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zenodo28/100

Table S1: Demographic data and clinical conditions

Table S1: Demographic data and clinical conditions.

opencc-by-4.0Jan 2020View details →

zenodo28/100

Elbow and wrist range of motion assessment comparing inertial sensors against goniometry_Raw data clinical validation

These data were taken during the validity and reliability analysis of inertial sensors (S) against goniometry (G) for the assessment of the elbow and wrist  range of motion. To study the intra-inter-rater reliability, two physiotherapists (A and B) and a technician were in charge of taking the measurements. 29 subjects were evaluated in two different sessions (1 and 2). In the elbow assessment, the flexo-extension, pronation and supination movements were performed. For the wrist, flexo-extension and radial-ulnar deviation movements were evaluated.

opencc-by-4.0Feb 2020View details →

zenodo28/100

Statistical methodologies applied to BCN02 clinical trial - Excel raw data

The Excel files correspond to the raw ELISpot assay data regarding the BCN02 clinical trial.

opencc-by-4.0May 2020View details →

dryad28/100

Data from: Clinically relevant cranio-caudal patterns of cervical cord atrophy evolution in MS

Objectives. To characterize the distribution and regional evolution of cervical cord atrophy in multiple sclerosis (MS) patients in a multicentre dataset. Methods. MRI and clinical evaluations were acquired from 179 controls and 435 patients (35 clinically isolated syndromes [CIS], 259 relapsing-remitting [RR], 99 secondary-progressive [SP] and 42 primary-progressive [PP]MS). Sixty-nine controls and 178 patients underwent a one-year MRI and clinical follow-up. Patients were classified as clinically stable/worsened according to their disability change. Longitudinal changes of cord atrophy were investigated with linear mixed-effect models. Sample size calculations were performed using age-, sex- and site-adjusted annualized percentage normalized cord cross-sectional area (CSAn) changes..Results. Baseline CSAn was lower in MS patients vs controls (p<0.001), but not different between controls and CIS or between early RRMS (disease duration<5 years) and CIS patients. Late RRMS (disease duration>5 years) showed significant cord atrophy vs early RRMS (p=0.02). Progressive MS patients had decreased CSAn (p<0.001) vs RRMS. Atrophy was located between C1/C2 and C5 in RRMS vs CIS, and widespread along the cord in progressive MS vs RRMS, with an additional C5/C6 involvement in SPMS vs PPMS. At follow-up, CSAn decreased in all phenotypes (p<0.001), except CIS. Cord atrophy rates were highest in early RRMS and clinically worsened patients, who had a more widespread cord involvement than stable patients. The sample size per arm required to detect a 50% treatment effect was 118 for early RRMS patients. Conclusions. Cord atrophy increased in MS during one year, except for CIS. A faster atrophy contributed to explain clinical worsening.

opencc-zeroJun 2020View details →

dryad28/100

Data from: Oral Cancer: clinical presentation and associated risk factors in a high risk population presenting to a major tertiary care center in Pakistan

Oral squamous cell carcinoma (OSCC) has the highest prevalence in head and neck cancers and is the first and second most common cancer in males and females of Pakistan respectively. Major risk factors include peculiar chewing habits like areca nut, betel quid, and tobacco. The majority of OSCC presents at an advanced stage with poor prognosis. On the face of such a high burden of this preventable cancer, there is a relative lack of recent robust data and its association with known risk factors from Pakistan. The aim of this study was to identify the socioeconomic factors and clinicopathological features that may contribute to the development of OSCC. A total of 186 patients diagnosed and treated at a tertiary care hospital, Karachi Pakistan were recruited. Clinicopathological and socioeconomic information was obtained on a structured questionnaire. Descriptive analysis was done for demographics and socioeconomic status (SES) while regression analysis was performed to evaluate the association between SES and chewing habits, tumor site, and tumor stage. The majority of patients were males and the mean age of OSCC patients was 47.62±12.18 years. Most of the patients belonged to low SES (68.3%) and 77.4% were habitual of chewing. Gender (male) and SES were significantly associated with chewing habits (p<0.05). Odds of developing buccal mucosa tumors in chewers (of any type of substance) and gutka users were 2 and 4 times higher than non-chewers respectively. Middle age, chewing habits, and occupation were significantly associated with late stage presentation of OSCC (p<0.05). In conclusion, male patients belonging to low SES in their forties who had chewing habits for years constituted the bulk of OSCC. Buccal mucosa was the most common site in chewers and the majority presented with late stage tumors.

