Adverse events and practice variability associated with paediatric endotracheal suction: An observational study

Background: Medication errors commonly occur when patients move from the community into hospital. Whereas medication reconciliation by pharmacists can detect errors, delays in undertaking this can increase the risk that patients receive incorrect admission medication regimens. Orthopedic patients are an at-risk group because they are often elderly and use multiple medications. Objective: To evaluate the prevalence and nature of medication errors when patients are admitted to an orthopedic unit where pharmacists routinely undertake postprescribing medication reconciliation. Methods: A 10-week retrospective observational study was conducted at a major metropolitan hospital in Australia. Medication records of orthopedic inpatients were evaluated to determine the number of prescribing and administration errors associated with patients’ preadmission medications and the number of related adverse events that occurred within 72 hours of admission. Results: Preadmission, 198 patients were taking at least 1 regular medication, of whom 176 (88.9%) experienced at least 1 medication error. The median number of errors per patient was 6 (interquartile range 3-10). Unintended omission of a preadmission medication was the most common prescribing error (87.4%). There were 17 adverse events involving 24 medications in 16 (8.1%) patients that were potentially related to medication errors; 6 events were deemed moderate consequence (moderate injury or harm, increased length of stay, or cancelled/delayed treatment), and the remainder were minor. Conclusion and Relevance: Medication errors were common when orthopedic patients were admitted to hospital, despite postprescribing pharmacist medication reconciliation. Some of these errors led to patient harm. Interventions that ensure that medications are prescribed correctly at admission are required.

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A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study)

Cephalalgia ◽

10.1177/0333102418762525 ◽

2018 ◽

Vol 38 (6) ◽

pp. 1038-1048 ◽

Cited By ~ 55

Author(s):

Amaal J Starling ◽

Stewart J Tepper ◽

Michael J Marmura ◽

Ejaz A Shamim ◽

Matthew S Robbins ◽

...

Keyword(s):

Adverse Events ◽

Observational Study ◽

Primary Endpoint ◽

Medication Use ◽

Responder Rate ◽

Migraine Prevention ◽

Performance Goal ◽

Open Label ◽

Data Set ◽

Headache Diary

Objective To evaluate the efficacy and tolerability of single pulse transcranial magnetic stimulation (sTMS) for the preventive treatment of migraine. Background sTMS was originally developed for the acute treatment of migraine with aura. Open label experience has suggested a preventive benefit. The objective of this trial was to evaluate the efficacy and tolerability of sTMS for migraine prevention. Methods The eNeura SpringTMS Post-Market Observational U.S. Study of Migraine (ESPOUSE) Study was a multicenter, prospective, open label, observational study. From December 2014 to March 2016, patients with migraine (n = 263) were consented to complete a 1-month baseline headache diary followed by 3 months of treatment. The treatment protocol consisted of preventive (four pulses twice daily) and acute (three pulses repeated up to three times for each attack) treatment. Patients reported daily headache status, medication use, and device use with a monthly headache diary. The primary endpoint, mean reduction of headache days compared to baseline, was measured over the 28-day period during weeks 9 to 12. The primary endpoint was compared to a statistically-derived placebo estimate (performance goal). Secondary endpoints included: 50% responder rate, acute headache medication consumption, HIT-6, and mean reduction in total headache days from baseline of any intensity. Results Of a total of 263 consented subjects, 229 completed a baseline diary, and 220 were found to be eligible based on the number of headache days. The device was assigned to 217 subjects (Safety Data Set) and 132 were included in the intention to treat Full Analysis Set. For the primary endpoint, there was a −2.75 ± 0.40 mean reduction of headache days from baseline (9.06 days) compared to the performance goal (−0.63 days) ( p < 0.0001). The 50% responder rate of 46% (95% CI 37%, 56%) was also significantly higher ( p < 0.0001) than the performance goal (20%). There was a reduction of −2.93 (5.24) days of acute medication use, headache impact measured by HIT-6, −3.1 (6.4) ( p < 0.0001), and total headache days of any intensity −3.16 days (5.21) compared to the performance goal (−0.63 days) ( p < 0.0001). The most common adverse events were lightheadedness (3.7%), tingling (3.2%), and tinnitus (3.2%). There were no serious adverse events. Conclusions This open label study suggests that sTMS may be an effective, well-tolerated treatment option for migraine prevention. Trial registration number NCT02357381

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Premedication practices for tracheal intubation in neonates transported by French medical transport teams: a prospective observational study

BMJ Open ◽

10.1136/bmjopen-2019-034052 ◽

2019 ◽

Vol 9 (11) ◽

pp. e034052 ◽

Cited By ~ 1

Author(s):

Ricardo Carbajal ◽

Noella Lode ◽

Azzedine Ayachi ◽

Ourida Chouakri ◽

Véronique Henry-Larzul ◽

...

