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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 -
Gait & Posture Sep 2022Objective gait analysis that fully captures the multi-segmental foot movement of a clubfoot may help in early identification of a relapse clubfoot. Unfortunately, this...
BACKGROUND
Objective gait analysis that fully captures the multi-segmental foot movement of a clubfoot may help in early identification of a relapse clubfoot. Unfortunately, this type of objective measure is still lacking in a clinical setting and it is unknown how it relates to clinical assessment.
RESEARCH QUESTION
The aim of this study was to identify differences in total gait and foot deviations between clubfoot patients with and without a relapse clubfoot and to evaluate their relationship with clinical status.
METHODS
In this study, Ponseti-treated idiopathic clubfoot patients were included and divided into clubfoot patients with and without a relapse. Objective gait analysis was done resulting in total gait and foot scores and clinical assessment was performed using the Clubfoot Assessment Protocol (CAP). Additionally, a new clubfoot specific foot score, the clubFoot Deviation Index (cFDI*), was calculated to better capture foot kinematics of clubfoot patients.
RESULTS
Clubfoot patients with a relapse show lower total gait quality (GDI*) and lower clinical status defined by the CAP than clubfoot patients without a relapse. Abnormal cFDI* was found in relapse patients, reflected by differences in corresponding variable scores. Moderate relationships were found for the subdomains of the CAP and total gait and foot quality in all clubfoot patients.
SIGNIFICANCE
A new total foot score was introduced in this study, which was more relevant for the clubfoot population. The use of this new foot score (cFDI*) besides the GDI*, is recommended to identify gait and foot motion deviations. Along with clinical assessment, this will give an overview of the overall status of the complex, multi-segmental aspects of a (relapsed) clubfoot. The relationships found in this study suggest that clinical assessment might be indicative of a deviation in total gait and foot pattern, therefore hinting towards personalised screening for better treatment decision making.
Topics: Casts, Surgical; Clubfoot; Foot; Gait; Gait Analysis; Humans; Recurrence; Treatment Outcome
PubMed: 35995000
DOI: 10.1016/j.gaitpost.2022.07.261 -
Rheumatology (Oxford, England) Oct 2023To develop the optimal US scanning protocol for the diagnosis of CPPD disease.
OBJECTIVE
To develop the optimal US scanning protocol for the diagnosis of CPPD disease.
METHODS
In this cross-sectional study, consecutive patients with a crystal-proven diagnosis of CPPD disease, and age-, sex-matched disease controls and with a negative synovial fluid analysis were prospectively enrolled in two Italian Institutions. Four rheumatologists, blinded to patients' clinical details, performed US examinations using a standardised scanning protocol including 20 joints (shoulders, elbows, wrists, metacarpophalangeal joints from 2nd to 5th fingers, hips, knees, ankles). CPPD was identified as presence/absence, according to the OMERACT definitions. Reduced US scanning protocols were developed by selecting the most informative joints to be imaged by US using the LASSO technique. Patients were randomly divided into training and validation sets. Their diagnostic accuracy was tested comparing the area under the ROC curves.
RESULTS
204 participants were enrolled: 102 with CPPD disease and 102 disease controls [age (mean±standard deviation) 71.3 ± 12.0 vs 71.1 ± 13.5 years, female: 62.8% vs 57.8%].The median number of joints with US evidence of CPPD was 5 (IQR: 4-7) and 0 (IQR: 0-1) in patients with CPPD disease and controls, respectively (p< 0 01).The detection of CPPD in ≥ 2 joints using a reduced scanning protocol (bilateral assessment of knees, wrists, and hips) showed a sensitivity of 96.7% (95%CI: 82.8-99.9) and a specificity of 100 (95%CI: 88.8-100.0) for the diagnosis of CPPD disease and had good feasibility [(mean±standard deviation) 12.5 ± 5.3 min].
CONCLUSION
Bilateral US assessment of knees, wrists, and hips had excellent accuracy and good feasibility for the diagnosis of CPPD disease.