opencc-zeroJul 2020View details →

dryad28/100

Intensive care unit patients' opinion on enrollment in clinical research: a multicenter survey - Study data bank

Background: In most emergency situations or severe illness, patients are unable to consent for clinical trial enrollment. In such circumstances, the decision about whether to participate in a scientific study or not is made by a legally designated representative. Objective: To address the willingness of patients admitted to the intensive care unit (ICU) to be enrolled in a scientific study as volunteers, and to assess the agreement between patients' and their legal representatives' opinion concerning enrollment in a scientific study. Methods: This survey was conducted in two hospitals in São Paulo, Brazil. Patients (≥18 years) with preserved cognitive functions accompanied by a surrogate admitted to the ICU were eligible for this study. A survey containing 28 questions for patients and 8 questions for surrogates was applied within the first 48h from ICU admission. The survey for patients comprised three sections: demographic characteristics, opinion about participation in clinical research and knowledge about the importance of research. The survey for legal representatives contained two sections: demographic characteristics and assessment of legal representatives' opinion in authorizing patients to be enrolled in research. Results: Between January 2017 and May 2018, 208 pairs of ICU patients and their respective legal representatives answered the survey. Out of 208 ICU patients answering the survey, 73.6% (153/208) were willing to be enrolled in the study as volunteers. Of those patients, 65.1% (97/149) would continue participating in a research even if their legal representative did not support their enrollment. Agreement between patients' and surrogates' opinion concerning participation was poor [Kappa=0.11 (IC95% -0.02 to 0.25)]. If a consent for study participation had been obtained, 69.1% (103/149) of patients would continue participating in the study until its conclusion, and 23.5% (35/149) would allow researchers to use data collected to date, but would withdraw from the study on that occasion. Conclusion: The majority of patients admitted to the ICU were willing to be enrolled in a scientific study as volunteers, also after a deferred informed consent procedure has been used. Nevertheless, contradictory opinions between patients and their and their legal representatives' concerning enrollment in a scientific study were often observed.

opencc-zeroJul 2020View details →

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Data from: Impact of a pre-feeding oral stimulation program on first feed attempt in preterm infants: Double-blind controlled clinical trial

Objective: To evaluate the effect of an oral stimulation program in preterm on the performance in the first oral feeding, oral feeding skills and transition time from tube to total oral intake. Study Designer: Double-blind randomized clinical trial including very preterm newborns. Congenital malformations, intracranial hemorrhage grade III or IV, bronchopulmonary dysplasia, and necrotizing enterocolitis were excluded. Intervention group (GI) received an oral stimulation program of tactile extra-, peri-, and intraoral tactile manipulation once a day for 15 minutes, during a 10-day period. Control group (GII) received sham procedure with same duration of time. Feeding ability was assessed by a speech-language pathologist blinded to group assignment. The classification of infants' oral performance was determined by Oral Feeding Skills (OFS). Neonates were monitored until hospital discharge. Results: Seventy-four (37 in each group) were randomized. Mean gestational ages and birth weights were 30±1.4 and 30±1.5 weeks, and 1,452±330g and 1,457±353g for intervention and control groups, respectively. Mean proficiency (PRO), transfer rate (RT), and overall transfer (OT) were 41.5%±18.3 and 19.9%±11.6 (p<0.001), 2.3 mL/min and 1.1 mL/min (p<0.001), 57.2%±19.7 and 35.0%±15.7 (p<0.001) in intervention and control groups, respectively. Median transition time from tube to oral feeding was 4 (3-11) and 8 days in intervention and control groups, respectively (p=0.003). Intake of breast milk was found to reduce transition time from tube feeds to exclusive oral feeding (p<0.001, HR 1.01, 95%CI 1.005-1.019), but the impact of the study intervention remained significant (p=0.007, HR 1.97, 95%CI 1.2-3.2). Conclusion: Infants who were breast-fed and an oral stimulation program proved beneficial in reducing transition time from tube feeding to oral feeding. ClinicalTrials.gov number NCT03025815

opencc-zeroAug 2020View details →

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CARE-CF-1 Clinical trial data: An exploratory, randomized, double-blind, placebo-controlled 6-arm clinical trial examining cysteamine as an adjunct therapy for the treatment of pulmonary exacerbations of cystic fibrosis

