, Drugs@FDA, corporate websites, data sharing platforms and registries (eg, the Yale Open Data Access (YODA) Project and Clinical Study Data Request (CSDR)), and personal communication with drug companies. Main outcome measures: Company level, multicomponent measure of accessibility of participant level clinical trial data (eg, analysis ready dataset and metadata); drug and trial level measures of registration, results reporting, and publication; company level overall transparency rankings; and feasibility of the measures and ranking tool to improve company data sharing policies and practices. Results: Only 25% of large pharmaceutical companies fully met the data sharing measure. The median company data sharing score was 63% (interquartile range 58-85%). Given feedback and a chance to improve their policies to meet this measure, three companies made amendments, raising the percentage of companies in full compliance to 33% and the median company data sharing score to 80% (73-100%). The most common reasons companies did not initially satisfy the data sharing measure were failure to share data by the specified deadline (75%) and failure to report the number and outcome of their data requests. Across new drug applications, a median of 100% (interquartile range 91-100%) of trials in patients were registered, 65% (36-96%) reported results, 45% (30-84%) were published, and 95% (69-100%) were publicly available in some form by six months after FDA drug approval. When examining results on the drug level, less than half (42%) of reviewed drugs had results for all their new drug applications trials in patients publicly available in some form by six months after FDA approval. Conclusions: It was feasible to develop a tool to measure data sharing policies and practices among large companies and have an impact in improving company practices. Among large companies, 25% made participant level trial data accessible to external investigators for new drug approvals in accordance with the current study's measures; this proportion improved to 33% after applying the ranking tool. Other measures of trial transparency were higher. Some companies, however, have substantial room for improvement on transparency and data sharing of clinical trials.
Data from: Antibody responses to Plasmodium vivax Duffy binding and erythrocyte binding proteins predict risk of infection and are associated with protection from clinical malaria
Background. The Plasmodium vivax Duffy Binding Protein (PvDBP) is a key target of naturally acquired immunity. However, the functional receptor-binding region II of PvDBP (PvDBPII) is highly polymorphic. The natural acquisition of antibodies to different variants of PvDBPII, including AH, O, P and Sal1 alleles, the central region III-V, and P. vivax Erythrocyte Binding Protein region II (PvEBPII) and their associations with risk of clinical P. vivax malaria are not well understood. Methodology. Total IgG and IgG subclasses 1, 2, and 3 that recognize four alleles of PvDBPII (AH, O, P, and Sal1), PvDBPIII-V and region II of PvEBP (PvEBPII) were measured in samples collected from a cohort of Papua New Guinean (PNG) children of aged 1-3 years living in a highly endemic area of PNG. The levels of binding inhibitory antibodies (BIAbs) to PvDBPII (AH, O, and Sal1) were also tested in a subset of children. The association of presence of IgG with age, cumulative exposure (measured as the product of age and malaria infections during follow-up, i.e. molFOB) and prospective risk of clinical malaria were evaluated. Results. Increase in antigen-specific total IgG, IgG1, and IgG3 with age and cumulative exposure was only observed for PvDBPII AH and PvEBPII. High total IgG responders and IgG3 specific responses to the predominant PvDBPII AH allele, were associated with decreased incidence of clinical P. vivax episodes (aIRR=0.56-0.68, P=<0.001-0.021 ). High total IgG and IgG1 to PvEBPII correlated more strongly with protection against clinical vivax malaria compared with those of all PvDBPII variants (aIRR=0.38, P<0.001). Antibodies to PvDBPII AH and PvEBPII showed evidence of an additive effect, with a joint protective association of 70%. The six children with high levels of Binding Inhibitory Antibodies (BIAbs) to PvDBPII and high strain-transcending blocking ability (i.e. >80%) tended to have less clinical diseases (IRR=0.45, P=0.083). Conclusion. Antibodies to the key parasite invasion ligands PvDBPII and PvEBPII are good correlates of protection against P. vivax malaria in PNG. This further strengthens the rationale for inclusion of PvDBPII in a recombinant subunit vaccine for P. vivax malaria and highlights the need for further functional studies to determine the potential of PvEBPII as a component of a subunit vaccine for P. vivax malaria.
