Quality improvement exercises in Inflammatory Bowel Disease (IBD) services: A scoping review.

OBJECTIVE: Quality Improvement initiatives aim to improve care in Inflammatory Bowel Disease (IBD). These address a range of aspects of care including adherence to published guidelines. The objectives of this review were to document the scope and quality of published quality improvement initiatives in IBD, highlight successful interventions and the outcomes achieved. DESIGN/METHOD: We searched MEDLINE, EMBASE, CINAHL and Web of Science. Two reviewers independently screened and extracted data. We included peer reviewed articles or conference proceedings reporting initiatives intended to improve the quality of IBD care, with both baseline and prospectively collected follow-up data. Initiatives were categorised based on problems, interventions and outcomes. We used the Quality Improvement Minimum Quality Criteria Set instrument to appraise articles. We mapped the focus of the articles to the six domains of the IBD standards. RESULTS: 100 studies were identified (35 full text; 65 conference abstracts). Many focused on vaccination, medication, screening, or meeting multiple quality measures. Common interventions included provider education, the development of new service protocols, or enhancements to the electronic medical records. Studies principally focused on areas covered by the IBD standards 'ongoing care' and 'the IBD service', with less focus on standards 'pre-diagnosis', 'newly diagnosed', 'flare management', 'surgery' or 'inpatient care'. CONCLUSION: Good quality evidence exists on approaches to improve the quality of a narrow range of IBD service functions, but there are many topic areas with little or no published quality improvement initiatives. We highlight successful quality improvement interventions and offer recommendations to improve reporting of future studies.

Capturing the True Cost of Breast Cancer Treatment: Molecular Subtype and Stage-Specific per-Case Activity-Based Costing.

BACKGROUND: Breast cancer (BC) treatment is rapidly evolving with new and costly therapeutics. Existing costing models have a limited ability to capture current treatment costs. We used an Activity-Based Costing (ABC) method to determine a per-case cost for BC treatment by stage and molecular subtype. METHODS: ABC was used to proportionally integrate multidisciplinary evidence-based patient and provider treatment options for BC, yielding a per-case cost for the total duration of treatment by stage and molecular subtype. Diagnostic imaging, pathology, surgery, radiation therapy, systemic therapy, inpatient, emergency, home care and palliative care costs were included. RESULTS: BC treatment costs were higher than noted in previous studies and varied widely by molecular subtype. Cost increased exponentially with the stage of disease. The per-case cost for treatment (2023C$) for DCIS was C$ 14,505, and the mean costs for all subtypes were C$ 39,263, C$ 76,446, C$ 97,668 and C$ 370,398 for stage I, II, III and IV BC, respectively. Stage IV costs were as high as C$ 516,415 per case. When weighted by the proportion of molecular subtype in the population, case costs were C$ 31,749, C$ 66,758, C$ 111,368 and C$ 289,598 for stage I, II, III and IV BC, respectively. The magnitude of cost differential was up to 10.9 times for stage IV compared to stage I, 4.4 times for stage III compared to stage I and 35.6 times for stage IV compared to DCIS. CONCLUSION: The cost of BC treatment is rapidly escalating with novel therapies and increasing survival, resulting in an exponential increase in treatment costs for later-stage disease. We provide real-time, case-based costing for BC treatment which will allow for the assessment of health system economic impacts and an accurate understanding of the cost-effectiveness of screening.

The utility of H2 receptor antagonists in preventing infusion-related reactions to paclitaxel chemotherapy.

