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1.
An. psicol ; 40(2): 179-188, May-Sep, 2024. graf, tab
Article in English | IBECS | ID: ibc-232713

ABSTRACT

Los trastornos emocionales (TEs) son los trastornos más comunes entre la población joven. El desarrollo de programas preventivos de los TEs es fundamental para evitar su posible aparición. Los programas de prevención transdiagnósticos podrían presentar una ventaja sobre los existentes para mejorar las estrategias de regulación emocional. Así, el objetivo de este estudio ha sido determinar la viabilidad y eficacia preliminar de un programa breve basado en el Protocolo Unificado (PU). El proyecto consistió en un estudio piloto utilizando un diseño experimental de línea base múltiple. Nueve estudiantes universitarios recibieron un programa de 5 sesiones basado en el PU en formato grupal online. Se encontraron diferencias significativas después de la intervención en la regulación de las emociones, el apoyo social percibido y la evitación, con tamaños del efecto moderados-grandes (r de Cohen = .49 - .59). Estas mejoras mostraron aumentos en los seguimientos al mes y a los 3 meses. Esos resultados están en línea con los que muestran que los programas preventivos transdiagnósticos breves podrían ser útiles para la prevención de los TEs en población universitaria.(AU)


Emotional disorders (EDs) are the most common disorders among the young population. The development of preventive programs for EDs is essential to avoid their possible appearance. Transdiagnostic prevention programs could present an advantage over existing ones to im-prove emotional regulation strategies. Thus, the objective of this study has been to determine the preliminary feasibility and effectiveness of a brief program based on the Unified Protocol (UP). The project consisted of a pilot study using a multiple baseline experimental design. Nine university students received a 5-session program based on the UP in online-group format. Significant differences were found after the intervention for emo-tion regulation, perceived social support and avoidance, with moderate-large effect sizes (Cohen's r= .49-.59). These improvements showed in-creases at 1-month and 3-month follow-ups. Those results are in line with those showing that brief transdiagnostic preventive programs could be use-ful for the prevention of EDs in the university population.(AU)


Subject(s)
Humans , Male , Female , Students/psychology , Mental Health , Student Health , Affective Symptoms , Disease Prevention , Pilot Projects , Psychology , Clinical Protocols
2.
Water Res ; 262: 122077, 2024 Jul 11.
Article in English | MEDLINE | ID: mdl-39018582

ABSTRACT

Wastewater treatment technologies opened the door for recovery of extracellular polymeric substances (EPS), presenting novel opportunities for use across diverse industrial sectors. Earlier studies showed that a significant amount of phosphorus (P) is recovered within extracted EPS. P recovered within the extracted EPS is an intrinsic part of the recovered material that potentially influences its properties. Understanding the P speciation in extracted EPS lays the foundation for leveraging the incorporated P in EPS to manipulate its properties and industrial applications. This study evaluated P speciation in EPS extracted from aerobic granular sludge (AGS). A fractionation lab protocol was established to consistently distinguish P species in extracted EPS liquid phase and polymer chains. 31P nuclear magnetic resonance (NMR) spectroscopy was used as a complementary technique to provide additional information on P speciation and track changes in P species during the EPS extraction process. Findings showed the dominance of organic phosphorus and orthophosphates within EPS, besides other minor fractions. On average, 25% orthophosphates in the polymer liquid phase, 52% organic phosphorus (equal ratio of mono and diesters) covalently bound to the polymer chains, 16% non-apatite inorganic phosphorus (NAIP) precipitates mainly FeP and AlP, and 7% pyrophosphates (6% in the liquid phase and 1% attached to the polymer chains) were identified. Polyphosphates were detected in initial AGS but hydrolyzed to orthophosphates, pyrophosphates, and possibly organic P (forming new esters) during the EPS extraction process. The knowledge created in this study is a step towards the goal of EPS engineering, manipulating P chemistry along the extraction process and enriching certain P species in EPS based on target properties and industrial applications.

