Negative Outcomes Research Articles

Cardiac dysfunction in patients with cirrhosis and acute decompensation.

The prevalence of cirrhotic cardiomyopathy (CCM) has been reported as high as 60%-70% in patients with liver cirrhosis and is associated with various negative outcomes. There has been a growing understanding of CCM over recent years. Indeed, the development of imaging techniques has enabled new diagnostic criteria to be proposed by the Cirrhotic Cardiomyopathy Consortium. However, important unanswered questions remain over pathophysiological mechanisms, optimal diagnostic modalities and potential treatment options. While there has been an increasing volume of literature evaluating CCM, there is a lack of clarity on its implications in acute decompensation, acute-on-chronic liver failure and following interventions such as transjugular intrahepatic portosystemic shunt insertion and liver transplantation. This review aims to summarise the literature in these challenging domains and suggest where future research should focus. We conclude that systemic inflammation and structural myocardial changes are likely to be crucial in the pathophysiology of the disease, but the relative contribution of different components remains elusive. Furthermore, future studies need to use standardised diagnostic criteria for CCM as well as incorporate newer imaging techniques assessing both myocardial structure and function. Finally, while specific treatments are currently lacking, therapeutics targeting systemic inflammation, microbial dysbiosis and bacterial translocation are promising targets and warrant further research.

Risk Factors for Complications in Patients Undergoing Temporal Bone Resection and Neck Dissection: Insights From a National Database.

Temporal bone resection (TBR) with or without neck dissection (ND) is performed for otologic malignancies with occult or clinical cervical lymph node metastases. To date, characterization of post-operative complications in single institution case series may be non-representative of real-world outcomes. Here, we used data from the National Inpatient Sample (NIS) to comprehensively assess the complications encountered, their frequencies, and to identify underlying risk factors to improve future outcomes. The population was patients undergoing TBR and ND derived from the NIS between the years of 2017 and 2019. We utilized ICD-10 diagnosis codes to identify patients with post-operative complications, those discharged to non-home facilities (DNHF), and those with increased length of stay (LOS). Multivariable regression was performed to identify significant variables related to the above outcomes. Ninety of 277 patients that underwent LTBR with ND had postoperative complications. Wound complications were the most frequent complication, occurring in 11 (4%) of patients, followed by CSF leak (n = 6; 2.2%), with acute respiratory failure being the most common medical complication (n = 4; 1.4%). Sixteen percent (45/277) were discharged to a facility besides home. Dementia (OR = 7.96; CI95 3.62-17.48), anemia (OR = 2.39; CI95 1.15-4.99), congestive heart failure (OR = 5.31; CI95 1.82-15.45), COPD (OR = 3.70; CI95 1.35-10.16), and history of prior stroke (OR = 8.50; CI95 1.55-46.68) increased the odds of DNHF. When evaluating LOS (median = 5 days, IQR = 1, 9), anemia (OR = 5.49; CI95 2.86-10.52), and Medicaid insurance (OR = 3.07; CI95 1.06-10.52) were found to increase the LOS. The vast majority of patients undergoing LTBR with ND have no complications and are discharged within a week. Liver disease is a risk factor for medical complications and increased charges. Patients with dementia or a prior stroke are at risk for DNHF, and those with prior anemia are at risk for a wound complication. This study identified factors related to worse post-operative outcomes in patients undergoing temporal bone resection and neck dissection. Although safe for most patients, an existing diagnosis of liver disease, stroke, dementia, and anemia specifically are at risk for developing negative outcomes. 3.

Risk equations for prosthetic joint infections (PJIs) in UK: a retrospective study using the Clinical Practice Research Datalink (CPRD) AURUM and GOLD databases

BackgroundProsthetic joint infections (PJIs) are a serious negative outcome of arthroplasty with incidence of about 1%. Risk of PJI could depend on local treatment policies and guidelines; no UK-specific risk...

Denitrifying bioreactors and dissolved phosphorus: Net source or sink?

