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At least 19 recordsLinked to original sources
PubMed2026

Immune Checkpoint Inhibitor-related Adverse Events in Publicly Accessible United States Malpractice Records: A Systematic Legal Database Review, 2015 to 2026.

OBJECTIVES: By 2023, an estimated 56.7% of US patients with advanced or metastatic cancer were eligible for immune checkpoint inhibitor (ICI) therapy. Grade 3 to 4 immune-related adverse events (irAEs) occur in ∼14% to 21% of patients depending on regimen, yet publicly accessible malpractice records involving ICI administration or irAE management have not been systematically described. METHODS: We searched Lexis+ and Westlaw Advantage for publicly accessible US malpractice records filed from January 1, 2015, through March 31, 2026. Sources included jury verdicts and settlement databases, federal and state dockets, and briefs, pleadings, and motions databases. Cases were included only when ICI administration, indication selection, toxicity counseling, toxicity recognition, toxicity monitoring, or irAE management was causally central to the alleged negligence. RESULTS: Among 38 legal matters identified after cross-platform deduplication, 4 met eligibility criteria. These matters reflected 4 pleaded negligence theories: inappropriate ICI indication, toxicity counseling and informed-consent failure, irAE mismanagement, and treatment-related multiorgan toxicity. Publicly visible irAE-centered malpractice records were rare relative to the clinical burden, but the data do not support a national litigation incidence estimate. CONCLUSIONS: Publicly accessible irAE-centered malpractice records appear rare. As ICI use expands, litigation risk may increasingly focus on indication documentation, individualized toxicity counseling, and structured monitoring.

immune checkpoint inhibitors↗
PubMed2006

Nutrition intervention using an eicosapentaenoic acid (EPA)-containing supplement in patients with advanced colorectal cancer. Effects on nutritional and inflammatory status: a phase II trial.

GOALS: The aim of the study was to assess the impact of an eicosapentanoic acid-containing protein and energy dense oral nutritional supplement (EPA-ONS) on nutritional and inflammatory status, quality of life (QOL), plasma phospholipids (PPL) and cytokine profile, tolerance of irinotecan-containing chemotherapy and EPA-ONS in patients with advanced colorectal cancer (CRC) receiving chemotherapy. MATERIALS AND METHODS: Patients with advanced CRC having one prior chemotherapy regimen received 480 ml of EPA-ONS daily for 3 weeks before commencing chemotherapy with folinic acid, 5-fluorouracil, irinotecan (FOLFIRI), and continued for 3 cycles of treatment (9 weeks). All assessments including weight, body composition, C-reactive protein (CRP), QOL, dietary intake, PPL and cytokine analyses were performed at baseline, 3 and 9 weeks. RESULTS: Twenty-three patients were enrolled, 20 completed 3 weeks, and 15 completed 9 weeks. The mean EPA-ONS intake was 1.7 tetrapaks (408 ml) daily. There was a significant increase in mean weight (2.5 kg) at 3 weeks (p=0.03). Lean body mass (LBM) was maintained. Protein and energy intake significantly decreased after the commencement of chemotherapy (protein p=0.003, energy p=0.02). There was a significant increase in energy levels (p=0.03), whilst all other QOL measures were maintained. PPL EPA levels increased significantly over the first 3 weeks. Mean CRP increased by 14.9 mg/L over the first 3 weeks (p=0.004), but decreased to baseline levels by the end of the trial. There was a significant correlation between plasma IL-6 and IL-10 concentrations and survival, and between IL-12 and toxicity. CONCLUSION: Dietary counseling and the provision of EPA-ONS may result in maintenance of nutritional status and QOL, however randomized trials are required to evaluate the impact of EPA on toxicity from chemotherapy.

Aged↗
PubMedDate not supplied

Unintentional ingestion of over the counter medications in children less than 5 years old.