3.
Diagn Microbiol Infect Dis ; 110(1): 116412, 2024 Jun 23.
Article in English | MEDLINE | ID: mdl-39018932

ABSTRACT

Rapid and reliable identification of the causal organism in bloodstream infections and sepsis is crucial for both individual patient care and public health. We have implemented a rapid in-house identification protocol (with 10 % Triton) using MALDI-TOF MS for identifying the causative organism in positive blood cultures without prior culture. Our objective was to retrospectively analyze data collected over a four-year period while implementing this rapid in-house identification protocol and to develop a guide for evaluating and reporting the obtained results. Overall, our method utilizing MALDI-TOF MS for rapid in-house identification, demonstrated comparable results to other commercially available and in-house methods reported in the literature. Over the past four years, direct identification has facilitated the distinction between clinically relevant positive blood cultures and irrelevant ones, guiding rapid focus control and appropriate antibiotic treatment. The established guide can serve as a valuable tool in reporting positive blood cultures and associated antibiotic treatments.

4.
Article in English | MEDLINE | ID: mdl-39018990

ABSTRACT

The isoelectric focusing has realized various improvements, including the protocols and creation of mIEF (microcolumn isoelectric focusing) instruments with excellent sensitivity for screening of diabetes and beta thalassemia. However, the problem of manual sample loading and hydration for the mIEF limits the operational capacity for stably detecting and quantitating most abnormal hemoglobin (Hb). Herein, we provided a high stable sample loading protocol for analysis of alpha thalassemia and Hb variants. In contrast to the previous volume of 20 µl, a 100 µl blood sample solution in this protocol was optimized with mixture of 6.4-7.5 and 3-10 pH carrier ampholytes, pI markers and loaded for 30 mins IPG microcolumn hydration. The hydrated microcolumn was then automatically loaded onto the mIEF chip array to which CH3COOH and NH4OH act as anodic and cathodic solutions. Lastly, the IEF was run for 9 mins. Hb H, Barts, A1c, F, A2 and CS were simultaneously separated and focused with higher resolution and sensitivity in quantifying H and Barts as low as 0.6 and 0.5 % respectively. Accordingly, there was an enhanced stability and linearity with a rapid assay time of 45 secs per sample. Moreover, analysis showed a fitting linear relationship with conventional technology at R2 = 0.9803 for H and R2 = 0.9728 for Barts thereby indicating greater accuracy confirmed by the AUC. Hence, the developed protocol could simply be employed for high stable and throughput batch sample loading of hydration, and accurate separation and quantitation of Hb variants for alpha and beta thalassemia.

5.
Contemp Clin Trials ; : 107632, 2024 Jul 15.
Article in English | MEDLINE | ID: mdl-39019155

ABSTRACT

BACKGROUND: Among people living with HIV (PLWH), unhealthy drinking presents an increased risk for negative outcomes. Physical inactivity and sedentariness raise additional health risks. Despite evidence that physical activity (PA) is associated with improved physical and mental functioning and reduced alcohol cravings, there have been no PA studies conducted with PLWH engaged in unhealthy drinking. We describe a study protocol of a remote lifestyle physical activity (LPA) intervention to increase PA and reduce alcohol consumption among PLWH. METHODS: Using online advertisements, 220 low-active PLWH engaged in unhealthy drinking will be recruited and randomized nationwide. After providing informed consent and completing a baseline interview, participants will receive a Fitbit. Participants will complete 15 days of ecologic momentary assessment through a phone application and up to 15 days of Fitbit wear time. Following this period, participants will be randomly assigned to a Fitbit-only control condition or a LPA and Fitbit intervention condition. Health counselors meet with control participants once (and have 6 subsequent brief check ins on Fibit use) and with intervention participants 7 times for PA counseling over a 12-week period. Follow-up assessments will be conducted at 3- and 6-months post-randomization. We hypothesize that individuals in the LPA and Fitbit condition will have lower rates of alcohol consumption and higher rates of PA at 6-month follow-up. CONCLUSION: The randomized controlled trial described in this paper investigates remote methods to influence multimorbidity among PLWH using a LPA approach for increasing PA and reducing alcohol consumption.