Background: Emerging data suggests a possible role for cysteamine as an adjunct treatment for pulmonary exacerbations of cystic fibrosis (CF) that continue to be a major clinical challenge. There are no studies investigating the use of cysteamine in pulmonary exacerbations of CF. This exploratory randomized clinical trial was conducted to answer the question: In future pivotal trials of cysteamine as an adjunct treatment in pulmonary exacerbations of CF, which candidate cysteamine dosing regimens should be tested and which are the most appropriate, clinically meaningful outcome measures to employ as endpoints? Methods and findings: Multicentre double-blind randomized clinical trial. Adults experiencing a pulmonary exacerbation of CF being treated with standard care that included aminoglycoside therapy were randomized equally to a concomitant 14-day course of placebo, or one of 5 dosing regimens of cysteamine. Outcomes were recorded on days 0, 7, 14 and 21 and included sputum bacterial load and the patient reported outcome measures (PROMs): Chronic Respiratory Infection Symptom Score (CRISS), the Cystic Fibrosis Questionnaire–Revised (CFQ-R); FEV1, blood leukocyte count, and inflammatory markers. Eighty nine participants in fifteen US and EU centres were randomized, 78 completed the 14-day treatment period. Cysteamine had no significant effect on sputum bacterial load, however technical difficulties limited interpretation. The most consistent findings were for cysteamine 450mg twice daily that had effects additional to that observed with placebo, with improved symptoms, CRISS additional 9.85 points (95% CI 0.02, 19.7) p=0.05, reduced blood leukocyte count by 2.46x109 /l (95% CI 0.11, 4.80), p=0.041 and reduced CRP by geometric mean 2.57 nmol/l (95% CI 0.15, 0.99), p=0.049. Conclusion: In this exploratory study cysteamine appeared to be safe and well-tolerated. Future pivotal trials investigating the utility of cysteamine in pulmonary exacerbations of CF need to include the cysteamine 450mg doses and CRISS and blood leukocyte count as outcome measures.

opencc-zeroDec 2020View details →

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Data from: Vitamin D status and COVID-19 clinical outcomes in hospitalized patients

Context: Populations severely affected by COVID-19 are also at risk for vitamin D deficiency. Common risk factors include older age, chronic illness, obesity, and non-Caucasian race. Vitamin D deficiency has been associated with risk for respiratory infections and failure, susceptibility and response to therapy for enveloped virus infection, and immune-mediated inflammatory reaction. Objective: To test the hypothesis that 25-hydroxyvitamin D[25(OH)D] deficiency is a risk factor for severity of COVID-19 respiratory and inflammatory complications. Design: We examined the relationship between retrospectively obtained prehospitalization 25(OH)D levels and COVID-19 clinical outcomes in 700 COVID-19 positive hospitalized patients. Primary Outcomes: Discharge status, mortality, length of stay, intubation status, renal replacement Secondary Outcomes: Inflammatory markers Results: 25(OH)D levels were available in 93 patients [25(OH)D:25(IQR:17–33)ng/mL]. Compared to those without 25(OH)D levels, those with measurements did not differ in age, BMI or distribution of sex and race, but were more likely to have comorbidities. Those with 25(OH)D<20ng/mL (n=35) did not differ from those with 25(OH)D³20ng/mL in terms of age, sex, race, BMI, or comorbidities. Low 25(OH)D tended to be associated with younger age and lower frequency of preexisting pulmonary disease. There were no significant between-group differences in any outcome. Results were similar in those ³50years, in male/female-only cohorts, and when differing 25(OH)D thresholds were used (<15ng/ml and <30ng/ml). There was no relationship between 25(OH)D as a continuous variable and any outcome, even after controlling for age and pulmonary disease. Conclusions: These preliminary data do not support a relationship between vitamin D status and COVID-19 clinical outcomes.