Data from: Intrauterine insemination: a UK survey on the adherence to NICE clinical guidelines by fertility clinics
Objective: To evaluate the awareness and response of fertility clinics in the UK to the National Institute for Health and Care Excellence (NICE) guideline recommendation that intrauterine insemination (IUI) should not be offered routinely, in order to report on current practice in the UK. Design: Online questionnaire survey of fertility clinics in the UK regarding their current clinical practice of IUI, formal discussion of the guideline recommendations, and any alterations made since the recommendations. Setting: 66 UK fertility clinics licensed to provide IUI. Participant:s 46 fertility clinics, including 6 clinic groups which represent 70% of all clinics and clinic groups licensed to provide IUI in April 2014 when the survey email was sent. Results: Of the 46 clinics that responded, 96% (44/46) of clinics continue to offer IUI. 98% (43/44) of those offering IUI also use ovarian stimulation. The most commonly used medications for ovarian stimulation are gonadotrophins (95%), followed by clomiphene citrate (49%) and letrozole (19%). 78% (36/46) of clinics had formally discussed NICE guideline recommendations. 17 clinics (37%) had made some changes to their practices; as a result, four clinics reported a reduction in the number of IUI cycles, six clinics had restricted the indications for IUI, and five clinics had begun informing patients of the guideline recommendations, while two did not specify. Conclusions: The majority of clinics were aware of the guideline recommendations. However, only a small proportion of clinics had made significant changes to their practice by reducing the number of IUI cycles or restricting the clinical indications for IUI. The availability of further evidence will assist NICE and clinicians in making recommendations on the use of IUI. There is a need to further explore the reasons for the lack of adherence to the recommendations.
Data from: Cluster analysis successfully identifies clinically meaningful knee valgus moment patterns: frequency of early peaks reflects sex-specific ACL injury incidence
Background: Biomechanical studies of ACL injury risk factors frequently analyze only a fraction of the relevant data, and typically not in accordance with the injury mechanism. Extracting a peak value within a time series of relevance to ACL injuries is challenging due to differences in the relative timing and size of the peak value of interest. Aims/hypotheses: The aim was to cluster analyze the knee valgus moment time series curve shape in the early stance phase. We hypothesized that 1a) There would be few discrete curve shapes, 1b) there would be a shape reflecting an early peak of the knee valgus moment, 2a) youth athletes of both sexes would show similar frequencies of early peaks, 2b) adolescent girls would have greater early peak frequencies. Methods: N = 213 (39% boys) youth soccer and team handball athletes (phase 1) and N = 35 (45% boys) with 5 year follow-up data (phase 2) were recorded performing a change of direction task with 3D motion analysis and a force plate. The time series of the first 30% of stance phase were cluster analyzed based on Euclidean distances in two steps; shape-based main clusters with a transformed time series, and magnitude based sub-clusters with body weight normalized time series. Group differences (sex, phase) in curve shape frequencies, and shape-magnitude frequencies were tested with chi-squared tests. Results: Six discrete shape-clusters and 14 magnitude based sub-clusters were formed. Phase 1 boys had greater frequency of early peaks than phase 1 girls (38% vs 25% respectively, P < 0.001 for full test). Phase 2 girls had greater frequency of early peaks than phase 2 boys (42% vs 21% respectively, P < 0.001 for full test). Conclusions: Cluster analysis can reveal different patterns of curve shapes in biomechanical data, which likely reflect different movement strategies. The early peak shape is relatable to the ACL injury mechanism as the timing of its peak moment is consistent with the timing of injury. Greater frequency of early peaks demonstrated by Phase 2 girls is consistent with their higher risk of ACL injury in sports.
Data from: Agreements between industry and academia on publication rights: a retrospective study of protocols and publications of randomized clinical trials
Background: Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i) the existence and types of publication agreements in trial protocols, (ii) the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii) the frequency of co-authorship by industry employees. Methods and Findings: We used a retrospective cohort of randomized clinical trials (RCTs) based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5%) mentioned an agreement regarding publication of results. Of these 456, 393 (86.2%) documented an industry partner's right to disapprove or at least review proposed manuscripts; 39 (8.6%) agreements were without constraints of publication. The remaining 24 (5.3%) protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0%) trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]). Of 71 agreements reported in publications, 52 (73.2%) were concordant with those documented in the protocol. In 14 of 37 (37.8%) publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements. Conclusions: Publication agreements constraining academic authors' independence are common. Journal articles seldom report on publication agreements, and, if they do, statements can be discrepant with the trial protocol.