6.
Contemp Clin Trials ; : 107635, 2024 Jul 15.
Article in English | MEDLINE | ID: mdl-39019156

ABSTRACT

BACKGROUND: Approximately 16.5% of U.S. young adults have a cannabis use disorder (CUD) and are at risk for negative outcomes. Treatment can reduce cannabis use, but young adults are less likely to seek help than older adults. Peer Network Counseling-txt (PNC-txt) is a brief, text-delivered, Motivational Interviewing-informed substance use intervention focusing on peer relations and activity spaces as mechanisms for behavioral change. PNC-txt has shown evidence of reducing tobacco and cannabis use with adolescents and young adults, but it has not been tested in the context of legal cannabis use. The current randomized controlled trial sought to expand the evidence regarding the context of PNC-txt effects, comparing one state in which cannabis is legal (Colorado) and one state in which it is not (Tennessee). We hypothesized that participants randomized to PNC-txt would show significant reductions in cannabis use compared to controls, with larger reductions for females and those in Colorado, and that peer relations and activity space would mediate effects. METHODS: One thousand, seventy eight 18-25 year olds (CO: 551; TN: 527) who met screening criteria for CUD and biologically-verified cannabis use were randomly assigned to PNC-txt or waitlist control condition. Every other day for 4 weeks, participants assigned to PNC-txt received pre-programmed text conversations, tailored via data from the baseline assessment. Self-report and biological indicators of cannabis use were measured at 1-, 3-, and 6-months. DISCUSSION: Data analysis is underway. Results will provide evidence regarding whether, and how, PNC-txt reduces cannabis use in young adults with CUD. TRIAL REGISTRATION: This trial was prospectively registered on September 28, 2020 with ClinicalTrials.gov (NCT04567394).

7.
Ergonomics ; : 1-17, 2024 Jul 18.
Article in English | MEDLINE | ID: mdl-39023126

ABSTRACT

Car-lock sounds are designed to inform the lock status of vehicles. However, drivers often experience a lack of confidence regarding whether the car is locked, and car thefts persistently occur, frequently attributed to unlocked doors. Without identification of critical factors for evaluating effects of car-lock sounds on drivers, a strategy to car-lock sound design with increased locking efficiency remains implicit. This study proposes a method to identify critical factors influencing drivers' perceived certainty of car-lock status and behaviours during car-locking. An experiment was conducted to simulate the locking process and verbal protocol analysis was employed to comprehend participants' cognitive processes and behaviours. The results show that mechanical sound yielded high certainty and few hesitations, while tonal and crisp sound elicited low certainty and frequent hesitations. Seven critical factors on participants' behaviours and cognitive processes were identified, which provides a data-driven approach for future research in car-lock sounds evaluation and design.


The effect of car-lock sounds on drivers is significant to inform the locking status of vehicles. However, the strategy for car-lock sounds evaluation remains implicit. This study proposes a method to identify critical factors on drivers' behaviours and cognitive processes that would inform further car-lock sounds evaluation and design.

8.
Niger Med J ; 65(3): 367-375, 2024.
Article in English | MEDLINE | ID: mdl-39022564

ABSTRACT

A quality management system for clinical and public health research operations is indispensable because it ensures the integrity and reliability of research outcomes. By implementing a robust quality management practice in research implementation and operation, research teams can uphold the highest standard of research conduct, thereby enhancing the credibility and trustworthiness of research findings. This paper elucidates the significance and role of a quality management system in clinical and public health research operations and its efficacy in minimising and eliminating protocol deviations and highlights the key steps in setting up a quality management system for research operations.

9.
Heliyon ; 10(12): e31846, 2024 Jun 30.
Article in English | MEDLINE | ID: mdl-38952363

ABSTRACT

The Internet of Things communication protocol is prone to security vulnerabilities when facing increasing types and scales of network attacks, which can affect the communication security of the Internet of Things. It is crucial to effectively detect these vulnerabilities in order to improve the security of IoT communication protocols and promptly fix them. Therefore, this study proposes a distributed IoT communication protocol vulnerability detection method based on an improved parallelized fuzzy testing algorithm. Firstly, based on design principles and by comparing different communication protocols, a communication architecture for the distribution network's Internet of Things was constructed, and the communication protocols were formalized and decomposed. Next, preprocess the vulnerability detection samples, and then use genetic algorithm to improve the parallelized fuzzy testing algorithm to perform vulnerability detection. Through this improved algorithm, the missed detection rate and false detection rate can be effectively reduced, thereby improving the security of IoT communication protocols. The experimental results show that the highest missed detection rate of this method is only 4.0 %, and the false detection rate is low, with high detection efficiency. This indicates that the method has good performance and reliability in detecting vulnerabilities in IoT communication protocols.