OBJECTIVE: Childhood ingestion of medications remains a substantial problem. Medication available over the counter (OTC) is widely used and has significant toxicity. The present study aims to investigate the nature and extent of unintentional ingestion of OTC medication in children < 5 years old in Victoria, Australia, during the period 1996-2000, in order to highlight critical factors. METHODS: Numbers of enquiries relating to unintentional ingestion of OTC medication in children < 5 years old and medication types were obtained from the Victorian Poisons Information Centre for 1998-2000. Emergency Department presentations involving poisoning of children < 5 years old, the medication types and subsequent admissions were obtained from the Victorian Emergency Minimum Dataset for 1996-2000. RESULTS: Numbers of enquiries and Emergency Department attendances for poisoning were substantially higher for OTC medication than for prescription medication; however, a lower proportion of cases involving ingestion of OTC medication (24.8%) required hospital admission during the study period compared with cases involving ingestion of prescription medications (33.8%). Overall, the peak incidence was at 2 years of age, with a slight male over-representation. Paracetamol and cough/cold preparations were the most common agents. CONCLUSIONS: The causes of unintentional ingestion of OTC medications by children might include lack of child-resistant closure (CRC), inadequate design of CRC, attitudes concerning the toxicity of OTC medications, or lack of vigilance by parents and carers in the storage and administration of OTC medications. Consideration should be given to restricting sales of toxic OTC medications to pharmacies, and increasing counselling of consumers concerning the toxicity and safe storage of OTC medications and the correct usage of CRC. The adequacy of CRC design and OTC medications warranting CRC should be reviewed by the relevant authorities.

Age Distribution↗
PubMed2004

Proposed recommendations for the management of HIV post-exposure prophylaxis after sexual, injecting drug or other exposures in Europe.

Post-exposure prophylaxis (PEP) is the standard of care for a healthcare worker (HCW) accidentally exposed to an HIV infected source person (occupational exposure), but this is not the case for non-occupational exposures. Very few national guidelines exist for the management of non-occupational exposures to HIV in Europe, contrarily to the occupational ones. The administration of non-occupational post-exposure prophylaxis (NONOPEP) for HIV may be justified by: a biological plausibility, the effectiveness of PEP in animal studies and occupational exposures in humans, efficacy in the prevention of mother to child HIV transmission, and cost effectiveness studies. These evidences, the similar risk of HIV transmission for certain non-occupational exposures to occupational ones, and the conflicting information about attitudes and practices among physicians on NONOPEP led to the proposal of these European recommendations. Participant members of the European project on HIV NONOPEP, funded by the European Commission, and acknowledged as experts in bloodborne pathogen transmission and prevention, met from December 2000 to December 2002 at three formal meetings and a two day workshop for a literature review on risk exposure assessment and the development of the European recommendations for the management of HIV NONOPEP. NONOPEP is recommended in unprotected receptive anal sex and needle or syringe exchange when the source person is known as HIV positive or from a population group with high HIV prevalence. Any combination of drugs available for HIV infected patients can be used as PEP and the simplest and least toxic regimens are to be preferred. PEP should be given within 72 hours from the time of exposure, starting as early as possible and lasting four weeks. All patients should receive medical evaluation including HIV antibody tests, drug toxicity monitoring and counseling periodically for at least 6 months after the exposure. NONOPEP seems to be a both feasible and frequent clinical practice in Europe. Recommendations for its management have been achieved by consensus, but some remain controversial, and they should be updated periodically. NONOPEP should never be considered as a primary prevention strategy and the final decision for prescription must be made on the basis of the patient-physician relationship. Finally, a surveillance system for these cases will be useful to monitor NONOPEP practices in Europe.

Anti-HIV Agents↗
PubMed2001

Determinants of postembolization syndrome after hepatic chemoembolization.

PURPOSE: Postembolization syndrome (PES) occurs in the majority of patients undergoing hepatic chemoembolization, and is the major reason for hospitalization after the procedure. The ability to identify which groups of patients are at increased or decreased risk of PES would be useful to better counsel patients, to minimize toxicity, and to plan inpatient versus outpatient therapy. MATERIALS AND METHODS: Seventy hepatic chemoembolization procedures were performed in 29 patients using cytotoxic drugs mixed with Ethiodol and polyvinyl alcohol. The following procedural variables were retrospectively assessed and evaluated for association with PES and length of postprocedural hospitalization: gallbladder embolization, lobe embolized, percentage liver volume embolized, percentage embolized volume occupied by tumor, previous embolization of the same territory, and dose of chemoembolic emulsion. Logistic regression was used to quantify the relative effect of each procedural variable. RESULTS: Gallbladder embolization and dose administered were associated with an increased risk of PES and an extended hospitalization, with odds ratios of 2.8 and 3.0, and 3.0 and 4.6, respectively. Previous embolization was associated with a decreased risk of both PES and extended hospitalization, with odds ratios of 0.5 and 0.4, respectively. There was a statistical trend toward significance for gallbladder embolization (P = .06), dose administered (P = .07), and previous embolization (P = .14). CONCLUSION: Clinically relevant predictors of the severity of PES and length of postprocedural hospitalization may exist. Avoiding embolization of the gallbladder reduces the risk of PES. Re-embolization of previously treated vessels is associated with decreased toxicity and may assist in selecting patients for treatment on an outpatient basis, especially when a reduced dose is required.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1988

