Physician-patient communication about overactive bladder: Results of an observational sociolinguistic study

PubMed Central

Hahn, Steven R.; Bradt, Pamela; Hewett, Kathleen A.; Ng, Daniel B.

2017-01-01

Introduction Overactive bladder (OAB) and urinary incontinence are common problems that have significant impact on quality of life (QOL). Less than half of sufferers seek help from their physicians; many who do are dissatisfied with treatment and their physicians’ understanding of their problems. Little is known about the sociolinguistic characteristics of physician-patient communication about OAB in community practice. Methods An IRB-approved observational sociolinguistic study of dialogues between patients with OAB and treating physicians was conducted. Study design included semi-structured post-visit interviews, post-visit questionnaires, and follow-up phone calls. Conversations were analyzed using techniques from interactional sociolinguistics. Results Communication was physician- rather than patient-centered. Physicians spoke the majority of words and 83% of questions were closed-ended. The impact of OAB on QOL and concerns about and adherence to treatment were infrequently addressed by physicians, who were poorly aligned with patients in their understanding. These topics were addressed more frequently when open-ended questions successfully eliciting elaborated responses were used in ask-tell-ask or ask-tell sequences. Discussion Clinical dialogue around OAB is physician-centered; topics critical to managing OAB are infrequently and inadequately addressed. The use of patient-centered communication is correlated with more discussion of critical topics, and thus, more effective management of OAB. PMID:29140974

Design and implementation of the canadian kidney disease cohort study (CKDCS): A prospective observational study of incident hemodialysis patients

PubMed Central

2011-01-01

Background Many nephrology observational studies use renal registries, which have well known limitations. The Canadian Kidney Disease Cohort Study (CKDCS) is a large prospective observational study of patients commencing hemodialysis in five Canadian centers. This study focuses on delineating potentially reversible determinants of adverse outcomes that occur in patients receiving dialysis for end-stage renal disease (ESRD). Methods/Design The CKDCS collects information on risk factors and outcomes, and stores specimens (blood, dialysate, hair and fingernails) at baseline and in long-term follow-up. Such specimens will permit measurements of biochemical markers, proteomic and genetic parameters (proteins and DNA) not measured in routine care. To avoid selection bias, all consenting incident hemodialysis patients at participating centers are enrolled, the large sample size (target of 1500 patients), large number of exposures, and high event rates will permit the exploration of multiple potential research questions. Preliminary Results Data on the baseline characteristics from the first 1074 subjects showed that the average age of patients was 62 (range; 50-73) years. The leading cause of ESRD was diabetic nephropathy (41.9%), and the majority of the patients were white (80.0%). Only 18.7% of the subjects received dialysis in a satellite unit, and over 80% lived within a 50 km radius of the nearest nephrologist's practice. Discussion The prospective design, detailed clinical information, and stored biological specimens provide a wealth of information with potential to greatly enhance our understanding of risk factors for adverse outcomes in dialysis patients. The scientific value of the stored patient tissue will grow as new genetic and biochemical markers are discovered in the future. PMID:21324196

Virtual Visits and Patient-Centered Care: Results of a Patient Survey and Observational Study

PubMed Central

2017-01-01

Background Virtual visits are clinical interactions in health care that do not involve the patient and provider being in the same room at the same time. The use of virtual visits is growing rapidly in health care. Some health systems are integrating virtual visits into primary care as a complement to existing modes of care, in part reflecting a growing focus on patient-centered care. There is, however, limited empirical evidence about how patients view this new form of care and how it affects overall health system use. Objective Descriptive objectives were to assess users and providers of virtual visits, including the reasons patients give for use. The analytic objective was to assess empirically the influence of virtual visits on overall primary care use and costs, including whether virtual care is with a known or a new primary care physician. Methods The study took place in British Columbia, Canada, where virtual visits have been publicly funded since October 2012. A survey of patients who used virtual visits and an observational study of users and nonusers of virtual visits were conducted. Comparison groups included two groups: (1) all other BC residents, and (2) a group matched (3:1) to the cohort. The first virtual visit was used as the intervention and the main outcome measures were total primary care visits and costs. Results During 2013-2014, there were 7286 virtual visit encounters, involving 5441 patients and 144 physicians. Younger patients and physicians were more likely to use and provide virtual visits (P<.001), with no differences by sex. Older and sicker patients were more likely to see a known provider, whereas the lowest socioeconomic groups were the least likely (P<.001). The survey of 399 virtual visit patients indicated that virtual visits were liked by patients, with 372 (93.2%) of respondents saying their virtual visit was of high quality and 364 (91.2%) reporting their virtual visit was “very” or “somewhat” helpful to resolve their

Virtual Visits and Patient-Centered Care: Results of a Patient Survey and Observational Study.

PubMed

McGrail, Kimberlyn Marie; Ahuja, Megan Alyssa; Leaver, Chad Andrew

2017-05-26

Virtual visits are clinical interactions in health care that do not involve the patient and provider being in the same room at the same time. The use of virtual visits is growing rapidly in health care. Some health systems are integrating virtual visits into primary care as a complement to existing modes of care, in part reflecting a growing focus on patient-centered care. There is, however, limited empirical evidence about how patients view this new form of care and how it affects overall health system use. Descriptive objectives were to assess users and providers of virtual visits, including the reasons patients give for use. The analytic objective was to assess empirically the influence of virtual visits on overall primary care use and costs, including whether virtual care is with a known or a new primary care physician. The study took place in British Columbia, Canada, where virtual visits have been publicly funded since October 2012. A survey of patients who used virtual visits and an observational study of users and nonusers of virtual visits were conducted. Comparison groups included two groups: (1) all other BC residents, and (2) a group matched (3:1) to the cohort. The first virtual visit was used as the intervention and the main outcome measures were total primary care visits and costs. During 2013-2014, there were 7286 virtual visit encounters, involving 5441 patients and 144 physicians. Younger patients and physicians were more likely to use and provide virtual visits (P<.001), with no differences by sex. Older and sicker patients were more likely to see a known provider, whereas the lowest socioeconomic groups were the least likely (P<.001). The survey of 399 virtual visit patients indicated that virtual visits were liked by patients, with 372 (93.2%) of respondents saying their virtual visit was of high quality and 364 (91.2%) reporting their virtual visit was "very" or "somewhat" helpful to resolve their health issue. Segmented regression analysis

Efficacy and safety of dexmedetomidine infusion for patients undergoing awake craniotomy: An observational study

PubMed Central

Mahajan, Charu; Rath, Girija Prasad; Singh, Gyaninder Pal; Mishra, Nitasha; Sokhal, Suman; Bithal, Parmod Kumar

2018-01-01

Background: The goal of awake craniotomy is to maintain adequate sedation, analgesia, respiratory, and hemodynamic stability and also to provide a cooperative patient for neurologic testing. An observational study carried out to evaluate the efficacy of dexmedetomidine sedation for awake craniotomy. Materials and Methods: Adult patients with age >18 year who underwent awake craniotomy for intracranial tumor surgery were enrolled. Those who were uncooperative and had difficult airway were excluded from the study. In the operating room, the patients received a bolus dose of dexmedetomidine 1 μg/kg followed by an infusion of 0.2–0.7 μg/kg/h (bispectral index target 60–80). Once the patients were sedated, scalp block was given with bupivacaine 0.25%. The data on hemodynamics at various stages of the procedure, intraoperative complications, total amount of fentanyl used, intravenous fluids required, blood loss and transfusion, duration of surgery, Intensive Care Unit (ICU), and hospital stay were collected. The patients were assessed for Glasgow outcome scale (GOS) score and patient satisfaction score (PSS). Results: A total of 27 patients underwent awake craniotomy during a period of 2 years. Most common intraoperative complication was seizures; observed in five patients (18.5%). None of these patients experienced any episode of desaturation. Two patients had tight brain for which propofol boluses were administered. The average fentanyl consumption was 161.5 ± 85.0 μg. The duration of surgery, ICU, and hospital stays were 231.5 ± 90.5 min, 14.5 ± 3.5 h, and 4.7 ± 1.5 days, respectively. The overall PSS was 8 and GOS was good in all the patients. Conclusion: The use of dexmedetomidine infusion with regional scalp block in patients undergoing awake craniotomy is safe and efficacious. The absence of major complications and higher PSS makes it close to an ideal agent for craniotomy in awake state. PMID:29628833

Respiratory Viruses in Invasively Ventilated Critically Ill Patients-A Prospective Multicenter Observational Study.

PubMed

van Someren Gréve, Frank; Juffermans, Nicole P; Bos, Lieuwe D J; Binnekade, Jan M; Braber, Annemarije; Cremer, Olaf L; de Jonge, Evert; Molenkamp, Richard; Ong, David S Y; Rebers, Sjoerd P H; Spoelstra-de Man, Angelique M E; van der Sluijs, Koenraad F; Spronk, Peter E; Verheul, Kirsten D; de Waard, Monique C; de Wilde, Rob B P; Winters, Tineke; de Jong, Menno D; Schultz, Marcus J

2018-01-01

The presence of respiratory viruses and the association with outcomes were assessed in invasively ventilated ICU patients, stratified by admission diagnosis. Prospective observational study. Five ICUs in the Netherlands. Between September 1, 2013, and April 30, 2014, 1,407 acutely admitted and invasively ventilated patients were included. None. Nasopharyngeal swabs and tracheobronchial aspirates were collected upon intubation and tested for 14 respiratory viruses. Out of 1,407 patients, 156 were admitted because of a severe acute respiratory infection and 1,251 for other reasons (non-severe acute respiratory infection). Respiratory viruses were detected in 28.8% of severe acute respiratory infection patients and 17.0% in non-severe acute respiratory infection (p < 0.001). In one third, viruses were exclusively detected in tracheobronchial aspirates. Rhinovirus and human metapneumovirus were more prevalent in severe acute respiratory infection patients (9.6% and 2.6% vs 4.5 and 0.2%; p = 0.006 and p < 0.001). In both groups, there were no associations between the presence of viruses and the number of ICU-free days at day 28, crude mortality, and mortality in multivariate regression analyses. Respiratory viruses are frequently detected in acutely admitted and invasively ventilated patients. Rhinovirus and human metapneumovirus are more frequently found in severe acute respiratory infection patients. Detection of respiratory viruses is not associated with worse clinically relevant outcomes in the studied cohort of patients.

Construction of a patient observation system using KINECTTM

NASA Astrophysics Data System (ADS)

Miyaura, Kazunori; Kumazaki, Yu; Fukushima, Chika; Kato, Shingo; Saitoh, Hidetoshi

2014-03-01

Improvement in the positional accuracy of irradiation is expected by capturing patient motion (intra-fractional error) during irradiation. The present study reports the construction of a patient observation system using Microsoft® KINECTTM. By tracking movement, we made it possible to add a depth component to the acquired position coordinates and to display three-axis (X, Y, and Z) movement. Moreover, the developed system can be displayed in a graph which is constructed from the coordinate position at each time interval. Using the developed system, an observer can easily visualize patient movement. When the body phantom was moved a known distance in the X, Y, and Z directions, good coincidence was shown with each axis. We built a patient observation system which captures a patient's motion using KINECTTM.

Integrating data from randomized controlled trials and observational studies to predict the response to pregabalin in patients with painful diabetic peripheral neuropathy.

PubMed

Alexander, Joe; Edwards, Roger A; Savoldelli, Alberto; Manca, Luigi; Grugni, Roberto; Emir, Birol; Whalen, Ed; Watt, Stephen; Brodsky, Marina; Parsons, Bruce

2017-07-20

More patient-specific medical care is expected as more is learned about variations in patient responses to medical treatments. Analytical tools enable insights by linking treatment responses from different types of studies, such as randomized controlled trials (RCTs) and observational studies. Given the importance of evidence from both types of studies, our goal was to integrate these types of data into a single predictive platform to help predict response to pregabalin in individual patients with painful diabetic peripheral neuropathy (pDPN). We utilized three pivotal RCTs of pregabalin (398 North American patients) and the largest observational study of pregabalin (3159 German patients). We implemented a hierarchical cluster analysis to identify patient clusters in the Observational Study to which RCT patients could be matched using the coarsened exact matching (CEM) technique, thereby creating a matched dataset. We then developed autoregressive moving average models (ARMAXs) to estimate weekly pain scores for pregabalin-treated patients in each cluster in the matched dataset using the maximum likelihood method. Finally, we validated ARMAX models using Observational Study patients who had not matched with RCT patients, using t tests between observed and predicted pain scores. Cluster analysis yielded six clusters (287-777 patients each) with the following clustering variables: gender, age, pDPN duration, body mass index, depression history, pregabalin monotherapy, prior gabapentin use, baseline pain score, and baseline sleep interference. CEM yielded 1528 unique patients in the matched dataset. The reduction in global imbalance scores for the clusters after adding the RCT patients (ranging from 6 to 63% depending on the cluster) demonstrated that the process reduced the bias of covariates in five of the six clusters. ARMAX models of pain score performed well (R 2 : 0.85-0.91; root mean square errors: 0.53-0.57). t tests did not show differences between observed

Dose Titration of Pregabalin in Patients with Painful Diabetic Peripheral Neuropathy: Simulation Based on Observational Study Patients Enriched with Data from Randomized Studies.

PubMed

Alexander, Joe; Edwards, Roger A; Manca, Luigi; Grugni, Roberto; Bonfanti, Gianluca; Emir, Birol; Whalen, Edward; Watt, Stephen; Parsons, Bruce

2018-03-01

Achieving a therapeutic response to pregabalin in patients with painful diabetic peripheral neuropathy (pDPN) requires adequate upward dose titration. Our goal was to identify relationships between titration and response to pregabalin in patients with pDPN. Data were integrated from nine randomized, placebo-controlled clinical trials as well as one 6-week open-label observational study conducted by 5808 physicians (2642 patients with pDPN) in standard outpatient settings in Germany. These studies evaluated pregabalin for treatment of pDPN. Using these data, we examined "what if" scenarios using a microsimulation platform that integrates data from randomized and observational sources as well as autoregressive-moving-average with exogenous inputs models that predict pain outcomes, taking into account weekly changes in pain, sleep interference, dose, and other patient characteristics that were unchanging. Final pain levels were significantly different depending on dose changes (P < 0.0001), with greater proportions improving with upward titration regardless of baseline pain severity. Altogether, 78.5% of patients with pDPN had 0-1 dose change, and 15.2% had ≥ 2 dose changes. Simulation demonstrated that the 4.8% of inadequately titrated patients who did not improve/very much improve their pain levels would have benefited from ≥ 2 dose changes. Patient satisfaction with tolerability (range 90.3-96.2%) was similar, regardless of baseline pain severity, number of titrations, or extent of improvement, suggesting that tolerability did not influence treatment response patterns. Upward dose titration reduced pain in patients with pDPN who actually received it. Simulation also predicted pain reduction in an inadequately titrated nonresponder subgroup of patients had they actually received adequate titration. The decision not to uptitrate must have been driven by factors other than tolerability. Pfizer, Inc.

Patient engagement and study design of PROP UP: A multi-site patient-centered prospective observational study of patients undergoing hepatitis C treatment.

PubMed

Evon, Donna M; Golin, Carol E; Stewart, Paul; Fried, Michael W; Alston, Shani; Reeve, Bryce; Lok, Anna S; Sterling, Richard K; Lim, Joseph K; Reau, Nancy; Sarkar, Souvik; Nelson, David R; Reddy, K R; Di Bisceglie, Adrian M

2017-06-01

New highly efficacious direct-acting antiviral (DAA) therapies are available to treat chronic hepatitis C viral (HCV) infection. Real-world, patient-centered data on harms and benefits associated with these therapies are needed. PROP UP is a multi-center prospective observational study that plans to enroll 1600 patients starting treatment with recently-approved DAA regimens. Informed by extensive input from a HCV patient engagement group who prioritized outcomes most important to them, patient-reported outcomes will be characterized using surveys at five time points: Baseline (T1), treatment week 4 (T2), end of treatment (T3), 12weeks post-treatment (T4), 12months post-treatment (T5). (1) Changes in side effects, functioning, pre-existing conditions, and out-of-pocket costs during therapy (T1 vs T2/T3); (2) Medication adherence in relation to a history of mental health/substance abuse, treatment regimens, pill burden, reasons for missed doses, and cure rates; (3) Short term impact of cure on functioning and amelioration of symptoms (T1 vs T4); (4) Long-term treatment harms or benefits of cure on symptoms, side effects, pre-existing conditions, and functioning (T1 vs T5). Similarities between regimens will be examined where comparisons are appropriate and meaningful. PROP UP complements previous clinical trials by focusing on patient-reported outcomes in a representative sample of patients treated in clinical practice, by collaborating with a patient engagement group, by characterizing the experiences of vulnerable subgroups, and by investigating long-term harms and benefits of treatments. PROP UP is designed to provide novel and detailed information to support informed decision-making for patients and providers contemplating HCV treatment (PCORI CER-1408-20,660; NCT02601820). Copyright © 2017 Elsevier Inc. All rights reserved.

Patient Engagement and Study Design of PROP UP: A multi-site patient-centered prospective observational study of patients undergoing hepatitis C treatment

PubMed Central

Evon, Donna M.; Golin, Carol E.; Stewart, Paul; Fried, Michael W.; Alston, Shani; Reeve, Bryce; Lok, Anna S.; Sterling, Richard K.; Lim, Joseph K.; Reau, Nancy; Sarkar, Souvik; Nelson, David R.; Reddy, K. Rajender; Di Bisceglie, Adrian M.

2017-01-01

Background New highly efficacious direct-acting antiviral (DAA) therapies are available to treat chronic hepatitis C viral (HCV) infection. Real-world, patient-centered data on harms and benefits associated with these therapies are needed. Methods PROP UP is a multi-center prospective observational study that plans to enroll 1,600 patients starting treatment with recently-approved DAA regimens. Informed by extensive input from a HCV patient engagement group who prioritized outcomes most important to them, patient-reported outcomes will be characterized using surveys at five time points: Baseline (T1), treatment week 4 (T2), end of treatment (T3), 12 weeks post-treatment (T4), 12 months post-treatment (T5). Outcomes (1) Changes in side effects, functioning, pre-existing conditions, and out-of-pocket costs during therapy (T1 vs T2/T3); (2) Medication adherence in relation to a history of mental health/substance abuse, treatment regimens, pill burden, reasons for missed doses, and cure rates; (3) Short term impact of cure on functioning and amelioration of symptoms (T1 vs T4); (4) Long-term treatment harms or benefits of cure on symptoms, side effects, pre-existing conditions, and functioning (T1 vs T5). Similarities between regimens will be examined where comparisons are appropriate and meaningful. Conclusion PROP UP complements previous clinical trials by focusing on patient-reported outcomes in a representative sample of patients treated in clinical practice, by collaborating with a patient engagement group, by characterizing the experiences of vulnerable subgroups, and by investigating long-term harms and benefits of treatments. PROP UP is designed to provide novel and detailed information to support informed decision-making for patients and providers contemplating HCV treatment (PCORI CER-1408-20660; NCT02601820). PMID:28342989

Post-operative outcomes in older patients: a single-centre observational study.

PubMed

Tang, Benjamin; Green, Cameron; Yeoh, Aun Chian; Husain, Faisal; Subramaniam, Ashwin

2018-05-01

Improved life-expectancies have seen increased rates of older patients undergoing surgery worldwide. These patients are at increased risk of post-operative complications. Australian evidence is limited regarding the association between age and post-operative outcomes, especially rapid response calls (RRCs) as indicators of adverse outcomes. The aim was to compare the post-operative outcomes of older patients (≥80 years) to younger patients. Specifically, 30-day in-hospital mortality; unplanned intensive care unit (ICU) admission; and RRC activation within 72 h post-operatively. Single-centre retrospective observational study conducted over 12 months in a metropolitan Australian hospital. All adult patients (≥16 years) undergoing surgical procedures were included, excluding cardiac and obstetric/gynaecological surgeries. Patient co-morbidities were quantified using Charlson co-morbidity index (CCI) and American Society of Anesthesiologists physical status classification. Seven thousand four hundred and seventy-nine patients met inclusion criteria, 14.5% (n = 1086) aged ≥80 years. Most procedures (65%) were elective; and general surgical procedures were most common (24.2%). Compared to younger patients, older patients had significantly higher 30-day mortality (2.3% versus 0.2%; P < 0.001), increased post-operative RRC rates (7.3% versus 1.2%; P < 0.001), and unplanned ICU admissions (3.2% versus 1.6%; P < 0.001). Increasing age was associated with increased risk of post-operative RRC, unplanned ICU admission, and in-hospital mortality (all P < 0.01), with associations remaining significant after controlling for surgery type and CCI. Older patients are at increased risk of adverse post-operative outcomes, including post-operative RRC, unplanned ICU admission, and mortality, especially if they underwent emergency procedures. This has implications for preoperative risk stratification and post-operative management. Incidence of post

Racial differences in mortality among patients with acute ischemic stroke: an observational study.

PubMed

Xian, Ying; Holloway, Robert G; Noyes, Katia; Shah, Manish N; Friedman, Bruce

2011-02-01

Black patients are commonly believed to have higher stroke mortality. However, several recent studies have reported better survival in black patients with stroke. To examine racial differences in stroke mortality and explore potential reasons for these differences. Observational cohort study. 164 hospitals in New York. 5319 black and 18 340 white patients aged 18 years or older who were hospitalized with acute ischemic stroke between January 2005 and December 2006. Influence of race on mortality, examined by using propensity score analysis. Secondary outcomes were selected aspects of end-of-life treatment, use of tissue plasminogen activator, hospital spending, and length of stay. Patients were followed for mortality for 1 year after admission. Overall in-hospital mortality was lower for black patients than for white patients (5.0% vs. 7.4%; P < 0.001), as was all-cause mortality at 30 days (6.1% vs. 11.4%; P < 0.001) and 1 year (16.5% vs. 24.4%; P < 0.001). After propensity score adjustment, black race was independently associated with lower in-hospital mortality (odds ratio [OR], 0.77 [95% CI, 0.61 to 0.98]) and all-cause mortality up to 1 year (OR, 0.86 [CI, 0.77 to 0.96]). The adjusted hazard ratio was 0.87 (CI, 0.79 to 0.96). After adjustment for the probability of dying in the hospital, black patients with stroke were more likely to receive life-sustaining interventions (OR, 1.22 [CI, 1.09 to 1.38]) but less likely to be discharged to hospice (OR, 0.25 [CI, 0.14 to 0.46]). The study used hospital administrative data that lacked a stroke severity measure. The study design precluded determination of causality. Among patients with acute ischemic stroke, black patients had lower mortality than white patients. This could be the result of differences in receipt of life-sustaining interventions and end-of-life care.

A Retrospective Observational Study of Anesthetic Induction Dosing Practices in Female Elderly Surgical Patients: Are We Overdosing Older Patients?

PubMed

Akhtar, Shamsuddin; Heng, Joseph; Dai, Feng; Schonberger, Robert B; Burg, Mathew M

2016-10-01

Despite guidelines suggesting a 25-50 % reduction in induction doses of intravenous anesthetic agents in the elderly (≥65 years), we hypothesized that practitioners were not sufficiently correcting drug administration for age, contributing to an increased incidence of hypotension in older patients undergoing general anesthesia. We conducted a retrospective, observational study in a tertiary-care academic hospital. The study included 768 female patients undergoing gynecologic surgeries who received propofol-based induction of general anesthesia. Weight-adjusted anesthetic induction dosing, age-associated differences in dosing by ASA-PS (American Society of Anesthesiology-Physical Status), and hemodynamic outcomes between younger (18-64 years, n = 537) and older (≥65 years, n = 231) female patients were analyzed. Older patients received lower doses of propofol and midazolam than younger patients (propofol: 2.037 ± 0.783 vs 2.322 ± 0.834 mg/kg, p < 0.001; midazolam: 0.013 ± 0.014 vs 0.023 ± 0.042 mg/kg, p < 0.001). However, practitioners still consistently exceeded the FDA recommended dose (1-1.5 mg/kg) of propofol for elderly patients. There was no significant difference in the doses of fentanyl administered between the two age groups (1.343 ± 0.744 vs 1.363 ± 0.763 μg/kg, p = 0.744), and doses of fentanyl in older patients exceeded the recommended dose (0.5-1.0 μg/kg). Corresponding to observed overdosing of induction agents, older patients experienced larger decreases in post-induction blood pressure and were more likely to receive vasopressor therapy. Anesthetic induction doses of fentanyl and propofol were not sufficiently corrected in older patients in accordance with recommendations. Significantly greater frequency of post-induction hypotension occurred amongst older patients. Quality improvement efforts may lead to improved outcomes in this vulnerable population.

Pharmacotherapy of elderly patients in everyday anthroposophic medical practice: a prospective, multicenter observational study

PubMed Central

2010-01-01

Background Pharmacotherapy in the older adult is a complex field involving several different medical professionals. The evidence base for pharmacotherapy in elderly patients in primary care relies on only a few clinical trials, thus documentation must be improved, particularly in the field of complementary and alternative medicine (CAM) like phytotherapy, homoeopathy, and anthroposophic medicine. This study describes diagnoses and therapies observed in elderly patients treated with anthroposophic medicine in usual care. Methods Twenty-nine primary care physicians in Germany participated in this prospective, multicenter observational study on prescribing patterns. Prescriptions and diagnoses were reported for each consecutive patient. Data were included if patients were at least 60 years of age. Multiple logistic regression analysis was used to determine factors associated with anthroposophic prescriptions. Results In 2005, a total of 12 314 prescriptions for 3076 patients (68.1% female) were included. The most frequent diagnoses were hypertension (11.1%), breast cancer (3.5%), and heart failure (3.0%). In total, 30.5% of the prescriptions were classified as CAM remedies alone, 54.4% as conventional pharmaceuticals alone, and 15.1% as a combination of both. CAM remedies accounted for 41.7% of all medications prescribed (35.5% anthroposophic). The adjusted odds ratio (AOR) for receiving an anthroposophic remedy was significantly higher for the first consultation (AOR = 1.65; CI: 1.52-1.79), treatment by an internist (AOR = 1.49; CI: 1.40-1.58), female patients (AOR = 1.35; CI: 1.27-1.43), cancer (AOR = 4.54; CI: 4.12-4.99), arthropathies (AOR = 1.36; CI: 1.19-1.55), or dorsopathies (AOR = 1.34; CI: 1.16-1.55) and it decreased with patient age (AOR = 0.97; CI: 0.97-0.98). The likelihood of being prescribed an anthroposophic remedy was especially low for patients with hypertensive diseases (AOR = 0.36; CI: 0.32-0.39), diabetes mellitus (AOR = 0.17; CI: 0.14-0.22), or

Multivariate Analysis of Factors Associated with the Koebner Phenomenon in Vitiligo: An Observational Study of 381 Patients

PubMed Central

Khurrum, Huma; Bedaiwi, Khalid M.; AlBalahi, Naif Meshael

2017-01-01

Background The Koebner phenomenon (KP) is a common entity observed in dermatological disorders. The reported incidence of KP in vitiligo varies widely. Although the KP is frequently observed in patients with viltiligo, the associated factors with KP has not been established yet. Objective The aim is to estimate the prevalence of KP in vitiligo patients and to investigate the associated factors with KP among vitiligo characteristics. Methods A cross-sectional observational study was conducted using 381 vitiligo patients. Demographic and clinical information was obtained via the completion of Vitiligo European Task Force (VETF) questionnaires. Patients with positive history of KP were extracted from this vitiligo database. Multivariate analysis was performed to assess associations with KP. Results The median age of cases was 24 years (range, 0.6~76). In total, 237 of the patients were male (62.2%). Vitiligo vulgaris was the most common type observed (152/381, 39.9%). Seventy-two percent (274/381) patients did not exhibit KP, whereas 28.1% (107/381) of patients exhibited this condition. Multivariable analysis showed the following to be independent factors with KP in patients with vitiligo: the progressive disease (odds ratio [OR], 1.82; 95% confidence interval [95% CI], 1.17~2.92; p=0.041), disease duration longer than 5 years (OR, 1.92; 95% CI, 1.22~2.11; p=0.003), and body surface area more than 2% (OR, 2.20; 95% CI, 1.26~3.24; p<0.001). Conclusion Our results suggest that KP may be used to evaluate disease activity and investigate different associations between the clinical profile and course of vitiligo. Further studies are needed to predict the relationship between KP and responsiveness to therapy. PMID:28566906

Recovery in patients with major depressive disorder (MDD): results of a 6-month, multinational, observational study.

PubMed

Novick, Diego; Montgomery, William; Vorstenbosch, Ellen; Moneta, Maria Victoria; Dueñas, Héctor; Haro, Josep Maria

2017-01-01

Not all individuals treated for major depressive disorder (MDD) achieve recovery. This observational study examined the recovery rates in MDD patients and the patient characteristics associated with achieving recovery in a naturalistic clinical setting. Recovery was defined as having both clinical and functional remission. Data for this post hoc analysis were taken from a 24-week prospective, observational study that involved 1,549 MDD patients. Clinical remission was assessed using the 16-item Quick Inventory of Depressive Symptomatology Self-Report and functional remission through the Sheehan Disability Scale and no days of reduced productivity in the previous week. Generalized estimating equation regression models were used to examine the baseline factors associated with recovery during follow-up. Clinical and functional remission was achieved in 70.6% and 56.1% of the MDD patients, respectively. MDD patients who achieved recovery (52.1%) were significantly less likely to have impaired levels of functioning, concurrent medical or psychiatric conditions, low levels of education, or nonadherence to therapy at follow-up. The level of functioning during the index episode seems to be a better predictor of recovery than symptom severity. Therefore, the level of functioning should be considered while determining recovery from depression.

Persistent hyperphagia in acquired brain injury; an observational case study of patients receiving inpatient rehabilitation.

PubMed

Rowell, Arleen M; Faruqui, Rafey A

2010-01-01

Morbid hunger or persistent hyperphagia is a relatively rare but potentially life threatening complication of acquired brain injury (ABI). This paper presents findings from an observational case study of patients with hyperphagia receiving inpatient neurobehavioural rehabilitation following their acquired brain injury. The case study has utilized dietetic and medical records of identified patients to confirm the persistent and serious nature of this presentation in order to extract important management principles. The findings confirmed that hyperphagia or morbid hunger posed potentially life-threatening health risks to the patient, primarily around weight control and fluid balance, and risks of aggression towards professional and family carers. Pharmacological or behaviour modification interventions were only partially successful in management of this presentation. The study identified a high need for environmental and cue exposure control in management of this condition.

The real-world effectiveness and safety of fingolimod in relapsing-remitting multiple sclerosis patients: An observational study

PubMed Central

Damas, Fátima; Páramo, Maria Dolores; Ruiz-Peña, Juan Luis; Navarro, Guillermo

2017-01-01

Fingolimod approval was based mainly on two clinical trials, FREEDOMS and TRANSFORMS, which demonstrated the efficacy and safety of fingolimod in patients with multiple sclerosis (MS). We present an observational study that validates these trials findings in a real-world setting, whereby the effectiveness and safety of fingolimod was assessed in Seville’s’ (Spain) clinical practice. This retrospective study in MS patients assessed effectiveness (relapses, EDSS, gadolinium-enhancing T1 and new/enlarged T2-weighted lesions): total cohort (n = 249) and stratified according to prior treatment (glatiramer acetate/interferon beta-1 [immunomodulator], natalizumab, naïve), gender, basal EDSS score, basal Gd+ lesions, ARR prior to treatment, age at treatment initiation and number of prior treatments. A multivariante model was used to assess the ARR with baseline characteristics. The safety profile (adverse events [AEs]) was also described. Fingolimod reduced the annualized relapse rate (ARR) by 75%, 67% and 85% in the total cohort, patients previously treated with immunomodulatory and naïve patients (p<0.0001 all cases). However, patients previously treated with natalizumab kept a constant ARR. The ARR results and the consequent increase in the proportion of relapse-free patients were independent of the age at treatment initiation, number of prior treatments, gender and basal Gd+ lesions. Although fingolimod was effective regardless the basal EDSS score and ARR prior to fingolimod treatment, better outcomes were observed in patients with basal EDSS score <3 (0.2 vs. 0.4; p = 0.0244) and ARR ≥ 2 prior to fingolimod treatment (p = 0.0338). Only the basal EDSS score was association with ARR in the first 24 months of fingolimod treatment in the multivariante model (p = 0.0439). The cumulative probability of disability progression was 20% (month-24) in the total cohort, and was independent from prior treatment, age at treatment initiation, number of prior treatments

The impact of blood type O on mortality of severe trauma patients: a retrospective observational study.

PubMed

Takayama, Wataru; Endo, Akira; Koguchi, Hazuki; Sugimoto, Momoko; Murata, Kiyoshi; Otomo, Yasuhiro

2018-05-02

Recent studies have implicated the differences in the ABO blood system as a potential risk for various diseases, including hemostatic disorders and hemorrhage. In this study, we evaluated the impact of the difference in the ABO blood type on mortality in patients with severe trauma. A retrospective observational study was conducted in two tertiary emergency critical care medical centers in Japan. Patients with trauma with an Injury Severity Score (ISS) > 15 were included. The association between the different blood types (type O versus other blood types) and the outcomes of all-cause mortality, cause-specific mortalities (exsanguination, traumatic brain injury, and others), ventilator-free days (VFD), and total transfusion volume were evaluated using univariate and multivariate competing-risk regression models. Moreover, the impact of blood type O on the outcomes was assessed using regression coefficients in the multivariate analysis adjusted for age, ISS, and the Revised Trauma Score (RTS). A total of 901 patients were included in this study. The study population was divided based on the ABO blood type: type O, 284 (32%); type A, 285 (32%); type B, 209 (23%); and type AB, 123 (13%). Blood type O was associated with high mortality (28% in patients with blood type O versus 11% in patients with other blood types; p <  0.001). Moreover, this association was observed in a multivariate model (adjusted odds ratio = 2.86, 95% confidence interval 1.84-4.46; p <  0.001). The impact of blood type O on all-cause in-hospital mortality was comparable to 12 increases in the ISS, 1.5 decreases in the RTS, and 26 increases in age. Furthermore, blood type O was significantly associated with higher cause-specific mortalities and shorter VFD compared with the other blood types; however, a significant difference was not observed in the transfusion volume between the two groups. Blood type O was significantly associated with high mortality in severe trauma patients and

Improving patient safety during insertion of peripheral venous catheters: an observational intervention study.

PubMed

Kampf, Günter; Reise, Gesche; James, Claudia; Gittelbauer, Kirsten; Gosch, Jutta; Alpers, Birgit

2013-01-01

Peripheral venous catheters are frequently used in hospitalized patients but increase the risk of nosocomial bloodstream infection. Evidence-based guidelines describe specific steps that are known to reduce infection risk. However, the degree of guideline implementation in clinical practice is not known. The aim of this study was to determine the use of specific steps for insertion of peripheral venous catheters in clinical practice and to implement a multimodal intervention aimed at improving both compliance and the optimum order of the steps. The study was conducted at University Hospital Hamburg. An optimum procedure for inserting a peripheral venous catheter was defined based on three evidence-based guidelines (WHO, CDC, RKI) including five steps with 1A or 1B level of evidence: hand disinfection before patient contact, skin antisepsis of the puncture site, no palpation of treated puncture site, hand disinfection before aseptic procedure, and sterile dressing on the puncture site. A research nurse observed and recorded procedures for peripheral venous catheter insertion for healthcare workers in four different departments (endoscopy, central emergency admissions, pediatrics, and dermatology). A multimodal intervention with 5 elements was established (teaching session, dummy training, e-learning tool, tablet and poster, and direct feedback), followed by a second observation period. During the last observation week, participants evaluated the intervention. In the control period, 207 insertions were observed, and 202 in the intervention period. Compliance improved significantly for four of five steps (e.g., from 11.6% to 57.9% for hand disinfection before patient contact; p<0.001, chi-square test). Compliance with skin antisepsis of the puncture site was high before and after intervention (99.5% before and 99.0% after). Performance of specific steps in the correct order also improved (e.g., from 7.7% to 68.6% when three of five steps were done; p<0.001). The

Improving patient safety during insertion of peripheral venous catheters: an observational intervention study

PubMed Central

Kampf, Günter; Reise, Gesche; James, Claudia; Gittelbauer, Kirsten; Gosch, Jutta; Alpers, Birgit

2013-01-01

Background: Peripheral venous catheters are frequently used in hospitalized patients but increase the risk of nosocomial bloodstream infection. Evidence-based guidelines describe specific steps that are known to reduce infection risk. However, the degree of guideline implementation in clinical practice is not known. The aim of this study was to determine the use of specific steps for insertion of peripheral venous catheters in clinical practice and to implement a multimodal intervention aimed at improving both compliance and the optimum order of the steps. Methods: The study was conducted at University Hospital Hamburg. An optimum procedure for inserting a peripheral venous catheter was defined based on three evidence-based guidelines (WHO, CDC, RKI) including five steps with 1A or 1B level of evidence: hand disinfection before patient contact, skin antisepsis of the puncture site, no palpation of treated puncture site, hand disinfection before aseptic procedure, and sterile dressing on the puncture site. A research nurse observed and recorded procedures for peripheral venous catheter insertion for healthcare workers in four different departments (endoscopy, central emergency admissions, pediatrics, and dermatology). A multimodal intervention with 5 elements was established (teaching session, dummy training, e-learning tool, tablet and poster, and direct feedback), followed by a second observation period. During the last observation week, participants evaluated the intervention. Results: In the control period, 207 insertions were observed, and 202 in the intervention period. Compliance improved significantly for four of five steps (e.g., from 11.6% to 57.9% for hand disinfection before patient contact; p<0.001, chi-square test). Compliance with skin antisepsis of the puncture site was high before and after intervention (99.5% before and 99.0% after). Performance of specific steps in the correct order also improved (e.g., from 7.7% to 68.6% when three of five steps

Recovery in patients with major depressive disorder (MDD): results of a 6-month, multinational, observational study

PubMed Central

Novick, Diego; Montgomery, William; Vorstenbosch, Ellen; Moneta, Maria Victoria; Dueñas, Héctor; Haro, Josep Maria

2017-01-01

Not all individuals treated for major depressive disorder (MDD) achieve recovery. This observational study examined the recovery rates in MDD patients and the patient characteristics associated with achieving recovery in a naturalistic clinical setting. Recovery was defined as having both clinical and functional remission. Data for this post hoc analysis were taken from a 24-week prospective, observational study that involved 1,549 MDD patients. Clinical remission was assessed using the 16-item Quick Inventory of Depressive Symptomatology Self-Report and functional remission through the Sheehan Disability Scale and no days of reduced productivity in the previous week. Generalized estimating equation regression models were used to examine the baseline factors associated with recovery during follow-up. Clinical and functional remission was achieved in 70.6% and 56.1% of the MDD patients, respectively. MDD patients who achieved recovery (52.1%) were significantly less likely to have impaired levels of functioning, concurrent medical or psychiatric conditions, low levels of education, or nonadherence to therapy at follow-up. The level of functioning during the index episode seems to be a better predictor of recovery than symptom severity. Therefore, the level of functioning should be considered while determining recovery from depression. PMID:29184393

The Hawthorne effect in direct observation research with physicians and patients.

PubMed

Goodwin, Meredith A; Stange, Kurt C; Zyzanski, Stephen J; Crabtree, Benjamin F; Borawski, Elaine A; Flocke, Susan A

2017-12-01

This study examines the degree to which a "Hawthorne effect" alters outpatient-visit content. Trained research nurses directly observed 4454 visits to 138 family physicians. Multiple data sources were used to examine the Hawthorne effect including differences in medical record documentation for observed visits and the prior visit by the same patient, time use during visits on the first versus the second observation day of each physician, and report by the patient, physician, and observer of the effect of observation. Visits on the first versus the second observation day were longer by an average of 1 minute (P < .001); there were time-use differences for 4 of 20 behaviour categories evaluated. No effect of the observer on the interaction was reported by 74% of patients and 55% of physicians. Most of those that reported an affect indicated it was slight. Patients with non-White race, lower-educational level, and poorer health were more likely to report being affected by the observer. In a study that was designed to minimize the Hawthorne effect, the presence of an observer had little effect on most patient-physician visits but appeared to at least slightly effect a subgroup of vulnerable patients. © 2017 John Wiley & Sons, Ltd.

An observational study of patient satisfaction with fesoterodine in the treatment of overactive bladder: effects of additional educational material.

PubMed

Schneider, T; Arumi, D; Crook, T J; Sun, F; Michel, M C

2014-09-01

To compare the effects of additional educational material on treatment satisfaction of overactive bladder (OAB) patients treated with a muscarinic receptor antagonist. In an observational study of OAB patients being treated by their physician with fesoterodine for 4 months (FAKTEN study), sites were randomised to providing standard treatment or additional educational material including the SAGA tool. Patient satisfaction was assessed by three validated patient-reported outcomes including the Treatment Satisfaction Question. Because of premature discontinuation of the study, descriptive statistical analysis was performed. A total of 431 and 342 patients received standard treatment or additional educational material, respectively. At study end, 76.1% [95% CI = 71.3, 80.4] of patients with standard care and 79.6% [95% CI = 74.4, 84.1] with additional SAGA tool were satisfied with treatment (primary end-point). Comparable outcomes with and without the additional educational material were also found in various patient subgroups, at the 1-month time point, and for the other patient-reported outcomes. A notable exception was the subgroup of treatment-naïve patients in which the percentage of satisfied patients was 77.2% vs. 89.5% with standard treatment and additional SAGA tool, respectively (post hoc analysis). In an observational study, most overactive bladder patients were satisfied with fesoterodine treatment. Because of the small sample size, the study does not support or refute the hypothesis that adding the SAGA tool will improve patient satisfaction with treatment. The potential effect of additional educational material in treatment-naïve patients warrants further dedicated studies. © 2014 John Wiley & Sons Ltd.

Severe infection in patients with rheumatoid arthritis taking anakinra, rituximab, or abatacept: a systematic review of observational studies.

PubMed

Cabral, Vanderlea Poeys; Andrade, Carlos Augusto Ferreira de; Passos, Sonia Regina Lambert; Martins, Maria de Fátima Moreira; Hökerberg, Yara Hahr Marques

A question is raised about an increased risk of severe infection from the use of biological drugs in patients with rheumatoid arthritis. This systematic review of observational studies aimed at assessing the risk of severe infection associated with the use of anakinra, rituximab, and abatacept in patients with rheumatoid arthritis. The following databases were searched: PubMed, Science Direct, Scopus, Web of Knowledge, Scirus, Cochrane, Exerpta Medica Database, Scielo, and Lilacs up to July 2010. Severe infections were defined as those life-threatening ones in need of the use of parenteral antibiotics or of hospitalization. Longitudinal observational studies were selected without language restriction, involving adult patients diagnosed with rheumatoid arthritis and who used anakinra, rituximab, or abatacept. In four studies related to anakinra, 129 (5.1%) severe infections were related in 2896 patients, of which three died. With respect to rituximab, two studies reported 72 (5.9%) severe infections in 1224 patients, of which two died. Abatacept was evaluated in only one study in which 25 (2.4%) severe infections were reported in 1046 patients. The main site of infection for these three drugs was the respiratory tract. One possible explanation for the high frequency of severe infections associated with anakinra may be the longer follow-up time in the selected studies. The high frequency of severe infections associated with rituximab could be credited to the less strict inclusion criteria for the patients studied. Therefore, infection monitoring should be cautious in patients with rheumatoid arthritis in use of these three drugs. Copyright © 2016. Published by Elsevier Editora Ltda.

Dietary Micronutrient Intake and Micronutrient Status in Patients With Chronic Stable Heart Failure: An Observational Study.

PubMed

McKeag, Nicholas A; McKinley, Michelle C; Harbinson, Mark T; McGinty, Ann; Neville, Charlotte E; Woodside, Jayne V; McKeown, Pascal P

Observational studies suggest that patients with heart failure have a tendency to a reduced status of a number of micronutrients and that this may be associated with an adverse prognosis. A small number of studies also suggest that patients with heart failure may have reduced dietary intake of micronutrients, a possible mechanism for reduced status. The aims of this study were to assess dietary micronutrient intake and micronutrient status in a group of patients with heart failure. Dietary intake was assessed in 79 outpatients with chronic stable heart failure with a reduced ejection fraction using a validated food frequency questionnaire. Blood concentrations of a number of micronutrients, including vitamin D, were measured in fasting blood samples, drawn at the time of food frequency questionnaire completion. More than 20% of patients reported intakes less than the reference nutrient intake or recommended intake for riboflavin, vitamin D, vitamin A, calcium, magnesium, potassium, zinc, copper, selenium, and iodine. More than 5% of patients reported intakes less than the lower reference nutrient intake or minimum recommended intake for riboflavin, vitamin D, vitamin A, calcium, magnesium, potassium, zinc, selenium, and iodine. Vitamin D deficiency (plasma total 25-hydroxy-vitamin D concentration <50 nmol/L) was observed in 75.6% of patients. Vitamin D deficiency was common in this group of patients with heart failure. Based on self-reported dietary intake, a substantial number of individuals may not have been consuming enough vitamin D and a modest number of individuals may not have been consuming enough riboflavin, vitamin A, calcium, magnesium, potassium, zinc, copper, selenium, or iodine to meet their dietary needs.

Understanding Motivations to Participate in an Observational Research Study: Why do Patients Enroll?

PubMed Central

Soule, Michael C.; Beale, Eleanor E.; Suarez, Laura; Beach, Scott R.; Mastromauro, Carol A.; Celano, Christopher M; Moore, Shannon V; Huffman, Jeff C.

2016-01-01

By understanding common motivations for participating in observational research studies, clinicians may better understand the perceived benefits of research participation from their clients’ perspective. We enrolled 164 cardiac patients in a study about the effects of gratitude and optimism. Two weeks post-enrollment, participants completed a four-item questionnaire regarding motivations for study enrollment. Altruistic motivation ranked highest, while intellectual, health-related, and financial motivations rated lower. Four subgroups of participants emerged, each with distinct characteristics and different priorities for participating. These findings may help front-line clinicians to understand which motivations for participation apply to their clients who enroll in non-treatment-based research projects. PMID:26933943

SaMpling Antibiotics in Renal Replacement Therapy (SMARRT): an observational pharmacokinetic study in critically ill patients.

PubMed

Roberts, Jason A; Choi, Gordon Y S; Joynt, Gavin M; Paul, Sanjoy K; Deans, Renae; Peake, Sandra; Cole, Louise; Stephens, Dianne; Bellomo, Rinaldo; Turnidge, John; Wallis, Steven C; Roberts, Michael S; Roberts, Darren M; Lassig-Smith, Melissa; Starr, Therese; Lipman, Jeffrey

2016-03-01

Optimal antibiotic dosing is key to maximising patient survival, and minimising the emergence of bacterial resistance. Evidence-based antibiotic dosing guidelines for critically ill patients receiving RRT are currently not available, as RRT techniques and settings vary greatly between ICUs and even individual patients. We aim to develop a robust, evidence-based antibiotic dosing guideline for critically ill patients receiving various forms of RRT. We further aim to observe whether therapeutic antibiotic concentrations are associated with reduced 28-day mortality. We designed a multi-national, observational pharmacokinetic study in critically ill patients requiring RRT. The study antibiotics will be vancomycin, linezolid, piperacillin/tazobactam and meropenem. Pharmacokinetic sampling of each patient's blood, RRT effluent and urine will take place during two separate dosing intervals. In addition, a comprehensive data set, which includes the patients' demographic and clinical parameters, as well as modality, technique and settings of RRT, will be collected. Pharmacokinetic data will be analysed using a population pharmacokinetic approach to identify covariates associated with changes in pharmacokinetic parameters in critically ill patients with AKI who are undergoing RRT for the five commonly prescribed antibiotics. Using the comprehensive data set collected, the pharmacokinetic profile of the five antibiotics will be constructed, including identification of RRT and other factors indicative of the need for altered antibiotic dosing requirements. This will enable us to develop a dosing guideline for each individual antibiotic that is likely to be relevant to any critically ill patient with acute kidney injury receiving any of the included forms of RRT. Australian New Zealand Clinical Trial Registry ( ACTRN12613000241730 ) registered 28 February 2013.

Coagulation Profile in Patients with Different Etiologies for Cushing Syndrome: A Prospective Observational Study.

PubMed

Tirosh, Amit; Lodish, Maya; Lyssikatos, Charalampos; Belyavskaya, Elena; Feelders, Richard A; Stratakis, Constantine A

2017-05-01

Previous studies reported a higher prevalence of venous-thromboembolic events among patients with Cushing disease (CD) compared to those with ACTH-independent Cushing syndrome (CS) from adrenal sources. The objective of the current study was to evaluate the coagulation profile of patients with CS from different etiologies. A prospective observational study was conducted at a clinical research center. The study included adult patients admitted for evaluation of suspected CS (n=85), that were divided into 3 groups: CD (n=22), ACTH-independent CS from an adrenal tumor/hyperplasia (adrenal CS, n=21), and a control group consisting of subjects with negative screening for CS (rule-out CS, n=42). Coagulation profiles were drawn before and 8.5±4.3 months after surgery (trans-sphenoidal or adrenalectomy, n=18), and included fibrinogen, Factor VIII (FVIII), von Willebrand factor antigen (vWF:Ag), plasminogen activator inhibitor-1 (PAI-1), antithrombin III (ATIII), Protein C (PC), Protein S (PS), α2-antiplasmin (α2AP), and aPTT measurements. Patients with CD had higher baseline mean cortisol levels, ATIII activity and vWF:Ag levels compared with adrenal CS. Differences in ATIII activity and vWF:Ag levels remained even after controlling for BMI, and ATIII after also controlling for 24-h urinary free cortisol collections. Our study showed for the first time the differences in coagulation profiles between various etiologies of CS. We assume that the higher cortisol burden among CD patients may explain the differences found in the coagulation profile as well as the higher risk for VTE compared with primary adrenal CS patients. © Georg Thieme Verlag KG Stuttgart · New York.

Airway difficulty in Mallampati 'class zero' patients: a prospective double-blind observational study.

PubMed

Hegde, Harihar V; Prasad, Kothegala C; Bhat, Manjunath T; Hegde, Jyothirmay S; Santhosh Mysore, C b; Yaliwal, Vijay G; Raghavendra Rao, P

2012-07-01

Assessment of Mallampati class is an integral part of preoperative airway evaluation. Increasing Mallampati class is known to be associated with greater difficulty with intubation, but some cases of airway difficulty in Mallampati 'class zero' patients have been reported. We undertook this study to evaluate intubation difficulty and to correlate this with indirect laryngoscopy findings in Mallampati class zero patients. The incidence of Mallampati class zero airway in Indian patients and the difficulty in mask ventilation were also evaluated. Prospective double-blind observational study. A tertiary care medical college hospital in Karnataka, India. September 2010 to April 2011. Patients of either sex, 18 years and older, presenting for preanaesthetic examination for elective surgery were evaluated. All patients with Mallampati class zero airway undergoing general anaesthesia with tracheal intubation were included. Exclusion criteria were upper airway disorder, unstable cervical spine, increased risk for aspiration, ischaemic heart disease, increased intracranial pressure, respiratory distress, those unable to sit upright, or infected with hepatitis B, hepatitis C, HIV or pulmonary tuberculosis, or requiring emergency surgery. All underwent indirect laryngoscopy performed by the otorhinolaryngologist and subsequently, direct laryngoscopy performed by the anaesthesiologist. Intubation difficulty was assessed by the Cormack & Lehane grades. Evaluation of intubation difficulty and correlation with indirect laryngoscopy findings in Mallampati class zero patients. Estimation of the incidence of Mallampati class zero airway in Indian patients and the difficulty in mask ventilation. Twenty women and thirteen men, aged 18-65 years, of Mallampati class zero were identified out of 1937 (incidence, 1.7%). The data of 27 patients were analysed. Two patients had 'difficult' mask ventilation. All had a 'predicted easy' airway on indirect laryngoscopy and 'easy' (Cormack & Lehane

Medical student use of communication elements and association with patient satisfaction: a prospective observational pilot study.

PubMed

Turner, Joseph S; Pettit, Katie E; Buente, Bryce B; Humbert, Aloysius J; Perkins, Anthony J; Kline, Jeffrey A

2016-05-21

Effective communication with patients impacts clinical outcome and patient satisfaction. We measure the rate at which medical students use six targeted communication elements with patients and association of element use with patient satisfaction. Participants included fourth year medical students enrolled in an emergency medicine clerkship. A trained observer measured use of six communication elements: acknowledging the patient by name, introducing themselves by name, identifying their role, explaining the care plan, explaining that multiple providers would see the patient, and providing an estimated duration of time in the emergency department. The observer then conducted a survey of patient satisfaction with the medical student encounter. A total of 246 encounters were documented among forty medical student participants. For the six communication elements evaluated, in 61% of encounters medical students acknowledged the patient, in 91% they introduced themselves, in 58 % they identified their role as a student, in 64% they explained the care plan, in 80% they explained that another provider would see the patient, and in only 6% they provided an estimated duration of care. Only 1 encounter (0.4%) contained all six elements. Patients' likelihood to refer a loved one to that ED was increased when students acknowledged the patient and described that other providers would be involved in patient care (P = 0.016 and 0.015 respectively, Chi Square). Likewise, patients' likelihood to return to the ED was increased when students described their role in patient care (P = 0.035, Chi Square). This pilot study demonstrates that medical students infrequently use all targeted communication elements. When they did use certain elements, patient satisfaction increased. These data imply potential benefit to additional training for students in patient communication.

Classical homeopathy in the treatment of cancer patients--a prospective observational study of two independent cohorts.

PubMed

Rostock, Matthias; Naumann, Johannes; Guethlin, Corina; Guenther, Lars; Bartsch, Hans H; Walach, Harald

2011-01-17

Many cancer patients seek homeopathy as a complementary therapy. It has rarely been studied systematically, whether homeopathic care is of benefit for cancer patients. We conducted a prospective observational study with cancer patients in two differently treated cohorts: one cohort with patients under complementary homeopathic treatment (HG; n = 259), and one cohort with conventionally treated cancer patients (CG; n = 380). For a direct comparison, matched pairs with patients of the same tumour entity and comparable prognosis were to be formed. Main outcome parameter: change of quality of life (FACT-G, FACIT-Sp) after 3 months. Secondary outcome parameters: change of quality of life (FACT-G, FACIT-Sp) after a year, as well as impairment by fatigue (MFI) and by anxiety and depression (HADS). HG: FACT-G, or FACIT-Sp, respectively improved statistically significantly in the first three months, from 75.6 (SD 14.6) to 81.1 (SD 16.9), or from 32.1 (SD 8.2) to 34.9 (SD 8.32), respectively. After 12 months, a further increase to 84.1 (SD 15.5) or 35.2 (SD 8.6) was found. Fatigue (MFI) decreased; anxiety and depression (HADS) did not change. CG: FACT-G remained constant in the first three months: 75.3 (SD 17.3) at t0, and 76.6 (SD 16.6) at t1. After 12 months, there was a slight increase to 78.9 (SD 18.1). FACIT-Sp scores improved significantly from t0 (31.0 - SD 8.9) to t1 (32.1 - SD 8.9) and declined again after a year (31.6 - SD 9.4). For fatigue, anxiety, and depression, no relevant changes were found. 120 patients of HG and 206 patients of CG met our criteria for matched-pairs selection. Due to large differences between the two patient populations, however, only 11 matched pairs could be formed. This is not sufficient for a comparative study. In our prospective study, we observed an improvement of quality of life as well as a tendency of fatigue symptoms to decrease in cancer patients under complementary homeopathic treatment. It would take considerably larger samples

Treatment Outcome of Ovulation-inducing Agents in Patients with Anovulatory Infertility: A Prospective, Observational Study

PubMed Central

Prajapati, Kinjal; Desai, Mira; Shah, Samidh; Choudhary, Sumesh; Aggarwal, Rohina; Mishra, Vineet

2017-01-01

Objective: To compare different treatment regimens on pregnancy rate and outcome in patients with anovulatory infertility. Patients and Methods: A prospective observational study was conducted on patients with infertility due to anovulation. Patients treated with clomiphene citrate (CC) 50/100 mg/day from 2nd to 6th day of menstrual cycle (MC) (n = 38), short gonadotropin-releasing hormone (GnRH) agonist regimen (leuprolide [0.5 mg subcutaneous] + recombinant follicle-stimulating hormone [rFSH] [225 IU intramuscular [IM] from 2nd to 10th day of MC [n = 32]), long GnRH agonist regimen (leuprolide from 21st day followed by leuprolide + rFSH from 2nd to 10th day of MC [n = 19]), and antagonist regimen (human menopausal gonadotropin [hMG] [150 IU IM] from 2nd day followed by hMG + cetrorelix from 7th to 10th day of MC) (n = 6) were recruited and followed up for follicular size, endometrial thickness, and pregnancy test. Data were analyzed using appropriate statistical test andP < 0.05 was considered statistically significant. Results: A significant increase in follicular diameter and endometrial thickness was observed in patients treated with gonadotropin regimens as compared to CC alone (P < 0.0001). The highest number of positive pregnancy test with ultrasonographic evidence of gestational sac was observed with leuprolide + rFSH (long regimen) (10/19, 52.6%) followed by leuprolide + rFSH (short regimen) (13/32, 40.6%) while least in antagonist regimen (2/6, 33.3%) and CC (1/38, 2.63%). All regimens were well tolerated. Conclusion: Treatment outcome was better with long agonist regimen. PMID:29081619

Nurses' understanding influences comprehension of patients admitted in the observation unit.

PubMed

Desme, Aline; Mendes, Nathalie; Perruche, Franck; Veillard, Elsa; Elie, Caroline; Moulinet, Françoise; Sanson, Fabienne; Georget, Jean-Michel; Tissier, Anne; Pourriat, Jean-Louis; Claessens, Yann-Erick

2013-01-01

Comprehension is poor in patients admitted in the emergency observation unit. Teamwork communication gaps could contribute to patients' misunderstanding of their health condition. To determine in patients admitted in the emergency observation unit whether comprehension of diagnosis, prognosis, and management depended on nurses' comprehension, the authors conducted a prospective observational study in a busy adult emergency department of a tertiary teaching hospital in Paris over 2 months. Consecutive patients admitted in the emergency observation unit were included. Patients' and nurses' comprehension of diagnosis, prognosis, and management was compared with the statements of the emergency department attending physicians for these items. The authors observed whether patients' misunderstanding was associated with nurses' misunderstanding. A total of 544 patients were evaluated. For each patient, nurses' and patients' comprehension was available. Patients understood severity in 40%, organ involved in 69%, medical wording in 57%, reason for admission in 48%, and discharge instruction in 67%. In comparison with patients, nurses better understood each item except for discharge instruction. The authors observed that patients' comprehension was better when nurses understood diagnosis (p <.0001), reasons for admission (p =.032) and discharge instructions (p =.002). Nurses' understanding of severity did not modify patients' comprehension. These results support the conclusions that communication gaps in teamwork alter patients' comprehension and that nurses' and patients' misunderstandings are associated. Therefore, improving communication by nurses and physicians to patients may improve patients' understanding.

Observational descriptive study of cutaneous manifestations in patients from Mato Grosso with viral chronic hepatitis*

PubMed Central

Rostey, Renato Roberto Liberato; Souto, Francisco José Dutra

2015-01-01

BACKGROUND Extrahepatic manifestations are seen in association with chronic infection by hepatitis B or C virus including cutaneous disorders. The frequency of these findings seems to vary among different places and reports. There is a lack of information about this issue in Brazil. OBJECTIVES To estimate the prevalence of cutaneous findings affecting HBV or HCV carriers from a reference outpatient unit in Mato Grosso. METHODS A cross-sectional observational study. RESULTS 108 patients were studied. 88.9% presented some cutaneous findings but must of them were nonrelated to chronic viral infection. Four patients had cutaneous or autoimmune syndromes that may be HBV or HCV related. CONCLUSION In our study we found no statistical association between viral hepatitis and skin diseases. PMID:26734863

Home parenteral nutrition improves quality of life and nutritional status in patients with cancer: a French observational multicentre study.

PubMed

Culine, S; Chambrier, C; Tadmouri, A; Senesse, P; Seys, P; Radji, A; Rotarski, M; Balian, A; Dufour, P

2014-07-01

Malnutrition is a predictor of poor outcomes in patients with cancer. Little is known about the benefit of nutritional support in these patients. The purpose of this study was to assess the impact of home parenteral nutrition (HPN) on quality of life (Qol) in cancer patients. We performed an observational prospective study to determine the impact of HPN on Qol in a population of patients with heterogeneous cancer. Physicians, patients and family members had to complete a questionnaire before HPN administration and 28 days after the course of HPN. Qol was evaluated using the self-administered questionnaire FACT-G. We included 767 patients with cancer of whom 437 ended the study. Mean patient age was 63±11.4 years and 60.5% were men. Primary gastrointestinal cancer was reported in 50% of patients and 65.3% were presenting metastases. Malnutrition was reported in 98.3%. After 28 days of HPN intake, significant improvement was observed in the Qol (49.95±5.82 vs. 48.35±5.01 at baseline, p<0.0001). The mean weight, serum albumin and the nutrition risk index had also improved significantly. Most patients (78%) had perceived a positive impact of the HPN. A significant improvement in patient's well-being was perceived also by family members and physicians. Our data suggest that preventing and correcting malnutrition using HPN in patients with cancer might have a significant benefit on their well-being. Randomized controlled studies are required to confirm this finding.

Physical Trauma Patients with Symptoms of an Acute and Posttraumatic Stress Disorder: Protocol for an Observational Prospective Cohort Study.

