Higher Prevalence Of Adverse Events Research Articles

Assessment of Patient Safety in a Low-Resource Health Care System: Proposal for a Multimethod Study.

The high prevalence of adverse events (AEs) globally in health care delivery has led to the establishment of many guidelines to enhance patient safety. However, patient safety is a relatively nascent concept in low- and middle-income countries (LMICs) where health systems are already overburdened and underresourced. This is why it is imperative to study the nuances of patient safety from a local perspective to advocate for the judicious use of scarce public health resources. This study aims to assess the status of patient safety in a health care system within a low-resource setting, using a multipronged, multimethod approach of standardized methodologies adapted to the local setting. We propose purposive sampling to include a representative mix of public and private, rural and urban, and tertiary and secondary care hospitals, preferably those ascribed to the same hospital quality standards. Six different approaches will be considered at these hospitals including (1) focus group discussions on the status quo of patient safety, (2) Hospital Survey on Patient Safety Culture, (3) Hospital Consumer Assessment of Healthcare Providers and Systems, (4) estimation of incidence of AEs identified by patients, (5) estimation of incidence of AEs via medical record review, and (6) assessment against the World Health Organization's Patient Safety Friendly Hospital Framework via thorough reviews of existing hospital protocols and in-person surveys of the facility. The abovementioned studies collectively are expected to yield significant quantifiable information on patient safety conditions in a wide range of hospitals operating within LMICs. A multidimensional approach is imperative to holistically assess the patient safety situation, especially in LMICs. Our low-budget, non-resource-intensive research proposal can serve as a benchmark to conduct similar studies in other health care settings within LMICs. PRR1-10.2196/50532.

Hsa‑miR‑455‑3P as a predictive biomarker of anemia in patients with non‑small cell lung cancer treated with carboplatin plus paclitaxel.

Lung cancer is the leading cause of cancer-related morbidity and mortality worldwide. The initial treatment of lung cancer depends on the definition of the tumor type and its staging. The most common treatment is chemotherapy, and the first-line treatment is a combination of carboplatin and paclitaxel. Although this treatment has good efficacy, there is a high prevalence of adverse events, particularly hematological reactions. Studies on new biomarkers related to these adverse events, such as circulating microRNAs (miRNAs/miRs), are important for optimizing the quality of life of patients. miRNAs have high stability in several biological fluids and they have specific expressions in different tissues or pathologies. Thus, the present study aimed to assess the relationship between circulating miRNAs and adverse hematologic reactions caused by treatment with carboplatin + paclitaxel in patients with lung cancer. Blood was collected from patients before and 15 days after chemotherapy for hematological adverse reaction analysis, microarray and quantitative (q)PCR validation. Adverse reactions were classified according to the Common Terminology Criteria for Adverse Events v4.0. Microarray analysis was performed using plasma from six patients without anemia and six patients with anemia, and nine miRNAs were differentially expressed. miR-1273g-3p, miR-3613-5p and miR-455-3p, identified using microarray, were assessed using qPCR in 20 patients without anemia and 26 patients with anemia. Bioinformatic analyses of miR-455-3p were performed using miRWalk, the Database for Annotation, Visualization and Integrated Discovery and GeneMania software. Microarray analysis of patients with and without anemia revealed nine significant differentially-expressed plasma miRNAs among these patients. Of these, miR-1273g-3p, miR-3613-5p and miR-455-3p were chosen for further assessment. Only miR-455-3p demonstrated a significant reduction in expression (P=0.04) between the groups before chemotherapy with carboplatin + paclitaxel. Bioinformatics analysis of miR-455-3p revealed a relationship between this miRNA and the hematopoietic pathway, particularly with respect to the RUNX family transcription factor 1 (RUNX1) and TAL bHLH transcription factor 1, erythroid differentiation factor (TAL1) genes. The most prevalent adverse reactions in patients with lung cancer treated with carboplatin + paclitaxel were hematological, particularly anemia. This adverse reaction, caused by dysfunction of the hematopoietic system, may be explained by a possible association between the important genes in this system, RUNX1 and TAL1, and hsa-miR-455-3p.

