A protocol to reduce self-reported pain scores and adverse events following lumbar punctures in older adults.
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ABSTRACT: Objective
Lumbar punctures (LPs) are important for obtaining CSF in neurology studies but are associated with adverse events and feared by many patients. We determined adverse event rates and pain scores in patients prospectively enrolled in two cohort studies who underwent LPs using a standardized protocol and 25 g needle.Methods
Eight hundred and nine LPs performed in 262 patients age ≥ 60 years in the MADCO-PC and INTUIT studies were analyzed. Medical records were monitored for LP-related adverse events, and patients were queried about subjective complaints. We analyzed adverse event rates, including headaches and pain scores.Results
There were 22 adverse events among 809 LPs performed, a rate of 2.72% (95% CI 1.71-4.09%). Patient hospital stay did not increase due to adverse events. Four patients (0.49%) developed a post-lumbar puncture headache (PLPH). Twelve patients (1.48%) developed nausea, vasovagal responses, or headaches that did not meet PLPH criteria. Six patients (0.74%) reported lower back pain at the LP site not associated with muscular weakness or paresthesia. The median pain score was 1 [0, 3]; the mode was 0 out of 10.Conclusions
The LP protocol described herein may reduce adverse event rates and improve patient comfort in future studies.
SUBMITTER: Nobuhara CK
PROVIDER: S-EPMC7336280 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundWith increasing emphasis on patient satisfaction metrics, such as the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey, hospital reputations and reimbursements are being affected by their results. The purpose of the current study is to determine if post-operative self-reported patient satisfaction differed among patients who experienced any adverse event (AAE) following elective posterior lumbar fusion (PLF) surgery compared to those who did not.MethodsPatients who underwent elective PLF surgery performed at a single institution between February 2013 and May 2020 and returned an HCAHPS survey following discharge were included in the retrospective cohort analysis. Demographic, comorbidity, and HCAHPS survey data were compared between patients who did and did not experience any adverse event (AAE) in the 30-days postoperatively.ResultsOf 5,117 PLF patients, the HCAHPS survey was returned by 1,071 patients, of which 30-day AAE was experienced by 40 (3.73%). Of those that experienced AAE, the survey response rate was significantly lower (13.94% versus 21.35%, p=0.003). Those responding reported lower scores pertaining to if medication side-effects were adequately explained (22.22% versus 52.56%, p=0.002) and if post-discharge care was adequately explained (79.17% versus 93.76%, p=0.005), as well as overall top-box responses (67.62% versus 75.93% survey average, p<0.001).ConclusionsPatients experiencing AAE after elective PLF surgery are less likely to respond to surveys about their hospital experience. For those who did respond, they report less satisfaction with multiple aspects of their hospital care measured by the HCAHPS survey. Understanding how postoperative adverse events impact patients' perception of healthcare quality provides insight into what patients value and has implications for optimizing their care.
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Project description:BackgroundCore cerebrospinal fluid (CSF) amyloid and tau biomarker assessment has been recommended to refine the diagnostic accuracy of Alzheimer's disease. Lumbar punctures (LP) are invasive procedures that might induce anxiety and pain. The use of non-pharmacological techniques must be considered to reduce the patient's discomfort, in this setting. The objective of this study was to examine the efficacy of hypnosis on anxiety and pain associated with LP.MethodsA monocentric interventional randomized-controlled pilot study is conducted in a university geriatric day hospital. Cognitively impaired patients aged over 70 were referred for scheduled LP for the diagnostic purpose (CSF biomarkers). The participants were randomly assigned either to a hypnosis intervention group or usual care. Pain and anxiety were both self-assessed by the patient and hetero-evaluated by the operator.ResultsWe included 50 cognitively impaired elderly outpatients (women 54%, mean age 77.2 ± 5.0, mean Mini-Mental State Examination score 23.2 ± 3.5). Hypnosis was significantly associated with reduced self-assessed (p < 0.05) and hetero-assessed anxiety (p < 0.01). Hetero-evaluated pain was significantly lower in the hypnosis group (p < 0.05). The overall perception of hypnosis was safe, well-accepted, and feasible in all the participants of the intervention group with 68% perceiving the procedure as better or much better than expected.ConclusionsThis pilot study suggested that hypnosis was feasible and may be used to reduce the symptoms of discomfort due to invasive procedures in older cognitively impaired patients. Our results also confirmed the overall good acceptance of LP in this population, despite the usual negative perception.Trial registrationClinicalTrials.gov NCT04368572. Registered on April 30, 2020.