Effects of cancer treatment on the reproductive system.

Many patients with Hodgkin's disease, acute leukemia, non-Hodgkin's lymphoma, testicular cancer, and other tumors now regularly achieve sustained clinical remissions and cures. Drugs used in the treatment of cancer have profound and often lasting effects on the testis and ovary. Germ cell production and endocrine function may both be altered with the magnitude of the effect related to the age, pubertal status, and menstrual status of the patient as well as to the particular drug, dosage, or combination administered. The primary testicular lesion caused by all antitumor agents studied thus far is depletion of the germinal epithelium lining the seminiferous tubules. Combination chemotherapy regimens that include alkylating agents produce germinal aplasia and permanent infertility in the majority of patients. The risk of ovarian injury following combination chemotherapy is clearly related to the age of the patient at the time of treatment. Overall, 40 to 50% of women treated with combination chemotherapy become amenorrheic, although the frequency of amenorrhea in women older than 35 years may be as high as 90%. Interventions to protect the gonads from the effects of chemotherapy have not yet been developed; thus, male patients should be offered an opportunity to store semen prior to treatment and all patients should be counseled concerning the potential gonadal toxicity of cancer chemotherapy.

Antineoplastic Agents↗
PubMedDate not supplied

Lymphoid malignancy as a presenting sign of ataxia-telangiectasia.

Ataxia-telangiectasia (AT) is an uncommon genetic disorder characterized by cerebellar ataxia, oculocutaneous telangiectasias, progressive immunodeficiency, and a predisposition to lymphoid malignancy. The genetic defect in AT predisposes not only to malignancy but also to severe toxicity from anti-neoplastic therapies. It is important to consider the diagnosis of AT in any child with a lymphoid malignancy at a younger than expected age, or who has a pre-existing ataxia, to anticipate unusually severe toxicities from the antineoplastic therapy, to avoid confusing the development of ataxia with toxicity from therapy, and to provide appropriate genetic counseling. We describe two children at a young age with a lymphoid malignancy diagnosed before the diagnosis of AT. One patient had severe toxicity from his chemotherapy, requiring truncation of the planned course of treatment. The other child was able to tolerate his entire planned course of therapy, but ataxia that was initially interpreted as toxicity from chemotherapy rather than as a sign of his AT developed. Lymphoid malignancy may be the presenting sign of AT. Making this diagnosis may influence therapy of the malignancy. The neurologic manifestations of the disease can be misinterpreted as toxicities of the chemotherapy, and diagnosis of AT allows appropriate genetic counseling for the family.

Ataxia Telangiectasia↗
PubMed2005

Analysis of influence of age on acute and chronic radiotherapy toxicity in treatment of prostate cancer.

OBJECTIVES: To provide a single-institution analysis of the influence of age on acute and late genitourinary (GU) and gastrointestinal (GI) toxicity after radiotherapy (RT) administered in different prostate cancer scenarios. Improved understanding of the influence of age on toxicity outcome after RT for prostate cancer can assist in treatment decision-making. METHODS: The records of 527 consecutive nonmetastatic patients receiving RT at a single institution and for whom demographic, disease, treatment, and follow-up information were available were reviewed. The cohort was divided into four major categories as a function of age: younger than 60 years, 60 to 69 years, 70 to 74 years, and 75 years and older. The toxicity rates in each of these categories were tabulated according to the Radiation Therapy Oncology Group toxicity scales and compared using the chi-square test. Additionally, an ordered logit regression analysis was performed for each of these categories using all major patient, disease, and treatment factors. RESULTS: The toxicity rates were not significantly different as a function of age for either acute GU (P = 0.10) or acute GI (P = 0.19) toxicity or for either late GU (P = 0.22) or late GI (P = 0.09) toxicity. The ordered logit regression analysis showed that age was not a factor that correlated with toxicity in any setting (acute GU, P = 0.44; acute GI, P = 0.55; late GU, P = 0.65; late GI, P = 0.14). CONCLUSIONS: Patient age did not independently influence GI or GU toxicity after RT for nonmetastatic prostate cancer and should not be used as an independent factor in treatment decision-making or in patient counseling with regard to GI and GU toxicity outcomes after RT.