PubMed: 37882749
DOI: 10.1093/rheumatology/kead565 -
Investigative Radiology Apr 2022Apparent diffusion coefficient (ADC) and signal intensity (SI) measurements play an increasing role in magnetic resonance imaging (MRI) of monoclonal plasma cell...
Repeatability and Reproducibility of ADC Measurements and MRI Signal Intensity Measurements of Bone Marrow in Monoclonal Plasma Cell Disorders: A Prospective Bi-institutional Multiscanner, Multiprotocol Study.
BACKGROUND/OBJECTIVES
Apparent diffusion coefficient (ADC) and signal intensity (SI) measurements play an increasing role in magnetic resonance imaging (MRI) of monoclonal plasma cell disorders. The purpose of this study was to assess interrater variability, repeatability, and reproducibility of ADC and SI measurements from bone marrow (BM) under variation of MRI protocols and scanners.
PATIENTS AND METHODS
Fifty-five patients with suspected or confirmed monoclonal plasma cell disorder were prospectively included in this institutional review board-approved study and underwent several measurements after the standard clinical whole-body MR scan, including repeated scan after repositioning, scan with a second MRI protocol, scan at a second 1.5 T scanner with a harmonized MRI protocol, and scan at a 3 T scanner. For T1-weighted, T2-weighted STIR, B800 images, and ADC maps, regions of interest were placed in the BM of the iliac crest and sacral bone, and in muscle tissue for image normalization. Bland-Altman plots were constructed, and absolute bias, relative bias to mean, limits of agreement, and coefficients of variation were calculated.
RESULTS
Interrater variability and repeatability experiments showed a maximal relative bias of -0.077 and a maximal coefficient of variation of 16.2% for all sequences. Although the deviations at the second 1.5 T scanner with harmonized MRI protocol to the first 1.5 T scanner showed a maximal relative bias of 0.124 for all sequences, the variation of the MRI protocol and scan at the 3 T scanner led to large relative biases of up to -0.357 and -0.526, respectively. When comparing the 3 T scanner to the 1.5 T scanner, normalization to muscle reduced the bias of T1-weighted and T2-weighted sequences, but not of ADC maps.
CONCLUSIONS
The MRI scanners with identical field strength and harmonized MRI protocols can provide relatively stable quantitative measurements of BM ADC and SI. Deviations in MRI field strength and MRI protocol should be avoided when applying ADC cutoff values, which were established at other scanners or when performing multicentric imaging trials.
Topics: Bone Marrow; Diffusion Magnetic Resonance Imaging; Humans; Magnetic Resonance Imaging; Plasma Cells; Prospective Studies; Reproducibility of Results
PubMed: 34839306
DOI: 10.1097/RLI.0000000000000838 -
Pediatric Critical Care Medicine : a... Mar 2022To identify unique latent safety threats spanning routine pediatric critical care activities and categorize them according to their underlying work system factors (i.e.,... (Observational Study)
Observational Study
OBJECTIVES
To identify unique latent safety threats spanning routine pediatric critical care activities and categorize them according to their underlying work system factors (i.e., "environment, organization, person, task, tools/technology") and associated clinician behavior (i.e., "legal": expected compliance with or "illegal-normal": deviation from and "illegal-illegal": disregard for standard policies and protocols).
DESIGN
A prospective observational study with contextual inquiry of clinical activities over a 5-month period.
SETTING
Two PICUs (i.e., medical-surgical ICU and cardiac ICU) in an urban free-standing quaternary children's hospital.
SUBJECTS
Attending physicians and trainees, nurse practitioners, registered nurses, respiratory therapists, dieticians, pharmacists, and patient services assistants were observed.
INTERVENTIONS
None.
