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JCO Oncology Practice Jun 2024Implementation science endeavors to facilitate the translation of evidence-based research into clinical routine. The clinical pharmacological/pharmaceutical care program...
A Hybrid Type III Effectiveness-Implementation Trial to Optimize Medication Safety With Oral Antitumor Therapy in Real-World: The AMBORA Competence and Consultation Center.
PURPOSE
Implementation science endeavors to facilitate the translation of evidence-based research into clinical routine. The clinical pharmacological/pharmaceutical care program evaluated in the randomized AMBORA trial on medication safety with oral antitumor therapeutics (OAT) optimizes care delivery and provides significant benefits for patients, treatment teams, and health care systems. Thus, we aimed to investigate the implementation of this care program within the AMBORA Competence and Consultation Center (AMBORA Center).
METHODS
The AMBORA Center within a University Comprehensive Cancer Center offered several services (eg, patient consultations) and was evaluated according to the RE-AIM framework. This multicenter hybrid type III trial focused on implementation outcomes (eg, patient recruitment, referring units, evaluation of services) while concurrently investigating effectiveness (eg, side effects, medication errors). Quantitative and qualitative assessments were combined.
RESULTS
The AMBORA Center conducted over 800 consultations with 420 patients in seven institutions. The primary end point of counseling 70% of patients treated with OAT was not reached. Patients were referred by 15 treatment units compared with 11 units in the AMBORA trial. On the basis of heterogeneous referral rates and characteristics across the institutions, barriers and facilitators of the implementation process were derived. Several survey results (eg, stakeholder interviews, online/paper-based questionnaires) reflected a high appreciation of services by patients and health care professionals. The severity of 60.1% (178 of 296) of detected side effects improved, and 86.3% (297 of 344) of medication errors were resolved.
CONCLUSION
Despite not reaching the primary implementation outcome, the AMBORA Center included more treatment units and demonstrated patient benefit of the AMBORA care program by meeting all effectiveness outcomes. We outlined quantitative and qualitative implementation characteristics to enhance outreach and foster further dissemination of centers to optimize medication safety with OAT.
PubMed: 38848539
DOI: 10.1200/OP.23.00694 -
Journal of Alzheimer's Disease : JAD 2024The Adult Changes in Thought (ACT) study is a cohort of Kaiser Permanente Washington members ages 65+ that began in 1994.
BACKGROUND
The Adult Changes in Thought (ACT) study is a cohort of Kaiser Permanente Washington members ages 65+ that began in 1994.
OBJECTIVE
We wanted to know how well ACT participants represented all older adults in the region, and how well ACT findings on eye disease and its relationship with Alzheimer's disease generalized to all older adults in the Seattle Metropolitan Region.
METHODS
We used participation weights derived from pooling ACT and Behavioral Risk Factor Surveillance System (BRFSS) data to estimate prevalences of common eye diseases and their associations with Alzheimer's disease incidence. Cox proportional hazards models accounted for age, education, smoking, sex, and APOE genotype. Confidence intervals for weighted analyses were bootstrapped to account for error in estimating the weights.
RESULTS
ACT participants were fairly similar to older adults in the region. The largest differences were more self-reported current cholesterol medication use in BRFSS and higher proportions with low education in ACT. Incorporating the weights had little impact on prevalence estimates for age-related macular degeneration or glaucoma. Weighted estimates were slightly higher for diabetic retinopathy (weighted 5.7% (95% Confidence Interval 4.3, 7.1); unweighted 4.1% (3.6, 4.6)) and cataract history (weighted 51.8% (49.6, 54.3); unweighted 48.6% (47.3, 49.9)). The weighted hazard ratio for recent diabetic retinopathy diagnosis and Alzheimer's disease was 1.84 (0.34, 4.29), versus 1.32 (0.87, 2.00) in unweighted ACT.
