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JAMA Ophthalmology Dec 2023Intra-arterial chemotherapy (IAC) has quickly gained popularity as a mainstay of treatment for retinoblastoma. Intra-arterial chemotherapy has been described as having...
IMPORTANCE
Intra-arterial chemotherapy (IAC) has quickly gained popularity as a mainstay of treatment for retinoblastoma. Intra-arterial chemotherapy has been described as having several advantages over systemic chemotherapy, including reducing systemic toxicity and neutropenia; however, studies on the risk of neutropenia after IAC remain limited.
OBJECTIVE
To estimate the incidence of neutropenia after IAC, as well as identify risk factors associated with the development of neutropenia.
DESIGN, SETTING, AND PARTICIPANTS
This case series included pediatric patients with unilateral or bilateral retinoblastoma who were treated with IAC at a single quaternary care center from July 13, 2013, to January 6, 2023.
EXPOSURE
All patients were treated with IAC and underwent multiple IAC cycles depending on treatment response. The primary chemotherapy agent used was melphalan, but topotecan or carboplatin could be used along with melphalan. Melphalan doses were kept to 0.4 mg/kg or less per cycle. After each IAC cycle, complete blood cell counts were obtained within 10 to 12 days and repeated until the absolute neutrophil count (ANC) was greater than or equal to 1000/μL.
MAIN OUTCOMES AND MEASURES
The primary outcome was the minimum ANC after each IAC cycle. The secondary outcome was the development of severe (grade 3 or 4) neutropenia (ANC <1000/μL). Regression analyses were used to identify associations between variables and outcomes. Receiver operating characteristic curves were used to calculate threshold dose for each chemotherapy agent potentially associated with the development of severe neutropenia.
RESULTS
A total of 64 eyes of 49 patients (mean [SD] age, 1.7 [1.2] years; 25 females [51.0%]) with retinoblastoma were treated with 171 cycles of IAC. The mean (SD) nadir ANC was 1325.3 (890.7)/μL and occurred a median (IQR) of 10 (10-14) days (range, 6-28 days) after IAC administration. The frequency distribution of post-IAC neutropenia grades 0, 1, 2, 3, 4, and missing was 31 (18.1% of cycles), 25 (14.6%), 40 (23.4%), 37 (21.6%), 26 (15.2%), and 12 (7.0%), respectively. Factors weakly correlated with a lower ANC were higher melphalan dose (β = -2356 [95% CI, -4120.6 to -611.2]; adjusted R2 = 0.251; P = .01) and higher topotecan dose (β = -4056 [95% CI, -7003.6 to -1344.5]; adjusted R2 = 0.251; P = .006).
CONCLUSIONS AND RELEVANCE
In this case series of patients with retinoblastoma, the incidence of severe neutropenia after IAC was nearly 40%, which is higher than previously reported. Extended laboratory monitoring may aid in capturing previously overlooked cases of neutropenia. Topotecan may be associated with the development of neutropenia; limiting topotecan doses, especially in the setting of a high melphalan dose, may be beneficial in reducing the risk of neutropenia.
Topics: Female; Humans; Child; Infant; Retinoblastoma; Retinal Neoplasms; Melphalan; Topotecan; Incidence; Neutropenia; Infusions, Intra-Arterial; Risk Factors
PubMed: 37917073
DOI: 10.1001/jamaophthalmol.2023.4825 -
Diabetes Technology & Therapeutics Jan 2024Connected insulin pens are creating opportunities for the millions of individuals with diabetes using multiple daily injections (MDI) therapy across the globe....