opencc-zeroJan 2021View details →

dryad28/100

Data from: Daridorexant, a new dual orexin receptor antagonist in elderly subjects with insomnia disorder: a randomized clinical trial

Objective: To assess the dose-response of daridorexant, a new dual orexin receptor antagonist, on wake after sleep onset (WASO). Methods: Elderly (≥65 years) subjects (n = 58) with insomnia were randomly allocated (Latin square design) to receive five treatments (5, 10, 25, and 50 mg daridorexant and placebo) during five treatment periods, each consisting of two treatment nights followed by a 5–12-day washout period. Main efficacy endpoints were the absolute change from baseline in WASO (primary) and latency to persistent sleep (LPS; secondary) to Days 1&2 (mean of two treatment nights assessed by polysomnography) in each period. Safety and tolerability were also assessed. Results: Of 58 subjects included, 67% were female and median age was 69 years [range 65–85]). WASO and LPS were dose-dependently reduced from baseline to Days 1&2 following daridorexant administration (multiple comparison procedure-modeling, p<0.0001 and p=0.004, respectively); reductions were statistically significant for doses 10 mg and above compared with placebo (WASO: –32.0, –45.1, –61.4 min; LPS: –44.9, –43.8, –45.4 min; for 10, 25, and 50 mg, respectively, p≤0.025). Treatment-emergent adverse events were similar for daridorexant and placebo; the most frequent were fatigue, nasopharyngitis, gait disturbance, and headache (≤7% in any group). Conclusions: Daridorexant was well tolerated. Dose-dependent improvements in WASO and LPS were statistically significant (dose range 10–50 mg) in elderly subjects with insomnia disorder. ClinicalTrials.gov (NCT02841709). Classification of Evidence: This study provides Class III evidence that for elderly subjects with insomnia, daridorexant reduced wake after sleep onset time.

opencc-zeroJan 2021View details →

dryad28/100

Data from: Test collections for EHR-based clinical information retrieval

Objectives: To create test collections for evaluating clinical Information Retrieval (IR) systems and advancing clinical IR research. Materials and Methods: Electronic Health Records (EHR) data, including structured and free text data, from 45,000 patients who are a part of the Mayo Clinic Biobank cohort was retrieved from the clinical data warehouse. The clinical IR system indexed 42 million free-text EHR documents. The search queries consisted of 56 topics developed through a collaboration between Mayo Clinic and Oregon Health & Science University. We described the creation of test collections, including a to-be-evaluated document pool using five retrieval models, and human assessment guidelines. We analyzed the relevance judgment results in terms of human agreement and time spent, and results of three levels of relevance, and reported performance of five retrieval models. Results: The two judges had a moderate overall agreement with a Kappa value of 0.49, spent a consistent amount of time judging the relevance, and were able to identify easy and difficult topics. The conventional retrieval model performed best overall on most topics while a concept-based retrieval model had better performance on the topics requiring conceptual level retrieval. Discussion: Information Retrieval can provide an alternate approach to leveraging clinical narratives for patient information discovery as it is less dependent on semantics. Our study showed the feasibility of test collections as well as challenges. Conclusion: The conventional test collections for evaluating the IR system show potential for successfully evaluating clinical IR systems with a few challenges to be investigated.

opencc-zeroJun 2019View details →

dryad28/100

Data from: Clinical complications and outcomes of angiographically negative subarachnoid hemorrhage

