scholarly journals Association between workarounds and medication administration errors in bar-code-assisted medication administration in hospitals

2017 ◽  
Vol 25 (4) ◽  
pp. 385-392 ◽  
Author(s):  
Willem van der Veen ◽  
Patricia MLA van den Bemt ◽  
Hans Wouters ◽  
David W Bates ◽  
Jos WR Twisk ◽  
...  
Keyword(s):  
Prospective Observational Study ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Medication Administration ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Bar Code ◽  
Implementation Evaluation ◽  
Medication Administration Errors ◽  
Large Numbers

Abstract Objective To study the association of workarounds with medication administration errors using barcode-assisted medication administration (BCMA), and to determine the frequency and types of workarounds and medication administration errors. Materials and Methods A prospective observational study in Dutch hospitals using BCMA to administer medication. Direct observation was used to collect data. Primary outcome measure was the proportion of medication administrations with one or more medication administration errors. Secondary outcome was the frequency and types of workarounds and medication administration errors. Univariate and multivariate multilevel logistic regression analysis were used to assess the association between workarounds and medication administration errors. Descriptive statistics were used for the secondary outcomes. Results We included 5793 medication administrations for 1230 inpatients. Workarounds were associated with medication administration errors (adjusted odds ratio 3.06 [95% CI: 2.49-3.78]). Most commonly, procedural workarounds were observed, such as not scanning at all (36%), not scanning patients because they did not wear a wristband (28%), incorrect medication scanning, multiple medication scanning, and ignoring alert signals (11%). Common types of medication administration errors were omissions (78%), administration of non-ordered drugs (8.0%), and wrong doses given (6.0%). Discussion Workarounds are associated with medication administration errors in hospitals using BCMA. These data suggest that BCMA needs more post-implementation evaluation if it is to achieve the intended benefits for medication safety. Conclusion In hospitals using barcode-assisted medication administration, workarounds occurred in 66% of medication administrations and were associated with large numbers of medication administration errors.

A phase III trial of intramuscular recombinant interferon beta as treatment for exacerbating-remitting multiple sclerosis: design and conduct of study and baseline characteristics of patients

1995 ◽  
Vol 1 (2) ◽  
pp. 118-135 ◽  
Author(s):  
LD Jacobs ◽  
DL Cookfair ◽  
RA Rudick ◽  
RM Herndon ◽  
J R Richert ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Interferon Beta ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Phase Iii ◽  
Secondary Outcome ◽  
Recombinant Interferon ◽  
Study Population ◽  
The Mean ◽  
Baseline Characteristics

The design and conduct of a randomized, double-blinded, placebo-controlled, multicenter, phase III study of recombinant interferon beta-1a (IFN-β-1a) as treatment for exacerbating-remitting MS are described, as are baseline characteristics of the study population. The purpose of the study was to determine if 6.0 × 106 IU (30 μg) of IFN-β-1a, administered by weekly intramuscular (i.m.) injections, was effective in delaying the onset of sustained disability. The primary outcome measure was time to onset of treatment failure, defined as a worsening on the Kurtzke Expanded Disability Status Scale (EDSS) of greater than or equal to 1.0 point compared with baseline, persisting for at least 6 months. An intent-to-treat design was used. The primary outcome measure was analyzed using the Mantel-Cox log-rank statistic and Kaplan-Meier survival curves. Secondary outcomes included quantitative measures of upper and lower extremity function, neuropsychological test performance, functional and quality of life assessments and several measures derived from annual brain MRI studies. Entry criteria included prestudy exacerbation rates of at least 0.67 per year and EDSS scores of 1.0–3.5. A total of 301 MS patients were randomly assigned to receive weekly i.m. injections of IFN-β-1a or placebo. The average age of the study population at entry was 37 years; 92% were Caucasian and 73% were women. The mean prestudy disease duration was 6.5 years, mean prestudy exacerbation rate was 1.2 per year and the mean EDSS score was 2.3. The randomization yielded well-balanced treatment arms. Various aspects of the study are discussed, including: (1) the decision to focus study design on sustained disability; (2) the rationale for the treatment regimen; (3) measures taken to assure the reliability of the primary outcome measure; and (4) a description of the secondary outcome measures.