Connected insulin pens are creating opportunities for the millions of individuals with diabetes using multiple daily injections (MDI) therapy across the globe. Continuous glucose monitoring (CGM) data from connected insulin pens are revealing gaps and opportunities to significantly improve care for this population. In this article, we report real-world findings of the InPen™ smart insulin pen paired with CGM (InPen system), used by persons with type 1 diabetes (T1D) and type 2 diabetes (T2D). A retrospective cohort analysis was conducted with the real-world data collected from the InPen system of individuals ( = 3793 with T1D, = 552 with T2D, and = 808 unidentified) who used the system from January 01, 2020, to December 31, 2021. Diabetes management (e.g., missed and mistimed insulin dosing, mismatched food intake, and correction dose delivery) and glycemic outcomes were assessed. In the overall and T1D populations, a dosing frequency of ≥3 doses per day and a missed dose frequency of <20% was associated with improved glycemia. In adults with T2D, missing <20% of doses was the significant factor determining improved glycemia. This analysis, integrating data from a smart insulin pen and CGM, provides insights into the impact of dosing behavior on glycemic outcomes and informs counseling strategies for the diabetes care team, through technologically advanced insulin management for those using MDI therapy.
Topics: Adult; Humans; Insulin; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Blood Glucose Self-Monitoring; Retrospective Studies; Blood Glucose; Insulin, Regular, Human
PubMed: 37855818
DOI: 10.1089/dia.2023.0365 -
Intensive & Critical Care Nursing Dec 2023To observe nurse administration of carbapenem antibiotics, in the context of medication safety measures, in intensive care units.
OBJECTIVE
To observe nurse administration of carbapenem antibiotics, in the context of medication safety measures, in intensive care units.
RESEARCH METHODOLOGY/DESIGN
A quantitative study was conducted using observation principles.
SETTING
Three adult private and public Intensive Care Units in the health district of a capital city in KwaZulu-Natal, South Africa.
MAIN OUTCOME MEASURES
Nurse practices were observed for double-checking of the medication order, medication vial, and method of preparation and administration. Infusion bags were inspected for nurse labelling of medication and patient details. Patient medication treatment charts were inspected for nurse signature.
RESULTS
Carbapenem infusion administrations (n = 223) to twenty patients were observed. Adherence to the scheduled time occurred in 34.9% administrations, 5.4% doses were not given, and an incorrect dose given on 1.4% administrations. One hundred and forty-four (64.6%) infusion bags were inspected during the administrations: there was no medication label affixed to 21.5% bags, and only 8.3% of bags were labelled with essential details; the patient's name, drug, dose, date, time, signature of the nurse mixing and administering the dose, and signature of the secondary nurse.
CONCLUSION
There was a lack of compliance with accepted medication risk mitigation measures. Sub-optimal double-checking resulted in the incorrect dose given, missed dose, and non-adherence to scheduled administration time. This has implications for the optimal administration of antimicrobial medications, raising concerns about the efficacy of treatment for critically ill patients.
IMPLICATIONS FOR CLINICAL PRACTICE
Parenteral administration errors pose a challenge in acute care areas. Risk mitigation measures include double-checking of medications. If antimicrobial treatment is not administered at the prescribed dosing intervals, this may have implications for the efficacy of time-dependent broad-spectrum antibiotics such as carbapenems. Medication administration errors involving antimicrobial medications should therefore be considered as high-risk errors, with the potential to contribute towards antimicrobial resistance.
Topics: Adult; Humans; Cross-Sectional Studies; South Africa; Anti-Infective Agents; Intensive Care Units; Carbapenems; Documentation
PubMed: 37651822
DOI: 10.1016/j.iccn.2023.103527 -
Radiotherapy and Oncology : Journal of... Sep 2023To evaluate efficacy and feasibility of high-dose intensity-modulated radiotherapy (RT) with pre-operative helical tomotherapy, delivering 54 Gy/30 fractions in...
PURPOSE
To evaluate efficacy and feasibility of high-dose intensity-modulated radiotherapy (RT) with pre-operative helical tomotherapy, delivering 54 Gy/30 fractions in patients with retroperitoneal liposarcomas (RPLS).
