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NAVIGATE: improving survival in vulnerable patients with lung cancer through nurse navigation, symptom monitoring and exercise – study protocol for a multicentre randomised controlled trial

BMJ Open. 2022 Oct 31;12(10):e060242. doi: 10.1136/bmjopen-2021-060242.

ABSTRACT

INTRODUCTION AND AIM: Low socioeconomic position (SEP) has been shown to be strongly associated with impaired lung cancer survival. Barriers related to receiving recommended treatment among patients with lung cancer with low SEP may include adverse health behaviour and limited physical and psychosocial resources influencing the ability to react on high-risk symptoms and to navigate the healthcare system. To address the underlying factors that drive both decisions of treatment, adherence to treatment and follow-up in vulnerable patients with lung cancer, we developed the Navigate intervention. The aim of this randomised controlled trial is to investigate the effect of the intervention on survival (primary outcome), lung cancer treatment adherence, health-related quality of life and other psychosocial outcomes as well as health costs and process evaluation (secondary outcomes) in a study population of vulnerable patients with lung cancer.

METHODS AND ANALYSIS: This two-armed multicentre randomised trial will recruit patients from five lung cancer clinics in Denmark identified as vulnerable according to a screening instrument with nine clinical and patient-reported vulnerability criteria developed for the study. We will enrol 518 vulnerable patients >18 years old diagnosed with non-small cell lung cancer at all stages with a performance status <2. Participants will be randomly allocated to either standard treatment and intervention or standard treatment alone. The Navigate intervention is based on principles from motivational interviewing and includes three components of nurse navigation, systematic monitoring of patient-reported outcomes (PROs) and physical exercise in a person-centred delivery model. Data will be collected at baseline and 3, 6, 12 months after randomisation using questionnaires, clinical data and physical function tests.

ETHICS AND DISSEMINATION: Ethics Committee, Region Zealand (SJ-884/EMN-2020-37380) and the Data Protection Agency in Region Zealand (REG-080-2021) approved the trial. Participants will provide written informed consent. Results will be reported in peer-reviewed journals.

TRIAL REGISTRATION NUMBER: NCT05053997.

PMID:36316074 | DOI:10.1136/bmjopen-2021-060242

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Canadian Anaphylaxis Network-Predicting Recurrence after Emergency Presentation for Allergic REaction (CAN-PREPARE): a prospective, cohort study protocol

BMJ Open. 2022 Oct 31;12(10):e061976. doi: 10.1136/bmjopen-2022-061976.

ABSTRACT

INTRODUCTION: Anaphylaxis is a severe, potentially fatal multiorgan system manifestation of an allergic reaction. The highest incidence of anaphylaxis is in children and adolescents. Biphasic anaphylaxis (BA) is defined as the recurrence of allergic symptoms after resolution of an initial reaction. It has been reported to occur in 10%-20% of cases within 1-48 hours from the onset of the initial reaction. The dilemma for physicians is determining which patients with resolved anaphylaxis should be observed for BA and for how long. Guidelines for duration of postanaphylaxis monitoring vary, are based on limited evidence and can have unintended negative impacts on patient safety, quality of life and healthcare resources. The objectives of this study are to derive a prognostic model for BA and to develop a risk-scoring system that informs disposition decisions of children who present to emergency departments (ED) with anaphylaxis.

METHODS AND ANALYSIS: This prospective multicentre cohort study will enrol 1682 patients from seven paediatric EDs that are members of the Paediatric Emergency Research Canada network. We will enrol patients younger than 18 years of age with an allergic reaction meeting anaphylaxis diagnostic criteria. Trained ED research assistants will screen, obtain consent and prospectively collect study data. Research assistants will follow patients during their ED visit and ascertain, in conjunction with the medical team, if the patient develops BA. A standardised follow-up survey conducted following study enrolment will determine if a biphasic reaction occurred after ED disposition. Model development will conform to the broad principles of the PROGRESS (Prognosis Research Strategy) framework and reporting will follow the Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis Statement.