CONCLUSIONS
Most, but not all, associations were similar after participation weighting. Even in community-based cohorts, extending inferences to broader populations may benefit from evaluation with participation weights.
Topics: Humans; Male; Female; Aged; Aged, 80 and over; Cohort Studies; Prospective Studies; Alzheimer Disease; Eye Diseases; Washington; Prevalence; Proportional Hazards Models; Behavioral Risk Factor Surveillance System; Residence Characteristics
PubMed: 38848188
DOI: 10.3233/JAD-240247 -
Drugs & Aging Jun 2024Listing tools have been developed to improve medications in older patients, including the Fit fOR The Aged (FORTA) list, a clinically validated, positive-negative list...
BACKGROUND
Listing tools have been developed to improve medications in older patients, including the Fit fOR The Aged (FORTA) list, a clinically validated, positive-negative list of medication appropriateness. Here, we aim to validate MyFORTA, an automated tool for individualized application of the FORTA list.
METHODS
331 participants of a multi-center cohort study (AgeCoDe) for whom the FORTA score (sum of overtreatment and undertreatment errors) had been determined manually (gold standard [GS]) were reassessed using the automated MyFORTA (MF) tool. This tool determines the score from ATC and ICD codes combined with clinical parameters.
RESULTS
The FORTA scores were 9.01 ± 2.91 (mean ± SD, MF) versus 6.02 ± 2.52 (GS) (p < 0.00001). Removing undertreatment errors for calcium/vitamin D (controversial guidelines) and influenza/pneumococcal vaccinations (no robust information in the database), the difference decreased: 7.5 ± 2.7 (MF) versus 5.98 ± 2.55 (GS) (p < 0.00001). The remaining difference was driven by, for example, missing nitro spray in coronary heart disease/acute coronary syndrome as the related information was rarely found in the database, but notoriously detected by MF. Three hundred and forty errors from those 100 patients with the largest score deviation accounted for 68% of excess errors by MF.
CONCLUSION
MF was more sensitive to detect medication errors than GS, all frequent errors only detected by MF were plausible, and almost no adaptations of the MF algorithm seem indicated. This automated tool to check medication appropriateness according to the FORTA list is now validated and represents the first clinically directed algorithm in this context. It should ease the application of FORTA and help to implement the proven beneficial effects of FORTA on clinical endpoints.
Topics: Humans; Aged; Male; Female; Aged, 80 and over; Potentially Inappropriate Medication List; Cohort Studies; Inappropriate Prescribing
PubMed: 38848020
DOI: 10.1007/s40266-024-01120-1 -
Contemporary Clinical Trials... Jun 2024Enteral nutrition (EN) is preferred when oral feeding is not possible. The use of the Nasogastric Tube (NGT) ensures rapid and low-risk nutrient administration. However,...
BACKGROUND
Enteral nutrition (EN) is preferred when oral feeding is not possible. The use of the Nasogastric Tube (NGT) ensures rapid and low-risk nutrient administration. However, confirming the placement through chest radiography, besides delaying the initiation of nutritional therapy, exposes patients to radiation. The pH test of gastric aspirate provides a quicker check for NGT placement, but its reliability is compromised by challenges related to aspirating gastric secretions.
STUDY OBJECTIVE
The main objective of this study is to assess the high-performance placement of NGTs for nutritional purposes, optimizing the evaluation of correct insertion through pH testing using an electronic pH meter. Additionally, the study aims to evaluate patient tolerance to the intervention.
MATERIALS AND METHODS
This single-center RCT will include 150 EN candidate patients divided into three groups. Each group will use distinct NGTs, evaluating placement through pH testing and chest radiography for safety. Tolerance, complications related to NGT placement, and costs will be assessed, with data collected anonymously through a secure electronic database.
ETHICAL CONSIDERATIONS
authorization no. 3624, Territorial Ethical Committee Lombardy 5, October 20, 2023.