MATERIALS AND METHODS
Patients with operable, biopsy-proven, RPLS were included in this phase II multicenter study (ClinicalTrials.gov: NCT01841047). The primary objectives were to analyze loco-regional relapse free survival (LRFS), overall survival (OS) and toxicities, graded according to CTCAE V3.0.
RESULTS
From April 2009 to September 2013, 48 patients were included. Histological types were: 20 well differentiated and 28 dedifferentiated liposarcomas. Median clinical target volume (CTV) was 2570 cc (range, 230-8734 cc). The radio-surgical schedule was completed as planned in all patients apart from one. A monobloc wide excision was achieved for all patients. Surgical margins were R0 (16; 34%), R1 (28; 60%), R2 (2; 4%) or missing (1, 2%).With a median follow-up of 5.5 years, 3-year LRFS rate was 74.2% (95%CI: [59.1%; 84.5%]). At 5 years, cumulative incidence of loco-regional relapse for well differentiated and dedifferentiated RPLS was 10% and 18%, respectively. The 5-year OS was 73.9% [95%CI: 58.7-84.3%]. During RT, the most common grade 3-4 adverse events were hematological (N = 20; 41.6%). After surgery and during follow-up, 17 patients (35.4%) presented a grade 3-4 toxicity. Two patients (4.1%) died due to a duodenal toxicity. Nine second cancers were observed.
CONCLUSION
From this phase II trial of preoperative RT in RPLS patients, the dose level proposed cannot be considered safe, leading to non-negligible toxicity and second cancers rates. Our results, combined with STRASS-1 study, suggest that the ideal indication of RT for patients with RPLS still remains to be determined.
Topics: Humans; Radiotherapy, Intensity-Modulated; Neoplasms, Second Primary; Neoplasm Recurrence, Local; Liposarcoma
PubMed: 37437608
DOI: 10.1016/j.radonc.2023.109791 -
Vaccine May 2024In the era of Gavi's 5.0 vision of "leaving no one behind with immunization", childhood routine vaccination in missed communities is considered as a priority concern....
BACKGROUND
In the era of Gavi's 5.0 vision of "leaving no one behind with immunization", childhood routine vaccination in missed communities is considered as a priority concern. Despite having a success story at the national level, low uptake of immunization is still persistent in selected pocket areas of Bangladesh. However, prevalence and the associated factors of zero-dose (ZD) and under-immunization (UI) are still unknown at those geo-pockets of Bangladesh. Thus, the study aims to report and identify the factors associated with ZD and UI in selected geographical locations.
METHODS
This study used data from a Lot Quality Assurance Sampling (LQAS) survey where 504 households from 18 clusters of four hard to reach (HTR) and one urban slum were included. Caregivers of children aged 4.5 to 23 months were interviewed. Three outcome variables- ZD, UI and ZD/UI were considered and several related attributes were considered as independent variables. Data were analyzed through bivariate analysis, binary logistic regression and dominance analysis.
RESULTS
Overall, 32% of the children were either ZD (8%) or UI (26%) in the selected areas. The adjusted odds of ZD/UI for urban slum and haor (wetlands) areas were 5.62 and 3.61 respectively considering coastal areas as reference. However, distance of nearest EPI center, availability of EPI card, age of caregivers, education and occupation of mother and number of earning members in household were influential factors for ZD/UI. According to dominance analysis, availability of EPI card can explain the most of the variation of ZD/UI in this study.
CONCLUSION
The study findings highlight the high prevalence ZD/UI in certain geo-pockets of the country. It provided a powerful insight of current situation and associated factors in regards to ZD/UI in the country which will help policy-makers and programme managers in designing programmes to reduce missed communities in Bangladesh.
Topics: Humans; Bangladesh; Infant; Male; Female; Lot Quality Assurance Sampling; Prevalence; Vaccination; Vaccination Coverage; Adult; Cross-Sectional Studies; Family Characteristics; Immunization Programs
PubMed: 38627143
DOI: 10.1016/j.vaccine.2024.04.018 -
American Heart Journal Oct 2023Among patients with established cardiovascular disease, the ADAPTABLE trial found no significant differences in cardiovascular events and bleeding rates between 81 mg...