PubMed

Visser, Eva; Gosens, Taco; Den Oudsten, Brenda; De Vries, Jolanda

2018-03-29

Injury, medical treatment, and rehabilitation can have major impacts on patients' wellbeing. About 25-33% of the patients experience an acute stress disorder (ASD) or a posttraumatic stress disorder (PTSD) after injury. ASD is a relatively new diagnosis. Therefore, knowledge about patients' experiences, the course of ASD and PTSD, and who is at risk for developing ASD or PTSD is lacking. The aims of this multi-method study are to explore patients' experiences with injury (and their care) using a focus group study. Then, in the observational study, different courses of ASD, PTSD, and quality of life will be examined. In addition, this study will examine if these courses could be characterized by socio-demographic, clinical, and psychological variables. Consequently, a risk profile will be developed to determine which patients are at risk for developing ASD or PTSD during the 12 months after injury. Trauma patients treated in the shock room (in 2015) of the Elisabeth-TweeSteden Hospital will share their experiences with injury in the focus group study. Open, axial, and selective coding will be used to analyze the data. Concerning the observational study, patients treated in the shock room (during 2016 and 2017, Elisabeth-TweeSteden Hospital and Erasmus Medical Centre) will be asked to participate. The inclusion period is 12 months. Participants will complete the Impact of Event Scale-Revised, MINI-plus, the Hospital Anxiety and Depression Scale, and the World Health Organization Quality of Life-BREF after inclusion and at 3, 6, 9, and 12 months after injury. The NEO-Five Factor Inventory and the State-Trait Anxiety Inventory-Trait are completed after inclusion only. Repeated measures of latent class analysis and linear mixed models will be used to examine the research aims. This project was funded in August 2015 by ZonMw. The results of the focus group study are expected in the first trimester of 2018. With regard to the observational study, recruitment is currently

Reduction of perception of chronic fatigue in an observational study of patients receiving 12 weeks of Kampo therapy.

PubMed

Sekiya, Nobuyasu; Shimada, Yutaka; Shintani, Takahiro; Tahara, Eiichi; Kouta, Kazufumi; Shibahara, Naotoshi; Terasawa, Katsutoshi

2005-10-01

The aim of this study was to observe the influence of Kampo therapy on latent chronic fatigue of patients with chronic diseases. One hundred and seventy-three (173) consecutive patients with chronic diseases came to our department for the first time. This was a prospective study. Patients were divided into two groups: a chronic fatigue group (CFG) and a nonchronic fatigue group (NCFG). Based on Kampo diagnosis, both groups were prescribed Kampo formulae as an extract or decoction for 12 weeks. By using questionnaires, patients were assessed concerning their physical and mental types of fatigue, their sleep situation, and their attitude toward work or housekeeping, both before and after 12 weeks of treatment, according to Kampo diagnosis. The mental fatigue, physical fatigue, and sleep scores of both groups, and the work score of CFG, were decreased. The rate of reduction of the fatigue score was significantly greater in CFG than in NCFG. The factor responsible for this difference in fatigue score was physical fatigue. A reduction of the perception of chronic fatigue was observed in patients receiving 12 weeks of Kampo therapy.

Sarcopenia is associated with incident albuminuria in patients with type 2 diabetes: A retrospective observational study.

PubMed

Bouchi, Ryotaro; Fukuda, Tatsuya; Takeuchi, Takato; Minami, Isao; Yoshimoto, Takanobu; Ogawa, Yoshihiro

2017-11-01

Sarcopenia, defined as age-related loss of skeletal muscle mass and function, increases the risk of albuminuria. However, it has still unknown whether sarcopenia could increase the risk for the progression of albuminuria. A total 238 patients with type 2 diabetes (mean age 64 ± 12 years; 39.2% women) were studied in the present retrospective observational study. The prevalence of sarcopenia was 17.6%. During the median follow-up period of 2.6 years, albuminuria was measured 5.8 ± 1.8 times, and progression of albuminuria was observed in 14.9% of patients with normoalbuminuria, as was 11.5% in those with microalbuminuria. Sarcopenia was significantly associated with both progression (hazard ratio 2.61, 95% confidence interval 1.08-6.31, P = 0.034) and regression (hazard ratio 0.23, 95% confidence interval 0.05-0.98, P = 0.048) of albuminuria by multivariate Cox regression analysis. The present data suggest that sarcopenia is an important determinant of both progression and regression of albuminuria in patients with type 2 diabetes. © 2017 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

Perioperative patient outcomes in the African Surgical Outcomes Study: a 7-day prospective observational cohort study.

PubMed

Biccard, Bruce M; Madiba, Thandinkosi E; Kluyts, Hyla-Louise; Munlemvo, Dolly M; Madzimbamuto, Farai D; Basenero, Apollo; Gordon, Christina S; Youssouf, Coulibaly; Rakotoarison, Sylvia R; Gobin, Veekash; Samateh, Ahmadou L; Sani, Chaibou M; Omigbodun, Akinyinka O; Amanor-Boadu, Simbo D; Tumukunde, Janat T; Esterhuizen, Tonya M; Manach, Yannick Le; Forget, Patrice; Elkhogia, Abdulaziz M; Mehyaoui, Ryad M; Zoumeno, Eugene; Ndayisaba, Gabriel; Ndasi, Henry; Ndonga, Andrew K N; Ngumi, Zipporah W W; Patel, Ushmah P; Ashebir, Daniel Zemenfes; Antwi-Kusi, Akwasi A K; Mbwele, Bernard; Sama, Hamza Doles; Elfiky, Mahmoud; Fawzy, Maher A; Pearse, Rupert M

2018-04-21

There is a need to increase access to surgical treatments in African countries, but perioperative complications represent a major global health-care burden. There are few studies describing surgical outcomes in Africa. We did a 7-day, international, prospective, observational cohort study of patients aged 18 years and older undergoing any inpatient surgery in 25 countries in Africa (the African Surgical Outcomes Study). We aimed to recruit as many hospitals as possible using a convenience sampling survey, and required data from at least ten hospitals per country (or half the surgical centres if there were fewer than ten hospitals) and data for at least 90% of eligible patients from each site. Each country selected one recruitment week between February and May, 2016. The primary outcome was in-hospital postoperative complications, assessed according to predefined criteria and graded as mild, moderate, or severe. Data were presented as median (IQR), mean (SD), or n (%), and compared using t tests. This study is registered on the South African National Health Research Database (KZ_2015RP7_22) and ClinicalTrials.gov (NCT03044899). We recruited 11 422 patients (median 29 [IQR 10-70]) from 247 hospitals during the national cohort weeks. Hospitals served a median population of 810 000 people (IQR 200 000-2 000 000), with a combined number of specialist surgeons, obstetricians, and anaesthetists totalling 0·7 (0·2-1·9) per 100 000 population. Hospitals did a median of 212 (IQR 65-578) surgical procedures per 100 000 population each year. Patients were younger (mean age 38·5 years [SD 16·1]), with a lower risk profile (American Society of Anesthesiologists median score 1 [IQR 1-2]) than reported in high-income countries. 1253 (11%) patients were infected with HIV, 6504 procedures (57%) were urgent or emergent, and the most common procedure was caesarean delivery (3792 patients, 33%). Postoperative complications occurred in 1977 (18·2%, 95% CI 17·4-18·9

Coping with tuberculosis and directly observed treatment: a qualitative study among patients from South India.

PubMed

Yellappa, Vijayashree; Lefèvre, Pierre; Battaglioli, Tullia; Narayanan, Devadasan; Van der Stuyft, Patrick

2016-07-19

In India, the Revised National TB control programme (RNTCP) offers free diagnosis and treatment for tuberculosis (TB), based on the Directly Observed Treatment Short course (DOTS) strategy. We conducted a qualitative study to explore the experience and consequences of having TB on patients enrolled in DOTS and their caretakers in Tumkur district, located in a southern state of India, Karnataka. We conducted 33 in-depth interviews on a purposive sample of TB patients from three groups: (1) patients who reached RNTCP directly on their own and took DOTS at RNTCP; (2) patients who were referred by private practitioners (PPs) to RNTCP and took DOTS at RNTCP; and (3) patients diagnosed by RNTCP and took DOTS from PPs. Data was analyzed using a thematic approach with the support of NVivo9. The study revealed that TB and DOTS have a large impact on patient's lives, which is often extended to the family and caretakers. The most vulnerable patients faced the most difficulty in accessing and completing DOTS. The family was the main source of support during patient's recovery. Patients residing in rural areas and, taking DOTS from the government facilities had to overcome many barriers to adhere to the DOTS therapy, such as long travelling distance to DOTS centers, inconvenient timings and unfavorable attitude of the RNTCP staff, when compared to patients who took DOTS from PPs. Advantages of taking DOTS from PPs cited by the patients were privacy, flexibility in timings, proximity and more immediate access to care. Patients and their family had to cope with stigmatization and fear and financial hardships that surfaced from TB and DOTS. Young patients living in urban areas were more worried about stigmatisation, than elderly patients living in rural areas. Patients who were referred by PPs experienced more financial problems compared to those who reached RNTCP services directly. Our study provided useful information about patient's needs and expectations while taking DOTS. The

Continuous thermographic observation may predict extravasation in chemotherapy-treated patients.

PubMed

Oya, Maiko; Murayama, Ryoko; Oe, Makoto; Yabunaka, Koichi; Tanabe, Hidenori; Takahashi, Toshiaki; Matsui, Yuko; Otomo, Eiko; Komiyama, Chieko; Sanada, Hiromi

2017-06-01

Extravasation, or leakage of vesicant drugs into subcutaneous tissues, causes serious complications such as induration and necrosis in chemotherapy-treated patients. As macroscopic observation may overlook symptoms during infusion, we focused on skin temperature changes at puncture sites and studied thermographic patterns related to induration or necrosis caused by extravasation. Outpatients undergoing chemotherapy using peripheral intravenous catheters were enrolled in this prospective observational study. We filmed and classified infrared thermography movies of puncture sites during infusion; ultrasonography was also utilized at puncture sites to observe the subcutaneous condition. Multiple logistic regression analysis was performed to examine the association of thermographic patterns with induration or necrosis observed on the next chemotherapy day. Differences in patient characteristics, puncture sites, and infusions were analyzed by Mann-Whitney's U test and Fisher's exact test according to thermographic patterns. Eight patients developed induration among 74 observations in 62 patients. Among six thermographic patterns, a fan-shaped lower temperature area gradually spreading from the puncture site (fan at puncture site) was significantly associated with induration. Ultrasonography revealed that catheters of patients with fan at puncture site remained in the vein at the end of infusion, indicating that the infusion probably leaked from the puncture site. Patients with fan at puncture site had no significant differences in characteristics and infusion conditions compared with those with the other five thermographic patterns. We determined that fan at puncture site was related to induration caused by extravasation. Continuous thermographic observation may enable us to predict adverse events of chemotherapy. Copyright © 2017. Published by Elsevier Ltd.

Rasagiline for sleep disorders in patients with Parkinson’s disease: a prospective observational study

PubMed Central

Schettino, Carla; Dato, Clemente; Capaldo, Guglielmo; Sampaolo, Simone; Di Iorio, Giuseppe; Melone, Mariarosa AB

2016-01-01

Introduction Rasagiline is a selective, irreversible monoamine oxidase B inhibitor that ameliorates the symptoms of Parkinson’s disease (PD) by inhibiting striatal dopamine metabolism. There is also evidence that monoamine oxidase B inhibitors increase melatonin levels in the pineal gland and may have a beneficial effect on sleep disorders, which are a common feature in patients with PD. Methods This single-center, prospective, observational, 12-week study compared the effect of combination therapy with levodopa 200–300 mg/d + rasagiline 1 mg/d (n=19) with levodopa 200–300 mg/d alone (n=19) in the treatment of sleep disorders in patients with idiopathic PD. Results After 12 weeks’ treatment, mean sleep latency was significantly (P<0.001) lower and the improvement in sleep latency from baseline was significantly (P=0.001) greater in patients receiving levodopa + rasagiline than in patients receiving levodopa alone. Similarly, at the end of the study, the mean total sleep time was significantly (P=0.002) longer and the improvement from baseline in mean total sleep time was significantly (P=0.026) greater in patients receiving levodopa + rasagiline than levodopa alone. There were no significant differences between treatment groups for the mean number of awakenings reported at week 12 nor the change from baseline to week 12 in mean number of awakenings. Conclusion Adding rasagiline to levodopa improved sleep outcomes and may be an appropriate option for patients with PD experiencing sleep disorders. PMID:27729794

Is directly observed tuberculosis treatment strategy patient-centered? A mixed method study in Addis Ababa, Ethiopia.

PubMed

Getahun, Belete; Nkosi, Zethu Zerish

2017-01-01

The directly observed treatment, short course (DOTS) strategy has been considered as an efficacious approach for better tuberculosis (TB) treatment adherence and outcome. However, its level of patient centerdness has not been studied and documented well. Hence, the study aimed to determine the level of patient centeredness' of the DOTS. The study used explanatory sequential mixed method design in Addis Ababa, Ethiopia. The study employed an interviewer-administered questionnaire with 601 patients with TB, focus group discussions with 23 TB experts, and telephonic-interview with 25 persons lost to follow-up from TB treatment. Descriptive and multivariable analyses carried out for the quantitative data while thematic analysis was used for the qualitative data. Forty percent of patients with TB had not received patient-centered TB care (PC-TB care) with DOTS. Male gender (AOR = 0.45, 95% CI 0.3, 0.7), good communication (AOR = 3.2, 95%CI 1.6, 6.1), and health care providers as a treatment supporter (AOR = 3.4, 95% CI 2.1, 5.48) had significant associations with PC-TB care. All persons lost to follow-up and TB experts perceived that DOTS is merely patient-centered. The identified categories were patient preferences, treatment supporter choice, integration of DOTS with nutritional support, mental health, and transport services, provider's commitment and communication skills. DOTS is limited to provide patient-centered TB care. Hence, DOTS needs a model that enhances effectiveness towards patient centeredness of TB care.

Associations between Internet-based patient ratings and conventional surveys of patient experience in the English NHS: an observational study.

PubMed

Greaves, Felix; Pape, Utz J; King, Dominic; Darzi, Ara; Majeed, Azeem; Wachter, Robert M; Millett, Christopher

2012-07-01

Unsolicited web-based comments by patients regarding their healthcare are increasing, but controversial. The relationship between such online patient reports and conventional measures of patient experience (obtained via survey) is not known. The authors examined hospital level associations between web-based patient ratings on the National Health Service (NHS) Choices website, introduced in England during 2008, and paper-based survey measures of patient experience. The authors also aimed to compare these two methods of measuring patient experience. The authors performed a cross-sectional observational study of all (n=146) acute general NHS hospital trusts in England using data from 9997 patient web-based ratings posted on the NHS Choices website during 2009/2010. Hospital trust level indicators of patient experience from a paper-based survey (five measures) were compared with web-based patient ratings using Spearman's rank correlation coefficient. The authors compared the strength of associations among clinical outcomes, patient experience survey results and NHS Choices ratings. Web-based ratings of patient experience were associated with ratings derived from a national paper-based patient survey (Spearman ρ=0.31-0.49, p<0.001 for all). Associations with clinical outcomes were at least as strong for online ratings as for traditional survey measures of patient experience. Unsolicited web-based patient ratings of their care, though potentially prone to many biases, are correlated with survey measures of patient experience. They may be useful tools for patients when choosing healthcare providers and for clinicians to improve the quality of their services.

Oral mucosal diseases in anxiety and depression patients: Hospital based observational study from south India

PubMed Central

Shenai, Prashanth; Chatra, Laxmikanth; Ronad, Yusuf-Ahammed A.; Bilahari, Naduvakattu; Pramod, Redder C.; Kumar, Sreeja P.

2015-01-01

Objectives: The objective of this study was to evaluate the prevalence of different Oral Mucosal diseases in Anxiety and Depression patients. Material and Methods: A hospital based observational Study was conducted in the department of Psychiatry and department of Oral Medicine and Radiology. Patients who were diagnosed with Anxiety or Depression by the psychiatrists using Hamilton Anxiety and Depression scale were subjected to complete oral examination to check for oral diseases like Oral Lichen Planus (OLP), Recurrent Aphthous Stomatitis (RAS), and Burning Mouth Syndrome (BMS). Equal number of control group subjects were also included. Results: In this study statistically significant increase in the oral diseases in patients with anxiety and depression than the control group was recorded. Oral diseases were significantly higher in anxiety patients (20.86%) than in depression (9.04%) and control group patients (5.17%). In anxiety patients, the prevalence of RAS was 12%, OLP was 5.7%, and BMS was 2.87%. In depression patients, the prevalence of RAS was 4.02%, OLP was 2.01% and BMS was 3.01%. In control group the prevalence was 2.2%, 1.33% and 1.62% in RAS, OLP and BMS respectively. RAS and OLP were significantly higher in the younger age group (18-49) and BMS was seen between the age group of 50-77 years in both study and control groups. Conclusions: The results of the present study showed a positive association between psychological alterations and changes in the oral mucosa, particularly conditions like OLP, RAS and BMS. Thus psychogenic factors like anxiety and depression may act as a risk factor that could influence the initiation and development of oral mucosal diseases. Hence psychological management should be taken into consideration when treating patients with these oral diseases. Key words:Lichen planus, anxiety, depression, burning mouth syndrome, recurrent aphthous stomatitis. PMID:25810851

A prospective observational study of pigmented naevi changes in psoriasis patients on biologic therapy.

PubMed

Choi, Seohee Deanne; D'Souza, Mario I; Menzies, Scott W; Weninger, Wolfgang

2018-05-23

Patients on biologic therapy are thought to be at increased risk of developing non-melanoma skin cancers and melanomas. It is unknown whether biologic therapy alters the natural history of melanocytic naevi. Therefore, a prospective observational study was conducted to determine whether psoriasis patients on biologic therapy develop changes in naevi. Clinical and dermoscopic assessment of all melanocytic naevi was performed in 45 psoriasis patients on biologic therapy versus a control cohort of 43 subjects, using sequential digital dermoscopic imaging and total body photography. The mean follow-up period was 1.5 years. The study and control patients had comparable age, gender, previous and family history of non-melanoma skin cancers and melanomas, as well as previous sun exposure and total number of naevi. The number of naevi with major dermoscopic changes was 3% in the study and 1.9% in the control group, with an adjusted incidence rate ratio of 1.45 (95% confidence interval 0.90-2.33; P = 0.125). The rate of minor changes was 15.9% in the study group versus 19.4% in the control (adjusted incidence rate ratio 0.77, 95% confidence interval 0.57-1.08; P = 0.14). There were six new dysplastic naevi in 4/45 biologic patients and four in 4/43 controls; however, the difference was not significant (relative risk 0.96, 95% confidence interval -0.12 to 0.12; P = 0.95). There were no melanomas in either group. Over a mean follow-up period of 1.5 years there was no evidence of significantly different changes in naevi or development of new dysplastic naevi in psoriasis patients on biologic treatment compared to controls. © 2018 The Australasian College of Dermatologists.

Blood coagulation system in patients with chronic kidney disease: a prospective observational study

PubMed Central

Huang, Meng-Jie; Wei, Ri-bao; Wang, Yang; Su, Ting-yu; Di, Ping; Li, Qing-ping; Yang, Xi; Li, Ping; Chen, Xiang-mei

2017-01-01

Objectives Thromboembolic events are the major factor affecting the prognosis of patients with chronic kidney disease (CKD). Haemostatic alterations are possible causes of these complications, but their roles remain poorly characterised. In the prospective observational study, we investigated the entire coagulation process in patients with CKD to elucidate the mechanisms of their high thromboembolic risk. Methods A total of 95 patients with CKD and 20 healthy controls who met the inclusion criteria were consecutively recruited from September 2015 to March 2016. The platelet count, platelet aggregation, von Willebrand factor antigen (vWF:Ag), vWF ristocetin cofactor activity (vWF:RCo), fibrinogen, factor V (FV), FVII, FVIII, antithrombin III, protein C, protein S, D-dimer, standard coagulation tests and thromboelastography were measured in patients with CKD and controls. Associations between the estimated glomerular filtration rate (eGFR) and haemostatic biomarkers were tested using multivariable linear regression. Results The adjusted and unadjusted levels of vWF:Ag, vWF:RCo, fibrinogen, FVII, FVIII and D-dimer were significantly higher in patients with CKD than that in the healthy controls, and were elevated with CKD progression. However, after adjustment for baseline differences, platelet aggregation and thromboelastography parameters showed no significant differences between patients with CKD and healthy controls. In the correlation analysis, vWF:Ag, vWF:RCo and FVIII were inversely associated with eGFR (r=−0.359, p<0.001; r=−0.391, p<0.001; r=−0.327, p<0.001, respectively). During the 1-year of follow-up, one cardiovascular event occurred in patients with CKD 5 stage, whereas no thromboembolic event occurred in the CKD 3 and 4 and control groups. Conclusions Patients with CKD are characterised by endothelial dysfunction and increased coagulation, especially FVIII activity. The abnormal haemostatic profiles may contribute to the elevated risk of thrombotic

Do heroin overdose patients require observation after receiving naloxone?

PubMed

Willman, Michael W; Liss, David B; Schwarz, Evan S; Mullins, Michael E

2017-02-01

Heroin use in the US has exploded in recent years, and heroin overdoses requiring naloxone are very common. After awakening, some heroin users refuse further treatment or transport to the hospital. These patients may be at risk for recurrent respiratory depression or pulmonary edema. In those transported to the emergency department, the duration of the observation period is controversial. Additionally, non-medical first responders and lay bystanders can administer naloxone for heroin and opioid overdoses. There are concerns about the outcomes and safety of this practice as well. To search the medical literature related to the following questions: (1) What are the medical risks to a heroin user who refuses ambulance transport after naloxone? (2) If the heroin user is treated in the emergency department with naloxone, how long must they be observed prior to discharge? (3) How effective in heroin users is naloxone administered by first responders and bystanders? Are there risks associated with naloxone distribution programs? We searched PubMed and GoogleScholar with search terms related to each of the questions listed above. The search was limited to English language and excluded patents and citations. The search was last updated on September 31, 2016. The articles found were reviewed for relevance to our objective questions. Eight out of 1020 citations were relevant to the first 2 questions, 5 of 707 were relevant to the third question and 15 of 287 were relevant to the fourth question. In the prehospital environment, does a heroin user revived with naloxone always require ambulance transport and what are the medical risks if ambulance transport is refused after naloxone? The eight articles were all observational studies done either prospectively or retrospectively. Two studies focused on heroin overdoses and included 1069 patients not transported to the hospital. No deaths occurred in this group. In counting the patients from all eight studies, some of which

Characterizing emergency admissions of patients with sickle cell crisis in NHS brent: observational study

PubMed Central

Green, Stuart A; AlJuburi, Ghida; Majeed, Azeem; Okoye, Ogo; Amobi, Carole; Banarsee, Ricky; Phekoo, Karen J

2012-01-01

Objectives To characterize emergency admissions for patients with sickle cell crisis in NHS Brent and to determine which patients and practices may benefit most from primary care intervention. Design Observational study Setting Emergency departments attended by residents of the London borough of Brent Participants Patients with sickle cell disease registered with a general practitioner (GP) in the borough of Brent Main outcome measures Analysis of admissions between January 2008 and July 2010 that included length of stay (average and <2 days versus ≥2 days) by age group and registered GP practice. Results Thirty six percent of sickle cell disease admission spells resulted in a length of stay of less than two days. Seventy four percent of total bed days are associated with patients with more than one admission during the period of analysis, i.e. multiple admissions. Two general practices in Brent were identified as having the highest number of patients admitted to the emergency department for sickle cell crisis and may benefit most from primary care intervention. Discussion Patients with short length of stay and multiple admissions may be potentially amenable to primary care intervention. The practices which have the highest numbers of sickle cell disease patients who frequently seek emergency care will be earmarked for an education intervention designed to help further engage general practitioners in the care and management of their sickle cell patients. PMID:22768371

Characterizing emergency admissions of patients with sickle cell crisis in NHS brent: observational study.

PubMed

Green, Stuart A; Aljuburi, Ghida; Majeed, Azeem; Okoye, Ogo; Amobi, Carole; Banarsee, Ricky; Phekoo, Karen J

2012-06-01

To characterize emergency admissions for patients with sickle cell crisis in NHS Brent and to determine which patients and practices may benefit most from primary care intervention. Observational study Emergency departments attended by residents of the London borough of Brent Patients with sickle cell disease registered with a general practitioner (GP) in the borough of Brent Analysis of admissions between January 2008 and July 2010 that included length of stay (average and <2 days versus ≥2 days) by age group and registered GP practice. Thirty six percent of sickle cell disease admission spells resulted in a length of stay of less than two days. Seventy four percent of total bed days are associated with patients with more than one admission during the period of analysis, i.e. multiple admissions. Two general practices in Brent were identified as having the highest number of patients admitted to the emergency department for sickle cell crisis and may benefit most from primary care intervention. Patients with short length of stay and multiple admissions may be potentially amenable to primary care intervention. The practices which have the highest numbers of sickle cell disease patients who frequently seek emergency care will be earmarked for an education intervention designed to help further engage general practitioners in the care and management of their sickle cell patients.

Characteristics and outcomes of patients admitted to Spanish ICU: A prospective observational study from the ENVIN-HELICS registry (2006-2011).

PubMed

Olaechea, P M; Álvarez-Lerma, F; Palomar, M; Gimeno, R; Gracia, M P; Mas, N; Rivas, R; Seijas, I; Nuvials, X; Catalán, M

2016-05-01

To describe the case-mix of patients admitted to intensive care units (ICUs) in Spain during the period 2006-2011 and to assess changes in ICU mortality according to severity level. Secondary analysis of data obtained from the ENVN-HELICS registry. Observational prospective study. Spanish ICU. Patients admitted for over 24h. None. Data for each of the participating hospitals and ICUs were recorded, as well as data that allowed to knowing the case-mix and the individual outcome of each patient. The study period was divided into two intervals, from 2006 to 2008 (period 1) and from 2009 to 2011 (period 2). Multilevel and multivariate models were used for the analysis of mortality and were performed in each stratum of severity level. The study population included 142,859 patients admitted to 188 adult ICUs. There was an increase in the mean age of the patients and in the percentage of patients >79 years (11.2% vs. 12.7%, P<0.001). Also, the mean APACHE II score increased from 14.35±8.29 to 14.72±8.43 (P<0.001). The crude overall intra-UCI mortality remained unchanged (11.4%) but adjusted mortality rate in patients with APACHE II score between 11 and 25 decreased modestly in recent years (12.3% vs. 11.6%, odds ratio=0.931, 95% CI 0.883-0.982; P=0.008). This study provides observational longitudinal data on case-mix of patients admitted to Spanish ICUs. A slight reduction in ICU mortality rate was observed among patients with intermediate severity level. Copyright © 2015 Elsevier España, S.L.U. and SEMICYUC. All rights reserved.

Highly Prevalent Hyperuricaemia is Associated with Adverse Clinical Outcomes Among Ghanaian Stroke Patients: An Observational Prospective Study.

PubMed

Sarfo, F S; Akassi, J; Antwi, N K B; Obese, V; Adamu, S; Akpalu, A; Bedu-Addo, G

2015-09-01

Although a direct causal relationship between hyperuricaemia and stroke continues to be debated, strong associations between serum uric acid (SUA) and cerebrovascular disease exist. Very few studies have been conducted to evaluate the frequency and association between this potentially modifiable biomarker of vascular risk and stroke in sub-Saharan Africa. Therefore the aim of this study was to examine the association between hyperuricaemia and the traditional risk factors and the outcomes of stroke in Ghanaian patients. In this prospective observational study, 147 patients presenting with stroke at a tertiary referral centre in Ghana were consecutively recruited. Patients were screened for vascular risk factors and SUA concentrations measured after an overnight fast. Associations between hyperuricaemia and stroke outcomes were analysed using Kaplan-Meier and Cox proportional hazards regression analysis. The frequency of hyperuricaemia among Ghanaian stroke patients was 46.3%. Non-significant associations were observed between hyperuricaemia and the traditional risk factors of stroke. SUA concentration was positively correlated with stroke severity and associated with early mortality after an acute stroke with unadjusted hazards ratio of 2.3 (1.4 - 4.2, p=0.001). A potent and independent dose-response association between increasing SUA concentration and hazard of mortality was found on Cox proportional hazards regression, aHR (95% CI) of 1.65 (1.14-2.39), p=0.009 for each 100µmol/l increase in SUA. Hyperuricaemia is highly frequent and associated with adverse functional outcomes among Ghanaian stroke patients. Further studies are warranted to determine whether reducing SUA levels after a stroke would be beneficial within our setting.

Association between painful physical symptoms and clinical outcomes in East Asian patients with major depressive disorder: a 3-month prospective observational study.

PubMed

Ang, Q Q; Wing, Y K; He, Y; Sulaiman, A H; Chiu, N-Y; Shen, Y-C; Wang, G; Zhang, C; Lee, K-H; Singh, P; Granger, R E; Raskin, J; Dossenbach, M

2009-07-01

Reports from non-Asian populations indicate that painful physical symptoms (PPS) are associated with poorer clinical and functional outcomes in major depressive disorder (MDD). The purpose of this study is to report comparative changes in disease severity, treatment patterns and quality of life observed in East Asian patients with MDD, with and without PPS, as assessed prospectively over a 3-month observation period. This observational study enrolled 909 patients with MDD in psychiatric care settings in China, Hong Kong, Korea, Malaysia, Singapore and Taiwan. Patients were classified as PPS positive (PPS+) or negative (PPS-) based on mean modified Somatic Symptom Inventory scores of >or= 2 or < 2 respectively. The Clinical Global Impression of Severity (CGI-S) and 17-item Hamilton Depression Rating Scale (HAMD(17)) determined depression severity; a visual analogue scale (VAS) determined pain severity; and the EuroQoL (EQ-5D) assessed well-being after 3 months observation. Of the 909 enrollees, 355/471 (75.4%) of PPS+ patients and 363/438 (82.9%) of PPS- patients completed the study (p = 0.006). PPS+ patients improved less than PPS- patients on depression, pain and quality of life measures during the study (HAMD(17) p < 0.001, CGI-S p < 0.001, VAS p = 0.008 and EQ-5D p = 0.004). Fewer PPS+ patients (46.5%) achieved remission compared with PPS- patients (69.4%, p < 0.001). As the presence of PPS is associated with poorer outcomes in East Asian MDD patients, clinical management should aim to address both the mental and PPS associated with MDD.

Discontinuation of tofacitinib after achieving low disease activity in patients with rheumatoid arthritis: a multicentre, observational study.

PubMed

Kubo, Satoshi; Yamaoka, Kunihiro; Amano, Koichi; Nagano, Shuji; Tohma, Shigeto; Suematsu, Eiichi; Nagasawa, Hayato; Iwata, Kanako; Tanaka, Yoshiya

2017-08-01

To determine whether tofacitinib can be discontinued in patients with RA who achieve low disease activity (LDA). RA patients with LDA after tofacitinib treatment in a phase III and long-term extension study were enrolled in this multicentre, non-randomized, open, prospective, observational study. The decision of discontinuation or continuation of tofacitinib was determined based on patient-physician decision making with informed consent. The primary endpoint was the proportion of patients who remained tofacitinib-free at post-treatment week 52. Clinical outcome was compared between those who continued and those who discontinued tofacitinib. The last observation carried forward method was used for patients who could not discontinue tofacitinib before week 52. Of 64 patients, 54 discontinued and 10 continued tofacitinib therapy. At post-treatment week 52, 20 of the 54 patients (37%) of the discontinuation group remained tofacitinib-free without disease flare. Disease activity at post-treatment week 52 was higher in the discontinuation group than the continuation group. Among the discontinuation group, the RF titre at baseline was significantly lower in patients who remained tofacitinib-free than those who did not (40 vs 113 U/ml). In fact, a higher proportion of patients with lower RF remained tofacitinib-free at week 52 compared with those with higher RF at baseline. In patients who could not achieve tofacitinib-free status, re-initiation of tofacitinib or other biologics improved disease activity. It is possible to discontinue tofacitinib without flare in about a third of patients with RA. A low RF predicts maintenance of LDA after discontinuation of tofacitinib. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com

An observational study on patient admission in the anaesthesia gas monitor and minimum alveolar concentration monitoring: A deficiency with huge impact

PubMed Central

Karim, Habib Md Reazaul; Narayan, Anilkumar; Yunus, Md; Kumar, Sanjay; Prakash, Avinash; Sahoo, Sarasa Kumar

2017-01-01

Background and Aims: Minimum alveolar concentration (MAC) monitoring is an integral part of modern-day anaesthesia. Both MAC and MAC-awake are age dependant, and age of the patient needs to be entered in the monitor. This study was aimed to assess the practice of patient birth year entry in the anaesthesia monitor and its impact on MAC monitoring. Methods: Sixty volatile anaesthetic-based general anaesthetics (GAs) were observed silently in two tertiary care teaching hospitals with regard to ‘birth year’ entry in the patient monitor. The impact on MAC for non-entry of age was assessed. The observed MAC reading and the MAC corrected for age (MACage) of the patients were noted. Paired t-test was used to compare the differences in observed MAC and MACage values. P <0.05 was significant. Results: Sixty GAs of patients aged between 10 and 68 years were observed; 96.67% anaesthetics were conducted without entering ‘birth year’. Thirty-four patients (mean age 35.14 ± 15.38 years) were further assessed for impact of non-entry of age. The observed MAC was similar to MACage in patients aged 40 ± 5 years (36–45 years group). Nearly 79.41% of the observed MACs were incorrect; 55.88% patients were potentially underdosed whereas 23.53% were overdosed. Conclusion: Omitting patient age entry in the monitor results in erroneous MAC values, exposing patients <40 years to underdosing and older patients to overdose. PMID:28794529

Is directly observed tuberculosis treatment strategy patient-centered? A mixed method study in Addis Ababa, Ethiopia

PubMed Central

Getahun, Belete; Nkosi, Zethu Zerish

2017-01-01

Introduction The directly observed treatment, short course (DOTS) strategy has been considered as an efficacious approach for better tuberculosis (TB) treatment adherence and outcome. However, its level of patient centerdness has not been studied and documented well. Hence, the study aimed to determine the level of patient centeredness’ of the DOTS. Method The study used explanatory sequential mixed method design in Addis Ababa, Ethiopia. The study employed an interviewer-administered questionnaire with 601 patients with TB, focus group discussions with 23 TB experts, and telephonic-interview with 25 persons lost to follow-up from TB treatment. Descriptive and multivariable analyses carried out for the quantitative data while thematic analysis was used for the qualitative data. Result Forty percent of patients with TB had not received patient-centered TB care (PC-TB care) with DOTS. Male gender (AOR = 0.45, 95% CI 0.3, 0.7), good communication (AOR = 3.2, 95%CI 1.6, 6.1), and health care providers as a treatment supporter (AOR = 3.4, 95% CI 2.1, 5.48) had significant associations with PC-TB care. All persons lost to follow-up and TB experts perceived that DOTS is merely patient-centered. The identified categories were patient preferences, treatment supporter choice, integration of DOTS with nutritional support, mental health, and transport services, provider’s commitment and communication skills. Conclusion DOTS is limited to provide patient-centered TB care. Hence, DOTS needs a model that enhances effectiveness towards patient centeredness of TB care. PMID:28763456

MicroDAIMON study: Microcirculatory DAIly MONitoring in critically ill patients: a prospective observational study.

PubMed

Scorcella, Claudia; Damiani, Elisa; Domizi, Roberta; Pierantozzi, Silvia; Tondi, Stefania; Carsetti, Andrea; Ciucani, Silvia; Monaldi, Valentina; Rogani, Mara; Marini, Benedetto; Adrario, Erica; Romano, Rocco; Ince, Can; Boerma, E Christiaan; Donati, Abele

2018-05-15

Until now, the prognostic value of microcirculatory alterations in critically ill patients has been mainly evaluated in highly selected subgroups. Aim of this study is to monitor the microcirculation daily in mixed group of Intensive Care Unit (ICU)-patients and to establish the association between (the evolution of) microcirculatory alterations and outcome. This is a prospective longitudinal observational single-centre study in adult patients admitted to a 12-bed ICU in an Italian teaching hospital. Sublingual microcirculation was evaluated daily, from admission to discharge/death, using Sidestream Dark Field imaging. Videos were analysed offline to assess flow and density variables. Laboratory and clinical data were recorded simultaneously. A priori, a Microvascular Flow Index (MFI) < 2.6 was defined as abnormal. A binary logistic regression analysis was performed to evaluate the association between microcirculatory variables and outcomes; a Kaplan-Meier survival curve was built. Outcomes were ICU and 90-day mortality. A total of 97 patients were included. An abnormal MFI was present on day 1 in 20.6%, and in 55.7% of cases during ICU admission. Patients with a baseline MFI < 2.6 had higher ICU, in-hospital and 90-day mortality (45 vs. 15.6%, p = 0.012; 55 vs. 28.6%, p = 0.035; 55 vs. 26%, p = 0.017, respectively). An independent association between baseline MFI < 2.6 and outcome was confirmed in a binary logistic analysis (odds ratio 4.594 [1.340-15.754], p = 0.015). A heart rate (HR) ≥ 90 bpm was an adjunctive predictor of mortality. However, a model with stepwise inclusion of mean arterial pressure < 65 mmHg, HR ≥ 90 bpm, lactate > 2 mmol/L and MFI < 2.6 did not detect significant differences in ICU mortality. In case an abnormal MFI was present on day 1, ICU mortality was significantly higher in comparison with patients with an abnormal MFI after day 1 (38 vs. 6%, p = 0.001), indicating a time

An observational study to evaluate the clinical practice of cardiovascular risk management among hypertensive patients in Turkey.

PubMed

Kozan, Omer

2011-09-01

We evaluated clinical practice in cardiovascular risk management and related patient compliance among Turkish hypertensive patients. This noninterventional, observational study included 1023 patients (620 women, 403 men; mean age 58.4 ± 10.6 years) with essential hypertension, from 50 centers across Turkey. Patients were evaluated at a cross-sectional phase and a follow-up phase of nine months. Data obtained at the cross-sectional phase included patient demographics, medical and past history, cardiovascular risk status, and current practice patterns regarding cardiovascular risk management. The mean duration of hypertension was 8.1 ± 7.1 years. The mean body mass index was 30.3 ± 5.2 kg/m2 and systolic and diastolic blood pressures (BP) were 147.8 ± 22.4 and 88.9 ± 12.5 mmHg, respectively. Ten-year coronary heart disease risk and risk level were significantly higher in males, and significantly increased in the presence of diabetes, metabolic syndrome, and renal disease and/or microalbuminuria (p<0.05). In past year history of cardiovascular risk management, 7.3% of the patients did not have BP measurements; no diet was recommended to 15.6%; 79.3% had high BP levels, and patient compliance with antihypertensive drug treatment and dietary recommendations were 87.7% and 62.5%, respectively. A similar profile was observed for dyslipidemia and diabetes mellitus. The physicians' efforts to motivate the patients to quit smoking, to lose weight, and involve in physical exercise were far below satisfactory levels, and the patients' compliance rates with these recommendations were even lower. Our study demonstrates that hypertensive patients are not adequately evaluated for cardiovascular risk, which is significantly increased in the presence of various cardiovascular risk factors such as diabetes, metabolic syndrome, and renal disease.

Adjunctive Corticosteroids for Pneumocystis jirovecii Pneumonia in Non-HIV-infected Patients: A Systematic Review and Meta-analysis of Observational Studies.

PubMed

Fujikura, Yuji; Manabe, Toshie; Kawana, Akihiko; Kohno, Shigeru

2017-02-01

The clinical benefits of adjunctive corticosteroids for Pneumocystis jirovecii (P. jirovecii) pneumonia in patients not infected with the human immunodeficiency virus (HIV) has not been evaluated by meta-analysis. We conducted a systematic review of published studies describing the effects of adjunctive corticosteroids on outcome in non-HIV P. jirovecii pneumonia patients. Two investigators independently searched the PubMed and Cochrane databases for eligible articles written in English. A meta-analysis was performed using a random-effects model for measuring mortality as the primary outcome, and the need for intubation or mechanical ventilation as the secondary outcome. Seven observational studies were eligible. In these studies, adjunctive corticosteroids did not affect mortality in non-HIV patients (odds ratio [OR] 1.26; 95% CI 0.60-2.67) and there was no beneficial effect in patients with severe hypoxemia (PaO 2 <70mmHg) (OR 0.90; 95% CI 0.44-1.83). No significant effect on the secondary outcome was observed (OR 1.34; 95% CI 0.44-4.11). Although the studies were observational, meta-analysis showed that adjunctive corticosteroids did not improve the outcome of P. jirovecii pneumonia in non-HIV patients. The results warrant a randomized controlled trial. Copyright © 2016 SEPAR. Publicado por Elsevier España, S.L.U. All rights reserved.

Sequential compression devices in postoperative urologic patients: an observational trial and survey study on the influence of patient and hospital factors on compliance

PubMed Central

2013-01-01

Background Sequential compression devices (SCDs) are commonly used for thromboprophylaxis in postoperative patients but compliance is often poor. We investigated causes for noncompliance, examining both hospital and patient related factors. Methods 100 patients undergoing inpatient urologic surgery were enrolled. All patient had SCD sleeves placed preoperatively. Postoperative observations determined SCD compliance and reasons for non-compliance. Patient demographics, length of stay, inpatient unit type, and surgery type were recorded. At discharge, a patient survey gauged knowledge and attitudes regarding SCDs and bother with SCDs. Statistical analysis was performed to correlate SCD compliance with patient demographics; patient knowledge and attitudes regarding SCDs; and patient self-reported bother with SCDs. Results Observed overall compliance was 78.6%. The most commonly observed reasons for non-compliance were SCD machines not being initially available on the ward (71% of non-compliant observations on post-operative day 1) and SCD use not being restarted promptly after return to bed (50% of non-compliant observations for entire hospital stay). Mean self-reported bother scores related to SCDs were low, ranging from 1–3 out of 10 for all 12 categories of bother assessed. Patient demographics, knowledge, attitudes and bother with SCD devices were not significantly associated with non-compliance. Conclusions Patient self-reported bother with SCD devices was low. Hospital factors, including SCD machine availability and timely restarting of devices by nursing staff when a patient returns to bed, played a greater role in SCD non-compliance than patient factors. Identifying and addressing hospital related causes for poor SCD compliance may improve postoperative urologic patient safety. PMID:23578129

Sequential compression devices in postoperative urologic patients: an observational trial and survey study on the influence of patient and hospital factors on compliance.

PubMed

Ritsema, David F; Watson, Jennifer M; Stiteler, Amanda P; Nguyen, Mike M

2013-04-11

Sequential compression devices (SCDs) are commonly used for thromboprophylaxis in postoperative patients but compliance is often poor. We investigated causes for noncompliance, examining both hospital and patient related factors. 100 patients undergoing inpatient urologic surgery were enrolled. All patient had SCD sleeves placed preoperatively. Postoperative observations determined SCD compliance and reasons for non-compliance. Patient demographics, length of stay, inpatient unit type, and surgery type were recorded. At discharge, a patient survey gauged knowledge and attitudes regarding SCDs and bother with SCDs. Statistical analysis was performed to correlate SCD compliance with patient demographics; patient knowledge and attitudes regarding SCDs; and patient self-reported bother with SCDs. Observed overall compliance was 78.6%. The most commonly observed reasons for non-compliance were SCD machines not being initially available on the ward (71% of non-compliant observations on post-operative day 1) and SCD use not being restarted promptly after return to bed (50% of non-compliant observations for entire hospital stay). Mean self-reported bother scores related to SCDs were low, ranging from 1-3 out of 10 for all 12 categories of bother assessed. Patient demographics, knowledge, attitudes and bother with SCD devices were not significantly associated with non-compliance. Patient self-reported bother with SCD devices was low. Hospital factors, including SCD machine availability and timely restarting of devices by nursing staff when a patient returns to bed, played a greater role in SCD non-compliance than patient factors. Identifying and addressing hospital related causes for poor SCD compliance may improve postoperative urologic patient safety.

Clinical impact of negative-pressure wound therapy: a 1,126-patient observational prospective study.

PubMed

Téot, Luc; Guillot-Masanovic, Margot; Miquel, Pierre; Truchetet, François; Meaume, Sylvie; Dompmartin, Anne; Charles Kerihuel, Jean; Trial, Chloé; Faure, Christine

2014-01-01

Negative-pressure wound therapy (NPWT) was developed in the early 1990s and reported in 1997 by Argenta and Morykwas. Ignored at first, this technique progressively came to be considered as an outstanding advancement in reconstructive surgery. Several randomized controlled studies produced evidence for the effect of NPWT on promotion of granulation tissue formation and prevention of tissue damage and amputation. However, no important longitudinal study has yet produced clinical and economic data on the consequences of integrating NPWT into practice in multiple institutions. This prospective, comparative longitudinal study of NPWT as a clinical-practice innovation was conducted in 1,126 patients between March 2006 and June 2009 in 30 university and nonuniversity public and private hospitals in France. NPWT was proposed in a nonrandomized fashion for various clinical indications, and the patients were divided into two groups, one using NPWT, the second using standard care. Efficacy criteria were spontaneous closure, closure after surgical coverage using skin grafts or flaps, or achievement of 40% wound area regression. The results, observed in a pragmatic but not randomized study, are suggestive of a favorable impact of NPWT in multiple clinical situations. The significance of differences between surgical patients who underwent NPWT and those who did not was unclear, as NPWT had already been adopted by most of the surgical wards. © 2014 by the Wound Healing Society.

Effect of donepezil in patients with Alzheimer's disease previously untreated or treated with memantine or nootropic agents in Germany: an observational study.

PubMed

Klinger, Tatjana; Ibach, Bernd; Schoenknecht, Peter; Kamleiter, Martin; Silver, Gabrielle; Schroeder, Johannes; Mielke, Ruediger

2005-05-01

This open-label, prospective, observational, Post-Marketing Surveillance (PMS) study assessed the efficacy and safety of donepezil in patients who had been switched from therapies currently used in Germany to treat Alzheimer's disease (AD), such as memantine and nootropics, due to insufficient efficacy or poor tolerability. A treatment-naive population was included as a comparator. Patients with AD were treated with donepezil and observed for a period of approximately 3 months. A cognitive assessment was made using the Mini-Mental State Examination (MMSE). Quality of life (QoL) was assessed by the investigators who answered the question 'How did therapy with donepezil influence the QoL of the patient and/or his family over the observation period?' and was graded using three ratings: improved/unchanged/worsened. Adverse events (AEs) were also monitored. A total of 913 patients entered the study (mean +/- SD MMSE score 18.03 +/- 5.34). Efficacy assessments were analyzed for three groups: an overall group of patients who had received any form of prior AD drug therapy (N+ group; n = 709); a subgroup of patients from the N+ group who had received prior memantine therapy only (M+ group; n = 111) and patients who were drug treatment naive (N- group; n = 204). In the evaluable population donepezil improved MMSE scores by 2.21 +/- 3.47 points on average, with similar improvements observed in all three groups. QoL was judged to be improved in at least 70% of patients, again with similar results obtained for all three groups. Donepezil was well tolerated, with 85 of 913 (9.3%) patients reporting AEs. The most common AEs were those typically seen with cholinergic therapies (i.e., diarrhoea, vomiting and nausea). In this observational PMS study, donepezil was shown to be efficacious and well tolerated in patients who were being insufficiently treated with memantine or nootropic therapy. The magnitude of response was similar to that observed in patients who were previously

A clinical observational study on patient-reported outcomes, hip functional performance and return to sports activities in hip arthroscopy patients.

PubMed

Tijssen, Marsha; van Cingel, Robert; de Visser, Enrico; Nijhuis-van der Sanden, Maria

2016-07-01

To describe data of short- and midterm results of hip arthroscopy patients based on patient-reported hip function, hip functional performance and return to sports activities. Observational cohort study. Sports medical center. 37 recreational athletes (21 men) at least six months after finishing rehabilitation for hip arthroscopy. International Hip Outcome Tool 33 (IHOT-33), Pain Visual Analogue Scale (VAS), Global Perceived Effect Scale (GPE), sports questionnaires and hip functional performance tests. At a mean follow-up time of 2.3 years, 81% of participants reported improvement on the GPE and 84% returned to sports activities. The mean IHOT-33 score was 69.3; the mean VAS score was 35.0. Range of motion (ROM) and strength were within the 90% Limb Symmetry Index (LSI) limit, except for hip internal rotation ROM. A full recovery of hip functional performance, as measured with balance and hop tests, was established based on the 90% LSI limit. The overall short- and midterm results of these follow-up data show good recovery of hip arthroscopy patients on patient-reported outcomes, functional performance and return to sports activities. The functional performance tests used in this study seem adequate for measuring recovery in hip arthroscopy patients. Copyright © 2016 Elsevier Ltd. All rights reserved.

Verbal and non-verbal behaviour and patient perception of communication in primary care: an observational study.

PubMed

Little, Paul; White, Peter; Kelly, Joanne; Everitt, Hazel; Gashi, Shkelzen; Bikker, Annemieke; Mercer, Stewart

2015-06-01

Few studies have assessed the importance of a broad range of verbal and non-verbal consultation behaviours. To explore the relationship of observer ratings of behaviours of videotaped consultations with patients' perceptions. Observational study in general practices close to Southampton, Southern England. Verbal and non-verbal behaviour was rated by independent observers blind to outcome. Patients competed the Medical Interview Satisfaction Scale (MISS; primary outcome) and questionnaires addressing other communication domains. In total, 275/360 consultations from 25 GPs had useable videotapes. Higher MISS scores were associated with slight forward lean (an 0.02 increase for each degree of lean, 95% confidence interval [CI] = 0.002 to 0.03), the number of gestures (0.08, 95% CI = 0.01 to 0.15), 'back-channelling' (for example, saying 'mmm') (0.11, 95% CI = 0.02 to 0.2), and social talk (0.29, 95% CI = 0.4 to 0.54). Starting the consultation with professional coolness ('aloof') was helpful and optimism unhelpful. Finishing with non-verbal 'cut-offs' (for example, looking away), being professionally cool ('aloof'), or patronising, ('infantilising') resulted in poorer ratings. Physical contact was also important, but not traditional verbal communication. These exploratory results require confirmation, but suggest that patients may be responding to several non-verbal behaviours and non-specific verbal behaviours, such as social talk and back-channelling, more than traditional verbal behaviours. A changing consultation dynamic may also help, from professional 'coolness' at the beginning of the consultation to becoming warmer and avoiding non-verbal cut-offs at the end. © British Journal of General Practice 2015.

Age and sex of surgeons and mortality of older surgical patients: observational study

PubMed Central

Jena, Anupam B; Orav, E John; Blumenthal, Daniel M; Tsai, Thomas C; Mehtsun, Winta T; Jha, Ashish K

2018-01-01

Abstract Objective To investigate whether patients’ mortality differs according to the age and sex of surgeons. Design Observational study. Setting US acute care hospitals. Participants 100% of Medicare fee-for-service beneficiaries aged 65-99 years who underwent one of 20 major non-elective surgeries between 2011 and 2014. Main outcome measure Operative mortality rate of patients, defined as death during hospital admission or within 30 days of the operative procedure, after adjustment for patients’ and surgeons’ characteristics and indicator variables for hospitals. Results 892 187 patients who were treated by 45 826 surgeons were included. Patients’ mortality was lower for older surgeons than for younger surgeons: the adjusted operative mortality rates were 6.6% (95% confidence interval 6.5% to 6.7%), 6.5% (6.4% to 6.6%), 6.4% (6.3% to 6.5%), and 6.3% (6.2% to 6.5%) for surgeons aged under 40 years, 40-49 years, 50-59 years, and 60 years or over, respectively (P for trend=0.001). There was no evidence that adjusted operative mortality differed between patients treated by female versus male surgeons (adjusted mortality 6.3% for female surgeons versus 6.5% for male surgeons; adjusted odds ratio 0.97, 95% confidence interval 0.93 to 1.01). After stratification by sex of surgeon, patients’ mortality declined with age of surgeon for both male and female surgeons (except for female surgeons aged 60 or older); female surgeons in their 50s had the lowest operative mortality. Conclusion Using national data on Medicare beneficiaries in the US, this study found that patients treated by older surgeons had lower mortality than patients treated by younger surgeons. There was no evidence that operative mortality differed between male and female surgeons. PMID:29695473

From randomized controlled trials to observational studies.

PubMed

Silverman, Stuart L

2009-02-01

Randomized controlled trials are considered the gold standard in the hierarchy of research designs for evaluating the efficacy and safety of a treatment intervention. However, their results can have limited applicability to patients in clinical settings. Observational studies using large health care databases can complement findings from randomized controlled trials by assessing treatment effectiveness in patients encountered in day-to-day clinical practice. Results from these designs can expand upon outcomes of randomized controlled trials because of the use of larger and more diverse patient populations with common comorbidities and longer follow-up periods. Furthermore, well-designed observational studies can identify clinically important differences among therapeutic options and provide data on long-term drug effectiveness and safety.

Blood coagulation system in patients with chronic kidney disease: a prospective observational study.

PubMed

Huang, Meng-Jie; Wei, Ri-Bao; Wang, Yang; Su, Ting-Yu; Di, Ping; Li, Qing-Ping; Yang, Xi; Li, Ping; Chen, Xiang-Mei

2017-06-01

Thromboembolic events are the major factor affecting the prognosis of patients with chronic kidney disease (CKD). Haemostatic alterations are possible causes of these complications, but their roles remain poorly characterised. In the prospective observational study, we investigated the entire coagulation process in patients with CKD to elucidate the mechanisms of their high thromboembolic risk. A total of 95 patients with CKD and 20 healthy controls who met the inclusion criteria were consecutively recruited from September 2015 to March 2016. The platelet count, platelet aggregation, von Willebrand factor antigen (vWF:Ag), vWF ristocetin cofactor activity (vWF:RCo), fibrinogen, factor V (FV), FVII, FVIII, antithrombin III, protein C, protein S, D-dimer, standard coagulation tests and thromboelastography were measured in patients with CKD and controls. Associations between the estimated glomerular filtration rate (eGFR) and haemostatic biomarkers were tested using multivariable linear regression. The adjusted and unadjusted levels of vWF:Ag, vWF:RCo, fibrinogen, FVII, FVIII and D-dimer were significantly higher in patients with CKD than that in the healthy controls, and were elevated with CKD progression. However, after adjustment for baseline differences, platelet aggregation and thromboelastography parameters showed no significant differences between patients with CKD and healthy controls. In the correlation analysis, vWF:Ag, vWF:RCo and FVIII were inversely associated with eGFR (r=-0.359, p<0.001; r=-0.391, p<0.001; r=-0.327, p<0.001, respectively). During the 1-year of follow-up, one cardiovascular event occurred in patients with CKD 5 stage, whereas no thromboembolic event occurred in the CKD 3 and 4 and control groups. Patients with CKD are characterised by endothelial dysfunction and increased coagulation, especially FVIII activity. The abnormal haemostatic profiles may contribute to the elevated risk of thrombotic events but further longer-term study with

Conversations between community-based neurologists and patients with epilepsy: results of an observational linguistic study.

PubMed

Gilliam, Frank; Penovich, Patricia E; Eagan, Corey A; Stern, John M; Labiner, David M; Onofrey, Meaghan; Holmes, Gregory L; Mathis, Eileen; Cramer, Joyce

2009-10-01

An in-office linguistic study was conducted to assess neurologist-patient discussions of epilepsy. Naturally occurring interactions among 20 neurologists and 60 of their patients with epilepsy were recorded. Participants were interviewed separately postvisit. Transcripts were analyzed using sociolinguistic techniques. Of 59 patients taking antiepileptic drugs previsit, 44 (75%) discussed side effects with their neurologist. Side effect discussions were most often neurologist initiated. Postvisit, patients and neurologists often disagreed about which side effects were experienced. The presence of a caregiver (e.g., spouse) usually resulted in lengthier, more detailed discussions of side effects, without drastically increasing overall visit length. Discussions of mood- and behavior-related comorbidities occurred infrequently (14 of 60 visits); postvisit, neurologists stated that they felt that management of these conditions was outside their area of expertise. Communication gaps observed in discussions of epilepsy and its treatment warrant further exploration. Additional research is currently underway to assess the efficacy of a previsit assessment tool.

Effect of low-dose aspirin use on survival of patients with gastrointestinal malignancies; an observational study

PubMed Central

Frouws, M A; Bastiaannet, E; Langley, R E; Chia, W K; van Herk-Sukel, M P P; Lemmens, V E P P; Putter, H; Hartgrink, H H; Bonsing, B A; Van de Velde, C J H; Portielje, J E A; Liefers, G J

2017-01-01

Background: Previous studies suggested a relationship between aspirin use and mortality reduction. The mechanism for the effect of aspirin on cancer outcomes remains unclear. The aim of this study was to evaluate aspirin use and survival in patients with gastrointestinal tract cancer. Methods: Patients with gastrointestinal tract cancer diagnosed between 1998 and 2011 were included. The population-based Eindhoven Cancer Registry was linked to drug-dispensing data from the PHARMO Database Network. The association between aspirin use after diagnosis and overall survival was analysed using Cox regression models. Results: In total, 13 715 patients were diagnosed with gastrointestinal cancer. A total of 1008 patients were identified as aspirin users, and 8278 patients were identified as nonusers. The adjusted hazard ratio for aspirin users vs nonusers was 0.52 (95% CI 0.44–0.63). A significant association between aspirin use and survival was observed for patients with oesophageal, hepatobiliary and colorectal cancer. Conclusions: Post-diagnosis use of aspirin in patients with gastrointestinal tract malignancies is associated with increased survival in cancers with different sites of origin and biology. This adds weight to the hypothesis that the anti-cancer effects of aspirin are not tumour-site specific and may be modulated through the tumour micro-environment. PMID:28072768

Sleep Quality Improves During Treatment With Bryophyllum pinnatum: An Observational Study on Cancer Patients.

PubMed

Simões-Wüst, Ana Paula; Hassani, Taziri Al; Müller-Hübenthal, Boris; Pittl, Sandra; Kuck, Angela; Meden, Harald; Eberhard, Jutta; Decker, Michael; Fürer, Karin; von Mandach, Ursula

2015-09-01

Cancer patients frequently suffer from poor sleep quality. Bryophyllum pinnatum is a herbal medication used in anthroposophic medicine, which has been shown to be associated with improvements in sleep quality during pregnancy with only few and minor or moderate side-effects reported. In this study, the sleep quality of cancer patients during treatment with B pinnatum was investigated. In this prospective, observational study, cancer patients suffering from sleep problems were treated with B pinnatum (350 mg tablets, corresponding to 50% of leaf pressed juice [Weleda AG, Arlesheim, Switzerland], dosage at physician's consideration, but most frequently 2 tablets with evening meal and 2 before going to bed). Sleep quality (Pittsburgh Sleep Quality Index [PSQI]), daily sleepiness (Epworth Sleeping Scale [ESS]), and fatigue (Fatigue Severity Scale [FSS]) were assessed at the beginning of the treatment and after 3 weeks. Possible adverse drug reactions perceived by the patients during the treatment were recorded. From the 28 recruited patients, 20 completed both questionnaires and were considered in the present analysis. Data are expressed as mean ± standard deviation. Patients were 61 ± 10.4 years old and the majority were female (17 out of 20). During treatment with B pinnatum, the PSQI decreased from 12.2 ± 3.62 to 9.1 ± 3.61 (P < .01), and ESS changed from 8.4 ± 3.18 to 7.1 ± 3.98 (P < .05). There was no change in FSS. The treatment was well tolerated by the majority of patients, with only 6 patients reporting discomfort that might have been caused by B pinnatum (fatigue n = 3, dry throat n = 1, agitation n = 1, difficult digestion n = 1). No serious adverse drug reactions were detected. B pinnatum may be a suitable treatment for sleep problems of cancer patients. Controlled, randomized clinical trials of the use of B pinnatum in sleep disorders are urgently needed. © The Author(s) 2015.

Lymphoproliferative disorders in patients receiving thiopurines for inflammatory bowel disease: a prospective observational cohort study.

PubMed

Beaugerie, Laurent; Brousse, Nicole; Bouvier, Anne Marie; Colombel, Jean Frédéric; Lémann, Marc; Cosnes, Jacques; Hébuterne, Xavier; Cortot, Antoine; Bouhnik, Yoram; Gendre, Jean Pierre; Simon, Tabassome; Maynadié, Marc; Hermine, Olivier; Faivre, Jean; Carrat, Fabrice

2009-11-07

Reports of an increased risk of lymphoproliferative disorders in patients receiving thiopurines for inflammatory bowel disease are controversial. We assessed this risk in a prospective observational cohort study. 19,486 patients with inflammatory bowel disease, of whom 11,759 (60.3%) had Crohn's disease and 7727 (39.7%) had ulcerative colitis or unclassified inflammatory bowel disease, were enrolled in a nationwide French cohort by 680 gastroenterologists, who reported details of immunosuppressive therapy during the observation period, cases of cancer, and deaths. The risk of lymphoproliferative disorder was assessed according to thiopurine exposure. Median follow-up was 35 months (IQR 29-40). At baseline, 5867 (30.1%) of patients were receiving, 2809 (14.4%) had discontinued, and 10,810 (55.5%) had never received thiopurines. 23 new cases of lymphoproliferative disorder were diagnosed, consisting of one case of Hodgkin's lymphoma and 22 cases of non-Hodgkin lymphoproliferative disorder. The incidence rates of lymphoproliferative disorder were 0.90 per 1000 (95% CI 0.50-1.49) patient-years in those receiving, 0.20/1000 (0.02-0.72) patient-years in those who had discontinued, and 0.26/1000 (0.10-0.57) patient-years in those who had never received thiopurines (p=0.0054). The multivariate-adjusted hazard ratio of lymphoproliferative disorder between patients receiving thiopurines and those who had never received the drugs was 5.28 (2.01-13.9, p=0.0007). Most cases associated with thiopurine exposure matched the pathological range of post-transplant disease. Patients receiving thiopurines for inflammatory bowel disease have an increased risk of developing lymphoproliferative disorders. Programme Hospitalier de Recherche Clinique National (AOM05157), Association François Aupetit, Délégation Inter-régionale de la Recherche clinique Ile de France-Assistance Publique Hôpitaux de Paris (AP-HP), Ligue contre le Cancer, and Fonds de Recherche de la Société Nationale

Incidence, predictors and outcomes of postoperative coma: an observational study of 858,606 patients.