Understanding the world through a lens of phosphorus (P), as Dr. Andrew Sharpley aimed to do, adds a deeper dimension for water quality work in the heavily tile-drained US Midwest where nitrate is often the nutrient of biggest concern. Denitrifying woodchip bioreactors reduce nitrate pollution in drainage water, but dissolved phosphorus leached from the organic fill is a possible pollution tradeoff. Recent work by Dr. Sharpley and others defined such tradeoffs as strategic decisions in which a negative outcome is accepted with prior knowledge of the risk. In this vein, we assessed 23 site-years from full-size bioreactors in Illinois to determine if bioreactors were a net dissolved reactive phosphorus (DRP) source and, if so, to determine flow-related correlation agents (1904 sample events; 10 bioreactors). DRP was removed across the bioreactors in 15 of 23 site-years. The 23 site-years provided a median annual DRP removal efficiency of 12% and a median annual DRP removal rate of 7.1mg DRP/m3 bioreactor per day, but the ranges of all removal metrics overlapped zero. The highest daily bioreactor DRP removal rates occurred with high inflow concentrations and under low hydraulic retention times (i.e., under higher loading). Dr. Sharpley was one of the first to explore losses of DRP in subsurface drainage and performed decades of useful applied studies that inspired approaches to management of P loss on both drained and undrained land. We seek to honor this legacy with this practical study of the DRP benefits and tradeoffs of denitrifying bioreactors.

Standardized phase angle: relationship with functionality, muscle mass and postoperative outcomes in surgical cancer patients.

To evaluate the association of standardized phase angle (SPA) with nutritional status, functional parameters, and postoperative outcomes in surgical cancer patients. This prospective study includes 59 cancer patients from Pelotas (Brazil) admitted for elective cancer surgery. We obtained the phase angle through Bioelectrical Impedance Analysis (BIA) and standardized it according to the population's reference values. We estimated the muscle mass using BIA for later calculation of the Skeletal Muscle Index (SMI) and performed handgrip strength (HGS) and gait speed (GS) tests. We used the Patient-Generated Subjective Global Assessment (PG-SGA) to assess the nutritional status. Postoperative complications and duration of hospital stay were evaluated as the outcomes. The prevalence of malnutrition in the sample was 28.8%, according to ASG-PPP. SPA was statistically lower in patients with malnutrition, with lower HGS and reduced GS. For postoperative outcomes, patients with severe complications and those with prolonged hospitalization also had lower SPA values. The greater the number of functional alterations in patients, the lower the SPA value, mainly when associated with reduced muscle mass assessed by BIA, suggesting that muscle mass reduction plays an important role in the association between functional alterations and phase angle in patients with cancer. According to the parameters used in this study, low SPA value was associated with impaired nutritional and functional status and negative outcomes in the analyzed sample.

Postoperative Activity Restrictions After Slings: A Randomized Controlled Trial.

Restricting activity after midurethral slings is an unproven practice. The objective of this study was to evaluate the effect of postoperative activity restriction on satisfaction and outcomes after slings. This was a multicenter, 2-arm, noninferiority randomized controlled trial. Patients aged 18-85 years undergoing treatment with a midurethral sling were randomized 1:1 to postoperative activity restriction or liberal activity. Restrictions included avoidance of strenuous exercise and heavy lifting. The liberal group was allowed to resume activity at their discretion. Our primary outcome was satisfaction with postoperative instruction at 2 weeks. Secondary outcomes included surgical failure, mesh exposure rates, and other adverse events. In total, 158 patients were randomized with 80 to the liberal group and 78 to the restricted group. At 2 weeks, 54 (80.6%) of patients in the liberal group and 48 (73.9%) of patients in the restricted group were satisfied. We found statistical evidence supporting the hypothesis that postoperative liberal activity instruction is noninferior to activity restriction with regard to patient satisfaction (P = 0.0281). There was no significant difference in strenuous activity at 2 weeks (P = 0.0824). The liberal group reported significantly more moderate activity at 2 weeks (P = 0.0384) and more strenuous activity at 6 weeks and 6 months (P = 0.0171, P = 0.0118, respectively). The rate of recurrent or persistent stress incontinence for liberal versus restricted groups was 18.52% versus 23.53% (P = 0.635). There were no statistically significant differences in complication rates. Postoperative liberal activity was noninferior to activity restriction with regard to patients' satisfaction. There was no evidence supporting a statistically significant association between postoperative instruction and negative surgical outcomes.

Smaller subcortical volume relates to greater weight gain in girls with initially healthy weight.

Among 3614 youth who were 9 to 12 years old and initially did not have overweight or obesity (12% [n = 385] developed overweight or obesity), we examined the natural progression of weight gain and brain structure development during a 2-year period with a high risk for obesity (e.g., pre- and early adolescence) to determine the following: 1) whether variation in maturational trajectories of the brain regions contributes to weight gain; and/or 2) whether weight gain contributes to altered brain development. Data were gathered from the Adolescent Brain Cognitive Development (ABCD) Study. Linear mixed-effects regression models controlled for puberty, caregiver education, handedness, and intracranial volume (random effects: magnetic resonance scanner [MRI] scanner and participant). Because pubertal development occurs earlier in girls, analyses were stratified by sex. For girls, but not boys, independent of puberty, greater increases in BMI were driven by smaller volumes over time in the bilateral accumbens, amygdala, hippocampus, and thalamus, right caudate and ventral diencephalon, and left pallidum (all p < 0.05). The results suggest a potential phenotype for identifying obesity risk because underlying differences among regions involved in food intake were related to greater weight gain in girls, but not in boys. Importantly, 2 years of weight gain may not be sufficient to alter brain development, highlighting early puberty as a critical time to prevent negative neurological outcomes.