10.
Vet Res Commun ; 2024 Jul 02.
Article in English | MEDLINE | ID: mdl-38954258

ABSTRACT

A 4-month-old female Shar-pei dog was admitted with apathy, anorexia, and vomiting. The patient had an appropriate vaccination protocol, with the last vaccine administered 2.5 weeks prior to the onset of clinical signs. Physical examination revealed tachycardia, fever and swelling of the tibiotarsal joints. Several diagnostic tests including complete blood cell count, biochemistry profile, urinalysis, thoracic radiographs, hind limbs radiographs, abdominal ultrasound, and infectious diseases tests, were conducted to determine the underlying cause. Shar-Pei Auto-inflammatory Disease (SPAID) was diagnosed. Additionally, the patient developed skin necrosis in the inner aspect of the tibiotarsal joints as a complication. A skin biopsy revealed cutaneous vasculopathy causing degeneration, abrupt ulceration, and ischemic necrosis with intense neutrophilic inflammation of the dermis and subcutis. Moreover, a hospital-acquired infection was identified by skin culture. Debridement of the necrotic skin was performed, and due to its' severity and extent, the wound was closed by secondary intention. A diagnostic protocol and the therapeutic dose of acetylsalicylic acid, which led to clinical improvement, are recommended here. The patient has continued to present episodic manifestations of SPAID mainly fever and swelling of the tibiotarsal joints, but there has been no recurrence of necrosis or other cutaneous lesion in the last two years.

11.
J Eval Clin Pract ; 2024 Jul 04.
Article in English | MEDLINE | ID: mdl-38962836

ABSTRACT

OBJECTIVES: To analyse the general and primary outcome-related characteristics of clinical trials protocols on COVID-19 vaccines. STUDY DESIGN AND SETTING: A meta-research study. A search for clinical trial protocols on COVID-19 vaccines was conducted on the ClinicalTrials.gov platform. We considered all protocols of comparative trials registered up to October 26, 2021. RESULTS: Two hundred and eighty-two trials were analysed. The median expected trial duration was 445 days (interquartile range [IQR] = 225), and the median target sample size was 420 participants (IQR = 1638). A retrospective registry (after the start date) was observed for 42.55% of the trials. Randomization procedures were planned by 84.75% and full-blinding procedures by 34.75% of the 282 trials. Most trials were labelled as active or still recruiting, and 14 trials (5%) were completed. None of the 14 trials labelled as completed on our search date had results available. Industry funding was reported by 198 trials (70.2%). Most studies declared more than one primary outcome, usually a safety or immunogenicity outcome, and 59 studies (20.9%) had at least one primary efficacy outcome. The description of the primary efficacy outcomes was limited in most cases, referred to as a non-specified 'efficacy' outcome (18.6%) or described as 'COVID-19 cases' (32.2%). CONCLUSION: the primary outcomes of clinical trials on COVID-19 vaccines are poorly described, and the registers provide insufficient information about them. The registry was retrospectively fulfilled for many trials, which may lead to bias and research waste. Outcomes were generically described and did not provide transparent information for replication in practice, further trials or meta-analyses.

12.
Cureus ; 16(5): e61368, 2024 May.
Article in English | MEDLINE | ID: mdl-38947599

ABSTRACT

A 79-year-old female with chronic atrial fibrillation was being treated with dabigatran (Pradaxa). Pradaxa was discontinued after a significant bleeding episode. A WATCHMAN device was successfully implanted and Pradaxa was started. A transesophageal echocardiogram (TEE) 49 days later showed a 3.6×2.2 cm clot overlying the device. Pradaxa was switched to Coumadin. Subsequent TEEs showed the complete resolution of the thrombus after five months on Coumadin. Coumadin was discontinued. Six months later, TEE showed a large mobile thrombus attached to the left atrial appendage occlusion device (LAAOD). The patient's hypercoagulable workup was negative. Due to recurrent thrombotic events, she was started on apixaban (Eliquis) due to a prior history of bleeding on Coumadin. She is currently on Eliquis with no further episodes of bleeding or device thrombus.