Comparison of the effectiveness and safety of 2 aspirin doses in secondary prevention of cardiovascular outcomes in patients with chronic kidney disease: A subgroup analysis of ADAPTABLE.
BACKGROUND
Among patients with established cardiovascular disease, the ADAPTABLE trial found no significant differences in cardiovascular events and bleeding rates between 81 mg and 325 mg of aspirin (ASA) daily. In this secondary analysis from the ADAPTABLE trial, we studied the effectiveness and safety of ASA dosing in patients with a history of chronic kidney disease (CKD).
METHODS
ADAPTABLE participants were stratified based on the presence or absence of CKD, defined using ICD-9/10-CM codes. Within the CKD group, we compared outcomes between patients taking ASA 81 mg and 325 mg. The primary effectiveness outcome was defined as a composite of all cause death, myocardial infarction, or stroke and the primary safety outcome was hospitalization for major bleeding. Adjusted Cox proportional hazard models were utilized to report differences between the groups.
RESULTS
After excluding 414 (2.7%) patients due to missing medical history, a total of 14,662 patients were included from the ADAPTABLE cohort, of whom 2,648 (18%) patients had CKD. Patients with CKD were older (median age 69.4 vs 67.1 years; P < .0001) and less likely to be white (71.5% vs 81.7%; P < .0001) when compared to those without CKD. At a median follow-up of 26.2 months, CKD was associated with an increased risk of both the primary effectiveness outcome (adjusted HR 1.79 [1.57, 2.05] P < .001 and the primary safety outcome (adjusted HR 4.64 (2.98, 7.21), P < .001 and P < .05, respectively) regardless of ASA dose. There was no significant difference in effectiveness (adjusted HR 1.01 95% CI 0.82, 1.23; P = .95) or safety (adjusted HR 0.93; 95% CI 0.52, 1.64; P = .79) between ASA groups.
CONCLUSIONS
Patients with CKD were more likely than those without CKD to have adverse cardiovascular events or death and were also more likely to have major bleeding requiring hospitalization. However, there was no association between ASA dose and study outcomes among these patients with CKD.
Topics: Humans; Aged; Secondary Prevention; Renal Insufficiency, Chronic; Myocardial Infarction; Hemorrhage; Aspirin; Cardiovascular Diseases
PubMed: 37290700
DOI: 10.1016/j.ahj.2023.06.001 -
Vaccines Dec 2023The WHO recommended the use of the RTS,S/AS01 malaria vaccine (RTS,S) based on a pilot evaluation in routine use in Ghana, Kenya, and Malawi. A longitudinal qualitative...
Acceptance of and Adherence to a Four-Dose RTS,S/AS01 Schedule: Findings from a Longitudinal Qualitative Evaluation Study for the Malaria Vaccine Implementation Programme.
BACKGROUND
The WHO recommended the use of the RTS,S/AS01 malaria vaccine (RTS,S) based on a pilot evaluation in routine use in Ghana, Kenya, and Malawi. A longitudinal qualitative study was conducted to examine facilitators and barriers to uptake of a 4-dose RTS,S schedule.
METHODS
A cohort of 198 caregivers of RTS,S-eligible children from communities where RTS,S was provided through the pilot were interviewed three times over a ≈22-month, 4-dose schedule. The interviews examined caregiver perceptions and behaviors. Children's vaccination history was obtained to determine dose uptake.