MEASUREMENTS AND MAIN RESULTS
Conducted 188 hours of observations to prospectively identify unique latent safety threats. Qualitative observational notes were analyzed by human factors experts using a modified framework analysis methodology to summarize latent safety threats and categorize them based on associated clinical activity, predominant work system factor, and clinician behavior. Two hundred twenty-six unique latent safety threats were observed. The latent safety threats were categorized into 13 clinical activities and attributed to work system factors as follows: "organization" (n = 83; 37%), "task" (n = 52; 23%), "tools/technology" (n = 40; 18%), "person" (n = 32; 14%), and "environment" (n = 19; 8%). Twenty-three percent of latent safety threats were identified when staff complied with policies and protocols (i.e., "legal" behavior) and 77% when staff deviated from policies and protocols (i.e., "illegal-normal" behavior). There was no "illegal-illegal" behavior observed.
CONCLUSIONS
Latent safety threats span various pediatric critical care activities and are attributable to many underlying work system factors. Latent safety threats are present both when staff comply with and deviate from policies and protocols, suggesting that simply reinforcing compliance with existing policies and protocols, the common default intervention imposed by healthcare organizations, will be insufficient to mitigate safety threats. Rather, interventions must be designed to address the underlying work system threats. This human factors informed framework analysis of observational data is a useful approach to identifying and understanding latent safety threats and can be used in other clinical work systems.
Topics: Child; Critical Care; Health Personnel; Humans; Intensive Care Units, Pediatric; Prospective Studies
PubMed: 34593742
DOI: 10.1097/PCC.0000000000002832 -
Medicina Oral, Patologia Oral Y Cirugia... Jul 2023The insertion torque of dental implants will depend on a combination of different factors such as bone density, the design of the implant and the drilling protocol used....
BACKGROUND
The insertion torque of dental implants will depend on a combination of different factors such as bone density, the design of the implant and the drilling protocol used. However, it is not clear how the interaction of these factors affects the final insertion torque and which drilling protocol should be used in each clinical situation. The aim of this work is to analyse the influence of bone density, implant diameter and implant length on the insertion torque using different drilling protocols.
MATERIAL AND METHODS
An experimental study was carried out in which the maximum insertion torque was measured, in standardised polyurethane blocks (Sawbones Europe AB) of four densities, for M12 Oxtein dental implants (Oxtein, Spain) with diameters of 3.5, 4.0, 4.5 and 5mm, and lengths of 8.5mm, 11.5mm and 14.5mm. All these measurements were carried out following four drilling protocols, a standard protocol, adding a bone tap, cortical drill or conical drill. In this way, a total of 576 samples were obtained. For the statistical analysis, the table of confidence intervals, mean, standard deviation and covariance was carried out, in total and grouped by the parameters used.
RESULTS
The insertion torque for D1 bone obtained very high levels, reaching 77 6.95 N/cm, these values improved with the use of conical drills. In D2 bone, the mean torque obtained was 37.89± 13.70N/cm, with values within the standard. In D3 and D4 bone significantly low torques were obtained with values of 14.97± 4.40N/cm and 9.88± 4.16N/cm (p>0.001) respectively.
CONCLUSIONS
In D1 bone, conical drills must be incorporated in drilling to avoid excessive torque, while in D3 and D4 bone, these would be contraindicated, as they drastically decrease the insertion torque, which may compromise the treatment.
Topics: Humans; Dental Implants; Dental Implantation, Endosseous; Bone Density; Torque; Bone and Bones
PubMed: 37330951
DOI: 10.4317/medoral.25804 -
BMC Emergency Medicine May 2022The number of ambulance assignments and the influx of patients to the emergency departments (EDs) in Sweden have increased in recent years. This is one reason the...
BACKGROUND
The number of ambulance assignments and the influx of patients to the emergency departments (EDs) in Sweden have increased in recent years. This is one reason the protocol for prehospital emergency care was developed around referring patients for non-conveyance, either through the see-and-convey elsewhere approach or through the see-and-treat approach. However, this protocol has led to challenges in patient assessments. This study aimed to investigate the underlying causes of patient harm among those referred for the see-and-treat approach by the emergency medical services.