scholarly journals A Sternum-Disk Distance Method to Identify the Skin Level for Approaching a Surgical Segment without Fluoroscopy Guidance during Anterior Cervical Discectomy And Fusion

2017 ◽  
Vol 11 (1) ◽  
pp. 50-56
Author(s):  
Gun Woo Lee ◽  
Myun-Whan Ahn ◽  
Ji-Hoon Shin ◽  
Jae Woo Park ◽  
Jae-Hyung Uh ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Kappa Coefficient ◽  
Anterior Cervical Discectomy ◽  
Secondary Outcome ◽  
Distance Method ◽  
Cervical Discectomy ◽  
Observer Reliability ◽  
The Mean

<sec><title>Study Design</title><p>A retrospective review of prospectively collected data.</p></sec><sec><title>Purpose</title><p>To introduce the sternum-disk distance (SDD) method for approaching the exact surgical level without C-arm guidance during anterior cervical discectomy and fusion (ACDF) surgery and to evaluate its accuracy and reliability.</p></sec><sec><title>Overview of Literature</title><p>Although spine surgeons have tried to optimize methods for identifying the skin level for accessing the operative disk level without C-arm guidance during ACDF, success has rarely been reported.</p></sec><sec><title>Methods</title><p>In total, 103 patients who underwent single-level ACDF surgery with the SDD method were enrolled. The primary outcome measure was the accuracy of the SDD method. The secondary outcome measures were the mean SDD value at each cervical level from the cranial margin of the sternum in the neutral and extension positions of the cervical spine and the inter- and intra-observer reliability of the SDD outcome determined using repeated measurements by three orthopedic spine surgeons.</p></sec><sec><title>Results</title><p>The SDD accuracy (primary outcome measure) was indicated in 99% of the patients (102/103). The mean SDD values in the neutral-position magnetic resonance imaging (MRI) were 108.8 mm at C3–C4, 85.3 mm at C4–C5, 64.4 mm at C5–C6, 44.3 mm at C6–C7, and 24.1 mm at C7–T1; and those in the extension-position MRI were 112.9 mm at C3–C4, 88.7 mm at C4–C5, 67.3 mm at C5–C6, 46.5 mm at C6–C7, and 24.3 mm at C7–T1. The Cohen kappa coefficient value for intra-observer reliability was 0.88 (excellent reliability), and the Fleiss kappa coefficient value for inter-observer reliability as reported by three surgeons was 0.89 (excellent reliability).</p></sec><sec><title>Conclusions</title><p>Based on the results of the present study, we recommend performing ACDF surgery using the SDD method to determine the skin level for approaching the surgical cervical segment without fluoroscopic guidance.</p></sec>

scholarly journals Combining Lovastatin and Minocycline for the Treatment of Fragile X Syndrome: Results From the LovaMiX Clinical Trial

2022 ◽  
Vol 12 ◽  
Author(s):  
Camille Champigny ◽  
Florence Morin-Parent ◽  
Laurence Bellehumeur-Lefebvre ◽  
Artuela Çaku ◽  
Jean-François Lepage ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Fragile X Syndrome ◽  
Outcome Measures ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Fragile X ◽  
Combined Therapy ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Global Score