PubMed

Newman, Jessica; Blake, Kathryn; Fennema, Jordan; Harris, David; Shanks, Amy; Avidan, Michael S; Kelz, Max B; Mashour, George A

2013-08-01

Coma is a state of profound unresponsiveness that can occur as a serious perioperative complication. The study of risk factors for, and sequelae of, postoperative coma has been limited due to the rarity of the event. To determine the incidence, risk factors and impact of postoperative coma in a large patient population. Observational study using a prospectively gathered national dataset. Data from 858 606 patients were analysed. The incidence of postoperative coma of more than 24-h duration was identified. Logistic regression was used to identify independent predictors and develop a risk model of postoperative coma in derivation and validation cohorts; 30-day mortality was also analysed. The incidence of postoperative coma was 0.06%. Multivariate analysis revealed the following independent predictors: liver disease, systemic sepsis, age at least 63 years, renal disease, emergency operation, cardiac disease, hypertension, prior neurological disease, diabetes mellitus and BMI 25 to 29.99 kg m (protective). These predictors were incorporated into a risk index classification; odds ratios for postoperative coma increased from 2.5 with one risk factor to 18.4 with three. Coma was associated with 74.2% all-cause mortality; coma associated with cardiac arrest had a 1.9-fold higher mortality. This is the largest study of postoperative coma ever reported and will be useful for determining risk of coma of more than 24 h duration when evaluating an unresponsive patient following surgery. Data on prognosis will aid medical and ethical decision-making for the comatose surgical patient.

Patients' and observers' perceptions of involvement differ. Validation study on inter-relating measures for shared decision making.

PubMed

Kasper, Jürgen; Heesen, Christoph; Köpke, Sascha; Fulcher, Gary; Geiger, Friedemann

2011-01-01

Patient involvement into medical decisions as conceived in the shared decision making method (SDM) is essential in evidence based medicine. However, it is not conclusively evident how best to define, realize and evaluate involvement to enable patients making informed choices. We aimed at investigating the ability of four measures to indicate patient involvement. While use and reporting of these instruments might imply wide overlap regarding the addressed constructs this assumption seems questionable with respect to the diversity of the perspectives from which the assessments are administered. The study investigated a nested cohort (N = 79) of a randomized trial evaluating a patient decision aid on immunotherapy for multiple sclerosis. Convergent validities were calculated between observer ratings of videotaped physician-patient consultations (OPTION) and patients' perceptions of the communication (Shared Decision Making Questionnaire, Control Preference Scale & Decisional Conflict Scale). OPTION reliability was high to excellent. Communication performance was low according to OPTION and high according to the three patient administered measures. No correlations were found between observer and patient judges, neither for means nor for single items. Patient report measures showed some moderate correlations. Existing SDM measures do not refer to a single construct. A gold standard is missing to decide whether any of these measures has the potential to indicate patient involvement. Pronounced heterogeneity of the underpinning constructs implies difficulties regarding the interpretation of existing evidence on the efficacy of SDM. Consideration of communication theory and basic definitions of SDM would recommend an inter-subjective focus of measurement. Controlled-Trials.com ISRCTN25267500.

The clinical characteristics of patients with glaucoma presenting to Botswana healthcare facilities: an observational study.

PubMed

Jackson, Daniel J; Razai, Mohammad S; Falama, Rosemary; Mongwa, Matlhogonolo; Mutapanduwa, Mishell; Baemisi, Chao; Josiah, Engelinah; Nkomazana, Oathokwa; Lehasa, Alice; Brealey, Evelyn; White, Andrew J; Jankowski, Deborah; Kerr-Muir, Malcolm G; Martin, Keith R; Ngondi, Jeremiah M

2014-12-03

This study aimed to establish the clinical characteristics of patients with glaucoma attending eye care facilities in Botswana, and management of glaucoma among patients who received care in these facilities. The study also aimed to calculate the number of new diagnoses of glaucoma within the glaucoma service. A prospective, hospital-based, observational study. A multicentre study was undertaken in government-run eye departments in Botswana from June to August 2012. All patients with a diagnosis of glaucoma attending clinics at seven study sites were invited to participate. Examination findings, diagnosis and management were extracted from individual patient-held medical charts. Sociodemographic characteristics, patient knowledge and understanding of glaucoma were assessed through face-to-face interviews. In addition, details of outpatient attendances for 2011 were collected from 21 government-run hospitals. The majority of the 366 patients interviewed had a diagnosis of primary glaucoma (86.6%). The diagnoses were mainly made by ophthalmologists (48.6%) and ophthalmic nurses (44.0%). Many patients (38.5%) had been symptomatic for over 6 months before visiting an eye clinic. The mean presenting intraocular pressure was 28.2 mm Hg (SD 11.9 mm Hg). Most follow-up patients (79.2%) had not received surgery, however, many (89.5%) would accept surgery. Only 11.5% of participants had heard of glaucoma prior to diagnosis. Many participants (35.9%) did not understand glaucoma after being diagnosed. The majority (94.9%) of living first-degree relatives had never been examined. The number of newly diagnosed glaucoma cases for 2011 in the south of the country was 14.1/100,000; 95% CI (12.0 to 16.5), in the north it was 16.2/100,000; 95% CI (13.8 to 19.0). Glaucoma is a significant burden that presents challenges to ophthalmic services in Botswana. Many patients have limited understanding of the condition and poor access to services. There is a need to develop a treatment

The clinical characteristics of patients with glaucoma presenting to Botswana healthcare facilities: an observational study

PubMed Central

Jackson, Daniel J; Razai, Mohammad S; Falama, Rosemary; Mongwa, Matlhogonolo; Mutapanduwa, Mishell; Baemisi, Chao; Josiah, Engelinah; Nkomazana, Oathokwa; Lehasa, Alice; Brealey, Evelyn; White, Andrew J; Jankowski, Deborah; Kerr-Muir, Malcolm G; Martin, Keith R; Ngondi, Jeremiah M

2014-01-01

Objective This study aimed to establish the clinical characteristics of patients with glaucoma attending eye care facilities in Botswana, and management of glaucoma among patients who received care in these facilities. The study also aimed to calculate the number of new diagnoses of glaucoma within the glaucoma service. Design A prospective, hospital-based, observational study. Setting A multicentre study was undertaken in government-run eye departments in Botswana from June to August 2012. Participants All patients with a diagnosis of glaucoma attending clinics at seven study sites were invited to participate. Outcome measures Examination findings, diagnosis and management were extracted from individual patient-held medical charts. Sociodemographic characteristics, patient knowledge and understanding of glaucoma were assessed through face-to-face interviews. In addition, details of outpatient attendances for 2011 were collected from 21 government-run hospitals. Results The majority of the 366 patients interviewed had a diagnosis of primary glaucoma (86.6%). The diagnoses were mainly made by ophthalmologists (48.6%) and ophthalmic nurses (44.0%). Many patients (38.5%) had been symptomatic for over 6 months before visiting an eye clinic. The mean presenting intraocular pressure was 28.2 mm Hg (SD 11.9 mm Hg). Most follow-up patients (79.2%) had not received surgery, however, many (89.5%) would accept surgery. Only 11.5% of participants had heard of glaucoma prior to diagnosis. Many participants (35.9%) did not understand glaucoma after being diagnosed. The majority (94.9%) of living first-degree relatives had never been examined. The number of newly diagnosed glaucoma cases for 2011 in the south of the country was 14.1/100 000; 95% CI (12.0 to 16.5), in the north it was 16.2/100 000; 95% CI (13.8 to 19.0). Conclusions Glaucoma is a significant burden that presents challenges to ophthalmic services in Botswana. Many patients have limited understanding

Early impact of treatment with tiotropium, long-acting anticholinergic preparation, in patients with COPD – real-life experience from an observational study

PubMed Central

Jahnz-Różyk, Karina; Szepiel, Paweł

2015-01-01

Background Long-acting inhaled bronchodilators, including anticholinergic tiotropium, are recommended for the maintenance therapy of chronic obstructive pulmonary disease (COPD). It has been shown in a number of studies that treatment with tiotropium alleviates symptoms, improves exercise tolerance, health status, and reduces exacerbations in patients with moderate to very severe stage COPD. Aim The aim of this noninterventional study was to observe the early effects of the maintenance treatment with tiotropium in patients with COPD of different severities, who had been previously treated on a regular basis, or as required, with at least one short-acting bronchodilator, in a real-life setting in Poland. The effect of the treatment was assessed through the collection of COPD Assessment Test (CAT) data. Patients and methods The MATHS clinical study was an observational, noninterventional, open-label, prospective, uncontrolled, single-arm, postmarketing, surveillance, real-life study conducted with the involvement of 236 pulmonology clinics based in Poland. The tiotropium observational period was 3 months. The health and COPD status was measured with the CAT questionnaire. The primary efficacy endpoint was the mean change from the baseline in the total CAT score at the end of the 3-month observational period. Results Patients treated with 18 μg of tiotropium once daily for 3 months showed a statistically significant result, with a clinically meaningful mean reduction (improvement) of 7.0 points in the total CAT score. The improvement was slightly greater in patients with more severe COPD; the mean change in the total CAT score was 7.6 in the subgroup of patients with more severe COPD and 6.7 points in the subgroup of patients with moderate COPD. Conclusion Results of this real-life study provide further support for the use of tiotropium as a first-line maintenance treatment for patients with COPD of different severities in Poland. PMID:25834420

Four minutes for a patient, twenty seconds for a relative - an observational study at a university hospital

PubMed Central

2010-01-01

Background In the modern hospital environment, increasing possibilities in medical examination techniques and increasing documentation tasks claim the physicians' energy and encroach on their time spent with patients. This study aimed to investigate how much time physicians at hospital wards spend on communication with patients and their families and how much time they spend on other specific work tasks. Methods A non-participatory, observational study was conducted in thirty-six wards at the University Medical Center Freiburg, a 1700-bed academic hospital in Germany. All wards belonging to the clinics of internal medicine, surgery, radiology, neurology, and to the clinic for gynaecology took part in the study. Thirty-four ward doctors from fifteen different medical departments were observed during a randomly chosen complete work day. The Physicians' time for communication with patients and relatives and time spent on different working tasks during one day of work were assessed. Results 374 working hours were analysed. On average, a physician's workday on a university hospital ward added up to 658.91 minutes (10 hrs 58 min; range 490 - 848 min). Looking at single items of time consumption on the evaluation sheet, discussions with colleagues ranked first with 150 minutes on average. Documentation and administrative requirements took an average time of 148 minutes per day and ranked second. Total time for communication with patients and their relatives was 85 minutes per physician and day. Consequently, the available time for communication was 4 minutes and 17 seconds for each patient on the ward and 20 seconds for his or her relatives. Physicians assessed themselves to communicate twice as long with patients and sevenfold with relatives than they did according to this study. Conclusions Workload and time pressure for physicians working on hospital wards are high. To offer excellent medical treatment combined with patient centred care and to meet the needs of

Efficacy and tolerability of rasagiline in daily clinical use--a post-marketing observational study in patients with Parkinson's disease.

PubMed

Reichmann, H; Jost, W H

2010-09-01

The MAO-B inhibitor rasagiline is indicated for the treatment of idiopathic Parkinson's disease (PD), and its use is supported by evidence from large-scale, controlled clinical studies. The post-marketing observational study presented here investigated the efficacy and tolerability of rasagiline treatment (monotherapy or combination therapy) in daily clinical practice. The study included patients with idiopathic PD who received rasagiline (recommended dose 1 mg, once daily) as monotherapy or combination therapy. The treatment and observation period was approximately 4 months. Outcome measures included the change from baseline in the Columbia University Rating Scale (CURS), the Unified PD Rating Scale fluctuation subscale, daily OFF time (patient home diaries) and the PD Questionnaire-39. Adverse drug reactions/adverse events (ADRs/AEs) and the physician's global judgement of tolerability and efficacy were also examined. Overall, 754 patients received rasagiline during the study. Patients treated with rasagiline (monotherapy or combination therapy) showed significant improvements from baseline in symptom severity (including classical motor and non-classical motor/non-motor symptoms) and quality of life (QoL). Patients receiving combination therapy also experienced significant reductions in daily OFF time. Tolerability was rated as good/very good in over 90% of patients. In daily clinical practice, monotherapy or combination therapy with rasagiline is able to improve PD symptoms, reduce OFF time, and improve QoL, whilst demonstrating favourable tolerability. In addition, rasagiline has a simple dosing schedule of one tablet, once daily, with no titration. These results are consistent with the pivotal rasagiline clinical studies (TEMPO, LARGO and PRESTO).

Prevalence and Characteristics of Work Anxiety in Medical Rehabilitation Patients: A Cross-Sectional Observation Study.

PubMed

Muschalla, Beate; Jöbges, Michael

2018-01-01

To investigate frequency, type, and characteristics of work anxieties in patients with somatic illness. Cross-sectional observation study. Neurology, orthopedic, and cardiology rehabilitation clinics. Patients (N=1610; age, 18-65y) with work anxieties. Not applicable. Patients who scored high on at least 2 of 9 items in the work-anxiety screening questionnaire and who reported impairment were investigated with a differential diagnostic interview on work anxieties and with the Mini-International Neuropsychiatric Interview on non-work-related common mental disorders. Patients also filled out a self-rating questionnaire on their subjective symptom load and sociodemographic data. Approximately 20% to 27% of the investigated inpatients in somatic rehabilitation (altogether n=393) received a work-anxiety diagnosis. Patients with orthopedic illness report highest work anxiety and have previous longest sick leave (20.6wk in the past 12mo). Patients with orthopedic illness suffer from work-related adjustment disorder with anxiety, social anxieties, and workplace phobias, whereas patients with cardiac illness are more often affected by hypochondriac anxieties. Anxieties of insufficiency and worrying occur equally in all indications. About a quarter of patients in somatic rehabilitation are in need of additional diagnostic attention owing to work anxieties. Differential diagnostic of work anxiety is needed for initiating adequate therapeutic action. Somatic rehabilitation physicians should be aware of work anxieties in their patients, especially in patients with orthopedic illness with previous long-term sick leave. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

[Preliminary study on detox in outpatient care units with 18 alcoholic patients in Directly Observed Treatment].

PubMed

Lloréns Martínez, Ramón; Calatayud Francés, María; Morales Gallús, Esperanza; Añó Cervera, Consol; Adriá Caballero, Librada

2008-01-01

Directly Observed Treatment (TOD-DOT) has been tested in different conditions. The objective of this work is to check whether a UCA-CAB (Centre for Addictive Behaviour) can achieve detox and reduce the risk of early relapse (up to 12 weeks) in alcoholic patients. All patients had an established organic addiction and serious withdrawal syndrome, and had undergone multiple previous treatments. Furthermore, they had not managed to abstain for a 3-month consecutive period over the previous 2 years. The aim of the Directly Observed Treatment was to attain detox and reduce relapse by following a multi-method approach: medical, psychological and personal care, based on a brief daily consultation and pharmacological supervision. The results were as follows: Of the 18 patients included in the study, after 12 weeks, 13 (72 %) were still abstinent and 4 (22 %) had relapsed. Thus, 17 (94 %) were still following the treatment, with just one drop-out. We analysed the profiles of the patients abstaining, of those who relapsed (4) and of the one who dropped out. The average CIWA-Ar was 27.05 (21-36). Any value over 20 is considered to indicate serious withdrawal syndrome, though there were no negative events leading to hospitalization. Level of adherence to the treatment (94 %) meant that the most seriously affected patients and those with fewest financial resources could benefit, not only from any auxiliary social schemes, but also from basic health services, permitting them to improve the quality of their everyday life.

Patient-Related Benefits for Adults with Cochlear Implantation: A Multicultural Longitudinal Observational Study

PubMed Central

Lenarz, Thomas; Muller, Lida; Czerniejewska-Wolska, Hanna; Vallés Varela, Hector; Orús Dotú, César; Durko, Marcin; Huarte Irujo, Alicia; Piszczatowski, Bartosz; Zadrożniak, Marek; Irwin, Colin; Graham, Petra L.; Wyss, Josie

2017-01-01

Objectives To assess subjectively perceived, real-world benefits longitudinally for unilateral cochlear implant (CI) recipients in a multinational population treated routinely. To identify possible predictors of self-reported benefits. Design This was a prospective, multicenter, repeated-measures study. Self-assessment of performance at preimplantation and postimplantation at 1, 2, and 3 years using standardized, validated, local language versions of the Speech, Spatial, and Qualities of Hearing Scale (SSQ), and the Health Utilities Index Mark 3 (HUI3) was performed. Outcomes were analyzed using a longitudinal mixed-effects model incorporating country effect. Patient demographics were explored for associations with change over time. Subjects Two hundred ninety-one routinely treated, unilateral CI recipients, aged 137–81 years, from 9 clinics across 4 countries. Results Highly significant improvements were observed for all outcome measures (p < 0.0001). Postimplantation, mean outcome scores remained stable beyond 1 year, with notable individual variability. A significant association for one or more outcomes with preimplantation contralateral hearing aid use, telephone use, age at implantation, implantation side, preimplantation comorbidities, dizziness, and tinnitus was observed (p < 0.004). Conclusions Longitudinal benefits of CI treatment can be measured using clinically standardized self-assessment tools to provide a holistic view of patient-related benefits in routine clinical practice for aggregated data from multinational populations. Self-reported outcomes can provide medical-based evidence regarding CI treatment to support decision-making by health service providers. PMID:28719901

Patient-Related Benefits for Adults with Cochlear Implantation: A Multicultural Longitudinal Observational Study.

PubMed

Lenarz, Thomas; Muller, Lida; Czerniejewska-Wolska, Hanna; Vallés Varela, Hector; Orús Dotú, César; Durko, Marcin; Huarte Irujo, Alicia; Piszczatowski, Bartosz; Zadrożniak, Marek; Irwin, Colin; Graham, Petra L; Wyss, Josie

2017-01-01

To assess subjectively perceived, real-world benefits longitudinally for unilateral cochlear implant (CI) recipients in a multinational population treated routinely. To identify possible predictors of self-reported benefits. This was a prospective, multicenter, repeated-measures study. Self-assessment of performance at preimplantation and postimplantation at 1, 2, and 3 years using standardized, validated, local language versions of the Speech, Spatial, and Qualities of Hearing Scale (SSQ), and the Health Utilities Index Mark 3 (HUI3) was performed. Outcomes were analyzed using a longitudinal mixed-effects model incorporating country effect. Patient demographics were explored for associations with change over time. Two hundred ninety-one routinely treated, unilateral CI recipients, aged 13-81 years, from 9 clinics across 4 countries. Highly significant improvements were observed for all outcome measures (p < 0.0001). Postimplantation, mean outcome scores remained stable beyond 1 year, with notable individual variability. A significant association for one or more outcomes with preimplantation contralateral hearing aid use, telephone use, age at implantation, implantation side, preimplantation comorbidities, dizziness, and tinnitus was observed (p < 0.004). Longitudinal benefits of CI treatment can be measured using clinically standardized self-assessment tools to provide a holistic view of patient-related benefits in routine clinical practice for aggregated data from multinational populations. Self-reported outcomes can provide medical-based evidence regarding CI treatment to support decision-making by health service providers. © 2017 The Author(s) Published by S. Karger AG, Basel.

Factors affecting patient's perception of anticancer treatments side-effects: an observational study.

PubMed

Russo, Stefania; Cinausero, Marika; Gerratana, Lorenzo; Bozza, Claudia; Iacono, Donatella; Driol, Pamela; Deroma, Laura; Sottile, Roberta; Fasola, Gianpiero; Puglisi, Fabio

2014-02-01

Analysis of relative importance of side effects of anticancer therapy is extremely useful in the process of clinical decision making. There is evidence that patients' perception of the side effects of anticancer treatments changes over time. Aim of this study was to evaluate the cancer patients' perceptions of physical and non-physical side effects of contemporary anticancer therapy. Four hundred and sixty-four patients entered the study (153 men and 311 women). Participants were asked to rank their side effects in order of distress by using two sets of cards naming physical and non-physical effects, respectively. Influencing factors, including treatment and patient characteristics, were also analysed. Patients ranked the non-physical side effect 'Affects my family or partner' first. 'Constantly tired' and 'Loss of hair' were ranked second and third, respectively. Significant differences from previous studies on this topic emerged. In particular, 'Vomiting', a predominant concern in previous studies, almost disappeared, whereas 'Nausea' and 'Loss of hair' remained important side effects in the patients' perception. Interestingly, marital status was predominant in driving patients' perception, being associated with several side effects ('Constantly tired', 'Loss of appetite', 'Affects my work/Home duties', 'Affects my social activities', 'Infertility'). Other significant factors influencing patient's perception of side effects included age, disease characteristics and ongoing anticancer therapy. This study provided information on current status of patients' perceptions of side effects of anticancer treatment. These results could be used in pre-treatment patient education and counselling.

Black cohosh (Cimicifuga racemosa) in tamoxifen-treated breast cancer patients with climacteric complaints - a prospective observational study.

PubMed

Rostock, Matthias; Fischer, Julia; Mumm, Andreas; Stammwitz, Ute; Saller, Reinhard; Bartsch, Hans Helge

2011-10-01

The antihormonal therapy of breast cancer patients with the antiestrogen tamoxifen often induces or aggravates menopausal complaints. As estrogen substitution is contraindicated, herbal alternatives, e.g. extracts of black cohosh are often used. A prospective observational study was carried out in 50 breast cancer patients with tamoxifen treatment. All patients had had surgery, most of them had undergone radiation therapy (87%) and approximately 50% had received chemotherapy. Every patient was treated with an isopropanolic extract of black cohosh (1-4 tablets, 2.5 mg) for 6 months. Patients recorded their complaints before therapy and after 1, 3, and 6 months of therapy using the menopause rating scale (MRS II). The reduction of the total MRS II score under black cohosh treatment from 17.6 to 13.6 was statistically significant. Hot flashes, sweating, sleep problems, and anxiety improved, whereas urogenital and musculoskeletal complaints did not change. In all, 22 patients reported adverse events, none of which were linked with the study medication; 90% reported the tolerability of the black cohosh extract as very good or good. Black cohosh extract seems to be a reasonable treatment approach in tamoxifen treated breast cancer patients with predominantly psychovegetative symptoms.

Rehabilitation of Critical Illness Polyneuropathy and Myopathy Patients: An Observational Study

ERIC Educational Resources Information Center

Novak, Primoz; Vidmar, Gaj; Kuret, Zala; Bizovicar, Natasa

2011-01-01

Critical illness polyneuropathy and myopathy (CIPNM) frequently develops in patients hospitalized in intensive care units. The number of patients with CIPNM admitted to inpatient rehabilitation is increasing. The aim of this study was to comprehensively evaluate the outcome of their rehabilitation. Twenty-seven patients with CIPNM were included in…

Long-term adherence to apomorphine infusion in patients with Parkinson disease: a 10-year observational study.

PubMed

Kimber, Thomas E; Fang, Jing; Huddy, Lynda J; Thompson, Philip D

2017-05-01

Patients with Parkinson disease (PD) commonly experience motor fluctuations and dyskinesias in response to oral dopaminergic medications. Affected patients may benefit from device-assisted therapy, such as medication infusion or deep brain stimulation surgery. This is the first Australian study of the long-term adherence to apomorphine infusion (AI) in patients with PD. To assess the adherence to AI in patients with PD in a single centre over a 10-year period and to find the reasons for discontinuation in patients who discontinued AI. This is an observational study of patients with PD treated with AI between 2004 and 2014. Outcome measures included changes in motor function and quality of life following AI, change in dose of other dopaminergic medications following AI, duration of infusion, adverse effects, reasons for cessation of AI and subsequent treatment after cessation. Mean duration of AI was 21.65 months. No patient achieved apomorphine monotherapy, and the mean reduction in the levodopa-equivalent dose of other dopaminergic medications after AI was 22.7%. The benefit of AI on motor function and quality of life was rated as 'much improved' or 'better' in 83% of patients. The most common reasons for discontinuation of AI were adverse effects and inadequate motor benefit. Most patients who discontinued AI were subsequently treated with another device-assisted therapy. AI is an effective therapy for severe motor response complications in PD, especially in the short and medium term. However, many patients cannot be maintained on AI in the longer term. © 2017 Royal Australasian College of Physicians.

Mobile App Usage Patterns of Patients Prescribed a Smoking Cessation Medicine: Prospective Observational Study

PubMed Central

2018-01-01

/131, 89.3%) reported being extremely, very, or moderately satisfied with the app. A total of 97 survey respondents (97/131, 74.0%) reported setting up a quit date in the app. Of those, 74 (74/97, 76%) reported quitting on their quit date. Conclusions Positive patient engagement was observed in this study based on app download and usage. This study quantified how the Pfizer Meds app performed in an observational real-world data setting. The findings demonstrate the willingness of participants to set a quit date and use the app for support in medication adherence, refill reminders, and information regarding how to take the medication. This study provides real-world evidence of the contribution apps can make to the continued encouragement of smokers to improve their health by smoking cessation. PMID:29666043

Awareness and Observance of Patient Rights from the Perspective of Iranian Patients: A Systematic Review and Meta-Analysis

PubMed Central

Abedi, Ghassem; Shojaee, Jalil; Moosazadeh, Mahmood; Rostami, Farideh; Nadi, Aliasghar; Abedini, Ehsan; Palenik, Charles John; Askarian, Mehrdad

2017-01-01

Background: Recipients of healthcare services have rights, which must be acknowledged and protected. Such rights include observance of acceptable patient physical, mental, spiritual, and social needs guided by commonly accepted rules and regulations. The objective of this study was to conduct a systematic review and meta-analysis of awareness rates and observance of patient rights in Iran from the perspective of the patient. Methods: In this study, various references such as Medline (PubMed), Scopus, Scientific Information Database (SID), Google scholar, Magiran, and IranMedex were searched (from August to December 2015). Heterogeneity was assessed using the Q statistic. English and Persian search keywords and combinations included terms such as “patient bill of rights, patient rights, Iranian patient bill of rights, and Persian patient rights.” A meta-analysis of the primary search sources was accomplished using STATA (version 11.0). Results: Initial review included 20 articles of which 12 assessed observance rates of patient rights and three described service awareness rates of recipients concerning their personal rights. Five articles covered both topics and had an estimated 54.2% coverage based on the results of meta-analysis and the random-effects model with the heterogeneity. Conclusion: An Observance rate of patient bills of rights was considered somewhat adequate. However, contradictions in findings noted in this study suggest deficiencies do exist and need to be resolved. There appears a need to better describe and increase awareness rates of healthcare services by patients concerning their own bill of rights. PMID:28533570

Prospective Single-Center Observational Study of the Allergenic Potential of Mercromina Film and Other Common Antiseptics in Patients With Contact Dermatitis.

PubMed

Baltà Cruz, S; Moreno Ribera, N; Estrach Panella, M T

Although Mercromina Film and other topical antiseptics are widely used, they are not included in the standard series recommended by the Spanish Contact Dermatitis and Skin Allergy Research Group for testing suspected allergic contact dermatitis (ACD). Furthermore, no recent studies have investigated the allergenic potential of merbromin. To determine the allergenic potential of merbromin and compare it with that of other topical antiseptics widely used in clinical practice, including povidone-iodine, chlorhexidine, and eosin. Prospective single-center observational safety study of 105 patients with suspected ACD seen at the dermatology department of our hospital. Of the 105 patients studied, 1.9% had a positive patch test to merbromin and 12.4% were sensitized to povidone-iodine. The differences in the proportion of patients with ACD to Betadine Solución Dérmica (povidone-iodine) compared with the rest of the antiseptics was statistically significant (McNemar test, P<.05). No adverse reactions were observed in any of the patients. Based on the patch tests conducted, Mercromina Film has very low allergenic potential. The highest allergenic potential was observed for povidone-iodine. Copyright © 2017 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.

Patient-reported outcomes and associations with pleural effusion in outpatients with heart failure: an observational cohort study

PubMed Central

Gundersen, Guri H; Norekvål, Tone M; Graven, Torbjørn; Haug, Hilde H; Skjetne, Kyrre; Kleinau, Jens O; Gustad, Lise T; Dalen, Håvard

2017-01-01

Objectives We aimed to study whether patient-reported outcomes, measured by quality of life (QoL) and functional class, are sensitive to pleural effusion (PLE) in patients with heart failure (HF), and to study changes in QoL and functional class during follow-up of PLE. Methods A cohort of 62 patients from an outpatient HF clinic was included. The amount of PLE was quantified using a pocket-sized ultrasound imaging device. Self-reports of QoL and functional class were collected using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and the New York Heart Association (NYHA) functional classification. Results At baseline, 26 (42%) patients had PLE of which 19 (31%) patients had moderate to severe amounts of PLE. Patients with no to mild PLE had a lower MLHFQ score (mean 42, SD 21) compared with patients with a moderate to severe amount of PLE (mean 55, SD 24), p=0.03. For 28 patients (45%) with follow-up data, we observed a linear improvement of the MLHFQ-score (3.2, 95% CI 1.2 to 5.1) with each centimetre reduction of PLE. Correspondingly, patient-reported NYHA-class followed the same pattern as the MLHFQ-score. Conclusions Our study indicates that patient-reported outcome measures as MLHFQ may be sensitive tools to identify patients with HF at highest risk of symptomatic PLE and that treatment targeting reduction of PLE during follow-up is essential to improvement of QoL and functional capacity of outpatients with HF. Trial registration number NCT01794715; Results PMID:28320791

An investigation of the representativity of neuropsychiatrists and their patients in a drug utilization observation study on fluoxetine.

PubMed

Schaaf, B; Linden, M; Weber, H J

1997-01-01

This study presents a methodological approach to an expost facto investigation of sample bias in drug utilization observation (DUO) studies using the example of a DUO with the nontricyclic antidepressant fluoxetine. A total of 479 psychiatrists and neurologists and 2,401 patients were investigated. The purpose of the study was to judge the representativeness of our DUO sample for two populations: first, for all psychiatrics and neurologists prescribing fluoxetine or all patients being treated with fluoxetine in Germany and, second, for all psychiatrists and neurologists prescribing antidepressants or all patients being treated with antidepressants in Germany. Criteria for the representativeness test were physician variables (gender, size of community where practicing, federal state, age, volume of prescriptions) and patient variables (gender, age, prescription-related diagnosis, concurrent illnesses, concomitant medications). The study shows that the DUO sample can rightfully claim representativeness in the majority of parameters for the psychiatrists and neurologists prescribing fluoxetine and for the patients being treated with fluoxetine. There are more noticeable discrepancies with regard to the psychiatrists and neurologists in general and to the patients being treated with antidepressants in general. The methodological problems of pharmacoepidemiological investigation of representativeness are discussed.

Long-Term Neurological Outcomes in West Nile Virus–Infected Patients: An Observational Study

PubMed Central

Weatherhead, Jill E.; Miller, Vicki E.; Garcia, Melissa N.; Hasbun, Rodrigo; Salazar, Lucrecia; Dimachkie, Mazen M.; Murray, Kristy O.

2015-01-01

The Houston West Nile Cohort (HWNC) was founded in 2002 when West Nile virus (WNV) reached Houston, TX. The long-term outcomes following WNV infection are still mostly unknown, though neurological abnormalities up to 1 year postinfection have been documented. We report an observational study of neurological abnormalities at 1–3 and 8–11 years following WNV infection in the HWNC. We conducted standard neurological examinations at two separate time points to assess changes in neurological status over time. The majority of patients (86%, 30/35) with encephalitis had abnormal neurological exam findings at the time of the first assessment compared with uncomplicated fever (27%, 3/11) and meningitis (36%, 5/14) cases. At the time of the second assessment, 57% (4/7) of West Nile fever (WNF), 33% (2/6) of West Nile meningitis (WNM), and 36% (5/14) of West Nile encephalitis (WNE) had developed new neurological complications. The most common abnormalities noted were tandem gait, hearing loss, abnormal reflexes, and muscle weakness. Long-term neurological abnormalities were most commonly found in patients who experienced primary WNV encephalitis. New abnormalities may develop over time regardless of initial clinical infection. Future studies should aim to differentiate neurological consequences due to WNV neuroinvasive infection versus neurological decline related to comorbid conditions. PMID:25802426

Clinical efficacy of polyspecific intravenous immunoglobulin therapy in patients with streptococcal toxic shock syndrome: a comparative observational study.

PubMed

Linnér, Anna; Darenberg, Jessica; Sjölin, Jan; Henriques-Normark, Birgitta; Norrby-Teglund, Anna

2014-09-15

Streptococcal toxic shock syndrome (STSS) and necrotizing fasciitis are the 2 most severe invasive manifestations caused by group A Streptococcus (GAS). Intravenous immunoglobulin (IVIG) therapy has been suggested as adjunctive treatment with a beneficial effect on mortality. However the clinical evidence is limited. Here we aim to further document the clinical efficacy of administered IVIG therapy in a comparative observational study of well-defined patients with STSS. The effect of IVIG was evaluated in patients with STSS prospectively identified in a nationwide Swedish surveillance study conducted between April 2002 and December 2004. Detailed data on symptoms, severity of disease, treatment, and outcome were obtained from 67 patients. Crude and adjusted analyses with logistic regression were performed. Twenty-three patients received IVIG therapy compared with 44 who did not. No significant difference in comorbidities, severity of disease, organ failures, or sex was seen, but the IVIG group was slightly younger and had a higher degree of necrotizing fasciitis (56% vs 14%). The primary endpoint was 28-day survival. Adjusted analysis revealed that factors influencing survival in STSS were Simplified Acute Physiology Score II (odds ratio [OR], 1.1; P = .007), clindamycin (OR, 8.6; P = .007), and IVIG (OR, 5.6; P = .030). This comparative observational study of prospectively identified STSS patients demonstrates that both IVIG and clindamycin therapy contribute to a significantly improved survival in STSS. © The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

The safety and effectiveness profile of eldecalcitol in a prospective, post-marketing observational study in Japanese male patients with osteoporosis.

PubMed

Kondo, Satoshi; Kakihata, Hiroyuki; Nishida, Yosuke; Furuno, Yuko; Kobayashi, Yumiko; Tabata, Hidehiro; Nomura, Makoto

2018-03-12

We conducted a post-marketing observational study to investigate the safety and effectiveness of eldecalcitol for the treatment of osteoporosis in a Japanese clinical setting. The observation period was 12 months for women and 36 months for men. The final results for the female patients have already been published. In this article, the final results for the male patients are reported. A total of 470 male osteoporosis patients were enrolled. The safety analysis set included 431 patients (mean age, 76.8 years; mean ± SD follow-up period, 631.0 ± 450.3 days), and 175 patients continued treatment throughout the 3-year observational period. Adverse drug reactions (ADRs) were reported in 28 patients (6.49%); the most common ADRs were hypercalcemia (1.16%) and renal impairment (1.16%). Serious ADRs were reported in 5 patients (1.16%). Mean serum calcium was within the normal range throughout the observation period. The cumulative incidence of new vertebral and nonvertebral fractures at 36 months, estimated by Kaplan-Meier analysis, was 10.23 and 4.06%, respectively. At the last observation, mean lumbar spine bone mineral density was 3.49% higher (P < 0.0001) than at baseline, and levels of the bone turnover markers BAP and TRACP-5b were reduced (-14.64%; P = 0.0009, and - 29.51%; P < 0.0001, respectively). In conclusion, the safety and effectiveness of eldecalcitol for the treatment of Japanese male osteoporosis patients was confirmed in clinical practice. Careful monitoring of serum calcium and estimated glomerular filtration rate, both before and during treatment, is necessary to minimize the risk of hypercalcemia and renal impairment while maximizing the effectiveness of eldecalcitol.

Resuscitative Hyperkalemia in Noncrush Trauma: A Prospective, Observational Study

DTIC Science & Technology

2006-12-01

Resuscitative Hyperkalemia in Noncrush Trauma: A Prospective, Observational Study Robert M. Perkins,*† Matthew C. Aboudara,* Kevin C. Abbott,*† and...Surgical Research, San Antonio, Texas The trauma patient is exposed to physiologic processes and life-saving interventions that predispose to hyperkalemia ...in the care of the massively traumatized patient may or may not increase the risk for hyperkalemia . This prospective, observational study was

[Prospective observational study of angiotensin converting enzyme inhibitors-induced hyperkalemia in hospitalized patients with chronic renal failure].

PubMed

Ben Mahmoud, Lobna; Ghozzi, Hanene; Kammoun, Khawla; Hakim, Ahmed; Kharrat, Mahmoud; Ben Hmida, Mohamed; Jarraya, Faical; Sahnoun, Zouheir; Zeghal, Khaled; Hachicha, Jamil

2013-04-01

To study the incidence and risk factors of angiotensin converting enzyme inhibitors-induced hyperkalemia in hospitalized patients with hypertension and preexisting chronic renal failure. Two-months prospective observational study was used including all hospitalized patients older than 18 years with a history of hypertension, non-dialyzed chronic renal failure and who had angiotensin converting enzyme prescription at the time of the admission. Hyperkalemia greater than or equal to 5 mmol/L was detected in these patients. The studied variables were demographic, clinical, biological and therapeutic. Eight patients, among 27 included, had a hyperkalemia (2963%). They were 73±15 years old. Factors that predispose to hyperkalemia were present in all patients. Hyperkalemia was associated in six cases with decompensation of renal function. The age was associated with hyperkalaemia in patients treated with angiotensin converting enzyme inhibitors (RC=1.21; IC95 1,11-1,46; P=0,021). Diabetes is a possible risk factor (OR=59 021 et, 95 0.93 to 2410, P=0.053). Compared with patients who did not develop hyperkalemia, the occurrence of hyperkalemia in patients included was associated with a longer duration of hospitalization (OR=130, 95 112 to 160, P=0. 022). The prescription of angiotensin converting enzyme inhibitors in the elderly with chronic renal failure and diabetes requires careful monitoring of serum potassium. Copyright © 2012 Association Société de néphrologie. Published by Elsevier SAS. All rights reserved.

Complications of local anaesthesia. An observational study.

PubMed

Brand, H S; Bekker, W; Baart, J A

2009-11-01

Local anaesthesia is increasingly used by dental hygienists. As little is known about the incidence of adverse effects during and after the administration of local anaesthetics, we evaluated side-effects associated with local anaesthesia. A prospective observational study was conducted using standard criteria among a group of 103 patients receiving mandibular block anaesthesia. Physical reactions like clenching fists (14.5%), moaning (12.6%) and turning pale (7.8%) were frequently observed. Patients (3.8%) showed a painful reaction because of needle contact with a nerve or the periosteum. Systemic complications were not observed. After the injection, 41.7% said they felt tense during the administration; 4.9% of the patients reported swallowing problems and 3.9% a tachycardia. These results suggest that administration of local anaesthesia has a small risk of adverse events. Complications, if they occur, seem minor and transient in nature.

Somatostatin analogue-induced pancreatic exocrine insufficiency in patients with neuroendocrine tumours: results of a prospective observational study.

PubMed

Lamarca, Angela; McCallum, Lynne; Nuttall, Christina; Barriuso, Jorge; Backen, Alison; Frizziero, Melissa; Leon, Rebecca; Mansoor, Was; McNamara, Mairéad G; Hubner, Richard A; Valle, Juan W

2018-06-20

Background Patients with advanced well-differentiated neuroendocrine tumours(Wd-NETs) are commonly treated with somatostatin analogues(SSAs). Some patients may develop SSA-related side effects such as pancreatic exocrine insufficiency(PEI). Methods In this single-institution, prospective, observational study, the frequency of SSA-induced PEI in 50 sequential patients with advanced Wd-NETs treated with SSAs was investigated. Toxicity was assessed monthly and faecal elastase-1 (FE1) and quality of life (QoL) were assessed 3-monthly. Results The median age was 65.8 years, 58% were male and the majority (92%) of patients had metastatic disease; patients received 4-weekly long acting octreotide (60%) or lanreotide (40%). Twelve patients (24%) developed SSA-related PEI after a median of 2.9 months from SSA initiation; FE1 was a reliable screening tool, especially in symptomatic patients (risk ratio 8.25 (95% confidence interval 1.15-59.01)). Most of these patients (11/12; 92%) required PERT. Other SSA-related adverse events (any grade) included flatulence (50%), abdominal pain (32%), diarrhoea (30%) and fatigue (20%). Development of PEI did not significantly worsen overall QoL, however gastrointestinal symptoms and diarrhoea were increased. Conclusion This study demonstrated that PEI occurs at a higher rate than previously reported; clinicians need to diagnose and treat this SSA-related adverse-event which occurs in 1 in 4 patients with Wd-NETs treated with SSAs.

Voluntary activation failure is detectable in some myositis patients with persisting quadriceps femoris weakness: an observational study

PubMed Central

Molloy, Catherine B; Al-Omar, Ahmed O; Edge, Kathryn T; Cooper, Robert G

2006-01-01

This cross-sectional, observational study was undertaken to examine whether voluntary activation failure could contribute to the persisting weakness observed in some patients with treated idiopathic inflammatory myositis. In 20 patients with myositis of more than six months' duration (5 males, 15 females; mean [± 1 SD] age 53 [11] years) and 102 normal subjects (44 males, 58 females; mean age 32 [8] years), isometric maximum voluntary contractions (MVCs) of the dominant quadriceps femoris (QF) were quantified. Absolute MVC results of normal subjects and patients were then normalised with respect to lean body mass (force per units of lean body mass), giving a result in Newtons per kilogram. Based on mass-normalised force data of normal subjects, patients were arbitrarily stratified into "weak" and "not weak" subgroups. During further MVC attempts, the "twitch interpolation" technique was used to assess whether the QF voluntary activation of patients was complete. This technique relies on the fact that, because muscle activation is incomplete during submaximal voluntary contractions, electrical stimulation of the muscle can induce force increments superimposed on the submaximal voluntary force being generated. No between-gender differences were seen in the mass-normalised MVC results of healthy subjects, so the gender-combined results of 6.6 (1.5) N/kg were used for patient stratification. No between-gender difference was found for mass-normalised MVCs in patients: males 5.4 (3.2) and females 3.0 (1.7) N/kg (p > 0.05). Mass-normalised MVCs of male patients were as great as those of normal subjects (p > 0.05), but mass-normalised MVCs of female patients were significantly smaller than those of the normal subjects (p < 0.001). Only one of the six "not weak" patients exhibited interpolated twitches during electrical stimulation, but six of the 14 "weak" patients did, the biggest twitches being seen in the weakest patient. That interpolated twitches can be induced in

"Lies, damned lies ..." and observational studies in comparative effectiveness research.

PubMed

Albert, Richard K

2013-06-01

A new federal initiative has allocated $1.1 billion to comparative effectiveness research, and many have emphasized the importance of including observational studies in this effort. The rationale for using observational studies to assess comparative effectiveness is based on concerns that randomized controlled trials (RCTs) are not "real world" because they enroll homogeneous patient populations, measure study outcomes that are not important to patients, use protocols that are overly complex, are conducted in specialized centers, and use study treatments that are not consistent with usual care, and that RCTs are not always feasible because of a lack of equipoise, the need to assess delayed endpoints, and concerns that they take years to complete and are expensive. This essay questions the validity of each of these proposed limitations, summarizes concerns raised about the accuracy of results generated by observational studies, provides some examples of discrepancies between results of observational studies and RCTs that pertain to pulmonary and critical care, and suggests that using observational studies for comparative effectiveness research may increase rather than decrease the cost of health care and may harm patients.

Patient-reported outcomes and associations with pleural effusion in outpatients with heart failure: an observational cohort study.

PubMed

Gundersen, Guri H; Norekvål, Tone M; Graven, Torbjørn; Haug, Hilde H; Skjetne, Kyrre; Kleinau, Jens O; Gustad, Lise T; Dalen, Håvard

2017-03-20

We aimed to study whether patient-reported outcomes, measured by quality of life (QoL) and functional class, are sensitive to pleural effusion (PLE) in patients with heart failure (HF), and to study changes in QoL and functional class during follow-up of PLE. A cohort of 62 patients from an outpatient HF clinic was included. The amount of PLE was quantified using a pocket-sized ultrasound imaging device. Self-reports of QoL and functional class were collected using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and the New York Heart Association (NYHA) functional classification. At baseline, 26 (42%) patients had PLE of which 19 (31%) patients had moderate to severe amounts of PLE. Patients with no to mild PLE had a lower MLHFQ score (mean 42, SD 21) compared with patients with a moderate to severe amount of PLE (mean 55, SD 24), p=0.03. For 28 patients (45%) with follow-up data, we observed a linear improvement of the MLHFQ-score (3.2, 95% CI 1.2 to 5.1) with each centimetre reduction of PLE. Correspondingly, patient-reported NYHA-class followed the same pattern as the MLHFQ-score. Our study indicates that patient-reported outcome measures as MLHFQ may be sensitive tools to identify patients with HF at highest risk of symptomatic PLE and that treatment targeting reduction of PLE during follow-up is essential to improvement of QoL and functional capacity of outpatients with HF. NCT01794715; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Symptom clusters predict mortality among dialysis patients in Norway: a prospective observational cohort study.

PubMed

Amro, Amin; Waldum, Bård; von der Lippe, Nanna; Brekke, Fredrik Barth; Dammen, Toril; Miaskowski, Christine; Os, Ingrid

2015-01-01

Patients with end-stage renal disease on dialysis have reduced survival rates compared with the general population. Symptoms are frequent in dialysis patients, and a symptom cluster is defined as two or more related co-occurring symptoms. The aim of this study was to explore the associations between symptom clusters and mortality in dialysis patients. In a prospective observational cohort study of dialysis patients (n = 301), Kidney Disease and Quality of Life Short Form and Beck Depression Inventory questionnaires were administered. To generate symptom clusters, principal component analysis with varimax rotation was used on 11 kidney-specific self-reported physical symptoms. A Beck Depression Inventory score of 16 or greater was defined as clinically significant depressive symptoms. Physical and mental component summary scores were generated from Short Form-36. Multivariate Cox regression analysis was used for the survival analysis, Kaplan-Meier curves and log-rank statistics were applied to compare survival rates between the groups. Three different symptom clusters were identified; one included loading of several uremic symptoms. In multivariate analyses and after adjustment for health-related quality of life and depressive symptoms, the worst perceived quartile of the "uremic" symptom cluster independently predicted all-cause mortality (hazard ratio 2.47, 95% CI 1.44-4.22, P = 0.001) compared with the other quartiles during a follow-up period that ranged from four to 52 months. The two other symptom clusters ("neuromuscular" and "skin") or the individual symptoms did not predict mortality. Clustering of uremic symptoms predicted mortality. Assessing co-occurring symptoms rather than single symptoms may help to identify dialysis patients at high risk for mortality. Copyright © 2015 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Characterization and utilization of an international neurofibromatosis web-based, patient-entered registry: An observational study.

PubMed

Seidlin, Mindell; Holzman, Robert; Knight, Pamela; Korf, Bruce; Rangel Miller, Vanessa; Viskochil, David; Bakker, Annette

2017-01-01

The neurofibromatoses (neurofibromatosis type 1, neurofibromatosis type 2 and schwannomatosis) are rare disorders having clinical manifestations that vary greatly from patient to patient. The rarity and variability of these disorders has made it challenging for investigators to identify sufficient numbers of patients with particular clinical characteristics or specific germline mutations for participation in interventional studies. Similarly, because the natural history of all types of neurofibromatosis (NF) is variable and unique for each individual, it is difficult to identify meaningful clinical outcome measures for potential therapeutic interventions. In 2012, the Children's Tumor Foundation created a web-based patient-entered database, the NF Registry, to inform patients of research opportunities for which they fit general eligibility criteria and enable patients to contact investigators who are seeking to enroll patients in approved trials. Registrants were recruited through CTF-affiliated NF clinics and conferences, through its website, and by word-of-mouth and social media. Following online consent, demographic information and details regarding manifestations of NF were solicited on the Registry website. Statistical analyses were performed on data from a cohort of 4680 registrants (the number of registrants as of October 9, 2015) who met diagnostic criteria for one of the 3 NF conditions. The analyses support our hypothesis that patient-reported symptom incidences in the NF Registry are congruent with published clinician-sourced data. Between April 26, 2013 and July 8, 2016, the registry has been useful to investigators in recruitment, particularly for observational trials, especially those for development of patient-reported outcomes.

A prospective observational study assessing home parenteral nutrition in patients with gastrointestinal cancer: benefits for quality of life.

PubMed

Senesse, Pierre; Tadmouri, Abir; Culine, Stéphane; Dufour, Patrick R; Seys, Patrick; Radji, Abderraouf; Rotarski, Maciej; Balian, Axel; Chambrier, Cecile

2015-02-01

Patients with gastrointestinal cancer are at high risk for deterioration of nutrition. Home parenteral nutrition (HPN) could improve nutritional status and quality of life (QoL). The purpose of this study was 1) to evaluate the impact of HPN on QoL, 2) to assess changes in nutritional status, and 3) to assess proxy perception of patient well-being. We conducted a prospective, observational, and a multicenter study. Inclusion criteria were adult patients with gastrointestinal cancer, for whom HPN was indicated and prescribed for at least 14 days. The physician, the patient, and a family member completed questionnaires at inclusion and 28 days later. The QoL was assessed by the patients using the Functional Assessment of Cancer Therapy-General questionnaire, at inclusion and 28 days later. The study included 370 patients with gastrointestinal cancer. The HPN was indicated for cancer-related undernutrition in 89% of the patients and was used as a complement to oral intake in 84%. After 28 days of parenteral intake, global QoL was significantly increased (48.9 at inclusion vs. 50.3, P=0.007). The patients' weight improved significantly by 2.7% (P<0.001). The nutrition risk screening also decreased significantly (3.2±1.1 vs. 2.8±1.3, P=0.003). HPN could provide benefit for malnourished patients with gastrointestinal cancer. However, randomized controlled studies are required to confirm this benefit and the safety profile. Copyright © 2015. Published by Elsevier Inc.

Observational study of intravenous lacosamide in patients with convulsive versus non-convulsive status epilepticus.

PubMed

Moreno Morales, Eros Yamel; Fernandez Peleteiro, Manuel; Bondy Peña, Ernesto Carlo; Domínguez Lorenzo, Jose Maria; Pardellas Santiago, Elva; Fernández, Anxo

2015-07-01

Status epilepticus (SE) is an important emergency situation associated with high morbidity and mortality. The goal of pharmacological therapy-rapid seizure termination-is only achieved in just over half of patients with first-line anti-epileptic drug (AED) therapy and many patients require second and higher lines of AEDs to achieve seizure termination; therefore, there is a clear need for more effective treatment options. Lacosamide is a relatively new AED and the intravenous formulation has shown promise for treatment of SE. The aim of the current study was to compare electroencephalographic (EEG) response and seizure termination with intravenous lacosamide (±other AEDs) in patients with convulsive versus non-convulsive SE, in a Spanish intensive care setting. In this prospective, observational study, patients with convulsive or non-convulsive SE who received intravenous lacosamide 400 mg/day for 8 days were compared in terms of EEG response and seizure termination. Adverse events were not specifically assessed. Fifty-three patients (69.8 % male; mean age 55.2 years) were treated with lacosamide (mean dose 390.6 mg) as first- (20.8 %), second- (34 %), third (22.6 %) or fourth-line (22.6 %) treatment for convulsive (n = 23, 43.4 %) or non-convulsive (n = 30, 56.6 %) SE. The majority of patients (73.6 %) had a comorbid condition, predominantly hypertension (35.8 %), and most (79.2 %) received at least one concomitant AED, including midazolam (54.7 %), valproic acid (52.8 %), and levetiracetam (30.2 %). Patient characteristics and treatment received did not differ significantly between the convulsive and non-convulsive SE groups. EEG recordings following lacosamide treatment demonstrated the elimination of paroxysmal activity (disappearance and/or attenuation of epileptiform activity in >60 % of recording time) in 56.6 % of patients; 69.6 % of convulsive and 46.7 % of non-convulsive SE groups. Among all patients, 90.6 % showed some EEG improvement (disappearance of

Patient safety incidents in hospice care: observations from interdisciplinary case conferences.

PubMed

Oliver, Debra Parker; Demiris, George; Wittenberg-Lyles, Elaine; Gage, Ashley; Dewsnap-Dreisinger, Mariah L; Luetkemeyer, Jamie

2013-12-01

In the home hospice environment, issues arise every day presenting challenges to the safety, care, and quality of the dying experience. The literature pertaining to the safety challenges in this environment is limited. The study explored two research questions; 1) What types of patient safety incidents occur in the home hospice setting? 2) How many of these incidents are recognized by the hospice staff and/or the patient or caregiver as a patient safety incident? Video-recordings of hospice interdisciplinary team case conferences were reviewed and coded for patient safety incidents. Patient safety incidents were defined as any event or circumstance that could have resulted or did result in unnecessary harm to the patient or caregiver, or that could have resulted or did result in a negative impact on the quality of the dying experience for the patient. Codes for categories of patient safety incidents were based on the International Classification for Patient Safety. The setting for the study included two rural hospice programs in one Midwestern state in the United States. One hospice team had two separately functioning teams, the second hospice had three teams. 54 video-recordings were reviewed and coded. Patient safety incidents were identified that involved issues in clinical process, medications, falls, family or caregiving, procedural problems, documentation, psychosocial issues, administrative challenges and accidents. This study distinguishes categories of patient safety events that occur in home hospice care. Although the scope and definition of potential patient safety incidents in hospice is unique, the events observed in this study are similar to those observed with in other settings. This study identifies an operating definition and a potential classification for further research on patient safety incidents in hospice. Further research and consensus building of the definition of patient safety incidents and patient safety incidents in this setting is

Learning Curves Among All Patients Undergoing Transcatheter Aortic Valve Implantation in Germany: A Retrospective Observational Study.

PubMed

Kaier, Klaus; Reinecke, Holger; Schmoor, Claudia; Frankenstein, Lutz; Vach, Werner; Hehn, Philip; Zirlik, Andreas; Bode, Christoph; Zehender, Manfred; Reinöhl, Jochen

2017-05-15

Transcatheter aortic valve implantation (TAVI) is a rapidly evolving technique for therapy of aortic stenosis. Previous studies report learning curves with respect to in-hospital mortality and clinical complications. We aim to determine whether observed improvements of in-hospital outcomes after TAVI are the result of improvements in procedures or due to a change in the patient population, and whether improvements differ between the transfemoral (TF) and the transapical (TA) approach. Data was analyzed using risk-adjusted regression analyses in order to track the development of clinical outcomes of all isolated TAVI procedures performed in Germany from 2008 to 2013 (N=32.436) in all German hospitals performing TAVI. Measurements include in-hospital mortality, stroke, bleeding, and mechanical ventilation. Unadjusted mortality rates decrease over time for both TA-TAVI and TF-TAVI. Reductions in mortality were smaller for TA-TAVI than for TF-TAVI. These trends could also be observed for risk-adjusted (standardized) mortality rates, indicating that time trends and differences between TA-TAVI (around 7% in 2013) and TF-TAVI (around 4% in 2013) cannot be explained by changes in the risk factor composition of the patient populations. Bleeding complications decreased for both access routes. Both unadjusted and standardized bleeding rates were substantially higher for TA-TAVI. In addition, TA-TAVI procedures were associated with an increased likelihood of requiring >48h of mechanical ventilation. Observed improvements in TAVI-related in-hospital mortality are not due to a change in patient population. The results indicate the superiority of a TF-first approach. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

The effectiveness of Korean medicine treatment in male patients with infertility: a study protocol for a prospective observational pilot study.

PubMed

Kim, Kwan-Ii; Jo, Junyoung

2018-01-01

Male factor subfertility has increasingly been considered the cause of infertility in couples. Many men with male infertility have sperm problems such as oligozoospermia, asthenozoospermia, or teratozoospermia. Because abnormal semen parameters are idiopathic to some extent, no standard therapy has been established to date. Herbal medicine has been reported to have beneficial properties in the treatment of subfertility, especially in improving semen quality both in vivo and in human studies. Therefore, we intend to investigate the effectiveness and safety of treatment using Korean medicine (KM) for infertile male patients with poor semen quality.This will be a single-center, prospective, case-only observational pilot study. About 20 male patients with infertility who visit Conmaul Hospital of Korean Medicine will be recruited. We will follow the standard treatment protocol, which has shown good results in the treatment of male infertility. The protocol is composed mainly of a 10-week herbal decoction treatment; acupuncture and/or pharmacopuncture are added when needed. Semen samples, quality of life, and the scrotal temperatures of infertile men will be observed before and after the 10-week treatment with KM.The study has received ethical approval from the Public Institutional Review Board (approval number: P01-201708-21-008). The findings will be disseminated to appropriate audiences via peer-reviewed publication and conference presentations. Korean Clinical Trial Registry (CRIS), Republic of Korea: KCT0002611.

A multinational, observational study to investigate the efficacy, safety and tolerability of acarbose as add-on or monotherapy in a range of patients: the Gluco VIP study.

PubMed

Zhang, Weiwei; Kim, Dongjun; Philip, Elizabeth; Miyan, Zahid; Barykina, Irina; Schmidt, Birgit; Stein, Herbert

2013-04-01

The burden of type 2 diabetes mellitus is growing rapidly, particularly in the Asia-Pacific region. The aim of this international, large-scale, observational study was to investigate the efficacy and tolerability of the antidiabetic agent acarbose as add-on or monotherapy in a range of patients with type 2 diabetes, including those with cardiovascular morbidities. The majority of practices were included from high-burden regions (predominantly those in the Asia-Pacific region). This was an observational study conducted in 15 countries/regions. Adults with pre-treated or untreated type 2 diabetes prescribed acarbose as add-on or monotherapy were eligible. Two-hour postprandial blood glucose (2-h PPG), glycosylated haemoglobin (HbA1c) and fasting blood glucose (FBG) were measured over a 3-month observation period. A total of 15,034 patients were valid for the efficacy analysis and 15,661 for the safety analysis (mean age was 57.6 years and 92.6 % of patients were Asian). Mean (SD) 2-h PPG decreased by -71.9 (62.3) mg/dL, to 170.2 (46.5) mg/dL at final visit (after 12.8 [4.1] weeks). Mean HbA1c decreased by -1.1 % (1.3) to 7.2 % (1.1) and mean FBG decreased by -33.0 (43.3) mg/dL to 124.8 (30.5) mg/dL. Acarbose was effective regardless of the presence of cardiovascular co-morbidities or diabetic complications. The efficacy of acarbose was rated 'very good' or 'good' in 85.5 % of patients, and tolerability as 'very good' or 'good' in 84.9 % of patients. Drug-related adverse events, mainly gastrointestinal, were reported in 490/15,661 patients (3.13 %). The results of this observational study support the notion that acarbose is effective, safe and well tolerated in a large cohort of Asian patients with type 2 diabetes.

Patterns of use and appropriateness of antibiotics prescribed to patients receiving haemodialysis: an observational study.

PubMed

Hui, Katrina; Nalder, Michelle; Buising, Kirsty; Pefanis, Aspasia; Ooi, Khai Y; Pedagogos, Eugenie; Nelson, Craig; Kirkpatrick, Carl M J; Kong, David C M

2017-05-12

There are limited published data on the types and appropriateness of oral and intravenous (IV) antibiotics prescribed to patients receiving haemodialysis. This information is critical to optimise antibiotic prescribing. Therefore this study aims to describe the patterns of use and the appropriateness of oral and IV antibiotics prescribed to patients receiving haemodialysis. This was a prospective, observational study across four community and two hospital inpatient haemodialysis units in Melbourne, Australia. Data were collected from July 2014 to January 2015 from participants. Antibiotic regimens prescribed were compared with nationally available antibiotic guidelines and then classified as being either appropriate, inappropriate or not assessable by an expert multidisciplinary team using the National Antimicrobial Prescribing Survey tool. Overall, 114 participants consented to this study where 55.3% (63/114) received antibiotics and 235 antibiotic regimens were prescribed at a rate of 69.1 antibiotic regimens/100 patient-months. The most common oral antibiotics prescribed were amoxycillin/clavulanic acid and cephalexin. The most common IV antibiotics prescribed were vancomycin, piperacillin/tazobactam, cephazolin and ceftriaxone. The percentage of inappropriate antibiotic regimens prescribed were 34.9% (15/43) in the community setting and 22.1% (40/181) in the hospital setting. Furthermore, 29.4% (30/102) of oral and 20.5% (25/122) of IV antibiotic regimens were inappropriate with incorrect dosing as the primary reason. Although this study is limited by the sample size, it describes the high antibiotic exposure that patients receiving haemodialysis experience. Of concern is inappropriate dose and frequency being a major issue. This requires interventions focused on the quality use of medicines and antimicrobial stewardship aspects of prescribing in this population.

Effect of Observation of Simple Hand Movement on Brain Activations in Patients with Unilateral Cerebral Palsy: An fMRI Study

ERIC Educational Resources Information Center

Dinomais, Mickael; Lignon, Gregoire; Chinier, Eva; Richard, Isabelle; Minassian, Aram Ter; The Tich, Sylvie N'Guyen

2013-01-01

The aim of this functional magnetic resonance imaging (fMRI) study was to examine and compare brain activation in patients with unilateral cerebral palsy (CP) during observation of simple hand movement performed by the paretic and nonparetic hand. Nineteen patients with clinical unilateral CP (14 male, mean age 14 years, 7-21 years) participated…

Long-term neurological outcomes in West Nile virus-infected patients: an observational study.

PubMed

Weatherhead, Jill E; Miller, Vicki E; Garcia, Melissa N; Hasbun, Rodrigo; Salazar, Lucrecia; Dimachkie, Mazen M; Murray, Kristy O

2015-05-01

The Houston West Nile Cohort (HWNC) was founded in 2002 when West Nile virus (WNV) reached Houston, TX. The long-term outcomes following WNV infection are still mostly unknown, though neurological abnormalities up to 1 year postinfection have been documented. We report an observational study of neurological abnormalities at 1-3 and 8-11 years following WNV infection in the HWNC. We conducted standard neurological examinations at two separate time points to assess changes in neurological status over time. The majority of patients (86%, 30/35) with encephalitis had abnormal neurological exam findings at the time of the first assessment compared with uncomplicated fever (27%, 3/11) and meningitis (36%, 5/14) cases. At the time of the second assessment, 57% (4/7) of West Nile fever (WNF), 33% (2/6) of West Nile meningitis (WNM), and 36% (5/14) of West Nile encephalitis (WNE) had developed new neurological complications. The most common abnormalities noted were tandem gait, hearing loss, abnormal reflexes, and muscle weakness. Long-term neurological abnormalities were most commonly found in patients who experienced primary WNV encephalitis. New abnormalities may develop over time regardless of initial clinical infection. Future studies should aim to differentiate neurological consequences due to WNV neuroinvasive infection versus neurological decline related to comorbid conditions. © The American Society of Tropical Medicine and Hygiene.