ETHICS AND DISSEMINATION: Ethics approval has been received from all participating centres. Our dissemination plan focuses on informing clinicians, policy makers and parents of the results through publication in peer-reviewed journals and broadcasting on multiple media platforms.

TRIAL REGISTRATION NUMBER: NCT05135377.

PMID:36316072 | DOI:10.1136/bmjopen-2022-061976

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Extent of disability among paediatric Japanese encephalitis survivors and predictors of poor outcome: a retrospective cohort study in North India

BMJ Open. 2022 Oct 31;12(10):e060795. doi: 10.1136/bmjopen-2022-060795.

ABSTRACT

OBJECTIVE: To determine the Japanese encephalitis (JE)-associated long-term functional and neurological outcomes, the extent of reduced social participation and predictors of poor outcomes among paediatric JE survivors.

DESIGN: A retrospective cohort study.

SETTING: Laboratory-confirmed JE-positive paediatric cases (<16 years of age) hospitalised at the paediatric ward of Baba Raghav Das Medical College, Gorakhpur, India, between 1 January 2017 and 31 December 2017, were followed up after 6-12 months of hospital discharge.

PARTICIPANTS: 126 patients were included in the study; median age was 7.5 years (range: 1.5-15 years), and 74 (58.73%) were male.

OUTCOME MEASURES: Functional outcome defined by Liverpool Outcome Score (LOS) dichotomised into poor (LOS=1-2) and good (LOS=3-5) outcome groups compared for demographic, clinical and biochemical parameters for prognostic factors of poor outcomes. Social participation of patients scaled on Child and Adolescent Scale of Participation score 2-5.

RESULTS: About 94 of 126 (74.6%) children developed neurological sequelae at different levels of severity. Age-expected social participation was compromised in 90 out of 118 children. In multivariate logistic regression analysis, a combination of parameters, JE unvaccinated status (OR: 61.03, 95% CI (14.10 to 264); p<0.001), low Glasgow Coma Score (GCS) at admission (≤8) (OR: 8.6, 95% CI (1.3 to 57.1); p=0.026), malnutrition (OR: 13.56, 95% CI (2.77 to 66.46); p=0.001) and requirement of endotracheal intubation (OR: 5.43, 95% CI (1.20 to 24.44); p=0.027) statistically significantly predicted the poor outcome with 77.8% sensitivity and 94.6% specificity. The goodness-of-fit test showed that the model fit well (Hosmer-Lemeshow goodness-of-fit test) (χ 2=3.13, p=0.988), and area under the receiver operating characteristic curve was 0.950.

CONCLUSION: This study estimates the burden of JE-presenting post-discharge deaths (15.4%) and disability (63.08%). Those who did not receive JE vaccine, were suffering from malnutrition, had GCS ≤8 at admission and required endotracheal intubation had poorer outcomes.

PMID:36316071 | DOI:10.1136/bmjopen-2022-060795

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Ticagrelor-Aspirin Versus Clopidogrel-Aspirin Among CYP2C19 Loss-of-Function Carriers With Minor Stroke or Transient Ischemic Attack in Relation to Renal Function: A Post Hoc Analysis of the CHANCE-2 Trial

Ann Intern Med. 2022 Nov 1. doi: 10.7326/M22-1667. Online ahead of print.

ABSTRACT

BACKGROUND: Evidence on the risk-benefit ratio of dual antiplatelet therapies among patients with stroke and impaired renal function is limited and inconsistent.

OBJECTIVE: To investigate the effect of renal function on the efficacy and safety of ticagrelor-aspirin versus clopidogrel-aspirin treatment.

DESIGN: Post hoc analysis of a multicenter, randomized, double-blind, placebo-controlled trial. (ClinicalTrials.gov: NCT04078737).