Evaluating patient safety: Analysis of adverse events in hospitals in Hidalgo

This descriptive observational study analyzes adverse events in public hospitals in Hidalgo between 2013 and 2021. The main objective is to understand patient safety at the local level using data from the Adverse Event Recording System. Data from 1,830 surveys from 14 hospitals were collected, focusing on sociodemographic, clinical, and hospital service variables. The results indicate a higher prevalence of adverse events in women (59.78%) and in the age group of 21 to 30 years. The most common places of occurrence were Internal Medicine and Hospitalization, mainly during the morning shift. The most frequent incidents were medication-related, falls, and infections, with a majority classified as 'no harm'. Patient characteristics and the application of protocols were identified as factors most commonly present in adverse events. However, only 2.02% of the events underwent a root cause analysis. The study highlights the need to develop specific strategies for prevention and reporting, emphasizing continuous education of medical staff and the strengthening of hospital policies, and the consolidation of information on adverse events for future research.

The Challenges and Solutions of Breaking Bad News in Midwifery: a Narrative Review

Introduction: Due to the high prevalence of adverse events during pregnancy and childbirth, the present study was conducted as a narrative review study investigating the challenges of disclosing bad news in the midwifery field and various intervention approaches for teaching bad news.
 Method: This study is in the form of a narrative review and by searching Persian and English databases including Medline, PubMed, Embase, Web of Science, Scopus, CINAHL, IRANDOC, Google Scholar, Iranmedex, medlib, Sid, and Mag-Iran with key Words including bad news, midwifery, childbirth, pregnancy, spikes (S-P-I-K-E-S), midwifery education were conducted in the time range of 1990-2022. Finally, 20 quantitative and qualitative articles were included in the research.
 Results: These articles were examined in two areas: the challenges of health personnel in conveying bad news and different strategies for teaching how to convey bad news. In studies, various techniques have been used to teach the delivery of bad news, such as Spikes protocol, ABCDE method, simulated patient or Mini-CEX, in the teaching of delivery of bad news in various fields of obstetrics, such as IVF failure, intrauterine death, etc. have been. The use of clinical encounter cards or CECs, Asci tests and Mini-CEX are techniques that were used to evaluate students.
 Conclusion: Proper transmission of bad news is one of the challenges of healthcare personnel. Using appropriate educational techniques for students and medical personnel can reduce the negative consequences of inappropriate transmission of bad news.

Is primary care a patient-safe setting? Prevalence, severity, nature, and causes of adverse events: numerous and mostly avoidable.

Knowing the frequency and characteristics of adverse events is key to implementing actions that can prevent their occurrence. However, reporting systems are insufficient for this purpose and epidemiological studies are also required. Currently, the reviewing of clinical records is the gold standard method for knowing the frequency and characteristics of adverse events.Research on adverse events in primary care setting have been limited and primarily focuses on specific types of events (medication errors…) or patients. Large studies that search for any kind of adverse event in all patients are scarce.This study aimed to estimate the prevalence of adverse events in the primary care setting and their characteristics. Setting: all 262 primary healthcare centres in the Madrid region (Spain) during the last quarter of 2018.Design: cross-sectional descriptive study.Eligible population: subjects over 18 years of age who attended medical consultation over the last year (N=2,743,719). Randomised sample stratified by age.Main outcomes: age, sex, occurrence of an adverse event, number of consultations in the study period, avoidability, severity, place of occurrence, type of event, and contributory factors. The clinical records were reviewed by three teams, each composed of one doctor and one nurse trained and with expertise in patient safety.The SPSS software package (version 26) was used for the statistical analyses. The evaluators reviewed 1,797 clinical records. The prevalence ofadverse events over the study period was 5.0%[confidence interval (CI) 95%:4.0%‒6.0%], with higher values in women (5.7%;CI95%:4.6%‒6.8%;P=0.10) and patients over 75 years of age (10.3%;CI95%:8.9%‒11.7%;P<0.001). The overall occurrence per hundred consultations was estimated to be 1.58% (CI95%:1.28%‒1.94%).Of the detected adverse events, 71.3%(CI95%:62.1%‒80.5%) were avoidable. Additionally, 60.6%(CI95%:50.7%‒70.5%) were categorised as mild, 31.9%(CI95%:22.4%‒41.4%) as moderate, and 7.4%(CI95%:2.1%‒12.7%) as severe. Primary care was the occurrence setting in 76.6%(CI95%:68.0%‒85.2%) of cases. The overall incidence of adverse events related to medication was 53.2%(CI95%:50.9%‒55.5%). The most frequent types of AE were prescription errors (28.7%;CI95%:19.5%‒37.9%), followed by drug administration errors by patients (17.0%;CI95%:9.4%‒24.6%), and clinical assessment errors (11.7%;CI95%:5.2%‒18.2%). The most common contributory factors were those related to the patient (80.6%;CI95%:71.1%‒90.1%) and tasks (59.7%;CI95%:48.0%‒71.4%). A high prevalence of adverse events (1 in 66 consultations) was observed, which was slightly higher than those reported in similar studies. About three out of four such events were considered to be avoidable and one out of 13 were severe. Prescription errors, drug administration errors by patients, and clinical assessment errors were the most frequent types of adverse events.