Usefulness of Positron Emission Tomography in Patients with Syphilis: A Systematic Review of Observational Studies.

PubMed

Chen, Jian-Hua; Zheng, Xin; Liu, Xiu-Qin

2017-05-05

Diagnosis of syphilis is difficult. Follow-up and therapy evaluation of syphilitic patients are poor. Little is known about positron emission tomography (PET) in syphilis. This review was to systematically review usefulness of PET for diagnosis, disease extent evaluation, follow-up, and treatment response assessment in patients with syphilis. We searched PubMed, EMBASE, SCOPUS, Cochrane Library, Web of Science, ClinicalTrials.gov, and three Chinese databases (SinoMed, Wanfang, and CNKI) for English and Chinese language articles from inception to September 2016. We also collected potentially relevant studies and reviews using a manual search. The search keywords included the combined text and MeSH terms "syphilis" and "positron emission tomography". We included studies that reporting syphilis with a PET scan before and/or after antibiotic treatment. The diagnosis of syphilis was based on serological criteria or dark field microscopy. Outcomes include pre- and post-treatment PET scan, pre- and post-treatment computed tomography, and pre- and post-treatment magnetic resonance imaging. We excluded the articles not published in English or Chinese or not involving humans. Of 258 identified articles, 34 observational studies were included. Thirty-three studies were single-patient case reports and one study was a small case series. All patients were adults. The mean age of patients was 48.3 ± 12.1 years. In primary syphilis, increased fluorodeoxyglucose (FDG) accumulation could be seen at the site of inoculation or in the regional lymph nodes. In secondary syphilis with lung, bone, gastrointestinal involvement, or generalized lymphadenopathy, increased FDG uptake was the most commonly detected changes. In tertiary syphilis, increased glucose metabolic activity, hypometabolic lesions, or normal glucose uptake might be seen on PET. There were five types of PET scans in neurosyphilis. A repeated PET scan after treatment revealed apparent or complete resolution of the

Tuberculosis patients hospitalized in the Albert Schweitzer Hospital, Lambaréné, Gabon-a retrospective observational study.

PubMed

Stolp, S M; Huson, M A M; Janssen, S; Beyeme, J O; Grobusch, M P

2013-11-01

Epidemiological data on tuberculosis in Central Africa are limited. We performed a retrospective observational study on clinical characteristics of 719 hospitalized tuberculosis patients in Lambaréné, Gabon. Human immunodeficiency virus (HIV) co-infection rate was high (34%) and in-hospital mortality was significantly higher in HIV-positive patients (10% versus 2%). Long-term information on patient outcome was limited; however, from 2008 to 2011, loss to follow up was noted in 28% of cases. Our data illustrate the high burden of TB in Gabon, where loss to follow up and emerging drug resistance are important problems for which comprehensive data are still lacking. © 2013 The Authors Clinical Microbiology and Infection © 2013 European Society of Clinical Microbiology and Infectious Diseases.

Who Should Be Investigated for Haematuria? Results of a Contemporary Prospective Observational Study of 3556 Patients.

PubMed

Tan, Wei Shen; Feber, Andrew; Sarpong, Rachael; Khetrapal, Pramit; Rodney, Simon; Jalil, Rumana; Mostafid, Hugh; Cresswell, Joanne; Hicks, James; Rane, Abhay; Henderson, Alastair; Watson, Dawn; Cherian, Jacob; Williams, Norman; Brew-Graves, Chris; Kelly, John D

2018-07-01

There remains a lack of consensus among guideline relating to which patients require investigation for haematuria. We determined the incidence of urinary tract cancer in a prospective observational study of 3556 patients referred for investigation of haematuria across 40 hospitals between March 2016 and June 2017 (DETECT 1; ClinicalTrials.gov: NCT02676180) and the appropriateness of age at presentation in cases with visible (VH) and nonvisible (NVH) haematuria. The overall incidence of urinary tract cancer was 10.0% (bladder cancer 8.0%, renal parenchymal cancer 1.0%, upper tract transitional cell carcinoma 0.7%, and prostate cancer 0.3%). Patients with VH were more likely to have a diagnosis of urinary tract cancer compared with NVH patients (13.8% vs 3.1%). Older patients, male gender, and smoking history were independently associated with urinary tract cancer diagnosis. Of bladder cancers diagnosed following NVH, 59.4% were high-risk cancers, with 31.3% being muscle invasive. The incidence of cancer in VH patients <45 yr of age was 3.5% (n=7) and 1.0% (n=4) in NVH patients <60 yr old. Our results suggest that patients with VH should be investigated regardless of age. Although the risk of urinary tract cancer in NVH patients is low, clinically significant cancers are detected below the age threshold for referral for investigation. This study highlights the requirement to investigate all patients with visible blood in the urine and an age threshold of ≥60 yr, as recommended in some guidelines, as the investigation of nonvisible blood in the urine will miss a significant number of urinary tract cancers. Patient preference is important, and evidence that patients are willing to submit to investigation should be considered in reaching a consensus recommendation for the investigation of haematuria. International consensus to guide that patients will benefit from investigation should be developed. Copyright © 2018. Published by Elsevier B.V.

Relation between troponin T concentration and mortality in patients presenting with an acute stroke: observational study

PubMed Central

James, P; Ellis, C J; Whitlock, R M L; McNeil, A R; Henley, J; Anderson, N E

2000-01-01

Objective To assess whether a raised serum troponin T concentration would be an independent predictor of death in patients with an acute ischaemic stroke. Design Observational study. Setting Auckland Hospital, Auckland, New Zealand. Subjects All 181 patients with an acute ischaemic stroke admitted over nine months in 1997-8, from a total of 8057 patients admitted to the acute medical service. Main outcome measures Blood samples for measuring troponin T concentration were collected 12-72 hours after admission; other variables previously associated with severity of stroke were also recorded and assessed as independent predictors of inpatient mortality. Results Troponin T concentration was raised (>0.1 μg/l) in 17% (30) of patients admitted with an acute ischaemic stroke. Thirty one patients died in hospital (12/30 (40%) patients with a raised troponin T concentration v 19/151 (13%) patients with a normal concentration (relative risk 3.2 (95% confidence 1.7 to 5.8; P=0.0025)). Of 17 possible predictors of death, assessed in a multivariate stepwise model, only a raised troponin T concentration (P=0.0002), age (P=0.0008), and an altered level of consciousness at presentation (P=0.0074) independently predicted an adverse outcome. Conclusions Serum troponin T concentration at hospital admission is a powerful predictor of mortality in patients admitted with an acute ischaemic stroke. PMID:10834890

Multicentre, Prospective Observational Study of Pegfilgrastim Primary Prophylaxis in Patients at High Risk of Febrile Neutropenia in Poland: PROFIL Study

PubMed Central

Jurczak, Wojciech; Kalinka-Warzocha, Ewa; Chmielowska, Ewa; Duchnowska, Renata; Wojciechowska-Lampka, Elzbieta

2015-01-01

Aim of the study PROFIL was a prospective observational study conducted to investigate physicians’ evaluation of febrile neutropenia (FN) risk and reasons for giving pegfilgrastim primary prophylaxis (PP) in routine clinical practice in Poland. Material and methods Adult cancer patients treated with chemotherapy (CT), assessed by investigators as having high overall FN risk, and who received pegfilgrastim in cycle 1 were enrolled between 03/2009 and 09/2010. Investigators assessed FN risk of the CT regimen, individual risk factors, and overall FN risk, and were asked to provide the most important reasons for providing pegfilgrastim PP. Investigator-assessed CT FN risk was compared with guideline classification. Results Data were analysed from 1006 breast, ovarian, and lung cancer, and non-Hodgkin (NHL) and Hodgkin lymphoma (HL) patients. The most important reasons for using pegfilgrastim PP were high CT FN risk and advanced disease; these were consistent across tumour types and treatment intent. The investigators generally assessed high CT FN risk in agreement with guideline classification. Febrile neutropenia occurred in 4% of patients, most commonly in HL, NHL, and patients with advanced disease. Conclusions High CT FN risk and advanced stage of disease were found to be the most important reasons for providing pegfilgrastim PP by physicians in Poland. PMID:26557762

Characteristics and outcomes of pediatric patients presenting at Cambodian referral hospitals without appointments: an observational study.

PubMed

Yore, Mackensie A; Strehlow, Matthew C; Yan, Lily D; Pirrotta, Elizabeth A; Woods, Joan L; Somontha, Koy; Sovannra, Yim; Auerbach, Lauren; Backer, Rebecca; Grundmann, Christophe; Mahadevan, Swaminatha V

2018-03-13

Emergency medicine is a young specialty in many low- and middle-income countries (LMICs). Although many patients seeking emergency or acute care are children, little information is available about the needs and current treatment of this group in LMICs. In this observational study, we sought to describe characteristics, chief complaints, management, and outcomes of children presenting for unscheduled visits to two Cambodian public hospitals. Children enrolled in the study presented without appointment for treatment at one of two Cambodian public referral hospitals during a 4-week period in 2012. Researchers used standardized questionnaires and hospital records to collect demographic and clinical data. Patients were followed up at 48 h and 14 days after initial presentation. Multivariate logistic regression identified factors associated with hospital admission. This study included 867 unscheduled visits. Mean patient age was 5.7 years (standard deviation 4.8 years). Of the 35 different presenting complaints, fever (63%), respiratory problems (25%), and skin complaints (24%) were most common. The majority of patients were admitted (51%), while 1% were transferred to another facility. Seven patients (1%) died within 14 days. Follow-up rates were 83% at 48 h and 75% at 14 days. Predictors of admission included transfer or referral from another health provider, seeking prior care for the presenting problem, low socioeconomic status, onset of symptoms within 24 h of seeking care, abnormal vital signs or temperature, and chief complaint of abdominal pain or fever. While the admission rate in this study was high, mortality was low. More effective identification and management of children who can be treated and released may free up scarce inpatient resources for children who warrant admission.

Management of minor head injury in patients receiving oral anticoagulant therapy: a prospective study of a 24-hour observation protocol.

PubMed

Menditto, Vincenzo G; Lucci, Moira; Polonara, Stefano; Pomponio, Giovanni; Gabrielli, Armando

2012-06-01

Patients receiving warfarin who experience minor head injury are at risk of intracranial hemorrhage, and optimal management after a single head computed tomography (CT) scan is unclear. We evaluate a protocol of 24-hour observation followed by a second head CT scan. In this prospective case series, we enrolled consecutive patients receiving warfarin and showing no intracranial lesions on a first CT scan after minor head injury treated at a Level II trauma center. We implemented a structured clinical pathway, including 24-hour observation and a CT scan performed before discharge. We then evaluated the frequency of death, admission, neurosurgery, and delayed intracranial hemorrhage. We enrolled and observed 97 consecutive patients. Ten refused the second CT scan and were well during 30-day follow-up. Repeated CT scanning in the remaining 87 patients revealed a new hemorrhage lesion in 5 (6%), with 3 subsequently hospitalized and 1 receiving craniotomy. Two patients discharged after completing the study protocol with 2 negative CT scan results were admitted 2 and 8 days later with symptomatic subdural hematomas; neither received surgery. Two of the 5 patients with delayed bleeding at 24 hours had an initial international normalized ratio greater than 3.0, as did both patients with delayed bleeding beyond 24 hours. The relative risk of delayed hemorrhage with an initial international normalized ratio greater than 3.0 was 14 (95% confidence interval 4 to 49). For patients receiving warfarin who experience minor head injury and have a negative initial head CT scan result, a protocol of 24-hour observation followed by a second CT scan will identify most occurrences of delayed bleeding. An initial international normalized ratio greater than 3 suggests higher risk. Copyright © 2011 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.

Clinical characteristics of pneumonia in bedridden patients receiving home care: a 3-year prospective observational study.

PubMed

Ishida, Tadashi; Tachibana, Hiromasa; Ito, Akihiro; Ikeda, Satoshi; Furuta, Kenjiro; Nishiyama, Akihiro; Noyama, Maki; Tokioka, Fumiaki; Yoshioka, Hiroshige; Arita, Machiko

2015-08-01

The aim of the study was to describe the epidemiology, clinical features, antimicrobial treatment, and outcomes of bedridden pneumonia patients receiving home healthcare. A 3-year prospective observational study of poor performance status (PS) 3-4 patients receiving long-term home healthcare and hospitalized at a single center with pneumonia between October 2010 and September 2013 was conducted, and their clinical characteristics were compared with non-bedridden community-acquired pneumonia (CAP) patients. A total of 131 CAP patients with PS 3-4, and 400 CAP patients with PS 0-2 were evaluated. The PS 3-4 patients were older, and exhibited a higher frequency of underlying diseases. Aspiration was thought to be associated with pneumonia in 77.1% of the PS 3-4 patients. Streptococcus pneumoniae was the leading pathogen in both groups, whereas the frequency of streptococci and polymicrobial infections was higher in the PS 3-4 group. The incidence of multidrug-resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA) or Pseudomonas aeruginosa was lower than in previous healthcare-associated pneumonia reports. The in-hospital mortality and recurrence rates were significantly higher in the PS 3-4 group than in the good PS group (17.6% vs. 6.0%, p < 0.001 and 15.3% vs. 7.5%, p = 0.008, respectively). The clinical characteristics of pneumonia in poor PS patients were similar to healthcare-associated pneumonia (HCAP), except for the frequency of drug-resistant pathogens. Hence, it might be beneficial to categorize pneumonia in home residents with poor PS separately from pneumonia in CAP patients who were previously healthy or experienced mild comorbidities. Copyright © 2015 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Observational study to analyze patterns of treatment of breakthrough dyspnea in cancer patients in clinical practice.

PubMed

Cabezón-Gutiérrez, Luis; Delgado-Mingorance, Ignacio; Nabal-Vicuña, María; Jiménez-López, Antonio Javier; Cabezón-Álvarez, Ana; Soler-López, Begoña

2018-06-12

Although breakthrough dyspnea is very frequent in cancer patients, there are no precise recommendations for treating it. The main objective of this study was to analyze what treatments are used in clinical practice for the management of breakthrough dyspnea in cancer patients in Spain and the secondary objectives were to describe the characteristics of cancer patients with breakthrough dyspnea and the attributes of the disorder. Cancer patients over 18 years of age, with breakthrough dyspnea and a Karnofsky performance score of ≥30, who were treated at departments of oncology in institutes across Spain were included in this cross-sectional observational study. The characteristics of breakthrough dyspnea, history of treatment, anthropometric variables, Mahler dyspnea index, Borg scale, Edmonton Symptoms Assessment Scale, and patient satisfaction with current breakthrough dyspnea treatment were assessed. The mean age of the 149 included patients was 66 years (95% confidence interval: 64.3 to 67.9), and 53 were females (35.6%). The mean breakthrough dyspnea intensity was 5.85 (95% confidence interval 5.48 to 6.22, Borg scale). A total of 55.1% of the first-choice treatments consisted of opioids, followed by oxygen (17.3%). A total of 119 patients (79.9%) received monotherapy for breakthrough dyspnea. Patients presenting with basal dyspnea received oxygen in a greater proportion of cases (21.1% vs 7.4%; p = 0.07). Patients with predictable dyspnea received a greater proportion of opioids (70.9% vs 44.4%; p = 0.01). Opioids constitute first-line therapy for breakthrough dyspnea in routine clinical practice, though the scientific evidence supporting their use is scarce. Further information derived from controlled clinical trials is needed regarding the comparative efficacy of the different treatments in order to justify their use.

Patient reported outcome of adult perioperative anaesthesia in the United Kingdom: a cross-sectional observational study.

PubMed

Walker, E M K; Bell, M; Cook, T M; Grocott, M P W; Moonesinghe, S R

2016-06-12

Understanding the patient perspective on healthcare is central to the evaluation of quality. This study measured selected patient-reported outcomes after anaesthesia in order to identify targets for research and quality improvement. This cross-sectional observational study in UK National Health Service hospitals, recruited adults undergoing non-obstetric surgery requiring anaesthesia care over a 48 h period. Within 24 h of surgery, patients completed the Bauer questionnaire (measuring postoperative discomfort and satisfaction with anaesthesia care), and a modified Brice questionnaire to elicit symptoms suggestive of accidental awareness during general anaesthesia (AAGA). Patient, procedural and pharmacological data were recorded to enable exploration of risk factors for these poor outcomes. 257 hospitals in 171 NHS Trusts participated (97% of eligible organisations). Baseline characteristics were collected on 16,222 patients; 15,040 (93%) completed postoperative questionnaires. Anxiety was most frequently cited as the worst aspect of the perioperative experience. Thirty-five per cent of patients reported severe discomfort in at least one domain: thirst (18.5%; 95% CI 17.8-19.1), surgical pain (11.0%; 10.5-11.5) and drowsiness (10.1%; 9.6-10.5) were most common. Despite this, only 5% reported dissatisfaction with any aspect of anaesthesia-related care. Regional anaesthesia was associated with a reduced burden of side-effects. The incidence of reported AAGA was one in 800 general anaesthetics (0.12%) Anxiety and discomfort after surgery are common; despite this, satisfaction with anaesthesia care in the UK is high. The inconsistent relationship between patient-reported outcome, patient experience and patient satisfaction supports using all three of these domains to provide a comprehensive assessment of the quality of anaesthesia care. © The Author 2016. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For

Physiotherapists' compliance with ankle injury guidelines is different for patients with acute injuries and patients with functional instability: an observational study.

PubMed

Kooijman, Margit K; Swinkels, Ilse Cs; Veenhof, Cindy; Spreeuwenberg, Peter; Leemrijse, Chantal J

2011-01-01

What are the characteristics of patients with acute ankle injuries or functional instability of the ankle? Do physiotherapists treat these patients according to evidence-based guidelines? What are the determinants of adherence to the guidelines? Observational study using multi-level analyses of data from the National Information Service for Allied Health Care in the Netherlands. This network continuously collects healthcare-related information on characteristics of patients and their referral, health problem, and treatment plan. 1413 patients treated for ankle injuries. Adherence to the guidelines was measured using three quality indicators: number of sessions, interventions, and accomplished treatment goals. Interventions and treatment goals were often aimed at the improvement of body functions, especially in patients with functional instability. Although not advised in the guidelines, manual manipulation was applied during treatment in 21% of the patients with functional instability. On average, patients with acute ankle injuries have a 38% chance of being treated according to the guidelines. Adherence can be explained partly by the duration of the complaint, whether the complaint is recurrent, the patient's age and the experience of the therapist, but it depends substantially on the therapist. There is some discrepancy between the guidelines and practice, especially regarding the interventions applied to patients with functional instability. However, there is large variation between therapists. The sooner a patient presents for treatment and the greater the experience of the physiotherapist with ankle injuries, the greater the likelihood that treatment will follow the guidelines. Copyright © 2011 Australian Physiotherapy Association. Published by .. All rights reserved.

Co-prescription of gastroprotective agents and their efficacy in elderly patients taking nonsteroidal anti-inflammatory drugs: a systematic review of observational studies.

PubMed

Medlock, Stephanie; Eslami, Saeid; Askari, Marjan; Taherzadeh, Zhila; Opondo, Dedan; de Rooij, Sophia E; Abu-Hanna, Ameen

2013-10-01

Guidelines recommend prescribing gastroprotective agents (proton pump inhibitors, misoprostol) to older patients (primarily ≥65 years old) taking nonsteroidal anti-inflammatory drugs (NSAIDs) to prevent gastrointestinal ulcers. Older individuals are underrepresented in clinical trials of these agents. We systematically reviewed evidence from observational studies on the use of gastroprotective agents in elderly patients and their ability to prevent NSAID-related ulcers in this population. We performed a systematic search of Embase and MEDLINE and identified 23 observational studies that focused on elderly patients and reported data on co-prescription of gastroprotective agents and NSAIDs and/or the effectiveness of the agents in preventing gastrointestinal events in NSAID users. We collected data on rates of co-prescription and NSAID-related gastrointestinal events in patients with and without gastroprotection. A median of 24% (range, 10%-69%) of elderly patients taking NSAIDs received a co-prescription for gastroprotective agents; this percentage was only slightly higher in the oldest age groups. All studies of efficacy showed a positive effect of gastroprotection. However, the adjusted results were not suitable for synthesis, and the 5 studies reporting unadjusted results were too heterogeneous for meta-analysis (I(2) = 97%). The studies differed in outcomes, definitions of co-prescription, and differences in baseline risk factors between patients with and without gastroprotection. None of the studies assessed adverse effects of gastroprotective agents. The 2 cost-effectiveness studies reached opposing conclusions. In a systematic review, the observational evidence for the efficacy of gastroprotective agents in preventing NSAID-associated gastrointestinal events was in agreement with results of randomized controlled trials. However, because of heterogeneity of included studies, it is not clear what the effect would be if more patients were treated, or at what

Identifying patients at high risk for obstructive sleep apnoea syndrome in Nigeria: A multicentre observational study.

PubMed

Desalu, Olufemi O; Onyedum, Cajetan C; Adeoti, Adekunle O; Fadare, Joseph O; Sanya, Emmanuel O; Fawale, Michael B; Bello, Hamzat A

2017-06-01

Obstructive sleep apnoea is associated with significant health consequences. A significant proportion of hospitalized patients at risk for obstructive sleep apnoea were never identified and referred for polysomnography for diagnosis. The objective of this study was to determine the factors associated with high risk for obstructive sleep apnoea and use it to identify patients at risk for the condition in tertiary hospitals in Nigeria. This was a multicentre observational study of adult patients hospitalized in three selected hospitals from 15th January to 17th March 2015. Berlin questionnaire and Epworth sleepiness scale were used to assess for obstructive sleep apnoea risk and excessive daytime sleepiness respectively. Additional questions on traditional risk factors for obstructive sleep apnoea were also obtained. Nine hundred and twenty-six patients were recruited into the study. Respondents' mean age was 44.3 years ± 15.2years, 486 (52.5%) were females and 556 (60.0%) had one or more medical co-morbidity and none of the patients had a previous diagnosis of obstructive sleep apnoea. Factors that were independently associated with high risk for obstructive sleep apnoea include systemic hypertension(aOR-10.33;95%: CI 6.42-16.61), obesity(aOR-7.87;95% CI: 4.33-14.29); excessive daytime sleepiness (aOR-3.77;95% CI :2.28-6.22), tobacco smoking (aOR-2.99;95% CI: 1.76-5.07), snoring in a first-degree relative (aOR-1.83;95% CI: 1.19-2.81); and the use of sedative (aOR-1.82;95% CI: 1.06-3.15). This study shows that patients with systemic hypertension, obesity, excessive daytime sleepiness, history of smoking, snoring in a first-degree relative and use of sedatives are at high risk of obstructive sleep apnoea. None of the patients at high risk had a previous diagnosis of sleep apnoea by a physician, highlighting the diagnostic challenges of this condition. The results of this study will assist health care professionals in early identification of individuals at risk of

Mortality in patients with diabetes mellitus and Addison's disease: a nationwide, matched, observational cohort study.

PubMed

Chantzichristos, Dimitrios; Persson, Anders; Eliasson, Björn; Miftaraj, Mervete; Franzén, Stefan; Bergthorsdottir, Ragnhildur; Gudbjörnsdottir, Soffia; Svensson, Ann-Marie; Johannsson, Gudmundur

2017-01-01

Our hypothesis was that patients with diabetes mellitus obtain an additional risk of death if they develop Addison's disease (AD). Nationwide, matched, observational cohort study cross-referencing the Swedish National Diabetes Register with Inpatient, Cancer and Cause of Death Registers in patients with diabetes (type 1 and 2) and AD and matched controls with diabetes. Clinical characteristics at baseline, overall, and cause-specific mortality were assessed. The relative risk of death was assessed using a Cox proportional hazards regression model. Between January 1996 and December 2012, 226 patients with diabetes and AD were identified and matched with 1129 controls with diabetes. Median (interquartile range) follow-up was 5.9 (2.7-8.6) years. When patients with diabetes were diagnosed with AD, they had an increased frequency of diabetes complications, but both medical history of cancer and coronary heart disease did not differ compared with controls. Sixty-four of the 226 patients with diabetes and AD (28%) died, while 112 of the 1129 controls (10%) died. The estimated relative risk increase (hazard ratio) in overall mortality in the diabetes and AD group was 3.89 (95% confidence interval 2.84-5.32) compared with controls with diabetes. The most common cause of death was cardiovascular in both groups, but patients with diabetes and AD showed an increased death rate from diabetes complications, infectious diseases and unknown causes. Patients with the rare combination of diabetes and AD showed a markedly increased mortality and died more frequently from infections and unknown causes than patients with diabetes alone. Improved strategy for the management of this combination of metabolic disorders is needed. © 2017 European Society of Endocrinology.

Occult pneumothorax in the blunt trauma patient: tube thoracostomy or observation?

PubMed

Wilson, Heather; Ellsmere, James; Tallon, John; Kirkpatrick, Andrew

2009-09-01

The term occult pneumothorax (OP) describes a pneumothorax that is not suspected on the basis of either clinical examination or initial chest radiography, but is subsequently detected on computed tomography (CT) scan. The optimal management of OP in the blunt trauma setting remains controversial. Some physicians favour placement of a thoracostomy tube for patients with OP, particularly those undergoing positive pressure ventilation (PPV), while others favour close observation without chest drainage. This study was conducted both to determine the incidence of OP and to describe its current treatment status in the blunt trauma population at a Canadian tertiary trauma centre. Of interest were the rates of tube thoracostomy vs. observation without chest drainage and their respective outcomes. A retrospective review was conducted of the Nova Scotia Trauma Registry. The data on all consecutive blunt trauma patients between October 1994 and March 2003 was reviewed. Outcome measures evaluated include length of stay, discharge status-dead vs. alive, intervention and time to intervention (tube thoracostomy and its relation to institution of PPV). Direct comparison was made between the OP with tube thoracostomy group and OP without tube thoracostomy group (observation or control group). They were compared in terms of their baseline characteristics and outcome measures. In 1881 consecutive blunt trauma patients over a 102-month period there were 307 pneumothoraces of which 68 were occult. Thirty five patients with OP underwent tube thoracostomy, 33 did not. Twenty nine (82.8%) with tube thoracostomy received positive pressure ventilation (PPV), as did 16 (48.4%) in the observation group. Mean injury severity score (ISS) for tube thoracostomy and observation groups were similar (25.80 and 22.39, p=0.101) whereas length of stay (LOS) was different (17.4 and 10.0 days, p=0.026). Mortality was similar (11.4% and 9.1%). There were no tension pneumothoraces. The natural history of

Patient-Centered Handovers: Ethnographic Observations of Attending and Resident Physicians: Ethnographic Observations of Attending and Resident Physicians.

PubMed

Mount-Campbell, Austin F; Rayo, Michael F; OʼBrien, James J; Allen, Theodore T; Patterson, Emily S

Handover communication improvement initiatives typically employ a "one size fits all" approach. A human factors perspective has the potential to guide how to tailor interventions to roles, levels of experience, settings, and types of patients. We conducted ethnographic observations of sign-outs by attending and resident physicians in 2 medical intensive care units at one institution. Digitally audiotaped data were manually analyzed for content using codes and time spent using box plots for emergent categories. A total of 34 attending and 58 resident physician handovers were observed. Resident physicians spent more time for "soon to be discharged" and "higher concern" patients than attending physicians. Resident physicians spent less time discussing patients which they had provided care for within the last 3 days ("handbacks"). The study suggested differences for how handovers were conducted for attending and resident physicians for 3 categories of patients; handovers differ on the basis of role or level of expertise, patient type, and amount of prior knowledge of the patient. The findings have implications for new directions for subsequent research and for how to tailor quality improvement interventions based upon the role, level of experience, level of prior knowledge, and patient categories.

Manikin Laryngoscopy Motion as a Predictor of Patient Intubation Outcomes: A Prospective Observational Study

PubMed Central

Kedarisetty, Suraj; Johnson, Jennifer Moitoza; Glaser, Dale; Delson, Nathan

2018-01-01

Background: The goal of this study was to determine whether motion parameters during laryngoscopy in a manikin differed with experienced operators versus novice trainees and whether motion measurements would predict trainee outcomes when intubating patients. Methods: Motion, force, and duration of laryngoscopy on a manikin were compared in two separate experiments between beginning anesthesiology residents (CA1) and anesthesiologists with more than 24 months of anesthesiology training (CA3 or attendings). In one experiment, CA1 residents were also evaluated for the percentage of their laryngoscope path that followed the route used by attending anesthesiologists. The residents were then observed for patient intubation outcomes for 4 weeks after manikin testing. The relationship between manikin test metrics and patient intubation outcomes was analyzed by multilevel modeling. Results: CA1 residents positioned the laryngoscope blade farther right and with less lift than did experienced anesthesiologists. Endpoint position was 0.6 ± 0.3 cm left of midline for residents (n = 10) versus 2.7 ± 0.3 cm for advanced anesthesiologists (n = 8; P = .0003), and 15.6 ± 0.8 versus 17.7 ± 0.2 cm above the table surface, respectively (P = .033). On average, only 74 ± 6% of the CA1 laryngoscopy trajectory coincided with the Attending Route (P < .001 versus 100%). For each percentage point increase in Attending Route match, residents' odds of intubating a patient's trachea improved by a factor of 1.033 (95% confidence interval [CI] 1.007–1.059, P = .040), and their rate of failed laryngoscopy attempts decreased by a factor of 0.982 (0.969–0.996, P = .045). Discussion: Laryngoscopy motion in manikins may predict which trainees can complete a patient intubation successfully in a few attempts. The assessment could help determine readiness for intubating patients with indirect supervision.

The rapid suicide protection of mood stabilizers on patients with bipolar disorder: A nationwide observational cohort study in Taiwan.

PubMed

Tsai, Chia-Jui; Cheng, Chin; Chou, Po-Han; Lin, Ching-Heng; McInnis, Melvin G; Chang, Chia-Li; Lan, Tsuo-Hung

2016-05-15

The suicide rate is high among bipolar disorder (BD) patients. Previous studies have focused on the anti-suicidal effect of long-term treatment with mood stabilizers but less on the immediate preventive effects of interventions. The aim of the study was to evaluate the short-term and immediate anti-suicidal effects of mood stabilizers on recent-onset BD patients. The National Health Insurance Database (NHID) of Taiwan was used to perform a nationwide cohort observation study of suicide behaviors in bipolar disorder. All the recent-onset BD patients (ICD-9-CM code 296 except 296.2 and 296.3) diagnosed between 2000-2005 were collected (n=5091) and followed through 2009. The primary endpoint was the presence of a suicide code or the end of observation; exposure to mood stabilizers in the final month of observation was the independent variable. The hazard ratios (HRs) of suicide-related events, completed suicide, and all-cause mortality were significantly lower for those treated with lithium, divalproex, or carbamazepine compared with no use in the last month (HRs of suicide-related events were 0.10, 0.14 and 0.10, respectively, and all-cause mortality HRs were 0.03; P<0.0001); there was no significant difference in HR between the mood stabilizers. The NIHD does not provide information on the severity, mood status, or treatment adherence of BD patients. Neither substance-related disorder nor personality disorder were included in the analysis. We focused on the effect of the final prescription time period, not the long-term protective effect. The immediate recent use of any mood stabilizer significantly lowers the rate of death, suicide, or suicidal behavior in BD. Copyright © 2016 Elsevier B.V. All rights reserved.

Impact of Resident Rotations on Critically Ill Patient Outcomes: Results of a French Multicenter Observational Study.

PubMed

Chousterman, Benjamin G; Pirracchio, Romain; Guidet, Bertrand; Aegerter, Philippe; Mentec, Hervé

2016-01-01

The impact of resident rotation on patient outcomes in the intensive care unit (ICU) has been poorly studied. The aim of this study was to address this question using a large ICU database. We retrospectively analyzed the French CUB-REA database. French residents rotate every six months. Two periods were compared: the first (POST) and fifth (PRE) months of the rotation. The primary endpoint was ICU mortality. The secondary endpoints were the length of ICU stay (LOS), the number of organ supports, and the duration of mechanical ventilation (DMV). The impact of resident rotation was explored using multivariate regression, classification tree and random forest models. 262,772 patients were included between 1996 and 2010 in the database. The patient characteristics were similar between the PRE (n = 44,431) and POST (n = 49,979) periods. Multivariate analysis did not reveal any impact of resident rotation on ICU mortality (OR = 1.01, 95% CI = 0.94; 1.07, p = 0.91). Based on the classification trees, the SAPS II and the number of organ failures were the strongest predictors of ICU mortality. In the less severe patients (SAPS II<24), the POST period was associated with increased mortality (OR = 1.65, 95%CI = 1.17-2.33, p = 0.004). After adjustment, no significant association was observed between the rotation period and the LOS, the number of organ supports, or the DMV. Resident rotation exerts no impact on overall ICU mortality at French teaching hospitals but might affect the prognosis of less severe ICU patients. Surveillance should be reinforced when treating those patients.

Effectiveness of the Medtep Hemophilia online platform for adherence to prophylactic treatment in haemophilia patients: Results from a 1-year observational study.

PubMed

Cuesta-Barriuso, R; López-Pina, J A; Nieto-Munuera, J; Sagarra-Valls, G; Panisello-Royo, J M; Torres-Ortuño, A

2018-03-01

Medtep Hemophilia platform is an online tool that allows patients with congenital coagulopathies to keep track of their daily condition-related events with the objective of ensuring successful adherence to therapy. To assess the effectiveness of Medtep Hemophilia in improving adherence to prophylactic treatment in haemophilia A and B patients in a 1-year prospective observational study, as well as its impact on the patient's disease status. Patients (>13 years old) received support material to familiarize themselves with Medtep Hemophilia. Adherence to treatment, quality of life (QoL) and illness perception were assessed. Values at baseline, 1, 6 and 12 months, and changes from baseline value were analysed. The Hemophilia Joint Health Score (HJHS) test was applied at baseline and study completion. Forty-six patients were enrolled (43 evaluable). After 1 year, 56.4% patients showed continued use of the platform (100% compliance) whereas 25.6% were inactive. Treatment adherence increased both significantly (P < .001) and progressively during the study. Similarly, improved QoL and illness perception were observed with respect to baseline in most of the questionnaire components (P < .05 after 12 months). A patient's age had no influence on the results, whereas compliant patients (>80% of platform use) tended to score better than noncompliant. The HJHS test values remained similar during the study. The Medtep Hemophilia online platform helped the studied patients with haemophilia to improve their adherence to prophylactic treatment, while increasing their QoL and illness perception, as well as joint arthropathies stabilization. © 2018 John Wiley & Sons Ltd.

Efficacy and safety of thrice weekly DOTS in tuberculosis patients with and without HIV co-infection: an observational study

PubMed Central

2013-01-01

Background Despite the latest World Health Organization guidelines advocating daily therapy in HIV-TB co-infected individuals, there are few recent studies comparing outcomes of thrice-weekly anti-tuberculosis treatment in HIV-positive and HIV-negative patients with TB. The present study sets out to compare TB treatment outcomes in these two groups in the Indian national programme, which currently involves thrice-weekly therapy for all, regardless of HIV status. Methods HIV-positive and HIV-negative were consecutively screened for enrolment into this prospective observational study, carried out at the All India Institute of Medical Sciences hospital, New Delhi, India, between 2006 and 2010. Patients were given short-course thrice-weekly rifampicin-based therapy, with all HIV-positive patients being started on highly active antiretroviral therapy at least 14 days after commencing TB treatment. Patients were regularly followed-up for 24 months after completion of treatment. Results 150 HIV-positive, 155 HIV-negative patients were enrolled consecutively for the study. Significantly higher treatment success (93.5% vs. 76.7% at end of treatment, p < 0.001) and lower mortality (2.8% vs. 21.6% on follow up, p < 0.001) were observed in HIV-negative patients. No significant difference was found in treatment failure (p = 0.16), sputum smear (p = 0.58) and culture conversion (p = 0.55), and non-serious adverse event incidence (p = 0.851) between the two groups. Low baseline CD4 cell count (<100 cells/ mm3) was the only predictor of mortality in HIV-TB patients (odds ratio 8 · 43, p = 0 · 013). Conclusions Thrice-weekly anti-tuberculosis therapy is more effective in HIV-negative than in HIV-positive patients. However, outcomes in this HIV co-infected cohort were found to be similar to those reported previously with daily therapy, with no safety concerns. This should prompt further study into whether intermittent or daily therapy should be

Predictors for half-year outcome of impairment in daily life for back pain patients referred for physiotherapy: a prospective observational study.

PubMed

Karstens, Sven; Hermann, Katja; Froböse, Ingo; Weiler, Stephan W

2013-01-01

From observational studies, there is only sparse information available on the predictors of development of impairment in daily life for patients receiving physiotherapy. Therefore, our aim was to identify factors which predict impairment in daily life for patients with back pain 6 months after receiving physiotherapy. We conducted a prospective cohort study with 6-month follow-up. Patients were enrolled for treatment in private physiotherapy practices. Patients with a first physiotherapy referral because of thoracic or low back pain, aged 18 to 65 years were included. Primary outcome impairment was measured utilising the 16-item version of the Musculoskeletal Function Assessment Questionnaire. Therapy was documented on a standardized form. Baseline scores for impairment in daily life, symptom characteristics, sociodemographic and psychosocial factors, physical activity, nicotine consumption, intake of analgesics, comorbidity and delivered primary therapy approach were investigated as possible predictors. Univariate and multiple linear regression analyses were performed. A total of 792 patients participated in the study (59% female, mean age 44.4 (SD 11.4), with 6-month follow-up results available from 391 patients. In univariate analysis 17 variables reached significance. In multiple linear regression identified predictors were: impairment in daily life before therapy, mental disorders, duration of the complaints, self-prognosis on work ability, rheumatoid arthritis, age, form of stress at work and physical activity. The variables explain 34% of variance (adjusted R(2), p<0.001). With minimal information available from observational studies on the predictors of development of back problems for physiotherapy patients, this study adds new knowledge for forming appropriate referral guidelines. Impairment in daily life before therapy, mental disorder as comorbidity and the duration of the complaints can be named as outstanding factors. The results of this study can be

Molecular profiling in Italian patients with advanced non-small-cell lung cancer: An observational prospective study.

PubMed

Gobbini, Elisa; Galetta, Domenico; Tiseo, Marcello; Graziano, Paolo; Rossi, Antonio; Bria, Emilio; Di Maio, Massimo; Rossi, Giulio; Gregorc, Vanesa; Riccardi, Ferdinando; Scotti, Vieri; Ceribelli, Anna; Buffoni, Lucio; Delmonte, Angelo; Franchina, Tindara; Migliorino, Maria Rita; Cortinovis, Diego; Pisconti, Salvatore; Bordi, Paola; Catino, Annamaria; Maiello, Evaristo; Arizio, Francesca; Novello, Silvia

2017-09-01

Molecular profiling of advanced non-small-cell lung cancer (NSCLC) is recommended according to European and Italian guidelines. However, molecular routine assessment remains still heterogeneous. This observational study aimed to take a picture of the real clinical practice in molecular testing and therapeutic choices in advanced Italian NSCLCs. This study prospectively enrolled newly diagnosed advanced or recurrent NSCLCs referred to 38 Italian centres, from November 2014 to November 2015. Information regarding molecular profiling and treatment choices were collected. Description of patients' outcome included overall survival (OS), progression-free survival in first (PFS1) and second-line (PFS2). Among 1787 patients enrolled, 1388 (78%) performed at least one molecular analysis during the history of disease: 76% were tested for EGFR, 53% for ALK, 27% for KRAS, 16% for ROS1, 14% for BRAF, 5% for HER2, 4% for MET and 1% for FGFR. The remaining 399 patients (22.3%) did not receive any molecular test. Among patients receiving at least one molecular analysis, 583 (42%) presented a molecular alteration. Considering EGFR mutated and/or ALK rearranged patients (402), for which target agents were routinely reimbursed at time of study in Italy, the 86% received a personalized treatment as first and/or second line: the 90% (286) of EGFR mutants received an EGFR tyrosine kinase inhibitor, mostly gefitinib (41.1%) or afatinib (36.4%) while 74% (62) of ALK translocated patients received an ALK inhibitor, mostly crizotinib (64%). Median OS was 9.34 months (95% CI 8.62-10.0), median PFS1 was 4.61 months (95%CI 4.31-4.84) and median PFS2 was 2.76 months (95%CI 2.57-3.19). In the Italian clinical practice, routine molecular assessment was largely applied in NSCLC patients, according to national guidelines, but a low level of ALK test was reached. Most of EGFR mutants an ALK rearranged patients received a personalized treatment as first and/or second line. Copyright © 2017 Elsevier

CURB-65 Score is Equal to NEWS for Identifying Mortality Risk of Pneumonia Patients: An Observational Study.

PubMed

Brabrand, Mikkel; Henriksen, Daniel Pilsgaard

2018-06-01

The CURB-65 score is widely implemented as a prediction tool for identifying patients with community-acquired pneumonia (cap) at increased risk of 30-day mortality. However, since most ingredients of CURB-65 are used as general prediction tools, it is likely that other prediction tools, e.g. the British National Early Warning Score (NEWS), could be as good as CURB-65 at predicting the fate of CAP patients. To determine whether NEWS is better than CURB-65 at predicting 30-day mortality of CAP patients. This was a single-centre, 6-month observational study using patients' vital signs and demographic information registered upon admission, survival status extracted from the Danish Civil Registration System after discharge and blood test results extracted from a local database. The study was conducted in the medical admission unit (MAU) at the Hospital of South West Jutland, a regional teaching hospital in Denmark. The participants consisted of 570 CAP patients, 291 female and 279 male, median age 74 (20-102) years. The CURB-65 score had a discriminatory power of 0.728 (0.667-0.789) and NEWS 0.710 (0.645-0.775), both with good calibration and no statistical significant difference. CURB-65 was not demonstrated to be significantly statistically better than NEWS at identifying CAP patients at risk of 30-day mortality.

Endoscopic lung volume reduction coil treatment in patients with chronic hypercapnic respiratory failure: an observational study.

PubMed

Simon, Marcel; Harbaum, Lars; Oqueka, Tim; Kluge, Stefan; Klose, Hans

2017-01-01

Endoscopic lung volume reduction coil (LVRC) treatment is an option for selected patients with severe emphysema. In the advanced stages, emphysema leads to respiratory failure: hypoxemia and eventually chronic hypercapnic respiratory failure. It can be hypothesized that LVRC treatment, a procedure targeting hyperinflation and thereby reducing ventilatory workload, may be especially beneficial in patients with chronic hypercapnic respiratory failure. This study was conducted to gain first insights into the effects and the safety of LVRC treatment in patients with emphysema and chronic hypercapnic respiratory failure. A retrospective observational study conducted in the Department of Respiratory Medicine at the University Medical Center Hamburg-Eppendorf, Germany on all patients with chronic hypercapnic respiratory failure in whom bilateral LVRC treatment was performed between 1 April 2012 and 30 September 2015. During the study period, bilateral LVRC treatment was performed in 10 patients with chronic hypercapnic respiratory failure. Compared with baseline, bilateral LVRC treatment led to a significant increase in mean forced expiratory volume in one second (FEV 1 ) from 0.5 ± 0.1 l to 0.6 ± 0.2 l ( p = 0.004), a decrease in residual volume (RV) from 6.1 ± 0.9 l to 5.6 ± 1.1 l ( p = 0.02) and a reduction in partial pressure of carbon dioxide in arterial blood (PaCO 2 ) from 53 ± 5 mmHg to 48 ± 4 mmHg ( p = 0.03). One case of hemoptysis requiring readmission to hospital was the only severe adverse event. LVRC treatment was safe and effective in patients with nonsevere chronic hypercapnic respiratory failure. It led not only to an improvement in lung function but also to a significant decrease in PaCO 2 .

[CONDYDAV: A multicentre observational study of patients presenting external genital warts in France].

PubMed

Chanal, J; Fouéré, S; Yassir-Oria, F; Spenatto, N; Bouscarat, F; Picot, E; Martinet, P; Vernay-Vaisse, C; Pelletier, F; Courtieu, C; Baclet, V; Bernier, C; Aymar-Moulene, D; Dupuis-Fourdan, F; Passeron, A; Bara-Passot, C; Pinault, A-L; Misery, L; Janier, M; Dupin, N

2016-11-01

Since 2007 in France, human papilloma virus (HPV) vaccination has been licensed for use as a vaccine against HPV 6, 11, 16 and 18. The impact on the epidemiology of external genital warts (EGWs) in a large population remains unclear. To determine epidemiologic and clinical features of patients presenting EGWs in France in the era of HPV vaccination. In this prospective, observational study, we analyzed clinical features and treatments between January 1st, 2012 and March 31, 2012 for patients consulting for EGWs at 15 STI clinics throughout France. A total of 372 men and 111 women were included; mean age 31.2 years. The women were younger than the men (31.7 and 28.9 years respectively P<0.05). Among the patients, 416 (85.7%) were heterosexual, 13 bisexual and 54 (11.2%) homosexual, including one female. Males reported more sexual partners in the last 12 months (more than 3 partners in 32.6% versus 11.9%, P<0.01). Among the men, 230 had involvement of the penis alone and 46 had involvement of the anus alone. Seventy-six patients had EGWs of the anus, and of these 26 were MSM. In females, 76 had an infection of the vulva alone and 22 co-infection of the vulva and anus. MSM and females were at higher risk than heterosexual males for anal involvement (P<0.0001 and P=0.004, respectively). Three women had been vaccinated: two with Gardasil ® and one with Cervarix ® . Cryotherapy was the preferred treatment. With the advent of HPV vaccination, a global strategy for the prevention and treatment of EGW should be implemented. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Verbal and non-verbal behaviour and patient perception of communication in primary care: an observational study

PubMed Central

Little, Paul; White, Peter; Kelly, Joanne; Everitt, Hazel; Gashi, Shkelzen; Bikker, Annemieke; Mercer, Stewart

2015-01-01

Background Few studies have assessed the importance of a broad range of verbal and non-verbal consultation behaviours. Aim To explore the relationship of observer ratings of behaviours of videotaped consultations with patients’ perceptions. Design and setting Observational study in general practices close to Southampton, Southern England. Method Verbal and non-verbal behaviour was rated by independent observers blind to outcome. Patients competed the Medical Interview Satisfaction Scale (MISS; primary outcome) and questionnaires addressing other communication domains. Results In total, 275/360 consultations from 25 GPs had useable videotapes. Higher MISS scores were associated with slight forward lean (an 0.02 increase for each degree of lean, 95% confidence interval [CI] = 0.002 to 0.03), the number of gestures (0.08, 95% CI = 0.01 to 0.15), ‘back-channelling’ (for example, saying ‘mmm’) (0.11, 95% CI = 0.02 to 0.2), and social talk (0.29, 95% CI = 0.4 to 0.54). Starting the consultation with professional coolness (‘aloof’) was helpful and optimism unhelpful. Finishing with non-verbal ‘cut-offs’ (for example, looking away), being professionally cool (‘aloof’), or patronising, (‘infantilising’) resulted in poorer ratings. Physical contact was also important, but not traditional verbal communication. Conclusion These exploratory results require confirmation, but suggest that patients may be responding to several non-verbal behaviours and non-specific verbal behaviours, such as social talk and back-channelling, more than traditional verbal behaviours. A changing consultation dynamic may also help, from professional ‘coolness’ at the beginning of the consultation to becoming warmer and avoiding non-verbal cut-offs at the end. PMID:26009530

A prospective observational study comparing a physiological scoring system with time-based discharge criteria in pediatric ambulatory surgical patients.

PubMed

Armstrong, James; Forrest, Helen; Crawford, Mark W

2015-10-01

Discharge criteria based on physiological scoring systems can be used in the postanesthesia care unit (PACU) to fast-track patients after ambulatory surgery; however, studies comparing physiological scoring systems with traditional time-based discharge criteria are lacking. The purpose of this study was to compare PACU discharge readiness times using physiological vs time-based discharge criteria in pediatric ambulatory surgical patients. We recorded physiological observations from consecutive American Society of Anesthesiologists physical status I-III patients aged 1-18 yr who were admitted to the PACU after undergoing ambulatory surgery in a tertiary academic pediatric hospital. The physiological score was a combination of the Aldrete and Chung systems. Scores were recorded every 15 min starting upon arrival in the PACU. Patients were considered fit for discharge once they attained a score ≥12 (maximum score, 14), provided no score was zero, with the time to achieve a score ≥12 defining the criteria-based discharge (CBD) time. Patients were discharged from the PACU when both the CBD and the existing time-based discharge (TBD) criteria were met. The CBD and TBD data were compared using Kaplan-Meier and log-rank analysis. Observations from 506 children are presented. Median (interquartile range [IQR]) age was 5.5 [2.8-9.9] yr. Median [IQR] CBD and TBD PACU discharge readiness times were 30 [15-45] min and 60 [45-60] min, respectively. Analysis of Kaplan-Meier curves indicated a significant difference in discharge times using the different criteria (hazard ratio, 5.43; 95% confidence interval, 4.51 to 6.53; P < 0.001). All patients were discharged home without incident. This prospective study suggests that discharge decisions based on physiological criteria have the potential for significantly speeding the transit of children through the PACU, thereby enhancing PACU efficiency and resource utilization.

Effectiveness and safety of fixed dose combination of acarbose/metformin in Indian Type 2 diabetes patients: Results from observational GLOBE Study

PubMed Central

Saboo, Banshi; Reddy, Gundam Chandrasekhara; Juneja, Subhashchander; Kedia, Ashok Kumar; Manjrekar, Pravin; Rathod, Rahul

2015-01-01

Primary objective - evaluate effectiveness and safety of acarbose/metformin fixed dose FDC on glycemic control in Indian T2DM patients in real life clinical setting. Secondary objective - evaluate safety and satisfaction of treatment. Materials and Methods: Open-label, prospective, multicentre, single-arm, non-interventional study. Patients included were aged ≥18 years with T2DM on Acarbose (25/50 mg) and Metformin (500 mg) FDC. Glycemic parameters were recorded during observation. Results: Total 9364 patients were enrolled in the study (mean age, 50.7 years and 60.1% were male). Mean (SD) FBG and PPG was significantly reduced by 42.4 (32.6) mg/dl (P < 0.0001) and 80.2 (49.7) mg/dl (P < 0.0001) respectively at the end of observation. Mean (SD) HbA1c reduced by -1.0% (0.8) to 7.3% (0.7) at the last follow-up visit (P <0.0001). Majority of patients (97.5%) and physicians (98.42%) were satisfied with acarbose/metformin FDC treatment. Also, significant reduction in body weight by -1.7 (2.2) kg was observed (P < 0.0001). Patients with known T2DM and newly diagnosed showed a similar glycemic control (P < 0.0001). Drug-related adverse events were reported by only 1.4% patients mostly gastrointestinal. Conclusions: Acarbose/metformin FDC was efficacious, safe well accepted in routine clinical practice. It was well-tolerated without significant risk of hypoglycemia and can be used in early T2DM management PMID:25593840

Temporomandibular disorders in burning mouth syndrome patients: an observational study.

PubMed

Corsalini, Massimo; Di Venere, Daniela; Pettini, Francesco; Lauritano, Dorina; Petruzzi, Massimo

2013-01-01

Burning Mouth Syndrome (BMS) is a chronic disease characterized by absence of any lesions and burning of the oral mucosa associated to a sensation of dry mouth and/or taste alterations. The purpose of our study is to estimate signs and symptoms of Temporomandibular Disorders (TMD) in patients with BMS and to investigate for the existence of an association between BMS and TMD. Forty-four BMS patients were enrolled; BMS subtype was established according to the classification of Lamey. After a gnathological evaluation, according to the protocol of the European Academy of Craniomandibular Disorders, patients were classified by RDC/TMD criteria. The data were compared and analyzed using a chi-square test to describe the existence of an association between BMS and TMD. 65.9% the BMS patients showed disorders classified as primary signs and symptoms of TMD according to RDC / TMD criteria, and 72.7% showed parafunctional habits. The chi-square test revealed a statistically significant association (p = 0.035) between BMS and TMD. The data suggest that there is a possible relationship not yet well understood between BMS and TMD, may be for neurophatic alterations assumed for BMS that could be also engaged in TMD pathogenesis.

Tinea pedis and onychomycosis frequency in diabetes mellitus patients and diabetic foot ulcers. A cross sectional - observational study.

PubMed

Akkus, Gamze; Evran, Mehtap; Gungor, Dilek; Karakas, Mehmet; Sert, Murat; Tetiker, Tamer

2016-01-01

Impaired cellular immunity and reduced phagocytic function of polymorphonuclear leukocytes facilitate the development of skin fungal and bacterial infections due to uncontrolled hyperglycemia in diabetic patients. In our study, we aimed to assess onychomycosis and/or tinea pedis frequency in diabetic patients, and effects on the development of chronic complications, particularly foot ulcer. We included 227 diabetic patients in the study. Forty-three patients had diabetic foot ulcer. We screened and recorded demographic characteristics, HbA1c levels of patients, and presence of complications We examined patients dermatologically, and collected samples by scalpel from skin between toes, and from sole, toe nail, and area surrounding nails from suspected to have fungal infection. Native positivity between toes was higher in men compared to women (p<0.05). We obtained significant relation between HbA1c elevation and native positivity between toes (p<0.05). Fungal infection between toes, at sole and toe nail significantly increased in patients with diabetic foot ulcer compared to patients without diabetic foot ulcer (p<0.05). Moreover, native positivity in patients with diabetic foot ulcer correlated with presence of fungal infection examination findings (p<0.05). Fungal infections were more frequently observed in the presence of poor glycemic control and peripheral vascular disease in diabetic patients in compliance with the literature, and the presence of fungal infection may also responsible for the development of foot ulcers.

Long-term safety and efficacy of deferasirox in young pediatric patients with transfusional hemosiderosis: Results from a 5-year observational study (ENTRUST).

PubMed

Vichinsky, Elliott; El-Beshlawy, Amal; Al Zoebie, Azzam; Kamdem, Annie; Koussa, Suzanne; Chotsampancharoen, Thirachit; Bruederle, Andreas; Gilotti, Geralyn; Han, Jackie; Elalfy, Mohsen

2017-09-01

Children with red blood cell disorders may receive regular transfusions from an early age and consequently accumulate iron. Adequate iron chelation therapy can prevent organ damage and delayed growth/development. Deferasirox is indicated for treatment of pediatric patients with chronic iron overload due to transfusional hemosiderosis; however, fewer than 10% of patients in the registration studies were aged 2 to less than 6 years. Deferasirox, a once-daily oral iron chelator, was evaluated in young pediatric patients with transfusional hemosiderosis during the observational 5-year ENTRUST study. Patients aged 2 to less than 6 years at enrollment received deferasirox according to local prescribing information, with the primary objective of evaluating safety, specifically renal and hepatic function. Serum ferritin was observed as a surrogate efficacy parameter. In total, 267 patients (mean age 3.2 years) predominantly with β-thalassemia (n = 176, 65.9%) were enrolled. Mean ± standard deviation deferasirox dose was 25.8 ± 6.5 mg/kg per day over a median of 59.9 months. A total of 145 patients (54.3%) completed 5 years' treatment. The proportion of patients with two or more consecutive postbaseline measurements (≥7 days apart) of serum creatinine higher than age-adjusted upper limit of normal (ULN) and alanine aminotransferase more than five times the ULN was 4.4% (95% confidence interval [CI]: 2.1-7.9) and 4.0% (95% CI: 1.8-7.4), respectively. Median serum ferritin decreased from 1,702 ng/ml at baseline to 1,127 ng/ml at 5 years. There were no new safety signals. Safety and efficacy of deferasirox in young pediatric patients in this long-term, observational study in everyday clinical practice were consistent with the known deferasirox profile. © 2017 The Authors. Pediatric Blood & Cancer Published by Wiley Periodicals, Inc.

The relationship of patient and spouse personality to cardiac patients' health: two observational studies of mediation and moderation.

PubMed

Karademas, Evangelos C; Tsaousis, Ioannis

2014-02-01

Little is known about the ways that personality is related to patient health, although there is some evidence that illness self-regulation as well as partner personality play a significant role. The aim of the two present studies was to examine the intra-personal (i.e., through illness representations) and the inter-personal (i.e., partner) effects of personality on cardiac patients' subjective health. One hundred fifteen patients participated in study 1; 75 patients and their spouses participated in study 2. The representations of illness consequences, personal control, and the attribution of illness to emotional causes mediated the relation of personality to health (first study). The relations of patients' extraversion, agreeableness, and conscientiousness to their health were statistically significant at the higher levels (+1 SD) of spouse corresponding traits (second study). Personality affects patients' health through illness representations (intrapersonal level), as well as by interacting with partner personality (interpersonal level).

Emergency Department Observation Units and the Older Patient

PubMed Central

Moseley, Mark G.; Hawley, Miles P.; Caterino, Jeffrey M.

2013-01-01

Synopsis An increasing number of emergency departments (EDs) are providing extended care and monitoring of patients in ED observation units (EDOUs). EDOUs can be particularly useful for older adults both as an alternative to hospitalization in appropriately selected patients and as a means to risk-stratify older adults with unclear presentations. They can also provide a period of therapeutic intervention and reassessment for older patients in whom the appropriateness and safety of immediate outpatient care is unclear. They offer the opportunity for more comprehensive evaluation of many characteristics of particular importance to the care of older adults which cannot be accomplished during a short ED stay. The manuscript first discusses the general characteristics of EDOUs. Next, it reviews appropriate entry and exclusion criteria for older adults in EDOU including specific focus on several of the most common observation unit protocols, focusing on their relevance to older adults. Finally, it briefly discusses regulatory implications of observation status for patients with Medicare. PMID:23177601

Physicians' responses to patients' expressions of negative emotions in hospital consultations: a video-based observational study.

PubMed

Mjaaland, Trond A; Finset, Arnstein; Jensen, Bård Fossli; Gulbrandsen, Pål

2011-09-01

Patients express their negative emotions in medical consultations either implicitly as cue to an underlying unpleasant emotion or explicitly as a clear, unambiguous concern. The health provider's response to such cues and concerns is important for the outcome of consultations. Yet, physicians often neglect patient's negative emotions. Most studies of this subject are from primary health care. We aimed to describe how physicians in a hospital respond to negative emotions in an outpatient setting. Ninety six consultations were videotaped in a general teaching hospital. The Verona Coding Definitions of Emotional Sequences was used to identify patients' expression of negative emotions in terms of cue and concern and to code physicians' subsequent responses. Cohen's kappa was used as interrater reliability measure. Acceptable kappa level was set to .60. We observed 163 expressions of negative emotions. In general, the physician responses to patients' cues and concerns did not include follow up or exploration. Concerns more often than cues led to lack of emotional exploration. When patients expressed negative emotions or cues to such, hospital physicians tended to move away from emotional communication, particularly if the emotion was expressed as an explicit concern. Medical training should enable physicians' to explore the patients' emotions in situations where it will improve the medical treatment. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Quality of prescribing in community-dwelling elderly patients in France: an observational study in community pharmacies.

PubMed

Bourcier, E; Mille, F; Brunie, V; Korb-Savoldelli, V; Lafortune, C; Buyse, M; Fernandez, C; Hindlet, P

2017-12-01

Background In order to ensure safer prescriptions in the elderly, lists of potentially inappropriate medications (PIMs) and guidelines have been introduced. Whereas the effectiveness of these measures has been well studied in hospitals, data are sparse for the community-dwelling patients. Objective To assess the quality of prescriptions among community-dwelling elderly patients, and potential associations between prescription patterns, patient characteristics and medication adherence. Setting Community pharmacies in France. Method We conducted a prospective observational study between January and June 2013. Patients aged 75 and over coming to the community pharmacy with a prescription from a general practitioner were invited to participate to the study. The compliance of the prescription was assessed with regards to Beers Criteria and French Health Authority guidelines (FHA) for prescription in the elderly, the degree of adherence was assessed with the Girerd score. Main outcome measure Percentage of prescriptions compliant with Beers Criteria and FHA guidelines. Results Among the 1206 prescriptions analysed, 67.49% (n = 814) contained a PIM. Only 12.77% (n = 154) complied with mandatory requirements of the FHA. Prescriptions were ordered by therapeutic field in 51.24% (n = 618) of cases. Dosing regimen was incomplete in 57.21% (n = 690) of prescriptions. Only 29.19% (n = 352) of patients reported no difficulty with regard to adherence (Girerd score = 0). The use of International Non-proprietary Name was associated with an increased risk of nonadherence (adjusted OR = 1.59 [95% CI = 1.13-2.23] and 1.68 [95% CI = 1.12-2.49] respectively). Patient satisfaction with formulation was associated with a lower risk of non-adherence (adjusted OR = 0.63 [95% CI = 0.45-0.90]). Conclusion A substantial proportion of patients are exposed to PIMs and prescriptions that do not comply with the FHA Guidelines. This issue, as well as identified risk factors for

Adverse reactions due to directly observed treatment strategy therapy in Chinese tuberculosis patients: a prospective study.

PubMed

Lv, Xiaozhen; Tang, Shaowen; Xia, Yinyin; Wang, Xiaomeng; Yuan, Yanli; Hu, Daiyu; Liu, Feiying; Wu, Shanshan; Zhang, Yuan; Yang, Zhirong; Tu, Dehua; Chen, Yixin; Deng, Peiyuan; Ma, Yu; Chen, Ru; Zhan, Siyan

2013-01-01

More than 1 million tuberculosis (TB) patients are receiving directly observed treatment strategy (DOTS) therapy in China every year. As to the profile of adverse drug reactions (ADRs) due to DOTS therapy, no consensus has been reached. There is no report regarding ADRs due to DOTS therapy with a large Chinese TB population. This study aimed to determine the incidence and prognosis of ADRs due to DOTS therapy, and to evaluate their impact on anti-TB treatment in China. A prospective population-based cohort study was performed during 2007-2008. Sputum smear positive pulmonary TB patients who received DOTS therapy were included and followed up for six to nine months in 52 counties of four regions in China. The suspected ADRs were recorded and reviewed by Chinese State Food and Drug Administration. A total of 4304 TB patients were included in this study. 649 patients (15.08%) showed at least one ADR and 766 cases in total were detected. The incidence (count) of ADR based on affected organ was: liver dysfunction 6.34% (273), gastrointestinal disorders 3.74% (161), arthralgia 2.51% (108), allergic reactions 2.35% (101), neurological system disorders 2.04% (88), renal impairment 0.07% (3) and others 0.05% (2). Most cases of ADRs (95%) had a good clinical outcome, while two with hepatotoxicity and one with renal impairment died. Compared with patients without ADRs, patients with ADRs were more likely to have positive smear test results at the end of the intensive phase (adjusted OR, 2.00; 95%CI, 1.44-2.78) and unsuccessful anti-TB outcomes (adjusted OR, 2.58; 95%CI, 1.43-4.68). The incidence of ADRs due to DOTS therapy was 15.08%. Those ADRs had a substantial impact on TB control in China. This highlighted the importance of developing strategies to ameliorate ADRs both to improve the quality of patient care and to control TB safely.