Age Factors↗
PubMed1999

[Early diagnosis and early treatment of cognitive disorders: a study of geriatric screening of an unselected patient population in general practice].

To investigate the feasibility of early assessment of preventable disabilities in primary care, we developed a geriatric preventive screening examination with various indicators of physical, emotional, and social functions as well as laboratory exams. Cognitive impairment was measured by the modified MMSE. Severe cases of dementia, who would deserve home visits were excluded. Results of the assessment procedure in 446 patients aged 70 and over (71.5% females) were compared to ratings of general practitioners (n = 67). In these patients we found 4250 medical, 374 psychiatric, and 528 social problems. 45.4% of medical, 61.8% of psychiatric, and 56.8% of social problems where hitherto unknown to the GPs. The prevalence of cognitive impairment was 4.6% according to GPs diagnosis and 21% according to the MMSE. The sensitivity of GPs diagnosis was 14%, the specificity 98%, and the overall agreement measured by kappa was 0.17. There were significant (p < 0.05) associations of cognitive impairment with poor health, vascular disease, syncope, weight loss, previous hospitalization, depression, and ADL and IADL-items. Hypertension, or pathological thyroid function, occurred more frequently in the cognitively impaired (p > 0.05). Only 19.5% of dementia cases had severe functional loss, which substantiates our hypothesis that mild dementia was studied. Of all cases with newly identified cognitive impairment (n = 83 of 446 patients), three (3.6%) had reversible disorder such as depression (n = 1), drug toxicity (n = 2) 3 (3.6%) received counseling, and 5 (6%) further diagnostic assessment or treatment. One (1.2%) patient did not accept any treatment. In the remainder of 71 patients (85.5%), the GPs adopted a wait and see strategy with no intervention. In conclusion, memory deficits seem to be underdiagnosed in general practice despite much treatable comorbidity or social problems, and some reversible conditions such as depression and drug adverse effects.

Activities of Daily Living↗
PubMed2005

Prostate brachytherapy for localized prostate cancer.

After skin cancer, prostate cancer (CaP) is the most common cancer diagnosed in men. As a result of screening with prostate-specific antigen, CaP is being caught earlier than it was in the past. This has led to an increase in cure rates across all treatment modalities. There are no firm, reproducible data that demonstrate the superiority of one modality over another. The expectations for cure should be approximately 90% for low-risk patients and approximately 80% for intermediate-risk patients, regardless of treatment modality. The toxicity of available treatment modalities discriminates among them. All modalities have acute toxicity of similar severity; however, prostate brachytherapy (PI) has the least amount of long-term toxicity when compared with external beam radiotherapy and radical prostatectomy. Therefore, a patient who is confronted with the diagnosis of CaP is counseled to choose among the modalities based on the toxicity rather than the efficacy of the treatment options available. Adopting this evidence-based algorithm has led to the increased application of PI.

Antineoplastic Protocols↗
PubMed2003

Postexposure prophylaxis: an intervention to prevent human immunodeficiency virus infection in adolescents.

Postexposure prophylaxis is an effective intervention to prevent transmission of the human immunodeficiency virus (HIV). Administration of antiretroviral medications within 72 hours of a percutaneous or mucous membrane exposure to HIV can prevent infection. The use of postexposure prophylaxis for occupational and perinatal HIV exposures is well established. Its efficacy for nonoccupational exposures has only recently been studied. To date in the United States, there are no national guidelines regarding postexposure prophylaxis for nonoccupational exposures. Decisions regarding its use should be made after weighing the risks of seroconversion for a given exposure, the risks of HIV in the source, and the potential toxicities of the antiretroviral medications. Several state guidelines may also serve as important resources. Clinicians should consider initiating postexposure prophylaxis in adolescents for any oral, anal, or vaginal exposure to definitely or possibly HIV-infected blood or body fluids. Adolescents treated should be followed closely for medication toxicity, acute seroconversion, and risk-reduction counseling. Further studies are needed to characterize the use and efficacy of postexposure prophylaxis in an adolescent population.