13.
Res Involv Engagem ; 10(1): 68, 2024 Jul 01.
Article in English | MEDLINE | ID: mdl-38951878

ABSTRACT

BACKGROUND: Public involvement and engagement (PI&E) is increasingly recognised as an important component of research. It can offer valuable insights from those with experiential knowledge to improve research quality, relevance, and reach. Similarly, schools are ever more common sites for health research and, more recently, PI&E. However, 'gold-standard' practice is yet to be established, and activities/approaches remain underreported. As a result, knowledge can remain localised or lost. Diversity and inclusion also remains a challenge. METHODS: This protocol has been informed by UK national guidance, evidence-based frameworks and available implementation literature. It describes both rationale and approach to conducting PI&E activities within a secondary school context. Activities are designed to be engaging, safe and accessible to young people with diverse experiences, with scope to be iteratively developed in line with public collaborator preference. DISCUSSION: Young people should be architects of their involvement and engagement. Ongoing appraisal and transparency of approaches to PI&E in school settings is crucial. Expected challenges of implementing this protocol include facilitating a safe space for the discussion of sensitive topics, absence and attrition, recruiting students with a diverse range of experiences, and potential knowledge and capacity barriers of both facilitator and contributors. Activities to mitigate these risks are suggested and explored.


Schools are increasingly becoming hubs for health research. However, there is a lack of knowledge about how researchers, schools and students can best work together to shape the studies we do. This is a problem as, in the world of research, involving those with first hand experiences (public collaborators) in the research process is seen as crucial.This protocol outlines our plan for conducting public involvement and engagement activities in secondary schools. It is based on national guidance and existing evidence. The goal is to make these activities interesting, safe, and accessible to young people with diverse experiences. The approach is designed to be flexible, allowing adjustments based on the preferences of the public collaborators.We acknowledge that we may face some difficulties with our approach. This may include challenges in recruitment of public collaborators, dealing with absence and attrition, and creating a safe space for discussing sensitive topics. Collaborators from both academic and lived backgrounds may also experience barriers in knowledge and capacity. This protocol suggests activities to address and overcome these challenges. We emphasise the need for ongoing evaluation and transparency in public involvement and engagement approaches within school settings.

14.
Front Cardiovasc Med ; 11: 1401269, 2024.
Article in English | MEDLINE | ID: mdl-38957330

ABSTRACT

Background: Slow flow/no-reflow (SF-NR) during percutaneous coronary intervention (PCI) is associated with poor prognosis of patients with acute myocardial infarction (AMI). Currently, effective treatment is not available for SF-NR. Electroacupuncture (EA) has shown significant efficacy as an adjuvant therapy for many cardiovascular diseases by improving microcirculation and reducing ischemia-reperfusion injury. However, its effects on SF-NR in the AMI patients during PCI are not clear. This pilot trial aims to determine the efficacy of intraoperative EA in alleviating SF-NR in AMI patients undergoing PCI. Methods: This prospective, single-center, randomized controlled, pilot trial will recruit 60 AMI patients scheduled for PCI at the Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, China. The patients will be randomized in a 1:1 ratio into the EA or the control groups. Patients in the control group will undergo standard PCI. Patients in the EA group will undergo intraoperative electroacupuncture while undergoing standard PCI. Incidence of SF-NR is the primary outcome for this study. This study will also assess secondary outcomes including cardiac biomarkers, inflammatory biomarkers, pain and anxiety scores, electrocardiography parameters, traditional Chinese medicine (TCM) symptom score, and major adverse cardiovascular and cerebrovascular events (MACCE). All the included patients will undergo laboratory tests including routine blood tests, levels of electrolytes, as well as liver and renal function tests. Patients will be followed up for 1 month after the procedure. Discussion: This pilot trial will provide evidence for the potential benefits of intraoperative EA in improving microvascular perfusion and preventing or alleviating SF-NR during PCI in patients with AMI. If proven effective, intraoperative EA will provide a new and effective strategy against SF-NR and provide evidence for subsequent multicenter trials. Clinical Trial Registration: ClinicalTrials.gov, identifier (ChiCTR2300072265). Registered on 8 June 2023.