Prospective Epidemiological Observations on the Course of the Disease in Fibromyalgia Patients

PubMed Central

Nöller, Vera; Sprott, Haiko

2003-01-01

Objectives The aim of the study was to carry out a survey in patients with fibromyalgia (FM), to examine their general health status and work incapacity (disability-pension status), and their views on the effectiveness of therapy received, over a two-year observation period. Methods 48 patients diagnosed with FM, according to the American College of Rheumatology (ACR) criteria, took part in the study. At baseline, and on average two years later, the patients underwent clinical investigation (dolorimetry, laboratory diagnostics, medical history taking) and completed the Fibromyalgia questionnaire (Dettmer and Chrostek [1]). Results 27/48 (56%) patients participated in the two-year follow-up. In general, the patients showed no improvement in their symptoms over the observation period, regardless of the type of therapy they had received. General satisfaction with quality of life improved, as did satisfaction regarding health status and the family situation, although the degree of pain experienced remain unchanged. In comparison with the initial examination, there was no change in either work-capacity or disability-pension status. Conclusions The FM patients showed no improvement in pain, despite the many various treatments received over the two-year period. The increase in general satisfaction over the observation period was believed to be the result of patient instruction and education about the disease. To what extent a population of patients with FM would show similar outcomes if they did not receive any instruction/education about their disorder, cannot be ascertained from the present study; and, indeed, the undertaking of a study to investigate this would be ethically questionable. As present, no conclusions can be made regarding the influence of therapy on the primary and secondary costs associated with FM. PMID:12969513

The prevalence of oral anticoagulation in patients with atrial fibrillation in Portugal: Systematic review and meta-analysis of observational studies.

PubMed

Caldeira, Daniel; Barra, Márcio; David, Cláudio; Costa, João; Ferreira, Joaquim J; Pinto, Fausto J

2014-09-01

Oral anticoagulation (OAC) is an effective treatment in the prevention of thromboembolic events in patients with atrial fibrillation (AF). The aim of this review was to estimate the prevalence of OAC therapy in patients with AF in Portugal. MEDLINE, the Index of Portuguese Medical Journals and SIBUL (the Bibliographic Catalog of the Integrated Library System of the University of Lisbon) were searched for Portuguese observational studies reporting the proportion of anticoagulated patients with AF. The pooled estimated prevalence of anticoagulated patients and respective 95% confidence interval (CI) were determined by means of a meta-analysis. Seven studies were included for analysis, of which four were conducted in a hospital environment and three in the general community. These studies enrolled a total of 891 patients with AF. The pooled estimated prevalence of anticoagulated patients was 40% (95% CI: 32-48%). The prevalence of OAC in Portuguese AF patients is low. There is a need to promote change in OAC prescribing habits for AF patients in Portugal, in accordance with international guidelines. Copyright © 2014 Sociedade Portuguesa de Cardiologia. Published by Elsevier España. All rights reserved.

Patient Satisfaction with Spanish Pain Centers: Observational Study with More than 3,000 Patients

PubMed Central

Hernández-Puiggròs, Patricia; Tesedo Nieto, Javier; Acín Lázaro, María Pilar; Carrera González, Alfredo; Soler, Miguel José Arranz; Maldonado Vega, Sergio

2016-01-01

Chronic pain is a serious problem in Spain. This multicenter, epidemiological 3-month follow-up study investigates pain management efficacy in Spanish centers using patient satisfaction criteria. 3,414 eligible adult patients (65,6% female) with moderate to severe chronic pain from 146 pain centers were included. Patient satisfaction was assessed based onto question 18 of Spanish healthcare barometer-CSI. Pain evolution (Brief Pain Inventory-Short Form (BPI-SF) and visual analog scale (VAS)), quality of life/EuroQol-5, and pain control expectations fulfillment were also assessed. Mean age was 61.3 years. 64.4% of participating centers employed multidisciplinary pain management approach. After 3 months, mean patient satisfaction was 7.8 (1–10) on the CIS barometer. Medical staff received the highest scores, whereas waiting for tests, appointment request to appointment date time, and waiting times at the center the lowest. Mean pain decreased from 7.4 to 4.0; BPI-SF intensity decreased from 6.5 to 3.8; pain control expectations were met in 78.7% of patients; EuroQoL-5D utility index increased from 0.37 to 0.62, p < 0.001, and health status (VAS) from 40.6 to 61.9, p < 0.001. Chronic pain patients (90%) are satisfied with Spanish centers care; 80% had their pain control expectations met. Quality of life improved remarkably: 71% felt moderately to significantly better. However, waiting times need improvement. PMID:27516902

Constipation is more frequent than diarrhea in patients fed exclusively by enteral nutrition: results of an observational study.

PubMed

Bittencourt, Amanda F; Martins, Juliana R; Logullo, Luciana; Shiroma, Glaucia; Horie, Lilian; Ortolani, Maria Claudia; Silva, Maria de Lourdes T; Waitzberg, Dan L

2012-08-01

Digestive complications in enteral nutrition (EN) can negatively affect the nutrition clinical outcome of hospitalized patients. Diarrhea and constipation are intestinal motility disorders associated with pharmacotherapy, hydration, nutrition status, and age. The aim of this study was to analyze the frequency of these intestinal motility disorders in patients receiving EN and assess risk factors associated with diarrhea and constipation in hospitalized patients receiving exclusive EN therapy in a general hospital. The authors performed a sequential and observational study of 110 hospitalized adult patients fed exclusively by EN through a feeding tube. Patients were categorized according to the type of intestinal transit disorder as follows: group D (diarrhea, 3 or more watery evacuations in 24 hours), group C (constipation, less than 1 evacuation during 3 days), and group N (absence of diarrhea or constipation). All prescription drugs were recorded, and patients were analyzed according to the type and amount of medication received. The authors also investigated the presence of fiber in the enteral formula. Patients classified in group C represented 70% of the study population; group D comprised 13%, and group N represented 17%. There was an association between group C and orotracheal intubation as the indication for EN (P < .001). Enteral formula without fiber was associated with constipation (logistic regression analysis: P < .001). Constipation is more frequent than diarrhea in patients fed exclusively by EN. Enteral diet with fiber may protect against medication-associated intestinal motility disorders. The addition of prokinetic drugs seems to be useful in preventing constipation.

Assessing the Use of Mobile Health Technology by Patients: An Observational Study in Primary Care Clinics.

PubMed

Ramirez, Veronica; Johnson, Emily; Gonzalez, Cesar; Ramirez, Vanessa; Rubino, Barbara; Rossetti, Gina

2016-04-19

There is significant potential for mobile health technology to improve health outcomes for patients with chronic diseases. However, there is a need for further development of mobile health technology that would help to improve the health of lower-income communities. The study objective was to assess mobile phone and app usage among a culturally diverse patient population, and to determine whether patients would be interested in using mobile health technology to help manage their chronic diseases. An observational study was conducted with patients of the Internal Medicine resident primary care clinics of Los Angeles County and University of Southern California (LAC+USC) Medical Center. Self-reported information regarding demographics, current mobile phone usage, current mobile health app and social media usage, barriers to using mobile phones or mobile health apps, and interest in using a mobile health app was collected. Ninety-one percent of patients owned a mobile phone, with 76% (169/223) of these reporting having a mobile phone with Internet capability. Fifty-seven percent of subjects used mobile apps on their mobile phones, and 32% (41/130) of these used mobile apps related to their health. Eighty-six percent (207/241) of respondents voiced interest in using a mobile app to improve their health, and 40% (88/221) stated they would use such an app daily. Patients stated they would find the mobile health app most useful for nutrition, exercise, and obtaining general information on medical conditions. Despite the fact that the majority of our primary care patients were of lower socioeconomic status, they utilized mobile phones with Internet and mobile app capabilities to a great extent. There was substantial interest among our patients in using mobile health technology to both manage chronic disease and improve overall health. Given that cultural, educational, and socioeconomic disparities strongly correlate with higher rates of chronic diseases such as obesity

Assessing the Use of Mobile Health Technology by Patients: An Observational Study in Primary Care Clinics

PubMed Central

Johnson, Emily; Gonzalez, Cesar; Ramirez, Vanessa; Rubino, Barbara; Rossetti, Gina

2016-01-01

Background There is significant potential for mobile health technology to improve health outcomes for patients with chronic diseases. However, there is a need for further development of mobile health technology that would help to improve the health of lower-income communities. Objective The study objective was to assess mobile phone and app usage among a culturally diverse patient population, and to determine whether patients would be interested in using mobile health technology to help manage their chronic diseases. Methods An observational study was conducted with patients of the Internal Medicine resident primary care clinics of Los Angeles County and University of Southern California (LAC+USC) Medical Center. Self-reported information regarding demographics, current mobile phone usage, current mobile health app and social media usage, barriers to using mobile phones or mobile health apps, and interest in using a mobile health app was collected. Results Ninety-one percent of patients owned a mobile phone, with 76% (169/223) of these reporting having a mobile phone with Internet capability. Fifty-seven percent of subjects used mobile apps on their mobile phones, and 32% (41/130) of these used mobile apps related to their health. Eighty-six percent (207/241) of respondents voiced interest in using a mobile app to improve their health, and 40% (88/221) stated they would use such an app daily. Patients stated they would find the mobile health app most useful for nutrition, exercise, and obtaining general information on medical conditions. Conclusions Despite the fact that the majority of our primary care patients were of lower socioeconomic status, they utilized mobile phones with Internet and mobile app capabilities to a great extent. There was substantial interest among our patients in using mobile health technology to both manage chronic disease and improve overall health. Given that cultural, educational, and socioeconomic disparities strongly correlate with

Reliability of patient-reported outcomes in rheumatoid arthritis patients: an observational prospective study.

PubMed

Studenic, Paul; Stamm, Tanja; Smolen, Josef S; Aletaha, Daniel

2016-01-01

Patient-reported outcomes (PROs) such as pain, patient global assessment (PGA) and fatigue are regularly assessed in RA patients. In the present study, we aimed to explore the reliability and smallest detectable differences (SDDs) of these PROs, and whether the time between assessments has an impact on reliability. Forty RA patients on stable treatment reported the three PROs daily over two subsequent months. We assessed the reliability of these measures by calculating intraclass correlation coefficients (ICCs) and the SDDs for 1-, 7-, 14- and 28-day test-retest intervals. Overall, SDD and ICC were 25 mm and 0.67 for pain, 25 mm and 0.71 for PGA and 30 mm and 0.66 for fatigue, respectively. SDD was higher with longer time period between assessments, ranging from 19 mm (1-day intervals) to 30 mm (28-day intervals) for pain, 19 to 33 mm for PGA, and 26 to 34 mm for fatigue; correspondingly, ICC was smaller with longer intervals, and ranged between the 1- and the 28-day interval from 0.80 to 0.50 for pain, 0.83 to 0.57 for PGA and 0.76 to 0.58 for fatigue. The baseline simplified disease activity index did not have any influence on reliability. Lower baseline PRO scores led to smaller SDDs. Reliability of pain, PGA and fatigue measurements is dependent on the tested time interval and the baseline levels. The relatively high SDDs, even for patients in the lowest tertiles of their PROs, indicate potential issues for assessment of the presence of remission. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Reliability of videotaped observational gait analysis in patients with orthopedic impairments

PubMed Central

Brunnekreef, Jaap J; van Uden, Caro JT; van Moorsel, Steven; Kooloos, Jan GM

2005-01-01

Background In clinical practice, visual gait observation is often used to determine gait disorders and to evaluate treatment. Several reliability studies on observational gait analysis have been described in the literature and generally showed moderate reliability. However, patients with orthopedic disorders have received little attention. The objective of this study is to determine the reliability levels of visual observation of gait in patients with orthopedic disorders. Methods The gait of thirty patients referred to a physical therapist for gait treatment was videotaped. Ten raters, 4 experienced, 4 inexperienced and 2 experts, individually evaluated these videotaped gait patterns of the patients twice, by using a structured gait analysis form. Reliability levels were established by calculating the Intraclass Correlation Coefficient (ICC), using a two-way random design and based on absolute agreement. Results The inter-rater reliability among experienced raters (ICC = 0.42; 95%CI: 0.38–0.46) was comparable to that of the inexperienced raters (ICC = 0.40; 95%CI: 0.36–0.44). The expert raters reached a higher inter-rater reliability level (ICC = 0.54; 95%CI: 0.48–0.60). The average intra-rater reliability of the experienced raters was 0.63 (ICCs ranging from 0.57 to 0.70). The inexperienced raters reached an average intra-rater reliability of 0.57 (ICCs ranging from 0.52 to 0.62). The two expert raters attained ICC values of 0.70 and 0.74 respectively. Conclusion Structured visual gait observation by use of a gait analysis form as described in this study was found to be moderately reliable. Clinical experience appears to increase the reliability of visual gait analysis. PMID:15774012

Temporomandibular Disorders in Burning Mouth Syndrome Patients: An Observational Study

PubMed Central

Corsalini, Massimo; Di Venere, Daniela; Pettini, Francesco; Lauritano, Dorina; Petruzzi, Massimo

2013-01-01

BACKGROUND: Burning Mouth Syndrome (BMS) is a chronic disease characterized by absence of any lesions and burning of the oral mucosa associated to a sensation of dry mouth and/or taste alterations. The purpose of our study is to estimate signs and symptoms of Temporomandibular Disorders (TMD) in patients with BMS and to investigate for the existence of an association between BMS and TMD. MATERIALS AND METHODS: Forty-four BMS patients were enrolled; BMS subtype was established according to the classification of Lamey. After a gnathological evaluation, according to the protocol of the European Academy of Craniomandibular Disorders, patients were classified by RDC/TMD criteria. The data were compared and analyzed using a chi-square test to describe the existence of an association between BMS and TMD. RESULTS: 65.9% the BMS patients showed disorders classified as primary signs and symptoms of TMD according to RDC / TMD criteria, and 72.7% showed parafunctional habits. The chi-square test revealed a statistically significant association (p = 0.035) between BMS and TMD. CONCLUSION: The data suggest that there is a possible relationship not yet well understood between BMS and TMD, may be for neurophatic alterations assumed for BMS that could be also engaged in TMD pathogenesis. PMID:24273452

An international observational study suggests that artificial intelligence for clinical decision support optimizes anemia management in hemodialysis patients.

PubMed

Barbieri, Carlo; Molina, Manuel; Ponce, Pedro; Tothova, Monika; Cattinelli, Isabella; Ion Titapiccolo, Jasmine; Mari, Flavio; Amato, Claudia; Leipold, Frank; Wehmeyer, Wolfgang; Stuard, Stefano; Stopper, Andrea; Canaud, Bernard

2016-08-01

Managing anemia in hemodialysis patients can be challenging because of competing therapeutic targets and individual variability. Because therapy recommendations provided by a decision support system can benefit both patients and doctors, we evaluated the impact of an artificial intelligence decision support system, the Anemia Control Model (ACM), on anemia outcomes. Based on patient profiles, the ACM was built to recommend suitable erythropoietic-stimulating agent doses. Our retrospective study consisted of a 12-month control phase (standard anemia care), followed by a 12-month observation phase (ACM-guided care) encompassing 752 patients undergoing hemodialysis therapy in 3 NephroCare clinics located in separate countries. The percentage of hemoglobin values on target, the median darbepoetin dose, and individual hemoglobin fluctuation (estimated from the intrapatient hemoglobin standard deviation) were deemed primary outcomes. In the observation phase, median darbepoetin consumption significantly decreased from 0.63 to 0.46 μg/kg/month, whereas on-target hemoglobin values significantly increased from 70.6% to 76.6%, reaching 83.2% when the ACM suggestions were implemented. Moreover, ACM introduction led to a significant decrease in hemoglobin fluctuation (intrapatient standard deviation decreased from 0.95 g/dl to 0.83 g/dl). Thus, ACM support helped improve anemia outcomes of hemodialysis patients, minimizing erythropoietic-stimulating agent use with the potential to reduce the cost of treatment. Copyright © 2016 International Society of Nephrology. Published by Elsevier Inc. All rights reserved.

Assessing treatment effects in older breast cancer patients: systematic review of observational research methods.

PubMed

de Glas, N A; Kiderlen, M; de Craen, A J M; Hamaker, M E; Portielje, J E A; van de Velde, C J H; Liefers, G J; Bastiaannet, E

2015-03-01

Solid evidence of treatment effects in older women with breast cancer is lacking, as they are generally underrepresented in randomized clinical trials on which guideline recommendations are based. An alternative way to study treatment effects in older patients could be to use data from observational studies. However, using appropriate methods in analyzing observational data is a key condition in order to draw valid conclusions, as directly comparing treatments generally results in biased estimates due to confounding by indication. The aim of this systematic review was to investigate the methods that have been used in observational studies that assessed the effects of breast cancer treatment on survival, breast cancer survival and recurrence in older patients (aged 65 years and older). Studies were identified through systematic review of the literature published between January 1st 2009 and December 13th 2013 in the PubMed database and EMBASe. Finally, 31 studies fulfilled the inclusion criteria. Of these, 22 studies directly compared two treatments. Fifteen out of these 22 studies addressed the problem of confounding by indication, while seven studies did not. Nine studies used some form of instrumental variable analysis. In conclusion, the vast majority of observational studies that investigate treatment effects in older breast cancer patients compared treatments directly. These studies are therefore likely to be biased. Observational research will be essential to improve treatment and outcome of older breast cancer patients, but the use of accurate methods is essential to draw valid conclusions from this type of data. Copyright © 2015 Elsevier Ltd. All rights reserved.

Prospective observational study comparing three different treatment regimes in patients with Clostridium difficile infection.

PubMed

Wenisch, Judith M; Schmid, Daniela; Kuo, Hung-Wei; Allerberger, Franz; Michl, Verena; Tesik, Philip; Tucek, Gerhard; Laferl, Hermann; Wenisch, Christoph

2012-04-01

In a hospital-based, prospective cohort study, the effects of the three standard treatment regimens for mild Clostridium difficile infection (CDI), oral (p.o.) metronidazole at 500 mg three times/day, intravenous (i.v.) metronidazole at 500 mg three times/day, and oral (p.o.) vancomycin at 250 mg four times/day, were compared with respect to the risk of occurrence of complications, sequelae, and all-cause death within 30 days after the date of starting treatment. Differences in the incidence of these outcomes were tested by χ² or Fisher's exact tests. A Poisson regression model was performed to control for possible confounding effects of sex, age, and severity of comorbidity categorized according to the Charlson comorbidity index. The highest mortality was observed in the metronidazole i.v. group, with a mortality rate 38.1% (16/42) compared to mortality rates of 7.4% (9/121) in the metronidazole p.o. group and 9.5% (4/42) in the vancomycin p.o. group (P < 0.001). After adjustment for possible effects of sex, age (> 65 years), and severity of comorbidity, the relative risk of a 30-day fatal outcome for patients receiving metronidazole i.v. was 4.3 (95% confidence interval [CI] = 1.92 to 10; P < 0.0001) compared to patients treated with metronidazole p.o. and 4.0 (95% CI = 1.31 to 5.0; P < 0.015) compared to patients treated with vancomycin p.o. There were no significant differences in the risk of complications between the three treatment groups. This study generates the hypothesis that treatment with i.v. metronidazole is inferior to the oral alternatives metronidazole and vancomycin.

Prospective Observational Study Comparing Three Different Treatment Regimes in Patients with Clostridium difficile Infection

PubMed Central

Wenisch, Judith M.; Schmid, Daniela; Kuo, Hung-Wei; Allerberger, Franz; Michl, Verena; Tesik, Philip; Tucek, Gerhard; Laferl, Hermann

2012-01-01

In a hospital-based, prospective cohort study, the effects of the three standard treatment regimens for mild Clostridium difficile infection (CDI), oral (p.o.) metronidazole at 500 mg three times/day, intravenous (i.v.) metronidazole at 500 mg three times/day, and oral (p.o.) vancomycin at 250 mg four times/day, were compared with respect to the risk of occurrence of complications, sequelae, and all-cause death within 30 days after the date of starting treatment. Differences in the incidence of these outcomes were tested by χ2 or Fisher's exact tests. A Poisson regression model was performed to control for possible confounding effects of sex, age, and severity of comorbidity categorized according to the Charlson comorbidity index. The highest mortality was observed in the metronidazole i.v. group, with a mortality rate 38.1% (16/42) compared to mortality rates of 7.4% (9/121) in the metronidazole p.o. group and 9.5% (4/42) in the vancomycin p.o. group (P < 0.001). After adjustment for possible effects of sex, age (>65 years), and severity of comorbidity, the relative risk of a 30-day fatal outcome for patients receiving metronidazole i.v. was 4.3 (95% confidence interval [CI] = 1.92 to 10; P < 0.0001) compared to patients treated with metronidazole p.o. and 4.0 (95% CI = 1.31 to 5.0; P < 0.015) compared to patients treated with vancomycin p.o. There were no significant differences in the risk of complications between the three treatment groups. This study generates the hypothesis that treatment with i.v. metronidazole is inferior to the oral alternatives metronidazole and vancomycin. PMID:22252830

Observational study to characterise 24-hour COPD symptoms and their relationship with patient-reported outcomes: results from the ASSESS study.

PubMed

Miravitlles, Marc; Worth, Heinrich; Soler Cataluña, Juan José; Price, David; De Benedetto, Fernando; Roche, Nicolas; Godtfredsen, Nina Skavlan; van der Molen, Thys; Löfdahl, Claes-Göran; Padullés, Laura; Ribera, Anna

2014-10-21

Few studies have investigated the 24-hour symptom profile in patients with COPD or how symptoms during the 24-hour day are inter-related. This observational study assessed the prevalence, severity and relationship between night-time, early morning and daytime COPD symptoms and explored the relationship between 24-hour symptoms and other patient-reported outcomes. The study enrolled patients with stable COPD in clinical practice. Baseline night-time, early morning and daytime symptoms (symptom questionnaire), severity of airflow obstruction (FEV1), dyspnoea (modified Medical Research Council Dyspnoea Scale), health status (COPD Assessment Test), anxiety and depression levels (Hospital Anxiety and Depression Scale), sleep quality (COPD and Asthma Sleep Impact Scale) and physical activity level (sedentary, moderately active or active) were recorded. The full analysis set included 727 patients: 65.8% male, mean ± standard deviation age 67.2 ± 8.8 years, % predicted FEV1 52.8 ± 20.5%. In each part of the 24-hour day, >60% of patients reported experiencing ≥1 symptom in the week before baseline. Symptoms were more common in the early morning and daytime versus night-time (81.4%, 82.7% and 63.0%, respectively). Symptom severity was comparable for each period assessed. Overall, in the week before baseline, 56.7% of patients had symptoms throughout the whole 24-hour day (3 parts of the day); 79.9% had symptoms in ≥2 parts of the 24-hour day. Symptoms during each part of the day were inter-related, irrespective of disease severity (all p < 0.001). Early morning and daytime symptoms were associated with the severity of airflow obstruction (p < 0.05 for both). Night-time, early morning and daytime symptoms were all associated with worse dyspnoea, health status and sleep quality, and higher anxiety and depression levels (all p < 0.001 versus patients without symptoms in each corresponding period). In each part of the 24-hour day, there was also an association between

Inconsistencies in patient perceptions and observer ratings of shared decision making: the case of colorectal cancer screening.

PubMed

Wunderlich, Tracy; Cooper, Gregory; Divine, George; Flocke, Susan; Oja-Tebbe, Nancy; Stange, Kurt; Lafata, Jennifer Elston

2010-09-01

To compare patient-reported and observer-rated shared decision making (SDM) use for colorectal cancer (CRC) screening and evaluate patient, physician and patient-reported relational communication factors associated with patient-reported use of shared CRC screening decisions. Study physicians are salaried primary care providers. Patients are insured, aged 50-80 and due for CRC screening. Audio-recordings from 363 primary care visits were observer-coded for elements of SDM. A post-visit patient survey assessed patient-reported decision-making processes and relational communication during visit. Association of patient-reported SDM with observer-rated elements of SDM, as well as patient, physician and relational communication factors were evaluated using generalized estimating equations. 70% of patients preferred SDM for preventive health decisions, 47% of patients reported use of a SDM process, and only one of the screening discussions included all four elements of SDM per observer ratings. Patient report of SDM use was not associated with observer-rated elements of SDM, but was significantly associated with female physician gender and patient-reported relational communication. Inconsistencies exist between patient reports and observer ratings of SDM for CRC screening. Future studies are needed to understand whether SDM that is patient-reported, observer-rated or both are associated with informed and value-concordant CRC screening decisions. Copyright (c) 2010 Elsevier Ireland Ltd. All rights reserved.

Inconsistencies in Patient Perceptions and Observer Ratings of Shared Decision Making: The Case of Colorectal Cancer Screening

PubMed Central

Wunderlich, Tracy; Cooper, Gregory; Divine, George; Flocke, Susan; Oja-Tebbe, Nancy; Stange, Kurt; Lafata, Jennifer Elston

2010-01-01

Objective To compare patient-reported and observer-rated shared decision making (SDM) use for colorectal cancer (CRC) screening and evaluate patient, physician and patient-reported relational communication factors associated with patient-reported use of shared CRC screening decisions. Methods Study physicians are salaried primary care providers. Patients are insured, aged 50-80 and due for CRC screening. Audio-recordings from 363 primary care visits were observer-coded for elements of SDM. A post-visit patient survey assessed patient-reported decision-making processes and relational communication during visit. Association of patient-reported SDM with observer-rated elements of SDM, as well as patient, physician and relational communication factors were evaluated using generalized estimating equations. Results 70% of patients preferred SDM for preventive health decisions, 47% of patients reported use of a SDM process, and only one of the screening discussions included all four elements of SDM per observer ratings. Patient report of SDM use was not associated with observer-rated elements of SDM, but was significantly associated with female physician gender and patient-reported relational communication. Conclusion Inconsistencies exist between patient reports and observer ratings of SDM for CRC screening. Practice Implications Future studies are needed to understand whether SDM that is patient-reported, observer-rated or both are associated with informed and value-concordant CRC screening decisions. PMID:20667678

Glycemic control according to glomerular filtration rate in patients with type 2 diabetes and overt nephropathy: a prospective observational study.

PubMed

Joly, Dominique; Choukroun, Gabriel; Combe, Christian; Dussol, Bertrand; Fauvel, Jean-Pierre; Halimi, Jean-Michel; Quéré, Stéphane; Fiquet, Béatrice

2015-04-01

Type 2 diabetes (T2D) and chronic kidney disease (CKD) are closely linked. This study aimed to describe and analyze the relations between renal function and glycemic control in T2D patients with overt nephropathy. Data were collected from a French observational prospective multicenter study. Patients included were adults with T2D, clinical proteinuria and an estimated glomerular filtration rate (eGFR) over 15 mL/min/1.73 m(2). Baseline data and glycemic control after a one-year follow-up are presented here. Data from 986 adult patients were analyzed. Mean age was 70 years. Mean eGFR was 42 mL/min/1.73 m(2), 66% of patients had proteinuria above 1g/day. HbA1c was higher in patients with lower eGFR in a model adjusted to age, gender, body mass index, hemoglobin level and erythropoietin use. Statistical significance was lost when stepwise multivariate analysis took into account the type of pharmacological treatment used to treat hyperglycemia.The type of antidiabetic agents differed across eGFR strata. Below 60 mL/min/1.73 m(2), the use of metformin declined while the use of insulin increased.After one year of follow up, 35% of patients had persistently poor or worsened glycemic control (HbA1c>8%). The only covariate independently associated with this characteristic was the duration of insulin therapy. In patients with T2D and overt nephropathy, the observed correlation of low eGFR with high HbA1c was not predicted by eGFR. Our data rather underscore a different use of antidiabetic treatments in patients with advanced renal dysfunction, and the difficulty to improve glycemic control in patients with long standing insulin therapy. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Physical activity levels and torso orientations of hospitalized patients at risk of developing a pressure injury: an observational study.

PubMed

Chaboyer, Wendy; Mills, Peter M; Roberts, Shelley; Latimer, Sharon

2015-02-01

Pressure injury guidelines recommend regular repositioning yet patients' mobility and repositioning patterns are unknown. An observational study using activity monitors was undertaken to describe the 24 h activity patterns of 84 hospitalized patients at risk of developing a pressure injury. The vast majority of participants' time was spent in the sedentary activity range (94% ± 3%) followed by the light range (5% ± 4 %). Patients changed their posture a median of 94 (interquartile range 48) time in the 24-h period (range 11-154), or ≈ 3.8 times per hour. Although a main focus for pressure injury prevention has been on repositioning, this study shows that patients with restricted mobility are actually moving quite often. Therefore, it might be appropriate to focus more attention on other pressure injury prevention strategies such as adequate nutrition, appropriate support surfaces and good skin care. © 2013 Wiley Publishing Asia Pty Ltd.

A global patient outcomes registry: Cochlear paediatric implanted recipient observational study (Cochlear™ P-IROS)

PubMed Central

2014-01-01

Background Currently, there is a paucity of data concerning the long-term outcomes, educational placement and quality of life of children implanted with hearing devices from large and representative samples of the population. To address this concern, a large, prospective, multicentre, multinational patient-outcomes registry for paediatric recipients of implantable hearing devices was developed. The benefits of this registry, its approach and methodology are described. Methods/Design The Cochlear™ Paediatric Implanted Recipient Observational Study (Cochlear P-IROS) is a prospective international patient-outcomes registry for children who are implanted in routine clinical practice with one or more hearing devices. The study aims to collect data on patient comorbidities, device use, auditory performance, quality of life and health-related utilities, across different types of implantable hearing devices from a range of manufacturers. Patients will be evaluated with a set of standardised and non-standardised questionnaires prior to initial device activation (baseline) and at six-monthly follow-up intervals up to 24 months and annually thereafter. The Cochlear P-IROS utilises a secure web interface to administer electronic case report forms to clinicians and families of implanted children. The web interface is currently available in five languages: English, Japanese, Korean, Mandarin and Russian. The interface also provides printable versions of the case report forms translated into 22 local languages for collection of data prior to entry online; additional languages may be added, as required. Participation in the Cochlear P-IROS registry is investigator-driven and voluntary. To date, the Cochlear P-IROS has recruited implant clinics across Australia, China, India, Indonesia, Turkey and Vietnam. The registry also aims to recruit multiple clinics in Cuba, Israel, Japan, Malaysia, Singapore, South Africa, South Korea and Russia. Discussion The use of a registry such as

Long-term Response of Cerebrospinal Fluid Pressure in Patients with Idiopathic Intracranial Hypertension - A Prospective Observational Study.

PubMed

Gafoor, V Abdul; Smita, B; Jose, James

2017-01-01

Idiopathic intracranial hypertension (IIH) is increased intracranial pressure (ICP) with normal cerebrospinal fluid (CSF) contents, in the absence of an intracranial mass, hydrocephalus, or other identifiable causes. The current knowledge of the treatment outcome of IIH is limited, and the data on the natural history of this entity are scant. The objective of the study is to study the treatment response of IIH by serially measuring the CSF opening pressure and to delineate the factors influencing the same. A prospective observational study in a cohort of fifty patients with IIH in whom CSF opening pressure was serially measured at pre-specified intervals. The mean CSF opening pressure at baseline was 302.4 ± 51.69 mm of H 2 O (range: 220-410). Even though a higher body mass index (BMI) showed a trend toward a higher CSF opening pressure, the association was not significant ( P = 0.168). However, the age of the patient had a significant negative correlation with the CSF pressure ( P = 0.006). The maximum reduction in CSF pressure occurred in the first 3 months of treatment, and thereafter it plateaued. Remission was attained in 12 (24%) patients. BMI had the strongest association with remission ( P = 0.001). In patients with IIH, treatment response is strongly related to BMI. However, patients with normal BMI are also shown to relapse and hence should have continuous, long-term follow-up. The reduction in CSF pressure attained in the first 3 months could reflect the long-term response to treatment.

Efficacy and Safety of apatinib in patients with intermediate/advanced hepatocellular carcinoma: A prospective observation study.

PubMed

Yu, Wen-Chang; Zhang, Kong-Zhi; Chen, Shi-Guang; Liu, Wei-Fu

2018-01-01

This prospective study aimed to evaluate the efficacy and safety of apatinib in patients with intermediate/advanced hepatocellular carcinoma (HCC).The patients with intermediate/advanced HCC, who met predetermined inclusion and exclusion criteria, underwent oral treatment of apatinib 500 mg daily. The drug-related adverse effects were monitored by regular follow-up and workup including laboratory tests and imaging examinations. Tumor response was assessed by response evaluation criteria in solid tumor criteria. The time to tumor progression (TTP) and overall survival rate (OS) were calculated using the Kaplan-Meier method.A total of 31 patients were enrolled in the study from October 28, 2015 to December 28, 2016. The number of patients with intermediate and advanced HCC was 4 (12.90%) and 27 (87.10%), respectively. The mean tumor size was 9.47 ± 5.48 cm (range: 1.2-19 cm). Vascular invasion was seen in 14 patients (45.16%). A total of 21 (67.74%) patients exhibited extrahepatic metastases. On the basis of first follow-up computed tomography and magnetic resonance imaging at 6 weeks after treatment, 10 (32.26%), 15 (48.39%), and 6 (19.35%) of 31 patients achieved a partial response, stable disease, and progression of disease, respectively. Response rate and disease control rate were 32.26% and 80.65%, respectively. The median TTP was 4.8 months (95% confidence interval: 3.75-5.86 months). Furthermore, 6- and 12-month OS rates were 73.8% and 55.4%, respectively. Grade 3 thrombocytopenia (6.45%) and hypertension (48.39%) were the most common hematologic and nonhematologic toxicities. Grade 3 elevation of either serum total bilirubin or aminotransferase (6.45%) was observed as the top incidence among important indexes of liver function.Our preliminary findings suggest apatinib is a safe and effective therapy in intermediate/advanced HCC patients with high tumor response and survival rates. Copyright © 2017 The Authors. Published by Wolters Kluwer Health, Inc

Efficacy and Safety of apatinib in patients with intermediate/advanced hepatocellular carcinoma: A prospective observation study

PubMed Central

Yu, Wen-Chang; Zhang, Kong-Zhi; Chen, Shi-Guang; Liu, Wei-Fu

2018-01-01

Abstract This prospective study aimed to evaluate the efficacy and safety of apatinib in patients with intermediate/advanced hepatocellular carcinoma (HCC). The patients with intermediate/advanced HCC, who met predetermined inclusion and exclusion criteria, underwent oral treatment of apatinib 500 mg daily. The drug-related adverse effects were monitored by regular follow-up and workup including laboratory tests and imaging examinations. Tumor response was assessed by response evaluation criteria in solid tumor criteria. The time to tumor progression (TTP) and overall survival rate (OS) were calculated using the Kaplan–Meier method. A total of 31 patients were enrolled in the study from October 28, 2015 to December 28, 2016. The number of patients with intermediate and advanced HCC was 4 (12.90%) and 27 (87.10%), respectively. The mean tumor size was 9.47 ± 5.48 cm (range: 1.2–19 cm). Vascular invasion was seen in 14 patients (45.16%). A total of 21 (67.74%) patients exhibited extrahepatic metastases. On the basis of first follow-up computed tomography and magnetic resonance imaging at 6 weeks after treatment, 10 (32.26%), 15 (48.39%), and 6 (19.35%) of 31 patients achieved a partial response, stable disease, and progression of disease, respectively. Response rate and disease control rate were 32.26% and 80.65%, respectively. The median TTP was 4.8 months (95% confidence interval: 3.75–5.86 months). Furthermore, 6- and 12-month OS rates were 73.8% and 55.4%, respectively. Grade 3 thrombocytopenia (6.45%) and hypertension (48.39%) were the most common hematologic and nonhematologic toxicities. Grade 3 elevation of either serum total bilirubin or aminotransferase (6.45%) was observed as the top incidence among important indexes of liver function. Our preliminary findings suggest apatinib is a safe and effective therapy in intermediate/advanced HCC patients with high tumor response and survival rates. PMID:29505026

The host response in critically ill sepsis patients on statin therapy: a prospective observational study.

PubMed

Wiewel, Maryse A; Scicluna, Brendon P; van Vught, Lonneke A; Hoogendijk, Arie J; Zwinderman, Aeilko H; Lutter, René; Horn, Janneke; Cremer, Olaf L; Bonten, Marc J; Schultz, Marcus J; van der Poll, Tom

2018-01-18

Statins can exert pleiotropic anti-inflammatory, vascular protective and anticoagulant effects, which in theory could improve the dysregulated host response during sepsis. We aimed to determine the association between prior statin use and host response characteristics in critically ill patients with sepsis. We performed a prospective observational study in 1060 patients admitted with sepsis to the mixed intensive care units (ICUs) of two hospitals in the Netherlands between January 2011 and July 2013. Of these, 351 patients (33%) were on statin therapy before admission. The host response was evaluated by measuring 23 biomarkers providing insight into key pathways implicated in sepsis pathogenesis and by analyzing whole-blood leukocyte transcriptomes in samples obtained within 24 h after ICU admission. To account for indication bias, a propensity score-matched cohort was created (N = 194 in both groups for protein biomarkers and N = 95 in both groups for gene expression analysis). Prior statin use was not associated with an altered mortality up to 90 days after admission (38.0 vs. 39.7% in the non-statin users in the propensity-matched analysis). Statin use did not modify systemic inflammatory responses, activation of the vascular endothelium or the coagulation system. The blood leukocyte genomic response, characterized by over-expression of genes involved in inflammatory and innate immune signaling pathways as well as under-expression of genes associated to T cell function, was not different between patients with and without prior statin use. Statin therapy is not associated with a modified host response in sepsis patients on admission to the ICU.

Mycobacterium genavense in the Netherlands: an opportunistic pathogen in HIV and non-HIV immunocompromised patients. An observational study in 14 cases.

PubMed

Hoefsloot, W; van Ingen, J; Peters, E J G; Magis-Escurra, C; Dekhuijzen, P N R; Boeree, M J; van Soolingen, D

2013-05-01

Mycobacterium genavense is an opportunistic non-tuberculous mycobacterium previously mostly associated with HIV-infected patients with CD4 counts below 100/μL. In this retrospective observational study of medical charts we studied all Dutch patients in whom M. genavense was detected between January 2002 and January 2010. Of the 14 patients identified, 13 (93%) showed clinically relevant M. genavense disease. All patients with M. genavense disease were severely immunocompromised, including HIV-infected patients, solid organ transplant recipients, those with chronic steroid use in combination with other immune modulating drugs, recipients of chemotherapy for non-Hodgkin lymphoma, and those with immunodeficiency syndromes. Two patients had non-disseminated pulmonary M. genavense disease. Of the 12 patients treated, eight (75%) showed a favourable outcome. Four patients died in this study, three despite treatment for M. genavense disease. We conclude that M. genavense is a clinically relevant pathogen in severely immunocompromised patients that causes predominantly disseminated disease with serious morbidity and mortality. M. genavense is increasingly seen among non-HIV immunocompromised patients. © 2012 The Authors. Clinical Microbiology and Infection © 2012 European Society of Clinical Microbiology and Infectious Diseases.

Feasibility and observer reproducibility of speckle tracking echocardiography in congenital heart disease patients.

PubMed

Mokhles, Palwasha; van den Bosch, Annemien E; Vletter-McGhie, Jackie S; Van Domburg, Ron T; Ruys, Titia P E; Kauer, Floris; Geleijnse, Marcel L; Roos-Hesselink, Jolien W

2013-09-01

The twisting motion of the heart has an important role in the function of the left ventricle. Speckle tracking echocardiography is able to quantify left ventricular (LV) rotation and twist. So far this new technique has not been used in congenital heart disease patients. The aim of our study was to investigate the feasibility and the intra- and inter-observer reproducibility of LV rotation parameters in adult patients with congenital heart disease. The study population consisted of 66 consecutive patients seen in the outpatient clinic (67% male, mean age 31 ± 7.7 years, NYHA class 1 ± 0.3) with a variety of congenital heart disease. First, feasibility was assessed in all patients. Intra- and inter-observer reproducibility was assessed for the patients in which speckle tracking echocardiography was feasible. Adequate image quality, for performing speckle echocardiography, was found in 80% of patients. The bias for the intra-observer reproducibility of the LV twist was 0.0°, with 95% limits of agreement of -2.5° and 2.5° and for interobserver reproducibility the bias was 0.0°, with 95% limits of agreement of -3.0° and 3.0°. Intra- and inter-observer measurements showed a strong correlation (0.86 and 0.79, respectively). Also a good repeatability was seen. The mean time to complete full analysis per subject for the first and second measurement was 9 and 5 minutes, respectively. Speckle tracking echocardiography is feasible in 80% of adult patients with congenital heart disease and shows excellent intra- and inter-observer reproducibility. © 2013, Wiley Periodicals, Inc.

A cross-sectional observational study to assess inhaler technique in Saudi hospitalized patients with asthma and chronic obstructive pulmonary disease

PubMed Central

Ammari, Maha Al; Sultana, Khizra; Yunus, Faisal; Ghobain, Mohammed Al; Halwan, Shatha M. Al

2016-01-01

Objectives: To assess the proportion of critical errors committed while demonstrating the inhaler technique in hospitalized patients diagnosed with asthma and chronic obstructive pulmonary disease (COPD). Methods: This cross-sectional observational study was conducted in 47 asthmatic and COPD patients using inhaler devices. The study took place at King Abdulaziz Medical City, Riyadh, Saudi Arabia between September and December 2013. Two pharmacists independently assessed inhaler technique with a validated checklist. Results: Seventy percent of patients made at least one critical error while demonstrating their inhaler technique, and the mean number of critical errors per patient was 1.6. Most patients used metered dose inhaler (MDI), and 73% of MDI users and 92% of dry powder inhaler users committed at least one critical error. Conclusion: Inhaler technique in hospitalized Saudi patients was inadequate. Health care professionals should understand the importance of reassessing and educating patients on a regular basis for inhaler technique, recommend the use of a spacer when needed, and regularly assess and update their own inhaler technique skills. PMID:27146622

Chronic Hepatitis C Treatment in Patients with Drug Injection History: Findings of the INTEGRATE Prospective, Observational Study.

PubMed

Robaeys, Geert; Christensen, Stefan; Lucidarme, Damien; Arain, Amber; Bruggmann, Philip; Kunkel, Jan; Keim, Sofia; Jäkel, Martin; DeMasi, Ralph; Liu, Chris; Lonjon-Domanec, Isabelle; Foster, Graham R

2017-06-01

People who inject drugs represent an under-treated chronic hepatitis C virus (HCV)-infected patient population. INTEGRATE was a prospective, observational study investigating the effectiveness, safety, and adherence in routine clinical practice to telaprevir in combination with peg-interferon and ribavirin (Peg-IFN/RBV) in patients with history of injecting drug use chronically infected with genotype 1 HCV. A total of 46 patients were enrolled and included in the intent-to-treat (ITT) population. Among heroin and/or cocaine users (n = 37; 80%), 22% reported use in the past month; 74% (34/46) of patients were on opioid substitution therapy in the pre-treatment phase, and 43% (20/46) discontinued HCV treatment prematurely. Sustained virologic response rate was 54% (25/46) in the ITT population and 74% (25/34) in the per protocol (evaluable-for-effectiveness) population. The main reason for failure in the ITT analysis was loss to follow-up (n = 8; 17%). Adverse events occurred in 91% (42/46) of patients. Mean patient-reported adherence to study drugs was >89% at Week 4, Week 12 and end of treatment. Despite a high rate of treatment discontinuation (including loss to follow-up), self-reported adherence to treatment was good and virologic cure rates were similar to those reported in large real-world cohorts. Our findings suggest that people with a history of injecting drug use should be considered for treatment of chronic HCV infection, and highlight the need for improvements in patient support to boost retention in care and, in turn, help to prevent reinfection and transmission. Clinicaltrials.gov identifier, NCT01980290. Janssen Pharmaceuticals.

An observational cohort study of patients with newly diagnosed digital ulcer disease secondary to systemic sclerosis registered in the EUSTAR database.

PubMed

Brand, Monika; Hollaender, Rebecca; Rosenberg, Daniel; Scott, Martin; Hunsche, Elke; Tyndall, Alan; Denaro, Valentina; Carreira, Patricia; Varju, Cecilia; Gabrielli, Barbara; Zingarelli, Stefania; Caramaschi, Paola; Simic-Pasalic, Katarina; Müller-Ladner, Ulf; Vasile, Massimiliano; Mihai, Carina; Rosato, Edoardo; Vacca, Alessandra; Zenone, Thierry; Mohamed, Walid A; Ancuta, Codrina; Zampogna, Giuseppe; Rednic, Simona; Jabaar, Nadia; Belloli, Laura; Pozzi, Maria R; Foti, Rosario; Walker, Ulrich A

2015-01-01

This study describes clinical characteristics, prognostic factors, and quality of life in patients with newly diagnosed (incident) digital ulcers (DU). Observational cohort study of 189 consecutive SSc patients with incident DU diagnosis identified from the EUSTAR database (22 centres in 10 countries). Data were collected from medical charts and during one prospective visit between 01/2004 and 09/2010. Median age at DU diagnosis was 51 years, majority of patients were female (88%), and limited cutaneous SSc was the most common subtype (61%). At incident DU diagnosis, 41% of patients had one DU and 59% had ≥2 DU; at the prospective visit 52% had DU. Pulmonary arterial hypertension (PAH) and multiple DU at diagnosis were associated with presence of any DU at the prospective visit (odds ratios: 4.34 and 1.32). During the observation period (median follow-up was 2 years) 127 patients had ≥1 hospitalisation. The event rate of new DU per person-year was 0.66, of DU-associated complications was 0.10, and of surgical or diagnostic procedures was 0.12. At the prospective visit, patients with ≥1 DU reported impairment in daily activities by 57%, those with 0 DU by 37%. The mean difference between patients with or without DU in the SF-36 physical component was 2.2, and in the mental component 1.4. DU patients were not routinely prescribed endothelin receptor antagonists or prostanoids. This real world cohort demonstrates that DU require hospital admission, and impair daily activity. PAH and multiple DU at diagnosis were associated with future occurrence of DU.

Plasticity and response to action observation: a longitudinal FMRI study of potential mirror neurons in patients with subacute stroke.

PubMed

Brunner, Iris C; Skouen, Jan Sture; Ersland, Lars; Grüner, Renate

2014-01-01

Action observation has been suggested as a possible gateway to retraining arm motor function post stroke. However, it is unclear if the neuronal response to action observation is affected by stroke and if it changes during the course of recovery. To examine longitudinal changes in neuronal activity in a group of patients with subacute stroke when observing and executing a bimanual movement task. Eighteen patients were examined twice using 3-T functional magnetic resonance imaging; 1 to 2 weeks and 3 months post stroke symptom onset. Eighteen control participants were examined once. Image time series were analyzed (SPM8) and correlated with clinical motor function scores. During action observation and execution, an overlap of neuronal activation was observed in the superior and inferior parietal lobe, precentral gyrus, insula, and inferior temporal gyrus in both control participants and patients (P < .05; false discovery rate corrected). The neuronal response in the observation task increased from 1 to 2 weeks to 3 months after stroke. Most activated clusters were observed in the inferior temporal gyrus, the thalamus and movement-related areas, such as the premotor, supplementary and motor cortex (BA4, BA6). Increased activation of cerebellum and premotor area correlated with improved arm motor function. Most patients had regained full movement ability. Plastic changes in neurons responding to action observation and action execution occurred in accordance with clinical recovery. The involvement of motor areas when observing actions early and later after stroke may constitute a possible access to the motor system. © The Author(s) 2014.

Plasma proteome analysis in patients with pulmonary arterial hypertension: an observational cohort study.

PubMed

Rhodes, Christopher J; Wharton, John; Ghataorhe, Pavandeep; Watson, Geoffrey; Girerd, Barbara; Howard, Luke S; Gibbs, J Simon R; Condliffe, Robin; Elliot, Charles A; Kiely, David G; Simonneau, Gerald; Montani, David; Sitbon, Olivier; Gall, Henning; Schermuly, Ralph T; Ghofrani, H Ardeschir; Lawrie, Allan; Humbert, Marc; Wilkins, Martin R

2017-09-01

Idiopathic and heritable pulmonary arterial hypertension form a rare but molecularly heterogeneous disease group. We aimed to measure and validate differences in plasma concentrations of proteins that are associated with survival in patients with idiopathic or heritable pulmonary arterial hypertension to improve risk stratification. In this observational cohort study, we enrolled patients with idiopathic or heritable pulmonary arterial hypertension from London (UK; cohorts 1 and 2), Giessen (Germany; cohort 3), and Paris (France; cohort 4). Blood samples were collected at routine clinical appointment visits, clinical data were collected within 30 days of blood sampling, and biochemical data were collected within 7 days of blood sampling. We used an aptamer-based assay of 1129 plasma proteins, and patient clinical details were concealed to the technicians. We identified a panel of prognostic proteins, confirmed with alternative targeted assays, which we evaluated against the established prognostic risk equation for pulmonary arterial hypertension derived from the REVEAL registry. All-cause mortality was the primary endpoint. 20 proteins differentiated survivors and non-survivors in 143 consecutive patients with idiopathic or heritable pulmonary arterial hypertension with 2 years' follow-up (cohort 1) and in a further 75 patients with 2·5 years' follow-up (cohort 2). Nine proteins were both prognostic independent of plasma NT-proBNP concentrations and confirmed by targeted assays. The functions of these proteins relate to myocardial stress, inflammation, pulmonary vascular cellular dysfunction and structural dysregulation, iron status, and coagulation. A cutoff-based score using the panel of nine proteins provided prognostic information independent of the REVEAL equation, improving the C statistic from area under the curve 0·83 (for REVEAL risk score, 95% CI 0·77-0·89; p<0·0001) to 0·91 (for panel and REVEAL 0·87-0·96; p<0·0001) and improving

Itopride in the treatment of functional dyspepsia in Chinese patients: a prospective, multicentre, post-marketing observational study.

PubMed

Sun, Jing; Yuan, Yao-Zong; Holtmann, Gerald

2011-12-01

Prokinetic agents are commonly used in the symptomatic treatment of functional dyspepsia (FD). Safety or efficacy issues associated with the use of available prokinetics, such as metoclopramide, domperidone, cisapride and mosapride, mean there is a need for an effective and well tolerated prokinetic agent. Itopride is a novel prokinetic agent with a dual mode of action, good safety profile and documented efficacy in placebo-controlled trials. The objective of this study was to assess the effectiveness and safety of itopride in the management of FD. This was a prospective, multicentre, post-marketing observational study carried out in private outpatient clinics throughout China. The study included patients with symptomatic FD aged ≥18 years. Patients were prescribed itopride 50 mg three times daily before meals for 4 weeks, after which there was a 2-week follow-up period during which they did not take itopride. Effectiveness and tolerability data obtained from patients who completed 4 weeks of therapy were analysed. The treatment response rate after 4 weeks was measured by patient global assessment; scores at the end of treatment were compared with baseline scores. Response rate based on symptom scoring was also measured after 4 weeks, with an effective treatment being defined as a symptom improvement of ≥50%. In total, 587 patients with FD were enrolled. The mean ± SD difference in the total symptom score before and after the 4-week treatment period was -5.62 ± 3.27, corresponding to a 69.23 ± 26.53% reduction from baseline (p < 0.001). The treatment response rates in patients who fulfilled Rome I, II and III criteria for FD were 33.68%, 34.71% and 35.50%, respectively, after 1 week of treatment; 52.82%, 54.61% and 56.51%, respectively, after 2 weeks; 66.67%, 67.23% and 68.64%, respectively, after 3 weeks; and 72.82%, 73.54% and 75.15%, respectively, after 4 weeks. Response rates were significantly different at 1 week versus 4 weeks of

Risk of low bone mineral density and low body mass index in patients with non-celiac wheat-sensitivity: a prospective observation study.

PubMed

Carroccio, Antonio; Soresi, Maurizio; D'Alcamo, Alberto; Sciumè, Carmelo; Iacono, Giuseppe; Geraci, Girolamo; Brusca, Ignazio; Seidita, Aurelio; Adragna, Floriana; Carta, Miriam; Mansueto, Pasquale

2014-11-28

Non-celiac gluten sensitivity (NCGS) or 'wheat sensitivity' (NCWS) is included in the spectrum of gluten-related disorders. No data are available on the prevalence of low bone mass density (BMD) in NCWS. Our study aims to evaluate the prevalence of low BMD in NCWS patients and search for correlations with other clinical characteristics. This prospective observation study included 75 NCWS patients (63 women; median age 36 years) with irritable bowel syndrome (IBS)-like symptoms, 65 IBS and 50 celiac controls. Patients were recruited at two Internal Medicine Departments. Elimination diet and double-blind placebo controlled (DBPC) wheat challenge proved the NCWS diagnosis. All subjects underwent BMD assessment by Dual Energy X-Ray Absorptiometry (DXA), duodenal histology, HLA DQ typing, body mass index (BMI) evaluation and assessment for daily calcium intake. DBPC cow's milk proteins challenge showed that 30 of the 75 NCWS patients suffered from multiple food sensitivity. Osteopenia and osteoporosis frequency increased from IBS to NCWS and to celiac disease (CD) (P <0.0001). Thirty-five NCWS patients (46.6%) showed osteopenia or osteoporosis. Low BMD was related to low BMI and multiple food sensitivity. Values of daily dietary calcium intake in NCWS patients were significantly lower than in IBS controls. An elevated frequency of bone mass loss in NCWS patients was found; this was related to low BMI and was more frequent in patients with NCWS associated with other food sensitivity. A low daily intake of dietary calcium was observed in patients with NCWS.

In-Hospital Recruitment to Observational Studies of Stroke

ERIC Educational Resources Information Center

Pickering, Ruth M.; Kunkel, Dorit; Fitton, Carolyn; Ashburn, Ann; Jenkinson, Damian

2010-01-01

The objective of this study was to examine recruitment in three observational follow-up studies of patients with stroke, focusing on reasons for nonparticipation and the role of potential factors in explaining recruitment rates. It comprised secondary analysis of the three studies. Recruitment rates varied between the studies. Between 10 and 50%…

Development of posttraumatic empyema in patients with retained hemothorax: results of a prospective, observational AAST study.

PubMed

DuBose, Joseph; Inaba, Kenji; Okoye, Obi; Demetriades, Demetrios; Scalea, Thomas; O'Connor, James; Menaker, Jay; Morales, Carlos; Shiflett, Tony; Brown, Carlos; Copwood, Ben

2012-09-01

The natural history of retained hemothorax (RH), in particular factors contributing to the subsequent development of empyema, is not well known. The intent of our study was to establish the modern incidence of empyema among patients with trauma and RH and identify the independent predictors for development of this complication. An American Association for the Surgery of Trauma multicenter prospective observational trial was conducted, enrolling patients with placement of a thoracostomy tube within 24 hours of trauma admission, and subsequent development of RH was confirmed on computed tomography of the chest. Demographics, interventions, and outcomes were analyzed. Logistic regression analysis was used to identify the independent predictors for the development of empyema. Among 328 patients with posttraumatic RH from the 20 participating centers, overall incidence of empyema was 26.8% (n = 88). On regression analysis, the presence of rib fractures (adjusted odds ratio [OR], 2.3; 95% confidence interval [CI], 1.3-4.1; p = 0.006), Injury Severity Score of 25 or higher (adjusted OR, 2.4; 95% CI, 1.3-4.4; p = 0.005), and the need for any additional therapeutic intervention (adjusted OR, 28.8; 95% CI, 6.6-125.5; p < 0.001) were found to be independent predictors for the development of empyema for patients with posttraumatic RH. Patients with empyema also had a significantly longer adjusted intensive care unit stay (adjusted mean difference, 4.1; 95% CI, 1.3-6.9; p = 0.008) and hospital stay (adjusted mean difference, -7.9; 95% CI, -12.7 to -3.2; p = 0.01). Among patients with trauma and posttraumatic RH, the incidence of empyema was 26.8%. Independent predictors of empyema development after posttraumatic RH included the presence of rib fractures, Injury Severity Score of 25 or higher, and the need for additional interventions to evacuate retained blood from the thorax. Our findings highlight the need to minimize the risk associated with subsequent thoracic procedures

Predictors of the development of myocarditis or acute renal failure in patients with leptospirosis: An observational study

PubMed Central

2012-01-01

Background Leptospirosis has a varied clinical presentation with complications like myocarditis and acute renal failure. There are many predictors of severity and mortality including clinical and laboratory parameters. Early detection and treatment can reduce complications. Therefore recognizing the early predictors of the complications of leptospirosis is important in patient management. This study was aimed at determining the clinical and laboratory predictors of myocarditis or acute renal failure. Methods This was a prospective descriptive study carried out in the Teaching Hospital, Kandy, from 1st July 2007 to 31st July 2008. Patients with clinical features compatible with leptospirosis case definition were confirmed using the Microscopic Agglutination Test (MAT). Clinical features and laboratory measures done on admission were recorded. Patients were observed for the development of acute renal failure or myocarditis. Chi-square statistics, Fisher's exact test and Mann-Whitney U test were used to compare patients with and without complications. A logistic regression model was used to select final predictor variables. Results Sixty two confirmed leptospirosis patients were included in the study. Seven patients (11.3%) developed acute renal failure and five (8.1%) developed myocarditis while three (4.8%) had both acute renal failure and myocarditis. Conjunctival suffusion - 40 (64.5%), muscle tenderness - 28 (45.1%), oliguria - 20 (32.2%), jaundice - 12 (19.3%), hepatomegaly - 10 (16.1%), arrhythmias (irregular radial pulse) - 8 (12.9%), chest pain - 6 (9.7%), bleeding - 5 (8.1%), and shortness of breath (SOB) 4 (6.4%) were the common clinical features present among the patients. Out of these, only oliguria {odds ratio (OR) = 4.14 and 95% confidence interval (CI) 1.003-17.261}, jaundice (OR = 5.13 and 95% CI 1.149-28.003), and arrhythmias (OR = 5.774 and 95% CI 1.001-34.692), were predictors of myocarditis or acute renal failure and none of the laboratory

Tinea pedis and onychomycosis frequency in diabetes mellitus patients and diabetic foot ulcers. A cross sectional – observational study

PubMed Central

Akkus, Gamze; Evran, Mehtap; Gungor, Dilek; Karakas, Mehmet; Sert, Murat; Tetiker, Tamer

2016-01-01

Objective: Impaired cellular immunity and reduced phagocytic function of polymorphonuclear leukocytes facilitate the development of skin fungal and bacterial infections due to uncontrolled hyperglycemia in diabetic patients. In our study, we aimed to assess onychomycosis and/or tinea pedis frequency in diabetic patients, and effects on the development of chronic complications, particularly foot ulcer. Methods: We included 227 diabetic patients in the study. Forty-three patients had diabetic foot ulcer. We screened and recorded demographic characteristics, HbA1c levels of patients, and presence of complications We examined patients dermatologically, and collected samples by scalpel from skin between toes, and from sole, toe nail, and area surrounding nails from suspected to have fungal infection. Results: Native positivity between toes was higher in men compared to women (p<0.05). We obtained significant relation between HbA1c elevation and native positivity between toes (p<0.05). Fungal infection between toes, at sole and toe nail significantly increased in patients with diabetic foot ulcer compared to patients without diabetic foot ulcer (p<0.05). Moreover, native positivity in patients with diabetic foot ulcer correlated with presence of fungal infection examination findings (p<0.05). Conclusion: Fungal infections were more frequently observed in the presence of poor glycemic control and peripheral vascular disease in diabetic patients in compliance with the literature, and the presence of fungal infection may also responsible for the development of foot ulcers. PMID:27648034

Endotoxin Elimination in Patients with Septic Shock: An Observation Study.

PubMed

Adamik, Barbara; Zielinski, Stanislaw; Smiechowicz, Jakub; Kübler, Andrzej

2015-12-01

To evaluate the effectiveness of endotoxin elimination with an adsorption column in patients with septic shock and endotoxemia. The elimination therapy was guided by a new bedside method of measuring endotoxin activity (EA). Intensive care unit (ICU) patients with septic shock and suspected Gram-negative infection were consecutively added to the study group within the first 24 h. Endotoxin elimination was performed using hemoperfusion with the Alteco LPS Adsorber. The primary endpoint was improvement in organ function within the first 24 h of treatment. A secondary objective was to assess the usefulness of a new method of measuring EA to help guide endotoxin elimination therapy. Out of 64 patients 18 had a high baseline EA [0.70 EA units (0.66-0.77)]. Those patients had endotoxin elimination treatment in addition to conventional medical therapy. At 24 h after endotoxin elimination, the EA had decreased to 0.56 EA units (0.43-0.77), (p = 0.005); MAP increased from 69 (62-80) to 80 mm Hg (68-88), (p = 0.002), and noradrenaline use decreased from 0.28 (0.15-0.80) to 0.1 μg/kg/min (0.00-0.70) at the same time (p = 0.04). The SOFA score had decreased from 11 (9-15) to 9 (7-14) points 24 h after endotoxin elimination (p = 0.01) with a median delta SOFA -2 points. Endotoxin elimination did not have a significant effect on the ICU length of stay or ICU mortality. Effective endotoxin elimination resulted in a significant improvement in hemodynamic parameters and of organ function. The application of the EA assay was useful for the bedside monitoring of endotoxemia in critically ill ICU patients.