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Project description:BackgroundVaccination against coronavirus disease 2019 (COVID-19) is underway globally to prevent the infection caused by the severe acute respiratory syndrome coronavirus 2. We aimed to investigate the adverse events following immunization (AEFIs) for COVID-19 among healthcare workers (HCWs).MethodsThis was a retrospective study of the AEFIs associated with the first dose of the ChAdOx1 nCoV-19 vaccine at the Kosin University Gospel Hospital from March 3 to March 22, 2021. We investigated the systemic and local adverse events during the 7 days following the vaccination using the Mobile Vaccine Adverse Events Reporting System (MVAERS) developed by our hospital.ResultsA total of 1,503 HCWs were vaccinated, and the data of 994 HCWs were reported in the MVAERS. The most commonly reported AEFIs were tenderness at the injection site (94.5%), fatigue (92.9%), pain at the injection site (88.0%), and malaise (83.8%). The severity of most AEFIs was mild-to-moderate, and the severity and number of AEFIs were less in the older age group. There were no serious events requiring hospitalization, and most AEFIs improved within a few days.ConclusionThe AEFIs associated with the ChAdOx1 nCoV-19 vaccine were tolerable, and the use of the MVAERS was helpful in monitoring the AEFIs. The use of MVAERS will help in sharing accurate and ample information about vaccination against COVID-19.
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Project description:Cerebrospinal fluid (CSF) biomarkers for Alzheimer's disease and related disorders can provide early and accurate prediction of underlying neuropathology even when the clinical symptoms are mild, but lumbar punctures (LP) to obtain CSF can be perceived as frightening and invasive. We previously demonstrated that this negative perception of the LP is strongly associated with a negative LP experience in terms of discomfort and complications, but it is not known what factors can lead to a negative perception of the LP. It has also been proposed that LP is less well-perceived by adults in the U.S. compared to Europe and elsewhere, although there is a paucity of primary data to support this. To address these knowledge gaps, we conducted a survey of 237 younger and older adults in the Atlanta area including a significant number born outside of the U.S. (n = 82, 34%) to determine demographic, medical, and experiential factors associated with the perception of LP as well as the willingness to undergo LP for medical or research purposes. Our results show that one in four respondents in this cohort with limited first-hand LP experience viewed the LP as a frightening invasive procedure, but the majority (89%) were willing to undergo LP for medical reasons. General awareness of the LP was associated with both standard and negative views of the LP, but perception did not influence willingness to undergo the procedure. Multi-variate models showed that higher annual household income, not place of birth or past experience, was associated with greater willingness to undergo LPs. We conclude that Americans (born in the U.S. or abroad) are not resistant to LPs if there is useful information to improve their health, although there is limited enthusiasm to undergo LPs solely for research purposes. At the same time, we failed to find modifiable factors to improve the perception of LP among those who already perceive it as frightening and invasive. Future recruitment effort should target adults with no preconceived notion of the LP with emphasis on data related to safety and tolerability.
| S-EPMC5300987 | biostudies-literature
Project description:IntroductionThe rapid roll-out of novel COVID-19 vaccines made near real-time post-marketing safety surveillance essential to identify rare and long-term adverse events following immunization (AEFIs). In light of the ongoing booster vaccination campaigns, it is key to monitor changes in observed safety patterns post-vaccination. The effect of sequential COVID-19 vaccinations, as well as heterologous vaccination sequences, on the observed post-vaccination safety pattern, remains largely unknown.MethodsThe primary objective of this study was to describe the profile of spontaneously reported AEFIs following COVID-19 vaccination in the Netherlands, including the primary and booster series. Reports from consumers and healthcare professionals were collected via a COVID-19 vaccine-tailored online reporting form by the National Pharmacovigilance Centre Lareb (Lareb) between 6 January 2021 and 31 August 2022. The data were used to describe the most frequently reported AEFIs per vaccination moment, the consumer experienced burden per AEFI, and differences in AEFIs reported for homologous and heterologous vaccination sequences.ResultsLareb received 227,884 spontaneous reports over a period of twenty months. Overall, a high degree of similarity in local and systemic AEFIs per vaccination moment was observed, with no apparent change in the number of reports of serious adverse events after multiple COVID-19 vaccinations. No differences in the pattern of reported AEFIs per vaccination sequence was observed.ConclusionSpontaneous reported AEFIs demonstrated a similar reporting pattern for homologous and heterologous primary and booster series of COVID-19 vaccination in the Netherlands.