Exercise adherence for patients with trismus after head and neck cancer treatment.

Head and neck cancer treatment often leads to trismus, a condition characterized by limited mouth opening. Exercise-based therapy is the most common intervention but there are no clear guidelines as to the optimal exercise regimen. Restorabite™ is a portable and force-regulated trismus device designed to enhance exercise adherence. This study explores the adherence to exercises using Restorabite™ in head and neck cancer patients with trismus and identifies facilitators and barriers to exercise therapy. Mixed-methods, prospective cohort study undertaken at a quaternary oncology hospital, in Sydney Australia involving participants diagnosed with head and neck cancer diagnosed with trismus (maximal incisal opening under 35 mm). Patients underwent a 10-week individualized trismus program using Restorabite™ with weekly speech pathology reviews. Exercise adherence was tracked through categorized descriptors. Data were collected prospectively at baseline, during 10 weeks of therapy with Restorabite™, and at 6- and 12-month post-trismus exercise. Participants described facilitators of trismus therapy, and barriers to completing the prescribed exercises. Clinical documentation of these responses was then analyzed using content analysis. One-hundred and thirty-five participants were recruited. During the intervention 69% (n = 93) exercised as recommended, 24% (n = 32) exercised less, and 7% (n = 10) exercised more than recommended. At 6 months post-intervention, 55.5% (n = 75) exercised as recommended, 38.5% (n = 52) exercised less, and 4% (n = 6) exercised more. At 12 months, 36% (n = 49) exercised as recommended, 48% (n = 62) exercised less, and 11% (n = 15) exercised more. MIO increased from a mean of 18.6 mm at baseline, to 30.1 mm at the end of the 10-week intervention. This was maintained at 6 and 12 months (31.7 and 32.1 mm, respectively). Adherence to the exercise program was associated with greater improvement in maximum interincisal opening (p < 0.001). Facilitators of adherence included intrinsic motivation, device portability, perceived functional change, and external support tools. Barriers included cancer treatment toxicities, competing priorities, and health challenges. Positive outcomes included functional improvements, while negative outcomes included increased pain. Seventy-six percent of patients prescribed Restorabite™ performed trismus exercises at or more than the recommended frequency. Facilitators and barriers identified provide insights into factors influencing adherence. Future research should involve comparative studies that compare the adherence and effectiveness of different exercise programs.

Prevalence and risk factors of depression and anxiety symptoms in intensive care unit patients with cardiovascular disease: A cross-sectional study.

To investigate the prevalence of anxiety and depression symptoms in intensive care unit (ICU) patients with cardiovascular disease (CVD) and to explore which elements are risk factors for the development of anxiety and depression symptoms. A cross-sectional study. A total of 1028 ICU patients with CVD were enrolled in this cross-sectional study. Logistic regression was used to assess risk factors and associations between anxiety and depression symptoms, and mediation analysis was used to explore the effect of risk factors on the association between anxiety and depression symptoms. Reporting of the study followed the STROBE checklist. The results showed that among ICU patients with CVD, 38.1% had anxiety symptoms, 28.7% had depression symptoms and 19.3% had both anxiety and depression symptoms, and there was a significant association between anxiety and depression symptoms. We also identified female gender, hypertension, hyperlipidemia and cardiac function class IV as independent risk factors for anxiety and depression symptoms. Importantly, these factors also mediated the association between anxiety and depression symptoms, emphasising their role in the psychological well-being of this patient group. ICU patients with CVD were prone to anxiety and depression symptoms. Female gender, hypertension, hyperlipidemia and cardiac function class IV were identified as independent risk factors that also served as mediators in the relationship between anxiety and depression symptoms. Especially, cardiac function class IV emerged as a critical factor in this association. It is imperative for critical care professionals to recognize the elevated risk of depression and anxiety among ICU patients with severe CVD, especially those with cardiac function class IV, hypertension, hyperlipidemia and females. Proactive and supportive measures are essential for this vulnerable group during their ICU stay to safeguard their mental health and prevent negative outcomes. No Patient or Public Contribution.