Understanding the use of emergency department and urgent care services by diabetic patients of a Family Medicine Health Team: a retrospective observational study.

PubMed

Ward, Matthew

2017-03-01

Aim To understand the frequency, urgency, and rationale of emergency department and urgent care (ED/UC) use by diabetic patients of a Family Medicine Health Team (FHT). A retrospective, observational study with comparison control groups was conducted from 1 January 2013 to 31 December 2014. A total of 693 diabetic patients were compared with two, age-standardized non-diabetic groups: one with a higher disease burden based on International Classification of Diseases 9 diagnoses and the other from a randomized patient pool. Findings The diabetic group utilized ED/UC services 1.25 and 1.92 times more often than the two control populations, consistent with that observed in other studies. Canadian Triage and Acuity Scale scores were essentially the same for the diabetic population. Only 3.1% of visits were for diabetic related emergencies, in contrast to the expected 23% by surveyed physicians of the FHT. Diabetic patient's sought treatment for cellulitis, wounds, abscesses, and infections more often than the control populations.

Contemporary Trends in the Management and Outcomes of Patients With Familial Hypercholesterolemia in Canada: A Prospective Observational Study.

PubMed

Brunham, Liam R; Cermakova, Lubomira; Lee, Terry; Priecelova, Ida; Alloul, Karine; de Chantal, Marilyn; Francis, Gordon A; Frohlich, Jiri

2017-03-01

Heterozygous familial hypercholesterolemia (HeFH) is one of the most common genetic diseases in the world and an important cause of premature cardiovascular (CV) disease. The purpose of this study was to characterize the clinical features, current treatment patterns, and CV outcomes of patients with HeFH in British Columbia, Canada. We conducted a longitudinal observational study of patients with HeFH attending a specialized lipid clinic. We collected data on lipid levels, medication use, and CV events at baseline and last follow-up. We recruited 339 patients with clinically diagnosed HeFH, with a total of 3700 person-years of follow-up. The mean low-density lipoprotein cholesterol (LDL-C) level was 5.9 mmol/L at baseline and 3.7 mmol/L at last follow-up. Use of lipid-lowering therapy (LLT) increased from 35.7% at baseline to 84.7% at last follow-up. A ≥ 50% reduction in LDL-C level was achieved in 34.5% of patients, and an LDL-C level ≤ 2 mmol/L was seen in 8.3%. The overall CV event rate in this cohort was 33.5/1000 person-years. Among patients who had a CV event during follow-up, 59% experienced a recurrent event within 5 years. These data contribute to our understanding of contemporary trends in the management of patients with HeFH in Canada. Despite a majority of patients receiving LLT, few patients reached high-risk lipid targets. These data highlight important opportunities to improve the care of patients with HeFH. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Psychosocial impact of prognostic genetic testing in the care of uveal melanoma patients: protocol of a controlled prospective clinical observational study.

PubMed

Erim, Yesim; Scheel, Jennifer; Breidenstein, Anja; Metz, Claudia Hd; Lohmann, Dietmar; Friederich, Hans-Christoph; Tagay, Sefik

2016-07-07

Uveal melanoma patients with a poor prognosis can be detected through genetic analysis of the tumor, which has a very high sensitivity. A large number of patients with uveal melanoma decide to receive information about their individual risk and therefore routine prognostic genetic testing is being carried out on a growing number of patients. It is obvious that a positive prediction for recidivism in the future will emotionally burden the respective patients, but research on the psychosocial impact of this innovative method is lacking. The aim of the current study is therefore to investigate the psychosocial impact (psychological distress and quality of life) of prognostic genetic testing in patients with uveal melanoma. This study is a non-randomized controlled prospective clinical observational trial. Subjects are patients with uveal melanoma, in whom genetic testing is possible. Patients who consent to genetic testing are allocated to the intervention group and patients who refuse genetic testing form the observational group. Both groups receive cancer therapy and psycho-oncological intervention when needed. The psychosocial impact of prognostic testing is investigated with the following variables: resilience, social support, fear of tumor progression, depression, general distress, cancer-specific and general health-related quality of life, attitude towards genetic testing, estimation of the perceived risk of metastasis, utilization and satisfaction with psycho-oncological crisis intervention, and sociodemographic data. Data are assessed preoperatively (at initial admission in the clinic) and postoperatively (at discharge from hospital after surgery, 6-12 weeks, 6 and 12 months after initial admission). Genetic test results are communicated 6-12 weeks after initial admission to the clinic. We created optimal conditions for investigation of the psychosocial impact of prognostic genetic testing. This study will provide information on the course of disease and

Conjunctival microcirculatory blood flow is altered but not abolished in brain dead patients: a prospective observational study.

PubMed

Tamosuitis, Tomas; Pranskunas, Andrius; Balciuniene, Neringa; Pilvinis, Vidas; Boerma, E Christiaan

2016-07-11

The conjunctival microcirculation has potential as a window to cerebral perfusion due to related blood supply, close anatomical proximity and easy accessibility for microcirculatory imaging technique, such as sidestream dark field (SDF) imaging. Our study aims to evaluate conjunctival and sublingual microcirculation in brain dead patients and to compare it with healthy volunteers in two diametrically opposed conditions: full stop versus normal arterial blood supply to the brain. In a prospective observational study we analyzed conjunctival and sublingual microcirculation using SDF imaging in brain dead patients after reaching systemic hemodynamic targets to optimize perfusion of donor organs, and in healthy volunteers. All brain death diagnoses were confirmed by cerebral angiography. Microcirculatory images were obtained and analyzed using standardized published recommendations. Study registered at ClinicalTrials.gov, number NCT02483273. Eleven brain dead patients and eleven apparently healthy controls were enrolled in the study. Microvascular flow index (MFI) of small vessels was significantly lower in brain dead patients in comparison to healthy controls in ocular conjunctiva (2.7 [2.4-2.9] vs. 3.0 [2.9-3.0], p = 0.01) and in sublingual mucosa (2.8 [2.6-2.9] vs. 3.0 [2.9-3.0], p = 0.02). Total vessel density (TVD) and perfused vessel density (PVD) of small vessels were significantly lower in brain dead patients in comparison to healthy controls in ocular conjunctiva (10.2 [6.6-14.8] vs. 18.0 [18.0-25.4] mm/mm(2), p = 0.001 and 5.0 [3.5-7.3] vs. 10.9 [10.9-13.5] 1/mm, p = 0.001), but not in sublingual mucosa. In comparison to healthy controls brain dead patients had a significant reduction in conjunctival microvascular blood flow and density. However, the presence of conjunctival flow in case general cerebral flow is completely absent makes it impossible to use the conjunctival microcirculation as a substitute for brain flow, and further research should focus on

[Therapeutic effects of venlafaxine extended release for patients with depressive and anxiety disorders in the German outpatient setting - results of 2 observational studies including 8500 patients].

PubMed

Anghelescu, I-G; Dierkes, W; Volz, H-P; Loeschmann, P-A; Schmitt, A B

2009-11-01

The therapeutic effects of venlafaxine extended release have been investigated by two prospective observational studies including 8506 patients in the outpatient setting of office based general practitioners and specialists. The efficacy has been documented by the Clinical Global Impression (CGI) scale and by the Hamilton depression (HAMD-21) scale. The tolerability has been assessed by the documentation of adverse events. About (2/3) of the patients were treated because of depression and about (1/3) mainly because of anxiety disorder. The patients of specialists did receive higher dosages and were more severely affected. The response rate on the CGI scale was 87.4 for the patients of general practitioners and 74.2 % for the patients of specialists. The results of the HAMD-21 scale, which has been used by specialists, showed a response rate of 71.8 and a remission rate of 56.3 %. These positive effects could be demonstrated even for the more severely and chronically affected patients. The incidence of adverse events was low in both studies and comparable to the tolerability profile of randomized studies. Importantly, the good tolerability profile was similar even for patients with concomitant cardiovascular disease. In conclusion, these results confirm the efficacy and good tolerability of venlafaxine extended release in the outpatient setting in Germany. Georg Thieme Verlag KG Stuttgart, New York.

[Observational study of patients admitted to an Internal Medicine service].

PubMed

Delgado Morales, J L; Alonso del Busto, R; Pascual Calleja, I; Villacorta Martín, M M; Ergueta Martín, P; González Sarmiento, E

2004-01-01

To analyse the entered more frequent disease in an Internal Medicine Department, the reasons for hospital admission diagnosis at discharge (according to entrance symptom's guide), the group of affected population and its correlation among them. Over a total of 758 internal medicine admissions of the University Hospital of Valladolid during the year 1999 based on the information of discharge and clinical histories, a descriptive and observational epidemic study was made using the variables of sex, age, reason for admission (guide symptom) and diagnosis at discharge. The obtained results were represented by mean of diagrams of sectors and bars according to the analyzed variables. The data synthesis was made by measures of central tendency and dispersion. SPSS 10.0 version for windows program was used for the statistical study. The non parametric analysis for independent samples was made by the test of median and the U of Mann Whitney, and the parametric by chi-squired test and resistance of Kolmogorov-Smirnov. The median of age is 70 years. Rank 84 years. Interquartile rank 23, fashion in men 75 years and in women 86. The distribution in sex men 51%, women 49%. The more frequent reasons for entrance are dyspnea (35%) and neurological focus (11%). The more frequent diagnosis at discharge are dyspnea and chronic obstructive lung disease worsened by respiratory infection (11%), pneumonia (8%) and acute ischemic stroke (7%). In-patients in this service, are advanced in years (mainly women) (alpha = 0.05). The age does not get a normal distribution (alpha = 0.05). The frequency of the distribution in sex is similar. The most frequent reason for admission is dyspnea (35%). The most frequent diagnoses at discharge are chronic obstructive lung disease (11%), pneumonia (8%) and acute ischemic stroke (7%). The primary and secondary prevention and an improvement of the therapeutic measures of chronic cardiopulmonary disease would reduce significantly the welfare pressure in

Effective chemomobilization with etoposide and cytarabine (EC regimen) in lymphoma patients: a single-center, retrospective, observational study.

PubMed

Koyama, Daisuke; Nishiwaki, Satoshi; Harada, Yasuhiko; Yamamoto, Satomi; Kurahashi, Shingo; Sugimoto, Takumi; Iwasaki, Toshihiro; Sugiura, Isamu

2017-09-01

Autologous stem cell transplantation is an important strategy for patients with relapsed or refractory lymphoma. Although various regimens for peripheral blood stem cell collection have been used, the optimal regimen has not yet been established. We aimed to evaluate the mobilization efficacy and safety of the regimen consisted of etoposide and cytarabine (EC regimen). We retrospectively analyzed the clinical data of 46 lymphoma patients who received peripheral blood stem cell mobilization with the EC regimen [etoposide (100 mg/m2/day, days 1-4) and cytarabine (100 mg/m2/day, days 1-4)] at Toyohashi municipal hospital from 2004 to 2013. The median age of the patients was 55 years. The most common underlying diseases were diffuse large B-cell lymphoma (46%) and follicular lymphoma (26%). Three-quarters of patients were in their second complete or partial remission. The median total number of collected CD34+ cells was 10.6 × 106 kg-1. Forty-two patients (91%) yielded at least 2 × 106 kg-1 CD34+ cells within a median of 2 apheresis days, and 33 patients (72%) achieved it with only one apheresis. Successful mobilization was observed in five of six patients who failed to mobilize previously. Although febrile neutropenia occurred in 22 patients (48%), no fatal infection was observed. The EC regimen was highly effective in lymphoma patients, including patients who mobilized poorly with other regimens. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Unrecognised bipolar disorder among UK primary care patients prescribed antidepressants: an observational study.

PubMed

Hughes, Tom; Cardno, Alastair; West, Robert; Marino-Francis, Federica; Featherstone, Imogen; Rolling, Keeley; Locker, Alice; McLintock, Kate; House, Allan

2016-02-01

Bipolar disorder is not uncommon, is associated with high disability and risk of suicide, often presents with depression, and can go unrecognised. To determine the prevalence of unrecognised bipolar disorder among those prescribed antidepressants for depressive or anxiety disorder in UK primary care; whether those with unrecognised bipolar disorder have more severe depression than those who do not; and the accuracy of a screening questionnaire for bipolar disorder, the Mood Disorder Questionnaire (MDQ), in this setting. Observational primary care study of patients on the lists of 21 general practices in West Yorkshire aged 16-40 years and prescribed antidepressant medication. Participants were recruited using primary care databases, interviewed using a diagnostic interview, and completed the screening questionnaire and rating scales of symptoms and quality of life. The prevalence of unrecognised bipolar disorder was 7.3%. Adjusting for differences between the sample and a national database gives a prevalence of 10.0%. Those with unrecognised bipolar disorder were younger and had greater lifetime depression. The predictive value of the MDQ was poor. Among people aged 16-40 years prescribed antidepressants in primary care for depression or anxiety, there is a substantial proportion with unrecognised bipolar disorder. When seeing patients with depression or anxiety disorder, particularly when they are young or not doing well, clinicians should review the life history for evidence of unrecognised bipolar disorder. Some clinicians might find the MDQ to be a useful supplement to non-standardised questioning. © British Journal of General Practice 2016.

Osteoporosis therapies: evidence from health-care databases and observational population studies.

PubMed

Silverman, Stuart L

2010-11-01

Osteoporosis is a well-recognized disease with severe consequences if left untreated. Randomized controlled trials are the most rigorous method for determining the efficacy and safety of therapies. Nevertheless, randomized controlled trials underrepresent the real-world patient population and are costly in both time and money. Modern technology has enabled researchers to use information gathered from large health-care or medical-claims databases to assess the practical utilization of available therapies in appropriate patients. Observational database studies lack randomization but, if carefully designed and successfully completed, can provide valuable information that complements results obtained from randomized controlled trials and extends our knowledge to real-world clinical patients. Randomized controlled trials comparing fracture outcomes among osteoporosis therapies are difficult to perform. In this regard, large observational database studies could be useful in identifying clinically important differences among therapeutic options. Database studies can also provide important information with regard to osteoporosis prevalence, health economics, and compliance and persistence with treatment. This article describes the strengths and limitations of both randomized controlled trials and observational database studies, discusses considerations for observational study design, and reviews a wealth of information generated by database studies in the field of osteoporosis.

Observational Study of a French and Belgian Multicenter Cohort of 23 Patients Diagnosed in Adulthood With Mevalonate Kinase Deficiency.

PubMed

Durel, Cécile-Audrey; Aouba, Achille; Bienvenu, Boris; Deshayes, Samuel; Coppéré, Brigitte; Gombert, Bruno; Acquaviva-Bourdain, Cécile; Hachulla, Eric; Lecomte, Frédéric; Touitou, Isabelle; Ninet, Jacques; Philit, Jean-Baptiste; Messer, Laurent; Brouillard, Marc; Girard-Madoux, Marie-Hélène; Moutschen, Michel; Raison-Peyron, Nadia; Hutin, Pascal; Duffau, Pierre; Trolliet, Pierre; Hatron, Pierre-Yves; Heudier, Philippe; Cevallos, Ramiro; Lequerré, Thierry; Brousse, Valentine; Lesire, Vincent; Audia, Sylvain; Maucort-Boulch, Delphine; Cuisset, Laurence; Hot, Arnaud

2016-03-01

The aim of this study was to describe the clinical and biological features of Mevalonate kinase deficiency (MKD) in patients diagnosed in adulthood. This is a French and Belgian observational retrospective study from 2000 to 2014. To constitute the cohort, we cross-check the genetic and biochemical databases. The clinical, enzymatic, and genetic data were gathered from medical records. Twenty-three patients were analyzed. The mean age at diagnosis was 40 years, with a mean age at onset of symptoms of 3 years. All symptomatic patients had fever. Febrile attacks were mostly associated with arthralgia (90.9%); lymphadenopathy, abdominal pain, and skin lesions (86.4%); pharyngitis (63.6%); cough (59.1%); diarrhea, and hepatosplenomegaly (50.0%). Seven patients had psychiatric symptoms (31.8%). One patient developed recurrent seizures. Three patients experienced renal involvement (13.6%). Two patients had angiomyolipoma (9.1%). All but one tested patients had elevated serum immunoglobulin (Ig) D level. Twenty-one patients had genetic diagnosis; most of them were compound heterozygote (76.2%). p.Val377Ile was the most prevalent mutation. Structural articular damages and systemic AA amyloidosis were the 2 most serious complications. More than 65% of patients displayed decrease in severity and frequency of attacks with increasing age, but only 35% achieved remission. MKD diagnosed in adulthood shared clinical and genetic features with classical pediatric disease. An elevated IgD concentration is a good marker for MKD in adults. Despite a decrease of severity and frequency of attacks with age, only one-third of patients achieved spontaneous remission.

Safety Hazards During Intrahospital Transport: A Prospective Observational Study.

PubMed

Bergman, Lina M; Pettersson, Monica E; Chaboyer, Wendy P; Carlström, Eric D; Ringdal, Mona L

2017-10-01

To identify, classify, and describe safety hazards during the process of intrahospital transport of critically ill patients. A prospective observational study. Data from participant observations of the intrahospital transport process were collected over a period of 3 months. The study was undertaken at two ICUs in one university hospital. Critically ill patients transported within the hospital by critical care nurses, unlicensed nurses, and physicians. None. Content analysis was performed using deductive and inductive approaches. We detected a total of 365 safety hazards (median, 7; interquartile range, 4-10) during 51 intrahospital transports of critically ill patients, 80% of whom were mechanically ventilated. The majority of detected safety hazards were assessed as increasing the risk of harm, compromising patient safety (n = 204). Using the System Engineering Initiative for Patient Safety, we identified safety hazards related to the work system, as follows: team (n = 61), tasks (n = 83), tools and technologies (n = 124), environment (n = 48), and organization (n = 49). Inductive analysis provided an in-depth description of those safety hazards, contributing factors, and process-related outcomes. Findings suggest that intrahospital transport is a hazardous process for critically ill patients. We have identified several factors that may contribute to transport-related adverse events, which will provide the opportunity for the redesign of systems to enhance patient safety.

Prediction and Observation of Post-Admission Hematoma Expansion in Patients with Intracerebral Hemorrhage

PubMed Central

Ovesen, Christian; Havsteen, Inger; Rosenbaum, Sverre; Christensen, Hanne

2014-01-01

Post-admission hematoma expansion in patients with intracerebral hemorrhage (ICH) comprises a simultaneous major clinical problem and a possible target for medical intervention. In any case, the ability to predict and observe hematoma expansion is of great clinical importance. We review radiological concepts in predicting and observing post-admission hematoma expansion. Hematoma expansion can be observed within the first 24 h after symptom onset, but predominantly occurs in the early hours. Thus capturing markers of on-going bleeding on imaging techniques could predict hematoma expansion. The spot sign observed on computed tomography angiography is believed to represent on-going bleeding and is to date the most well investigated and reliable radiological predictor of hematoma expansion as well as functional outcome and mortality. On non-contrast CT, the presence of foci of hypoattenuation within the hematoma along with the hematoma-size is reported to be predictive of hematoma expansion and outcome. Because patients tend to arrive earlier to the hospital, a larger fraction of acute ICH-patients must be expected to undergo hematoma expansion. This renders observation and radiological follow-up investigations increasingly relevant. Transcranial duplex sonography has in recent years proven to be able to estimate hematoma volume with good precision and could be a valuable tool in bedside serial observation of acute ICH-patients. Future studies will elucidate, if better prediction and observation of post-admission hematoma expansion can help select patients, who will benefit from hemostatic treatment. PMID:25324825

Wilson's disease-cause of mortality in 164 patients during 1992-2003 observation period.

PubMed

Członkowska, A; Tarnacka, B; Litwin, T; Gajda, J; Rodo, M

2005-06-01

We studied the cause of death in a consecutive series of 164 patients with Wilson's disease (WD) diagnosed over an 11 year period. A total of 20 [12% (95% CI 10.3-16.0)] died during the observation period. The relative survival rate of all patients in our group was statistically smaller than in Polish population. The main cause of death was the diagnosis in advanced stage of disease, but in six patients presenting with mild signs, we observed the progression of the disease despite treatment. There was no difference in mortality rate in patients treated with d-penicillamine or zinc sulphate as initial therapy. The prognosis for survival in the majority of WD patients is favourable, provided that therapy is introduced early.

Observation Versus Embolization in Patients with Blunt Splenic Injury After Trauma: A Propensity Score Analysis.

PubMed

Olthof, Dominique C; Joosse, Pieter; Bossuyt, Patrick M M; de Rooij, Philippe P; Leenen, Loek P H; Wendt, Klaus W; Bloemers, Frank W; Goslings, J Carel

2016-05-01

Non-operative management (NOM) is the standard of care in hemodynamically stable patients with blunt splenic injury after trauma. Splenic artery embolization (SAE) is reported to increase observation success rate. Studies demonstrating improved splenic salvage rates with SAE primarily compared SAE with historical controls. The aim of this study was to investigate whether SAE improves success rate compared to observation alone in contemporaneous patients with blunt splenic injury. We included adult patients with blunt splenic injury admitted to five Level 1 Trauma Centers between January 2009 and December 2012 and selected for NOM. Successful treatment was defined as splenic salvage and no splenic re-intervention. We calculated propensity scores, expressing the probability of undergoing SAE, using multivariable logistic regression and created five strata based on the quintiles of the propensity score distribution. A weighted relative risk (RR) was calculated across strata to express the chances of success with SAE. Two hundred and six patients were included in the study. Treatment was successful in 180 patients: 134/146 (92 %) patients treated with observation and 48/57 (84 %) patients treated with SAE. The weighted RR for success with SAE was 1.17 (0.94-1.45); for complications, the weighted RR was 0.71 (0.41-1.22). The mean number of transfused blood products was 4.4 (SD 9.9) in the observation group versus 9.1 (SD 17.2) in the SAE group. After correction for confounders with propensity score stratification technique, there was no significant difference between embolization and observation alone with regard to successful treatment in patients with blunt splenic injury after trauma.

Dispatch and prehospital transport for acute septic patients: an observational study.

PubMed

Pedersen, Peter Bank; Henriksen, Daniel Pilsgaard; Mikkelsen, Søren; Lassen, Annmarie Touborg

2017-05-12

In order to dispatch ambulances with the correct level of urgency, the dispatch center has to balance the perceived urgency and traffic safety considerations with the available resources. As urgency is not clear in all clinical situations, some high urgency patients may end up with a suboptimal mode of transport. Patients with severe sepsis or septic shock suffer from highly time dependent conditions but they present with a wide range of symptoms, which might be difficult to identify in the dispatch system. The aim of the study is to investigate the modes of prehospital transport among acute admitted patients with sepsis, severe sepsis and septic shock. We included all adult patients (≥15 years) presenting to an acute medical unit at Odense University Hospital with a first-time admission of community-acquired sepsis between September 2010-August 2011. Cases and prehospital ambulance transport were identified by structured manual chart review. In all cases it was registered, whether the ordinary ambulance was assisted by the mobile emergency care unit (MECU), manned by anesthesiologists. We included 1,713 patients median age 72 years (IQR 57-81), 793 (46.3%) male, 621 (36.3%) had sepsis, 1,071 (62.5%) severe sepsis, and 21 (1.2%) septic shock. In the group of sepsis patients, 390 (62.8%) arrived without public prehospital transport, 197 (31.7%) were transported by ambulance, and 34 (5.5%) were assisted by MECU. In the group of severe sepsis patients, the same percentage 62.8% arrived without public pre-hospital transport, a lower percentage 28.2% were transported by ambulance, and a larger percentage 9.0% were transported by MECU. Among 21 patients with septic shock, 10 arrived without public pre-hospital transport (47.7%), 7 (33.3%) were transported by ambulance, and 4 (19.0%) by MECU. The 30-day mortality hazard ratio was associated with mode of transport, with the adjusted highest hazard ratio found in the group of MECU transported patients 1.76 (95%Cl 1

Efficacy and tolerability of lacosamide for secondary epileptic seizures in patients with brain tumor: A multicenter, observational retrospective study

PubMed Central

Sepúlveda-Sánchez, Juan Manuel; Conde-Moreno, Antonio; Barón, Manuel; Pardo, Javier; Reynés, Gaspar; Belenguer, Antonio

2017-01-01

The present observational, multicenter, retrospective study investigated the efficacy and tolerability of lacosamide in controlling secondary epileptic seizures in patients with brain tumors in Spain. Data from the medical records of patients ≥18 years of age with brain tumors, who had received at least one dose of lacosamide for seizure management between July 2013 and November 2013, were collected. The primary and secondary objectives of the present study were to assess the effectiveness and tolerability of lacosamide. Data from 39 patients (mean age, 54.1 years; 66.7% male) were collected, where the two main reasons for initiation of lacosamide treatment were the lack of efficacy of other antiepileptic drugs (in 76.9% of patients) and the presence of adverse events (12.8%) associated with other antiepileptic drugs. At the initiation of treatment, patients received a mean lacosamide dose of 138.5±68.3 mg/day. At 6 months, lacosamide had significantly reduced the mean number of seizures from 26.4 (standard deviation [SD], 50.4) seizures for the 6 months prior to lacosamide initiation to a mean of 9.4 (SD, 22.8) seizures during the 6 months subsequent to lacosamide initiation; P<0.001. Lacosamide was generally well tolerated; of the 25 patients who had complete safety data available at a 6-month follow-up, 3 patients (12%) reported an adverse event, including dizziness, asthenia, instability and irritability. The present retrospective analysis suggested that lacosamide is an effective and well-tolerated treatment in patients experiencing seizures due to brain tumors. Additional prospective studies with a larger patient population and randomized trial design are warranted. PMID:28599411

Efficacy and tolerability of lacosamide for secondary epileptic seizures in patients with brain tumor: A multicenter, observational retrospective study.

PubMed

Sepúlveda-Sánchez, Juan Manuel; Conde-Moreno, Antonio; Barón, Manuel; Pardo, Javier; Reynés, Gaspar; Belenguer, Antonio

2017-06-01

The present observational, multicenter, retrospective study investigated the efficacy and tolerability of lacosamide in controlling secondary epileptic seizures in patients with brain tumors in Spain. Data from the medical records of patients ≥18 years of age with brain tumors, who had received at least one dose of lacosamide for seizure management between July 2013 and November 2013, were collected. The primary and secondary objectives of the present study were to assess the effectiveness and tolerability of lacosamide. Data from 39 patients (mean age, 54.1 years; 66.7% male) were collected, where the two main reasons for initiation of lacosamide treatment were the lack of efficacy of other antiepileptic drugs (in 76.9% of patients) and the presence of adverse events (12.8%) associated with other antiepileptic drugs. At the initiation of treatment, patients received a mean lacosamide dose of 138.5±68.3 mg/day. At 6 months, lacosamide had significantly reduced the mean number of seizures from 26.4 (standard deviation [SD], 50.4) seizures for the 6 months prior to lacosamide initiation to a mean of 9.4 (SD, 22.8) seizures during the 6 months subsequent to lacosamide initiation; P<0.001. Lacosamide was generally well tolerated; of the 25 patients who had complete safety data available at a 6-month follow-up, 3 patients (12%) reported an adverse event, including dizziness, asthenia, instability and irritability. The present retrospective analysis suggested that lacosamide is an effective and well-tolerated treatment in patients experiencing seizures due to brain tumors. Additional prospective studies with a larger patient population and randomized trial design are warranted.

A New Method to Directly Observe Tuberculosis Treatment: Skype Observed Therapy, a Patient-Centered Approach.

PubMed

Buchman, Tavora; Cabello, Celina

Tuberculosis (TB) treatment completion is in part determined by patient's adherence to long-term drug regimens. To best ensure compliance, directly observed therapy (DOT) is considered the standard of practice. Nassau County Department of Health TB Control is responsible for providing DOT to patients with TB. Tuberculosis Control sought to use and evaluate Skype Observed Therapy (SOT) as an alternative to DOT for eligible patients. The evaluation included analysis of patient's acceptance and adherence to drug regimen using SOT. Tuberculosis Control assessed staff efficiency and cost savings for this program. Percentages of SOT of patients and successful SOT visits, mileage, and travel time savings. Twenty percent of the caseload used SOT and 100% of patients who were eligible opted in. Average SOT success was 79%. Total mileage savings and time saved were $9,929.07 and 614 hours. Because SOT saves cost and time and is a suitable alternative to DOT for patients, it should be considered as part of new policies and practices in TB control programs.

The MS@Work study: a 3-year prospective observational study on factors involved with work participation in patients with relapsing-remitting Multiple Sclerosis.

PubMed

van der Hiele, Karin; van Gorp, Dennis A M; Heerings, Marco A P; van Lieshout, Irma; Jongen, Peter J; Reneman, Michiel F; van der Klink, Jac J L; Vosman, Frans; Middelkoop, Huub A M; Visser, Leo H

2015-08-12

Multiple Sclerosis (MS) is the most common cause of neurological disability in young and middle-aged adults. At this stage in life most people are in the midst of their working career. The majority of MS patients are unable to retain employment within 10 years from disease onset. Leading up to unemployment, many may experience a reduction in hours or work responsibilities and increased time missed from work. The MS@Work study examines various factors that may influence work participation in relapsing-remitting MS patients, including disease-related factors, the working environment and personal factors. The MS@Work study is a multicenter, 3-year prospective observational study on work participation in patients with relapsing-remitting MS. We aim to include 350 patients through 15-18 MS outpatient clinics in the Netherlands. Eligible participants are 18 years and older, and either currently employed or within three years since their last employment. At baseline and after 1, 2 and 3 years, the participants are asked to complete online questionnaires (including questions on work participation, work problems and accommodations, cognitive and physical ability, anxiety, depression, psychosocial stress, quality of life, fatigue, empathy, personality traits and coping strategies) and undergo cognitive and neurological examinations. After six months, patients are requested to only complete online questionnaires. Patient perspectives on maintaining and improving work participation and reasons to stop working are gathered through semi-structured interviews in a sub-group of patients. Prospective studies with long-term follow-up on work participation in MS are rare, or take into account a limited number of factors. The MS@Work study provides a 3-year follow-up on various factors that may influence work participation in patients with relapsing-remitting MS. We aim to identify factors that relate to job loss and to provide information about preventative measures for physicians

OMT associated with reduced analgesic prescribing and fewer missed work days in patients with low back pain: an observational study.

PubMed

Prinsen, Joseph K; Hensel, Kendi L; Snow, Richard J

2014-02-01

Randomized controlled trials (RCTs) are considered the standard for establishing practice guidelines; however, they are expensive and time-consuming, and often the generalizability of the results is limited. To conduct an observational study using the findings of the American Osteopathic Association's Clinical Assessment Program (AOA-CAP) low back pain module, and to compare these findings with those of a major back pain-related RCT to determine the validity and generalizability of this pseudoexperimental model. Data were abstracted from the AOA-CAP for Residencies platform from April 1, 2006, through October 5, 2007, with a diagnosis code consistent with low back pain. Process and outcome measures were compared after segregating a similar patient population to an RCT that compared "osteopathic spinal manipulation" with standard care. A total of 1013 medical records were abstracted and entered into the AOA-CAP low back pain module. Mean (standard deviation [SD]) age was 44.7 (15.9) years, and body mass index was 29.6 (8.1). The eligible patients comprised 415 men (41.0%) and 598 women (59.0%), and common comorbid disease was found in 69 patients (6.8%). Activities of daily living were limited in 402 patients (42.4%), whereas 546 (57.6%) had no limitations. Previous exacerbations of low back pain occurred in 653 patients (65.9%). Most patients had no sensory or proprioception deficit (729 [87.7%]), and motor function was normal in 636 patients (74.5%). Normal ankle and knee reflexes were found in 744 of 814 (91.4%) and 755 of 829 (89.0%) patients, respectively. Osteopathic manipulative treatment (OMT) was performed on the lumbar spine (576 patients [56.9%]), thoracic spine (411 [40.6%]), sacrum/pelvis (440 [43.4%]), rib (261 [25.8%]), and lower extremity (256 [25.3%]). A segregated patient cohort (n=539) showed statistically significant differences between patients who received OMT and those who did not with the use of analgesics, steroids, spinal injections

Describing the Sequence of Cognitive Decline in Alzheimer's Disease Patients: Results from an Observational Study.

PubMed

Henneges, Carsten; Reed, Catherine; Chen, Yun-Fei; Dell'Agnello, Grazia; Lebrec, Jeremie

2016-01-01

Improved understanding of the pattern of cognitive decline in Alzheimer's disease (AD) would be useful to assist primary care physicians in explaining AD progression to patients and caregivers. To identify the sequence in which cognitive abilities decline in community-dwelling patients with AD. Baseline data were analyzed from 1,495 patients diagnosed with probable AD and a Mini-Mental State Examination (MMSE) score ≤ 26 enrolled in the 18-month observational GERAS study. Proportional odds logistic regression models were applied to model MMSE subscores (orientation, registration, attention and concentration, recall, language, and drawing) and the corresponding subscores of the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog), using MMSE total score as the index of disease progression. Probabilities of impairment start and full impairment were estimated at each MMSE total score level. From the estimated probabilities for each MMSE subscore as a function of the MMSE total score, the first aspect of cognition to start being impaired was recall, followed by orientation in time, attention and concentration, orientation in place, language, drawing, and registration. For full impairment in subscores, the sequence was recall, drawing, attention and concentration, orientation in time, orientation in place, registration, and language. The sequence of cognitive decline for the corresponding ADAS-cog subscores was remarkably consistent with this pattern. The sequence of cognitive decline in AD can be visualized in an animation using probability estimates for key aspects of cognition. This might be useful for clinicians to set expectations on disease progression for patients and caregivers.

Comparison of volatile organic compounds from lung cancer patients and healthy controls-challenges and limitations of an observational study.

PubMed

Schallschmidt, Kristin; Becker, Roland; Jung, Christian; Bremser, Wolfram; Walles, Thorsten; Neudecker, Jens; Leschber, Gunda; Frese, Steffen; Nehls, Irene

2016-10-12

This paper outlines the design and performance of an observational study on the profiles of volatile organic compounds (VOCs) in the breath of 37 lung cancer patients and 23 healthy controls of similar age. The need to quantify each VOC considered as a potential disease marker on the basis of individual calibration is elaborated, and the quality control measures required to maintain reproducibility in breath sampling and subsequent instrumental trace VOC analysis using solid phase microextraction-gas chromatography-mass spectrometry over a study period of 14 months are described. Twenty-four VOCs were quantified on the basis of their previously suggested potential as cancer markers. The concentration of aromatic compounds in the breath was increased, as expected, in smokers, while lung cancer patients displayed significantly increased levels of oxygenated VOCs such as aldehydes, 2-butanone and 1-butanol. Although sets of selected oxygenated VOCs displayed sensitivities and specificities between 80% and 90% using linear discriminant analysis (LDA) with leave-one-out cross validation, the effective selectivity of the breath VOC approach with regard to cancer detection is clearly limited. Results are discussed against the background of the literature on volatile cancer marker investigations and the prospects of linking increased VOC levels in patients' breath with approaches that employ sniffer dogs. Experience from this study and the literature suggests that the currently available methodology is not able to use breath VOCs to reliably discriminate between cancer patients and healthy controls. Observational studies often tend to note significant differences in levels of certain oxygenated VOCs, but without the resolution required for practical application. Any step towards the exploitation of differences in VOC profiles for illness detection would have to solve current restrictions set by the low and variable VOC concentrations. Further challenges are the technical

Comparing nutritional requirements, provision and intakes among patients prescribed therapeutic diets in hospital: An observational study.

PubMed

Rattray, Megan; Desbrow, Ben; Roberts, Shelley

Nutrition is an important part of recovery for hospitalized patients. The aim of this study was to assess the nutritional adequacy of meals provided to and consumed by patients prescribed a therapeutic diet. Patients (N = 110) prescribed a therapeutic diet (texture-modified, low-fiber, oral fluid, or food allergy or intolerance diets) for medical or nutritional reasons were recruited from six wards of a tertiary hospital. Complete (24-h) dietary provisions and intakes were directly observed and analyzed for energy (kJ) and protein (g) content. A chart audit gathered demographic, clinical, and nutrition-related information to calculate each patient's disease-specific estimated energy and protein requirements. Provisions and intake were considered adequate if they met ≥75% of the patient's estimated requirements. Mean energy and protein provided to patients (5844 ± 2319 kJ, 53 ± 30 g) were significantly lower than their mean estimated requirements (8786 ± 1641 kJ, 86 ± 18 g). Consequently, mean nutrition intake (4088 ± 2423 kJ, 37 ± 28 g) were significantly lower than estimated requirements. Only 37% (41) of patients were provided with and 18% (20) consumed adequate nutrition to meet their estimated requirements. No therapeutic diet provided adequate food to meet the energy and protein requirements of all recipients. Patients on oral fluid diets had the highest estimated requirements (9497 ± 1455 kJ, 93 ± 16 g) and the lowest nutrient provision (3497 ± 1388 kJ, 25 ± 19 g) and intake (2156 ± 1394 kJ, 14 ± 14 g). Hospitalized patients prescribed therapeutic diets (particularly fluid-only diets) are at risk for malnutrition. Further research is required to determine the most effective strategies to improve nutritional provision and intake among patients prescribed therapeutic diets. Copyright © 2017 Elsevier Inc. All rights reserved.

Implementation of a cystic fibrosis lung transplant referral patient decision aid in routine clinical practice: an observational study.

PubMed

Stacey, Dawn; Vandemheen, Katherine L; Hennessey, Rosamund; Gooyers, Tracy; Gaudet, Ena; Mallick, Ranjeeta; Salgado, Josette; Freitag, Andreas; Berthiaume, Yves; Brown, Neil; Aaron, Shawn D

2015-02-07

The decision to have lung transplantation as treatment for end-stage lung disease from cystic fibrosis (CF) has benefits and serious risks. Although patient decision aids are effective interventions for helping patients reach a quality decision, little is known about implementing them in clinical practice. Our study evaluated a sustainable approach for implementing a patient decision aid for adults with CF considering referral for lung transplantation. A prospective pragmatic observational study was guided by the Knowledge-to-Action Framework. Healthcare professionals in all 23 Canadian CF clinics were eligible. We surveyed participants regarding perceived barriers and facilitators to patient decision aid use. Interventions tailored to address modifiable identified barriers included training, access to decision aids, and conference calls. The primary outcome was >80% use of the decision aid in year 2. Of 23 adult CF clinics, 18 participated (78.2%) and 13 had healthcare professionals attend training. Baseline barriers were healthcare professionals' inadequate knowledge for supporting patients making decisions (55%), clarifying patients' values for outcomes of options (58%), and helping patients handle conflicting views of others (71%). Other barriers were lack of time (52%) and needing to change how transplantation is discussed (42%). Baseline facilitators were healthcare professionals feeling comfortable discussing bad transplantation outcomes (74%), agreeing the decision aid would be easy to experiment with (71%) and use in the CF clinic (87%), and agreeing that using the decision aid would not require reorganization of the CF clinic (90%). After implementing the decision aid with interventions tailored to the barriers, decision aid use increased from 29% at baseline to 85% during year 1 and 92% in year 2 (p < 0.001). Compared to baseline, more healthcare professionals at the end of the study were confident in supporting decision-making (p = 0.03) but

Predictors of responses to corticosteroids for anorexia in advanced cancer patients: a multicenter prospective observational study.

PubMed

Matsuo, Naoki; Morita, Tatsuya; Matsuda, Yoshinobu; Okamoto, Kenichiro; Matsumoto, Yoshihisa; Kaneishi, Keisuke; Odagiri, Takuya; Sakurai, Hiroki; Katayama, Hideki; Mori, Ichiro; Yamada, Hirohide; Watanabe, Hiroaki; Yokoyama, Taro; Yamaguchi, Takashi; Nishi, Tomohiro; Shirado, Akemi; Hiramoto, Shuji; Watanabe, Toshio; Kohara, Hiroyuki; Shimoyama, Satofumi; Aruga, Etsuko; Baba, Mika; Sumita, Koki; Iwase, Satoru

2017-01-01

Although corticosteroids are widely used to relieve anorexia, information regarding the factors predicting responses to corticosteroids remains limited. The purpose of the study is to identify potential factors predicting responses to corticosteroids for anorexia in advanced cancer patients. Inclusion criteria for this multicenter prospective observational study were patients who had metastatic or locally advanced cancer and had an anorexia intensity score of 4 or more on a 0-10 Numerical Rating Scale (NRS). Univariate and multivariate analyses were conducted to identify the factors predicting ≥2-point reduction in NRS on day 3. Among 180 patients who received corticosteroids, 99 (55 %; 95 % confidence interval [CI], 47-62 %) had a response with ≥2-point reduction. Factors that significantly predicted responses were Palliative Performance Scale (PPS) > 40 and absence of drowsiness. In addition, factors that tended to be associated with ≥2-point reduction in NRS included PS 0-3, absence of diabetes mellitus, absence of peripheral edema, presence of lung metastasis, absence of peritoneal metastasis, baseline anorexia NRS of >6, presence of pain, and presence of constipation. A multivariate analysis showed that the independent factors predicting responses were PPS of >40 (odds ratio = 2.7 [95 % CI = 1.4-5.2]), absence of drowsiness (2.6 [1.3-5.0]), and baseline NRS of >6 (2.4 [1.1-4.8]). Treatment responses to corticosteroids for anorexia may be predicted by PPS, drowsiness, and baseline symptom intensity. Larger prospective studies are needed to confirm these results.

Incidence and Risk of Cardiac Events in Patients With Previously Treated Multiple Myeloma Versus Matched Patients Without Multiple Myeloma: An Observational, Retrospective, Cohort Study.

PubMed

Kistler, Kristin D; Kalman, Jill; Sahni, Gagan; Murphy, Brian; Werther, Winifred; Rajangam, Kanya; Chari, Ajai

2017-02-01

Multiple myeloma (MM) patients have age-, disease-, and treatment-related risk factors for cardiac events. We analyzed the 2006 to 2011 MarketScan database to determine whether the risk of cardiac events is greater in MM patients than in non-MM patients. Included were 1723 MM patients treated with corticosteroids and ≥ 3 drugs (bortezomib, immunomodulatory derivatives, and alkylating agents or anthracyclines). The index date (ID) was the date on which the 3-drug exposure criterion was met. Also included were 8615 age- and gender-matched non-MM patients (5:1). The distribution of non-MM patients' IDs matched that of the MM patients' IDs. Baseline was 6 months before the ID. The follow-up duration was from the ID to study end (ie, 2011 or end of enrollment or prescription drug coverage). Hazard ratios (HRs) and 95% confidence intervals (CIs) were adjusted for baseline variables when the univariate analyses showed a 10% difference. The median duration of observation was 9 months (range, 0-60 months) for MM patients and 19 months (range, 0-66 months) for non-MM patients. The risk of any cardiac event (HR, 2.2; 95% CI, 1.9-2.5), dysrhythmia (HR, 4.1; 95% CI, 3.5-4.8), congestive heart failure (HR, 2.9; 95% CI, 2.2-3.7), cardiomyopathy (HR, 2.6; 95% CI, 1.8-3.8), and conduction disorders (HR, 1.7; 95% CI, 1.2-2.5) was significantly greater for MM than for non-MM patients. The incidence of hypertensive or arterial events and ischemic heart disease was similar between the 2 groups. The present study provides the first known comparison of cardiac event risk in patients with MM versus age- and gender-matched patients without MM. The cardiac event risk was greater in MM patients with ≥ 3 previous drugs for any cardiac event, dysrhythmias, congestive heart failure, cardiomyopathy, and conduction disorders compared with patients without MM. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Efficacy of early switch from intravenous to oral antimicrobials in patients with aspiration pneumonia: A prospective observational study.

PubMed

Uni, Masahiro; Nishimura, Naoki; Yamano, Yasuhiko; Ishikawa, Genta; Kitamura, Atsushi; Tomishima, Yutaka; Jinta, Torahiko; Takahashi, Osamu; Deshpande, Gautam; Chohnabayashi, Naohiko

2015-09-01

Previous reports have documented the efficacy of an early switch from intravenous to oral antimicrobials in community-acquired pneumonia, but not aspiration pneumonia. Therefore, we assessed the feasibility and efficacy of these newly developed criteria for community-acquired pneumonia in patients with aspiration pneumonia. This prospective observational study included consecutive patients admitted with aspiration pneumonia over a 10-month period at St. Luke's International Hospital; we excluded patients that required intensive care. The criteria for an early switch were stability of vital signs (temperature ≤ 38 °C; respiratory rate ≤ 24 breaths/min; pulse rate ≤ 100 beats/min for >24 h) and a successful swallow evaluation (repetitive saliva swallowing test score ≥ 2; modified water swallowing test score ≥ 4). Our primary endpoint was successful completion of antimicrobial treatment 30 days after the switch, without reversion to intravenous antimicrobials. Our anticipated success rate was set as 60-75%, based on a previous study. Of the 70 patients admitted with aspiration pneumonia, 32 (45.7%) were excluded, and 38 (54.3%) met the inclusion criteria. Of these 38 patients, 29 (76.3%) met the switch criteria. The median duration of hospital stay for the included patients was 16 (5-30) days and 30 (12-68) days, respectively (P=0.03). Among patients who met the switch criteria, 26 (89.7%) completed oral treatment successfully while 3 (10.3%) reverted to intravenous antimicrobials. Approximately 75% of patients met the switch criteria; of these, nearly 90% underwent safe conversion to oral therapy. These results demonstrate the efficacy and feasibility of our switch criteria. Copyright © 2015. Published by Elsevier B.V.

Palliative care team visits. Qualitative study through participant observation.

PubMed

Alfaya Góngora, Maria Del Mar; Bueno Pernias, Maria José; Hueso Montoro, César; Guardia Mancilla, Plácido; Montoya Juárez, Rafael; García Caro, Maria Paz

2016-03-30

To describe the clinical encounters that occur when a palliative care team provides patient care and the features that influence these encounters and indicate whether they are favorable or unfavorable depending on the expectations and feelings of the various participants. A qualitative case study conducted via participant observation. A total of 12 observations of the meetings of palliative care teams with patients and families in different settings (home, hospital and consultation room) were performed. The visits were follow-up or first visits, either scheduled or on demand. Content analysis of the observation was performed. The analysis showed the normal follow-up activity of the palliative care unit that was focused on controlling symptoms, sharing information and providing advice on therapeutic regimens and care. The environment appeared to condition the patients' expressions and the type of patient relationship. Favorable clinical encounter conditions included kindness and gratitude. Unfavorable conditions were deterioration caused by approaching death, unrealistic family objectives and limited resources. Home visits from basic palliative care teams play an important role in patient and family well-being. The visits seem to focus on controlling symptoms and are conditioned by available resources.

Palliative care team visits. Qualitative study through participant observation

PubMed Central

Bueno Pernias, Maria José; Hueso Montoro, César; Guardia Mancilla, Plácido; Montoya Juárez, Rafael; García Caro, Maria Paz

2016-01-01

Objectives: To describe the clinical encounters that occur when a palliative care team provides patient care and the features that influence these encounters and indicate whether they are favorable or unfavorable depending on the expectations and feelings of the various participants. Methods: A qualitative case study conducted via participant observation. A total of 12 observations of the meetings of palliative care teams with patients and families in different settings (home, hospital and consultation room) were performed. The visits were follow-up or first visits, either scheduled or on demand. Content analysis of the observation was performed. Results: The analysis showed the normal follow-up activity of the palliative care unit that was focused on controlling symptoms, sharing information and providing advice on therapeutic regimens and care. The environment appeared to condition the patients' expressions and the type of patient relationship. Favorable clinical encounter conditions included kindness and gratitude. Unfavorable conditions were deterioration caused by approaching death, unrealistic family objectives and limited resources. Conclusion: Home visits from basic palliative care teams play an important role in patient and family well-being. The visits seem to focus on controlling symptoms and are conditioned by available resources. PMID:27226663

Use of an electronic patient portal among the chronically ill: an observational study.

PubMed

Riippa, Iiris; Linna, Miika; Rönkkö, Ilona; Kröger, Virpi

2014-12-08

Electronic patient portals may enhance effective interaction between the patient and the health care provider. To grasp the full potential of patient portals, health care providers need more knowledge on which patient groups prefer electronic services and how patients should be served through this channel. The objective of this study was to assess how chronically ill patients' state of health, comorbidities, and previous care are associated with their adoption and use of a patient portal. A total of 222 chronically ill patients, who were offered access to a patient portal with their health records and secure messaging with care professionals, were included in the study. Differences in the characteristics of non-users, viewers, and interactive users of the patient portal were analyzed before access to the portal. Patients' age, gender, diagnoses, levels of the relevant physiological measurements, health care contacts, and received physiological measurements were collected from the care provider's electronic health record. In addition, patient-reported health and patient activation were assessed by a survey. Despite the broad range of measures used to indicate the patients' state of health, the portal user groups differed only in their recorded diagnosis for hypertension, which was most common in the non-user group. However, there were significant differences in the amount of care received during the year before access to the portal. The non-user group had more nurse visits and more measurements of relevant physiological outcomes than viewers and interactive users. They also had fewer referrals to specialized care during the year before access to the portal than the two other groups. The viewers and the interactive users differed from each other significantly in the number of nurse calls received, the interactive users having more calls than the viewers. No significant differences in age, gender, or patient activation were detected between the user groups. Previous

Comparison of the medical students' perceived self-efficacy and the evaluation of the observers and patients.

PubMed

Ammentorp, Jette; Thomsen, Janus Laust; Jarbøl, Dorte Ejg; Holst, René; Øvrehus, Anne Lindebo Holm; Kofoed, Poul-Erik

2013-04-08

The accuracy of self-assessment has been questioned in studies comparing physicians' self-assessments to observed assessments; however, none of these studies used self-efficacy as a method for self-assessment. The aim of the study was to investigate how medical students' perceived self-efficacy of specific communication skills corresponds to the evaluation of simulated patients and observers. All of the medical students who signed up for an Objective Structured Clinical Examination (OSCE) were included. As a part of the OSCE, the student performance in the "parent-physician interaction" was evaluated by a simulated patient and an observer at one of the stations. After the examination the students were asked to assess their self-efficacy according to the same specific communication skills. The Calgary Cambridge Observation Guide formed the basis for the outcome measures used in the questionnaires. A total of 12 items was rated on a Likert scale from 1-5 (strongly disagree to strongly agree). We used extended Rasch models for comparisons between the groups of responses of the questionnaires. Comparisons of groups were conducted on dichotomized responses. Eighty-four students participated in the examination, 87% (73/84) of whom responded to the questionnaire. The response rate for the simulated patients and the observers was 100%. Significantly more items were scored in the highest categories (4 and 5) by the observers and simulated patients compared to the students (observers versus students: -0.23; SE:0.112; p=0.002 and patients versus students:0.177; SE:0.109; p=0.037). When analysing the items individually, a statistically significant difference only existed for two items. This study showed that students scored their communication skills lower compared to observers or simulated patients. The differences were driven by only 2 of 12 items. The results in this study indicate that self-efficacy based on the Calgary Cambridge Observation guide seems to be a reliable

Morphological and functional changes of chronic pancreatitis in patients with dyspepsia: A prospective, observational, cross-sectional study.

PubMed

Lariño-Noia, José; de la Iglesia, Daniel; Iglesias-García, Julio; Macías, Fernando; Nieto, Laura; Bastón, Iria; Villalba, Carmen; Domínguez-Muñoz, J Enrique

2018-04-01

Whether chronic pancreatitis (CP) may present with dyspepsia is controversial. We aimed at evaluating the frequency and risk factors of changes of CP in patients presenting with epigastric pain syndrome (EPS)-like symptoms. A prospective, observational, cross-sectional study was carried out in patients with EPS-like symptoms. Patients underwent endoscopic ultrasound (EUS) evaluation of the pancreas, and changes of CP were defined as the presence of five or more EUS criteria of the disease. In patients with 3 or 4 EUS criteria, magnetic resonance dynamic evaluation of the pancreas (MRI/sMRCP) and endoscopic pancreatic function test (ePFT) were carried out to confirm or exclude the presence of changes of CP. A multivariate logistic regression analysis was performed to evaluate factors associated with CP findings, and results are shown as odds ratio (OR) and 95% confidence interval (CI). 213 patients were included. Changes of CP were confirmed by EUS (≥5 criteria) in 18 patients (8.4%). Thirty-four patients had 3-4 EUS criteria, and changes of CP were confirmed in 27 of them by MRI/sMRCP and ePFT (12.7%). Morphological and functional findings of CP were then present in 45 patients (21.1%). Male gender (OR 2.97; 95%CI 1.39-6.37) and alcohol and tobacco consumption (OR 6.56; 95%CI 1.97-21.85) were associated with the presence of changes of CP. Morphological and functional changes of CP are frequent in patients with EPS-like symptoms. Whether these pancreatic changes explain EPS-like symptoms requires further investigation. Copyright © 2018 IAP and EPC. Published by Elsevier B.V. All rights reserved.

Shared decision-making in older patients with colorectal or pancreatic cancer: Determinants of patients' and observers' perceptions.

PubMed

Geessink, Noralie H; Ofstad, Eirik H; Olde Rikkert, Marcel G M; van Goor, Harry; Kasper, Jürgen; Schoon, Yvonne

2018-06-13

To identify determinants of older patients' perceptions of involvement in decision-making on colorectal (CRC) or pancreatic cancer (PC) treatment, and to compare these with determinants of observers' perceptions. Patients' perceptions of involvement were constructed by the 9-item SDM questionnaire (SDM-Q-9) and a Visual Analogue Scale for Involvement (VAS-I). Observers' perceptions were constructed by the OPTION5, OPTION12, and MAPPIN'SDM. Convergent validities were calculated between the patient-sided and observer instruments using Spearman's correlation coefficient. Linear regression was used to identify determinants per criterion. 58 CRC and 22 PC patients were included (mean age: 71.8 ± 5.2 years, 45.0% female). No significant correlations were found between the patient-sided and observer instruments. Patients' impression of involvement was influenced by patient characteristics such as quality of life and satisfaction, while observers' perceptions mainly referred to encounter characteristics such as the mean duration of consultations and general communication skills. Due to evident differences in determinants, older CRC/PC patients' and observers' perceptions of involvement should both be collected in evaluating the quality of medical decision-making. General communication skills should be integrated in SDM training interventions. New SDM measurement tools for patients are needed to sufficiently discriminate between the constructs of involvement and satisfaction. Copyright © 2018 Elsevier B.V. All rights reserved.

Predictors of survival in critically ill patients with acute respiratory distress syndrome (ARDS): an observational study.

PubMed

Balzer, Felix; Menk, Mario; Ziegler, Jannis; Pille, Christian; Wernecke, Klaus-Dieter; Spies, Claudia; Schmidt, Maren; Weber-Carstens, Steffen; Deja, Maria

2016-11-08

Currently there is no ARDS definition or classification system that allows optimal prediction of mortality in ARDS patients. This study aimed to examine the predictive values of the AECC and Berlin definitions, as well as clinical and respiratory parameters obtained at onset of ARDS and in the course of the first seven consecutive days. The observational study was conducted at a 14-bed intensive care unit specialized on treatment of ARDS. Predictive validity of the AECC and Berlin definitions as well as P a O 2 /F i O 2 and F i O 2 /P a O 2 *P mean (oxygenation index) on mortality of ARDS patients was assessed and statistically compared. Four hundred forty two critically-ill patients admitted for ARDS were analysed. Multivariate Cox regression indicated that the oxygenation index was the most accurate parameter for mortality prediction. The third day after ARDS criteria were met at our hospital was found to represent the best compromise between earliness and accuracy of prognosis of mortality regarding the time of assessment. An oxygenation index of 15 or greater was associated with higher mortality, longer length of stay in ICU and hospital and longer duration of mechanical ventilation. In addition, non-survivors had a significantly longer length of stay and duration of mechanical ventilation in referring hospitals before admitted to the national reference centre than survivors. The oxygenation index is suggested to be the most suitable parameter to predict mortality in ARDS, preferably assessed on day 3 after admission to a specialized centre. Patients might benefit when transferred to specialized ICU centres as soon as possible for further treatment.

A prospective, observational, open-label, multicentre study to investigate the daily treatment practice of ranibizumab in patients with neovascular age-related macular degeneration.

PubMed

van Asten, Freekje; Evers-Birkenkamp, Kim U; van Lith-Verhoeven, Janneke J C; de Jong-Hesse, Yvonne; Hoppenreijs, Vincent P T; Hommersom, Richard F; Scholten, Agnes M; Hoyng, Carel B; Klaver, Johannes H J

2015-03-01

The HELIOS (Health Economics with Lucentis in Observational Settings) study was designed on request of the Dutch Health Authority for an observational study to assess the effectiveness and safety of ranibizumab for neovascular age-related macular degeneration (wet AMD) in daily practice. The HELIOS study was a 2-year prospective, observational, open-label, multicentre study involving 14 sites. Patients with wet AMD were enrolled and observed for a period of 24 months. The data were collected at baseline and at the visits closest around the time-points 3, 6, 12, 18 and 24 months after inclusion. Treatment with ranibizumab resulted in prevention of vision loss. The mean ETDRS score increased from 45.1 letters at baseline to 48.5 letters at 24 months. This was achieved with a mean of 7.8 injections over 24 months. Stabilization of visual acuity was also reflected by the scores on the quality of life EQ-5D questionnaire, which did not significantly change over the study period. The more subjective EQ-VAS questionnaire showed an overall improvement. The VFQ-25 questionnaire was also mostly stable over time. After 24 months, 32.2% of the patients gained ≥1 letter and 17.1% gained >15 letters. Patients completing the loading phase were better responders, as demonstrated by increased long-term visual acuity. In addition, ranibizumab was well tolerated and had a safety profile commonly seen in routine clinical practice. This study demonstrates that also in daily practice ranibizumab was effective in preventing vision loss over a period of 24 months. No new safety findings were identified. © 2014 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

Challenges in translating endpoints from trials to observational cohort studies in oncology

PubMed Central

Ording, Anne Gulbech; Cronin-Fenton, Deirdre; Ehrenstein, Vera; Lash, Timothy L; Acquavella, John; Rørth, Mikael; Sørensen, Henrik Toft

2016-01-01

Clinical trials are considered the gold standard for examining drug efficacy and for approval of new drugs. Medical databases and population surveillance registries are valuable resources for post-approval observational research, which are increasingly used in studies of benefits and risk of new cancer drugs. Here, we address the challenges in translating endpoints from oncology trials to observational studies. Registry-based cohort studies can investigate real-world safety issues – including previously unrecognized concerns – by examining rare endpoints or multiple endpoints at once. In contrast to clinical trials, observational cohort studies typically do not exclude real-world patients from clinical practice, such as old and frail patients with comorbidity. The observational cohort study complements the clinical trial by examining the effectiveness of interventions applied in clinical practice and by providing evidence on long-term clinical outcomes, which are often not feasible to study in a clinical trial. Various endpoints can be included in clinical trials, such as hard endpoints, soft endpoints, surrogate endpoints, and patient-reported endpoints. Each endpoint has it strengths and limitations for use in research studies. Endpoints used in oncology trials are often not applicable in observational cohort studies which are limited by the setting of standard clinical practice and by non-standardized endpoint determination. Observational studies can be more helpful moving research forward if they restrict focus to appropriate and valid endpoints. PMID:27354827

Generic versus branded medicines: An observational study among patients with chronic diseases attending a public hospital outpatient department

PubMed Central

Das, Manisha; Choudhury, Supriyo; Maity, Somnath; Hazra, Avijit; Pradhan, Tirthankar; Pal, Aishee; Roy, Ranendra Kumar

2017-01-01

Background: The concept of generic prescription is widely accepted in various parts of the world. Nevertheless, it has failed to gain popularity in India due to factors such as nonavailability and distrust on the product quality. However, since 2012, the Government of West Bengal, India, has initiated exclusive generic drug outlets called “fair price medicine shop” (FPMS) inside the government hospital premises in a “public-private-partnership” model. This study was undertaken to evaluate the experience and attitude of patients who were consuming generic drugs purchased from these FPMS. Materials and Methods: It was a questionnaire-based cross-sectional study where we have interviewed 100 patients each consuming generic and branded drugs, respectively. The perceived effectiveness, reported safety, medication adherence, cost of therapy, and availability of drugs was compared between two mentioned groups. Medication adherence was estimated through Drug Attitude Inventory-10. Results: 93% of generic and 87% branded drug users believed that their drugs were effective (P = 0.238) in controlling their ailments. No significant difference (9% generic, 10% branded drug users, P = 1.000) was observed in reported adverse effects between generic and branded drug users. 82% and 77% of patients were adherent generic and branded drugs, respectively (P = 0.289). As expected, a significantly lower cost of generic drugs was observed compared to its branded counterpart. Conclusion: The policy of FPMS implemented by the Government of West Bengal, India appeared to be promising in terms of perceived effectiveness, safety, and adherence of generic drugs from FPMS compared to drugs purchased from open market retailers. Therefore, this study might act as an impetus for the policy-makers to initiate similar models across the country. PMID:28250671

Patient-centered and clinical outcomes of mandibular overdentures retained with the locator system: A prospective observational study.

PubMed

Fernandez-Estevan, Lucia; Montero, Javier; Selva Otaolaurruchi, Eduardo J; Sola Ruiz, Fernanda

2017-03-01

Whether clinical or demographic variables affect the perception of treatment in terms of quality of life and satisfaction is unknown. The purpose of this prospective study was to make an evidence-based assessment of the treatment outcomes (patient- and clinically based) of locator-retained mandibular overdentures. This prospective observational study assessed patients with edentulism who had worn mandibular overdentures supported by 2 implants and retained by the locator system for at least 1 year of functional life (N=80). Medical histories were reviewed, and patients underwent oral examinations. Prosthetic clinical outcomes and patient well-being were registered using the Oral Health Impact Profile 20 (OHIP-20) and Oral Satisfaction Scale (OSS). Patient well-being scored an overall OHIP-20 score of 19.0 ±14.0 of 80 (the higher the score, the greater the impact and the worse the oral health-related quality of life); overall oral satisfaction was 8.3 ±1.7 of 10. Women suffered greater social impact (0.8 ±1.0) and disability (0.4 ±0.8) than men (0.4 ±0.7 versus 0.2 ±0.4, respectively). Impact on well-being was inversely proportional to both patient age and the age of the prosthesis (r=-0.25; P<.01). Implants had been placed on average 73.6 ±39.2 months previously, showing a survival rate of 82.5%. Most of the overdentures had been functioning for over 60 months. Relining (46.3%), readjustments (82.5%), and changes of nylon retention (1.5 ±1.8 per patient over 60 months of use) devices negatively influenced well-being. Mandibular overdentures produced good results with regard to quality of life and oral satisfaction, but attention should be paid to factors affecting clinical outcomes and patient well-being. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Zonisamide in Brain Tumor-Related Epilepsy: An Observational Pilot Study.