A systematic review of the determinants of implementation of a locomotor training program using a powered exoskeleton for individuals with a spinal cord injury

Background Wearable powered exoskeletons represent a promising rehabilitation tool for locomotor training in various populations, including in individuals with a spinal cord injury. The lack of clear evidence on how to implement a locomotor powered exoskeleton training program raises many challenges for patients, clinicians and organizations. Objective To report determinants of implementation in clinical practice of an overground powered exoskeleton locomotor training program for persons with a spinal cord injury. Data sources Medline, CINAHL, Web of Science. Study selection Studies were included if they documented determinants of implementation of an overground powered exoskeleton locomotor training program for individuals with spinal cord injury. Data extraction Eligible studies were identified by two independent reviewers. Data were extracted by one reviewer, based on constructs of the Consolidated Framework for Implementation Research, and validated by a second reviewer. Results Sixty-three articles were included. 49.4% of all determinants identified were related to the intervention characteristics, 29.6% to the individuals’ characteristic and 13.5% to the inner setting. Recurrent barriers identified were the high prevalence of adverse events (e.g., skin issues, falls) and device malfunctions. Adequate training for clinicians, time and resource available, as well as discussion about patients’ expectations were identified as facilitators. Conclusions Powered exoskeleton training is a complex intervention. The limited information on the context and the implementation process domains may represent a barrier to a successful transition from knowledge to action.

Prevalence of Adverse Events in Healthcare Professionals Using Personal Protective Equipment to Treat COVID-19: A Web-based Survey

Introduction: Healthcare Professionals (HCPs) involved in managing Coronavirus Disease 2019 (COVID-19) pandemic were instructed to wear Personal Protective Equipment (PPE) to protect themselves from contracting virus. However, PPE use can sometimes lead to adverse events which create greater impact on health status of HCPs. Thus, the prevalence of adverse events and associated risk factors should be estimated for taking necessary preventive measures. Aim: To evaluate the prevalence of adverse events in HCPs due to PPE use during second wave of COVID-19 in Tamil Nadu, India. Materials and Methods: A cross-sectional study was conducted in different levels of healthcare centres in Tamil Nadu, India, from April to May 2021. Data were collected using a pre-validated questionnaire from HCPs of any discipline who were directly involved in managing COVID-19 patients. A total of 282 responses were collected through Google forms and proportion of HCPs who experienced adverse events due to PPE and percentage of different adverse events associated with PPE wearing were assessed. Data were analysed using Chi-square test. Results: Out of 282 respondents of the survey included 224 doctors, 34 nurses and 24 lab technicians with a mean age of 30 years. There were 164 females and 118 males. A total of 177 (62.76%) participants experienced adverse events which included dehydration, thirst and heat, headaches, inability to go to restroom and other urinary/respiratory problems. With respect to duration of exposure to PPE, 163 (57.8%) HCPs had &gt;6 hours/day and 102 (36.2%) had 4-6 hours/day. It was observed that factors such as age, gender, profession, various wards posted for COVID-19 duty and duration of PPE worn daily were significantly associated with adverse events to PPE (p-value&lt;0.05). Conclusion: The results of the study concluded that higher prevalence of adverse events with PPE was seen among doctors and nurses. Most common encountered adverse events were dehydration, headache and skin problems, which have been associated with prolonged use of PPE.