A new framework for ethical artificial intelligence: keeping HRD in the loop

ABSTRACT As a result of the rapid development of technologies, artificial intelligence (AI) is changing human experiences and workplaces in ways that we are not prepared for. Recognized as a double-edged tool, AI has brought both positive and negative outcomes to organisations and employees. With its increasing popularity in the workplace and our daily practice, how to use AI intelligently and responsibly has become a top concern raised by both academics and practitioners. In this article, we discuss the desired and unintended consequences of AI as documented in current literature, examine the ethical concerns, and identify current solutions. We propose ‘keeping HRD in the loop’ as a means to addressing ethical challenges associated with AI and offer a new conceptual framework as a tool for reference. Integrating general AI principles and ethical guidelines developed by the Academy of HRD, we map out an ethical boundary consisting of nine human-centred principles and suggest a sample of six HRD interventions that can facilitate responsible AI practices and productive human-machine interfaces. By bringing HRD perspectives into the domain of AI practice, we hope to bring ethical considerations to the forefront of AI decision-making and stimulate more interest in interdisciplinary research and academic-industry collaboration.

Youth Experiencing Parental Death Due to Drug Poisoning and Firearm Violence in the US, 1999-2020.

Youth (those aged <18 years) parental death has been associated with negative health outcomes. Understanding the burden of parental death due to drug poisoning (herein, drugs) and firearms is essential for informing interventions. To estimate the incidence of youth parental death due to drugs, firearms, and all other causes. This cross-sectional observational study was conducted using vital registration, including all US decedents, and census data from January 1990 through December 2020. Data were analyzed from May 30, 2023, to March 28, 2024. Parental death due to drug poisoning or firearms. A demographic matrix projection model was used to estimate the number and incidence of youth experiencing parental death, defined as the death of 1 or more parents, per 1000 population aged less than 18 years. Analyses evaluated parental deaths by drugs, firearms, and all other causes from 1999 through 2020 by race and ethnicity. Between 1999 and 2020, there were 931 785 drug poisoning deaths and 736 779 firearm-related deaths with a mean (SD) age of 42.6 (16.3) years. Most deaths occurred among males (73.8%) and White decedents (70.8%) followed by Black (17.5%) and Hispanic (9.5%) decedents. An estimated 759 000 (95% CI, 722 000-800 000) youth experienced parental death due to drugs and an estimated 434 000 (95% CI, 409 000-460 000) youth experienced parental death due to firearms, accounting for 17% of all parental deaths. From 1999 to 2020, the estimated number of youth who experienced parental death increased 345% (95% CI, 334%-361%) due to drugs and 39% (95% CI, 37%-41%) due to firearms compared with 24% (95% CI, 23%-25%) due to all other causes. Black youth experienced a disproportionate burden of parental deaths, based primarily on firearm deaths among fathers. In 2020, drugs and firearms accounted for 23% of all parental deaths, double the proportion in 1999 (12%). Results of this modeling study suggest that US youth are at high and increasing risk of experiencing parental death by drugs or firearms. Efforts to stem this problem should prioritize averting drug overdoses and firearm violence, especially among structurally marginalized groups.

Workplace Microaggressions: Results of a Survey of the American College of Surgeons Members.

Workplace microaggressions are a longstanding but understudied problem in the surgical specialties. Microaggressions in healthcare are linked to negative emotional and physical health outcomes and can contribute to burnout and suboptimal delivery of patient care. They also negatively impact recruitment, retention and promotion, which often results in attrition. Further attrition at the time of an impending surgical workforce shortage risks compromising delivery of health care to the diverse US population and may jeopardize the financial stability of health care organizations. To date, studies on microaggressions have consisted of small focus groups comprised of women faculty or trainees at a single institution. There are no large, multi-organizational, gender-inclusive studies on microaggressions experienced by practicing surgeons. To examine the demographic and occupational characteristics of surgeons who do and do not report experiencing workplace microaggressions and whether these experiences would influence a decision to pursue a career in surgery again. We developed and internally validated a web-based survey to assess surgeon experiences with microaggressions and associated sequelae. The survey was distributed through a convenience sample of nine American College of Surgeons (ACS) online Communities from November 2022 to January 2023. All ACS Communities comprised members who had completed residency or fellowship training and had experience in the surgical workforce. The survey contained demographic, occupational, and validated microaggression items. Analyses include descriptive and chi-squared statistics, t-tests, and bivariable and multivariable logistic regression. The survey was completed by 377 ACS members with the following characteristics: working as a surgeon (80.9%), non-Hispanic white (71.8%), general surgeons (71.0%), age ≥ 50 years (67.4%), fellowship-trained (61.0%), and women (58.4%). A total of 254 (67.4%) respondents reported experiencing microaggressions. Younger surgeons (p=0.002), women (p<0.001) and fellowship-trained surgeons (p=0.001) were more likely to report experiencing microaggressions than their counterparts. Surgeons working in academic medical centers or healthcare systems with teaching responsibilities were more likely to experience microaggressions than those in private practice (p<0.01). Surgeons currently working as a surgeon or those who are unable to work reported more experience with microaggressions (p=0.003). There was no difference in microaggressions experienced among respondents by surgical specialties, race/ethnicity, or for surgeons with a self-reported disability. In multivariable logistic regression, women had higher odds of experiencing microaggressions than men [aOR 15.9; 95% C.I.: 7.7-32.8] and surgeons in private practice had significantly lower odds of experiencing microaggressions compared to surgeons in academic medicine (aOR 0.3; 95% C.I. 0.1-0.8) or in healthcare systems with teaching responsibilities (aOR 0.2; 95% C.I. 0.1-0.6). Among surgeons responding to an online survey, respondents reporting microaggressions were less likely to say they would choose a career in surgery again (p<0.001). Surgeons reporting experience with microaggressions reflect the diversification of surgical specialties and subspecialties. With continued expansion of surgeon gender and race/ethnicity representation, deliberate efforts to address and eliminate workplace microaggressions could have broad implications for improving recruitment and retention of surgeons.