Adolescent↗
PubMed1987

Mucocutaneous and systemic toxicity of retinoids: monitoring and management.

Oral retinoid therapy is associated with significant mucocutaneous and systemic toxicity similar to that found in hypervitaminosis A. Beside the well-known mucocutaneous adverse effects like cheilitis, xerosis, desquamation, dryness of mucous membranes, more troublesome findings are ocular effects, hair loss or hypergranulation tissue. The most unwanted systemic side effects under both retinoids (isotretinoin and etretinate) are teratogenicity, bone toxicity and serum lipid increments. Careful patient counselling and monitoring will enable the physician to modulate these effects and reduce their impact on patient compliance.

Eye Diseases↗
PubMed2004

Advising cancer patients on natural health products--a structured approach.

BACKGROUND: Many patients with cancer (45-60%) use natural health products (NHPs). Pharmacists often find it difficult to advise these patients effectively. OBJECTIVE: To explore pharmacists' perceptions of the information needed to advise cancer patients on NHPs and develop a structured counseling approach. METHODS: A qualitative study was conducted using a focus group of pharmacists from an integrated cancer care organization in Canada. The outcome measures were the definitions of and reasons for the information needed to advise patients on NHPs and a counseling approach using laymen terms. RESULTS: Eight focus group sessions took place, from which 6 categories of information emerged: role of the advisor, evaluation of evidence, assessment of efficacy, assessment of toxicity, monitoring parameters, and provision of a closure. A patient counseling approach was developed based on this information. CONCLUSIONS: The findings provided a description of and rationale for categories of information needed to advise cancer patients on NHPs. A structured, step-by-step approach to counseling these patients was developed.

Biological Factors↗
PubMed2000

Experience of healthcare workers taking postexposure prophylaxis after occupational HIV exposures: findings of the HIV Postexposure Prophylaxis Registry.

OBJECTIVE: To collect information about the safety of taking antiretroviral drugs for human immunodeficiency virus (HIV) postexposure prophylaxis (PEP). DESIGN: A voluntary, confidential registry. SETTING: Hospital occupational health clinics, emergency departments, private physician offices, and health departments in the United States. RESULTS: 492 healthcare workers (HCWs) who had occupational exposures to HIV, were prescribed HIV PEP, and agreed to be enrolled in the registry by their healthcare providers were prospectively enrolled in the registry. Three hundred eight (63%) of 492 of the PEP regimens prescribed for these HCWs consisted of at least three antiretroviral agents. Of the 449 HCWs for whom 6-week follow-up was available, 195 (43%) completed the PEP regimen as initially prescribed. Forty-four percent (n=197) of HCWs discontinued all PEP drugs and did not complete a PEP regimen. Thirteen percent (n=57) discontinued > or =1 drug or modified drug dosage or added a drug but did complete a course of PEP Among the 254 HCWs who modified or discontinued the PEP regimen, the two most common reasons for doing so were because of adverse effects attributed to PEP (54%) and because the source-patient turned out to be HIV-negative (38%). Overall, 340 (76%) HCWs with 6-week follow-up reported some symptoms while on PEP: nausea (57%), fatigue or malaise (38%), headache (18%), vomiting (16%), diarrhea (14%), and myalgias or arthralgias (6%). The median time from start of PEP to onset of each of the five most frequently reported symptoms was 3 to 4 days. Only 37 (8%) HCWs with 6-week follow-up were reported to have laboratory abnormalities; review of the reported abnormalities revealed that most were unremarkable. Serious adverse events were reported to the registry for 6 HCWs; all but one event resolved by the 6-month follow-up visit. Fewer side effects were reported by HCWs taking two-drug PEP regimens than by HCWs taking three-drug PEP regimens. CONCLUSIONS: Side effects from HIV PEP were very common but were rarely severe or serious. The nature and frequency of HIV PEP toxicity were consistent with information already available on the use of these antiretroviral agents. Clinicians prescribing HIV PEP need to counsel HCWs about PEP side effects and should know how to manage PEP toxicity when it arises.

