Predicting cumulative incidence of adverse events in older patients with cancer undergoing first-line palliative chemotherapy: Korean Cancer Study Group (KCSG) multicentre prospective study.
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SUBMITTER: Kim JW
PROVIDER: S-EPMC5943243 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectiveTo explore timing in relation to all types of adverse events (AEs), severity and preventability for patients undergoing acute and elective hip arthroplasty.DesignA multicentre cohort study using retrospective record review with Global Trigger Tool methodology in combination with data from several registers.Setting24 hospitals in 4 major regions of Sweden.ParticipantsPatients ≥18 years, undergoing acute or elective total or hemiarthroplasty of the hip, were eligible for inclusion. Reviews of weighted samples of 1998 randomly selected patient records were carried out using Global Trigger Tool methodology. The patients were followed for readmissions up to 90 days postoperatively throughout the whole country.ResultsThe cohort consisted of 667 acute and 1331 elective patients. Most AEs occurred perioperatively and postoperatively (n=2093, 99.1%) and after discharge (n=1142, 54.1%). The median time from the day of surgery to the occurrence of AE was 8 days. The median days for different AE types ranged from 0 to 24.5 for acute and 0 to 71 for elective patients and peaked during different time periods. 40.2% of the AEs, both major and minor, occurred within postoperative days 0-5 and 86.9% of the AEs occurred within 30 days. Most of the AEs were deemed to be of major severity (n=1370, 65.5%) or preventable (n=1591, 76%).ConclusionsA wide variability was found regarding the timing of different AEs with the majority occurring within 30 days. The timing and preventability varied regarding the severity. Most of the AEs were deemed to be preventable and/or of major severity. To increase patient safety for patients undergoing hip arthroplasty surgery, a better understanding of the multifaceted nature of the timing of AEs in relation to the occurrence of differing AEs is needed.
| S-EPMC10277118 | biostudies-literature
Project description:ObjectiveTo prospectively assess the construct and criterion validity of ClassIntra version 1.0, a newly developed classification for assessing intraoperative adverse events.DesignInternational, multicentre cohort study.Setting18 secondary and tertiary centres from 12 countries in Europe, Oceania, and North America.ParticipantsThe cohort study included a representative sample of 2520 patients in hospital having any type of surgery, followed up until discharge. A follow-up to assess mortality at 30 days was performed in 2372 patients (94%). A survey was sent to a representative sample of 163 surgeons and anaesthetists from participating centres.Main outcome measuresIntraoperative complications were assessed according to ClassIntra. Postoperative complications were assessed daily until discharge from hospital with the Clavien-Dindo classification. The primary endpoint was construct validity by investigating the risk adjusted association between the most severe intraoperative and postoperative complications, measured in a multivariable hierarchical proportional odds model. For criterion validity, inter-rater reliability was evaluated in a survey of 10 fictitious case scenarios describing intraoperative complications.ResultsOf 2520 patients enrolled, 610 (24%) experienced at least one intraoperative adverse event and 838 (33%) at least one postoperative complication. Multivariable analysis showed a gradual increase in risk for a more severe postoperative complication with increasing grade of ClassIntra: ClassIntra grade I versus grade 0, odds ratio 0.99 (95% confidence interval 0.69 to 1.42); grade II versus grade 0, 1.39 (0.97 to 2.00); grade III versus grade 0, 2.62 (1.31 to 5.26); and grade IV versus grade 0, 3.81 (1.19 to 12.2). ClassIntra showed high criterion validity with an intraclass correlation coefficient of 0.76 (95% confidence interval 0.59 to 0.91) in the survey (response rate 83%).ConclusionsClassIntra is the first prospectively validated classification for assessing intraoperative adverse events in a standardised way, linking them to postoperative complications with the well established Clavien-Dindo classification. ClassIntra can be incorporated into routine practice in perioperative surgical safety checklists, or used as a monitoring and outcome reporting tool for different surgical disciplines. Future studies should investigate whether the tool is useful to stratify patients to the appropriate postoperative care, to enhance the quality of surgical interventions, and to improve long term outcomes of surgical patients.Trial registrationClinicalTrials.gov NCT03009929.