IMPLICATIONS AND PERSPECTIVES
This protocol introduces innovative technologies, such as advanced NGTs and an electronic pH meter, aiming to optimize enteral nutrition management. This RCT focuses on replacing X-rays as the primary method for verifying NGT placement, thereby reducing costs, time, and patient exposure to radiation. Data analysis may provide insights into managing patients on pH-altering medication. Implementing innovative technologies has the potential to reduce errors and improve economic efficiency and process sustainability.
PubMed: 38845620
DOI: 10.1016/j.conctc.2024.101312 -
BMC Nursing Jun 2024When any aspect of patient care is overlooked or delayed, it is known as Missed Nursing Care (MNC), leading to adverse events such as medication errors, infections,...
BACKGROUND
When any aspect of patient care is overlooked or delayed, it is known as Missed Nursing Care (MNC), leading to adverse events such as medication errors, infections, increased mortality rates, and poor prognosis. Moral competence is crucial for clinical nurses as it guarantees high-quality patient care in nursing practice. Thus, this study aimed to investigate the correlation between moral competencies and MNC among nurses.
METHODS
This study was conducted with a descriptive-correlational design. The participants in the study were nurses who were currently enrolled at Shahid Beheshti University of Medical Sciences. In order to recruit nurses for the study, a convenience sampling method was implemented. The study tools were completed by a total of two hundred nurses. Research tools included a demographic questionnaire, the Moral Competence of Clinical Nurses Questionnaire, and the Kalisch and Williams Missed Nursing Care (MISSCARE) survey.
ETHICAL CONSIDERATION
This study was approved by the Medical Ethics and Law Research Center of Shahid Beheshti University of Medical Sciences.
RESULTS
The mean scores of moral competencies and MNC were 151.83 ± 12.60 and 42.71 ± 9.38, respectively. In other words, descriptive statistics showed that the moral competence score was more than 75%, and the MNC score was less than 50%. Also, there was a significant negative correlation between the total scores of moral competencies and MNC (r = -0.38, p < 0.001), indicating that more moral competence was correlated with lower levels of MNC.
CONCLUSION
The study revealed a negative correlation between nurses' moral competence and MNC, suggesting that enhancing moral competence could reduce MNC. To reduce MNC occurrences, hospitals, and organizations should prioritize moral competency, according to our research.
PubMed: 38844989
DOI: 10.1186/s12912-024-02058-w -
BMC Public Health Jun 2024To explore the risk factors for maternal near-miss (MNM) using the WHO near-miss approach.
OBJECTIVE
To explore the risk factors for maternal near-miss (MNM) using the WHO near-miss approach.
METHODS
Data were obtained from the Maternal Near-Miss Surveillance System in Hunan Province, China, 2012-2022. Multivariate logistic regression analysis (method: Forward, Wald, α = 0.05) and adjusted odds ratios (aORs) were used to identify risk factors for MNM.
RESULTS
Our study included 780,359 women with 731,185 live births, a total of 2461 (0.32%) MNMs, 777,846 (99.68%) non-MNMs, and 52 (0.006%) maternal deaths were identified. The MNM ratio was 3.37‰ (95%CI: 3.23-3.50). Coagulation/hematological dysfunction was the most common cause of MNM (75.66%). Results of multivariate logistic regression analysis showed risk factors for MNM: maternal age > = 30 years old (aOR > 1, P < 0.05), unmarried women (aOR = 2.21, 95%CI: 1.71-2.85), number of pregnancies > = 2 (aOR > 1, P < 0.05), nulliparity (aOR = 1.51, 95%CI: 1.32-1.72) or parity > = 3 (aOR = 1.95, 95%CI: 1.50-2.55), prenatal examinations < 5 times (aOR = 1.13, 95%CI: 1.01-1.27), and number of cesarean sections was 1 (aOR = 1.83, 95%CI: 1.64-2.04) or > = 2 (aOR = 2.48, 95%CI: 1.99-3.09).