Grandiose narcissism associates with higher cognitive performance under stress through more efficient attention distribution: An eye-tracking study.

Narcissism is a part of the Dark Triad that consists also of the traits of Machiavellianism and psychopathy. Two main types of narcissism exist: grandiose and vulnerable narcissism. Being a Dark Triad trait, narcissism is typically associated with negative outcomes. However, recent research suggests that at least the grandiose type may be linked (directly or indirectly) to positive outcomes including lower levels of psychopathology, higher school grades in adolescents, deeper and more strategic learning in university students and higher cognitive performance in experimental settings. The current pre-registered, quasi-experimental study implemented eye-tracking to assess whether grandiose narcissism indirectly predicts cognitive performance through wider distribution of attention on the Raven's Progressive Matrices task. Fifty-four adults completed measures of the Dark Triad, self-esteem and psychopathology. Eight months to one year later, participants completed the Raven's, while their eye-movements were monitored during high stress conditions. When controlling for previous levels of psychopathology, grandiose narcissism predicted higher Raven's scores indirectly, through increased variability in the number of fixations across trials. These findings suggest that grandiose narcissism predicts higher cognitive performance, at least in experimental settings, and call for further research to understand the implications of this seemingly dark trait for performance across various settings.

How Mental Health and Suicidality Changed during the COVID-19 Pandemic: A Longitudinal Study in the General and Psychiatric Population Illustrating Risk and Protective Factors

The COVID-19 pandemic has led to an increase in psychological distress in the general population, but contrasting results have been shown regarding its impact on psychological symptoms in clinical and non-clinical samples. Consequently, the aim of the present study was to compare in a longitudinal design (September–November 2020 and February–April 2021) the mental health outcomes of a clinical and a control sample and to determine the implications of various risk and protective factors in this regard. A total of 234 participants from the general population and 80 psychiatric patients took part in the present online study using the following measurements: the Brief Symptom Checklist (BSCL); Three-Item Loneliness Scale (TILS); Resilience Scale-13 (RS-13); and Functional Assessment of Chronic Illness Therapy—Spiritual Well-Being Scale—Non-Illness (FACIT-Sp Non-Illness). The results show an overall decrease in active suicidal ideation as well as “peace”, a subscale of spiritual well-being, as well as increases in passive suicidal activation in the clinical sample, which did not change in the control sample. Psychological symptoms did not significantly change in either group. Significant group effects show an increase in resilience in the clinical sample. Resilience and peace turned out to be protective factors for negative mental health outcomes. However, loneliness, which interestingly increased only in the control sample, was shown to be an overall potential risk factor. Our results highlight the complex implications of the COVID-19 pandemic on the mental health outcomes of different groups in the population, demonstrating the necessity of further research, specifically regarding the risk of active and passive suicidal activation. Highlighted protective factors are discussed in regards to spirituality (i.e., peace), which is not strictly related to religion but rather personal spirituality related to the meaning of situations of one’s life, as well as in terms of mental health interventions.

A clinical audit in a UK-based acupuncture private practice: assessing patient demographics, outcomes and experience.