Background: Limited success of previous clinical trials for Fragile X syndrome (FXS) has led researchers to consider combining different drugs to correct the pleiotropic consequences caused by the absence of the Fragile X mental retardation protein (FMRP). Here, we report the results of the LovaMiX clinical trial, the first trial for FXS combining two disease-modifying drugs, lovastatin, and minocycline, which have both shown positive effects when used independently.Aim: The main goals of the study were to assess the safety and efficacy of a treatment combining lovastatin and minocycline for patients with FXS.Design: Pilot Phase II open-label clinical trial. Patients with a molecular diagnostic of FXS were first randomized to receive, in two-step titration either lovastatin or minocycline for 8 weeks, followed by dual treatment with lovastatin 40 mg and minocycline 100 mg for 2 weeks. Clinical assessments were performed at the beginning, after 8 weeks of monotherapy, and at week 20 (12 weeks of combined therapy).Outcome Measures: The primary outcome measure was the Aberrant Behavior Checklist-Community (ABC-C) global score. Secondary outcome measures included subscales of the FXS specific ABC-C (ABC-CFX), the Anxiety, Depression, and Mood Scale (ADAMS), the Social Responsiveness Scale (SRS), the Behavior Rating Inventory of Executive Functions (BRIEF), and the Vineland Adaptive Behavior Scale second edition (VABS-II).Results: Twenty-one individuals out of 22 completed the trial. There were no serious adverse events related to the use of either drugs alone or in combination, suggesting good tolerability and safety profile of the combined therapy. Significant improvement was noted on the primary outcome measure with a 40% decrease on ABC-C global score with the combined therapy. Several outcome measures also showed significance.Conclusion: The combination of lovastatin and minocycline is safe in patients for FXS individuals and appears to improve several elements of the behavior. These results set the stage for a larger, placebo-controlled double-blind clinical trial to confirm the beneficial effects of the combined therapy.

scholarly journals Identification and comparing the risk factors of new onset afebrile seizures with neuroimaging studies in children

2018 ◽  
Vol 5 (2) ◽  
pp. 338
Author(s):  
Manikandan Paramasivam ◽  
Maheshkumar Muthuraja
Keyword(s):  
Risk Factors ◽  
Prospective Observational Study ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Tertiary Care ◽  
Primary Outcome Measure ◽  
And Gender ◽  
Tertiary Care Hospitals ◽  
Neuroimaging Techniques ◽  
New Onset

Background: The study was aimed to identify the risk factors associated with new onset afebrile seizures by using neuroimaging techniques and comparing the same with neuroimaging studies in children of different age groups.Methods: This prospective observational study included 65 children aged 1 month to 16 years with afebrile seizures, admitted to the tertiary care hospitals in Chennai during the period from July 2014 to August 2016. Neuroimaging was done in all the patients. The primary outcome measure was identification of risk factors/clinical variables, (if any) that could predict individuals at high or low risk for neuroimaging abnormalities.Results: No statistical significant association was seen between differences in age group among children(p=0.127) and gender (p=0.185). Type of seizures, Number of seizure episodes and duration of seizure episodes seemed to be an important risk factor and a statistically significant association was observed between them and neuroimaging abnormalities with p values of 0.022, 0.008 and 0.001 respectively.Conclusion: Our findings indicate that neuroimaging techniques were helpful in assessing the abnormalities related to new onset afebrile seizures

scholarly journals 188 The Use of a Group Based Upper Limb Programme in Improving Outcome in Acute Stroke Rehabilitation

2019 ◽  
Vol 48 (Supplement_3) ◽  
pp. iii17-iii65
Author(s):  
Kerri Donnelly ◽  
Enya Mulcahy ◽  
Catherine Merrick ◽  
Orla Fitzgerald
Keyword(s):  
Acute Stroke ◽  
Grip Strength ◽  
Outcome Measures ◽  
Upper Limb ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Dominant Hand ◽  
Nine Hole Peg Test