Givosiran in acute intermittent porphyria: A personalized medicine approach.

In patients with acute intermittent porphyria (AIP), induction of delta aminolevulinic acid synthase 1 (ALAS1) leads to haem precursor accumulation that may cause recurring acute attacks. In a recent phase III trial, givosiran significantly reduced the attack rate in severe AIP patients. Frequent adverse events were injection-site reaction, fatigue, nausea, chronic kidney disease and increased alanine aminotransferase. To describe the efficacy and safety of givosiran based on a personalized medical approach. We conducted a retrospective patient file study in 25 severe AIP patients treated with givosiran in France. We collected data on clinical and biochemical efficacy along with reports of adverse events. Givosiran drastically reduced the attack rate in our cohort, as 96% were attack-free at the time of the study. The sustained efficacy of givosiran in most patients allowed us to personalize dosing frequency. In 42%, givosiran was only given when haem precursor levels were increasing. Our data suggest that givosiran is most effective when given early in the disease course. We confirmed a high prevalence of adverse events. One patient discontinued treatment due to acute pancreatitis. All patients had hyperhomocysteinemia, and all patients with initial homocysteine levels available showed an increase under treatment. In this context, one patient was diagnosed with pulmonary embolism. The sustained effect of givosiran allowed a decrease in dosing frequency without compromising treatment efficacy. The high prevalence of adverse events emphasizes the importance of restricting the treatment to severe AIP and administering the minimum effective dose for each patient.

Warfarin: time in therapeutic range, a single centre study on patients using warfarin for stroke prevention in non-valvular atrial fibrillation and prosthetic heart valves

Background: Two common indications for oral anticoagulants are patients with non-valvular atrial fibrillation (AF) or prosthetic heart valves (PHV). The degree of anticoagulation is monitored by evaluating the international normalised ratio (INR); however, the quality of anticoagulation, determined by the time in therapeutic range (TTR), is less often evaluated. TTR has significant clinical implications in patient outcomes. Objectives: We sought to identify the indications for anticoagulation and determine its quality via the TTR at a single centre, community-based and district level hospital in the setting of usual care. We documented the prevalence of thrombo-embolic and haemorrhagic adverse events and we also collected data on factors that may contribute to a poor TTR or increased risk of adverse events. Methods: We conducted a retrospective, descriptive and observational study with chart audits evaluating the anticoagulation indication and control for the preceding 1 year for each patient. Descriptive statistics included mean and standard deviation for quantitative data and frequencies for categorical data. Chi-square tests were used to analyse comparisons of categorical data and the student’s t-test for continuous variables. Two-tailed p-values less than 0.05 were considered significant. Results: TTR was poor for patients with AF and PHV (44.5% and 13.7% respectively). We identified older age, less frequent testing and high target ranges as significant factors associated with poorer outcomes. We demonstrated a high prevalence of adverse events (25.4%). Conclusion: Patients in this setting demonstrated poor quality of anticoagulation and had a high prevalence of adverse events.

The possible impact of socioeconomic, income, and educational status on adverse effects of drug and their therapeutic episodes in patients targeted with a combination of tuberculosis interventions.

First-line antituberculosis (anti-TB) compounds have been considered as proven components of the Directly Observed Treatment-Short course (DOTS). Drug therapy against tuberculosis has been categorized as I, II, or III following the Revised National Tuberculosis Control Program guidelines. Anti-TB are drugs are quite common and show limited adverse effects. However, first-line anti-TB compounds mediated DOTS therapy and were found with several complications. Thus, those drugs have been discontinued. Therefore, the present study was designed to find out the possible impact of socioeconomic, income, and educational status on the adverse effects of drugs and their therapeutic episodes in patients targeted with a combination of tuberculosis intervention. This study found that an increased incidence of tuberculosis was found in patients who have finished high school, contributing to a high percentage of adverse effects. Notably, adverse events were shown maximally in poor patients compared with rich- or high-income patients. On the contrary, a high prevalence of adverse events was shown to be increased in partially skilled workers compared with full-skilled workers. Consequently, adversely considerable events were implicated to be raised in patients associated with minimal socioeconomic class. Such interesting factors would help in monitoring such events in experimental patients.

