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Journal of Clinical Pharmacy and... Mar 2022Paediatric intensive care patients are at high risk for prescription errors due to the more complex process of medication prescribing. Clinical decision support systems... (Observational Study)
Observational Study
WHAT IS KNOWN AND OBJECTIVE
Paediatric intensive care patients are at high risk for prescription errors due to the more complex process of medication prescribing. Clinical decision support systems (CDSS) have shown good results in effectively reducing prescription errors. A specific dosing CDSS was developed that can check and suggest normal dose, dose limits and administration frequencies. This study aimed to assess the effect of this CDSS on protocol deviation (as measure of prescription error) types and frequency in a paediatric intensive care unit (PICU).
METHODS
A retrospective observational study was conducted evaluating 9342 prescriptions in a 4-month period before and after the implementation of a CDSS in the PICU of the University Medical Center Utrecht. Medication forms were reviewed to identify protocol deviations (and therefore possible prescription errors). The incidence and nature of deviations from evidence-based protocols that were unintended and needed to be adjusted, were determined.
RESULTS AND DISCUSSION
In the period before the dosing CDSS, we identified 45 protocol deviations in 5034 prescriptions (0.89%), 28 of which could not be justified (0.56%) and 11 needed to be adjusted (0.22%). In the period after the implementation of the CDSS, there were 21 protocol deviations in 4308 prescriptions (0.49%) of which ten without a valid reason (0.23%) of which two were adjusted (0.05%).
WHAT IS NEW AND CONCLUSION
The specific dosing CDSS was able to significantly reduce unintentional prescription dose deviations and the number of prescriptions that needed to be adjusted, in an existing low incidence situation.
Topics: Child; Decision Support Systems, Clinical; Drug Prescriptions; Humans; Incidence; Intensive Care Units, Pediatric; Medication Errors
PubMed: 34734650
DOI: 10.1111/jcpt.13562 -
Clinical Trials (London, England) Feb 2019Intention-to-treat comparisons of randomized trials provide asymptotically consistent estimators of the effect of treatment assignment, without regard to compliance....
BACKGROUND
Intention-to-treat comparisons of randomized trials provide asymptotically consistent estimators of the effect of treatment assignment, without regard to compliance. However, decision makers often wish to know the effect of a per-protocol comparison. Moreover, decision makers may also wish to know the effect of treatment assignment or treatment protocol in a user-specified target population other than the sample in which the trial was fielded. Here, we aimed to generalize results from the ACTG A5095 trial to the US recently HIV-diagnosed target population.
METHODS
We first replicated the published conventional intention-to-treat estimate (2-year risk difference and hazard ratio) comparing a four-drug antiretroviral regimen to a three-drug regimen in the A5095 trial. We then estimated the intention-to-treat effect that accounted for informative dropout and the per-protocol effect that additionally accounted for protocol deviations by constructing inverse probability weights. Furthermore, we employed inverse odds of sampling weights to generalize both intention-to-treat and per-protocol effects to a target population comprising US individuals with HIV diagnosed during 2008-2014.
RESULTS
Of 761 subjects in the analysis, 82 dropouts (36 in the three-drug arm and 46 in the four-drug arm) and 59 protocol deviations (25 in the three-drug arm and 34 in the four-drug arm) occurred during the first 2 years of follow-up. A total of 169 subjects incurred virologic failure or death. The 2-year risks were similar both in the trial and in the US HIV-diagnosed target population for estimates from the conventional intention-to-treat, dropout-weighted intention-to-treat, and per-protocol analyses. In the US target population, the 2-year conventional intention-to-treat risk difference (unit: %) for virologic failure or death comparing the four-drug arm to the three-drug arm was -0.4 (95% confidence interval: -6.2, 5.1), while the hazard ratio was 0.97 (95% confidence interval: 0.70, 1.34); the 2-year risk difference was -0.9 (95% confidence interval: -6.9, 5.3) for the dropout-weighted intention-to-treat comparison (hazard ratio = 0.95, 95% confidence interval: 0.68, 1.32) and -0.7 (95% confidence interval: -6.7, 5.5) for the per-protocol comparison (hazard ratio = 0.96, 95% confidence interval: 0.69, 1.34).