Data from: Low prevalence of methicillin-resistant Staphylococcus aureus among men who have sex with men attending an STI clinic in Amsterdam, a cross-sectional study
Objective: Community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) is common among men who have sex with men (MSM) in the USA. It is unknown whether this is also the case in Amsterdam, the Netherlands. Design: Cross-sectional study. Setting: Sexually transmitted infection outpatient low- threshold clinic, Amsterdam, the Netherlands. Participants: Between October 2008 and April 2010, a total of 211 men were included, in two groups: (1) 74 MSM with clinical signs of a skin or soft tissue infection (symptomatic group) and (2) 137 MSM without clinical signs of such infections (asymptomatic group). Primary outcome measures: S aureus and MRSA infection and/or colonisation. Swabs were collected from the anterior nasal cavity, throat, perineum, penile glans and, if present, from infected skin lesions. Culture for S aureus was carried out on blood agar plates and for MRSA on selective chromagar plates after enrichment in broth. If MRSA was found, the spa- gene was sequenced. Secondary outcome measures: Associated demographic characteristics, medical history, risk factors for colonisation with S aureus and high-risk sexual behaviour were collected through a self- completed questionnaire. Results: The prevalence of S aureus colonisation in the nares was 37%, the pharynx 11%, the perianal region 12%, the glans penis 10% and in skin lesions 40%. In multivariable analysis adjusting for age, anogenital S aureus colonisation was significantly associated with the symptomatic group (p=0.01) and marginally with HIV ( p=0.06). MRSA was diagnosed in two cases: prevalence 0.9% (95% CI 0.1% to 3.4%)). Neither had CA-MRSA strains. Conclusions: CA-MRSA among MSM in Amsterdam is rare. Genital colonisation of S aureus is not associated with high-risk sexual behaviour.
Data from: Refining eligibility criteria for amyotrophic lateral sclerosis clinical trials
Objective: To assess the effect of eligibility criteria on exclusion rates, generalizability and outcome heterogeneity in ALS clinical trials, and to assess the value of a risk-based inclusion criterion. Methods: A literature search was performed to summarize eligibility criteria of clinical trials. The extracted criteria were applied to an incidence cohort of 2,904 consecutive ALS patients to quantify their effects on generalizability and outcome heterogeneity. We evaluated the effect of a risk-based selection approach on trial design using a personalized survival prediction model. Results: We identified 38 trials: enrolled patients reveal a large variability between trials of all patient characteristics (p < 0.001), except for the proportion of males (p = 0.21). Exclusion rates varied widely (from 14% to 95%; mean 59.8% (95% CI 52.6-66.7)). Stratification of the eligible populations into prognostic subgroups showed that eligibility criteria lead to exclusion of patients in all prognostic groups. Eligibility criteria neither reduce heterogeneity in survival time (from 22.0 to 20.5 months, p = 0.09) nor affect between-patient variability in functional decline (from 0.62 to 0.65, p = 0.25). In none of the 38 trials were the eligibility criteria found to be more efficient than the prediction model in optimizing sample size and eligibility rate. Conclusions: The majority of ALS patients are excluded from trial participation, which questions the generalizability of trial results. Importantly, eligibility criteria only minimally improve homogeneity in trial endpoints. An individualized risk-based criterion could be used to balance the gains in trial design and loss in generalizability.
Data from: Adjunctive use of modified Yunu-Jian in the non-surgical treatment of male smokers with chronic periodontitis: a randomized double-blind, placebo-controlled clinical trial
Background: Yunu-Jian (YJ) is a Chinese medicine (CM) heat purging formula, which is used to reduce wei huo (stomach-heat, SH) and enrich shen yin (kidney-yin, KY). This formula is also commonly used to manage diabetes mellitus and gum/oral inflammation. The activity of YJ can be modified or refined by the addition of other CM herbs and/or minor changes to one of its five key ingredients. The aim of this study was to evaluate the adjunctive use of modified YJ (mYJ) or YJ containing additional osteoblast-stimulating and inflammation-modulating CM herbs in the non-surgical periodontal treatment of smokers with chronic periodontitis in a randomized, double-blind, prospective, placebo-controlled study. Methods: Healthy adult male smokers with untreated chronic periodontitis who showed CM syndrome of SH and KY deficiency (KYD) whilst attending a dental teaching hospital from October to December, 2005, were invited to participate in a randomized double-blind, placebo-controlled clinical trial. The trial itself involved the once-daily oral administration of a placebo or mYJ for 3 months as an adjunct to non-surgical periodontal therapy. Several periodontal parameters, including radiographic alveolar bone density, were measured by computer-assisted densitometric image analysis (CADIA) on selected sites, and CM signs of SH and KYD were followed from their baseline values to various time points up to 12 months or the end of study. Results: Twenty-five smokers (consumed 25.0 ± 15.3 smoking-pack years, ranged 7.5–80; aged 46.3 ± 6.8 years) with periodontitis and SH and KYD were recruited (Placebo, n = 14; mYJ, n = 11). All of the participants showed good tolerance towards the CM recipe. All of the periodontal parameters had improved after 12-month follow-up, and no statistically significant differences were detected between the control group and test group, except for the higher CADIA values observed compared with the baseline at 12 months for test sites (P = 0.025). 4/3/3 test vs 14/13/13 control participants had persisting SH and KYD at 6, 9 and 12 months (P < 0.001), respectively. Conclusions: The adjunctive use of mYJ preserved the post-treatment increases in the radiographic alveolar bone density at the study sites and led to an overall improvement in SH and KYD compared with the controls.