A Likert-Type scale for evaluating the “bottom line” of patient safety

The formally reported number of adverse events may be open to ambivalent interpretation – actual higher prevalence of adverse events versus a patient safety culture supporting reporting and learning. Many methods appearing in the literature that are not based on reporting systems struggle for adequately assess the precise level of prevalence of adverse events. Confronting this challenge in patient safety research, we suggest evaluating the perceived state of “almost no adverse events” in the ward, by using a short Likert- type scale we developed for this purpose. Some evidence for its reliability and validity are presented using two samples (99 head nurses, and 383 nurses). As was expected, leadership had a significant direct effect on the measured state of “almost no adverse events” as well as an indirect effect mediated successively by psychological safety, and safety behavior.

Planned early delivery versus expectant management to reduce adverse pregnancy outcomes in pre-eclampsia in a low- and middle-income setting: study protocol for a randomised controlled trial (CRADLE-4 Trial)

BackgroundPre-eclampsia is a pregnancy complication characterised by high blood pressure and multi-organ dysfunction in the mother. It is a leading contributor to maternal and perinatal mortality, with 99% of these deaths occurring in low- and middle-income countries (LMIC). Whilst clear guidelines exist for management of early-onset (< 34 weeks) and term (≥ 37 weeks) disease, the optimal timing of delivery in pre-eclampsia between 34+ 0 and 36+ 6 weeks is less clear. In a high-income setting, delivery may improve maternal outcomes without detriment to the baby, but this intervention is yet to be evaluated in LMIC.MethodsThe CRADLE-4 Trial is a non-masked, randomised controlled trial comparing planned early delivery (initiation of delivery within 48 h of randomisation) with routine care (expectant management) in women with pre-eclampsia between 34+ 0 and 36+ 6 weeks’ gestation in India and Zambia. The primary objective is to establish whether a policy of planned early delivery can reduce adverse maternal outcomes, without increasing severe neonatal morbidity.DiscussionThe World Health Organization recommends delivery for all women with pre-eclampsia from 37 weeks onwards, based on evidence showing clear maternal benefit without increased neonatal risk. Before 34 weeks, watchful waiting is preferred, with delivery recommended only when there is severe maternal or fetal compromise, due to the neonatal risks associated with early preterm delivery. Currently, there is a lack of guidance for clinicians managing women with pre-eclampsia between 34+ 0 and 36+ 6 weeks. Early delivery benefits the mother but may increase the need for neonatal unit admission in the infant (albeit without serious morbidity at this gestation). On the other hand, waiting to deliver may increase the risk of stillbirth, fetal growth restriction and hypoxic brain injury in the neonate as a result of severe maternal complications. This is especially true for LMIC where there is a higher prevalence of adverse events. The balance of risks and benefits therefore needs to be carefully assessed before making firm recommendations. This is the first trial evaluating the optimal timing of delivery in pre-eclampsia in LMIC, where resources and disease burden are considerably different.Trial registrationISRCTN 10672137. Registered on 28 November 2019.

Subjective Toxicity Profiles of Children in Treatment for Cancer: A New Guide to Supportive Care?