Objective: To define the in-hospital course, complications, short- and long-term functional outcomes of patients with angiographically negative subarachnoid hemorrhage (anSAH), particularly those with aneurysmal-pattern anSAH (aanSAH). Methods: Retrospective cohort study of patients with aneurysmal subarachnoid hemorrhage (aSAH), aanSAH and perimesencephalic-pattern anSAH (panSAH) treated at a single tertiary referral center between January 2006 and April 2018. Ninety-nine patients with anSAH (33 aanSAH and 66 panSAH) and 464 patients with aSAH were included in this study. Outcomes included symptomatic hydrocephalus requiring CSF drainage, need for ventriculoperitoneal shunt (VPS), radiographic vasospasm, delayed cerebral ischemia (DCI), radiographic infarction, disability level within one year of ictus and at last clinical follow-up as defined by modified Rankin Scale (mRS). Results: Patients with aanSAH and panSAH had similar rates of DCI and radiologic infarction, and patients with aanSAH had significantly lower rates compared to aSAH (P≤0.018). Patients with aanSAH were more likely than those with panSAH to require temporary CSF diversion and VPS (P≤0.03), with similar rates to those seen in aSAH. Only one patient with anSAH died in the hospital. Compared to those with aSAH, patients with aanSAH were significantly less likely to have a poor functional outcome within one year of ictus (OR 0.26, 95% CI 0.090 – 0.75) and at last follow-up (HR 0.30, 95% CI 0.19 – 0.49, P=0.002). Conclusions: DCI is very uncommon in anSAH, but patients with aanSAH have a similar need for short- and long-term CSF diversion to patients with aSAH. Nevertheless, patients with aanSAH have significantly better short- and long-term outcomes.

opencc-zeroDec 2018View details →

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Data from: The proportion of clinically relevant alarms decreases as patient clinical severity decreases in intensive care units: a pilot study

Objectives: To determine (1) the proportion and number of clinically relevant alarms based on the type of monitoring device; (2) whether patient clinical severity, based on the sequential organ failure assessment (SOFA) score, affects the proportion of clinically relevant alarms and to suggest; (3) methods for reducing clinically irrelevant alarms in an intensive care unit (ICU). Design: A prospective, observational clinical study. Setting: A medical ICU at the University of Tokyo Hospital in Tokyo, Japan. Participants: All patients who were admitted directly to the ICU, aged ≥18 years, and not refused active treatment were registered between January and February 2012. Methods: The alarms, alarm settings, alarm messages, waveforms and video recordings were acquired in real time and saved continuously. All alarms were annotated with respect to technical and clinical validity. Results: 18 ICU patients were monitored. During 2697 patient-monitored hours, 11 591 alarms were annotated. Only 740 (6.4%) alarms were considered to be clinically relevant. The monitoring devices that triggered alarms the most often were the direct measurement of arterial pressure (33.5%), oxygen saturation (24.2%), and electrocardiogram (22.9%). The numbers of relevant alarms were 12.4% (direct measurement of arterial pressure), 2.4% (oxygen saturation) and 5.3% (electrocardiogram). Positive correlations were established between patient clinical severities and the proportion of relevant alarms. The total number of irrelevant alarms could be reduced by 21.4% by evaluating their technical relevance. Conclusions: We demonstrated that (1) the types of devices that alarm the most frequently were direct measurements of arterial pressure, oxygen saturation and ECG, and most of those alarms were not clinically relevant; (2) the proportion of clinically relevant alarms decreased as the patients' status improved and (3) the irrelevance alarms can be considerably reduced by evaluating their technical relevance.

opencc-zeroDec 2012View details →

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Data from: Clinical characteristics and prognosis of drug-associated acute respiratory distress syndrome compared with non-drug-associated acute respiratory distress syndrome: a single-centre retrospective study in Japan

Objectives To report the clinical features and prognosis of drug-associatedacute respiratory distress syndrome (ARDS). Design A retrospective analysis of data collected during a prospective cohort study. Setting Intensive care unit in a teaching hospital. Participants A total of 197 Japanese patients with ARDS diagnosed by the Berlin definition who were admitted to the Division of Respiratory Medicine from October 2004 to December 2015 were enrolled in the study and were classified as two groups according to their causes: a drug-associated ARDS group (n=27) and a non-drug-associated ARDS group (n=170). Primary outcome measure is 28-day mortality, and the secondaryoutcome measure is ventilator-free days. Results The Acute Physiology and Chronic Health Evaluation II scores were significantly lower in the drug-associated ARDS group than in the non-drug-associated ARDS group (median (IQR): 18.0 (16.5–21.0) vs 23.0 (18.0–26.0), p<0.001), and the arterial oxygen tension/fractional inspired oxygen ratio was higher (148.0 (114.1–177.5) vs 101.0 (71.5–134.0), p=0.003). In the drug-associated ARDS group, although high-resolution CT scores indicative of the extent of fibroproliferation (301.6 (244.1–339.8) vs 208.3 (183.4–271.6), p<0.001), serum lactate dehydrogenase levels (477 (365–585) vs 322 (246–434), p=0.003) and the McCabe scores (score 1/2/3, n (%): 20 (74)/4 (15)/3 (11)vs154 (91)/7 (4)/9 (5), p=0.04) were significantly higher, ventilator weaning was earlier (p<0.001) and 28-day mortality was better (p=0.043). After adjusting for potentially confounding covariates, drug-associated ARDS group was associated with lower 28-day mortality (adjusted HR (HR) 0.275; 95% CI 0.106 to 0.711; p=0.008). Conclusions Although more severe lung damage with fibroproliferation was observed in patients with drug-associated ARDS, ventilator weaning was earlier, and their prognosis was better than the others. Further well-designed prospective studies are needed.