The aim of this clinical audit was to assess patient demographics, outcomes and experience with care in patients who received acupuncture in a private practice setting in the United Kingdom. Demographic and clinical data were extracted from patients' records over a 7-year period. The Measure Yourself Medical Outcomes Profile (MYMOP) questionnaire and an adapted Patient Global Impression of Change (PGIC) scale were used routinely to monitor patient outcomes over an 18-month period. Finally, a retrospective questionnaire was used to assess patient beliefs regarding treatment effectiveness, adverse events and overall experience with care. Patients not providing consent or known to be deceased were excluded. Data were collected for 306 patients presenting with 376 separate health complaints, 58% of which were musculoskeletal. Follow-up outcomes (MYMOP scores (n = 51) and PGIC scale responses (n = 50)) showed a clinically significant improvement compared to baseline for the majority of health complaints (93% of PGIC scores were 'improved' and 79% MYMOP demonstrated > 1 point change). Total mean MYMOP severity scores were reduced by almost 50% (p < 0.001) after 1-4 weeks, and this was sustained in the medium-to-long term. There was a strong negative correlation (r = -0.767, p < 0.001) between the MYMOP and PGIC scores. A total of 118 health complaints were reported by 85/255 patients who responded to a retrospective questionnaire. Over 84% of patients believed that the treatments they received were 'effective' at addressing their health complaints. Seven minor adverse events were reported and four patients experienced negative treatment outcomes. Although musculoskeletal conditions were the most common, this audit found that patients sought treatment for a wide range of predominantly chronic health complaints, for many of which there is a currently a lack of quality evidence to support the use of acupuncture. Overall, the small sample of patients who responded to outcome questionnaires reported clinically meaningful and sustained improvements.

Hidden stories and the dark side of entrepreneurial commitment

PurposeEntrepreneurs are generally considered to be committed in order to strive for highly desirable goals, such as growth or commercial success. However, commitment is a multidimensional concept and may have asymmetric relationships with positive or negative entrepreneurial outcomes. This paper aims to provide a nuanced perspective to show under what conditions commitment may be detrimental for entrepreneurs and lead to overinvestment.Design/methodology/approachUsing a sample of entrepreneurs from incubators in France (N = 437), this study employs a configurational perspective, fuzzy-set qualitative comparative analysis (fsQCA), to identify which commitment profiles lead entrepreneurs to overinvest different resources in their entrepreneurial projects.FindingsThe paper exposes combinations of conditions that lead to overinvestment and identifies five different commitment profiles: an “Affective profile”, a “Project committed profile”, a “Profession committed profile”, an “Instrumental profile”, and an “Affective project profile”.Originality/valueThe results show that affective commitment is a necessary condition for entrepreneurs to conduct overinvesting behaviors. This complements previous linear research on the interdependence between affect and commitment in fostering detrimental outcomes for nascent entrepreneurs.

Predictors of accessing seasonal malaria chemoprevention medicines through non-door-to-door distribution in Nigeria

BackgroundIn Nigeria, seasonal malaria chemoprevention (SMC) is typically administered door-to-door to children under five by community medicine distributors during high transmission seasons. While door-to-door distribution (DDD) is exclusively employed in Nigeria as part of standard operating procedures of SMC programmes, some households access SMC through non-DDD channels, such as fixed-point distributions, health facilities, and private purchase. However, analysis of access to SMC medicines through non-DDD has been limited, with little evidence of its outcomes on adherence to the three-day complete course of SMC medicines and caregiver actions in the event of adverse reactions to SMC medicines.MethodsData were obtained from SMC end-of-round coverage surveys conducted in Nigeria in 2021 and 2022, including 25,278 households for the analysis. The proportion of households accessing SMC medicine through non-DDD and the distribution of various non-DDD sources of SMC medicines were described. Multivariate random-effects logistic regression models were performed to identify predictors of accessing SMC medicines through non-DDD. The associations between non-DDD, and caregiver-reporting of adherence to complete administration of SMC medicines and caregiver actions in the event of adverse reactions to SMC medicines were also assessed.ResultsLess than 2% (314/24003) of households accessed SMC medicines through non-DDD in the states surveyed. Over 60% of non-DDD access was via health facility personnel and community medicine distributors from different locations. Variables associated with non-DDD access included heads of household being born in the local state (OR = 0.68, 95% CI 0.47 to 0.90), households residing in the study state since the first cycle of the SMC round (OR = 0.39, 95% CI 0.17 to 0.88), households with high wealth index (OR = 1.36, 95% CI 1.01 to 1.82), and caregivers hearing about date of SMC delivery in the previous cycle (OR = 0.18, 95%CI 0.14 to 0.24). Furthermore, non-DDD was associated with reduced SMC adherence and higher caregiver non-reporting of adverse reactions to SMC medicines in children compared with DDD.ConclusionThis study provides evidence on the characteristics of households accessing SMC medicines through non-DDD and its potential negative outcomes on adherence to SMC medicine and adverse reaction reporting, underscoring potential implementation issues that may arise if non-DDD delivery models are adopted in SMC, particularly in places where DDD had been firstly used.