BACKGROUND: Paclitaxel has a risk of infusion-related reactions (IRRs) and despite no prospective evidence, is often given with premedication including a corticosteroid, H1 antagonist, and H2 antagonist (H2RA). Backorders impacted the supply of intravenous H2RAs at our center, and it was removed as routine premedication. The authors compared the incidence of IRR in patients treated without H2RA to patients receiving standard H2RA premedication. METHODS: The authors reviewed outpatients starting paclitaxel at the Ottawa Hospital from December 2019 to October 2021. Two cohorts were created: patients treated without H2RA premedication (intervention), and those receiving standard H2RA (control). Demographics, treatment, and IRR information were collected retrospectively. Primary end point was rate of grade ≥2 IRRs during first two doses of paclitaxel. RESULTS: A total of 182 patients were treated without H2RA premedication, compared to 184 control patients treated during non-backorder periods. Baseline characteristics included: median age, 63 years; 86% female; and primary tumor 52% breast/24% gynecologic/10% gastric/esophageal/8% lung/6% other. There were no significant differences between cohorts in baseline characteristics. There was no difference in the rate of grade ≥2 IRR between cohorts; 12.1% (22 of 182; 95% confidence interval [CI], 7.7%-17.7%) for patients treated without H2RA, and 15.1% (28 of 185; 95% CI, 10.3%-21.1%) for control patients. The rate of grade ≥3 IRRs were also similar, 4.4% in intervention cohort versus 3.8% in control cohort. CONCLUSIONS: The removal of H2RAs from premedication for paclitaxel did not result in an increased incidence of IRRs. The use of H2RAs in preventing IRRs to paclitaxel should be re-evaluated.

Combined application of biosponges and an antifibrotic agent for the treatment of volumetric muscle loss.

Volumetric muscle loss (VML) causes irrecoverable loss of muscle mass and strength and results in permanent disability. VML injury shows extensive fibrosis, which impedes functional tissue regeneration. Our lab has created a biosponge scaffold composed of extracellular matrix (ECM) proteins (i.e., biosponge) that can enhance muscle regeneration and function following VML. In this work, a potent small molecule inhibitor of alpha v-subunit containing integrins known as IDL-2965 was incorporated into the biosponges for localized suppression of fibrosis post-VML. Our results demonstrate that local delivery of IDL-2965 via the biosponges attenuated the deposition of fibrotic tissue preceded by a downregulation of profibrotic genes in VML-injured muscles. The reduction in fibrotic tissue had no detrimental effects on muscle mass, function, size, or vascularity. Overall, these findings suggest that the codelivery of biosponges and IDL-2965 is a safe and effective strategy for the mitigation of fibrotic tissue deposition in VML-injured muscles.

COVID-19 booster vaccination in rural community pharmacies.

This study assessed rural community pharmacists' attitudes about COVID-19 vaccine booster doses and explored whether rural pharmacies offered these booster doses. Of the 80 rural Southeastern U.S. pharmacists who completed the online survey, the majority (n = 68, 85 %) offered boosters and 42 (52.5 %) had received the booster themselves. Alabama and Mississippi offered boosters less often than other states, and pharmacists who had foregone receiving COVID-19 vaccination or booster doses were less likely to offer the booster to their patients. Additionally, many pharmacists reported that they and their patients felt the booster was not needed. Community pharmacies provide access points for the COVID-19 booster in rural areas. Interventions for both pharmacists and patients are needed to address hesitancy and improve booster uptake in these communities.

The association of neurodevelopmental abnormalities, congenital heart and renal defects in a tuberous sclerosis complex patient cohort.

BACKGROUND: Tuberous sclerosis complex (TSC) is a rare multi-system genetic disorder characterised by the presence of benign tumours throughout multiple organs including the brain, kidneys, heart, liver, eyes, lungs and skin, in addition to neurological and neuropsychiatric complications. Intracardiac tumour (rhabdomyoma), neurodevelopmental disorders (NDDs) and kidney disorders (KD) are common manifestations of TSC and have been linked with TSC1 and TSC2 loss-of-function mutations independently, but the dynamic relationship between these organ manifestations remains unexplored. Therefore, this study aims to characterise the nature of the relationship specifically between these three organs' manifestations in TSC1 and TSC2 mutation patients. METHODS: Clinical data gathered from TSC patients across South Wales registered with Cardiff and Vale University Health Board (CAV UHB) between 1990 and 2020 were analysed retrospectively to evaluate abnormalities in the heart, brain and kidney development. TSC-related abnormalities such as tumour prevalence, location and size were analysed for each organ in addition to neuropsychiatric involvement and were compared between TSC1 and TSC2 mutant genotypes. Lastly, statistical co-occurrence between organ manifestations co-morbidity was quantified, and trajectories of disease progression throughout organs were modelled. RESULTS: This study found a significantly greater mutational frequency at the TSC2 locus in the cohort in comparison to TSC1. An equal proportion of male and female patients were observed in this group and by meta-analysis of previous studies. No significant difference in characterisation of heart involvement was observed between TSC1 and TSC2 patients. Brain involvement was seen with increased severity in TSC2 patients, characterised by a greater prevalence of cortical tubers and communication disorders. Renal pathology was further enhanced in TSC2 patients, marked by increased bilateral angiomyolipoma prevalence. Furthermore, co-occurrence of NDDs and KDs was the most positively correlated out of investigated manifestations, regardless of genotype. Analysis of disease trajectories revealed a more diverse clinical outcome for TSC2 patients: however, a chronological association of rhabdomyoma, NDD and KD was most frequently observed for TSC1 patients. CONCLUSIONS: This study marks the first empirical investigation of the co-morbidity between congenital heart defects (CHD), NDDs, and KDs in TSC1 and TSC2 patients. This remains a unique first step towards the characterisation of the dynamic role between genetics, heart function, brain function and kidney function during the early development in the context of TSC.

