UNASSIGNED: In the use of medical device procedures, learning effects have been shown to have a significant impact on the outcome, and are a critical component of medical device safety surveillance. To support estimation of these effects, we evaluated our methods for modeling these rates within several different actual datasets representing patients treated by physicians clustered within institutions to show the flexibility of this method across applications.
UNASSIGNED: In order to estimate the learning curve effects, we employed our unique modeling for the learning curves to incorporate the learning hierarchy between institution and physicians, and then modeled them within established methods that work with hierarchical data such as generalized estimating equations (GEE). Within the actual datasets, we looked at two device types and also two procedure types which had not been observed before: off pump coronary artery bypass (CABG) experience, and radial access experience. We also tried mediation analyses within the GEE framework for these various devices/procedures as well.
UNASSIGNED: We found that the choice of shape used to produce the \"learning-free\" dataset would still be dataset specific depending upon needs for modeling fast or slow learning but that in general the power series or logarithmic shapes would be better for modeling slower learning while exponential may be better for faster learning. Mediation analysis also showed promise in adapting the modeling of the learning curve.
UNASSIGNED: In showing the flexibility of using our method in various applications; this time utilizing more than one possible procedure done per patient so that each physician had more volume, we were able to show the flexibility of applying our method in different data applications to allow for more accurately capturing the learning curve rates in physicians nested within institutions. This can, therefore, be used across the board for device and procedure safety.

BACKGROUND: PNS is caused by an infection in the sacrococcygeal area triggered by hair particle accumulation in skin tunnels, resulting in infection. Surgical options range from simple excision to complex flap constructions. Primary wound healing failure and recurrence rates contribute to the burden of PNS. RD2 Ver.02, a novel autologous whole-blood clot product, demonstrated safety and efficacy in treating complex cutaneous wounds and was investigated for the management of PNS.
METHODS: A Phase II open-label, pilot, single-arm prospective study was conducted from May 2021 to May 2023 (Ethics Committee approval #7952-20). Patients with PNS underwent a minimally invasive trephine procedure under local anesthesia followed by RD2 Ver.02 instillation into the cavity. Primary healing was assessed at 3, 6, and 12 months. Secondary outcomes included the collection of adverse events.
RESULTS: Overall, 51 patients participated in the study. At 3 months, 42/51 healed (82.4%), 7/51 (13.7%) were granulating but not completely healed, and 2/51 (3.9%) failed to heal. At 6 and 12 months, 46/51 (90.2%) and 42/51 (82.4%) achieved complete healing, respectively. At 6 months, two PNSs recurred after initial healing and an additional four instances of PNS recurrence observed in 12 months, so a total of recurrence in six patients (11.8%). There were five adverse events (AEs) with no severe adverse events.
CONCLUSIONS: RD2 Ver.02 is a safe and effective treatment of PNS when coupled with a minimally invasive trephine PNS procedure. Further comparative studies are needed to fully assess the role of this novel therapy for PNS.

CONCLUSIONS: Sham procedures produce a clinically significant impact on patient-reported outcome measures This effect should be considered when designing and interpreting the results of RCTs.

BACKGROUND: Central venous oxygen saturation (ScvO2) obtained from a central venous catheter (CVC) is often used to approximate oxygen delivery in critically ill patients. Despite their importance in administering medications and monitoring oxygen delivery, the use of CVCs can be associated with significant complications. Midline catheters are inserted via a peripheral vein above the antecubital fossa and provide a safe alternative to CVCs. This study aimed to determine the equivalence of ScvO2 and midline catheter oxygen saturation (SmO2) in critically ill patients.
METHODS: This was a single-center observational study of critically ill adult patients who had concurrently placed CVCs (internal jugular and subclavian) and midline catheters as part of standard ICU care. Venous oxygen saturation and lactate levels were measured from both catheters using the Abbott point-of-care i-STAT analyzer. Demographic and ICU admission data were collected. Continuous variables were compared using the paired t-test. Pearson\'s correlation was used to evaluate the linear correlation between ScvO2 and SmO2. The systematic error (bias) was calculated using Bland-Altman analysis. Receiver operating characteristic curves were constructed to evaluate the sensitivities and specificities for different values of SmO2 to predict ScvO2.
RESULTS: Forty-eight patients (n = 48) were enrolled in the study. The mean ScvO2 and SmO2 were 65.5% +/- 11.2% and 62.7% +/- 17.6% respectively (p = 0.1197). In the Bland-Altman analysis, the mean bias between ScvO2 and SmO2 was 2.8% +/- 12.3% with 95% limits of agreement of -21.3% to 26.9%. More than 60% of the ScvO2 and SmO2 values diverged by ≥ 5%.
CONCLUSIONS: The difference between the mean SmO2 and ScvO2 was not statistically significant and the mean bias between SmO2 and ScvO2 is low. Despite this, the substantially large standard deviation and limits of agreement preclude the use of SmO2 as a direct surrogate of ScvO2.

Thoracentesis is one of the most important invasive procedures in the clinical setting. Particularly, thoracentesis can be relevant in the evaluation of a new diagnosed pleural effusion, thus allowing for the collection of pleural fluid so that laboratory tests essential to establish a diagnosis can be performed. Furthermore, thoracentesis is a maneuver that can have therapeutic and palliative purposes. Historically, the procedure was performed based on a physical examination. In recent years, the role of ultrasound has been established as a valuable tool for assistance and guidance in the thoracentesis procedure. The use of ultrasound increases success rates and significantly reduces complications. The aim of this educational review is to provide a detailed and sequential examination of the procedure, focusing on the two main modalities, the ultrasound-assisted and ultrasound-guided form.