ContextChildren and adolescents with cancer experience treatment-related, subjective adverse events (AEs). Identifying distinct groups of patients who predictably experience higher prevalence of AEs could guide patient care. ObjectivesStudy aims were to 1) identify groups of children and adolescents reporting AEs using the Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE); 2) determine whether demographic and clinical characteristics predict AE group membership; and 3) examine whether AE group membership was related to the distal outcome of psychological stress. MethodsFour hundred seventy-seven patients self-reported AEs via the Ped-PRO-CTCAE at T1 (beginning of treatment) and the PROMIS Pediatric Psychological Stress measure at T2 (7–28 days later). Latent class analysis was conducted to identify groups of patients and the relationships of the groups with demographic and clinical characteristics, and with stress. ResultsThree distinct a priori unknown AE groups were identified (high AE prevalence, moderate AE prevalence, and low AE prevalence). Females, blacks, patients with high psychological stress, and patients more recently diagnosed were more likely to be in the high AE prevalence group. Gender, age, race, and time since diagnosis were associated with psychological stress. ConclusionChildren with cancer are heterogeneous in experiencing subjective AEs. Gender, race, and time since diagnosis were significantly associated with higher subjective AE prevalence that may lead to psychological stress.

Effect Of Energy Drink Consumption On Heart Rate Variability And Blood Glucose In Relation To Exercise

There is high prevalence of adverse events associated with caffeinated energy drink (CED) consumption. PURPOSE: This study aimed to examine the acute physiological effects of CED in apparently-healthy volunteers, pre-, during-, and post-exercise. METHODS: A randomized cross-over double-blind design with three experimental conditions was used: a CED condition, a matched caffeine-carbohydrate beverage condition (MB), and a control beverage condition (CB). Participants underwent blood glucose, heart rate variability (HRV), and heart rate measures pre- and post-exercise. During the exercise component, participants increased cycling intensity to a respiratory exchange ratio of 0.96 to 0.98 and maintained the workload for 20-minutes. Blood glucose, HRV, and heart rate measures were compared using two-way ANOVA, and exercise measures were compared using one-way ANOVA. RESULTS: As seen in Figure 1, an effect of condition on blood glucose (p < 0.001), an effect of time on blood glucose (p < 0.001), and an effect of condition x time on blood glucose (p < 0.001) was observed. Specifically, pre-exercise there was a increase in blood glucose in the CED condition relative to the MB condition (6.59±0.63 vs. 5.61±0.76 mmol⋅L-1, p < 0.001), and in the MB condition relative to the CB condition (5.61±0.76 vs. 5.28±0.40 mmol⋅L-1, p = 0.045). There was no effect of condition on HRV, heart rate, or exercise measures. CONCLUSION: Given the increased blood glucose in the CED condition relative to the MB conditions it is concluded that an ingredient in commercial CED must stimulate the endogenous release of glucose into circulation.Fig. 1: Mean condition blood glucose concentration values over time. Effect of condition and time (p < 0.001), effect of condition x time (p < 0.001). * indicates statistical significance between conditions (p < 0.050).

Mobile home residence as a risk factor for adverse events among children in a mixed rural-urban community: A case for geospatial analysis.

Given the significant health effects, we assessed geospatial patterns of adverse events (AEs), defined as physical or sexual abuse and accidents or poisonings at home, among children in a mixed rural-urban community. We conducted a population-based cohort study of children (<18 years) living in Olmsted County, Minnesota, to assess geographic patterns of AEs between April 2004 and March 2009 using International Classification of Diseases, Ninth Revision codes. We identified hotspots by calculating the relative difference between observed and expected case densities accounting for population characteristics (; hotspot ≥ 0.33) using kernel density methods. A Bayesian geospatial logistic regression model was used to test for association of subject characteristics (including residential features) with AEs, adjusting for age, sex, and socioeconomic status (SES). Of the 30,227 eligible children (<18 years), 974 (3.2%) experienced at least one AE. Of the nine total hotspots identified, five were mobile home communities (MHCs). Among non-Hispanic White children (85% of total children), those living in MHCs had higher AE prevalence compared to those outside MHCs, independent of SES (mean posterior odds ratio: 1.80; 95% credible interval: 1.22-2.54). MHC residency in minority children was not associated with higher prevalence of AEs. Of addresses requiring manual correction, 85.5% belonged to mobile homes. MHC residence is a significant unrecognized risk factor for AEs among non-Hispanic, White children in a mixed rural-urban community. Given plausible outreach difficulty due to address discrepancies, MHC residents might be a geographically underserved population for clinical care and research.