| S-EPMC7500355 | biostudies-literature
Project description:Background and purposePrimary ovarian insufficiency (POI) has serious physical and psychological consequences due to estradiol deprivation, leading to increased morbidity and mortality. However, the causes of most POI cases remain unknown. Psychological stress, usually caused by stressful life events, is known to be negatively associated with ovarian function. It is important to explore high-frequency adverse life events among women with POI for future interventions.MethodsForty-three women (mean age=33·8 years) were recruited who were newly- diagnosed with idiopathic POI (FSH levels >40 IU/L) to participate in semi-structured interviews through convenience sampling. The main questions covered by the topic guide were designed to explore adverse life events prior to POI diagnosis. Interviews were audio recorded, transcribed and analyzed thematically. Data were analyzed from June 2019 to August 2020.ResultsAmong the women with POI, mean age at diagnosis of POI was 33·8 years (range from 19 to 39 years), and the average time between the onset of irregular menstruation and POI diagnosis was 2.3 years. These women with POI had a relatively normal menstrual cycle before the diagnosis. A number of stressful life events prior to POI diagnosis were discussed by them as important factors influencing their health. Four core themes emerged: 1) persistent exposure to workplace stress, 2) persistent exposure to family-related adverse life events, 3) sleep problem/disturbance existed in women with POI before diagnosis, and 4) participants' general cognition and concerns about POI.ConclusionsPersistent exposures to adverse life events related to work stress, family stress and sleep problem existed in women with POI. Our findings are consistent with the hypothesis that adverse life events play a role in the development of POI. Future research should investigate how social environmental factors influence POI disease risks, and whether provision of tailored interventions (i.e. preventing or mitigating impact of adverse life events) aimed at high-risk populations may help prevent new POI cases and improve conditions of women with POI. We gained an in-depth understanding of the experiences of these women via 1:1 qualitative method, and find adverse life events are frequent in women with POI prior to the diagnosis.
| S-EPMC9259945 | biostudies-literature
Project description:IntroductionNon-steroidal anti-inflammatory drugs (NSAIDs) are recommended as postoperative analgesia by the Enhanced Recovery After Surgery Society. Recent studies have raised concerns that NSAID administration following colorectal anastomosis may be associated with increased risk of anastomotic leak. This multicentre study aims to determine NSAIDs' safety profile following gastrointestinal resection.Methods and analysisThis prospective, multicentre cohort study will be performed over a 2-week period utilising a collaborative methodology. Consecutive adults undergoing open or laparoscopic, elective or emergency gastrointestinal resection will be included. The primary end point will be the 30-day morbidity, assessed using the Clavien-Dindo classification. This study will be disseminated through medical student networks, with an anticipated recruitment of at least 900 patients. The study will be powered to detect a 10% increase in complication rates with NSAID use.Ethics and disseminationFollowing the Research Ethics Committee Chairperson's review, a formal waiver was received. This study will be registered as a clinical audit or service evaluation at each participating hospital. Dissemination will take place through previously described novel research collaborative networks.
| S-EPMC4078775 | biostudies-literature
Project description:BackgroundThe prognosis of advanced pancreatic cancer (APC) is poor and differs considerably among patients. Therefore, it is clinically relevant to identify patients with APC who are more likely to benefit from palliative chemotherapy with reduced risk of toxicity. To date, there is no prognostic score universally recommended to help clinicians in planning the therapeutic management.MethodsUsing individual patient data from 319 cases of APC treated with gemcitabine-based chemotherapy and enrolled in the SAKK 44/00-CECOG/PAN.1.3.001 randomized trial, several baseline variables, including inflammatory markers, were analysed post hoc as predictors of mortality and/or grade 3 or 4 chemotherapy-related toxicity and separate risk scores were developed.ResultsMedian survival of the study patients was 7.9 months (interquartile range 3.7-13.3 months). Independent predictors of mortality included increased Aspartate transaminase (ASAT), low performance status, increased derived neutrophil to lymphocyte ratio, increased Carbohydrate Antigen 19-9 (CA 19-9), low haemoglobin, presence of pain, presence of metastasis and increased alkaline phosphatase (ALP). During the study, 117 patients experienced at least one grade 3 or 4 adverse event. Independent predictors of toxicity included white blood cells, ALP, renal function and bilirubin levels at baseline. Both models displayed moderate levels of discrimination (C-statistic 0.68 and 0.64 for mortality and toxicity, respectively) and adequate calibration.ConclusionsWe developed simple-to-use prognostic scores for mortality and severe toxicity for patients with APC. These scores can be useful in daily practice to identify patients with increased risk of death or toxicity and to plan the most appropriate therapeutic strategy to improve survival and quality of life. Further prospective studies to validate such scores are needed.