15.
J Craniovertebr Junction Spine ; 15(2): 153-165, 2024.
Article in English | MEDLINE | ID: mdl-38957754

ABSTRACT

Background: Missed diagnosis of evolving or coexisting idiopathic (IIH) and spontaneous intracranial hypotension (SIH) is often the reason for persistent or worsening symptoms after foramen magnum decompression for Chiari malformation (CM) I. We explore the role of artificial intelligence (AI)/convolutional neural networks (CNN) in Chiari I malformation in a combinatorial role for the first time in literature, exploring both upstream and downstream magnetic resonance findings as initial screening profilers in CM-1. We have also put together a review of all existing subtypes of CM and discuss the role of upright (gravity-aided) magnetic resonance imaging (MRI) in evaluating equivocal tonsillar descent on a lying-down MRI. We have formulated a workflow algorithm MaChiP 1.0 (Manjila Chiari Protocol 1.0) using upstream and downstream profilers, that cause de novo or worsening Chiari I malformation, which we plan to implement using AI. Materials and Methods: The PRISMA guidelines were used for "CM and machine learning and CNN" on PubMed database articles, and four articles specific to the topic were encountered. The radiologic criteria for IIH and SIH were applied from neurosurgical literature, and they were applied between primary and secondary (acquired) Chiari I malformations. An upstream etiology such as IIH or SIH and an isolated downstream etiology in the spine were characterized using the existing body of literature. We propose the utility of using four selected criteria for IIH and SIH each, over MRI T2 images of the brain and spine, predominantly sagittal sequences in upstream etiology in the brain and multiplanar MRI in spinal lesions. Results: Using MaChiP 1.0 (patent/ copyright pending) concepts, we have proposed the upstream and downstream profilers implicated in progressive Chiari I malformation. The upstream profilers included findings of brain sagging, slope of the third ventricular floor, pontomesencephalic angle, mamillopontine distance, lateral ventricular angle, internal cerebral vein-vein of Galen angle, and displacement of iter, clivus length, tonsillar descent, etc., suggestive of SIH. The IIH features noted in upstream pathologies were posterior flattening of globe of the eye, partial empty sella, optic nerve sheath distortion, and optic nerve tortuosity in MRI. The downstream etiologies involved spinal cerebrospinal fluid (CSF) leak from dural tear, meningeal diverticula, CSF-venous fistulae, etc. Conclusion: AI would help offer predictive analysis along the spectrum of upstream and downstream etiologies, ensuring safety and efficacy in treating secondary (acquired) Chiari I malformation, especially with coexisting IIH and SIH. The MaChiP 1.0 algorithm can help document worsening of a previously diagnosed CM-1 and find the exact etiology of a secondary CM-I. However, the role of posterior fossa morphometry and cine-flow MRI data for intracranial CSF flow dynamics, along with advanced spinal CSF studies using dynamic myelo-CT scanning in the formation of secondary CM-I is still being evaluated.