RESULTS
162 caregivers remained at round 3 (R3); vaccination history was available for 152/162 children. Despite early rumors/fears, the uptake of initial doses was high, driven by vaccine trust. Fears dissipated by R2, replaced with an enthusiasm for RTS,S as caregivers perceived its safety and less frequent and severe malaria. By R3, 98/152 children had received four doses; 34 three doses; 9 one or two doses; and 11 zero doses. The health system and information barriers were important across all under-dose cases. Fears about AEFIs/safety were important in zero-, one-, and two-dose cases. Competing life/livelihood demands and complacency were found in three-dose cases. Regardless of the doses received, caregivers had positive attitudes towards RTS,S by R3.
CONCLUSIONS
Findings from our study will help countries newly introducing the vaccine to anticipate and preempt reasons for delayed acceptance and missed RTS,S doses.
PubMed: 38140205
DOI: 10.3390/vaccines11121801 -
BMC Psychiatry Oct 2023Schizophrenia is a common mental disorder that seriously affects patients' daily lives and brings heavy psychological and economic burdens to their families and society....
BACKGROUND
Schizophrenia is a common mental disorder that seriously affects patients' daily lives and brings heavy psychological and economic burdens to their families and society. The oral problems of patients with schizophrenia are gradually gaining attention, among which dental caries are among the most common oral diseases. Sex differences may be related not only to the various clinical symptoms of schizophrenia but also to different oral hygiene statuses; therefore, the main purpose of this paper is to investigate sex differences related to influencing factors for dental caries in patients with schizophrenia.
METHOD
Inpatients with schizophrenia over 18 years old were included in this study, and multidimensional indicators such as demographics, symptom and cognitive impairment assessments, medications, and the caries index of decayed, missing, and filled teeth (DMFT) were collected. An analysis of sex-based influential factors for dental caries in schizophrenia patients was performed.
RESULTS
Four-hundred and ninety-six patients with schizophrenia were included, with a mean age of 46.73 ± 12.23 years, of which 142 were females and 354 were males. The mean DMFT was significantly higher in males (8.81 ± 8.50) than in females (5.63 ± 6.61, p < 0.001), and the odd ratio of caries in males to females was significantly higher as well (OR = 2.305, p < 0.001). The influential factors of caries in male patients were independently associated with age and smoking status, in which current smokers were at the highest risk for developing caries, and different smoking statuses had various influencing factors for caries. The influencing factors for caries in female patients were independently associated with age, antipsychotic dose, PANSS-positive symptoms, and MMSE levels.
CONCLUSION
Our findings suggest sex differences exist among influential factors for caries in patients with schizophrenia. These risk factors may even be associated with and affect the treatment and prognosis of psychiatric symptoms in patients. Therefore, oral hygiene management of patients with schizophrenia should be enhanced. These differential factors provide new visions and ideas for formulating individual interventions, treatments, and care priorities.
Topics: Humans; Male; Female; Adult; Middle Aged; Adolescent; Schizophrenia; Dental Caries; Psychotic Disorders; Antipsychotic Agents; Risk Factors; Prevalence
PubMed: 37817127
DOI: 10.1186/s12888-023-05256-z -
Acta Neurochirurgica Jun 2024The management of perioperative venous thrombembolism (VTE) prophylaxis is highly variable between neurosurgical departments and general guidelines are missing. The main...
BACKGROUND
The management of perioperative venous thrombembolism (VTE) prophylaxis is highly variable between neurosurgical departments and general guidelines are missing. The main issue in debate are the dose and initiation time of pharmacologic VTE prevention to balance the risk of VTE-based morbidity and potentially life-threatening bleeding. Mechanical VTE prophylaxis with intermittend pneumatic compression (IPC), however, is established in only a few neurosurgical hospitals, and its efficacy has not yet been demonstrated. The objective of the present study was to analyze the risk of VTE before and after the implementation of IPC devices during elective neurosurgical procedures.
METHODS
All elective surgeries performed at our neurosurgical department between 01/2018-08/2022 were investigated regarding the occurrence of VTE. The VTE risk and associated mortality were compared between groups: (1) only chemoprophylaxis (CHEMO; surgeries 01/2018-04/2020) and (2) IPC and chemoprophylaxis (IPC; surgeries 04/2020-08/2022). Furthermore, general patient and disease characteristics as well as duration of hospitalization were evaluated and compared to the VTE risk.