CONCLUSION
No benefit of four-drug antiretroviral regimen over three-drug regimen was found from the conventional intention-to-treat, dropout-weighted intention-to-treat or per-protocol estimates in the trial sample or target population.
Topics: Adult; Anti-Retroviral Agents; Clinical Protocols; Female; HIV Infections; Humans; Intention to Treat Analysis; Male; Middle Aged; Sustained Virologic Response; Viral Load
PubMed: 30326736
DOI: 10.1177/1740774518806311 -
Evidence-based Complementary and... 2015In the 1960s Bong Han Kim discovered and characterized a new vascular system. He was able to differentiate it clearly from vascular blood and lymph systems by the use of... (Review)
Review
In the 1960s Bong Han Kim discovered and characterized a new vascular system. He was able to differentiate it clearly from vascular blood and lymph systems by the use of a variety of methods, which were available to him in the mid-20th century. He gave detailed characterization of the system and created comprehensive diagrams and photographs in his publications. He demonstrated that this system is composed of nodes and vessels, and it was responsible for tissue regeneration. However, he did not disclose in detail his methods. Consequently, his results are relatively obscure from the vantage point of contemporary scientists. The stains that Kim used had been perfected and had been in use for more than 100 years. Therefore, the names of the stains were directed to the explicit protocols for the usage with the particular cells or molecules. Traditionally, it was not normally necessary to describe the method used unless it is significantly deviated from the original method. In this present work, we have been able to disclose staining methods used by Kim.
PubMed: 26379743
DOI: 10.1155/2015/361974 -
Acta Ophthalmologica May 2022To assess the diagnostic accuracy and agreement between a paediatric electroretinography protocol used at Great Ormond Street Hospital (GOSH-ERG) and the 'gold standard'...
PURPOSE
To assess the diagnostic accuracy and agreement between a paediatric electroretinography protocol used at Great Ormond Street Hospital (GOSH-ERG) and the 'gold standard' international protocol (ISCEV-ERG) in health and disease.
METHODS
Patient databases between 2010 and 2020 were screened to identify children with an ISCEV-ERG recorded within four years of a GOSH-ERG. Electroretinogram (ERG) component peak times and amplitudes were re-measured, and data were analysed in terms of absolute abnormality and proportional deviation from respective reference ranges. Abnormality was defined by the retinal system affected and by individual ERG a- and b-wave component analysis.
RESULTS
A total of 59 patients were included: 38 patients had retinal disease defined by an abnormal ISCEV-ERG and 21 had normal ISCEV-ERGs. When absolute abnormality was defined by combined retinal systems, the GOSH-ERG showed an excellent overall sensitivity of 95% (accuracy 86%). Individual retinal systems showed good-excellent sensitivity (67%-100%) and specificity (68%-97%). Electroretinogram (ERG) component sensitivities ranged between 60% and 97% and specificities between 79% and 97% dependent upon the protocol step. The proportional relationship appeared mostly linear between protocols. Electroretinogram (ERG) morphology was comparable for both protocols in a range of retinal diseases including those with pathognomonic ERGs.
CONCLUSION
We demonstrate the high diagnostic accuracy of a paediatric ERG protocol (GOSH-ERG) relative to ISCEV standard ERGs. The close proportional deviation and similar waveform morphology indicate ERGs from each protocol are similarly affected in disease. This encourages the use of the GOSH-ERG protocol in the screening, diagnosis and monitoring of retinal disease in children who are unable to comply with the rigorous ISCEV-ERG protocol.