BACKGROUND: As an established treatment for major depressive disorder (MDD), cognitive behavioral therapy (CBT) is now implemented and assessed in internet-based formats that, when combined with smartphone apps, enable secure text messaging. As an adjunct to such internet-based CBT (ICBT) approaches, text messaging has been associated with increased adherence and therapeutic alliance.
OBJECTIVE: This study analyzed data from the intervention arm of a randomized control trial evaluating 24-week ICBT for MDD (intervention arm) against standard-care psychiatry (waitlist control). The aim of this secondary analysis was to assess MDD symptom improvement in relation to the frequency and content of text messages sent by ICBT participants to Navigator-Coaches during randomized control trial participation. Higher text frequency in general and in 3 conceptual categories (appreciating alliance, alliance building disclosures, and agreement confirmation) was hypothesized to predict larger MDD symptom improvement.
METHODS: Participants were young adults (18-30 years) from the Centre for Addiction and Mental Health. The frequencies of categorized texts from 20 ICBT completers were analyzed with respect to MDD symptom improvement using linear regression models. Texts were coded by 2 independent coders and categorized using content analysis. MDD symptoms were measured using the Beck Depression Inventory-II (BDI-II).
RESULTS: Participants sent an average of 136 text messages. Analyses indicated that BDI-II improvement was negatively associated with text messaging frequency in general (β=-0.029, 95% CI -0.11 to 0.048) and in each of the 3 categories: appreciating alliance (β=-0.096, 95% CI -0.80 to 0.61), alliance building disclosures (β=-0.098, 95% CI -0.28 to 0.084), and agreement confirmation (β=-0.076, 95% CI -0.40 to 0.25). Altogether, the effect of text messaging on BDI-II improvement was uniformly negative across statistical models. More text messaging appeared associated with less MDD symptom improvement.
CONCLUSIONS: The hypothesized positive associations between conceptually categorized text messages and MDD symptom improvement were not supported in this study. Instead, more text messaging appeared to indicate less treatment benefit. Future studies with larger samples are needed to discern the optimal use of text messaging in ICBT approaches using adjunctive modes of communication.
BACKGROUND: Clinical Trials.gov NCT03406052; https://www.clinicaltrials.gov/ct2/show/NCT03406052.

UNASSIGNED: Human error and violation of rules are perceived as deviations from some desired behavior, appearing variably in literature as either similar or opposing concepts. Behavioral deviations may be linked to accidents or considered a protective factor against them.
UNASSIGNED: This article aims to explore definitions, characteristics, classifications, and management approaches for behavioral deviations, specifically human error and violation of rules.
UNASSIGNED: A systematic literature review was conducted.
UNASSIGNED: The authors differ in defining and classifying error and violation, associating them with generation of accidents or their prevention. The management proposals for deviations highlighted by the authors were emphasized.
UNASSIGNED: The findings of this article reinforce the prominence of authors Jens Rasmussen and James Reason in the field. They assert that deviations are a natural aspect of the work process and even serve as a preventive factor against accidents, although their frequent association with accidents remains common in organizations. This study contributes to theoretical understanding by systematizing prevalent perspectives on deviation, human error, and violation of rules. It proposes a taxonomy and emphasizing the need for managing deviations, rather than combating them, especially in an organizational context.

OBJECTIVE: Procedures are manual technical skills clinicians perform for their patients. Family physicians (FPs) acquire these skills during residency; most are undertaken in outpatient settings. We performed a retrospective observational cohort study to describe the extent to which FPs perform the core procedures recommended by the Council of Academic Family Medicine (CAFM) and how this might have changed over time.
METHODS: The CAFM recommended a list of procedures all FP residents should perform competently after graduation. We modified this list for Medicare beneficiaries to enable matching with Current Procedural Terminology codes. We probed Medicare Part B databases for modified CAFM procedure claims submitted by FPs in 2021 and how these claims changed from 2014 to 2021.
RESULTS: In 2021, there were 904,278 modified CAFM procedures filed by 9,410 FPs in the outpatient setting. All procedures were clustered with respect to organ system (eg, musculoskeletal, skin, pulmonary). Beginning in 2014 and continuously through 2021, there was a 33% decrease in outpatient procedures filed and a 36% decrease in the number of FPs filing them.
CONCLUSIONS: Office-based procedures are integral to a primary care physician\'s role, although the activity is rarely analyzed. At a time when the Medicare population is growing, the number of available FPs and the number of procedures they perform are not. This decrease might result from the changing scope of FP practice, new referral patterns, task shifting, and/or increased delegation to physician associates and nurse practitioners.

Venesection is common procedure performed in day to day life of every doctor. Conventional vein finders available are costly and not easily available. The present paper highlights the use of makeshift vein finder.

Trichodynia is a common symptom, which is characterized by a painful, burning or stinging sensation of the scalp, often in patients presenting with hair loss. It is typically associated with co-morbid psychiatric conditions and remains challenging to treat, with no Food and Drug Administration (FDA) treatments currently available. We herein report the successful use of off-label onabotulinumtoxin-A in treating a patient with trichodynia who has failed conventional therapies.