[Opioids for Cancer Pain and its Use under Particular Conditions: A Narrative Review].

All health professionals should be aware of the importance of evaluating pain - fifth vital sign- in cancer patients. Peripheral and central acting analgesics are widely used to treat moderate to severe pain, particularly cancer pain. Many guidelines have addressed this issue. However, real life patients' have other problems and comorbidities that may raise doubts when prescribing. Authors made a literature search, trying to clarify same specific situations: loss of oral route, renal impairment (hemodialysis), hepatic impairment, frequent opiod interactions and the availability of short-acting formulations. The following medicines were included in this analysis: the natural opiates (morphine and codeine), their synthetic and semisynthetic derivatives (hydromorphone, oxycodone, and fentanyl), the partial agonist buprenorphine and finally tramadol and tapentadol. Transdermal systems are only available for buprenorphine and fentanyl. In hepatic impairment, fentanyl is safe, but with the exception of codeine and tramadol; other opioids should be used with caution. In renal failure: fentanyl, hydromorphone, and tapentadol are safe. Morphine should be avoided; other opioids should be used with caution. In hemodialysis, buprenorphine, fentanyl, hydromorphone and tramadol (at doses up to 200 mg/day) may be used. Failure to recognize the impact of various situations described throughout this work, including the bioavailability due to loss of oral route, due to pharmacokinetics and pharmacodynamics of the various drugs, either in the context of the impaired metabolism or excretion, or in due to pharmacological interactions, conditions a serious risk of subtreatment of pain and consequent impact in terms of quality of life. Opioid prescription is safe and effective, even in moderate to severe comorbidities such as renal and hepatic impairment and in patients with no oral route available. In this case, as when considering pharmacological interactions, an individualized therapeutic plan is the best solution and the patient should be assessed regularly. Unadjusted doses may relate to bad pain control and a higher prevalence of adverse events.

Enhanced skin targeting of retinoic acid spanlastics: in vitro characterization and clinical evaluation in acne patients

Acne vulgaris is the most common dermatological disorder affecting millions of individuals. Acne therapeutic solutions include topical treatment with retinoic acid (RA) which showed a good efficacy in treatment of mild and moderate cases. However, the high prevalence of adverse events, such as skin dryness, shedding and skin irritation affects the patient convenience and obstruct the acne treatment. Thus, the objective of this paper was to produce Span 60 based elastic vesicles enriched with penetration enhancers, and study their influence on the delivery of RA and its skin irritation. RA-loaded nanovesicles, enriched with Transcutol®/Labrasol®, were made using the thin film hydration technique, and assessed for entrapment efficiency, particle size and zeta potential. The optimized RA-loaded nanovesicles (composed of Span 60-Tween 20, and Transcutol®) were morphologically assessed via transmission electron microscopy. Moreover, RA deposition into newborn mice skin was assessed in vitro under non-occlusive conditions, where the optimized RA-loaded nanovesicles showed 2-fold higher RA deposition in the skin compared to the corresponding one lacking Transcutol. The optimized RA-loaded nanovesicles incorporated into 1% carbopol gel was evaluated for in-vivo clinical performance in acne patients, and showed appreciable advantages over the marketed formulation (Acretin®) in the treatment of acne regarding skin tolerability and patient’s compliance.

Adverse effects observed in lung cancer patients undergoing first-line chemotherapy and effectiveness of supportive care drugs in a resource-limited setting.