Topics: Child; Electroretinography; Humans; Photic Stimulation; Retina; Retinal Diseases; Societies, Medical
PubMed: 34126657
DOI: 10.1111/aos.14938 -
Trials Dec 2023Retention to trials is important to ensure the results of the trial are valid and reliable. The SPIRIT guidelines (18b) require "plans to promote participant retention... (Review)
Review
BACKGROUND
Retention to trials is important to ensure the results of the trial are valid and reliable. The SPIRIT guidelines (18b) require "plans to promote participant retention and complete follow-up, including list of any outcome data to be collected for participants who discontinue or deviate from intervention protocols" be included in trial protocols. It is unknown how often protocols report this retention information. The purpose of our scoping review is to establish if, and how, trial teams report plans for retention during the design stage of the trial.
MATERIALS AND METHODS
A scoping review with searches in key databases (PubMed, Scopus, EMBASE, CINAHL (EBSCO), and Web of Science from 2014 to 2019 inclusive) to identify randomised controlled trial protocols. We produced descriptive statistics on the characteristics of the trial protocols and also on those adhering to SPIRIT item 18b. A narrative synthesis of the retention strategies was also conducted.
RESULTS
Eight-hundred and twenty-four protocols met our inclusion criteria. RCTs (n = 722) and pilot and feasibility trial protocols (n = 102) reported using the SPIRIT guidelines during protocol development 35% and 34.3% of the time respectively. Of these protocols, only 9.5% and 11.4% respectively reported all aspects of SPIRIT item 18b "plans to promote participant retention and to complete follow-up, including list of any outcome data for participants who discontinue or deviate from intervention protocols". Of the RCT protocols, 36.8% included proactive "plans to promote participant retention" regardless of whether they reported using SPIRIT guidelines or not. Most protocols planned "combined strategies" (48.1%). Of these, the joint most commonly reported were "reminders and data collection location and method" and "reminders and monetary incentives". The most popular individual retention strategy was "reminders" (14.7%) followed by "monetary incentives- conditional" (10.2%). Of the pilot and feasibility protocols, 40.2% included proactive "plans to promote participant retention" with the use of "combined strategies" being most frequent (46.3%). The use of "monetary incentives - conditional" (22%) was the most popular individual reported retention strategy.
CONCLUSION
There is a lack of reporting of plans to promote participant retention in trial protocols. Proactive planning of retention strategies during the trial design stage is preferable to the reactive implementation of retention strategies. Prospective retention planning and clear communication in protocols may inform more suitable choice, costing and implementation of retention strategies and improve transparency in trial conduct.
Topics: Humans; Randomized Controlled Trials as Topic; Retention in Care; Research Design
PubMed: 38049833
DOI: 10.1186/s13063-023-07775-2 -
Radiotherapy and Oncology : Journal of... May 2022Image-guided adaptive brachytherapy (IGABT) is a key component in the treatment of cervical cancer, but the nature of the clinical workflow makes it vulnerable to...
BACKGROUND AND PURPOSE
Image-guided adaptive brachytherapy (IGABT) is a key component in the treatment of cervical cancer, but the nature of the clinical workflow makes it vulnerable to suboptimal plans, as the theoretical optimal plan depends heavily on organ configuration. Patient anatomy-based quality-assurance (QA) with overlap volume histograms (OVHs) is a promising tool to detect such suboptimal plans, and in this analysis its suitability as a multi-institutional clinical QA tool is investigated.
MATERIALS AND METHODS
A total of 223 plans of 145 patients treated in accordance with the current state-of-the-art IGABT protocols from UMC Utrecht (UMCU) and Erasmus MC (EMC) were included. Machine-learning models were trained to predict dose D to bladder, rectum, sigmoid and small bowel with the help of OVHs. For this strategy, points are sampled on the organs-at-risk (OARs), and the distances of the sampled points to the target are computed and combined in a histogram. Machine-learning models can then be trained to predict dose-volume histograms (DVHs) for unseen data. Single-center model robustness to needle use and applicator type and multi-center model translatability were investigated. Performance of models was assessed by the difference between planned (clinical) and predicted D values.