SETTING: 202 centers in China.

PATIENTS: CYP2C19 loss-of-function allele carriers with minor stroke or transient ischemic attack.

INTERVENTION: Ticagrelor-aspirin and clopidogrel-aspirin.

MEASUREMENTS: Renal function was evaluated by estimated glomerular filtration rate (eGFR) levels. The primary efficacy and safety outcomes were recurrent stroke and severe or moderate bleeding within 90 days, respectively.

RESULTS: Among 6378 patients, 4050 (63.5%) had normal (eGFR ≥90 mL/min/1.73 m2), 2010 (31.5%) had mildly decreased (eGFR 60 to 89 mL/min/1.73 m2), and 318 (5.0%) had moderately to severely decreased (eGFR <60 mL/min/1.73 m2) renal function. The corresponding differences in recurrent stroke between ticagrelor-aspirin and clopidogrel-aspirin for normal, mildly decreased, and moderately to severely decreased renal function was -2.8 percentage points (95% CI, -4.4 to -1.3 percentage points) (hazard ratio [HR], 0.63 [CI, 0.49 to 0.81]), -0.2 percentage point (CI, -2.4 to 2.0 percentage points) (HR, 0.98 [CI, 0.69 to 1.39]), and 3.7 percentage points (CI, -2.3 to 10.1 percentage points) (HR, 1.31 [CI, 0.48 to 3.55]), respectively. Rates of severe or moderate bleeding did not substantially differ by treatment assignments across eGFR categories.

LIMITATION: Renal function was only evaluated by using eGFR, and the proportion of patients with severely decreased renal function was low.

CONCLUSION: Patients with normal, rather than impaired, renal function received greater benefit from ticagrelor-aspirin versus clopidogrel-aspirin.

PRIMARY FUNDING SOURCE: Ministry of Science and Technology of the People’s Republic of China.

PMID:36315949 | DOI:10.7326/M22-1667

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Slow Uptake of an Effective Therapy: Patterns of Olanzapine Prescribing for Those Receiving Highly Emetogenic Chemotherapy

JCO Oncol Pract. 2022 Oct 31:OP2200389. doi: 10.1200/OP.22.00389. Online ahead of print.

ABSTRACT

PURPOSE: For the past 5 years, most major antiemesis guidelines have included olanzapine-containing regimens among the recommended options for prophylaxis with highly emetogenic chemotherapy (HEC). We analyzed the uptake of olanzapine in clinical practice and the changing composition of multidrug antiemetic regimens.

METHODS: A retrospective analysis was performed using an OptumLabs deidentified database of medical and pharmacy claims, which was filtered for patients starting HEC in the interval of 2006 to Q2 of 2021. Descriptive statistics were used to analyze patient characteristics and year-by-year antiemetic prescribing patterns, coinciding with cycles 1 and 2 of chemotherapy.

RESULTS: A total of 63,154 distinct patients were included. The median age was 58 years (range, 18-88). Breast (45.2%) and hematologic (20.8%) cancers were the most common diagnoses. In 2016, olanzapine was prescribed to 1.4% of patients with cycle 1 of HEC. Prescriptions increased modestly each year, and by 2021, 13.9% of patients received olanzapine with their first cycle of chemotherapy. An additional 5.7% of patients received olanzapine for breakthrough symptoms or enhanced prophylaxis during cycle 2. In 2021, more than three-quarters of patients were prescribed antiemetics in a guideline-concordant manner, with an olanzapine-containing quadruplet (12.2%), an NK1-receptor antagonist triplet (64.5%), or an olanzapine triplet (suppressed for small sample size).

CONCLUSION: Despite inclusion in major antiemesis guidelines, there has been relatively slow uptake of olanzapine for prophylaxis with HEC. This finding highlights the challenges of disseminating information and keeping prescribing systems updated with the newest evidence in supportive oncology.