CONCLUSION
The MNM ratio was relatively low in Hunan Province. Advanced maternal age, unmarried status, a high number of pregnancies, nulliparity or high parity, a low number of prenatal examinations, and cesarean sections were risk factors for MNM. Our study is essential for improving the quality of maternal health care and preventing MNM.
Topics: Humans; Female; China; Risk Factors; Pregnancy; Adult; Near Miss, Healthcare; Young Adult; Pregnancy Complications; Logistic Models; Maternal Mortality
PubMed: 38844895
DOI: 10.1186/s12889-024-18970-4 -
PloS One 2024The pharmacist plays an essential role in identifying and managing drug-related problems. The aim of this research was to assess the costs avoided by clinical pharmacist...
BACKGROUND
The pharmacist plays an essential role in identifying and managing drug-related problems. The aim of this research was to assess the costs avoided by clinical pharmacist interventions to resolve drug-related problems.
RESEARCH DESIGN AND METHODS
Clinical pharmacists identified drug-related problems and interventions to address them in consecutive outpatients visiting internal medicine clinics at major teaching and public hospitals in Jordan from September 2012 to December 2013. The costs avoided by each intervention to address drug-related problems were collected from the literature. The collected data were used to calculate the overall cost saved and avoided by the interventions implemented to address the identified drug-related problems, adopting a Jordanian healthcare system perspective.
RESULTS
A total of 2747 patients were enrolled in the study. Diagnostic interventions, such as the need for additional diagnostic testing, were employed in 95.07% of the 13935 intervention to address the drug-related problem "Miscellaneous" which was the most frequent drug-related problems. Other common drug-related problems categories included inappropriate knowledge (n = 6972), inappropriate adherence (4447), efficacy-related drug-related problem (3395) and unnecessary drug therapy (1082). The total cost avoided over the research period was JOD 1418720 per month and total cost saved over the study period was JOD 17250.204. Drug-related problems were associated the number of prescription medications (odds ratio = 1.105; 95% confidence interval = 1.069-1.142), prescribed gastrointestinal drugs (3.485; 2.86-4.247), prescribed antimicrobials (3.326; 1.084-10.205), and prescribed musculoskeletal drugs (1.385; 1.011-1.852).
CONCLUSIONS
The study revealed that pharmacists have provided cognitive input to rationalize and optimize the medication use and prevent errors, that led to the reported projected avoided and saved expenditures via various interventions to address drug-related problems. This highlights the added economic impact to the clinical impact of drug-related problems on patients and the healthcare system. The high prevalence and cost of drug-related problems offer strong rationale for pharmacists to provide more vigilant intervention to improve patient outcomes while maintaining cost effectiveness.
Topics: Humans; Jordan; Pharmacists; Male; Female; Middle Aged; Drug-Related Side Effects and Adverse Reactions; Ambulatory Care Facilities; Aged; Adult; Cost Savings
PubMed: 38843244
DOI: 10.1371/journal.pone.0302287 -
European Journal of Hospital Pharmacy :... Jun 2024Medication dispensing errors cause wastage of medicines and increase healthcare costs, with serious consequences for patients. However, few studies have systematically...
Exploring susceptibility factors to medication dispensing errors through a retrospective study of patient-reported dispensing errors over 11 years: are dispensing errors indeed due to personal reasons for pharmacists?
BACKGROUND
Medication dispensing errors cause wastage of medicines and increase healthcare costs, with serious consequences for patients. However, few studies have systematically and completely reviewed dispensing errors, with inadequate attention to the objective regularity and risk factors for dispensing errors.
OBJECTIVES
To explore the potential causes and risk factors influencing the prevalence of medication dispensing errors.
METHODS
We collected patient-reported medication dispensing errors from a large tertiary care hospital in South China over 11 years. We assessed the characteristics of dispensing errors, labelled the causes, compared them with more than 25 million prescriptions from 2012 to 2022, identified the susceptibility factors for the occurrence of dispensing errors, and analysed the characteristics and patterns of the errors.