Abstract Background After a stroke 85% of patients experience altered arm function. Current research demonstrates that increasing upper limb rehabilitation results in improved outcomes (Ward et al., 2019). The Graded Repetitive Arm Supplementary Programme (GRASP) group is an established adjunctive therapy in the stroke service. The group provides additional therapy for suitable patients with upper extremity deficits. The group is run jointly by a physiotherapist and an occupational therapist. Patients attend twice weekly for a one hour period in addition to their regular therapy. The GRASP group consists of 3 levels of varying abilities and patients are categorised by their Fugl-Meyer score. Methods A prospective audit was completed in 2019 and data was collected using a word document and excel spread sheet. Standardised outcome measures were completed on admission and discharge to establish upper limb ability. The primary outcome measure was the Fugl-Meyer and the secondary outcome measures were the nine hole peg test and grip strength using the Dynamometer. Results 12 patients attended the GRASP group over this period. 75% were males. The average age was 76 years with the age range from 48-95 years. 58% of patients experienced upper limb weakness in their non-dominant hand. Post intervention data was not obtained for 5 patients due to unforeseeable discharge from the acute setting. Preliminary data to date shows that our primary outcome measure improved in 86% of patients with increases ranging from 2-11 points on the Fugl-Meyer score (Minimally Clinical Important Difference =5points). Our secondary outcome measures demonstrated patients had no change (28%) or an improvement (72%) in grip strength and 100% of patients improved on the time taken to complete the nine hole peg test. Conclusion The GRASP group was found to be effective in improving upper limb outcome measures in an acute stroke inpatient hospital setting.

scholarly journals Prognostic value of reduction in left atrial size during a follow-up of heart failure: an observational study

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e044409
Author(s):  
Masayuki Shiba ◽  
Takao Kato ◽  
Takeshi Morimoto ◽  
Hidenori Yaku ◽  
Yasutaka Inuzuka ◽  
...  
Keyword(s):  
Heart Failure ◽  
Lower Risk ◽  
Left Atrial ◽  
Primary Outcome ◽  
Outcome Measure ◽  
No Reduction ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Group Change

ObjectiveThe association between sequential changes in left atrial diameter (LAD) and prognosis in heart failure (HF) remains to be elucidated. The present study aimed to investigate the link between reduction in LAD and clinical outcomes in patients with HF.DesignA multicentre prospective cohort study.SettingThis study was nested from the Kyoto Congestive Heart Failure registry including consecutive patients admitted for acute decompensated heart failure (ADHF) in 19 hospitals throughout Japan.ParticipantsThe current study population included 673 patients with HF who underwent both baseline and 6-month follow-up echocardiography with available paired LAD data. We divided them into two groups: the reduction in the LAD group (change <0 mm) (n=398) and the no-reduction in the LAD group (change ≥0 mm) (n=275).Primary and secondary outcomesThe primary outcome measure was a composite of all-cause death or hospitalisation for HF during 180 days after 6-month follow-up echocardiography. The secondary outcome measures were defined as the individual components of the primary composite outcome measure and a composite of cardiovascular death or hospitalisation for HF.ResultsThe cumulative 180-day incidence of the primary outcome measure was significantly lower in the reduction in the LAD group than in the no-reduction in the LAD group (13.3% vs 22.2%, p=0.002). Even after adjusting 15 confounders, the lower risk of reduction in LAD relative to no-reduction in LAD for the primary outcome measure remained significant (HR 0.59, 95% CI 0.36 to 0.97 p=0.04).ConclusionPatients with reduction in LAD during follow-up after ADHF hospitalisation had a lower risk for a composite endpoint of all-cause death or HF hospitalisation, suggesting that the change of LAD might be a simple and useful echocardiographic marker during follow-up.

Hypokalemia Measurement and Management in Patients With Status Asthmaticus on Continuous Albuterol

2022 ◽  
Author(s):  
Courtney Cox ◽  
Krishna Patel ◽  
Rebecca Cantu ◽  
Chary Akmyradov ◽  
Katherine Irby
Keyword(s):  
Potassium Level ◽  
Primary Outcome ◽  
Pediatric Patients ◽  
Status Asthmaticus ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Secondary Outcome Measure ◽  
Treatment Frequency ◽  
Care Costs