PMID:36315918 | DOI:10.1200/OP.22.00389

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High-Fidelity Simulation Effects on Cardiopulmonary Resuscitation Self-Efficacy and Knowledge Retention in Undergraduate Nursing Students: A Two-Group, Experimental, Longitudinal Pilot Study

Nurs Educ Perspect. 2022 Nov-Dec 01;43(6):E118-E120. doi: 10.1097/01.NEP.0000000000000984.

ABSTRACT

This pilot study aimed to assess the effects of high-fidelity simulation on cardiopulmonary resuscitation (CPR) self-efficacy and knowledge retention compared to case-based learning. A two-group, experimental, longitudinal design was adopted. Fifty-two undergraduate nursing students were invited to participate in the study, which was conducted between March and May 2019. The results show statistically significant differences in favor of the experimental group on both CPR knowledge retention and self-efficacy one month after training. These findings may assist nurse educators to implement high-fidelity simulation in CPR education.

PMID:36315894 | DOI:10.1097/01.NEP.0000000000000984

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The Impact of a Cognitive Behavioral Intervention on Test Anxiety in a BSN Program

Nurs Educ Perspect. 2022 Nov-Dec 01;43(6):E97-E99. doi: 10.1097/01.NEP.0000000000000989. Epub 2022 May 13.

ABSTRACT

Test anxiety and attrition are prevalent in nursing programs. Efforts should be made to assist nursing students in obtaining coping mechanisms to reduce anxiety. The aim of this quantitative, quasi-experimental, before and after study was to determine the impact of a cognitive-behavioral intervention on test anxiety during first-semester nursing courses. Thirty bachelor of science in nursing students in a rural university participated in a cognitive-behavioral intervention and completed the Cognitive Test Anxiety Scale. A two-tailed, dependent-samples t-test determined a statistically significant decrease in test anxiety scores (p < .001), supporting interventions aimed at reducing both the physical and mental effects of test anxiety.

PMID:36315890 | DOI:10.1097/01.NEP.0000000000000989

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Observed Injury Rates Did Not Follow Theoretically Predicted Injury Risk Patterns in Professional Human Circus Artists

Clin J Sport Med. 2022 Nov 1;32(6):e627-e634. doi: 10.1097/JSM.0000000000001045. Epub 2022 May 20.

ABSTRACT

OBJECTIVE: Identifying which types of athletes have increased injury risk (ie, predictive risk factors) should help develop cost-effective selective injury prevention strategies. Our objective was to compare a theoretical injury risk classification system developed by coaches and rehabilitation therapists, with observed injury rates in human circus acts across dimensions of physical stressors, acrobatic complexity, qualifications, and residual risks.

DESIGN: Descriptive epidemiological study.

SETTING: professional circus company.

PATIENTS OR OTHER PARTICIPANTS: Human circus artists performing in routine roles between 2007 and 2017.

ASSESSMENT OF RISK FACTORS: Characteristics of circus acts categorized according to 4 different dimensions.

MAIN OUTCOME MEASURES: Medical attention injury rates (injury requiring a visit to the therapist), time-loss injury rates (TL-1; injury resulting in at least one missed performance), and time-loss 15 injury rates (TL-15; injury resulting in at least 15 missed performances).

RESULTS: Among 962 artists with 1 373 572 performances, 89.4% (860/962) incurred at least one medical attention injury, 74.2% (714/962) incurred at least one TL-1 injury, and 50.8% (489/962) incurred at least one TL-15 injury. There were important inconsistencies between theoretical and observed injury risk patterns in each of the 4 dimensions for all injury definitions (medical attention, TL-1, and TL-15).

CONCLUSIONS: Although theoretical classifications are the only option when no data are available, observed risk patterns based on injury surveillance programs can help identify artists who have a high (or low) theoretical risk but are nonetheless actually at low (or high) risk of injury, given their current roles. This will help develop more cost-effective selective injury prevention programs.