RESULTS
A total of 376 patient-reported dispensing errors were recorded. It took an average of 5.2 days for a patient to find an error. Only 37.5% of errors were reviewed by the patient within 24 hours. These errors directly contributed to a medication loss of US$188 406. Of the 160 recorded pharmacists, 112 (70%) committed dispensing errors. Dispensing errors were affected by the pharmacists' use of the machine, workload and the length of monthly vacation. Of the dispensing errors, 47.9% (n=180) were caused by medication packaging or names that were similar. Antibiotics (n=32, 8.5%) were the most common types of drugs dispensed incorrectly, and traditional Chinese medicines (n=31, 8.2%) and immunosuppressants (n=21, 5.6%) were the most likely to be dispensed in inaccurate quantities.
CONCLUSIONS
Organising adequate staff and using machines to prepare medicines may be necessary to reduce dispensing errors. When pharmacists have been away from work for more than 72 hours they should find their rhythm in other positions before dispensing medicines. It is more important to prioritise the differentiation of medicines with similar packaging over those with similar names when arranging drug shelving.
PubMed: 38839267
DOI: 10.1136/ejhpharm-2023-004064 -
Annals of Internal Medicine May 2024
Topics: Humans; Inappropriate Prescribing; Nurse Practitioners; Aged; Physicians, Primary Care; Practice Patterns, Physicians'; United States
PubMed: 38837986
DOI: 10.7326/L24-0119 -
CNS Drugs Jul 2024BACKGROUND AND OBJECTIVES: Clozapine is the medication of choice for treatment-resistant schizophrenia. However, it has a complex metabolism and unexplained...
UNLABELLED
BACKGROUND AND OBJECTIVES: Clozapine is the medication of choice for treatment-resistant schizophrenia. However, it has a complex metabolism and unexplained interindividual variability. The current work aims to develop a pharmacokinetic model of clozapine and norclozapine in non-smokers and assess the impact of demographic and genetic predictors.
METHODS
Healthy volunteers were recruited in a population pharmacokinetic study. Blood samples were collected at 30 min and 1, 2, 3, 5 and 8 h following a single flat dose of clozapine (12.5 mg). The clozapine and norclozapine concentrations were measured via high-performance liquid chromatography-ultraviolet method. A semi-physiological pharmacokinetic model of clozapine and norclozapine was developed using nonlinear mixed-effects modeling. Clinical and genetic predictors were evaluated, including CYP1A2 (rs762551) and ABCB1 (rs2032582), using restriction fragment length polymorphism.
RESULTS
A total of 270 samples were collected from 33 participants. The data were best described using a two-compartment model for clozapine and a two-compartment model for norclozapine with first-order absorption and elimination and pre-systemic metabolism. The estimated (relative standard error) clearance of clozapine and norclozapine were 27 L h (31.5 %) and 19.6 L h (30%), respectively. Clozapine clearance was lower in sub-Saharan Africans (n = 4) and higher in Caucasians (n = 9) than Asians (n = 20). Participants with CYP1A2 (rs762551) (n = 18) and ABCB1 (rs2032582) (n = 12) mutant alleles had lower clozapine clearance in the univariate analysis.
CONCLUSIONS
This is the first study to develop a semi-physiological pharmacokinetic model of clozapine and norclozapine accounting for the pre-systemic metabolism. Asians required lower doses of clozapine as compared with Caucasians, while clozapine pharmacokinetics in sub-Saharan Africans should be further investigated in larger trials.
Topics: Clozapine; Humans; Adult; Male; Antipsychotic Agents; Female; Cytochrome P-450 CYP1A2; Young Adult; Models, Biological; Healthy Volunteers; ATP Binding Cassette Transporter, Subfamily B; Middle Aged
PubMed: 38836990
DOI: 10.1007/s40263-024-01092-1