Data from: Sharing of clinical trial data among trialists: a cross sectional survey
Objective: To investigate clinical trialists' opinions and experiences of sharing of clinical trial data with investigators who are not directly collaborating with the research team. Design and setting: Cross sectional, web based survey. Participants: Clinical trialists who were corresponding authors of clinical trials published in 2010 or 2011 in one of six general medical journals with the highest impact factor in 2011. Main outcome measures: Support for and prevalence of data sharing through data repositories and in response to individual requests, concerns with data sharing through repositories, and reasons for granting or denying requests. Results: Of 683 potential respondents, 317 completed the survey (response rate 46%). In principle, 236 (74%) thought that sharing de-identified data through data repositories should be required, and 229 (72%) thought that investigators should be required to share de-identified data in response to individual requests. In practice, only 56 (18%) indicated that they were required by the trial funder to deposit the trial data in a repository; of these 32 (57%) had done so. In all, 149 respondents (47%) had received an individual request to share their clinical trial data; of these, 115 (77%) had granted and 56 (38%) had denied at least one request. Respondents' most common concerns about data sharing were related to appropriate data use, investigator or funder interests, and protection of research subjects. Conclusions: We found strong support for sharing clinical trial data among corresponding authors of recently published trials in high impact general medical journals who responded to our survey, including a willingness to share data, although several practical concerns were identified.
Data from: Self-cannulation for haemodialysis: patient attributes, clinical correlates and self-cannulation predilection models
Background and objectives: With emerging evidence in support of home haemodialysis (HHD), patient factors which determine uptake of the modality need to be better understood. Self-cannulation (SC) is a major step towards enabling self-care 'in-centre' and home HD and remains the foremost barrier to its uptake. Human factors governing this aspect of HD practice are poorly understood. The aim of this study is to better understand self-cannulation preferences and factors which define them in end stage renal disease (ESRD). Design: In this multicentre study, 508 of 535 patients from predialysis (Group A: n=222), in-centre (Group B: n= 213), and home HD (Group C: n= 100) responded to a questionnaire with 3 self-cannulation questions. Simultaneously, data on clinical, cognitive and psychosocial variables were ascertained. The primary outcome measure was 'perceived ability to self-cannulate AV access'. Predictive models were developed using logistic regression analysis. Results: 36.6% of predialysis patients (A) and 29.1% of the 'in-centre' haemodialysis patients (B) felt able to consider SC for HD. Technical-skills related apprehension was highest in Group B (14.4%) patients. Response to routine venepuncture and the types of SC concerns were significant predictors of perceived ability to self-cannulate. There was no significant difference in concern for pain across the groups. In multivariable regression analysis, age, education level, 3MS score, hypoalbuminemia in Groups B & C and additionally, attitude to routine phlebotomy and the nature of specific concern for self-cannulation in Groups A, B and C, are significant predictors of SC preference. The unadjusted c-statistics of models 1 (derived from Group A and validated on A) and 2 (derived from B+C and validated on B), are 0.76(95% CI 0.69, 0.83) and 0.80 (95% CI 0.74, 0.87) respectively. Conclusions: There is high prevalence of perceived ability to self-cannulate. Modifiable SC concerns exist in ESRD. The use of predictive models to objectively define and target education and training strategies could potentially impact on HD self-management and future uptake of home HD.