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Project description:BackgroundSignificant intraprocedural adverse events (AE) are reported in children who receive anesthesia for procedures outside the Operating Rooms (NORA). No study, so far, has characterized AE in children who receive anesthesia in the operating rooms (ORA) and NORA when anesthesia care is provided by the same team in a consistent manner.Objective/aimWe used the same patient-specific Quality Assurance questionnaires (QAs), to elucidate incidences of intraoperative reported AE for children receiving anesthesia in NORA and ORA locations. Through multivariate logistic regression analysis, we assessed the association between patient's AE risk and procedure's location while adjusting for American Society of Anesthesiologists (ASA) status, age, and unscheduled nature of the procedure.Methods/materialsAfter Institutional Review Board approval, we used returned QAs of patients under 21 years, who received anesthesia from our pediatric anesthesia faculty from May 1 2006 through September 30, 2007. We analyzed QA data on: service location, unscheduled/scheduled procedure, age, ASA status, presence, and type of AE. We excluded QAs with incomplete information on date, location, age, and ASA status.ResultsWe included 8707 cases, with 3.5% incidence of reported AE. We had 1898 NORA and 6808 ORA cases with AE incidence of 2.5% and 3.7%, respectively. Multivariate regression analysis revealed that patients with higher ASA status or younger age had higher incidence of reported AE, irrespective of location or unscheduled nature of the procedure. The most common AE type, for both sites, was respiratory related (1.9%).ConclusionsPediatric reported AE incidence was comparable for NORA and ORA locations. Younger age or higher ASA status are associated with increased risk of AE.
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Project description:ObjectiveBone marrow aspiration and lumbar puncture are procedures frequently performed in pediatric oncology. We aimed at assessing the incidence and risk factors of perioperative complications in children undergoing these procedures under sedation or general anesthesia.MethodsBased on the APRICOT study, we performed a secondary analysis, including 893 children undergoing bone marrow aspiration and lumbar puncture. The primary outcome was the incidence of perioperative complications. Secondary outcomes were their risk factors.ResultsWe analyzed data of 893 children who underwent 915 procedures. The incidence of severe adverse events was 1.7% and of respiratory complications was 1.1%. Prematurity (RR 4.976; 95% CI 1.097-22.568; P = 0.038), intubation (RR: 6.80, 95% CI 1.66-27.7; P =0.008), and emergency situations (RR 3.99; 95% CI 1.14-13.96; P = 0.030) increased the risk for respiratory complications. The incidence of cardiovascular instability was 0.4%, with premedication as risk factor (RR 6.678; 95% CI 1.325-33.644; P =0.021).ConclusionA low incidence of perioperative adverse events was observed in children undergoing bone marrow aspiration or lumbar puncture under sedation and/or general anesthesia, with respiratory complications being the most frequent. Careful preoperative assessment should be undertaken to identify risk factors associated with an increased risk, allowing for appropriate adjustment of anesthesia management.