RESULTS
Intra-validation of UMCU data demonstrated OVH model robustness to needle use and applicator type. The model trained on UMCU data was found to be robust within the same protocol on EMC data, for all investigated OARs. Mean squared error between planned and predicted D values of OARs ranged between 0.13 and 0.40 Gy within the same protocol, indicating model translatability. For the former protocol cohort of Erasmus MC large deviations were found between the planned and predicted D values, indicating plan deviation from protocol. Mean squared error for this cohort ranged from 0.84 to 4.71 Gy.
CONCLUSION
OVH-based models can provide a solid basis for multi-institutional QA when trained on a sufficiently strict protocol. Further research will quantify the model's impact as a QA tool.
Topics: Brachytherapy; Female; Humans; Machine Learning; Organs at Risk; Radiotherapy Dosage; Radiotherapy Planning, Computer-Assisted; Uterine Cervical Neoplasms
PubMed: 35219799
DOI: 10.1016/j.radonc.2022.02.022 -
Infection Control and Hospital... Sep 2017OBJECTIVE To evaluate healthcare worker (HCW) risk of self-contamination when donning and doffing personal protective equipment (PPE) using fluorescence and MS2...
OBJECTIVE To evaluate healthcare worker (HCW) risk of self-contamination when donning and doffing personal protective equipment (PPE) using fluorescence and MS2 bacteriophage. DESIGN Prospective pilot study. SETTING Tertiary-care hospital. PARTICIPANTS A total of 36 HCWs were included in this study: 18 donned/doffed contact precaution (CP) PPE and 18 donned/doffed Ebola virus disease (EVD) PPE. INTERVENTIONS HCWs donned PPE according to standard protocols. Fluorescent liquid and MS2 bacteriophage were applied to HCWs. HCWs then doffed their PPE. After doffing, HCWs were scanned for fluorescence and swabbed for MS2. MS2 detection was performed using reverse transcriptase PCR. The donning and doffing processes were videotaped, and protocol deviations were recorded. RESULTS Overall, 27% of EVD PPE HCWs and 50% of CP PPE HCWs made ≥1 protocol deviation while donning, and 100% of EVD PPE HCWs and 67% of CP PPE HCWs made ≥1 protocol deviation while doffing (P=.02). The median number of doffing protocol deviations among EVD PPE HCWs was 4, versus 1 among CP PPE HCWs. Also, 15 EVD PPE protocol deviations were committed by doffing assistants and/or trained observers. Fluorescence was detected on 8 EVD PPE HCWs (44%) and 5 CP PPE HCWs (28%), most commonly on hands. MS2 was recovered from 2 EVD PPE HCWs (11%) and 3 CP PPE HCWs (17%). CONCLUSIONS Protocol deviations were common during both EVD and CP PPE doffing, and some deviations during EVD PPE doffing were committed by the HCW doffing assistant and/or the trained observer. Self-contamination was common. PPE donning/doffing are complex and deserve additional study. Infect Control Hosp Epidemiol 2017;38:1077-1083.
Topics: Adult; Female; Gloves, Protective; Guideline Adherence; Health Personnel; Humans; Infection Control; Levivirus; Male; Middle Aged; Missouri; Personal Protective Equipment; Pilot Projects; Protective Clothing; Respiratory Protective Devices; Reverse Transcriptase Polymerase Chain Reaction; Tertiary Care Centers; Ultraviolet Rays; Video Recording
PubMed: 28606192
DOI: 10.1017/ice.2017.121 -
Perspectives in Clinical Research 2023
PubMed: 37325573
DOI: 10.4103/picr.picr_69_23 -
BMJ Open Dec 2021Gentamicin is the aminoglycoside antibiotic of choice in the UK. It has a narrow therapeutic index: underdosing results in inefficacy while overdosing is characterised...
OBJECTIVES
Gentamicin is the aminoglycoside antibiotic of choice in the UK. It has a narrow therapeutic index: underdosing results in inefficacy while overdosing is characterised by nephrotoxicity and ototoxicity. To improve patient safety, hospitals have protocols for the prescription of gentamicin, which vary in complexity and approach. This study aimed to explore two distinct protocols for prescribing gentamicin in hospital settings, in order to understand the mechanisms they trigger and the outcomes they achieve.