Keyword(s):

Adverse Events ◽

Observational Study ◽

Prospective Observational Study ◽

Drug Regimen ◽

Muscle Rigidity ◽

Neonatal Transport ◽

Registration Number ◽

Medical Transport ◽

The Mean ◽

Paris Region

ObjectivesPremedication practices for neonatal tracheal intubations have not yet been described for neonatal transport teams. Our objective is to describe the use of sedation/analgesia (SA) for tracheal intubations and to assess its tolerance in neonates transported by medical transport teams in France.SettingThis prospective observational study was part of the EPIPPAIN 2 project and collected around-the-clock data on SA practices in neonates intubated by all five paediatric medical transport teams of the Paris region during a 2-month period. Intubations were classified as emergent, semiemergent and non-emergent. Sedation level and conditions of intubation were assessed with the Tonus, Reactivity, Awareness and Conditions of intubation to Help in Endotracheal intubation Assessment (TRACHEA score). The scores range from 0 to 10 representing an increasing ladder from adequate to inadequate sedation, and from excellent to very poor conditions of intubation.Participants40 neonates intubated in 28 different centres.ResultsThe mean (SD) age was 34.9 (3.9) weeks, and 62.5% were intubated in the delivery room. 30/40 (75%) of intubations were performed with the use of SA. In 18/30 (60.0%) intubations performed with SA, the drug regimen was the association of sufentanil and midazolam. Atropine was given in 19/40 intubations. From the 16, 21 and 3 intubations classified as emergent, semiemergent and non-emergent, respectively, 8 (50%), 19 (90.5%) and 3 (100%) were performed with SA premedication. 79.3% of intubations performed with SA had TRACHEA scores of 3 or less. 22/40 (55%) infants had at least one of the following adverse events: muscle rigidity, bradycardia below 100/min, desaturation below 80% and nose or pharynx–larynx bleeding. 7/24 (29.2%) of those who had only one attempt presented at least one of these adverse events compared with 15/16 (93.8%) of those who needed two or more attempts (p<0.001).ConclusionSA premedication is largely feasible for tracheal intubations performed in neonates transported by medical transport teams including intubations judged as emergent or semiemergent.Trial registration numberNCT01346813; Results.

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Efficacy and safety of eltrombopag in the treatment of severe chronic immune thrombocytopenia in children of China: A single-center observational study

International Journal of Immunopathology and Pharmacology ◽

10.1177/2058738419872120 ◽

2019 ◽

Vol 33 ◽

pp. 205873841987212 ◽

Cited By ~ 1

Author(s):

Xiaoling Cheng ◽

Kuo Yan ◽

Jingyao Ma ◽

Zhenping Chen ◽

Libo Zhao ◽

...

Keyword(s):

Adverse Events ◽

Observational Study ◽

Immune Thrombocytopenia ◽

Response Rates ◽

Drug Dosage ◽

Efficacy And Safety ◽

Bleeding Events ◽

Serious Adverse Events ◽

Durable Response ◽

Chronic Immune Thrombocytopenia

The treatment of severe chronic immune thrombocytopenia (SCITP) in pediatric patients is challenging. We evaluated the clinical efficacy and safety of eltrombopag in children with SCITP in China. This observational study was carried out at the Hematology Oncology Center, Beijing Children’s Hospital between April 2017 and July 2018. Patients with SCITP who had at least 12 weeks of eltrombopag treatment and follow-up data were included. Baseline data, such as age, drug dosage, pre-study platelet count, concomitant medications, and bleeding severity, were collected. Treatment response rates, durable response rates, bleeding events, and adverse events were assessed during eltrombopag therapy for at least 12 weeks. The median duration of eltrombopag therapy was 16 (12–48) weeks. The overall, complete, and partial response rates were 75% (15/20), 35% (7/20), and 40% (8/20), respectively. The durable response rate was 70% (14/20). No serious bleeding events or serious adverse events occurred during the study period. Eltrombopag appears to be effective and safe in children with SCITP, although additional research is needed to confirm this.

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