16.
Transpl Infect Dis ; : e14338, 2024 Jul 09.
Article in English | MEDLINE | ID: mdl-38980934

ABSTRACT

BACKGROUND: The Banff Working Group has updated the histological classification of BK virus nephropathy (BKVN), highlighting the importance of early detection. However, an early detection strategy for BKVN using biopsy has not yet been established. Our investigation aimed to assess the efficacy of protocol biopsy for the diagnosis of BKVN. METHODS: We performed a retrospective cohort study of 314 patients who had undergone kidney transplantation between 2006 and 2021. Kidney allograft biopsies were performed as part of a protocol biopsy at 3 months and 1 year post-transplantation. Following the diagnosis of BKVN, the immunosuppressant dose was reduced. RESULTS: Twelve patients (3.8%) were diagnosed with BKVN by biopsy. Most diagnoses are established during the early stages of BKVN (polyomavirus nephropathy class 1 in six, class 2 in five, and class 3 in one). Following the reduction in immunosuppressant dose, kidney allograft function did not deteriorate in any patients. Additionally, test for BK virus DNA in the blood was negative. All but one patient demonstrated histological resolution of BKVN, and the other had a very slight positivity for the simian virus 40 large T antigen. The median follow-up time after BKVN diagnosis was 6 years. One patient developed de novo donor-specific antibody and subclinical acute antibody-mediated rejection that was successfully cured. CONCLUSIONS: Our analysis indicates that protocol biopsy may enable the early detection of BKVN, resulting in the preservation of kidney function.

17.
Expert Rev Med Devices ; : 1-8, 2024 Jul 09.
Article in English | MEDLINE | ID: mdl-38982753

ABSTRACT

OBJECTIVE: Combining clinical investigations with usability studies provides valuable information for medical devices evaluation. But both types of study are very different in terms of objectives and methodologies. How are usability studies integrated into clinical investigations in practice? METHODS: We searched the ClinicalTrials.gov database for clinical investigation protocols that included usability outcome(s) and analyzed them. RESULTS: 77 study protocols were identified for the analysis, including 102 outcomes related to usability in total. The most frequently assessed outcomes were satisfaction (53/102) and ease of use (33/102). The questionnaire was the most frequently planned technique (85/102) followed by interviews (24/102). Other methods were used, such as observation (9/102), mostly when the end users was a healthcare professional, and diary (6/102), mostly with patients. CONCLUSION: Our study results showed that the collection of usability data can be included in a clinical investigation, with various levels of investment. Resource-light, rapid integration via a questionnaire will enable the collection of subjective data on the users' perceptions. When more resources are available, observation in accessible environments can be set up (especially during use by healthcare professionals in hospital) or interviews and/or diaries for home-based environments (especially by patients).

18.
Article in English | MEDLINE | ID: mdl-38989783

ABSTRACT

PURPOSE: To compare the outcomes and complications of two perioperative protocols for the management of patients who underwent medial unicompartmental knee arthroplasty (UKA): 24 h (1-day surgery [OS]) versus 72 h (enhanced recovery after surgery [ERAS]) of the length of hospital stay (LOS). In our hypothesis, the reduction of the LOS from 3 to 1 day did not influence the outcomes and complications. METHODS: A total of 42 patients (21 in each group) with isolated anteromedial knee osteoarthritis and meeting specific criteria were prospectively included in the study. Clinical outcomes included Knee Society Score (KSS) and Forgotten joint score while pain evaluation was performed using a Visual Analogue Scale (VAS). Functional outcomes were assessed measuring the knee range of motion (ROM) while radiographic outcomes were evaluated measuring the amelioration of the varus deformity through the hip-knee-ankle angle (HKA). RESULTS: Clinical and functional outcomes did not significantly differ between the two groups. Complications occurred in 9.5% of OS and 4.7% of ERAS group patients. Significant improvements in knee ROM, VAS pain, KSS and HKA angle were observed postsurgery, with no significant differences between groups except in KSS expectations and function trends. CONCLUSION: The OS protocol is safe and effective and LOS, in a well-defined fast-track protocol, did not significantly impact clinical and functional outcomes. OS may lead to reduced hospitalisation costs and potential reductions in complications associated with prolonged stays, benefiting both patients and healthcare facilities. However, further research with larger sample sizes and longer follow-up periods is needed to confirm these findings. Early mobilisation and rehabilitation protocols are key components of successful patient recovery following UKA procedures. LEVEL OF EVIDENCE: Level II.