Insurer Medication Utilization Barriers are Associated with Decreased Insurance Satisfaction and Adverse Clinical Outcomes: An IBD Partners Survey

Background: Insurer-mandated barriers to timely initiation of advanced therapies used to treat inflammatory bowel disease (IBD) have been shown to worsen clinical outcomes and increase healthcare utilization, yet rarely alter the medication ultimately prescribed. Methods: We conducted a survey within the IBD Partners longitudinal cohort to evaluate the frequency and patient-reported impacts of medication utilization barriers on insurance satisfaction and clinical outcomes. Barriers included medication denials, prior authorizations, and forced medication switches. Variables associated with insurance satisfaction, measured on a 1-7 Likert scale, were identified. The association between insurance-related barriers and downstream clinical outcomes (surgery, corticosteroid requirement, and disease activity) were evaluated. Results: 2,017 patients (Age 45 [IQR 34-58], 73% female) were included. Seventy-two percent experienced an insurer-mandated barrier, most commonly prior authorizations (51%). Fifteen percent were denied an IBD medication by their insurer, 22% experienced an insurance-related gap in therapy, and 8% were forced by their insurer to switch from an effective medication. Insurance satisfaction was negatively associated with medication denials, prior authorization-related delays, gaps in therapy, and high-deductible health plan coverage. In the year following the initial survey, several insurance barriers were linked to negative downstream clinical outcomes, including prior authorizations associated with corticosteroid rescue (OR 2.24, 95%CI 1.25-4.00), forced medication switches associated with continued disease activity (OR 3.28, 95%CI 1.56-6.89), and medication denials associated with IBD-related surgery (OR 8.92, 95%CI 1.97-40.39). Conclusions: These data illustrate the frequency and negative impacts of insurer-mandated medication barriers on patients with IBD, including decreased insurance satisfaction and negative downstream clinical outcomes.

Abstract PO2-12-01: Five-year quality of life (QOL) trajectories among young breast cancer (BC) survivors

Abstract Background: Young BC survivors are at risk for impaired QOL in part due to issues that are unique to their life stage. We sought to characterize trajectories of QOL in the 5 years following diagnosis among young BC survivors as well as evaluate patient and clinical characteristics associated with poorer or deteriorating QOL trajectories over time. Methods: Women diagnosed with stage I-III BC at age ≤40 enrolled in the Young Women’s BC Study, a prospective cohort in North America, who completed ≥2 study surveys through 5 years of post-diagnosis follow-up. QOL was evaluated with the Cancer Rehabilitation Evaluation System (CARES) physical, psychosocial, and sexual subscale scores. Demographic, treatment, and clinical characteristics were ascertained through surveys and chart review. Longitudinal trajectories for each CARES subscale were defined using group-based trajectory modeling; associations between patient/clinical characteristics and trajectory group membership were estimated for each subscale using multivariable multinomial logistic regression. Results: Among 900 women, median age at diagnosis was 36 (range: 17-40) 89% were white, 2% Black, and 4% Hispanic. At baseline, 73% were partnered, 61% parous and 49% perceived themselves as financially comfortable. Most had hormone-receptor positive (74%), HER2-negative (70%) BC, and most received chemotherapy (82%); 36% underwent mastectomy with radiation. Physical and psychosocial scores each clustered into 4 trajectories, with &amp;gt;75% of participants clustering in groups reflecting excellent or good QOL that was stable over time and few (6% for physical and 4% for psychosocial) clustering into groups that reflected poorer QOL at baseline that did not improve over time. Sexual health trajectories were more variable, clustering into 5 trajectories, with over half of participants clustered into groups reflecting good (35%) or excellent (20%) QOL that remained relatively stable over time, 22% clustered into a trajectory that was poor at baseline but moderately improved over follow-up, 13% in a group that reflected deteriorating from moderate-to-poor QOL and 11% in a group with poor QOL at baseline that did not improve over time. In multivariable regression analyses (Table), factors associated with clustering in a poorer trajectory (vs. clustering in an excellent trajectory), in multiple QOL domains included baseline financial discomfort (associated with poorer QOL across all 3 domains), mastectomy+radiation (vs. lumpectomy, associated with poorer QOL across all 3 domains); chemotherapy receipt (associated with poorer physical and sexual health trajectories); and baseline BMI &amp;gt;25 (vs. 18.5-24.9, associated with poorer physical and poorer/deteriorating sexual health trajectories). Conclusions: Young BC survivors follow distinct QOL trajectories in survivorship. While most will not experience substantial QOL impairment through the first 5 years following diagnosis, a substantial minority report persistently poor or deteriorating QOL. The association between more extensive local therapy and poorer physical/psychosocial/sexual health trajectories underscores the importance of communicating the potential for negative QOL outcomes when women are making surgical decisions. Additionally, the pervasive impact of financial wellbeing on multiple QOL domains supports the potential value of systematic screening for and addressing of financial distress to prevent or mitigate financial toxicity in survivorship Factors associated with clustering in poorer/deteriorating (vs. excellent) QOL trajectories *Reference trajectory=excellent QOL Citation Format: Tal Sella, Zheng Yue, Kathryn Ruddy, Shari Gelber, Rulla Tamimi, Jeffrey Peppercorn, Lidia Schapira, Virginia Borges, Steven Come, Eric Winer, Ann Partridge, Shoshana Rosenberg. Five-year quality of life (QOL) trajectories among young breast cancer (BC) survivors [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-12-01.