opencc-zeroDec 2016View details →

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Data from: Prognostic and clinical significance of miRNA-205 in endometrioid endometrial cancer

Endometrial cancer is one of the most common malignancies of the reproductive female tract, with endometrioid endometrial cancer being the most frequent type. Despite the relatively favourable prognosis in cases of endometrial cancer, there is a necessity to evaluate clinical and prognostic utility of new molecular markers. MiRNAs are small, non-coding RNA molecules that take part in RNA silencing and post-transcriptional regulation of gene expression. Altered expression of miRNAs may be associated with cancer initiation, progression and metastatic capabilities. MiRNA-205 seems to be one of the key regulators of gene expression in endometrial cancer. In this study, we investigated clinical and prognostic role of miRNA-205 in endometrioid endometrial cancer. After total RNA extraction from 100 archival formalin-fixed paraffin-embedded tissues, real-time quantitative RT-PCR was used to define miRNA-205 expression levels. The aim of the study was to evaluate miRNA-205 expression levels in regard to patients' clinical and histopathological features, such as: survival rate, recurrence rate, staging, myometrial invasion, grading and lymph nodes involvement. Higher levels of miRNA-205 expression were observed in tumours with less than half of myometrial invasion and non-advanced cancers. Kaplan-Maier analysis revealed that higher levels of miRNA-205 were associated with better overall survival (p = 0,034). These results indicate potential clinical utility of miRNA-205 as a prognostic marker.

opencc-zeroDec 2015View details →

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Data from: Effect of HIV and malaria parasites co-infection on immune-hematological profiles among patients attending anti-retroviral treatment (ART) clinic in Infectious Disease Hospital Kano, Nigeria