The association between pre-conception intuitive eating and gestational weight gain.

PURPOSE: To determine if pre-conception intuitive eating, an adaptive eating behavior, was related to gestational weight gain (GWG) and the likelihood of exceeding GWG recommendations. METHODS: This prospective survey study took place in an outpatient obstetric clinic. Participants completed the pre-conception Intuitive Eating Scale for Pregnancy during a prenatal check-up appointment and total GWG was collected from the medical record. The pre-conception Intuitive Eating Scale for Pregnancy assesses unconditional permission to eat, eating for physical rather than emotional reasons, and reliance on hunger and satiety to inform what, when, and how much to eat. Hierarchical linear multiple regression and logistic multiple regression analyses determined associations between pre-conception intuitive eating and GWG on the total sample and stratified by weight status (normal/underweight, overweight, and obese). RESULTS: The majority of the sample (n = 253) was white, married, employed, had annual household income > $50,000, and had a college degree. No aspects of pre-conception intuitive eating predicted the likelihood of excess GWG. However, in the total sample, unconditional permission to eat (subscale) was inversely related to total GWG (B = -0.16, p < 0.05). Among women with obesity (n = 36), eating for physical rather than emotional reasons (subscale) was inversely related to total GWG (B = -0.47, p < 0.05). DISCUSSION: Some aspects of intuitive eating during the pre-conception period were related to total GWG, particularly for women with obesity. However, intuitive eating scores did not increase or decrease the likelihood of excess GWG. More research is needed to understand the mechanisms for this association before clinical recommendations can be made. LEVEL OF EVIDENCE: Level III (Evidence obtained from well-designed cohort or case-control analytic studies).

Using the Drug Burden Index to identify older adults at highest risk for medication-related falls.

BACKGROUND: The Drug Burden Index (DBI) was developed to assess patient exposure to medications associated with an increased risk of falling. The objective of this study was to examine the association between the DBI and medication-related fall risk. METHODS: The study used a retrospective cohort design, with a 1-year observation period. Participants (n = 1562) were identified from 31 community pharmacies. We examined the association between DBI scores and four outcomes. Our primary outcome, which was limited to participants who received a medication review, indexed whether the review resulted in at least one medication-related recommendation (e.g., discontinue medication) being communicated to the participant's health care provider. Secondary outcomes indexed whether participants in the full sample: (1) screened positive for fall risk, (2) reported 1+ falls in the past year, and (3) reported 1+ injurious falls in the past year. All outcome variables were dichotomous (yes/no). RESULTS: Among those who received a medication review (n = 387), the percentage of patients receiving at least one medication-related recommendation ranged from 10.2% among those with DBI scores of 0 compared to 60.2% among those with DBI scores ≥1.0 (Chi-square (4)=42.4, p < 0.0001). Among those screened for fall risk (n = 1058), DBI scores were higher among those who screened positive compared to those who did not (Means = 0.98 (SD = 1.00) versus 0.59 (SD = 0.74), respectively, p < 0.0001). CONCLUSION: Our findings suggest that the DBI is a useful tool that could be used to improve future research and practice by focusing limited resources on those individuals at greatest risk of medication-related falls.

Impact of STEADI-Rx: A Community Pharmacy-Based Fall Prevention Intervention.