PubMed

Maschio, Marta; Dinapoli, Loredana; Zarabla, Alessia; Maialetti, Andrea; Giannarelli, Diana; Fabi, Alessandra; Vidiri, Antonello; Cantelmi, Tonino

Epilepsy heavily affects the quality of life (QoL) of patients with brain tumor because in addition to taking treatments for the oncological illness, patients are required to live with the long-term taking of antiepileptic drugs (AEDs). The AEDs' adverse effects are common in these patients and can negatively influence their perceptions of their QoL.We conducted an observational pilot study in patients with brain tumor-related epilepsy to verify efficacy, tolerability, and impact on QoL and global neurocognitive performances of zonisamide (ZNS) in add-on. We recruited 13 patients (5 females, 8 males; mean age, 49.6 years) presenting uncontrolled seizures. At first visit and at final follow-up at 6 months, patients underwent neurological examination, evaluation of adverse events, and cognitive and QoL tests. A seizure diary was given. Eight patients underwent chemotherapy, 3 underwent radiotherapy, and 5 had disease progression. Mean dosage of ZNS at final follow-up was 300 mg/d.Of 9 patients who reached the sixth month follow-up, the mean weekly seizure number before ZNS had been 3.2 ± 5.0, and at final follow-up, the mean weekly seizure number was 0.18 ± 0.41 (P = 0.05).Compared with baseline, we observed stability in all cognitive domains, except for verbal fluency that significantly worsened.Results on QoL tests showed that QoL remained unchanged over time, which could indicate that ZNS did not influence the patients' perceived QoL. Zonisamide as add-on in our patients seems to be well tolerated and efficacious in controlling seizures. Despite having limitations represented by the fact that our study is observational, with a small study population and a short follow-up period, our results confirm that when choosing an AED, in addition to efficacy, the drug's effect on patients' QoL also needs to be considered, especially for patients facing many psychosocial challenges, such as those with brain tumor-related epilepsy.

Comparison of case fatality in south Asian and white patients after acute myocardial infarction: observational study.

PubMed

Wilkinson, P; Sayer, J; Laji, K; Grundy, C; Marchant, B; Kopelman, P; Timmis, A D

1996-05-25

To compare mortality in south Asian (Indian, Pakistani, and Bangladeshi) and white patients in the six months after hospital admission for acute myocardial infarction. Observational study. District general hospital in east London. 149 south Asian and 313 white patients aged < 65 years admitted to the coronary care unit with acute myocardial infarction from 1 December 1988 to 31 December 1992. All cause mortality in the first six months after myocardial infarction. The admission rate in the south Asians was estimated to be 2.04 times that in the white patients. Most aspects of treatment were similar in the two groups, except that a higher proportion of the south Asians received thrombolytic drugs (81.2% v 73.8%). After adjustment for age, sex, previous myocardial infarction, and treatment with thrombolysis or aspirin, or both, the south Asians had a poorer survival over the six months from myocardial infarction (hazard ratio 2.02 (95% confidence interval 1.14 to 3.56), P = 0.018), but a substantially higher proportion were diabetic (38% v 11%, P < 0.001), and additional adjustment for diabetes removed much of their excess risk (adjusted hazard ratio 1.26 (0.68 to 2.33), P = 0.47). South Asian patients had a higher risk of admission with myocardial infarction and a higher risk of death over the ensuing six months than the white patients. The higher case fatality among the south Asians, largely attributable to diabetes, may contribute to the increased risk of death from coronary heart disease in south Asians living in Britain.

Daily pilates exercise or inactivity for patients with low back pain: a clinical prospective observational study.

PubMed

Notarnicola, A; Fischetti, F; Maccagnano, G; Comes, R; Tafuri, S; Moretti, B

2014-02-01

Studies have shown the effectiveness of a few weekly pilates sessions as helping to reduce lower back pain (LBP). However many patients fear that physical activity can actually make the pain and disability worse. We carried out this observational prospective clinical study to look at the effects that taking part in daily pilates has one on side and on the other the effects of LBP management without physical exercise. The volunteers who participated in this study were recruited from among some local cultural associations. Patients affected by LBP were evaluated. The subjects were 60 volunteers (27 males and 33 females) with a mean age of 51.2 years who had chronic low back pain (CLBP). They were allocated to pilates group (N.=30) or inactivity control group (N.=30). The pilates group performed one-hour lesson of pilates exercise, 5 lessons per week during the following 6 months. The inactivity group continued with their normal daily activities. The Roland-Morris Disability, the Oswestry, the SF-36 and the Spinal Functional Sort Questionaries of all subjects were measured at the baseline (T1) and at 6 months (T2). At T2 improvements were observed in the pilates group with increases in physical and social functioning, general health and vitality (P<0.05) and decreases in disability and pain (P<0.05). The inactivity group showed worsening in the same measures at T2. We found an important improvement of pain, disability and physical and psychological perception of health in individuals who did the daily sessions of pilates. Some authors underlined the possible risk of a lack of adherence to an exercise program at home. This study suggests that a daily pilates program is effective for the management of CLBP. On the other hand, the inactivity contributes to further worsening, inducing a vicious cycle in which pain and physical activity intolerance follow each other.

A real-world observational cohort of patients with primary biliary cholangitis: TARGET-primary biliary cholangitis study design and rationale.

PubMed

Levy, Cynthia; Bowlus, Christopher L; Carey, Elizabeth; Crawford, Julie M; Deane, Karen; Mayo, Marlyn J; Kim, W Ray; Fried, Michael W

2018-05-01

Primary biliary cholangitis (PBC) is a rare chronic cholestatic liver disease that may progress to biliary cirrhosis if left untreated. The first-line therapy for PBC is ursodeoxycholic acid (UDCA). Unfortunately, 1 of 3 patients does not respond to UDCA. These patients are at risk for developing clinical events, including cirrhosis, complications of portal hypertension, hepatocellular carcinoma, liver transplant, or death. Recently, the U.S. Food and Drug Administration approved obeticholic acid to be used in certain patients with PBC. Off-label therapies are also used, and several other therapies are currently under evaluation. Real-world effectiveness of newly approved and off-label therapies remains unknown. TARGET-PBC is a 5-year, longitudinal, observational study of patients with PBC that will evaluate the effectiveness of clinical practice interventions and provide practical information unobtainable in registration trials. Enrollment will take place at both academic and community sites. In addition to consenting to medical records review, participants will be asked to provide an annual blood sample and complete patient reported outcome surveys at predetermined intervals. Any available liver biopsies will be digitally preserved. Conclusion: Key study outcomes will be the evaluation of the safety and effectiveness of PBC interventions and the assessment of disease progression under real-world conditions. ( Hepatology Communications 2018;2:484-491).

A global patient outcomes registry: Cochlear paediatric implanted recipient observational study (Cochlear(™) P-IROS).

PubMed

Sanderson, Georgina; Ariyaratne, Thathya V; Wyss, Josephine; Looi, Valerie

2014-01-01

Currently, there is a paucity of data concerning the long-term outcomes, educational placement and quality of life of children implanted with hearing devices from large and representative samples of the population. To address this concern, a large, prospective, multicentre, multinational patient-outcomes registry for paediatric recipients of implantable hearing devices was developed. The benefits of this registry, its approach and methodology are described. The Cochlear(™) Paediatric Implanted Recipient Observational Study (Cochlear P-IROS) is a prospective international patient-outcomes registry for children who are implanted in routine clinical practice with one or more hearing devices. The study aims to collect data on patient comorbidities, device use, auditory performance, quality of life and health-related utilities, across different types of implantable hearing devices from a range of manufacturers. Patients will be evaluated with a set of standardised and non-standardised questionnaires prior to initial device activation (baseline) and at six-monthly follow-up intervals up to 24 months and annually thereafter. The Cochlear P-IROS utilises a secure web interface to administer electronic case report forms to clinicians and families of implanted children. The web interface is currently available in five languages: English, Japanese, Korean, Mandarin and Russian. The interface also provides printable versions of the case report forms translated into 22 local languages for collection of data prior to entry online; additional languages may be added, as required. Participation in the Cochlear P-IROS registry is investigator-driven and voluntary. To date, the Cochlear P-IROS has recruited implant clinics across Australia, China, India, Indonesia, Turkey and Vietnam. The registry also aims to recruit multiple clinics in Cuba, Israel, Japan, Malaysia, Singapore, South Africa, South Korea and Russia. The use of a registry such as the Cochlear P-IROS will generate

Use of cumulative mortality data in patients with acute myocardial infarction for early detection of variation in clinical practice: observational study.

PubMed

Lawrance, R A; Dorsch, M F; Sapsford, R J; Mackintosh, A F; Greenwood, D C; Jackson, B M; Morrell, C; Robinson, M B; Hall, A S

2001-08-11

Use of cumulative mortality adjusted for case mix in patients with acute myocardial infarction for early detection of variation in clinical practice. Observational study. 20 hospitals across the former Yorkshire region. All 2153 consecutive patients with confirmed acute myocardial infarction identified during three months. Variable life-adjusted displays showing cumulative differences between observed and expected mortality of patients; expected mortality calculated from risk model based on admission characteristics of age, heart rate, and systolic blood pressure. The performance of two individual hospitals over three months was examined as an example. One, the smallest district hospital in the region, had a series of 30 consecutive patients but had five more deaths than predicted. The variable life-adjusted display showed minimal variation from that predicted for the first 15 patients followed by a run of unexpectedly high mortality. The second example was the main tertiary referral centre for the region, which admitted 188 consecutive patients. The display showed a period of apparently poor performance followed by substantial improvement, where the plot rose steadily from a cumulative net lives saved of -4 to 7. These variations in patient outcome are unlikely to have been revealed during conventional audit practice. Variable life-adjusted display has been integrated into surgical care as a graphical display of risk-adjusted survival for individual surgeons or centres. In combination with a simple risk model, it may have a role in monitoring performance and outcome in patients with acute myocardial infarction.

Nursing workload, patient safety incidents and mortality: an observational study from Finland

PubMed Central

Kinnunen, Marina; Saarela, Jan

2018-01-01

Objective To investigate whether the daily workload per nurse (Oulu Patient Classification (OPCq)/nurse) as measured by the RAFAELA system correlates with different types of patient safety incidents and with patient mortality, and to compare the results with regressions based on the standard patients/nurse measure. Setting We obtained data from 36 units from four Finnish hospitals. One was a tertiary acute care hospital, and the three others were secondary acute care hospitals. Participants Patients’ nursing intensity (249 123 classifications), nursing resources, patient safety incidents and patient mortality were collected on a daily basis during 1 year, corresponding to 12 475 data points. Associations between OPC/nurse and patient safety incidents or mortality were estimated using unadjusted logistic regression models, and models that adjusted for ward-specific effects, and effects of day of the week, holiday and season. Primary and secondary outcome measures Main outcome measures were patient safety incidents and death of a patient. Results When OPC/nurse was above the assumed optimal level, the adjusted odds for a patient safety incident were 1.24 (95% CI 1.08 to 1.42) that of the assumed optimal level, and 0.79 (95% CI 0.67 to 0.93) if it was below the assumed optimal level. Corresponding estimates for patient mortality were 1.43 (95% CI 1.18 to 1.73) and 0.78 (95% CI 0.60 to 1.00), respectively. As compared with the patients/nurse classification, models estimated on basis of the RAFAELA classification system generally provided larger effect sizes, greater statistical power and better model fit, although the difference was not very large. Net benefits as calculated on the basis of decision analysis did not provide any clear evidence on which measure to prefer. Conclusions We have demonstrated an association between daily workload per nurse and patient safety incidents and mortality. Current findings need to be replicated by future studies. PMID

Evaluation of the Effect of Aneurysmal Clipping on Electrocardiography and Echocardiographic Changes in Patients With Subarachnoid Hemorrhage: A Prospective Observational Study.

PubMed

Jangra, Kiran; Grover, Vinod K; Bhagat, Hemant; Bhardwaj, Avanish; Tewari, Manoj K; Kumar, Bhupesh; Panda, Nidhi B; Sahu, Seelora

2017-07-01

Electrocardiographic (ECG) and echocardiographic changes that are subsequent to aneurysmal subarachnoid hemorrhage (a-SAH) are commonly observed with a prevalence varying from 27% to 100% and 13% to 18%, respectively. There are sparse data in the literature about the pattern of ECG and echocardiographic changes in patients with SAH after clipping of the aneurysm. Hence, we observed the effect of aneurysmal clipping on ECG and echocardiographic changes during the first week after surgery, and the impact of these changes on outcome at the end of 1 year. This prospective, observational study was conducted in 100 consecutive patients with a-SAH undergoing clipping of ruptured aneurysm. ECG and echocardiographic changes were recorded preoperatively and every day after surgery until 7 days. Outcome was evaluated using the Glasgow outcome scale at the end of 1 year. Of 100 patients, 75 had ECG changes and 17 had echocardiographic changes preoperatively. The ECG changes observed were QTc prolongation, conduction defects, ST-wave and T-wave abnormalities, tachyarrhythmias, and bradyarrhythmias. The echocardiography changes included global hypokinesia and regional wall motion abnormalities. Both echocardiographic and ECG changes showed significant recovery on the first postoperative day. Patients presenting with both echocardiographic and ECG changes were found to require higher ionotropic support to maintain the desired blood pressure, and were associated with poor outcome (Glasgow outcome scale, 1 to 2) at 1 year after surgery. There was no association of ECG and echocardiographic changes with mortality (both in-hospital or at 1 year). The ECG changes, such as QTc prolongation, bradycardia, conduction abnormality, and echocardiographic changes, recover on postoperative day-1, in most of the cases after clipping. Patients with combined ECG and echocardiographic changes tend to have poor neurological outcome at the end of 1 year.

Health beliefs toward cardiovascular risk reduction in patients admitted to chest pain observation units.

PubMed

Katz, David A; Graber, Mark; Birrer, Emily; Lounsbury, Patricia; Baldwin, Austin; Hillis, Stephen L; Christensen, Alan J

2009-05-01

Even after acute coronary syndrome (ACS) is ruled out, observational studies have suggested that many patients with nonspecific chest pain have a high burden of cardiovascular risk factors (CRFs) and are at increased long-term risk of ischemic heart disease (IHD)-related mortality. The aim of this study was to evaluate the premise that evaluation in an observation unit for symptoms of possible ACS is a "teachable moment" with regard to modification of CRFs. The authors conducted a baseline face-to-face interview and a 3-month telephone interview of 83 adult patients with at least one modifiable CRF who presented with symptoms of possible ACS to an academic medical center. Existing questionnaires were adapted to measure Health Belief Model (HBM) constructs for IHD. Stage of change and self-reported CRF-related behaviors (diet, exercise, and smoking) were assessed using previously validated measures. The paired t-test or signed rank test was used to compare baseline and 3-month measures of health behavior within the analysis sample. Of the 83 study patients, 45 and 40% reported having received clinician advice regarding diet and physical activity during the observation unit encounter, respectively; 69% of current smokers received advice to quit smoking. Patients reported lower susceptibility to IHD (13.3 vs. 14.0, p = 0.06) and greater perceived benefit of healthy lifestyles (27.5 vs. 26.4, p = 0.0003) at 3-month follow-up compared to baseline. Patients also reported greater readiness to change and improved self-reported behaviors at follow-up (vs. baseline): decreased intake of saturated fat (10.1% vs. 10.5% of total calories, p = 0.005), increased fruit and vegetable intake (4.0 servings/day vs. 3.6 servings/day, p = 0.01), and fewer cigarettes (13 vs. 18, p = 0.002). Observed changes in IHD health beliefs and CRF-related behaviors during follow-up support the idea that observation unit admission is a teachable moment. Patients with modifiable risk factors may

Clinical decision making in dermatology: observation of consultations and the patients' perspectives.

PubMed

Hajjaj, F M; Salek, M S; Basra, M K A; Finlay, A Y

2010-01-01

Clinical decision making is a complex process and might be influenced by a wide range of clinical and non-clinical factors. Little is known about this process in dermatology. The aim of this study was to explore the different types of management decisions made in dermatology and to identify factors influencing those decisions from observation of consultations and interviews with the patients. 61 patient consultations were observed by a physician with experience in dermatology. The patients were interviewed immediately after each consultation. Consultations and interviews were audio recorded, transcribed and their content analysed using thematic content analysis. The most common management decisions made during the consultations included: follow-up, carrying out laboratory investigation, starting new topical treatment, renewal of systemic treatment, renewal of topical treatment, discharging patients and starting new systemic treatment. Common influences on those decisions included: clinical factors such as ineffectiveness of previous therapy, adherence to prescribing guidelines, side-effects of medications, previous experience with the treatment, deterioration or improvement in the skin condition, and chronicity of skin condition. Non-clinical factors included: patient's quality of life, patient's friends or relatives, patient's time commitment, travel or transportation difficulties, treatment-related costs, availability of consultant, and availability of treatment. The study has shown that patients are aware that management decisions in dermatology are influenced by a wide range of clinical and non-clinical factors. Education programmes should be developed to improve the quality of decision making. Copyright © 2010 S. Karger AG, Basel.

Health Instruction Packages: Nursing--Patient Observation and Assessment.

ERIC Educational Resources Information Center

Cooper, Freda; And Others

Text, illustrations, and exercises are utilized in this set of three learning modules to instruct nurses and nursing students in patient observation and assessment skills. The first module, "The ABC's of Observation" by Freda Cooper, provides psychiatric nurses and technicians with guidelines for determining the mental status of incoming…

Withdrawal of antiepileptic drugs in glioma patients after long-term seizure freedom: design of a prospective observational study.

PubMed

Koekkoek, Johan A F; Kerkhof, Melissa; Dirven, Linda; Heimans, Jan J; Postma, Tjeerd J; Vos, Maaike J; Bromberg, Jacoline E C; van den Bent, Martin J; Reijneveld, Jaap C; Taphoorn, Martin J B

2014-08-15

Epilepsy is common in patients with a glioma. Antiepileptic drugs (AEDs) are the mainstay of epilepsy treatment, but may cause side effects and may negatively impact neurocognitive functioning and quality of life. Besides antiepileptic drugs, anti-tumour treatment, which currently consists of surgery, radiotherapy and/or chemotherapy, may contribute to seizure control as well. In glioma patients with seizure freedom after anti-tumour therapy the question emerges whether AEDs should be continued, particularly in the case where anti-tumour treatment has been successful. We propose to explore the possibility of AED withdrawal in glioma patients with long-term seizure freedom after anti-tumour therapy and without signs of tumour progression. We initiate a prospective, observational study exploring the decision-making process on the withdrawal or continuation of AEDs in low-grade and anaplastic glioma patients with stable disease and prolonged seizure freedom after anti-tumour treatment, and the effects of AED withdrawal or continuation on seizure freedom. We recruit participants through the outpatient clinics of three tertiary referral centers for brain tumour patients in The Netherlands. The patient and the treating physician make a shared decision to either withdraw or continue AED treatment. Over a one-year period, we aim to include 100 glioma patients. We expect approximately half of the participants to be willing to withdraw AEDs. The primary outcome measures are: 1) the outcome of the shared-decision making on AED withdrawal or continuation, and decision related arguments, and 2) seizure freedom at 12 months and 24 months of follow-up. We will also evaluate seizure type and frequency in case of seizure recurrence, as well as neurological symptoms, adverse effects related to AED treatment or withdrawal, other anti-tumour treatments and tumour progression. This study addresses two issues that are currently unexplored. First, it will explore the willingness to

Comparison of outcomes after use of biphasic or monophasic defibrillators among out-of-hospital cardiac arrest patients: a nationwide population-based observational study.

PubMed

Tanabe, Seizan; Yasunaga, Hideo; Ogawa, Toshio; Koike, Soichi; Akahane, Manabu; Horiguchi, Hiromasa; Hatanaka, Tetsuo; Yokota, Hiroyuki; Imamura, Tomoaki

2012-09-01

The use and popularity of the biphasic waveform defibrillator as a replacement for the monophasic waveform defibrillator are increasing, but it is unclear whether this can improve the rate of survival among out-of-hospital cardiac arrest patients. This study aimed to verify the hypothesis that the outcome of out-of-hospital cardiac arrest patients who received defibrillation shock with the biphasic waveform defibrillator was better than that of patients who received defibrillation shock with the monophasic defibrillator. This prospective, nationwide, population-based, observational study included 21 172 out-of-hospital cardiac arrest patients with initial ventricular fibrillation or pulseless ventricular tachycardia from January 1, 2005, through December 31, 2007. Defibrillation shock was performed by monophasic defibrillator on 8224 (39%) patients and by biphasic defibrillator on 12 948 (61%) patients. The rate of survival at 1 month with minimal neurological impairment was 11.6% (951/8192) in the monophasic defibrillator group and 12.8% (1653/12 928) in the biphasic defibrillator group. Hierarchical logistic regression analysis using a generalized estimation equation showed no significant difference between the biphasic and monophasic groups in 1-month survival with minimal neurological impairment (adjusted odds ratio, 1.07; 95% confidence interval, 0.91-1.26; P=0.42). Confirmatory propensity score analyses showed similar results. Although monophasic defibrillators are being replaced by biphasic defibrillators, our nationwide population-based observational study failed to demonstrate a statistically significant association between defibrillation waveform and 1-month survival rate with minimal neurological impairment.

Impact of acute bleeding on daily activities of patients with congenital hemophilia with inhibitors and their caregivers and families: observations from the Dosing Observational Study in Hemophilia (DOSE).

PubMed

Recht, Michael; Neufeld, Ellis J; Sharma, Vivek R; Solem, Caitlyn T; Pickard, A Simon; Gut, Robert Z; Cooper, David L

2014-09-01

There is limited understanding of the effects of bleeding episodes on the daily lives of patients with congenital hemophilia with inhibitors and their caregivers. This analysis of the Dosing Observational Study in Hemophilia examined the impact of acute bleeding episodes on work, school, and family activities. Patients and caregivers participated in a diary study for 90 or more days or until patients experienced four bleeding episodes. All bleed treatments, interference with daily activities, and quality-of-life assessments were captured in daily records. Patients and caregivers reported planned workdays or school days eligible to be "lost" so as to differentiate from days lost because of disability or nonworking status, weekends, and vacations. Diaries were completed for 39 patients (18 adults and 21 children). Bleeding episodes that continued for 3 or more days (16.4%) accounted for most of the major changes to family plans. For the 38 patients with bleeding episodes, 47% of 491 bleed days fell on planned workdays or school days; the remainder fell on weekends, holidays, or nonworkdays or non-school days and therefore did not count as "lost days." Patients reported a loss of productivity on a greater percentage of eligible bleed days than did caregivers (3.9% vs. 0.8%, respectively). Patients and caregivers reported 13.5%/9.3% fully missed and 3.5%/7.6% partially missed days. This study demonstrated that in hemophilia with inhibitors, bleeding episodes interfere with the daily activities of patients and their caregivers. Furthermore, documenting only lost days underestimated the impact of bleeding episodes because of the high percentage of days without planned work or school. Copyright © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Hand hygiene compliance in transplant and other special patient groups: an observational study.

PubMed

Graf, Karolin; Ott, Ella; Wolny, Michael; Tramp, Nadine; Vonberg, Ralf-Peter; Haverich, Axel; Chaberny, Iris Freya

2013-06-01

This study evaluates hand hygiene behavior of health care workers in a German university hospital stratified for treatment of special patient groups (eg, transplant patients). From 2008 to 2010, comprehensive education and training of all health care workers was implemented to improve hand hygiene compliance. Consumption rates of alcohol-based hand rub and gloves were collected and evaluated. Of the 5,647 opportunities of hand disinfection evaluated, 1,607 occurred during care for transplant patients. To our knowledge, this is the largest survey of hand hygiene compliance in special patient groups on intensive care units in a university hospital in Germany. Health care workers on surgical intensive care units showed lower hand hygiene compliance compared with health care workers on other types of intensive care units. Compliance toward hand hygiene was significantly higher on hemato-oncologic and pediatric wards. In general, hand disinfection was performed significantly more frequently after an intervention than before (P < .05, 95% confidence interval: 1.24-1.84). Overall, there was no significant difference in hand hygiene compliance when caring for transplant patients or other patients (odds ratio, 1.16; 95% confidence interval: 0.95-1.42). Nurse's and physician's hand hygiene compliance improved because of education. Hand hygiene compliance is not increased in the care for transplant patients (despite their predisposition for nosocomial infections) compared with other patients. Additional studies will be necessary to further investigate these findings. Copyright © 2013 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Mosby, Inc. All rights reserved.

Hospitalization and survival in patients using epoprostenol for injection in the PROSPECT observational study.

PubMed

Frantz, Robert P; Schilz, Robert J; Chakinala, Murali M; Badesch, David B; Frost, Adaani E; McLaughlin, Vallerie V; Barst, Robyn J; Rosenberg, Daniel M; Miller, Dave P; Hartline, Brian K; Benton, Wade W; Farber, Harrison W

2015-02-01

Few studies have prospectively reported outcomes in patients with pulmonary arterial hypertension (PAH) treated with epoprostenol in the modern-day era of oral therapy and combination treatments. The Registry to Prospectively Describe Use of Epoprostenol for Injection (Veletri, prolonged room temperature stable-epoprostenol [RTS-Epo]) in Patients with Pulmonary Arterial Hypertension (PROSPECT) was established to prospectively describe the course of PAH in patients prescribed RTS-Epo. PROSPECT is a multicenter, US-based drug registry of primarily group 1 patients with PAH treated with RTS-Epo who were parenteral-naive or parenteral-transitioned at enrollment. Patients were followed until discontinuation of RTS-Epo, withdrawal, loss to follow-up, death, or end of study (maximum 1 year). One-year freedom from hospitalization (FH) and survival estimates were summarized by prostacyclin history (parenteral-naive or parenteral-transitioned), sex, and chronic renal insufficiency (CRI). A total of 336 patients were included. The overall 1-year FH estimate was 51.0% ± 2.8% and was lower in parenteral-naive patients than parenteral-transitioned patients (42.8% ± 4.3% vs 57.1% ± 3.7%, respectively; P = .002). FH estimates were lower in male patients than female patients (38.3% ± 5.9% vs 54.6% ± 3.2%, respectively; P < .015) and in patients with CRI than patients without CRI (17.0% ± 8.4% vs 53.7% ± 2.9%, respectively; P < .001). The overall 1-year survival estimate was 84.0% ± 2.1%. Survival was poorer in parenteral-naive patients, male patients, and patients with CRI. Risk of hospitalization and mortality remain high in patients with PAH. In particular, patients who are parenteral-naive at initiation of RTS-Epo therapy, male patients, and patients with CRI require close monitoring and aggressive clinical management.

Hospitalization and Survival in Patients Using Epoprostenol for Injection in the PROSPECT Observational Study

PubMed Central

Frantz, Robert P.; Schilz, Robert J.; Chakinala, Murali M.; Badesch, David B.; Frost, Adaani E.; McLaughlin, Vallerie V.; Barst, Robyn J.; Rosenberg, Daniel M.; Miller, Dave P.; Hartline, Brian K.; Benton, Wade W.

2015-01-01

BACKGROUND: Few studies have prospectively reported outcomes in patients with pulmonary arterial hypertension (PAH) treated with epoprostenol in the modern-day era of oral therapy and combination treatments. The Registry to Prospectively Describe Use of Epoprostenol for Injection (Veletri, prolonged room temperature stable-epoprostenol [RTS-Epo]) in Patients with Pulmonary Arterial Hypertension (PROSPECT) was established to prospectively describe the course of PAH in patients prescribed RTS-Epo. METHODS: PROSPECT is a multicenter, US-based drug registry of primarily group 1 patients with PAH treated with RTS-Epo who were parenteral-naive or parenteral-transitioned at enrollment. Patients were followed until discontinuation of RTS-Epo, withdrawal, loss to follow-up, death, or end of study (maximum 1 year). One-year freedom from hospitalization (FH) and survival estimates were summarized by prostacyclin history (parenteral-naive or parenteral-transitioned), sex, and chronic renal insufficiency (CRI). RESULTS: A total of 336 patients were included. The overall 1-year FH estimate was 51.0% ± 2.8% and was lower in parenteral-naive patients than parenteral-transitioned patients (42.8% ± 4.3% vs 57.1% ± 3.7%, respectively; P = .002). FH estimates were lower in male patients than female patients (38.3% ± 5.9% vs 54.6% ± 3.2%, respectively; P < .015) and in patients with CRI than patients without CRI (17.0% ± 8.4% vs 53.7% ± 2.9%, respectively; P < .001). The overall 1-year survival estimate was 84.0% ± 2.1%. Survival was poorer in parenteral-naive patients, male patients, and patients with CRI. CONCLUSIONS: Risk of hospitalization and mortality remain high in patients with PAH. In particular, patients who are parenteral-naive at initiation of RTS-Epo therapy, male patients, and patients with CRI require close monitoring and aggressive clinical management. PMID:25320967

Quality of life, compliance, safety and effectiveness in fit older metastatic colorectal patients with cancer treated in first-line with chemotherapy plus cetuximab: A restrospective analysis from the ObservEr study.

PubMed

Rosati, Gerardo; Pinto, Carmine; Di Fabio, Francesca; Chiara, Silvana; Lolli, Ivan R; Ruggeri, Enzo M; Ciuffreda, Libero; Ferrara, Raimondo; Antonuzzo, Lorenzo; Adua, Daniela; Racca, Patrizia; Bilancia, Domenico; Benincasa, Elena; Stroppolo, Maria Elena; Di Costanzo, Francesco

2018-05-01

The influence of age (<70 years and ≥70 years) was retrospectively studied on the quality of life (QoL), incidence of side effects (including skin reactions) and efficacy of chemotherapy plus cetuximab in patients with KRAS wild type (WT) metastatic colorectal cancer (mCRC). 225 patients of the Observed study (PS 0-1) were retrieved based on age (< 70 and ≥70 years) and evaluated through EORTC QLQ-C30 and DLQI questionnaires. The two patient groups (141 < 70 and 84 ≥ 70 years, respectively) were balanced with no differences in any of the clinical and pathological characteristics considered. Both groups underwent similar type of first-line chemotherapy plus cetuximab, treatment duration and compliance. Cetuximab therapy caused similar incidence of side effects and impact on QoL in older and younger patients. No difference was observed in progression free survival (PFS) and in disease control rates between the two patient populations. Median overall survival (OS) was higher in patients <70 (27 months, 95% CI: 22.7-31.27) than in patients ≥70 (19 months, 95% CI: 14.65-23.35) (p = 0.002), which is likely due to higher proportions of metastatic resection (27.0% vs 8.3%; p = 0.001) and utilization of second-line therapy in younger group (58.9% vs 42.9%; p = 0.028). The current data suggest that fit older patients with mCRC can be safely treated with a cetuximab-based therapy, as QoL and safety profile do not seem to be affected by age. In addition, age did not impact the choice of chemotherapy to be associated to cetuximab and treatment compliance. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

Prospective Observational Study on acute Appendicitis Worldwide (POSAW).

PubMed

Sartelli, Massimo; Baiocchi, Gian L; Di Saverio, Salomone; Ferrara, Francesco; Labricciosa, Francesco M; Ansaloni, Luca; Coccolini, Federico; Vijayan, Deepak; Abbas, Ashraf; Abongwa, Hariscine K; Agboola, John; Ahmed, Adamu; Akhmeteli, Lali; Akkapulu, Nezih; Akkucuk, Seckin; Altintoprak, Fatih; Andreiev, Aurelia L; Anyfantakis, Dimitrios; Atanasov, Boiko; Bala, Miklosh; Balalis, Dimitrios; Baraket, Oussama; Bellanova, Giovanni; Beltran, Marcelo; Melo, Renato Bessa; Bini, Roberto; Bouliaris, Konstantinos; Brunelli, Daniele; Castillo, Adrian; Catani, Marco; Che Jusoh, Asri; Chichom-Mefire, Alain; Cocorullo, Gianfranco; Coimbra, Raul; Colak, Elif; Costa, Silvia; Das, Koray; Delibegovic, Samir; Demetrashvili, Zaza; Di Carlo, Isidoro; Kiseleva, Nadezda; El Zalabany, Tamer; Faro, Mario; Ferreira, Margarida; Fraga, Gustavo P; Gachabayov, Mahir; Ghnnam, Wagih M; Giménez Maurel, Teresa; Gkiokas, Georgios; Gomes, Carlos A; Griffiths, Ewen; Guner, Ali; Gupta, Sanjay; Hecker, Andreas; Hirano, Elcio S; Hodonou, Adrien; Hutan, Martin; Ioannidis, Orestis; Isik, Arda; Ivakhov, Georgy; Jain, Sumita; Jokubauskas, Mantas; Karamarkovic, Aleksandar; Kauhanen, Saila; Kaushik, Robin; Kavalakat, Alfie; Kenig, Jakub; Khokha, Vladimir; Khor, Desmond; Kim, Dennis; Kim, Jae I; Kong, Victor; Lasithiotakis, Konstantinos; Leão, Pedro; Leon, Miguel; Litvin, Andrey; Lohsiriwat, Varut; López-Tomassetti Fernandez, Eudaldo; Lostoridis, Eftychios; Maciel, James; Major, Piotr; Dimova, Ana; Manatakis, Dimitrios; Marinis, Athanasio; Martinez-Perez, Aleix; Marwah, Sanjay; McFarlane, Michael; Mesina, Cristian; Pędziwiatr, Michał; Michalopoulos, Nickos; Misiakos, Evangelos; Mohamedahmed, Ali; Moldovanu, Radu; Montori, Giulia; Mysore Narayana, Raghuveer; Negoi, Ionut; Nikolopoulos, Ioannis; Novelli, Giuseppe; Novikovs, Viktors; Olaoye, Iyiade; Omari, Abdelkarim; Ordoñez, Carlos A; Ouadii, Mouaqit; Ozkan, Zeynep; Pal, Ajay; Palini, Gian M; Partecke, Lars I; Pata, Francesco; Pędziwiatr, Michał; Pereira Júnior, Gerson A; Pintar, Tadeja; Pisarska, Magdalena; Ploneda-Valencia, Cesar F; Pouggouras, Konstantinos; Prabhu, Vinod; Ramakrishnapillai, Padmakumar; Regimbeau, Jean-Marc; Reitz, Marianne; Rios-Cruz, Daniel; Saar, Sten; Sakakushev, Boris; Seretis, Charalampos; Sazhin, Alexander; Shelat, Vishal; Skrovina, Matej; Smirnov, Dmitry; Spyropoulos, Charalampos; Strzałka, Marcin; Talving, Peep; Teixeira Gonsaga, Ricardo A; Theobald, George; Tomadze, Gia; Torba, Myftar; Tranà, Cristian; Ulrych, Jan; Uzunoğlu, Mustafa Y; Vasilescu, Alin; Occhionorelli, Savino; Venara, Aurélien; Vereczkei, Andras; Vettoretto, Nereo; Vlad, Nutu; Walędziak, Maciej; Yilmaz, Tonguç U; Yuan, Kuo-Ching; Yunfeng, Cui; Zilinskas, Justas; Grelpois, Gérard; Catena, Fausto

2018-01-01

Acute appendicitis (AA) is the most common surgical disease, and appendectomy is the treatment of choice in the majority of cases. A correct diagnosis is key for decreasing the negative appendectomy rate. The management can become difficult in case of complicated appendicitis. The aim of this study is to describe the worldwide clinical and diagnostic work-up and management of AA in surgical departments. This prospective multicenter observational study was performed in 116 worldwide surgical departments from 44 countries over a 6-month period (April 1, 2016-September 30, 2016). All consecutive patients admitted to surgical departments with a clinical diagnosis of AA were included in the study. A total of 4282 patients were enrolled in the POSAW study, 1928 (45%) women and 2354 (55%) men, with a median age of 29 years. Nine hundred and seven (21.2%) patients underwent an abdominal CT scan, 1856 (43.3%) patients an US, and 285 (6.7%) patients both CT scan and US. A total of 4097 (95.7%) patients underwent surgery; 1809 (42.2%) underwent open appendectomy and 2215 (51.7%) had laparoscopic appendectomy. One hundred eighty-five (4.3%) patients were managed conservatively. Major complications occurred in 199 patients (4.6%). The overall mortality rate was 0.28%. The results of the present study confirm the clinical value of imaging techniques and prognostic scores. Appendectomy remains the most effective treatment of acute appendicitis. Mortality rate is low.

Patients with prior vertebral or hip fractures treated with teriparatide in the Direct Assessment of Nonvertebral Fractures in Community Experience (DANCE) observational study.

PubMed

Beall, D P; Feldman, R G; Gordon, M L; Gruber, B L; Lane, J M; Valenzuela, G; Yim, D; Alam, J; Krege, J H; Krohn, K

2016-03-01

In patients in the Direct Assessment of Nonvertebral Fractures in Community Experience (DANCE) observational study with and without a prior vertebral or hip fracture, the incidence of nonvertebral fractures was lower with >6 months of teriparatide treatment than during the first 6 months. Clinical evidence on the effect of teriparatide in patients with prior fracture is limited. In the DANCE observational study, the incidence of nonvertebral fragility fractures (NVFX) decreased significantly in patients receiving teriparatide for >6 months (6-24 months) versus >0 to ≤6 months (reference period). We performed a post hoc analysis to assess the effect of teriparatide 20 μg/day in patients who entered DANCE with prior vertebral or hip fractures. The incidence of patients experiencing a NVFX for four 6-month intervals during and after treatment was compared with the reference period. Overall, 4085 patients received ≥1 dose of teriparatide. Of 3720 with sufficient data for efficacy analysis, 692 had prior vertebral fracture, including 179 with previous kyphoplasty/vertebroplasty; 290 had prior hip fracture. These patients were older, and those with prior vertebral fractures had more comorbid conditions at baseline than those without prior vertebral fractures. The incidence of patients experiencing NVFX declined over time in all patient groups. The fracture incidence rate declined 49 and 46%, respectively, in patients with and without prior vertebral fracture and was 63 and 46% lower in patients with previous kyphoplasty/vertebroplasty and without prior vertebral fracture. NVFX declined 43 and 48% in patients with and without prior hip fracture. The reduced incidence over time was consistent in the subgroups (all interaction p values >0.05). Patients with prior fracture were more likely to experience serious adverse events. The incidence of NVFX decreased over time in patients receiving teriparatide in DANCE regardless of prior fracture status.

Pneumoperitoneum deteriorates intratidal respiratory system mechanics: an observational study in lung-healthy patients.

PubMed

Wirth, Steffen; Biesemann, Andreas; Spaeth, Johannes; Schumann, Stefan

2017-02-01

Pneumoperitoneum during laparoscopic surgery leads to atelectasis and impairment of oxygenation. Positive end-expiratory pressure (PEEP) is supposed to counteract atelectasis. We hypothesized that the derecruiting effects of pneumoperitoneum would deteriorate the intratidal compliance profile in patients undergoing laparoscopic surgery. In 30 adult patients scheduled for surgery with pneumoperitoneum, respiratory variables were measured during mechanical ventilation. We calculated the dynamic compliance of the respiratory system (C RS ) and the intratidal volume-dependent C RS curve using the gliding-SLICE method. The C RS curve was then classified in terms of indicating intratidal recruitment/derecruitment (increasing profile) and overdistension (decreasing profile). During the surgical interventions, the PEEP level was maintained nearly constant at 7 cm H 2 O. Data are expressed as mean [confidence interval]. Baseline C RS was 60 [54-67] mL cm H 2 O -1 . Application of pneumoperitoneum decreased C RS to 40 [37-43] mL cm H 2 O -1 which partially recovered to 54 [50-59] mL cm H 2 O -1 (P < 0.001) after removal but remained below the value measured before pneumoperitoneum (P < 0.001). Baseline compliance profiles indicated intratidal recruitment/derecruitment in 48 % patients. After induction of pneumoperitoneum, intratidal recruitment/derecruitment was indicated in 93 % patients (P < 0.01), and after removal intratidal recruitment/derecruitment was indicated in 59 % patients. Compliance profiles showing overdistension were not observed. Analyses of the intratidal compliance profiles reveal that pneumoperitoneum during laparoscopic surgery causes intratidal recruitment/derecruitment which partly persists after its removal. The analysis of the intratidal volume-dependent C RS profiles could be used to guide intraoperative PEEP adjustments during elevated intraabdominal pressure.

A prospective, observational study comparing the PK/PD relationships of generic Meropenem (Mercide®) to the innovator brand in critically ill patients.

PubMed

Mer, Mervyn; Snyman, Jacques Rene; van Rensburg, Constance Elizabeth Jansen; van Tonder, Jacob John; Laurens, Ilze

2016-01-01

Clinicians' skepticism, fueled by evidence of inferiority of some multisource generic antimicrobial products, results in the underutilization of more cost-effective generics, especially in critically ill patients. The aim of this observational study was to demonstrate equivalence between the generic or comparator brand of meropenem (Mercide ® ) and the leading innovator brand (Meronem ® ) by means of an ex vivo technique whereby antimicrobial activity is used to estimate plasma concentration of the active moiety. Patients from different high care and intensive care units were recruited for observation when prescribed either of the meropenem brands under investigation. Blood samples were collected over 6 hours after a 30 minute infusion of the different brands. Meropenem concentration curves were established against United States Pharmacopeia standard meropenem (Sigma-Aldrich) by using standard laboratory techniques for culture of Klebsiella pneumoniae. Patients' plasma samples were tested ex vivo, using a disc diffusion assay, to confirm antimicrobial activity and estimate plasma concentrations of the two brands. Both brands of meropenem demonstrated similar curves in donor plasma when concentrations in vials were confirmed. Patient-specific serum concentrations were determined from zones of inhibition against a standard laboratory Klebsiella strain ex vivo, confirming at least similar in vivo concentrations as the concentration curves (90% confidence interval) overlapped; however, the upper limit of the area under the curve for the ratio comparator/innovator exceeded the 1.25-point estimate, i.e., 4% higher for comparator meropenem. This observational, in-practice study demonstrates similar ex vivo activity and in vivo plasma concentration time curves for the products under observation. Assay sensitivity is also confirmed. Current registration status of generic small molecules is in place. The products are therefore clinically interchangeable based on

Hypomagnesemia associated with hypocalcemia after total thyroidectomy: an observational study.

PubMed

Mahmoud, Renata Regina da Graça Lorencetti; Neto, Vergilius José Furtado de Araujo; Alves, Wellington; Lin, Chin Shien; Leite, Ana Kober Nogueira; Matos, Leandro Luongo; Filho, Vergilius José Furtado de Araujo; Cernea, Claudio Roberto

2016-06-01

Serum magnesium is frequently low in patients with hypocalcemia after total thyroidectomy. The aim of the present study was to analyze the variations in serum magnesium and calcium concentrations after total thyroidectomy, and the relationship between both ions. We conducted an observational study of 142 patients who had undergone total thyroidectomy, measuring serum calcium and magnesium levels preoperatively and on the day following surgery. The incidence of postoperative hypocalcemia was compared with that of postoperative hypomagnesemia. A total of 142, total thyroidectomies were performed: 54 patients (38%) presented with hypocalcemia on the first postoperative day. A marked decrease in blood magnesium in the group of patients with hypocalcemia was observed when compared to those with normal calcemia on the first postoperative day (mean variation respectively, 0.125 ± 0.065 mmol/L versus 0.035 ± 0.020 mmol/L; P = 0.0002). Hypomagnesemia is significantly associated with early hypocalcemia following thyroidectomy.

[The association of eccentricity indexes with cardiac biomarkers in normotensive acute pulmonary embolism patients: an observational study].

PubMed

Cetiner, Mehmet Ali; Sayın, Muhammet Raşit; Yıldırım, Nesligül; Karabağ, Turgut; Aydın, Mustafa

2013-03-01

The present study aims at investigating the association of systolic and diastolic eccentricity indexes with cardiac biomarkers in hemodynamically stable patients with acute pulmonary embolism (APE). Thirty hemodynamically stable (systolic blood pressure >90 mmHg) patients with APE (17M, mean age 61.67±17.6 years) were included in this cross-sectional observational study. The associations of serum troponin I, D-dimer, brain natriuretic peptide (BNP) and heart type fatty acid binding protein (hFABP) levels with systolic and diastolic eccentricity indices, tricuspid annular plane systolic excursion (TAPSE), myocardial performance index (MPI), systolic pulmonary artery pressure and the index of the inferior vena cava were investigated. The relationships between parameters were evaluated by Pearson and Spearman correlation analysis according to the distribution of data. Correlation analysis revealed that the most significant relationship between cardiac biomarkers and echocardiographic measurements was in the BNP value. Meanwhile, systolic and diastolic eccentricity indexes were found to have significant correlation with serum troponin I (respectively r=0.470, p=0.009/r=0.310, p=0.095) and BNP (respectively r=0.402, p=0.028/r=0.384, p=0.036) values. On the other hand, elevated D-dimer levels led to statistical significance in none of the echocardiographic parameters. According to our results, hFABP was rarely positive in normotensive patients with APE. An elevated D-dimer alone was not significant in predicting RVD. Eccentricity indexes revealed significant relationship with BNP and troponin I values. The results obtained indicate that early echocardiographic evaluation is important in patients with abnormal cardiac biomarkers.

Clinical and economic impact of remote monitoring on the follow-up of patients with implantable electronic cardiovascular devices: an observational study.

PubMed

Costa, Paulo Dias; Reis, A Hipólito; Rodrigues, Pedro P

2013-02-01

Traditional follow-up of patients with cardiovascular devices is still an activity that, in addition to serving an increasing population, requires a considerable amount of time and specialized human and technical resources. Our aim was to evaluate the applicability of the CareLink(®) (Medtronic, Minneapolis, MN) remote monitoring system as a complementary option to the follow-up of patients with implanted devices, between in-office visits. Evaluated outcomes included both clinical (event detection and time to diagnosis) and nonclinical (patient's satisfaction and economic costs) aspects. An observational, longitudinal, prospective study was conducted with patients from a Portuguese central hospital sampled by convenience during 1 week (43 patients). Data were collected in four moments: two in-office visits and two remote evaluations, reproducing 1 year of clinical follow-up. Data sources included health records, implant reports, initial demographic data collection, follow-up printouts, and a questionnaire. After selection criteria were verified, 15 patients (11 men [73%]) were included, 63.4±10.8 years old, representing 14.0±6.3 implant months. Clinically, 15 events were detected (9 by remote monitoring and 6 by patient-initiated activation), of which only 9 were symptomatic. We verified that remote monitoring could detect both symptomatic and asymptomatic events, whereas patient-initiated activation only detected symptomatic ones (p=0.028). Moreover, the mean diagnosis anticipation in patients with events was approximately 58 days (p<0.001). In nonclinical terms, we observed high or very high satisfaction (67% and 33%, respectively) with using remote monitoring technology, but still 8 patients (53%) stated they preferred in-office visits. Finally, the introduction of remote monitoring technology has the ability to reduce total follow-up costs for patients by 25%. We conclude that the use of this system constitutes a viable complementary option to the follow

Assessing validity of observational intervention studies - the Benchmarking Controlled Trials.

PubMed

Malmivaara, Antti

2016-09-01

Benchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations. To create and pilot test a checklist for appraising methodological validity of a BCT. The checklist was created by extracting the most essential elements from the comprehensive set of criteria in the previous paper on BCTs. Also checklists and scientific papers on observational studies and respective systematic reviews were utilized. Ten BCTs published in the Lancet and in the New England Journal of Medicine were used to assess feasibility of the created checklist. The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies. The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies. However, the piloted checklist should be validated in further studies. Key messages Benchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations. This paper presents a checklist for appraising methodological validity of BCTs and pilot-tests the checklist with ten BCTs published in leading medical journals. The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies. The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies.

Satisfaction of patients with directly observed treatment strategy in Addis Ababa, Ethiopia: A mixed-methods study

PubMed Central

Getahun, Belete; Nkosi, Zethu Zerish

2017-01-01

Background Directly observed treatment, short course (DOTS) strategy has been a cornerstone for Tuberculosis (TB) control programs in developing countries. However, in Ethiopia satisfaction level of patients’ with TB with the this strategy is not well understood. Therefore, the study aimed to assess the satisfaction level of patients with TB with the DOTS. Method Explanatory sequential mixed method design was carried out in Addis Ababa, Ethiopia. Interviewer-administered questionnaire with 601 patients with TB who were on follow-up was employed in the quantitative approach. In the qualitative approach telephonic-interview with 25 persons lost to follow-up and focus group discussions with 23 TB experts were conducted. Result Sixty seven percent of respondent was satisfied with the DOTS. Rural residency (AOR = 3.4, 95% CI 1.6, 7.6), having TB symptoms (AOR = 0.6, 95% CI 0.4, 0.94) and treatment supporter (AOR = 4.3, 95%CI 2.7, 6.8) were associated with satisfaction with DOTS. In qualitative finding, all persons lost to follow-up were dissatisfied while TB experts enlightened lack of evidence to affirm the satisfaction level of patients with DOTS. Explored factors contributing to satisfaction include: on time availability of health care providers, DOTS service delivery process, general condition of health care facilities, nutritional support and transportation. Conclusion DOTS is limited to satisfy patients with TB and lacks a consistent system that determines the satisfaction level of patients with TB. Therefore, DOTS strategy needs to have a system to captures patients’ satisfaction level to respond on areas that need progress to improve DOTS service quality. PMID:28182754

Participant observation of time allocation, direct patient contact and simultaneous activities in hospital physicians.

PubMed

Weigl, Matthias; Müller, Andreas; Zupanc, Andrea; Angerer, Peter

2009-06-29

Hospital physicians' time is a critical resource in medical care. Two aspects are of interest. First, the time spent in direct patient contact - a key principle of effective medical care. Second, simultaneous task performance ('multitasking') which may contribute to medical error, impaired safety behaviour, and stress. There is a call for instruments to assess these aspects. A preliminary study to gain insight into activity patterns, time allocation and simultaneous activities of hospital physicians was carried out. Therefore an observation instrument for time-motion-studies in hospital settings was developed and tested. 35 participant observations of internists and surgeons of a German municipal 300-bed hospital were conducted. Complete day shifts of hospital physicians on wards, emergency ward, intensive care unit, and operating room were continuously observed. Assessed variables of interest were time allocation, share of direct patient contact, and simultaneous activities. Inter-rater agreement of Kappa = .71 points to good reliability of the instrument. Hospital physicians spent 25.5% of their time at work in direct contact with patients. Most time was allocated to documentation and conversation with colleagues and nursing staff. Physicians performed parallel simultaneous activities for 17-20% of their work time. Communication with patients, documentation, and conversation with colleagues and nursing staff were the most frequently observed simultaneous activities. Applying logit-linear analyses, specific primary activities increase the probability of particular simultaneous activities. Patient-related working time in hospitals is limited. The potential detrimental effects of frequently observed simultaneous activities on performance outcomes need further consideration.

Initial antibiotic selection and patient outcomes: observations from the National Pneumonia Project.

PubMed

Bratzler, Dale W; Ma, Allen; Nsa, Wato

2008-12-01

Guidelines for empirical treatment of hospitalized patients with pneumonia provide specific recommendations for antibiotic selection that are primarily based on findings from observational studies. We conducted a retrospective study of 27,330 community-dwelling, immunocompetent Medicare patients (age, >65 years) with pneumonia who were hospitalized in 1998-1999 and 2000-2001. Associations between initial antimicrobial regimens and risk-adjusted mortality were assessed, accounting for differences in patient characteristics, comorbidities, illness severity, geographic location, and processes of care. Treatment with nonpseudomonal third-generation cephalosporin monotherapy constituted the reference group for comparisons. For patients not in the intensive care unit, initial treatment with fluoroquinolone monotherapy was associated with reduced in-hospital mortality, 14-day mortality, and 30-day mortality rates (adjusted odds ratio [AOR] for 30-day mortality, 0.7; 95% confidence interval [CI], 0.6-0.9; P = .001). The combination of a cephalosporin plus a macrolide was associated with reduced 14-day and 30-day mortality rates (AOR for 30-day mortality, 0.7; 95% CI, 0.6-0.9; P < .001). For intensive care unit patients, the combination of a cephalosporin and a macrolide was associated with reduced in-hospital mortality (AOR, 0.6; 95% CI, 0.3-0.9; P = .018). Initial antimicrobial treatment with the combination of a second- or third-generation cephalosporin and a macrolide or initial treatment with a fluoroquinolone was associated with a reduced 30-day mortality rate, compared with treatment with third-generation cephalosporin monotherapy, among non-intensive care unit patients. Although our results are consistent with other observational studies, controversy continues to exist about the use of nonexperimental cohort studies to demonstrate associations between processes of care, such as antibiotic selection, and patient outcomes.

An Observational Longitudinal Study Investigating the Effectiveness of 75 mg Pregabalin Post-Hemodialysis among Uremic Pruritus Patients.

PubMed

Khan, Tahir Mehmood; Wu, David Bin-Chia; Goh, Bey-Hing; Lee, Learn-Han; Alhafez, Abdul Aziz; Syed Sulaiman, Syed Azhar

2016-11-08

A prospective, observational, longitudinal study was conducted to assess the effectiveness of 75 mg pregabalin (PG) post-hemodialysis (pHD) for treatment-resistant uremic pruritus (UP). A total of forty-five patients completed the entire six week follow-up. At the baseline assessment, the majority of the patients were distressed by the UP frequency and intensity. Sleep (mean = 3.30 ± 1.1), leisure/social activities (mean = 2.90 ± 0.80) and distribution (mean = 2.92 ± 0.34) were the three domains that were primarily effected by the UP. Overall, further reduction in the 5D-itching scale (IS) was noted at day 42, which confirmed a sustained (B = -12.729, CI -13.257 to -12.201, p < 0.001) relief of pruritus severity among patients with treatment-resistant pruritus. Patients with a higher serum calcium level had a score difference of +1 from the other patients (B = 1.010, p = 0.061). There was a reduction of 12 points compared to the baseline 5D-IS for each patient on day 42 after using pregabalin 75 mg PD pHD for 42 days, which represented major relief. Among the demographic factors, only gender was significantly associated with the 5D-IS score.

Study to Improve Cardiovascular Outcomes in high-risk older patieNts (ICON1) with acute coronary syndrome: study design and protocol of a prospective observational study.

PubMed

Kunadian, Vijay; Neely, R Dermot G; Sinclair, Hannah; Batty, Jonathan A; Veerasamy, Murugapathy; Ford, Gary A; Qiu, Weiliang

2016-08-23

The ICON1 study (a study to Improve Cardiovascular Outcomes in high-risk older patieNts with acute coronary syndrome) is a prospective observational study of older patients (≥75 years old) with non-ST-elevation acute coronary syndrome managed by contemporary treatment (pharmacological and invasive). The aim of the study was to determine the predictors of poor cardiovascular outcomes in this age group and to generate a risk prediction tool. Participants are recruited from 2 tertiary hospitals in the UK. Baseline evaluation includes frailty, comorbidity, cognition and quality-of-life measures, inflammatory status assessed by a biomarker panel, including microRNAs, senescence assessed by telomere length and telomerase activity, cardiovascular status assessed by arterial stiffness, endothelial function, carotid intima media thickness and left ventricular systolic and diastolic function, and coronary plaque assessed by virtual histology intravascular ultrasound and optical coherence tomography. The patients are followed-up at 30 days and at 1 year for primary outcome measures of death, myocardial infarction, stroke, unplanned revascularisation, bleeding and rehospitalisation. The study has been approved by the regional ethics committee (REC 12/NE/016). Findings of the study will be presented in scientific sessions and will be published in peer-reviewed journals. NCT01933581: Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Safety and effectiveness of long-term growth hormone therapy in Japanese patients with adult growth hormone deficiency: a postmarketing, multicenter, observational study.

PubMed

Shimatsu, Akira; Ishii, Hitoshi; Nishinaga, Hiromi; Murai, Osamu; Chihara, Kazuo

2017-07-28

We aimed to evaluate the long-term safety and effectiveness of growth hormone (GH) therapy in Japanese patients with adult growth hormone deficiency (AGHD). In this observational, multicenter study, Norditropin ® (Novo Nordisk A/S, Bagsvaerd, Denmark) was administered as injections of 0.021 mg/kg/week as a starting dose divided into 6-7 doses/week. The dose was increased according to clinical response. Patients' data were obtained from medical records. Measurements (lipids, glucose metabolism, and body composition) taken at baseline; 3, 6, and 12 months; and yearly until the end of the study were collected. Adverse drug reactions (ADRs), serious ADRs, and serious adverse events (SAEs) were evaluated. Of 387 registered patients, 334 were eligible for safety. After GH treatment initiation, a marked decrease in total cholesterol was observed earlier in the child-onset group than in the adult-onset group. LDL-cholesterol also decreased, but no significant differences in changes in LDL-cholesterol between adult-onset and child-onset groups were found. A significant increase in HDL-cholesterol starting 1 year after GH treatment initiation was found in the adult-onset group. There was no effect of GH treatment on glucose metabolism. Because of the small number of dual-energy X-ray absorptiometry data, the overall assessment of changes of body composition was difficult. Fifty-six (16.8%), 12 (3.6%), and 35 (10.5%) patients experienced ADRs, serious ADRs, and SAEs, respectively. This study demonstrated a favorable long-term safety and effectiveness profile of GH therapy in AGHD patients in the real-life Japanese clinical practice setting.

Clinical and laboratory parameters associated with acute kidney injury in patients with snakebite envenomation: a prospective observational study from Myanmar.

PubMed

Aye, Kyi-Phyu; Thanachartwet, Vipa; Soe, Chit; Desakorn, Varunee; Thwin, Khin-Thida; Chamnanchanunt, Supat; Sahassananda, Duangjai; Supaporn, Thanom; Sitprija, Visith

2017-03-16

Snakebite-related acute kidney injury (AKI) is a common community-acquired AKI in tropical countries leading to death and disability. The aims of this study were to (1) determine the occurrence of snakebite-related AKI, (2) assess factors at presentation that are associated with snakebite-related AKI, and (3) determine the outcomes of patients with snakebite-related AKI. We conducted a prospective observational study of patients with snake envenomation at the three academic tertiary care hospitals in Yangon, Myanmar between March 2015 and June 2016. Patient data including baseline characteristics, clinical and laboratory findings, hospital management, and outcomes were recorded in a case report form. A stepwise multivariate logistic regression analysis using a backward selection method determined independent factors significantly associated with AKI. AKI was observed in 140 patients (54.3%), the majority of whom were AKI stage III (110 patients, 78.6%). AKI occurred at presentation and developed during hospitalization in 88 (62.9%) and 52 patients (37.1%), respectively. Twenty-seven patients died (19.3%), and 69 patients (49.3%) required dialysis. On multivariate logistic regression analysis, (1) snakebites from the Viperidae family (odds ratio [OR]: 9.65, 95% confidence interval [CI]: 2.42-38.44; p = 0.001), (2) WBC >10 × 10 3 cells/μL (OR: 3.55, 95% CI: 1.35-9.34; p = 0.010), (3) overt disseminated intravascular coagulation (OR: 2.23, 95% CI: 1.02-4.89; p = 0.045), (4) serum creatine kinase >500 IU/L (OR: 4.06, 95% CI: 1.71-9.63; p = 0.001), (5) serum sodium <135 mmol/L (OR: 4.37, 95% CI: 2.04-9.38; p < 0.001), (6) presence of microscopic hematuria (OR: 3.60, 95% CI: 1.45-8.91; p = 0.006), and (7) duration from snakebite to receiving antivenom ≥2 h (OR: 3.73, 95% CI: 1.48-9.37; p = 0.005) were independently associated with AKI. Patients bitten by Viperidae with normal renal function who had serum sodium <135 mmol/L had a

Skeletal involvement in Gaucher disease: An observational multicenter study of prognostic factors in the Argentine Gaucher disease patients.

PubMed

Drelichman, Guillermo; Fernández Escobar, Nicolás; Basack, Nora; Aversa, Luis; Larroude, María Silvia; Aguilar, Gabriela; Szlago, Marina; Schenone, Andrea; Fynn, Alcyra; Cuello, María Fernanda; Aznar, Marcela; Fernández, Ramiro; Ruiz, Alba; Reichel, Paola; Guelbert, Norberto; Robledo, Hugo; Watman, Nora; Bolesina, Moira; Elena, Graciela; Veber, S Ernesto; Pujal, Graciela; Galván, Graciela; Chain, Juan José; Arizo, Adriana; Bietti, Julieta; Bar, Daniel; Dragosky, Marta; Marquez, Marisa; Feldman, Leonardo; Muller, Katja; Zirone, Sandra; Buchovsky, Greogorio; Lanza, Victoria; Sanabria, Alba; Fernández, Ignacio; Jaureguiberry, Rossana; Contte, Marcelo; Barbieri María, Angie; Maro, Alejandra; Zárate, Graciela; Fernández, Gabriel; Rapetti, María Cristina; Donato, Hugo; Degano, Adriana; Kantor, Gustavo; Albina, Roberto; Á Lvarez Bollea, María; Brun, María; Bacciedoni, Viviana; Del Río, Francis; Soberón, Bárbara; Boido, Nazario; Schweri, Maya; Borchichi, Sandra; Welsh, Victoria; Corrales, Marcela; Cedola, Alejandra; Carvani, Analía; Diez, Blanca; Richard, Lucía; Baduel, Ccecilia; Nuñez, Gabriela; Colimodio, Rubén; Barazzutti, Lucía; Medici, Hugo; Meschengieser, Susana; Damiani, Germán; Nucifora, María; Girardi, Beatriz; Gómez, Sergio; Papucci, Maura; Verón, David; Quiroga, Luis; Carro, Gustavo; De Ambrosio, Patricia; Ferro, José; Pujol, Marcelo; Castella, Cristina Cabral; Franco, Liliana; Nisnovich, Gisela; Veloso, María; Pacheco, Isabel; Savarino, Mario; Marino, Andrés; Saavedra, José Luis

2016-10-01

Patients with Gaucher type 1 (GD1) throughout Argentina were enrolled in the Argentine bone project to evaluate bone disease and its determinants. We focused on presence and predictors of bone lesions (BL) and their relationship to therapeutic goals (TG) with timing and dose of enzyme replacement therapy (ERT). A total of 124 patients on ERT were enrolled in a multi-center study. All six TG were achieved by 82% of patients: 70.1% for bone pain and 91.1% for bone crisis. However, despite the fact that bone TGs were achieved, residual bone disease was present in 108 patients on ERT (87%) at time 0. 16% of patients showed new irreversible BL (bone infarcts and avascular osteonecrosis) despite ERT, suggesting that they appeared during ERT or were not detected at the moment of diagnosis. We observed 5 prognostic factors that predicted a higher probability of being free of bone disease: optimal ERT compliance; early diagnosis; timely initiation of therapy; ERT initiation dose ≥45 UI/kg/EOW; and the absence of history of splenectomy. Skeletal involvement was classified into 4 major phenotypic groups according to BL: group 1 (12.9%) without BL; group 2 (28.2%) with reversible BL; group 3 (41.9%) with reversible BL and irreversible chronic BL; and group 4 (16.9%) with acute irreversible BL. Our study identifies prognostic factors for achieving best therapeutic outcomes, introduces new risk stratification for patients and suggests the need for a redefinition of bone TG. Am. J. Hematol. 91:E448-E453, 2016. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Blind bedside postpyloric placement of spiral tube as rescue therapy in critically ill patients: a prospective, tricentric, observational study.