Adolescent↗
PubMed1999

Predicting clinician injury prevention counseling for young children.

BACKGROUND: Injury is the primary cause of morbidity and mortality in children and an important topic for counseling. OBJECTIVE: To describe and explain clinicians' reported counseling behavior during the well-child examinations for children aged 5 years and younger on the following 4 injury prevention topics: motor vehicle crashes, toxic ingestion, drowning, and firearm injuries. METHODS: A random sample of 465 pediatricians, family physicians, and pediatric nurse practitioners in an urban setting received mailed questionnaires; 325 (69.9%) responded. Multivariate logistic regression predicting counseling on each injury prevention topic was performed. RESULTS: Most reported discussing motor vehicle occupant protection (66.2%) and toxic ingestion prevention (62.1%) during the well-child examination. Only 31.8% stated they counseled on drowning prevention and 15.7%, on firearm injury prevention. Knowledge of injury mortality and morbidity rates was not associated with counseling. For most topics, female respondents were more likely to counsel than male respondents (motor vehicle crash odds ratio [OR], 2.24 [P = .03]; toxic ingestion OR, 1.82 [P = .05]; drowning OR, 1.97 [P = .04]). Health maintenance organization settings predicted injury prevention counseling for most topics (motor vehicle crash OR, 2.52 [P = .04]; toxic ingestion OR, 2.77 [P = .01]; firearm injury OR, 2.97 [P = .001]). Clinicians placing lower importance on counseling were less likely to counsel on drowning and firearm injury (drowning OR, 0.73 [P = .006]; firearm injury OR, 0.58 [P<.001]). CONCLUSIONS: Clinicians' knowledge of local injury epidemiology did not influence their counseling on these topics. Clinicians and their patients might benefit by using programs such as The Injury Prevention Program to help them standardize their approach to injury prevention counseling during the routine well-child examination.

Accident Prevention↗
PubMed2000

Using radon risk to motivate smoking reduction: evaluation of written materials and brief telephone counselling.

OBJECTIVE: Radon and cigarette smoking have synergistic effects on lung cancer, even when radon concentrations are relatively low. Working through an electric utility company, we sought to reach smoking households with low radon concentrations and motivate smoking cessation or prohibiting smoking in the home. DESIGN: Eligible homes (n = 714) were randomised to receive: (1) the Environmental Protection Agency's (EPA's) "A citizen's guide to radon"; (2) a specially developed pamphlet; or (3) that pamphlet plus brief telephone counselling. PROCEDURE: Utility company "bill stuffers" offered free radon test kits to smoking households. All households received radon test results with an explanatory cover letter. Both the specially developed pamphlet and the telephone counselling emphasised that smoking cessation or prohibiting smoking in the home were the optimal risk reduction strategies. Households were followed up at 3 and 12 months after receiving materials. RESULTS: The specially developed pamphlet and the EPA guide yielded similar outcomes. There was a non-significant trend for telephone counselling to produce greater sustained quitting than the specially developed pamphlet, and phone counselling led to significantly more new household smoking bans. CONCLUSIONS: Working through a public utility company is an efficient way to reach smoking households, and brief telephone counselling is a promising method for promoting household smoking bans and cessation in homes alerted to the risk posed by the combination of radon and smoking.

Counseling↗
PubMedDate not supplied

Photodynamic therapy: the NCI experience and its nursing implications.

Recent laboratory and clinical data have demonstrated encouraging results with a new treatment modality, photodynamic therapy (PDT). Initially used as a technique for tumor localization, PDT produces cytotoxic effects in superficial tumors such as those growing on the surfaces of the bladder, pleura, head and neck, bronchus, chest wall, and peritoneal cavity. PDT has three components: a light-sensitizing drug, light (generally from a laser), and oxygen. Initial results of phase I clinical trials conducted at the National Cancer Institute (NCI) are encouraging, and systemic toxicities have been minimal. Nursing intervention includes teaching, counseling, monitoring acute reactions, and follow-up care of these patients. This study outlines the results of experience with PDT at NCI and the nursing implications.

Clinical Protocols↗