OBJECTIVES: To evaluate the effects of a community pharmacy-based fall prevention intervention (STEADI-Rx) on the risk of falling and use of medications associated with an increased risk of falling. DESIGN: Randomized controlled trial. SETTING: A total of 65 community pharmacies in North Carolina (NC). PARTICIPANTS: Adults (age ≥65 years) using either four or more chronic medications or one or more medications associated with an increased risk of falling (n = 10,565). INTERVENTION: Pharmacy staff screened patients for fall risk using questions from the Stopping Elderly Accidents, Deaths, and Injuries (STEADI) algorithm. Patients who screened positive were eligible to receive a pharmacist-conducted medication review, with recommendations sent to patients' healthcare providers following the review. MEASUREMENTS: At intervention pharmacies, pharmacy staff used standardized forms to record participant responses to screening questions and information concerning the medication reviews. For participants with continuous Medicare Part D/NC Medicaid coverage (n = 3,212), the Drug Burden Index (DBI) was used to assess exposure to high-risk medications, and insurance claims records for emergency department visits and hospitalizations were used to assess falls. RESULTS: Among intervention group participants (n = 4,719), 73% (n = 3,437) were screened for fall risk. Among those who screened positive (n = 1,901), 72% (n = 1,373) received a medication review; and 27% (n = 521) had at least one medication-related recommendation communicated to their healthcare provider(s) following the review. A total of 716 specific medication recommendations were made. DBI scores decreased from the pre- to postintervention period in both the control and the intervention group. However, the amount of change over time did not differ between these two groups (P = .66). Risk of falling did not change between the pre- to postintervention period or differ between groups (P = .58). CONCLUSION: We successfully implemented STEADI-Rx in the community pharmacy setting. However, we found no differences in fall risk or the use of medications associated with increased risk of falling between the intervention and control groups. J Am Geriatr Soc 68:1778-1786, 2020.

Care coordination and follow-up practices in the community pharmacy setting: A mixed methods study.

OBJECTIVES: This mixed methods study had 2 aims: (1) to describe the frequency of care coordination between pharmacists, prescribers, and care managers and (2) to identify pharmacists' strategies for care coordination and follow-up in a community pharmacy setting. DESIGN: This study used a mixed methods design. SETTING AND PARTICIPANTS: Pharmacists who were responsible for implementing North Carolina community pharmacy enhanced services network (NC CPESN®) activities in their pharmacy during the first or second year of the 3-year program (September 2014-August 2016). OUTCOME MEASURES: A survey was administered to gather data on care coordination in community pharmacies and for follow-up. In-depth interviews were conducted to expand on the findings from the quantitative data. Descriptive statistics were calculated for survey data. Interviews were recorded, transcribed verbatim, and analyzed using thematic analysis. RESULTS: Surveys were received from 101 pharmacies (82.1% response rate). Fourteen pharmacies with missing responses were removed, resulting in 87 pharmacies being included in the analysis. The majority of pharmacies were single, independent pharmacies (46.5%), and approximately one-third of pharmacies had a clinical pharmacist on the staff (31.1%). To communicate with prescribers, pharmacists most frequently used facsimile (fax) (82.1%) or phone (65.5%). A total of 12 pharmacists participated in the semistructured interviews. Pharmacists defined care coordination as interdisciplinary collaboration and communication among the members of the health care team to provide the best possible patient-centered care. All pharmacists agreed that good health care provider (i.e., care manager and prescriber) relationships are crucial to the success of patient care; however, participants mentioned that building these relationships has been or is currently difficult to establish. CONCLUSION: Care coordination among pharmacists, prescribers, and care managers is important for improving patients' medication management and overall outcomes. To our knowledge, this is the first study to quantify care coordination between pharmacists, prescribers, and care managers and to identify strategies to facilitate care coordination. Results from this study have the potential to inform how care coordination and longitudinal follow-up are best implemented within the community pharmacy setting.

Exploring Determinants of Parent Behaviors During Eating Episodes.