METHODS
This three-phase study involved a mixed-methods design. Cases of injuries, internal investigations and incident analyses of referrals for the see-and-treat approach in two regions in south eastern Sweden from 2015 to 2020 were examined using qualitative content analysis. This qualitative analysis was the basis for the quantitative analysis of the ambulance records. After the qualitative analysis was completed, a review protocol was developed; 34 variables were used to review 240 randomly selected ambulance records logged in 2020, wherein patients were referred for the see-and-treat approach. Finally, the review results were synthesised.
RESULTS
The qualitative analysis revealed three common themes: 'assessment of patients', 'guidelines' and 'environment and organisation'. These results were confirmed by a medical journal review. Shortcomings were found in the anamnesis and in the number of targeted examinations performed. The checklist for referring patients for the see-and-treat approach and the information sheet to be provided to the patients were not used. In 34% of the ambulance records examined, the EMS clinicians deviated from the current guidelines for a see-and-treat referral.
CONCLUSIONS
The results indicated that the low adherence to guidelines and the patient assessment deviating from the protocol put patients at risk of being harmed during a see-and-treat referral. Measures are needed to guarantee a safe assessment of an increasing number of patients who are referred for the see-and-treat approach, especially the multi-sick elderly patients.
Topics: Aged; Ambulances; Emergency Medical Services; Emergency Service, Hospital; Humans; Referral and Consultation; Sweden
PubMed: 35524195
DOI: 10.1186/s12873-022-00630-8 -
Therapeutic Innovation & Regulatory... Jul 2023In order to improve quality and efficiency of surgical trials, we assessed protocols complexity and examined whether it influenced the conduct, as measured by the number...
BACKGROUND
In order to improve quality and efficiency of surgical trials, we assessed protocols complexity and examined whether it influenced the conduct, as measured by the number and types of deviations that occurred during the execution phase. Knowledge of these facts and performance of research team would allow to effectively mitigate the occurrence of deviations.
METHODS
Thirty-five research protocols were rated according to a previously established complexity scoring model. Statistical analyses were performed to examine associations between protocol complexity, number of protocol/informed consent amendments vs. number/types of protocol deviations; as well as correlations with phase of the study, type of investigational product, personnel changes/experience level were assessed.
RESULTS
Assessment of complexity score in Pearson's correlation test with the number of protocol deviations showed weak correlation, suggesting that other factors can influence protocol adherence. There was no correlation observed between number of deviations and type of study by investigational product category. In examining association between protocol deviations and number of subjects enrolled a trend was observed towards increased number of deviations once more subjects have entered the study. The higher number of protocol deviations was associated with increased number of protocol amendments (p = 0.0396), and there was no statistical significance observed between number of deviations and informed consent amendments (p = 0.5083). There was a moderate correlation detected between increased number of protocol deviations and total number of investigators on the study.
CONCLUSION
Protocol adherence can be improved with effective training and retention of research coordinators, investigators and frequent internal auditing to address discrepancies and effectively implement corrective actions. Upfront training of research personnel, with subsequent monitoring of performance metrics throughout the execution phase can reduce the total number of protocol deviations, ensure data integrity and improve quality of research conducted. Engagement of all stakeholders upfront, including clinical site personnel, can help develop well-designed clinical trial protocol, avoid time consuming and costly protocol and informed consent amendments at execution phase and ensure higher quality of research conducted, while allowing to meet objectives of the trial in a more efficient manner.
Topics: Humans; Research Design; Informed Consent; Research Personnel; Pandemics
PubMed: 36930415
DOI: 10.1007/s43441-023-00506-4 -
Intensive & Critical Care Nursing Dec 2023Potassium replacement protocols are used to standardise practice, reduce risk, and ensure timely potassium replacement, but there is considerable variability in their... (Review)
Review
BACKGROUND
Potassium replacement protocols are used to standardise practice, reduce risk, and ensure timely potassium replacement, but there is considerable variability in their development and use, particularly as part of critical care nursing practice.