SETTING
A mixed-methods realist evaluation explored gentamicin prescribing protocols in two hospital surgical admissions units in South West England between January and August 2018. Site 1 had a traditional, complex protocol, while site 2 took a simplified protocol.
PARTICIPANTS
Testing the initial programme theory (IPT) involved semi-structured audio-recorded interviews of a volunteer sample of healthcare professionals (HCPs) involved in the prescribing and administering process, alongside a clinical audit reviewing accuracy of gentamicin prescribing.
OUTCOME MEASURES
Three sequential phases were used to identify factors in a successful protocol: IPT generation; testing; refinement of the IPT. The IPT was generated by literature search and analysis of existing protocols of sites 1 and 2. Refinement of the IPT synthesised the results of the quantitative and qualitative research to identify the key characteristics of a successful protocol.
RESULTS
One hundred gentamicin prescriptions were reviewed, with a mean accuracy of gentamicin prescribing at site 1 of 65.67% and at site 2 of 78.79% (p<0.01). Thirty HCPs were interviewed. Key contexts were identified including prescriptiveness, experience and availability of patient information. These triggered hidden mechanisms including uncertainty, fear, confidence and frustration leading to both intended outcomes but also unintended outcomes such as deviation from protocol and unnecessary gentamicin levels.
CONCLUSIONS
A simplified prescribing protocol for gentamicin is better accepted by prescribers, leading to better adherence to protocol and more accurate prescribing.
Topics: Gentamicins; Health Personnel; Hospitals; Humans; Qualitative Research; United Kingdom
PubMed: 34949620
DOI: 10.1136/bmjopen-2021-052697 -
Results of clubfoot management using the Ponseti method: do the details matter? A systematic review.Clinical Orthopaedics and Related... Apr 2014Although the Ponseti method is accepted as the best choice for treatment of clubfoot, the treatment protocol is labor intensive and requires strict attention to details.... (Review)
Review
BACKGROUND
Although the Ponseti method is accepted as the best choice for treatment of clubfoot, the treatment protocol is labor intensive and requires strict attention to details. Deviations in strict use of this method are likely responsible for the variations among centers in reported success rates.
QUESTIONS/PURPOSES
We wished to determine (1) to what degree the Ponseti method was followed in terms of manipulation, casting, and percutaneous Achilles tenotomy, (2) whether there was variation in the bracing type and protocol used for relapse prevention, and (3) if the same criteria were used to diagnose and manage clubfoot relapse.
METHODS
We conducted a systematic review of MEDLINE, EMBASE(TM), and the Cochrane Library. Studies were summarized according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses Statement. Five hundred ninety-one records were identified with 409 remaining after deduplication, in which 278 irrelevant studies and 22 review articles were excluded. Of the remaining 109 papers, 19 met our inclusion criteria. All 19 articles were therapeutic studies of the Ponseti method.
RESULTS
The details of manipulation, casting, or percutaneous Achilles tenotomy of the Ponseti method were poorly described in 11 studies, whereas the main principles were not followed in three studies. In three studies, the brace type deviated significantly from that recommended, whereas in another three studies the bracing protocol in terms of hours of recommended use was not followed. Furthermore no unified criteria were used for judgment of compliance with brace use. The indication for recognition and management of relapse varied among studies and was different from the original description of the Ponseti method.
CONCLUSIONS
We found that the observed clinically important variation may have been the result of deviations from the details regarding manipulation, casting, percutaneous Achilles tenotomy, use of the bar-connected brace, and indication for relapse recognition and management recommended for the classic Ponseti approach to clubfoot management. We strongly recommend that clinicians follow the Ponseti method as it initially was described without deviation to optimize treatment outcomes.
Topics: Achilles Tendon; Braces; Casts, Surgical; Clubfoot; Guideline Adherence; Humans; Orthopedic Procedures; Practice Guidelines as Topic; Practice Patterns, Physicians'; Secondary Prevention; Tenotomy; Treatment Outcome
PubMed: 24435715
DOI: 10.1007/s11999-014-3463-7