Data from: Clinical Outcomes Associated with the use of the NexSite™ Hemodialysis Catheter with New Exit Barrier Technology: Results from a Prospective, Observational Multi-center Registry Study
Purpose: Decreasing the risk of catheter related bloodstream infections (CRBSIs) remains a key focus for improving outcomes and reducing cost of care for hemodialysis (HD) patients. Recent studies demonstrate CRBSI rates can be improved by managing bacterial colonization at the catheter exit site. Herein we present the results of a study documenting the clinical performance of the NexSite® HD catheter, a new tunneled central venous catheter which incorporates Exit Site Management (ESM) technology. Methods: We conducted an observational study using a prospective, multi-center registry of HD patients implanted with the NexSite® HD catheter. The primary endpoint for the study was CRBSI rate for a period up to 180-days following catheter placement. Secondary endpoints included device placement success rate, exit site healing, development of an exit site or tunnel infection, and early or late non-infectious catheter-related complications. All reasons for early non-elective catheter removal were recorded. Results: A total of 115 HD patients at 6 sites were included in the final analysis. Cumulative catheter use was 10,924 days with a mean duration of 95 days. Seven patients experienced CRBSIs during the study period resulting in a CRBSI rate of 0.64 per 1,000 catheter-days. Seventy-four patients (64.3%) had either elective catheter removal (n=56) or utilized the catheter for the entire 180-day observation period (n=18). Thirty-five patients (30%) underwent non-elective device removal either due to CRBSI (n=5), low flow (n=16), exit site issues (n=7), or for other causes (n=7). Six patients died during the observation period with 1 death due to CRBSI-associated complications and the remaining 5 deaths attributed to non-device related causes. Conclusion: Our findings demonstrate that the NexSite HD catheter equipped with ESM technology can achieve a CRBSI rate in compliance with the NKF KDOQI (National Kidney Foundation Kidney Disease Outcome Quality Initiatives) Clinical Performance Guidelines stated goal of less than 1.0/1,000 catheter-days when used in hemodialysis patients using current standard of care nursing protocols.
Data from: Clinical characteristics and lipid lowering treatment of patients initiated on Proprotein convertase subtilisin/kexin type 9 inhibitors – a nationwide cohort study
Objectives: Given the novelty of proprotein convertase subtilisin–kexin type 9 inhibitors (PCSK9i), little is known regarding overall implementation or clinical characteristics among patients who initiate treatment. We aimed to assess the total number of patients initiated on PCSK9i along with a description of the clinical characteristics and lipid lowering treatment (LLT) of such patients. Setting: A register based descriptive cohort study of patients receiving a PCSK9i in the time period from 01-01-2016 to 31-03-2017 using a cross-linkage between three nationwide Danish registers. Information regarding PCSK9i prescriptions, patient demographics, concurrent pharmacotherapy, comorbidities, and previous coronary procedures was identified. Results: Overall, 137 patients initiated treatment with PCSK9i in the study period from 11 in the first quarter of 2016 to 40 in the first quarter of 2017. The majority had a history of ischemic heart disease (67.9%) with ischemic stroke and diabetes mellitus being present in 7.3% and 16.8% of patients, respectively. All patients initiated on PCSK9i had been previous prescribed statin treatment with Atorvastatin and Simvastatin being most frequently prescribed in 53% and 36% of patients, respectively. The majority of patients had received both statins and Ezetimibe (94.9%) and approximately half of these patients had also received bile acid sequestrant (45.3%). Clinical characteristics mainly differed in patients receiving triple LLT compared to patients not receiving triple LLT in the regards of heart failure. Conclusion: Patients treated with PCSK9i were rare, characterized by having ischemic heart disease and had received various and intensive conventional LLT prior to PCSK9i initiation in agreement with current international guidelines.
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Allen Brain Atlas
Allen Brain Atlas is an Allen Institute collection of brain map atlases, datasets, APIs, and analysis tools covering mouse, human, and non-human primate brain resources.
Annotated Behaviour and Observability Dataset (ABODe)
ABODe is a University of Edinburgh DataShare dataset for behavior classification in group-housed mice using home-cage video, identities, bounding boxes, ground-plate positions, and annotator labels.
DANDI Archive for NWB datasets
DANDI is a BRAIN Initiative archive for publishing and sharing neurophysiology data, including electrophysiology, optophysiology, and behavioral data packaged as NWB and related standards.
International Brain Laboratory public data
The International Brain Laboratory public data releases expose standardized mouse decision-making experiments, including Neuropixels recordings, widefield calcium imaging, behavior, and session metadata accessed through the ONE API.
OpenNeuro
OpenNeuro is a free, open platform for sharing neuroimaging datasets, with public search, dataset pages, and download paths for web, S3, DataLad, and the OpenNeuro CLI.