Background Human immunodeficiency virus (HIV) and malaria co-infection may present worse health outcomes in the tropics. Information on HIV/malaria co-infection effect on immune-hematological profiles is critical for patient care and there is a paucity of such data in Nigeria. Objective To evaluate immune-hematological profiles among HIV infected patients compared to HIV/malaria co-infected for ART management improvement. Methods This was a cross sectional study conducted at Infectious Disease Hospital, Kano. A total of 761 consenting adults attending ART clinic were randomly selected and recruited between June and December 2015. Participants' characteristics and clinical details including two previous CD4 counts were collected. Venous blood sample (4ml) was collected in EDTA tube for malaria parasite diagnosis by rapid test and confirmed with microscopy. Hematological profiles were analyzed by Sysmex XP-300 and CD4 count by Cyflow cytometry. Data was analyzed with SPSS 22.0 using Chi-Square test for association between HIV/malaria parasites co-infection with age groups, gender, ART, cotrimoxazole and usage of treated bed nets. Mean hematological profiles by HIV/malaria co-infection and HIV only were compared using independent t-test and mean CD4 count tested by mixed design repeated measures ANOVA. Statistical significant difference at probability of <0.05 was considered for all variables. Results Of the 761 HIV infected, 64% were females, with a mean age of ± (SD) 37.30 (10.4) years. Prevalence of HIV/malaria co-infection was 27.7% with Plasmodium falciparum specie accounting for 99.1%. No statistical significant difference was observed between HIV/malaria co-infection in association to age (p = 0.498) and gender (p = 0.789). A significantly (p = 0.026) higher prevalence (35.2%) of co-infection was observed among non-ART patients compared to (26%) ART patients. Prevalence of co-infection was significantly lower (20.0%) among cotrimoxazole users compared to those not on cotrimoxazole (37%). The same significantly lower co-infection prevalence (22.5%) was observed among treated bed net users compared to those not using treated bed nets (42.9%) (p = 0.001). Out of 16 hematology profiles evaluated, six showed significant difference between the two groups (i) packed cell volume (p = <0.001), (ii) mean cell volume (p = 0.005), (iii) mean cell hemoglobin concentration (p = 0.011), (iv) absolute lymphocyte count (p = 0.022), (v) neutrophil percentage count (p = 0.020) and (vi) platelets distribution width (p = <0.001). Current mean CD4 count cell/μl (349±12) was significantly higher in HIV infected only compared to co-infected (306±17), (p = 0.035). A significantly lower mean CD4 count (234.6 ± 6.9) was observed among respondents on ART compared to non-ART (372.5 ± 13.2), p<0.001, mean difference = -137.9). Conclusion The study revealed a high burden of HIV and malaria co-infection among the studied population. Co-infection was significantly lower among patients who use treated bed nets as well as cotrimoxazole chemotherapy and ART. Six hematological indices differed significantly between the two groups. Malaria and HIV co-infection significantly reduces CD4 count. In general, to achieve better management of all HIV patients in this setting, diagnosing malaria, prompt antiretroviral therapy, monitoring CD4 and some hematology indices on regular basis is critical.

opencc-zeroDec 2016View details →

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Data from: Patient factors that influence decision-making in self-management support: a clinical vignette study

Background and aim: Self-management support is an integral part of current chronic care guidelines. The success of self-management interventions varies between individual patients, suggesting a need for tailored self-management support. Understanding the role of patient factors in the current decision making of health professionals can support future tailoring of self-management interventions. The aim of this study is to identify the relative importance of patient factors in health professionals' decision making regarding self-management support. Method: A factorial survey was presented to primary care physicians and nurses. The survey consisted of clinical vignettes (case descriptions), in which 11 patient factors were systematically varied. Each care provider received a set of 12 vignettes. For each vignette, they decided whether they would give this patient self-management support and whether they expected this support to be successful. The associations between respondent decisions and patient factors were explored using ordered logit regression. Results: The survey was completed by 60 general practitioners and 80 nurses. Self-management support was unlikely to be provided in a third of the vignettes. The most important patient factor in the decision to provide self-management support as well as in the expectation that self-management support would be successful was motivation, followed by patient-provider relationship and illness perception. Other factors, such as depression or anxiety, education level, self-efficacy and social support, had a small impact on decisions. Disease, disease severity, knowledge of disease, and age were relatively unimportant factors. Conclusion: This is the first study to explore the relative importance of patient factors in decision making and the expectations regarding the provision of self-management support to chronic disease patients. By far, the most important factor considered was patient's motivation; unmotivated patients were less likely to receive self-management support. Future tailored interventions should incorporate strategies to enhance motivation in unmotivated patients. Furthermore, care providers should be better equipped to promote motivational change in their patients.

opencc-zeroDec 2016View details →

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Data from: Clinical EEG slowing correlates with delirium severity and predicts poor clinical outcomes

Objective To determine which findings on routine clinical EEGs correlate with delirium severity across various presentations, and to determine whether EEG findings independently predict important clinical outcomes. Methods We prospectively studied a cohort of non-intubated inpatients undergoing EEG for evaluation of altered mental status. Patients were assessed for delirium within one hour of EEG using the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) and 3D-CAM severity score (3D-CAM-S). EEGs were interpreted clinically by neurophysiologists, and reports were reviewed to identify features such as theta or delta slowing and triphasic waves. Generalized linear models were used to quantify associations between EEG findings, delirium, and clinical outcomes, including length of stay, Glasgow Outcome Scale scores, and mortality. Results We evaluated 200 patients (median age 60 years, IQR 48.5-72); 121 (60.5%) met delirium criteria. The EEG finding most strongly associated with delirium presence was a composite of generalized theta or delta slowing (OR 10.3, 95% CI 5.3-20.1). The prevalence of slowing correlated not only with overall delirium severity (R2 = 0.907), but also with the severity of each feature assessed by CAM-based delirium algorithms. Slowing was common in delirium even with normal arousal. EEG slowing was associated with longer hospitalizations, worse functional outcomes, and increased mortality, even after adjusting for delirium presence or severity. Conclusions Generalized slowing on routine clinical EEG strongly correlates with delirium and may be a valuable biomarker for delirium severity. Additionally, generalized EEG slowing should trigger elevated concern for the prognosis of patients with altered mental status.