PMID:36315828 | DOI:10.1097/JSM.0000000000001045

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Does the Addition of Whole-Body Vibration Training Improve Postural Stability and Lower Limb Strength During Rehabilitation Following Anterior Cruciate Ligament Reconstruction: A Systematic Review With Meta-analysis

Clin J Sport Med. 2022 Nov 1;32(6):627-634. doi: 10.1097/JSM.0000000000001001. Epub 2022 Jan 25.

ABSTRACT

OBJECTIVES: To investigate whether the addition of whole-body vibration therapy to standard rehabilitation improves postural stability and lower limb strength following anterior cruciate ligament (ACL) reconstruction.

DATA SOURCES: A computer-based literature search of MEDLINE, AMED, SPORTDiscus, Embase, CINAHL, CENTRAL, and Physiotherapy Evidence Database (PEDro) included studies up to October 2019.

MAIN RESULTS: Seven randomised controlled trials of moderate-to-high methodological quality involving 244 participants were included. Meta-analysis found statistically significant improvements in medial-lateral stability [standardized mean difference (SMD) = 0.50; 95% confidence interval (CI), 0.12-0.88] and overall stability (SMD = 0.60; 95% CI, 0.14-1.06) favoring whole-body vibration therapy, but effects were not significant for quadriceps strength (SMD = 0.24; 95% CI, -0.65 to 1.13), hamstring strength (SMD = 0.84; 95% CI, -0.05 to 1.72), lower limb strength (SMD = 0.76; 95% CI, -0.16 to 1.67), or anterior-posterior stability (SMD = 0.19; 95% CI, -0.39 to 0.76).

CONCLUSIONS: The addition of whole-body vibration therapy to standard postoperative rehabilitation following ACL reconstruction does not appear to significantly improve lower limb strength and anterior-posterior stability but may improve medial-lateral and overall postural stability. We found small sample sizes in all included trials, statistical heterogeneity, and methodological quality concerns, including publication bias, suggesting that larger high-quality trials are likely to be influential in this field. Registration: PROSPERO 155531.

PMID:36315822 | DOI:10.1097/JSM.0000000000001001

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Preliminary Evaluation of a Novel Point of Care Diagnostic Device for Sports-Related Concussion

Clin J Sport Med. 2022 Nov 1;32(6):623-626. doi: 10.1097/JSM.0000000000001056. Epub 2022 Jul 6.

ABSTRACT

OBJECTIVE: Visinin-like protein 1 (VILIP-1) is a neuron-specific calcium sensor protein rapidly released into blood after mild traumatic brain injury (mTBI) and may be a suitable biomarker for identification of sports-related concussion (SRC). The objective of the study is to test if quantification of a specific post-translationally modified (ubiquitinated) form of VILIP-1 (ubVILIP-1) from a fingerstick blood sample using a point of care (POC) lateral flow device (LFD) can be used to rapidly identify athletes with SRC.

DESIGN: Prospective cohort study.

SETTING: Side-line blood collection at football, soccer, and volleyball games/practices.

PARTICIPANTS: Division I athletes with/without SRC.

MAIN OUTCOME MEASURES: Blood ubVILIP-1 concentrations.

RESULTS: Data collected over 2 athletic seasons from non-SRC athletes (controls) show a small but statistically significant elevation of ubVILIP-1 over an individual season for male athletes (P = 0.02) dependent on sport (P = 0.014) and no significant changes in ubVILIP-1 levels between seasons. For SRC athletes, the data show ubVILIP-1 levels substantially increase above baseline as soon as 30 minutes postdiagnosis with peak concentrations and times postinjury that vary based on injury severity.

CONCLUSION: Results of the study suggest quantification of blood ubVILIP-1 levels measured using an LFD may provide an objective identification of athletes with SRC, setting the stage for further study with a larger number of SRC patients.

PMID:36315821 | DOI:10.1097/JSM.0000000000001056