| S-EPMC6317152 | biostudies-literature
Project description:PurposeThe purpose of this study was to prospectively validate the Korean Cancer Study Group Geriatric Score (KG)-7, a novel geriatric screening tool, in older patients with advanced cancer planned to undergo first-line palliative chemotherapy.Materials and methodsParticipants answered the KG-7 questionnaire before undergoing geriatric assessment (GA) and first-line palliative chemotherapy. The performance of KG-7 was evaluated by calculating the sensitivity (SE), specificity (SP), positive and negative predictive value (PPV and NPV), balanced accuracy (BA), and area under the curve (AUC).ResultsThe baseline GA and KG-7 results were collected from 301 patients. The median age was 75 years (range, 70 to 93 years). Abnormal GA was documented in 222 patients (73.8%). Based on the ≤ 5 cut-off value of KG-7 for abnormal GA, abnormal KG-7 score was shown in 200 patients (66.4%). KG-7 showed SE, SP, PPV, NPV, and BA of 75.7%, 59.7%, 84.4%, 46.0%, and 67.7%, respectively; AUC was 0.745 (95% confidence interval, 0.687 to 0.803). Furthermore, patients with higher KG-7 scores showed significantly longer survival (p=0.006).ConclusionKG-7 appears to be adequate in identifying patients with abnormal GA prospectively. Hence, KG-7 can be a useful screening tool for Asian countries with limited resources and high patient volume.
| S-EPMC6639235 | biostudies-literature
Project description:IntroductionPeripheral venous catheters (PVC) are medical devices most frequently used during hospital care. Although the frequency of specific PVC-related adverse events (PVCAEs) has been reported, the global risk related to the insertion of this device is poorly estimated. The aim of this study is to determine the incidence of PVCAEs during the indwell time, after catheter removal, and to identify practice-mirroring risk factors.MethodsA prospective observational study was conducted as a part of a research project, called CATHEVAL, in one surgery ward and four medicine wards from three public general tertiary care hospitals in Northern France that were invited to participate between June-2013 and June-2014. Each participating ward included during a two-month study period all patients older than 15 years carrying a PVC. All inserted PVCs were monitored from insertion of PVC to up to 48 hours after removal. Monitored data included several practice-mirroring items, as well as the occurrence of at least one PVCAE. A multivariate Cox proportional hazard model, based on a marginal risk approach, was used to identify factors associated with the occurrence of at least one PVCAE.ResultsData were analysed for 815 PVCs (1964 PVC-days) in 573 patients. The incidence of PVCAE was 52.3/100 PVCs (21.9/100 PVC-days). PVCAEs were mainly clinical: phlebitis (20.1/100 PVCs), haematoma (17.7/100 PVCs) and liquid/blood escape (13.1/100 PVCs). Infections accounted for only 0.4/100 PVCs. The most frequent mechanical PVCAEs, was obstruction/occlusion of PVC (12.4/100 PVCs). The incidence of post-removal PVCAEs was 21.7/100 PVCs. Unstable PVC and unclean dressing were the two main risk factors.ConclusionLimitation of breaches in healthcare quality including post-removal monitoring should be reinforced to prevent PVC-related adverse events in hospital settings.
| S-EPMC5207628 | biostudies-literature
Project description:Biliary and pancreatic diseases are common in the elderly; however, few studies have addressed the occurrence of adverse events in elderly patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). Our objective was to determine the incidence rates of specific adverse events in this group and calculate incidence rate ratios (IRRs) for selected comparison groups.Bibliographical searches were conducted in Medline, EMBASE, and Cochrane library databases. The studies included documented the incidence of adverse events (perforation, pancreatitis, bleeding, cholangitis, cardiopulmonary adverse events, mortality) in patients aged ≥ 65 who underwent ERCP. Pooled incidence rates were calculated for each reported adverse event and IRRs were determined for available comparison groups. A parallel analysis was performed in patients aged ≥ 80 and ≥ 90.Our literature search yielded 7429 articles, of which 69 studies met our inclusion criteria. Pooled incidence rates for adverse events (per 1000 ERCPs) in patients aged ≥ 65 were as follows: perforation 3.8 (95 %CI 1.8 - 7.0), pancreatitis 13.1 (95 %CI 11.0 - 15.5), bleeding 7.7 (95 %CI 5.7 - 10.1), cholangitis 16.1 (95 %CI 11.7 - 21.7), cardiopulmonary events 3.7 (95 %CI 1.5 - 7.6), and death 7.1 (95 %CI 5.2 - 9.4). Patients ≥ 65 had lower rates of pancreatitis (IRR 0.3, 95 %CI 0.3 - 0.4) compared with younger patients. Octogenarians had higher rates of death (IRR 2.4, 95 %CI 1.3 - 4.5) compared with younger patients, whereas nonagenarians had increased rates of bleeding (IRR 2.4, 95 %CI 1.1 - 5.2), cardiopulmonary events (IRR 3.7, 95 %CI 1.0 - 13.9), and death (IRR 3.8, 95 %CI 1.0 - 14.4). Conclusions ERCP appears to be safe in elderly patients, except in the very elderly who are at higher risk of some adverse events. These data on adverse event rates can help to inform clinical decision-making, the consent process, and comparative effectiveness analyses.