OBJECTIVE: Status asthmaticus is commonly treated in pediatric patients by using continuous albuterol, which can cause hypokalemia. The primary aim of this study was to determine if serial potassium monitoring is necessary by examining treatment frequency of hypokalemia. METHODS: This retrospective analysis was performed in 185 pediatric patients admitted with status asthmaticus requiring continuous albuterol between 2017 and 2019. All patients were placed on intravenous fluids containing potassium. The primary outcome measure was the treatment of hypokalemia in relation to the number of laboratory draws for potassium levels. The secondary outcome measure was hypokalemia frequency and relation to the duration and initial dose of continuous albuterol. RESULTS: Included were 156 patients with 420 laboratory draws (average, 2.7 per patient) for potassium levels. The median lowest potassium level was 3.40 mmol/L (interquartile range, 3.2–3.7). No correlation was found between initial albuterol dose and lowest potassium level (P = .52). Patients with hypokalemia had a mean albuterol time of 12.32 (SD, 15.76) hours, whereas patients without hypokalemia had a mean albuterol time of 11.50 (SD, 12.53) hours (P = .29). Potassium levels were treated 13 separate times. CONCLUSIONS: The number of laboratory draws for potassium levels was high in our cohort, with few patients receiving treatment for hypokalemia beyond the potassium routinely added to maintenance fluids. Length of time on albuterol and dose of albuterol were not shown to increase the risk of hypokalemia. Serial laboratory measurements may be decreased to potentially reduce health care costs, pain, and anxiety surrounding needlesticks.

Effectiveness of Unguided Internet-based Cognitive Behavioral Therapy and the Three Good Things Exercise for Insomnia: A Three-arm Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Daisuke Sato ◽  
Yoichi Sekizawa ◽  
Chihiro Sutoh ◽  
Yoshiyuki Hirano ◽  
Sho Okawa ◽  
...  
Keyword(s):  
Cognitive Behavioral Therapy ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Behavioral Therapy ◽  
Primary Outcome Measure ◽  
Cognitive Behavioral ◽  
Secondary Outcome ◽  
Economic Losses ◽  
Sleep Questionnaire ◽  
Insomnia Symptoms

BACKGROUND The treatment of insomnia with sleep medication causes problems such as long-term use, dependence, and significant economic losses, including medical expenses. Evidence-based lifestyle guidance is required to improve insomnia symptoms, not only in person but also in easy-to-use online formats. OBJECTIVE This study aimed to clarify whether unguided internet cognitive behavioral therapy (ICBT) or the three good things (TGT) exercise, both administered as self-help internet interventions without e-mail support, could improve insomnia symptoms compared to a waiting list control (WLC) group. METHODS A four week program was implemented, and participants were randomly allocated to one of the three groups. The primary outcome measure was Pittsburgh Sleep Questionnaire (PSQI) score at four weeks compared to baseline. RESULTS Of the 21,394 individuals who were invited to participate, 312 met the eligibility criteria and were randomly assigned to one of the three groups. Of these, 270 subjects (ICBT; n = 79, TGT; n = 88, WLC; n = 103) completed a post-intervention survey at four and eight weeks. The adjusted mean changes of the primary outcome measure (the Pittsburgh Sleep Questionnaire; PSQI) in the ICBT (-1.56, 95% CI: -2.52, -0.59; p <0.001) and TGT (-1.15, 95% CI: -2.08, -0.23; p = 0.0018) groups at four weeks from baseline showed a significant improvement compared to the WLC. The adjusted mean changes of the secondary outcome measures in sleep onset latency, total sleep time (TST), Athens Insomnia Scale (AIS) score, and Patient Health Questionnaire-9 (PHQ-9) score at four weeks from baseline, as well as in the PSQI at eight weeks from baseline, showed significant improvement in the ICBT. Moreover, TST, AIS and PHQ-9 scores at four weeks from baseline showed a significant improvement in the TGT group compared to the WLC. CONCLUSIONS Four weeks of unguided ICBT and the TGT exercises improved insomnia. CLINICALTRIAL The trial is registered with the UMIN Clinical Trial Registry (UMIN000034927)

Allogenic simple limbal epithelial transplantation (alloSLET) from cadaveric donor eyes in patients with persistent corneal epithelial defects