AIM
To synthesise the research evidence on how potassium replacement protocols are used in adult critical care; and how critical care nurses' role and practice is influenced by a potassium replacement protocol. The research question was 'How are protocols used by intensive care clinicians to guide potassium replacement in adult critical care?'
DESIGN
A structured integrative review was undertaken. A combination of keywords, synonyms, and Medical Subject Headings were used across the Ovid Medline and Embase databases. Records were independently assessed against inclusion and exclusion criteria. All papers were assessed for quality. A narrative synthesis was used to analyse and present the findings.
RESULTS
Ten studies were included in this review from 4076 records identified. Narrative synthesis revealed five categories: (i) protocol design demonstrating variation in protocol mechanisms, (ii) protocol rationale eliciting reasonings for protocol implementation, (iii) protocol use describing how protocols were nurse-driven enabling nursing autonomy (iv) protocol adherence highlighting variability in protocol compliance and (v) critical care nurse acceptability and feasibility coupling greater shared responsibility for patient care and improved clinician satisfaction.
CONCLUSION
Safe, high-quality care, supported by evidence continues to be a priority. Protocolised potassium replacement can improve patient outcomes and promote nurses' autonomy, efficiency, and job satisfaction.
IMPLICATIONS FOR CLINICAL PRACTICE
Recognising and promoting critical care nurses' expert assessment skills and clinical decision-making is essential for optimising efficient, safe, and high-quality patient care. Although protocol deviations are accommodated in protocol development, comprehensive documentation to justify protocol deviations is key to justifying practice. Understanding protocol deviations are crucial to inform future protocol development, improvements, and evaluation to further enhance critical care nursing practice.
Topics: Adult; Humans; Critical Care; Clinical Decision-Making; Critical Care Nursing; Job Satisfaction; Potassium
PubMed: 37598503
DOI: 10.1016/j.iccn.2023.103524 -
Resuscitation Plus Mar 2022Automated external defibrillators (AEDs) use various shock protocols with different characteristics when deployed in pediatric mode. The aim of this study is to assess...
AIM
Automated external defibrillators (AEDs) use various shock protocols with different characteristics when deployed in pediatric mode. The aim of this study is to assess and compare the safety and efficacy of different AED pediatric protocols using novel experimental approaches.
METHODS
Two defibrillation protocols (A and B) were assessed across two studies: Protocol A: escalating (50-75-90 J) defibrillation waveform with higher voltage, shorter duration and equal phase durations. Protocol B; non-escalating (50-50-50 J) defibrillation waveform with lower voltage, longer duration and unequal phase durations.Experiment 1: Isolated shock damage was assessed following shocks to 12 anesthetized pigs. Animals were randomized into two groups, receiving three shocks from Protocol A (50-75-90 J) or B (50-50-50 J). Cardiac function, cardiac troponin I (cTnI), creatine phosphokinase (CPK) and histopathology were analyzed. Experiment 2: Defibrillation safety and efficacy were assessed through shock success, ROSC, ST-segment deviation and contractility following 16 randomized shocks from protocol A or B delivered to 10 anesthetized pigs in VF.
RESULTS
Experiment 1: No clinically meaningful difference in cTnI, CPK, ST-segment deviation, ejection fraction or histopathological damage was observed following defibrillation with either protocol. No difference was observed between protocols at any timepoint. Experiment 2: all defibrillation types demonstrated shock success and ROSC ≥ 97.5%. Post-ROSC contractility was similar between protocols.
CONCLUSIONS
There is no evidence that administration of clinically relevant shock sequences, without experimental confounders, result in significant myocardial damage in this model of pediatric resuscitation. Typical variations in AED pediatric mode settings do not affect defibrillation safety and efficacy.
PubMed: 35146463
DOI: 10.1016/j.resplu.2022.100203