OBJECTIVE: To develop a conceptual model of determinants of parent feeding behaviors with preschoolers. DESIGN: Semistructured in-depth interviews were collected and transcribed verbatim. SETTING: University of Houston. PARTICIPANTS: Parents of preschool-aged children (aged 2-5 years). PHENOMENON OF INTEREST: Determinants of parent behaviors during eating episodes with preschoolers. ANALYSIS: Trained coders conducted thematic analysis with constant comparison of all interviews. RESULTS: The final sample (n = 20) included predominantly white (60%), married (70%) mothers (75%) from middle socioeconomic conditions (100% had at least some college education; 70% had a household income >$50,000). Five categories of themes emerged: child behaviors, proactive parent behaviors, reactive parent behaviors, contextual factors, and parent beliefs. The themes were organized into a conceptual model to describe how parents and children influenced each other's behaviors depending on the context and parent beliefs of themselves and their child. CONCLUSIONS AND IMPLICATIONS: A conceptual model outlining several determinants of parent feeding behaviors among preschoolers was developed. Next steps in the research are to validate the conceptual model identified in this qualitative study on a large, nationally representative sample.

Training and Toolkit Resources to Support Implementation of a Community Pharmacy Fall Prevention Service.

Community pharmacies are an ideal setting to manage high-risk medications and screen older adults at risk for falls. Appropriate training and resources are needed to successfully implement services in this setting. The purpose of this paper is to identify the key training, tools, and resources to support implementation of fall prevention services. The service was implemented in a network of community pharmacies located in North Carolina. Pharmacies were provided with onboard and longitudinal training, and a project coach. A toolkit contained resources to collect medication information, identify high-risk medications, develop and share recommendations with prescribers, market the service, and educate patients. Project champions at each pharmacy received a nine-question, web-based survey (Qualtrics) to identify usefulness of the training and resources. The quantitative data were analyzed using descriptive statistics. Thirty-one community pharmacies implemented the service. Twenty-three project champions (74%) completed the post-intervention survey. Comprehensive onboard training was rated as more useful than longitudinal training. Resources to identify high-risk medications, develop recommendations, and share recommendations with prescribers were considered most useful. By providing appropriate training and resources to support fall prevention services, community pharmacists can improve patient care as part of their routine workflow.

Progressive multifocal leukoencephalopathy secondary to hepatitis C virus infection-related T-cell lymphopenia.

Progressive multifocal leukoencephalopathy (PML) is an uncommon neurological condition known to occur in the setting of T-cell immune suppression. We report a case of hepatitis C virus (HCV) infection-related T-cell lymphopenia manifesting as PML. HCV treatment and transient viral suppression resulted in immunological recovery with clinical stabilisation.

"I didn't want to, but then I told": Adolescents' narratives regarding disclosure, concealment, and lying.

This study examined 131 U.S. middle class early, middle, and late adolescents' (Mage = 12.74, 15.81, and 20.40 years, respectively) narratives regarding experiences of disclosure, concealment, and lying to parents and responses to direct probes about lessons learned about self and parents. The thematic content focused primarily on routine activities and peer experiences, and to a lesser extent, romantic issues, risky or delinquent behavior, and academic achievement, with few content differences across narrative types. Greater psychological elaboration in narratives and, when directly probed, more evidence of psychological growth and positive lessons about parents, were observed when teens disclosed than concealed or lied. There was less factual elaboration when youth narrated about concealment than disclosure or lying, particularly among early adolescent males as compared to older males and same-age females. Narrative coherence increased with age and was greater in females' than males' lying narratives. Thus, adolescents learn different lessons from disclosing, concealing, and lying, with varying implications for the development of self, identity, and moral agency. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

A patient-derived explant (PDE) model of hormone-dependent cancer.

Breast and prostate cancer research to date has largely been predicated on the use of cell lines in vitro or in vivo. These limitations have led to the development of more clinically relevant models, such as organoids or murine xenografts that utilize patient-derived material; however, issues related to low take rate, long duration of establishment, and the associated costs constrain use of these models. This study demonstrates that ex vivo culture of freshly resected breast and prostate tumor specimens obtained from surgery, termed patient-derived explants (PDEs), provides a high-throughput and cost-effective model that retains the native tissue architecture, microenvironment, cell viability, and key oncogenic drivers. The PDE model provides a unique approach for direct evaluation of drug responses on an individual patient's tumor, which is amenable to analysis using contemporary genomic technologies. The ability to rapidly evaluate drug efficacy in patient-derived material has high potential to facilitate implementation of personalized medicine approaches.