Abstract PO5-07-01: A novel clinical risk score that can accurately predict the survival of young breast cancer patients: A UAE-based cohort study

Abstract Introduction: Breast cancer (BC) in women below the age of 40 accounts for approximately 7% of all BC cases. According to studies, BC in younger women is more likely to have negative tumor characteristics and outcomes compared to older women. The rate of early-onset breast cancer in the United Arab Emirates (UAE) is higher than in the Western population (24%, previously reported). Young breast cancer patients in the UAE have worse adverse features, including a higher grade, a larger tumor size, and lymph node involvement, as we reported previously. Therefore, combining several clinical indicators to predict recurrence risk in our unique, heterogeneous young breast cancer group is needed. Aim:The aim of this study is to develop a statistical machine learning model that can predict survival and the risk of recurrence in a young breast cancer population seen and treated in a large-volume tertiary cancer center in the United Arab Emirates (Tawam Hospital). Methods: Early-onset breast cancer patients from a retrospective observational cohort study were included in this study (N = 904). A broad range of clinical data was collected. A multivariate ridge Cox regression model was performed using age, histology, molecular type (ER,PR,HER-2 status), T-stage, N-Stage, M-stage, grade, and BMI, and the interaction term age*BMI at the time of diagnosis. The primary outcome was time-to-death. A novel breast cancer risk score (BCRS) was developed as the linear predictor of the fitted-ridge Cox regression model. Breast cancer patients were categorized into low, medium, and high risk using the 33th and 66th centiles of the novel BCRS. A univariate Cox regression model was performed with a categorized BCRS as a predictor of time-to-death. Hazard ratios (HR) with a 95% confidence interval (95% CI) were estimated. Kaplan-Meier (KM) curves were plotted and compared using the log-rank test. Time-dependent sensitivity and specificity were computed at five- and ten-year follow-ups, respectively. Statistical analyses were performed in R version 4.2.3. Results: The median age was 36 years (IQR: 32–38), and 64% were Arabic. Fifteen percent had an event with a median duration of follow-up of 15.4 years (95% CI: 13.6–17.1). The estimated HR of the categorized novel BCRS in a univariate Cox regression model was 1.968 (95% CI: 1.075- 3.601) and 8.040 (95% CI: 4.695–13.769) for the intermediate and high-risk groups as compared to the low-risk group, respectively. KM curves show a clear separation in terms of survival between the three risk groups, p&amp;lt; 0.0001 (Figure 1). A cutoff value of -1.733 gives a sensitivity of 93.8 and 90.6 with corresponding specificities of 31.42 and 31.31 at five- and ten-year follow-up, respectively. Conclusion: This is the first study in the region that uses clinical data that combines several clinical characteristics and aims to design a statistical machine learning model to predict the risk of death from breast cancer. Our novel model can be used in daily clinical practice to identify high risk breast cancer patients and aid clinical decision-making in patients with breast cancer. However, further validation studies are needed. Figure 1:KM curves of breast-cancer survival for patients with low-risk (BCRS in [-2.32, -1.63], black curve), intermediate-risk (BCRS in [-1.64, -1.25], red curve), and high-risk BCRS in [-1.26, 1.41], green curve). Citation Format: Aydah Al-Awadhi, Mohammed Hourani, Mawada Hussein, Fatima Alkindi, Lina Wahba, Abla AlAgha, Alaa Shoqeir, Mouza AlShebli, Atlal Abusanad, Amar Ahmad. A novel clinical risk score that can accurately predict the survival of young breast cancer patients: A UAE-based cohort study [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-07-01.