PubMed

Lv, Bo; Hu, Linhui; Chen, Lifang; Hu, Bei; Zhang, Yanlin; Ye, Heng; Sun, Cheng; Zhang, Xiunong; Lan, Huilan; Chen, Chunbo

2017-09-26

Various special techniques for blind bedside transpyloric tube placement have been introduced into clinical practice. However, transpyloric spiral tube placement facilitated by a blind bedside method has not yet been reported. The objective of this prospective study was to evaluate the safety and efficiency of blind bedside postpyloric placement of a spiral tube as a rescue therapy subsequent to failed spontaneous transpyloric migration in critically ill patients. This prospective, tricentric, observational study was conducted in the intensive care units (ICUs) of three tertiary hospitals. A total of 127 consecutive patients with failed spontaneous transpyloric spiral tube migration despite using prokinetic agents and still required enteral nutrition for more than 3 days were included. The spiral tube was inserted postpylorically using the blind bedside technique. All patients received metoclopramide intravenously prior to tube insertion. The exact tube tip position was determined by radiography. The primary efficacy endpoint was the success rate of postpyloric spiral tube placement. Secondary efficacy endpoints were success rate of a spiral tube placed in the third portion of the duodenum (D3) or beyond, success rate of placement in the proximal jejunum, time to insertion, length of insertion, and number of attempts. Safety endpoints were metoclopramide-related and major adverse tube-associated events. In 81.9% of patients, the spiral feeding tubes were placed postpylorically; of these, 55.1% were placed in D3 or beyond and 33.9% were placed in the proximal jejunum, with a median time to insertion of 14 min and an average number of attempts of 1.4. The mean length of insertion was 95.6 cm. The adverse event incidence was 26.0%, and no serious adverse event was observed. Blind bedside postpyloric placement of a spiral tube, as a rescue therapy subsequent to failed spontaneous transpyloric migration in critically ill patients, is safe and effective. This

Longitudinal assessment of brain-derived neurotrophic factor in Sardinian psychotic patients (LABSP): a protocol for a prospective observational study

PubMed Central

Primavera, Diego; Deriu, Luca; Collu, Roberto; Scherma, Maria; Fadda, Paola; Fratta, Walter; Carpiniello, Bernardo

2017-01-01

Introduction Brain-derived neurotrophic factor (BDNF) plays a crucial role in neurodevelopment, synaptic plasticity and neuronal function and survival. Serum and plasma BDNF levels are moderately, but consistently, decreased in patients with schizophrenia (SCZ) compared with healthy controls. There is a lack of knowledge, however, on the temporal manifestation of this decline. Clinical, illness course and treatment factors might influence the variation of BDNF serum levels in patients with psychosis. In this context, we propose a longitudinal study of a cohort of SCZ and schizophrenic and schizoaffective disorder (SAD) Sardinian patients with the aim of disentangling the relationship between peripheral BDNF serum levels and changes of psychopathology, cognition and drug treatments. Methods and analysis Longitudinal assessment of BDNF in Sardinian psychotic patients (LABSP) is a 24-month observational prospective cohort study. Patients with SAD will be recruited at the Psychiatry Research Unit of the Department of Medical Science and Public Health, University of Cagliari and University of Cagliari Health Agency, Cagliari, Italy. We will collect BDNF serum levels as well as sociodemographic, psychopathological and neurocognitive measures. Structured, semistructured and self-rating assessment tools, such as the Positive and Negative Syndrome Scale for psychopathological measures and the Brief Assessment of Cognition in Schizophrenia for cognitive function, will be used. Ethics and dissemination This study protocol was approved by the University of Cagliari Health Agency Ethics Committee (NP2016/5491). The study will be conducted in accordance with the principles of good clinical practice, in the Declaration of Helsinki in compliance with the regulations. Participation will be voluntary and written informed consent will be obtained for each participant upon entry into the study. We plan to disseminate the results of our study through conference presentations and

Heart rate as an independent risk factor in patients with multiple organ dysfunction: a prospective, observational study.

PubMed

Hoke, Robert S; Müller-Werdan, Ursula; Lautenschläger, Christine; Werdan, Karl; Ebelt, Henning

2012-02-01

To study the association between baseline heart rate and outcome in patients with multiple organ dysfunction (MODS) as well as the course of heart rate over the first 4 days during MODS. Prospective observational study in 89 patients with MODS, defined as an APACHE-II score ≥20. Baseline heart rate (HR(0)) was determined over a 60-minute period at the time of MODS diagnosis. 28-day all-cause mortality was the primary endpoint of the study, a fall of the APACHE-II score by 4 points or more from day 0 to day 4 constituted the secondary endpoint. Hazard ratios for heart rate of 90 beats per minute (bpm) or greater relative to less than 90 bpm were calculated using Cox proportional hazards model and adjusted for confounding variables. Median baseline heart rate was 83 bpm in survivors and 92 bpm in non-survivors (p = 0.048). 28-day mortality was 32 and 61% in patients with HR(0) < 90 bpm and HR(0) ≥ 90 bpm, respectively. The adjusted hazard ratio for 28-day mortality was 2.30 (95% confidence interval 1.21-4.36, p = 0.001) for HR(0) ≥ 90 bpm relative to HR(0) < 90 bpm. No correlation was found between baseline heart rate and the secondary endpoint. From day 0 to day 4, heart rate remained elevated in all patients, as well as in survivors and non-survivors. A heart rate ≥90 bpm at the time of MODS diagnosis is an independent risk factor for increased 28-day mortality. As in patients with cardiovascular conditions such as coronary heart disease or chronic heart failure, heart rate might constitute a target for heart rate-lowering therapy in the narrow initial treatment window of MODS.

An observational study of vitamin b12 levels and peripheral neuropathy profile in patients of diabetes mellitus on metformin therapy.

PubMed

Gupta, Kamesh; Jain, Anand; Rohatgi, Anurag

A descriptive, observational study was completed in a tertiary care hospital between November 2014 and March 2016. Fifty consecutive patients of Type 2-Diabetes Mellitus who had been on metformin therapy for at least three months were included in our study. Several Parameters were compared with vitamin B12 levels and severity of peripheral neuropathy (using Toronto Clinical Scoring System (TCSS) and Nerve Conduction Velocity). These included the duration of diabetes, duration of metformin usage, dietary history, and HbA1c levels. Definite B12 deficiency was defined as B12<150pg/ml and possible B12 deficiency as <220pg/ml. In our study, we found a negative correlation between duration of metformin use and Vitamin B12 levels(r=-0.40). The mean Vitamin B12 levels seen in our study was 212.3pg/mL. There is a positive correlation between the duration of metformin therapy and peripheral neuropathy (r=0.40). The mean TCSS score was 6.8. The percentage of patients with mild neuropathy was 28%, with moderate neuropathy was 20% and severe neuropathy in 12% of the patients. The average duration of metformin use in patients without peripheral neuropathy was 5.5yrs whereas the average length of metformin use in patients with peripheral neuropathy was 10.4 yrs. Patients on long-term metformin therapy are at a high risk for Vitamin B12 deficiency and peripheral neuropathy. Interval Screening for peripheral neuropathy is recommended for patients on metformin even if Vitamin B12 levels appear to be normal. Copyright © 2017 Diabetes India. Published by Elsevier Ltd. All rights reserved.

MAXimising Involvement in MUltiMorbidity (MAXIMUM) in primary care: protocol for an observation and interview study of patients, GPs and other care providers to identify ways of reducing patient safety failures

PubMed Central

Daker-White, Gavin; Hays, Rebecca; Esmail, Aneez; Minor, Brian; Barlow, Wendy; Brown, Benjamin; Blakeman, Thomas; Bower, Peter

2014-01-01

Introduction Increasing numbers of older people are living with multiple long-term health conditions but global healthcare systems and clinical guidelines have traditionally focused on the management of single conditions. Having two or more long-term conditions, or ‘multimorbidity’, is associated with a range of adverse consequences and poor outcomes and could put patients at increased risk of safety failures. Traditionally, most research into patient safety failures has explored hospital or inpatient settings. Much less is known about patient safety failures in primary care. Our core aims are to understand the mechanisms by which multimorbidity leads to safety failures, to explore the different ways in which patients and services respond (or fail to respond), and to identify opportunities for intervention. Methods and analysis We plan to undertake an applied ethnographic study of patients with multimorbidity. Patients’ interactions and environments, relevant to their healthcare, will be studied through observations, diary methods and semistructured interviews. A framework, based on previous studies, will be used to organise the collection and analysis of field notes, observations and other qualitative data. This framework includes the domains: access breakdowns, communication breakdowns, continuity of care errors, relationship breakdowns and technical errors. Ethics and dissemination Ethical approval was received from the National Health Service Research Ethics Committee for Wales. An individual case study approach is likely to be most fruitful for exploring the mechanisms by which multimorbidity leads to safety failures. A longitudinal and multiperspective approach will allow for the constant comparison of patient, carer and healthcare worker expectations and experiences related to the provision, integration and management of complex care. This data will be used to explore ways of engaging patients and carers more in their own care using shared decision

Effectiveness, safety and health-related quality of life of multiple sclerosis patients treated with fingolimod: results from a 12-month, real-world, observational PERFORMS study in the Middle East.

PubMed

Achiron, Anat; Aref, Hany; Inshasi, Jihad; Harb, Mohamad; Alroughani, Raed; Bijarnia, Mahendra; Cooke, Kathryn; Yuksel, Ozgur

2017-08-07

Evidence on the use of fingolimod in real-world clinical practice and data on patient-reported health-related quality of life (HRQoL) in countries such as the Middle East are sparse. The Prospective Evaluation of Treatment with Fingolimod for Multiple Sclerosis (PERFORMS) study assessed HRQoL and effectiveness and safety of fingolimod in patients with relapsing-remitting multiples sclerosis (RRMS), primarily in Middle Eastern countries. This 12-month, observational, multicentre, prospective, real-world study was conducted in patients with RRMS who initiated fingolimod or another approved disease-modifying treatment (DMT) within 4 weeks before study entry. Patients were enrolled in a 2:1 ratio to obtain more data in fingolimod and parallel in other DMTs cohort by physicians during routine medical care. Key study outcomes included HRQoL assessed using MS International QoL (MusiQoL), MS relapses and disability. Safety was assessed throughout the study period. Due to the observational nature of the study, no neuroimaging assessments were mandated and central reading was not performed. Of 249 enrolled patients, 247 were included in the analysis (fingolimod cohort 172; other DMTs cohort 75). Overall, the mean age of patients was 36.5 years, 64.4% were women and ~90% were Caucasians. At baseline, mean MS duration since diagnosis was 7.2 years in the fingolimod and 4.8 years in the other DMTs cohorts. Overall, mean changes in MusiQoL index scores were -2.1 in the fingolimod cohort and -0.7 in the other DMTs cohort at Month 12, but improvement was not significant vs. baseline in both cohorts. Proportion of relapse-free patients increased significantly during the study vs. 0-12 months before the study in the fingolimod cohort (80.2% vs. 24.4%; p < 0.0001). Proportion of patients free from disability progression was 86.5% in the fingolimod cohort. The incidences of AEs were 59.9% and 50.6% in the fingolimod and other DMTs cohorts, respectively. First-dose monitoring of

Quality of life, treatment satisfaction and efficacy of non-biological systemic therapies in patients with plaque psoriasis: study protocol for a prospective observational study.

PubMed

Fink, Christine; Schank, Timo E; Trenkler, Nina; Uhlmann, Lorenz; Schäkel, Knut

2017-06-30

Psoriasis vulgaris often leads to a significant impaired quality of life and dissatisfaction with the existing therapeutic approaches. However, patients' quality of life and treatment satisfaction are of utmost importance, since it is positively related to therapy adherence and encourages patient's compliance. The study described herein evaluates the quality of life, treatment satisfaction and efficacy during the initial 6 months of treatment with a non-biological systemic agent in a real-life clinical setting. This observational study compares quality of life, treatment satisfaction and the efficacy of non-biological systemic therapy between 60 patients suffering from plaque psoriasis receiving the non-biological systemic therapies with apremilast, methotrexate and fumaric acid esters. Ethics approval was provided by the ethics committee of the medical faculty of the University of Heidelberg. Ethics approval number is S-298/2015. The design and the final results of the study will be published and made available to the public. German Clinical Trial Register (DRKS): DRKS00008721 (https://www.germanctr.de/). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Observational study of sleep, respiratory mechanics and quality of life in patients with non-cystic fibrosis bronchiectasis: a protocol study

PubMed Central

Faria Júnior, Newton Santos; Oliveira, Luis Vicente Franco; Perez, Eduardo Araújo; de Oliveira, Ezequiel Fernandes; Apostolico, Nadua; Pereira, Nixon Alves; dos Santos, Israel dos Reis; Urbano, Jessica Julioti; Souza, Ismael Dias; Polonio, Igor Bastos; Romaldini, José Gustavo Barian; Pereira, Déborah Madeu; Alves, Vera Lúcia dos Santos; Souza, Ângela Honda; Nascimento, Oliver Augusto; Jardim, José Roberto; Stirbulov, Roberto

2015-01-01

Introduction Bronchiectasis is a chronic disorder characterised by permanent and irreversible abnormal dilation of the bronchi and bronchioles, primarily caused by repeated cycles of pulmonary infections and inflammation, which lead to reduced mucociliary clearance and to the excessive production of sputum. Patients with non-cystic fibrosis bronchiectasis may be predisposed to hypoxemia during sleep, or to symptoms that may lead to arousals and thereby reduce the quality of life, because of the irreversible dilation of the bronchi and the presence of secretions and airflow obstruction. Methods and analysis For this cross-sectional observational study, patients with a clinical diagnosis of non-cystic fibrosis bronchiectasis will be recruited from the Bronchiectasis Clinic of the Pneumology Department of the Santa Casa de Misericordia Hospital and the Federal University of São Paulo (São Paulo, Brazil). Patients of either sex will be included if high-resolution CT of the thorax and classic sweat test confirms they have non-cystic fibrosis bronchiectasis, are between 18 and 80 years old, use long-acting bronchodilators, are clinically stable for a least 1 month, agree to participate in the study and they sign a statement of informed consent. The first part of the study will involve a clinical evaluation, maximal respiratory pressures, spirometry and the Saint George's Respiratory Questionnaire. The Sleep Laboratory of the Master's and Doctoral Postgraduate Program in Rehabilitation Sciences of the Nove de Julho University (São Paulo, Brazil) will perform the polysomnographic studies, Berlin Questionnaire, Epworth Sleepiness Scale, waist and neck circumferences, modified Mallampati classification and tonsil index. Ethics and dissemination This protocol has been approved by the Human Research Ethics Committees of Santa Casa de Misericordia Hospital (process number 178/2012) and Human Research Ethics Committee of Nove de Julho University (process number 370474

The UK Cardiac and Vascular Surgery Interventional Anaemia Response (CAVIAR) Study: protocol for an observational cohort study to determine the impact and effect of preoperative anaemia management in cardiac and vascular surgical patients

PubMed Central

Chau, Marisa; Richards, Toby; Evans, Caroline; Butcher, Anna; Collier, Timothy; Klein, Andrew

2017-01-01

Introduction Preoperative anaemia is linked to poor postsurgical outcome, longer hospital stays, greater risk of complications and mortality. Currently in the UK, some sites have developed anaemia clinics or pathways that use intravenous iron to correct iron deficiency anaemia prior to surgery as their standard of care. Although intravenous iron has been observed to be effective in a variety of patient settings, there is insufficient evidence in its use in cardiac and vascular patients. The aim of this study is to observe the impact and effect of anaemia and its management in patients undergoing cardiac and vascular surgery. In addition, the UK Cardiac and Vascular Surgery Interventional Anaemia Response (CAVIAR) Study is also a feasibility study with the aim to establish anaemia management pathways in the preoperative setting to inform the design of future randomised controlled trials. Methods and analysis The UK CAVIAR Study is a multicentre, stepped, observational study, in patients awaiting major cardiac or vascular surgery. We will be examining different haematological variables (especially hepcidin), functional capacity and patient outcome. Patients will be compared based on their anaemia status, whether they received intravenous iron in accordance to their hospital’s preoperative pathway, and their disease group. The primary outcomes are the change in haemoglobin levels from baseline (before treatment) to before surgery; and the number of successful patients recruited and consented (feasibility). The secondary outcomes will include changes in biomarkers of iron deficiency, length of stay, quality of life and postoperative recovery. Ethics and dissemination The study protocol was approved by the London-Westminster Research Ethics Committee (15/LO/1569, 27 November 2015). NHS approval was also obtained with each hospital trust. The findings of the study will be published in peer-reviewed journals. Trial registration number Clinical Trials registry (NCT

German adjuvant intergroup node-positive study: a phase III trial to compare oral ibandronate versus observation in patients with high-risk early breast cancer.

PubMed

von Minckwitz, Gunter; Möbus, Volker; Schneeweiss, Andreas; Huober, Jens; Thomssen, Christoph; Untch, Michael; Jackisch, Christian; Diel, Ingo J; Elling, Dirk; Conrad, Bettina; Kreienberg, Rolf; Müller, Volkmar; Lück, Hans-Joachim; Bauerfeind, Ingo; Clemens, Michael; Schmidt, Marcus; Noeding, Stefanie; Forstbauer, Helmut; Barinoff, Jana; Belau, Antje; Nekljudova, Valentina; Harbeck, Nadia; Loibl, Sibylle

2013-10-01

Bisphosphonates prevent skeletal-related events in patients with metastatic breast cancer. Their effect in early breast cancer is controversial. Ibandronate is an orally and intravenously available amino-bisphosphonate with a favorable toxicity profile. It therefore qualifies as potential agent for adjuvant use. The GAIN (German Adjuvant Intergroup Node-Positive) study was an open-label, randomized, controlled phase III trial with a 2 × 2 factorial design. Patients with node-positive early breast cancer were randomly assigned 1:1 to two different dose-dense chemotherapy regimens and 2:1 to ibandronate 50 mg per day orally for 2 years or observation. In all, 2,640 patients and 728 events were estimated to be required to demonstrate an increase in disease-free survival (DFS) by ibandronate from 75% to 79.5% by using a two-sided α = .05 and 1-β of 80%. We report here the efficacy analysis for ibandronate, which was released by the independent data monitoring committee because the futility boundary was not crossed after 50% of the required DFS events were observed. Between June 2004 and August 2008, 2,015 patients were randomly assigned to ibandronate and 1,008 to observation. Patients randomly assigned to ibandronate showed no superior DFS or overall survival (OS) compared with patients randomly assigned to observation (DFS: hazard ratio, 0.945; 95% CI, 0.768 to 1.161; P = .589; OS: HR, 1.040; 95% CI, 0.763 to 1.419; P = .803). DFS was numerically longer if ibandronate was used in patients younger than 40 years or older than 60 years compared with patients age 40 to 59 years (test for interaction P = .093). Adjuvant treatment with oral ibandronate did not improve outcome of patients with high-risk early breast cancer who received dose-dense chemotherapy.

Thiamine in septic shock patients with alcohol use disorders: An observational pilot study.

PubMed

Holmberg, Mathias Johan; Moskowitz, Ari; Patel, Parth Vijay; Grossestreuer, Anne Victoria; Uber, Amy; Stankovic, Nikola; Andersen, Lars Wiuff; Donnino, Michael William

2018-02-01

Alcohol-use disorders (AUDs) have been associated with increased sepsis-related mortality. As patients with AUDs are often thiamine deficient, we investigated practice patterns relating to thiamine administration in patients with AUDs presenting with septic shock and explored the association between receipt of thiamine and mortality. We performed a retrospective cohort study of patients presenting with septic shock between 2008 and 2014 at a single tertiary care center. We identified patients with an AUD diagnosis, orders for microbial cultures and use of antibiotics, vasopressor dependency, and lactate levels≥4mmol/L. We excluded those who received thiamine later than 48h of sepsis onset. We included 53 patients. Thirty-four (64%) patients received thiamine. Five patients (15%) received their first thiamine dose in the emergency department. The median time to thiamine administration was 9 (quartiles: 4, 18) hours. The first thiamine dose was most often given parenterally (68%) and for 100mg (88%). In those receiving thiamine, 15/34 (44%) died, compared to 15/19 (79%) of those not receiving thiamine, p=0.02. A considerable proportion of patients with AUDs admitted for septic shock do not receive thiamine. Thiamine administration in this patient population was associated with decreased mortality. Copyright © 2017 Elsevier Inc. All rights reserved.

[Changes in quality of life and work function during phase prophylactic lamotrigine treatment in bipolar patients: 6 month, prospective, observational study].

PubMed

Gonda, Xenia; Kalman, Janos; Dome, Peter; Rihmer, Zoltan

2016-03-01

Bipolar disorder is a lifelong illness requiring lifelong pharmacotherapy. Therefore besides symptomatic remission, achievement of full work-related functioning and restoration of quality of life is a priority during successful treatment. The present prospective, observational, non-intervention study focused on investigating the effect of lamotrigine therapy on the quality of life and work-related function of bipolar patients in outpatient care. 969 bipolar or schizoaffective outpatients participated in the study who previously did not receive lamotrigine therapy. Our present phase-prophylactic study was a prospective, observational, non-intervention study with a six-month follow-up. Evaluations took place at baseline and at months 1, 2, 3 and 6. Patients were followed with a Clinical Global Impression-Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I). Changes in work-related function was evaluated using Social Adjustment Scale (SAS), while quality of life was assessed with the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) scale. SAS scoreds showed a consistent decrease in the overall sample and in all CGI-S initial groups reflecting the improvement of work-related function during the six months of the follow-up. Q-LES-Q values in the whole sample and in all initial CGI-S groups showed a steady increase indicating a continuous increase in quality of life during the study. Our results indicate that during long-term prophylactic lamotrigine therapy the work function and quality of life of bipolar patients shows a significant improvement, therefore lamotrigine provides a possibility for full functional remission and restoration of quality of life.

Mental health self-assessment in patients with moderate to severe psoriasis: an observational, multicenter study of 1164 patients in Spain (the VACAP Study).

PubMed

Pujol, R M; Puig, L; Daudén, E; Sánchez-Carazo, J L; Toribio, J; Vanaclocha, F; Yébenes, M; Sabater, E; Casado, M A; Caloto, M T; Aragón, B

2013-12-01

Poor self-assessed mental health appears to be related to the severity of psoriasis. To evaluate the impact of psoriasis severity on mood and anxiety disorders. A prospective, observational, multicenter study was conducted by 123 dermatologists in Spain. Patients (n=164; mean [SD] age, 45.11 [13.92] years; 60.8% males) with moderate to severe psoriasis were evaluated at baseline and 4 months later. Psoriasis severity was measured using the Psoriasis Area and Severity Index (PASI), with a score range of 0 (mild) to 72 (severe); body surface area involvement (BSA); and physician global assessment (PGA) scores, with a range of 1 (mild) to 7 (severe). Mental health was assessed using the Hospital Anxiety and Depression Scale (HADS), with a total possible score of 0-42 (higher scores representing worse mental health). Mean first and second visit scores were compared. Mean (SD) scores improved between the first and second visit as follows: 13.24 (9.50) to 5.07 (6.03) for PASI, 12.52 (7.92) to 10.78 (7.32) for overall HADS, 7.83 (4.55) to 6.85 (4.21) for the HADS anxiety subscale, and 4.72 (4.12) to 3.95 (3.76) for the HADS depression subscale (P<.001 in all cases). Multivariate analyses showed that the main factors related to anxiety were psoriasis severity, sex, and completion of graduate studies. The independent variables included in the model for depression were psoriasis severity, sex, and psoriasis located on the head. Reductions in disease severity improve self-assessed mood and anxiety disorders in patients with moderate to severe psoriasis. Copyright © 2012 Elsevier España, S.L. and AEDV. All rights reserved.

Correlation between model observers in uniform background and human observers in patient liver background for a low-contrast detection task in CT

NASA Astrophysics Data System (ADS)

Gong, Hao; Yu, Lifeng; Leng, Shuai; Dilger, Samantha; Zhou, Wei; Ren, Liqiang; McCollough, Cynthia H.

2018-03-01

Channelized Hotelling observer (CHO) has demonstrated strong correlation with human observer (HO) in both single-slice viewing mode and multi-slice viewing mode in low-contrast detection tasks with uniform background. However, it remains unknown if the simplest single-slice CHO in uniform background can be used to predict human observer performance in more realistic tasks that involve patient anatomical background and multi-slice viewing mode. In this study, we aim to investigate the correlation between CHO in a uniform water background and human observer performance at a multi-slice viewing mode on patient liver background for a low-contrast lesion detection task. The human observer study was performed on CT images from 7 abdominal CT exams. A noise insertion tool was employed to synthesize CT scans at two additional dose levels. A validated lesion insertion tool was used to numerically insert metastatic liver lesions of various sizes and contrasts into both phantom and patient images. We selected 12 conditions out of 72 possible experimental conditions to evaluate the correlation at various radiation doses, lesion sizes, lesion contrasts and reconstruction algorithms. CHO with both single and multi-slice viewing modes were strongly correlated with HO. The corresponding Pearson's correlation coefficient was 0.982 (with 95% confidence interval (CI) [0.936, 0.995]) and 0.989 (with 95% CI of [0.960, 0.997]) in multi-slice and single-slice viewing modes, respectively. Therefore, this study demonstrated the potential to use the simplest single-slice CHO to assess image quality for more realistic clinically relevant CT detection tasks.

Cinacalcet may improve oxidative DNA damage in maintenance hemodialysis patients: an observational study.

PubMed

Ari, Elif; Kaya, Yuksel; Demir, Halit; Asicioglu, Ebru; Eren, Zehra; Celik, Eray; Arikan, Hakki

2014-09-01

Oxidative stress is accepted as a non-classical cardiovascular risk factor in patients on maintenance hemodialysis (HD). The aim of this study was to evaluate the impact of cinacalcet on oxidative stress biomarkers, oxidative DNA damage (8-hydroxy-2'-deoxyguanosine/deoxyguanosine), endothelial function (FMD %) and carotid artery intima-media thickness (CIMT) in HD patients. Forty-two chronic HD patients with secondary hyperparathyroidism undergoing 60 mg/day cinacalcet treatment with a follow-up of 6 months and 38 age- and sex-matched healthy individuals were included in this prospective study. Plasma malondialdehyde (MDA) levels and 8-hydroxy-2'-deoxyguanosine/deoxyguanosine ratio (8-OHdG/dG) were determined as oxidative stress markers. Superoxide dismutase (SOD), paraoxonase (PON), catalase (CAT), carbonic anhydrase (CAN) and glutathione peroxidase (GPx) activities were measured as antioxidants. FMD % and CIMT were assessed by ultrasonography. MDA levels were decreased; SOD, PON, CAT, CAN and GPx activities were increased after 6 months of cinacalcet treatment in HD patients. Although CIMT remained stabile, there was a significant improvement in FMD % as well as a notable reduction trend in 8-OHdG/dG ratio after 6 months of treatment. Our data have demonstrated that cinacalcet improves oxidative stress, genomic damage, endothelial function and increases antioxidant protection in HD patients after 6 months of treatment.

Association of body temperature and antipyretic treatments with mortality of critically ill patients with and without sepsis: multi-centered prospective observational study

PubMed Central

2012-01-01

Introduction Fever is frequently observed in critically ill patients. An independent association of fever with increased mortality has been observed in non-neurological critically ill patients with mixed febrile etiology. The association of fever and antipyretics with mortality, however, may be different between infective and non-infective illness. Methods We designed a prospective observational study to investigate the independent association of fever and the use of antipyretic treatments with mortality in critically ill patients with and without sepsis. We included 1,425 consecutive adult critically ill patients (without neurological injury) requiring > 48 hours intensive care admitted in 25 ICUs. We recorded four-hourly body temperature and all antipyretic treatments until ICU discharge or 28 days after ICU admission, whichever occurred first. For septic and non-septic patients, we separately assessed the association of maximum body temperature during ICU stay (MAXICU) and the use of antipyretic treatments with 28-day mortality. Results We recorded body temperature 63,441 times. Antipyretic treatment was given 4,863 times to 737 patients (51.7%). We found that treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen independently increased 28-day mortality for septic patients (adjusted odds ratio: NSAIDs: 2.61, P = 0.028, acetaminophen: 2.05, P = 0.01), but not for non-septic patients (adjusted odds ratio: NSAIDs: 0.22, P = 0.15, acetaminophen: 0.58, P = 0.63). Application of physical cooling did not associate with mortality in either group. Relative to the reference range (MAXICU 36.5°C to 37.4°C), MAXICU ≥ 39.5°C increased risk of 28-day mortality in septic patients (adjusted odds ratio 8.14, P = 0.01), but not in non-septic patients (adjusted odds ratio 0.47, P = 0.11). Conclusions In non-septic patients, high fever (≥ 39.5°C) independently associated with mortality, without association of administration of NSAIDs or

A real-world, multi-site, observational study of infusion time and treatment satisfaction with rheumatoid arthritis patients treated with intravenous golimumab or infliximab.

PubMed

Daniel, Shoshana R; McDermott, John D; Le, Cathy; Pierce, Christine A; Ziskind, Michael A; Ellis, Lorie A

2018-05-25

To assess real-world infusion times for golimumab (GLM-IV) and infliximab (IFX) for rheumatoid arthritis (RA) patients and factors associated with treatment satisfaction. An observational study assessed infusion time including: clinic visit duration, RA medication preparation and infusion time, and infusion process time. Satisfaction was assessed by a modified Treatment Satisfaction Questionnaire for Medication (patient) and study-specific questionnaires (patient and clinic personnel). Comparative statistical testing for patient data utilized analysis of variance for continuous measures, and Fisher's exact or Chi-square test for categorical measures. Multivariate analysis was performed for the primary time endpoints and patient satisfaction. One hundred and fifty patients were enrolled from six US sites (72 GLM-IV, 78 IFX). The majority of patients were female (80.0%) and Caucasian (88.7%). GLM-IV required fewer vials per infusion (3.7) compared to IFX (4.9; p = .0001). Clinic visit duration (minutes) was shorter for GLM-IV (65.1) compared to IFX (153.1; p < .0001), as was total infusion time for RA medication (32.8 GLM-IV, 119.5 IFX; p < .0001) and infusion process times (45.8 GLM-IV, 134.1 IFX; p < .0001). Patients treated with GLM-IV reported higher satisfaction ratings with infusion time (p < .0001) and total visit time (p = .0003). Clinic personnel reported higher satisfaction with GLM-IV than IFX specific to medication preparation time, ease of mixing RA medication, frequency of patients requiring pre-medication, and infusion time. Findings may not be representative of care delivery for all RA infusion practices or RA patients. Shorter overall clinic visit duration, infusion process, and RA medication infusion times were observed for GLM-IV compared to IFX. A shorter duration in infusion time was associated with higher patient and clinic personnel satisfaction ratings.

Low Triiodothyronine Syndrome in Patients With Radiation Enteritis: Risk Factors and Clinical Outcomes an Observational Study.

PubMed

Fan, Shengxian; Ni, Xiaodong; Wang, Jian; Zhang, Yongliang; Tao, Shen; Chen, Mimi; Li, Yousheng; Li, Jieshou

2016-02-01

The implications of low triiodothyronine syndrome (LT3S) in patients with radiation enteritis (RE) have not been properly investigated. As such, we conducted this cohort study to investigate the association between LT3S and RE, to explore the etiology of LT3S in RE, to evaluate the clinical features and clinical outcomes of LT3S patients, and to inspect the correlation of clinical variables and LT3S in RE.This prospective study included 39 RE patients. Medical records and various laboratory parameters (including thyroidal, tumorous, nutritional, and radiotherapy variables) were collected in all participants.Our results showed that the incidence of LT3S was 84.6% in patients with RE. Total protein (71.7 ± 5.7 vs 63.2 ± 9.6 g/L, P = 0.04) and albumin (ALB, 46.0 ± 4.6 vs 38.7 ± 5.3 g/L, P = 0.01) were significantly lower in LT3S group compared with those in euthyroid group. Standard thyroid-stimulating hormone index (-0.89 ± 2.11 vs -2.39 ± 1.33, P = 0.03) and sum activity of deiodinases (19.74 ± 4.19 vs 12.55 ± 4.32 nmol/L, P = 0.01) were significantly lower in LT3S group. Patients with LT3S suffered longer duration of hospitalization (48.25 ± 23.29 days in LT3S vs 26.75 ± 10.56 days in euthyroid, P = 0.036). Low serum ALB (β = 0.694, 95% CI = 0.007-0.190, P = 0.037) was the only significant predictor of LT3S.LT3S was common in RE patients. A hypodeiodination condition and a potential pituitary-thyrotroph dysfunction might play a role in the pathophysiology of LT3S in RE. Worse nutritional status and clinical outcomes were confirmed in RE patients with LT3S. Furthermore, total protein and ALB were observed as protective and differentiating parameters of LT3S in RE. In summary, this was the 1st investigation to evaluate the clinical correlation between RE and LT3S, investigate the prevalence of LT3S in RE, and explore the pathogenesis of LT3S, despite the limitation of a

Temporomandibular Disorders in Psoriasis Patients with and without Psoriatic Arthritis: An Observational Study

PubMed Central

Crincoli, Vito; Di Comite, Mariasevera; Di Bisceglie, Maria Beatrice; Fatone, Laura; Favia, Gianfranco

2015-01-01

AIMS: Psoriasis is a chronic, remitting and relapsing inflammatory disorder, involving the skin, nails, scalp and mucous membranes, that impairs patients' quality of life to varying degrees. Psoriatic arthritis is a chronic seronegative, inflammatory arthritis, usually preceded by psoriasis. Temporomandibular disorders is a generic term referred to clinical conditions involving the jaw muscles and temporomandibular joint. The aim of this study was to assess symptoms and signs of temporomandibular disorders in psoriasis patients with and without psoriatic arthritis. METHODS: The study group included 112 patients (56 men, 56 women; median age 49.7±12 years) with psoriasis, 25 of them were affected by psoriatic arthritis. A group of 112 subjects without psoriasis (56 men, 56 women; median age 47.7±17 years) served as controls. Signs and symptoms of temporomandibular disorders were evaluated according to the standardized Research Diagnostic Criteria for Temporomandibular Disorders. Psoriasis patients were subgrouped according to the presence/absence of psoriatic arthritis and by gender, to assess the prevalence of traditional symptoms and signs of temporomandibular disorders. RESULTS: Patients with psoriasis, and to an even greater extent those with psoriatic arthritis, were more frequently affected by symptoms and signs of temporomandibular disorders, including an internal temporomandibular joint opening derangement than healthy subjects. A statistically significant increase in symptoms of temporomandibular disorders, in opening derangement, bruxism and sounds of temporomandibular joint was found in patients with psoriatic arthritis as compared with psoriasis patients without arthritis and controls. CONCLUSIONS: psoriasis seems to play a role in temporomandibular joint disorders, causing an increase in orofacial pain and an altered chewing function. PMID:26019683

Treatment efficacy with electrochemotherapy: A multi-institutional prospective observational study on 376 patients with superficial tumors.

PubMed

Campana, L G; Testori, A; Curatolo, P; Quaglino, P; Mocellin, S; Framarini, M; Borgognoni, L; Ascierto, P A; Mozzillo, N; Guida, M; Bucher, S; Rotunno, R; Marenco, F; De Salvo, G L; De Paoli, A; Rossi, C R; Bonadies, A

2016-12-01

Cutaneous metastases represent a therapeutic challenge. An increasing body of experience suggests that electrochemotherapy (ECT) provides effective tumor control, although its evidence basis should be strengthened. This prospective, multicenter, observational study enrolled patients with superficial metastases, who underwent ECT at 10 centers between 2008 and 2013. Outcomes included adherence to European Standard Operating Procedures of ECT (ESOPE), tumor response, local progression-free survival (LPFS), toxicity and patient-reported outcomes (PROs, EORTC QLQ-C30 plus an 8-item questionnaire). We enrolled 376 eligible patients. Tumor histotype distribution was as follows: melanoma, 56%; squamous cell carcinoma, 11%; Kaposi sarcoma, 11%; breast carcinoma, 8%; basal cell carcinoma, 6%; soft tissue sarcomas, 3%; others, 5%. We registered 1304 target tumors (median size 1 cm). Treatment adhered to ESOPE in 88% of patients as to the route of drug administration, and in 70% as to electrode application. The procedure was mainly performed under sedation (64.6%) and by using intravenous chemotherapy (93.4%). Tumor response rate at 60 days was 88% (complete, 50%). Small tumor size predicted complete response achievement (OR 2.24, p = 0.003), higher LPFS (HR 0.68, p = 0.004) and improved PROs (Global Health Status, p < 0.001; wound bleeding, p < 0.001; healing, p = 0.002; and aesthetics, p < 0.001). Skin toxicity (grade ≥3, 7.8%) was lower in patients with tumors <2 cm (p≤0.001). One-year LPFS was 73.7% (95%CI 68.4-78.3). ECT represents a valuable skin-directed therapy across a range of malignancies. The most frequently applied treatment modality is intravenous chemotherapy under sedation. Small tumor size predicts durable tumor control, fewer side-effects and better PROs. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Smoking and the risk of diabetic nephropathy in patients with type 1 and type 2 diabetes: a meta-analysis of observational studies.

PubMed

Jiang, Ning; Huang, Feng; Zhang, Xiurong

2017-11-03

Conflicting evidence exists for observational studies on whether tobacco smoking is a risk factor for diabetic nephropathy (DN) in patients with type 1 (T1DM) and type 2 diabetes mellitus (T2DM). In this meta-analysis, we aimed to assess the effects of tobacco smoking on the development of DN. We searched MEDLINE and EMBASE databases from their inception to March 31 st , 2017 for cross-sectional, case-control, and prospective cohort studies. We screened reference lists of retrieved articles. Summary relative risks (SRRs) and 95% confidence intervals (CIs) were calculated using a random-effects model. A total of nineteen observational studies (1 case-control, 8 cross-sectional and 10 prospective cohort studies) were identified, involving more than 78,000 participants and a total of 17,832 DN cases. Compared with never-smokers, there was an augmented SRR (95% CI) of DN in ever-smokers in patients with T1DM (1.31 [1.06-1.62]; P = 0.006) and T2DM (1.44 [1.24-1.67]; P < 0.001), respectively. In patients with T1DM, the SRR (95% CI) was 1.25 (0.86-1.83) for microalbuminuria only, 1.27 (1.10-1.48) for macroalbuminuria only, and 1.06 (0.97-1.15) for end-stage renal disease (ESRD). In patients with T2DM, the SRR (95% CI) associated with ever smoking was 1.46 (0.94-2.26) for microalbuminuria only, 1.72 (1.04-2.84) for macroalbuminuria only, and 1.10 (0.36-3.33) for ESRD. Our meta-analysis suggests evidence for cigarette smoking as an independent risk factor for the development of DN in patients with both T1DM and T2DM.

An observational study of socioeconomic and clinical gradients among diabetes patients hospitalized for avoidable causes: evidence of underlying health disparities in China?

PubMed

Chen, Brian; Eggleston, Karen; Li, Hong; Shah, Nilay; Wang, Jian

2014-01-30

Diabetes is an ambulatory care sensitive condition that can generally be managed in outpatient settings with little or no need for inpatient care. As a preliminary step to investigate whether health disparities can be detected in the inpatient setting in China, we study how diabetic patients hospitalized without prior primary care contact or with greater severity of illness differ from other diabetic inpatients along socioeconomic and clinical dimensions. We conduct an observational study using three years of clinical data for more than 1,800 adult patients with diabetes at two tertiary hospitals in East China. Univariate analysis and probit regression are used to characterize the differences in socioeconomic and clinical factors between patients hospitalized for diabetes with no prior primary care contact and those hospitalized with previous treatment experience. Secondarily, we use ordinary least squares regression to estimate the socioeconomic and clinical differences associated with poor serum glucose control at admission. We find that compared with patients hospitalized after prior treatment experience, inpatients with no previous primary care contact for diabetes have worse clinical laboratory values, are more likely to be young and male, to have lower education attainment, and to have poorer blood sugar control. Insurance, urban residence, and previous use of diabetic medication are in turn negatively correlated with HbA1c levels upon admission. Among hospitalized diabetic patients, socioeconomic factors such as lower education attainment, rural residence and lack of full insurance are associated with avoidable hospitalizations or worse indicators of health. Although we cannot definitively rule out selection bias, these findings are consistent with health disparities observable even at the inpatient level. Future studies should study the underlying mechanism by which traditionally vulnerable groups are more likely to be hospitalized for avoidable causes and

Characteristics and outcomes of older HIV-infected patients receiving antiretroviral therapy in Malawi: A retrospective observation cohort study.

PubMed

Tweya, Hannock; Feldacker, Caryl; Heller, Tom; Gugsa, Salem; Ng'ambi, Wingston; Nthala, Omisher; Kalulu, Mike; Chiwoko, Jane; Banda, Rabecca; Makwinja, Agness; Phiri, Sam

2017-01-01

To estimate patients enrolling on antiretroviral therapy (ART) over time; describe trends in baseline characteristics; and compare immunological response, loss to follow-up (LTFU), and mortality by three age groups (25-39, 40-49 and ≥50 years). A retrospective observation cohort study. This study used routine ART data from two public clinics in Lilongwe, Malawi. All HIV-infected individuals, except pregnant or breastfeeding women, aged ≥ 25 years at ART initiation between 2006 and 2015 were included. Poisson regression models estimated risk of mortality, stratified by age groups. Of 37,378 ART patients, 3,406 were ≥ 50 years old. Patients aged ≥ 50 years initiated ART with more advanced WHO clinical stage and lower CD4 cell count than their younger counterparts. Older patients had a significantly slower immunological response to ART in the first 18 months on ART compared to patients aged 25-39 years (p = 0.04). Overall mortality rates were 2.3 (95% confidence Interval (CI) 2.2-2.4), 2.9 (95% CI 2.7-3.2) and 4.6 (95% CI 4.2-5.1) per 100 person-years in patients aged 25-39 years, 40-49 years and 50 years and older, respectively. Overall LTFU rates were 6.3 (95% CI 6.1-6.5), 4.5 (95% CI 4.2-4.7), and 5.6 (95% CI 5.1-6.1) per 100 person years among increasing age cohorts. The proportion of patients aged ≥ 50 years and newly enrolling into ART care remained stable at 9% while the proportion of active ART patients aged ≥50 years increased from 10% in 2006 to 15% in 2015. Older people had slower immunological response and higher mortality. Malawi appears to be undergoing a demographic shift in people living with HIV. Increased consideration of long-term ART-related problems, drug-drug interactions and age-related non-communicable diseases is warranted.

Characteristics and outcomes of older HIV-infected patients receiving antiretroviral therapy in Malawi: A retrospective observation cohort study

PubMed Central

Tweya, Hannock; Feldacker, Caryl; Heller, Tom; Gugsa, Salem; Ng’ambi, Wingston; Nthala, Omisher; Kalulu, Mike; Chiwoko, Jane; Banda, Rabecca; Makwinja, Agness; Phiri, Sam

2017-01-01

Objective To estimate patients enrolling on antiretroviral therapy (ART) over time; describe trends in baseline characteristics; and compare immunological response, loss to follow-up (LTFU), and mortality by three age groups (25–39, 40–49 and ≥50 years). Design A retrospective observation cohort study. Methods This study used routine ART data from two public clinics in Lilongwe, Malawi. All HIV-infected individuals, except pregnant or breastfeeding women, aged ≥ 25 years at ART initiation between 2006 and 2015 were included. Poisson regression models estimated risk of mortality, stratified by age groups. Results Of 37,378 ART patients, 3,406 were ≥ 50 years old. Patients aged ≥ 50 years initiated ART with more advanced WHO clinical stage and lower CD4 cell count than their younger counterparts. Older patients had a significantly slower immunological response to ART in the first 18 months on ART compared to patients aged 25–39 years (p = 0.04). Overall mortality rates were 2.3 (95% confidence Interval (CI) 2.2–2.4), 2.9 (95% CI 2.7–3.2) and 4.6 (95% CI 4.2–5.1) per 100 person-years in patients aged 25–39 years, 40–49 years and 50 years and older, respectively. Overall LTFU rates were 6.3 (95% CI 6.1–6.5), 4.5 (95% CI 4.2–4.7), and 5.6 (95% CI 5.1–6.1) per 100 person years among increasing age cohorts. The proportion of patients aged ≥ 50 years and newly enrolling into ART care remained stable at 9% while the proportion of active ART patients aged ≥50 years increased from 10% in 2006 to 15% in 2015. Conclusion Older people had slower immunological response and higher mortality. Malawi appears to be undergoing a demographic shift in people living with HIV. Increased consideration of long-term ART-related problems, drug-drug interactions and age-related non-communicable diseases is warranted. PMID:28686636

Effect of Diabetes Mellitus on Tuberculosis Treatment Outcome and Adverse Reactions in Patients Receiving Directly Observed Treatment Strategy in India: A Prospective Study.

PubMed

Siddiqui, Ali Nasir; Khayyam, Khalid Umer; Sharma, Manju

2016-01-01

Despite successful implementation of directly observed treatment, short course (DOTS) in India, the growing number of diabetes mellitus (DM) patients appears to be a cause in the increasing tuberculosis (TB) incidence, affecting their management. In this regard, a prospective study was conducted on DOTS patients in three primary health care centers in urban slum region of South Delhi, India, to evaluate the effect of DM on sputum conversion, treatment outcome, and adverse drug reactions (ADR) due to anti-TB treatment. Eligible TB patients underwent blood glucose screening at treatment initiation. Disease presentation, clinical outcome, and ADRs were compared between patients of TB with and without DM. Out of 316 patients, the prevalence of DM was found to be 15.8%, in which 19.4% and 9.6% were PTB and EPTB patients, respectively. DM patients have observed higher sputum positivity (OR 1.247 95% CI; 0.539-2.886) at the end of 2-month treatment and poor outcome (OR 1.176 95% CI; 0.310-4.457) at the completion of treatment compared with non DM patients. Presence of DM was significantly associated (OR 3.578 95% CI; 1.114-11.494, p = 0.032) with the development of ADRs. DM influences the treatment outcome of PTB patients in our setting and also on the ADR incidence.

Correlation Between Body Temperature and Survival Rate in Patients With Hospital-Acquired Bacteremia: A Prospective Observational Study.

PubMed

Dai, Yu-Tzu; Lu, Shu-Hua; Chen, Yee-Chun; Ko, Wen-Je

2015-10-01

Fever is a complex and major sign of a patient's acute response to infection. However, analysis of the risks and benefits associated with the change in body temperature of an infected host remains controversial. To examine the relationship between the intensity of the change in body temperature and the mortality of patients with hospital-acquired bacteremia. A prospective observational study. Subjects were hospitalized adult patients who developed clinical signs of infection 48 hr or more after admission and had documented bacterial growth in blood culture. The maximum body temperature (maxTe) during the early period of infection measurements (i.e., the day before, the day of, and 2 days after the day of blood culture) was used to indicate the intensity of the body temperature response. Patients were categorized as discharged alive or died in hospital. Cox regression analysis was employed to analyze the data. The cohort consisted of 502 subjects. The mean maxTe of subjects was 38.6°C, and 14.9% had a maxTe lower than 38.0°C. The in-hospital mortality rate was 18.9%. The highest in-hospital mortality was found in subjects with a maxTe lower than 38°C (30.7%). Multivariate Cox regression analysis determined that the maxTe and the severity of comorbidity are the two variables associated with in-hospital mortality. Lack of a robust febrile response may be associated with greater risk of mortality in patients with bacteremia. Clinicians must be vigilant in identifying patients at risk for a blunted febrile response to bacteremia for more intensive monitoring. © The Author(s) 2014.

Safety and effectiveness of eribulin in Japanese patients with locally advanced or metastatic breast cancer: a post-marketing observational study.

PubMed

Watanabe, Junichiro; Ito, Yoshinori; Ohsumi, Shozo; Mizutani, Mitsuhiro; Tashiro, Hideya; Sakurai, Kenichi; Takahashi, Masato; Saito, Tsuyoshi; Tsurutani, Junji; Mukai, Hirofumi; Yoshinami, Tetsuhiro; Takao, Shintaro; Yamamoto, Yasuhisa; Matsuoka, Toshiyuki; Iwase, Hirotaka; Iwata, Hiroji; Nakamura, Seigo; Saeki, Toshiaki

2017-12-01

Background This large-scale study was conducted to evaluate the safety and effectiveness of eribulin for the treatment of inoperable or recurrent breast cancer in real-world settings in Japan. Methods Between July and December 2011, eligible patients with inoperable or recurrent breast cancer receiving eribulin for the first time were centrally registered and observed for 1 year. Eribulin was administered intravenously (1.4 mg/m 2 ) on days 1 and 8 of every 3-week cycle. The primary endpoint was the frequency and intensity of adverse drug reactions (ADRs). Secondary endpoints included overall response rate (ORR) and time to treatment failure (TTF). Results Of 968 patients registered at 325 institutions, 951 and 671 were included in the safety and effectiveness analyses, respectively. In the safety population, ADRs were observed in 841 patients (88.4%). The most common (≥15% incidence) were neutropenia (66.6%), leukopenia (62.4%), lymphopenia (18.4%), and peripheral neuropathy (16.8%). The most common grade ≥ 3 ADRs (>5% incidence) were neutropenia (59.8%), leukopenia (50.5%), lymphopenia (16.1%), and febrile neutropenia (7.7%). In the effectiveness population, ORR was 16.5% (95% confidence interval: 13.7, 19.4). The median TTF was 127 days (95% confidence interval: 120, 134). Conclusions The safety and effectiveness profile of eribulin was consistent with prior studies. Eribulin had a favorable risk-benefit balance when used in real-world clinical settings.

Partial response to proton pump inhibitor therapy for GERD: observational study of patient characteristics, burden of disease, and costs in the USA.

PubMed

Stålhammar, Nils-Olov; Spiegel, Brennan M; Granstedt Löfman, Helena; Karlsson, Maria; Wahlqvist, Peter; Næsdal, Jørgen; Nelson, M Todd; Despiégel, Nicolas

2012-01-01

Disease burden and associated costs are not well understood among patients with gastroesophageal reflux disease (GERD) who have persistent symptoms despite optimized proton pump inhibitor (PPI) therapy. The aim of this study was to investigate disease burden and costs of GERD in partial responders to PPI therapy. The Partial Response to PPI treatment: the Cost to Society and the Burden to the Patient in the US (REMAIN US) study was a 12-month, multicenter, noninterventional, observational study of 552 partial PPI responders in the USA. Participating sites were comprised of family practice (n = 30), internal medicine (n = 8), and specialist (gastroenterologist) centers (n = 15). GERD symptoms, health-related quality of life (HRQL), and impact on productivity were evaluated from patient-reported outcome instruments. Resource utilization data were also collected. Patients had a high symptom burden, impaired HRQL, and reduced productivity while at work and in daily activities, despite optimized PPI therapy. Mean annual GERD-related costs were US$9944 per patient, comprising total direct costs and mean productivity loss costs of US$4068 and US$5876 per patient, respectively. Patients with GERD and a partial response to PPI therapy have considerable direct and indirect costs, along with substantial impairments in HRQL and productivity.

Assessment of activity limitations with the health assessment questionnaire predicts the need for support measures in patients with rheumatoid arthritis: a multicenter observational study.

PubMed

Janssens, Xavier; Decuman, Saskia; De Keyser, Filip

2014-01-01

This study investigated whether the Health Assessment Questionnaire (HAQ) can be used as an instrument to assess the need for social support measures that address activity limitations and participation issues in patients with rheumatoid arthritis (RA). This multicenter observational study included patients with RA and disease duration of at least one year, consulting their rheumatologist for routine evaluation of disease activity. In the single study visit data on demographics, disease history and current treatment were collected. DAS28 values were collected to evaluate current RA disease activity. Patients were asked to fill out the HAQ and SF-36 questionnaires. Receiver Operator Characteristics (ROC) curves were constructed to evaluate the performance of the HAQ, SF-36 and DAS28 in predicting the need for nine supporting measures available for chronically ill patients in the Belgian social security system. The expert opinion of the treating rheumatologist was used as a reference. The study included 316 patients with a mean age of 59.8 ± 12.6 years, disease duration of 11.4 ± 9.3 years, mean DAS28 values of 2.83 ± 1.17. Mean HAQ score was 0.95 ± 0.73, mean SF-36 score 56.5 ± 21.3. HAQ scores >1 were observed in 39.4% of patients. The area under the HAQ ROC curve was consistently >0.7 and higher for the HAQ than for SF-36 or DAS28 for all support measures. Rheumatologists on average recommended 3.67 support measures. The HAQ score was found to be a good predictor of the need for social support measures in patients with RA.

Perception of co-speech gestures in aphasic patients: a visual exploration study during the observation of dyadic conversations.

PubMed

Preisig, Basil C; Eggenberger, Noëmi; Zito, Giuseppe; Vanbellingen, Tim; Schumacher, Rahel; Hopfner, Simone; Nyffeler, Thomas; Gutbrod, Klemens; Annoni, Jean-Marie; Bohlhalter, Stephan; Müri, René M

2015-03-01

Co-speech gestures are part of nonverbal communication during conversations. They either support the verbal message or provide the interlocutor with additional information. Furthermore, they prompt as nonverbal cues the cooperative process of turn taking. In the present study, we investigated the influence of co-speech gestures on the perception of dyadic dialogue in aphasic patients. In particular, we analysed the impact of co-speech gestures on gaze direction (towards speaker or listener) and fixation of body parts. We hypothesized that aphasic patients, who are restricted in verbal comprehension, adapt their visual exploration strategies. Sixteen aphasic patients and 23 healthy control subjects participated in the study. Visual exploration behaviour was measured by means of a contact-free infrared eye-tracker while subjects were watching videos depicting spontaneous dialogues between two individuals. Cumulative fixation duration and mean fixation duration were calculated for the factors co-speech gesture (present and absent), gaze direction (to the speaker or to the listener), and region of interest (ROI), including hands, face, and body. Both aphasic patients and healthy controls mainly fixated the speaker's face. We found a significant co-speech gesture × ROI interaction, indicating that the presence of a co-speech gesture encouraged subjects to look at the speaker. Further, there was a significant gaze direction × ROI × group interaction revealing that aphasic patients showed reduced cumulative fixation duration on the speaker's face compared to healthy controls. Co-speech gestures guide the observer's attention towards the speaker, the source of semantic input. It is discussed whether an underlying semantic processing deficit or a deficit to integrate audio-visual information may cause aphasic patients to explore less the speaker's face. Copyright © 2014 Elsevier Ltd. All rights reserved.

Correlation Between Serum Concentrations of N-Desmethylclozapine and Granulocyte Levels in Patients with Schizophrenia: A Retrospective Observational Study.

PubMed

Smith, Robert L; Haslemo, Tore; Andreassen, Ole A; Eliasson, Erik; Dahl, Marja-Liisa; Spigset, Olav; Molden, Espen

2017-11-01

Clozapine is restricted to use in patients with treatment-refractory schizophrenia due to the risk of a serious drop in absolute neutrophil granulocyte count (ANC). The formation of reactive, unstable metabolites (adducts) has been suggested as a mechanism of clozapine-induced granulocyte decline. These adducts are not detectable in vivo, but stable clozapine metabolites could potentially be indirect pharmacokinetic measures of adduct formation. The present retrospective observational study investigated the correlation between concentrations of N-desmethylclozapine, the major stable clozapine metabolite, and ANC in a real-life population of clozapine-treated patients. Patients were included from a therapeutic drug monitoring service at the Center for Psychopharmacology, Diakonhjemmet Hospital, Oslo, Norway, between March 2005 and December 2015. Information about clozapine and N-desmethylclozapine steady-state trough concentrations, as well as accompanying measurements of ANC, were collected from the laboratory database. Correlations of serum concentrations of N-desmethylclozapine and clozapine (and their respective ratios) with ANC were investigated by linear mixed-model analysis. Overall, 129 patients with 855 measurements of clozapine/N-desmethylclozapine concentrations and ANC (range 0.9-19 × 10 9 cells/L, median 4.6) were included. Concentrations of N-desmethylclozapine, but not clozapine, correlated significantly and positively with ANC (estimated model slope 0.0011 × 10 9 cells/L/nM; p = 0.002), and the N-desmethylclozapine/clozapine ratio also positively correlated with ANC (p = 0.040). N-Desmethylclozapine level and ANC significantly correlated in this real-life population of schizophrenia patients. The positive correlation, which was also present for the metabolic ratio, might reflect reduced clozapine availability for the formation of reactive metabolites potentially affecting granulocyte level. However, as our findings were based on ANC mainly

Retention, dosing, tolerability and patient reported seizure outcome of Zonisamide as only add-on treatment under real-life conditions in adult patients with partial onset seizures: Results of the observational study ZOOM.

PubMed

Hamer, Hajo; Baulac, Michel; McMurray, Rob; Kockelmann, Edgar

2016-01-01

Zonisamide is licensed for adjunctive therapy for partial-onset seizures with or without secondary generalisation in patients 6 years and older and as monotherapy for the treatment of partial seizures in adult patients with newly diagnosed epilepsy, and shows a favourable pharmacokinetic profile with low interaction potential with other drugs. The aim of the present study was to gather real-life data on retention and modalities of zonisamide use when administered as only add-on treatment to a current AED monotherapy in adult patients with partial-onset seizures. This multicenter observational study was performed in 4 European countries and comprised three visits: baseline, and after 3 and 6 months. Data on patients' retention, reported efficacy, tolerability and safety, and quality of life was collected. Of 100 included patients, 93 could be evaluated. After 6 months, the retention rate of zonisamide add-on therapy was 82.8%. At this time, a reduction of seizure frequency of at least 50% was observed in 79.7% of patients, with 43.6% reporting seizure freedom over the last 3 months of the study period. Adverse events were reported by 19.4% of patients, with fatigue, agitation, dizziness, and headache being most frequent. Approximately 25% of patients were older than 60 years, many of whom suffered from late-onset epilepsy. Compared to younger patients, these patients showed considerable differences with regard to their antiepileptic drug regimen at baseline, and slightly higher responder and retention rates at 6 months. Despite limitations due to the non-interventional open-label design and the low sample size, the results show that zonisamide as only add-on therapy is well retained, indicating effectiveness in the majority of patients under real-life conditions. Copyright © 2015. Published by Elsevier Ltd.

A prospective observational study of outcomes from rehabilitation of elderly patients with moderate to severe cognitive impairment.

PubMed

Vassallo, Michael; Poynter, Lynn; Kwan, Joseph; Sharma, Jagdish C; Allen, Stephen C

2016-09-01

To evaluate rehabilitation outcomes in patients with moderate to severe cognitive impairment. Prospective observational cohort study. Rehabilitation unit for older people. A total of 116 patients (70F) mean age (SD) 86.3 (6.4). Group 1: 89 patients with moderate cognitive impairment (Mini-Mental State Examination 11-20); and Group 2: 27 patients with severe cognitive impairment (Mini-Mental State Examination 0-10). A personalised rehabilitation plan. Barthel Activity of Daily Living score on admission and discharge, length of stay and discharge destination. Of 116 patients, 64 (55.2%) showed an improvement in Barthel score. Mini-Mental State Examination was significantly higher in those who improved, 15.4 (SD 3.7) vs.13.2 (SD 5.1): p = 0.01. The mean Barthel score improved in both groups; Group 1 - 14.7 (SD 19.1) vs. Group 2 - 9.3 (SD 16.3): p = 0.17. Of 84 home admissions in Group 1, more patients returning home showed improvements of at least 5 points in the Barthel score compared with nursing/residential home discharges (32/37 - 86.5% vs. 10/28 - 35.7%: p = 0.0001). In Group 2 of 17 home admissions, 6/6 (100%) home discharges showed improvement compared with 3/7 (42.8%) discharges to nursing/residential home (p = 0.07). In Group 1, a discharge home was associated with significantly greater improvement in number of Barthel items than a nursing/residential home discharge (3.27 (SD 2.07) vs. 1.86 (SD 2.32): p = 0.007). A similar non-significant pattern was noted for severe cognitive impairment patients (3.5 (3.06) vs. 1.14 (1.06); p = 0.1). Patients with moderate to severe cognitive impairment demonstrated significant improvements in Barthel score and Barthel items showing that such patients can and do improve with rehabilitation. © The Author(s) 2015.

Cardiovascular assessment of asymptomatic patients with juvenile-onset localized and systemic scleroderma: 10 years prospective observation.

PubMed

Borowiec, A; Dabrowski, R; Wozniak, J; Jasek, S; Chwyczko, T; Kowalik, I; Musiej-Nowakowska, E; Szwed, H