Teaching Parents About Responsive Feeding Through a Vicarious Learning Video: A Pilot Randomized Controlled Trial.

The American Academy of Pediatrics and World Health Organization recommend responsive feeding (RF) to promote healthy eating behaviors in early childhood. This project developed and tested a vicarious learning video to teach parents RF practices. A RF vicarious learning video was developed using community-based participatory research methods. Fifty parents of preschoolers were randomly assigned to watch Happier Meals or a control video about education. Knowledge and beliefs about RF practices were measured 1 week before and immediately after intervention. Experimental group participants also completed measures of narrative engagement and video acceptability. Seventy-four percent of the sample was White, 90% had at least a college degree, 96% were married, and 88% made >$50,000/year. RF knowledge increased ( p = .03) and positive beliefs about some unresponsive feeding practices decreased ( ps < .05) more among experimental than control parents. Knowledge and belief changes were associated with video engagement ( ps < .05). Parents perceived Happier Meals as highly relevant, applicable, and informative. Community-based participatory research methods were instrumental in developing this vicarious learning video, with preliminary evidence of effectiveness in teaching parents about RF. Happier Meals is freely available for parents or community health workers to use when working with families to promote healthy eating behaviors in early childhood.

GATA2 expression and biochemical recurrence following salvage radiation therapy for relapsing prostate cancer.

OBJECTIVE: High GATA2 expression has been associated with an increased risk of poor clinical outcomes after radical prostatectomy; however, this has not been studied in relation to risk of biochemical recurrence (BCR) after salvage radiation therapy (SRT) for recurrent prostate cancer after radical prostatectomy. Our aim was to evaluate the association between protein expression levels of GATA2 in primary prostate cancer tumour samples and the risk of BCR after SRT. METHODS: 109 males who were treated with SRT were included. The percentage of cells with nuclear staining and GATA2 staining intensity were both measured. These two measures were multiplied together to obtain a GATA2 H-score (range 0-12) which was our primary GATA2 staining measure. RESULTS: In unadjusted analysis, the risk of BCR was higher for patients with a GATA2 H-score >4 (hazard ratio = 2.04, p = 0.033). In multivariable analysis adjusting for SRT dose, pre-SRT PSA, pathological tumour stage and Gleason score, this association weakened substantially (hazard ratio = 1.45, p = 0.31). This lack of an independent association with BCR appears to be the result of correlations between GATA2 H-score >4 and higher pre-SRT PSA (p = 0.021), higher Gleason score (p = 0.044) and more severe pathological tumour stage (p = 0.068). CONCLUSION: Higher levels of GATA2 expression appear to be a marker of prostate cancer severity; however, these do not provide independent prognostic information regarding BCR beyond that of validated clinicopathological risk factors. Advances in knowledge: A higher GATA2 expression level appears to be correlated with known measures of prostate cancer severity and therefore is likely not an independent marker of outcome after SRT.

Systematic review of the health-related quality of life issues facing adolescents and young adults with cancer.

PURPOSE: For adolescents and young adults (AYAs), the impact of a cancer diagnosis and subsequent treatment is likely to be distinct from other age groups given the unique and complex psychosocial challenges of this developmental phase. In this review of the literature, we report the health-related quality of life (HRQoL) issues experienced by AYAs diagnosed with cancer and undergoing treatment. METHODS: MEDLINE, EMBASE, CINAHL, PsychINFO and the Cochrane Library Databases were searched for publications reporting HRQoL of AYAs. Issues generated from interviews with AYAs or from responses to patient reported outcome measures (PROMs) were extracted. RESULTS: 166 papers were reviewed in full and comprised 72 papers covering 69 primary studies, 49 measurement development or evaluation papers and 45 reviews. Of the 69 studies reviewed, 11 (16%) used interviews to elicit AYAs' descriptions of HRQoL issues. The majority of the PROMs used in the studies represent adaptations of paediatric or adult measures. HRQoL issues were organised into the following categories: physical, cognitive, restricted activities, relationships with others, fertility, emotions, body image and spirituality/outlook on life. CONCLUSION: The HRQoL issues presented within this review are likely to be informative to health care professionals and AYAs. The extensive list of issues suggests that the impact of a cancer diagnosis and treatment during adolescence and young adulthood is widespread and reflects the complexities of this developmental phase.