2020 ◽  
pp. bjophthalmol-2019-315176
Author(s):  
Jana Catharina Riedl ◽  
Aytan Musayeva ◽  
Joanna Wasielica-Poslednik ◽  
Norbert Pfeiffer ◽  
Adrian Gericke
Keyword(s):  
Medical Records ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Effective Treatment Option ◽  
Corneal Surface ◽  
Corneal Epithelial ◽  
Cadaveric Donor ◽  
Corrected Visual Acuity

Background/aimTo describe the clinical outcome of allogenic simple limbal epithelial transplantation (alloSLET) utilising tissue from cadaveric donor eyes after failed re-epithelialisation of the corneal surface.MethodsMedical records of 14 eyes from 14 patients treated for persistent corneal epithelial defects with alloSLET were reviewed. The primary outcome measure was complete epithelialisation of the corneal surface. Secondary outcome measures were best corrected visual acuity (BCVA) and postoperative side effects due to surgery or medical therapy.ResultsOf the 14 eyes, 7 received alloSLET only and 7 alloSLET together with penetrating keratoplasty (PK). Thirteen (92.9%) of 14 eyes had an epithelialised corneal surface 3 and 6 months after surgery and 10 (71.4%) of 14 eyes displayed an epithelialised corneal surface 12 months after surgery. In both subgroups, alloSLET only and alloSLET with PK, respectively, 5 (71.4%) of 7 eyes had a stable corneal epithelium 12 months after surgery, respectively. Postoperatively, BCVA improved markedly in the whole patient collective. However, the increase was not significant when looking at the two individual subgroups. One patient lost his bandage contact lens several times within the first postoperative month and had a partial detachment of the amniotic membrane. The ocular surface of this patient failed to epithelialise. In three patients, limbal donor pieces translocated to the centre of the cornea, which possibly prolonged the improvement of BCVA.ConclusionAlloSLET appears to be an effective treatment option in eyes with non-healing corneal epithelial defects when autologous limbal tissue is not available.

scholarly journals Efficacy of a strategy-based intervention on text-level reading comprehension in persons with aphasia: a study protocol for a repeated measures study

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e048126
Author(s):  
Sarah-Maria Thumbeck ◽  
Philipp Schmid ◽  
Sophie Chesneau ◽  
Frank Domahs
Keyword(s):  
Reading Comprehension ◽  
Outcome Measures ◽  
Repeated Measures ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Primary Objective ◽  
Secondary Outcome ◽  
Waiting Period ◽  
Reading Activities

IntroductionAt least 68% of persons with aphasia (PWA) experience reading difficulties. Even though strategy-based interventions are a promising treatment approach for text level reading comprehension deficits in PWA, empirical evidence for their efficacy remains rare. The primary objective of this study is the analysis of the efficacy of a strategy-based intervention on text-level reading comprehension and on reading activities in PWA.Methods and analysisIn a repeated measures trial, 24 PWA will first participate in a waiting period and then in a strategy-based intervention (14 face-to-face-sessions, 60 min each). We will apply two combinations of strategies to treat either the microstructure or the macrostructure, respectively. Participants will be randomly allocated to two parallel groups that will receive these combinations in interchanged sequences. Assessments will be implemented before and after each period as well as 3 and 6 months after the intervention. The primary outcome measure is text-level reading comprehension measured with a German version of the Test de Compréhension de Textes (TCT-D) and represented by the score TCT-D Total . A non-blinded and a blinded rater will evaluate the primary outcome measure. Secondary outcome measures will address specific reading functions, reading activities and cognitive functions. The sample size was determined with an a priori power analysis. For statistical analysis, we will use contrast analyses within repeated measures analysis of variance models. We expect significant improvements in primary and secondary outcome measures during the intervention as compared with changes during the waiting period.Ethics and disseminationThis study was approved by the ethics committee of Deutscher Bundesverband für akademische Sprachtherapie und Logopädie (20–10074-KA-MunmErw+Ko). Results and relevant data will be disseminated in peer-reviewed journals, at conferences and on the Open Science Framework.Trial registration numberDRKS00021411 (see Supplementary Table 1).

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