RESULTS
VTE occurred after 38 elective procedures among > 12.000 surgeries. The number of VTEs significantly differed between groups with an incidence of 31/6663 (0.47%) in the CHEMO group and 7/6688 (0.1%) events in the IPC group. In both groups, patients with malignant brain tumors represented the largest proportion of patients, while VTEs in benign tumors occurred only in the CHEMO group.
CONCLUSION
The use of combined mechanical and pharmacologic VTE prophylaxis can significantly reduce the risk of postoperative thromboembolism after neurosurgical procedures and, therefore, reduce mortality and morbidity.
Topics: Humans; Neurosurgical Procedures; Venous Thromboembolism; Female; Male; Middle Aged; Intermittent Pneumatic Compression Devices; Aged; Adult; Postoperative Complications; Retrospective Studies; Elective Surgical Procedures; Anticoagulants; Risk Factors
PubMed: 38874608
DOI: 10.1007/s00701-024-06129-4 -
Journal of Clinical Research in... Mar 2024Treatment adherence is crucial for the success of growth hormone (GH) therapy. Reported nonadherence rates in GH treatment have varied widely. Several factors may have...
OBJECTIVE
Treatment adherence is crucial for the success of growth hormone (GH) therapy. Reported nonadherence rates in GH treatment have varied widely. Several factors may have an impact on adherence. Apart from these factors, the global impact of the COVID-19 pandemic, including problems with hospital admission and routine follow-up of patients using GH treatment, may have additionally affected the adherence rate. The primary objective of this study was to investigate adherence to treatment in patients receiving GH. In addition, potential problems with GH treatment during the pandemic were investigated.
MATERIALS AND METHODS
This was a multicenter survey study that was sent to pediatric endocrinologists in pandemic period (June 2021-December 2021). Patient data, diagnosis, history of pituitary surgery, current GH doses, duration of GH therapy, the person administering therapy (either parent/patient), duration of missed doses, reasons for missed doses, as well as problems associated with GH therapy, and missed dose data and the causes in the recent year (after the onset of the pandemic) were queried. Treatment adherence was categorized based on missed dose rates over the past month (0 to 5%, full adherence; 5.1 to 10% moderate adherence; >10% nonadherence).
RESULTS
The study cohort consisted of 427 cases (56.2% male) from thirteen centers. Median age of diagnosis was 8.13 (0.13-16) years. Treatment indications were isolated GH deficiency (61.4%), multiple pituitary hormone deficiency (14%), Turner syndrome (7.5%), idiopathic GH deficiency (7.5%), small for gestational age (2.8%), and "others" (6.8%). GH therapy was administered by parents in 70% and by patients in 30%. Mean daily dose was 32.3 mcg/kg, the annual growth rate was 1.15 SDS (min -2.74, max 9.3). Overall GH adherence rate was good in 70.3%, moderate in 14.7%, and poor in 15% of the patients. The reasons for nonadherence were mainly due to forgetfulness, being tired, inability to access medication, and/or pen problems. It was noteworthy that there was a negative effect on adherence during the COVID-19 pandemic reported by 22% of patients and the main reasons given were problems obtaining an appointment, taking the medication, and anxiety about going to hospital. There was no difference between genders in the adherence rate. Nonadherence to GH treatment decreased significantly when the patient: administered the treatment; was older; had longer duration of treatment; and during the pandemic. There was a non-significant decrease in annual growth rate as nonadherence rate increased.
CONCLUSION
During the COVID-19 pandemic, the poor adherence rate was 15%, and duration of GH therapy and older age were important factors. There was a negative effect on adherence during the pandemic period.
PubMed: 38488049
DOI: 10.4274/jcrpe.galenos.2024.2023-10-8