| S-EPMC4423280 | biostudies-other
Project description:ObjectiveTo evaluate the association between human papillomavirus (HPV) vaccination and serious adverse events in adolescent girls in South Korea.DesignCohort study.SettingA large linked database created by linking the Korea Immunization Registry Information System and the National Health Information Database, between January 2017 and December 2019.Participants441 399 girls aged 11-14 years who had been vaccinated in 2017: 382 020 had been vaccinated against HPV and 59 379 had not been vaccinated against HPV.Main outcome measuresOutcomes were 33 serious adverse events, including endocrine, gastrointestinal, cardiovascular, musculoskeletal, haematological, dermatological, and neurological diseases. A cohort design was used for the primary analysis and a self-controlled risk interval design for the secondary analysis; both analyses used a risk period of one year after HPV vaccination for each outcome. Incidence rate and adjusted rate ratios were estimated using Poisson regression in the primary analysis, comparing the HPV vaccinated group with the HPV unvaccinated group, and adjusted relative risks were estimated using conditional logistic regression in the secondary analysis.ResultsAmong the 33 predefined serious adverse events, no associations were found with HPV vaccination in the cohort analysis, including Hashimoto's thyroiditis (incidence rate per 100 000 person years: 52.7 v 36.3 for the vaccinated and unvaccinated groups; adjusted rate ratio 1.24, 95% confidence interval 0.78 to 1.94) and rheumatoid arthritis (incidence rate per 100 000 person years: 168.1 v 145.4 for the vaccinated and unvaccinated groups; 0.99, 0.79 to 1.25), with the exception of an increased risk observed for migraine (incidence rate per 100 000 person years: 1235.0 v 920.9 for the vaccinated and unvaccinated groups; 1.11, 1.02 to 1.22). Secondary analysis using self-controlled risk intervals confirmed no associations between HPV vaccination and serious adverse events, including migraine (adjusted relative risk 0.67, 95% confidence interval 0.58 to 0.78). Results were robust to varying follow-up periods and for vaccine subtypes.ConclusionsIn this nationwide cohort study, with more than 500 000 doses of HPV vaccines, no evidence was found to support an association between HPV vaccination and serious adverse events using both cohort analysis and self-controlled risk interval analysis. Inconsistent findings for migraine should be interpreted with caution considering its pathophysiology and the population of interest.
| S-EPMC8030229 | biostudies-literature
Project description:BackgroundPatients with advanced stage non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC) often experience multidimensional impairments, affecting quality of life during their course of disease. In lung cancer patients with operable disease, several studies have shown that exercise has a positive impact on quality of life and physical functioning. There is limited evidence regarding efficacy for advanced lung cancer patients undergoing palliative treatment. Therefore, the POSITIVE study aims to evaluate the benefit of a 24-week exercise intervention during palliative treatment in a randomized controlled setting.Methods/designThe POSITIVE study is a randomized, controlled trial investigating the effects of a 24-week exercise intervention during palliative treatment on quality of life, physical performance and immune function in advanced, non-operable lung cancer patients. 250 patients will be recruited in the Clinic for Thoracic Diseases in Heidelberg, enrolment begun in November 2013. Main inclusion criterion is histologically confirmed NSCLC (stage IIIa, IIIb, IV) or SCLC (Limited Disease-SCLC, Extensive Disease-SCLC) not amenable to surgery. Patients are randomized into two groups. Both groups receive weekly care management phone calls (CMPCs) with the goal to assess symptoms and side effects. Additionally, one group receives a combined resistance and endurance training (3x/week). Primary endpoints are quality of life assessed by the Functional Assessment of Cancer Therapy for patients with lung cancer (FACT-L, subcategory Physical Well-Being) and General Fatigue measured by the Multidimensional Fatigue Inventory (MFI-20). Secondary endpoints are physical performance (maximal voluntary isometric contraction, 6-min walk distance), psychosocial (depression and anxiety) and immunological parameters and overall survival.DiscussionThe aim of the POSITIVE trial is the evaluation of effects of a 24-week structured and guided exercise intervention during palliative treatment stages. Analysis of various outcomes (such as quality of life, physical performance, self-efficacy, psychosocial and immunological parameters) will contribute to a better understanding of the potential of exercise in advanced lung cancer patients. In contrast to other studies with advanced oncological patients the POSITIVE trial provides weekly phone calls to support patients both in the intervention and control group and to segregate the impact of physical activity on quality of life.Trial registrationClinicalTrials.gov NCT02055508 (Date: December 12, 2013).
| S-EPMC4949758 | biostudies-literature