opencc-zeroOct 2019View details →

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Data from: Logical validation and evaluation of practical feasibility for the SCRuM (School Clinical Rugby Measure) test battery developed for young adolescent rugby players in a resource-constrained environment

There is a growing impetus towards usage of test batteries in talent identification (TID) programmes in rugby. Consequently, there are many test batteries in existence profiling anthropometric, physiological characteristics and rugby-specific skills. There is no consensus in the literature on the constituent variables and corresponding tests required to inform TID programs. Following development of a new test battery called the SCRuM (School Clinical Rugby Measure), this study aimed at establishing face, logical validity and practical feasibility of included tests. The test battery, initially comprised of 23 items, had its face and logical validity evaluated by five (5) adolescent rugby coaches and 20 rugby experts, respectively. Logical validation was conducted in two questionnaire-based rounds with Content Validity Index (I-CVI) calculated for each variable. Subsequently, a cross-sectional study targeting 30 local rugby coaches was conducted to determine the perceived practical feasibility of each test item. The results showed excellent I-CVI (>0.78) for 17 variables (speed, weight, height and skin fold measures, repeated high-intensity exercise performance ability, prolonged high-intensity intermittent running ability, change of direction speed, anaerobic capacity, lower-and upper body muscular power and strength, muscular flexibility, reactive agility, passing for accuracy, tackling proficiency, and catching). However, three tests, namely, Reactive Agility, One Repetition Maximum Back Squat and One Repetition Maximum Bench Press had low test-feasibility indices (T-FI< 35) suggesting practicality concerns with implementation in the Zimbabwean context. Thus, these findings suggest the need for substitution or development of new practically feasible tests for upper-and lower body muscular strength and reactive agility.

opencc-zeroDec 2017View details →

dryad28/100

Data from: Clinical decision making in spinal fusion for chronic low back pain. Results of a nationwide survey among spine surgeons

OBJECTIVES: To assess the use of prognostic patient factors and predictive tests in clinical decision making for spinal fusion in patients with chronic low back pain. DESIGN AND SETTING: Nationwide survey among spine surgeons. PARTICIPANTS: Surgeon members of the Dutch Spine Society were questioned on their treatment strategy for chronic low back pain. PRIMARY AND SECONDARY OUTCOME MEASURES: The surgeons' opinion on the use of prognostic factors and tests for patient selection were addressed, and the degree of uniformity was assessed. In addition, the influence of surgeon specific factors, such as clinical experience and training, was determined. RESULTS: The comments from 62 surgeons (70% response rate) were analysed. Forty-four surgeons (71%) had extensive clinical experience. There was a statistically significant lack of uniformity of opinion in 7 of the 11 items on prognostic factors and 8 of the 11 items on predictive tests, respectively. Imaging was valued much higher than predictive tests, psychological screening, or patient preferences (all p<0.01). Apart from the use of discography and long multi-segment fusions, differences in training or clinical experience did not appear to be of significant influence on treatment strategy. CONCLUSIONS: The present survey showed a lack of consensus among spine surgeons on the use of predictive tests for patient selection. Prognostic patient factors were not consistently incorporated in their treatment strategy. Clinical decision making for spinal fusion to treat chronic low back pain does not have a uniform evidence base in practice. Future research should focus on identifying subgroups of patients for whom spinal fusion is an effective treatment. Only a reliable prediction of surgical outcome, combined with the implementation of individual patient factors, may enable the instalment of consensus guidelines in surgical decision making for chronic low back pain.

opencc-zeroDec 2010View details →

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