Background:Lung cancer (LC) chemotherapy results in several adverse events (AEs). Data regarding supportive care medications (SCMs) offered to prevent/treat AEs in resource-limited settings are lacking. A prospective observational study was carried out to find the effectiveness of SCMs in real-life setting.Methods:Newly diagnosed LC patients receiving first-line chemotherapy at a tertiary referral center in North India (from July 2014 to September 2015) were enrolled. Incidence, timing of onset, duration, and grades of chemotherapy-related AEs were recorded. We assessed compliance to mandatory SCMs using a structured questionnaire. Patients also recorded various symptoms, frequency of need-based SCMs, visits to local practitioners, and hospitalization (if any) during the intercycle period.Results:Of the 112 patients enrolled, majority were males (83.9%, n = 94), current/ex-smokers (82.1%, n = 92), had advanced stage (Stage IIIB = 33.9% [n = 38] and Stage IV = 46.4% [n = 52]), and were non-small cell lung cancer (72.3%, n = 81). AEs were reported in 566 cycles (94%) out of a total of 602 chemotherapy cycles. Diarrhea was the most common AE (180 cycles, 29.9%) developing after a mean (standard deviation) duration of 3.6 (2.5) days and lasting for 4 (3.3) days. Vomiting (138 cycles, 22.9%) and constipation (121 cycles, 20.1%) were other common AEs. Grade 3/4 AEs occurred in 6.9% (39/566) cycles. Need-based SCMs were required in 479 of the 566 cycles (84.6%). Proportion of patients with Grade 3/4 AEs and hospitalization was highest for mucositis (16.1% Grade 3/4 and 9.7% hospitalized); followed by vomiting (10.1% Grade 3/4 and 8.7% hospitalized). Anemia was seen in 441 of 602 chemotherapy cycles (73.3%). Frequency and severity of anemia continued to increase with each chemotherapy cycle.Conclusion:LC chemotherapy has a high prevalence of AEs. However, the majority are low grade recovering with need-based SCMs, without any need for hospitalization.

Self-expandable metal stents are a valid option in long-term survivors of advanced esophageal cancer

self-expandable metal stents are often used for the palliative treatment of dysphagia in patients with advanced esophageal cancer and an anticipated limited survival. Due to previous reports of a high rate of adverse event when used long-term, concerns have been raised with regard to the use of self-expandable metal stents in patients with a longer survival. assess the role of esophageal self-expandable metal stents in patients with advanced esophageal cancer that have survived longer than six months. retrospective study of patients with advanced esophageal cancer with a self-expandable metal stent and a stent placement time greater than six months. forty-two patients were followed up for 298 days. There was a clinical improvement in all patients. However, 59% of patients experienced an adverse event. The median stent patency was 236 days. Endoscopic management was attempted in all self-expandable metal related adverse events, with a clinical success rate of 100%. However, the previously treated adverse event recurred in seven patients. Multivariate analysis showed that strictures that were traversable with an ultrathin gastroscope were associated with a higher risk of adverse events (p = 0.035). long-term esophageal stenting in patients with advanced esophageal cancer is associated with a high prevalence of adverse events without an impact on mortality; most cases can be managed endoscopically.

Neuropsychiatric adverse events of antiepileptic drugs in brain tumour-related epilepsy: an Italian multicentre prospective observational study.

We assessed the prevalence and magnitude of neuropsychiatric adverse events (NPAEs) associated with antiepileptic drugs (AEDs) among patients with brain tumour-related epilepsy (BTRE). This observational, prospective, multicentre study enrolled 259 patients with BTRE after neurosurgery. All patients received AED monotherapy. Efficacy was assessed through clinical diaries, whereas NPAEs were collected using the Neuropsychiatric Inventory Test-12 questionnaire at baseline and after 5 months. Tumour localization in the frontal lobe was associated with a higher prevalence of NPAEs (odds ratio, 7.73; P < 0.001). Independent of tumour localization, levetiracetam (LVT) treatment was associated with higher prevalence and magnitude of NPAEs (odds ratio, 7.94; P < 0.01) compared with other AEDs. Patients with oligodendroglioma reported more NPAEs than patients with other tumour types. NPAEs were not influenced by chemotherapy, radiotherapy or steroid treatment. Evaluating non-neurobehavioural adverse events of AEDs, no significant differences were found among AEDs, although patients treated with old AEDs had a higher prevalence of adverse events than those treated with new AEDs. Both tumour localization in the frontal lobe and LVT treatment are associated with a higher risk of NPAEs in patients with BTRE. LVT is regarded as a first-line option in patients with BTRE because of easy titration and few significant drug-to-drug interactions. Thus, as NPAEs lead to poor compliance and a high dropout rate, clinicians need to accurately monitor NPAEs after AED prescription, especially in patients with frontal lobe tumours receiving LVT.