19.
Am J Obstet Gynecol MFM ; : 101424, 2024 Jul 09.
Article in English | MEDLINE | ID: mdl-38992742

ABSTRACT

BACKGROUND: An institutional standardized, nurse-initiated protocol was implemented to improve the recognition of and response to perinatal hypertensive emergency. OBJECTIVE(S): The primary aim was to evaluate if the rate of guideline-based treatment of perinatal hypertensive emergency improved with implementation of the protocol. STUDY DESIGN: This quality improvement initiative was developed by a multidisciplinary team and consisted of clinician and nursing education and the implementation of a standardized, nurse-initiated severe hypertension protocol. The project took place in three phases: pre-implementation (July 2020-October 2020), implementation (November 2020-June 2021), and sustainment (July 2021-May 2022). The primary aim was to increase guideline-based treatment of hypertensive emergency among pregnant and postpartum persons. Guideline-based treatment was defined as repeat blood pressure within 30 minutes of severe hypertension to diagnose hypertensive emergency, antihypertensive medication administration within 30 minutes of diagnosis, and appropriately timed repeat blood pressure following treatment. Process measures included time to confirm the diagnosis, initiate the protocol, antihypertensive medication administration, repeat blood pressure after antihypertensive medication administration, and administration of a secondary dose as appropriate. Balancing measures included maternal intensive care unit admission, clinically significant maternal hypotension, fetal demise, neonatal birthweight, and Apgar <7 at 5 minutes. Data were evaluated using between-subjects statistics and a run chart was developed to assess relationship between the protocol and changes in guideline-based treatment over time. RESULTS: Overall, 503 hypertensive emergency encounters were identified during the project period (98 [20%] pre-implementation, 172 [34%] implementation, 233 [46%] sustainment). There were higher rates of persons with chronic hypertension and who self-identified as non-Hispanic Black race in the sustainment phase compared to the other phases. Guideline-based treatment increased from 18.4% pre-implementation to 75.1% in sustainment (p<0.001). Each component of guideline-based treatment also improved significantly from pre-implementation to sustainment (p<0.001). No episodes of clinically significant maternal hypotension occurred in any phase. There were four maternal intensive care unit admissions and three fetal demises during the initiative; none were related to hypertensive emergency. CONCLUSION(S): The nurse-initiated protocol for treatment of hypertensive emergency significantly increased guideline-based treatment of perinatal hypertensive emergency, reduced time to diagnose and treat hypertensive emergency, and increased the number of patients receiving treatment when indicated. This protocol was pragmatic, utilizing resources already available on obstetric units. Use of similar protocols may be considered at institutions providing obstetric care to improve recognition of and response to hypertensive emergency which may decrease maternal and neonatal morbidity and mortality related to hypertensive emergency.

20.
Article in English | MEDLINE | ID: mdl-38993171

ABSTRACT

OBJECTIVE: To evaluate the optimal endometrial preparation protocol for frozen-thawed embryo transfer (FET) following hysteroscopic polypectomy. METHODS: This was a retrospective clinical cohort study involving 464 patients who underwent their first FET after polyp resection between January 2021 and July 2023. The cohorts were categorized into three groups: the natural cycle (NC) group (n = 139), the ovarian induction (OI) group (n = 117), and the hormone replacement therapy (HRT) group (n = 208). RESULTS: In the initial unadjusted analysis, both NC and OI cycles exhibited similar pregnancy rates but were associated with significantly higher implantation rate (56.5%, 57.1% vs 42.0%, P < 0.001), clinical pregnancy rate (73.4%, 74.4% vs 57.2%, P = 0.001), and ongoing pregnancy rate (OPR; 67.6%, 63.2% vs 51.0%, P = 0.005) compared to the HRT group. Additionally, the three groups demonstrated comparable abortion rate (7.8%, 14.9% vs 10.9%, P = 0.299). After adjusting for potential confounders in the multiple logistic regression model, the HRT protocol resulted in a 54% significantly lower OPR compared to the NC protocol (adjusted odds ratio [aOR] = 0.46, 95% confidence interval [CI]: 0.28-0.77; P = 0.003). Meanwhile, the OPR difference between the OI protocol and the NC protocol remained insignificant (OI vs NC: aOR = 0.62, 95% CI: 0.35-1.12; P = 0.112). CONCLUSION: The ovulatory-FET scheme (NC and OI) following hysteroscopic polyp resection displayed promising clinical outcomes compared with HRT-FET scheme. The regimen without exogenous estrogen administration should be prioritized for endometrial preparation protocol after polypectomy.

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