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Project description:IntroductionThe rapid rollout of coronavirus disease 2019 (COVID-19) vaccines for a large proportion of the population necessitates a strong emphasis on safety. Complementary to the existing spontaneous reporting system, The Netherlands Pharmacovigilance Centre Lareb conducted patient-reported cohort event monitoring (CEM).ObjectiveThe primary aim was to investigate differences in the frequencies of any and commonly reported, 'well-known', systemic adverse events following immunization (AEFIs) with four COVID-19 vaccines (Pfizer's Comirnaty®, Moderna's Spikevax®, AstraZeneca's Vaxzevria® and the Janssen vaccine). As a secondary aim, we analyzed the frequencies of well-known systemic adverse events after the first and, if applicable, second COVID-19 vaccinations, taking into account age, sex and prior COVID-19 infection.MethodsPatient-reported outcomes (PROs) in the Netherlands starting in February 2021 were analyzed using a prospective cohort design.ResultsData of 27,554 participants who received one vaccination and 20,682 participants who received complete immunization were analyzed. The percentage of patients reporting any AEFI was high and ranged from approximately 53% for the Pfizer vaccine to approximately 94% for the Moderna vaccine. The frequency of serious AEFIs was low, with the highest frequency found for the AstraZeneca vaccine (0.228%). AEFIs were most often experienced by participants receiving the first dose of the AstraZeneca and Janssen vaccines and the second dose of the Moderna vaccine; the Pfizer vaccine was associated with the lowest rate of AEFIs. Participants with a COVID-19 history before vaccination experienced commonly reported systemic AEFIs more frequently after the first vaccination than after the second vaccination. Women and young people experienced more AEFIs than men and older people, respectively.ConclusionsThe analysis of a large cohort provides important information about the rates of AEFIs across age groups, among brands of vaccines and between those with and without prior COVID-19 infection. Participants reported a high number of AEFIs in general, but the frequency of serious AEFIs was low.
| S-EPMC8936041 | biostudies-literature
Project description:Lumbar puncture (LP) is a common invasive procedure in the acute medical setting but is not without its risks and complications, making best clinical practice and correct documentation important for patient safety. Previous audit revealed poor levels of consistency in technique and documentation in the acute medical setting, highlighting it as an area for improvement. This project aims to identify current levels of documentation and improve upon these through the departmental education and the introduction of a documentation tool to create a safer clinical environment for LPs. Gold standards in clinical practice were identified through literature review and national guidelines, establishing 15 key parameters as essential areas for documentation. Patient notes were retrospectively analysed after LP over a two month period to identify levels of documentation in these areas, and the clinical technique used. Results of this initial audit were presented to the department along with an education session regarding current evidence based best practice for LPs and the important aspects relating to patient safety. A documentation tool was also introduced. A re-audit was then performed of the same parameters and assessing the use of the documentation tool. Results showed a significant increase in overall documentation from 44% up to 95% after intervention, with 85% of cases using the new proforma. We can conclude that the introduction of a documentation tool and departmental education has significantly improved upon LP documentation in the acute medical setting. This is important for both the protection of medical professionals, as well as patient safety and quality of care, and could be implemented in other clinical environments.
| S-EPMC4645819 | biostudies-other
Project description:BackgroundLimited data exist on the safety of the measles, mumps, and rubella (MMR) vaccine in adults. We reviewed reports of adverse events (AEs) to the Vaccine Adverse Event Reporting System (VAERS) to assess safety in this previously understudied group.MethodsVAERS is the national spontaneous vaccine safety surveillance system coadministered by the Centers for Disease Control and Prevention and the US Food and Drug Administration. We searched the VAERS database for US reports of adults aged ≥19 years who received the MMR vaccine from 1 January 2003 to 31 July 2013. We clinically reviewed reports and available medical records for serious AEs, pregnancy reports, and reports for selected prespecified outcomes.ResultsDuring this period, VAERS received 3175 US reports after MMR vaccine in adults. Of these, 168 (5%) were classified as serious, including 7 reports of death. Females accounted for 77% of reports. The most common signs and symptoms for all reports were pyrexia (19%), rash (17%), pain (13%), and arthralgia (13%). We did not detect any new safety findings in empirical Bayesian data mining. We identified 131 reports of MMR vaccine administered to a pregnant woman; the majority of these vaccinations were in the first trimester and in 83 (62%), no AE was reported.ConclusionsIn our review of VAERS data, we did not detect any new or unexpected safety concerns for MMR vaccination in adults. We identified reports of pregnant women exposed to MMR, which is a group in whom the vaccine is contraindicated, suggesting the need for continued provider education on vaccine recommendations and screening.
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