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Farmacia Hospitalaria : Organo Oficial... 2024The off-label use in clinical practice of non-approved syringes for intravitreal drug administration has resulted in the detection of silicone oil drops in the vitreous... (Review)
Review
OBJECTIVE
The off-label use in clinical practice of non-approved syringes for intravitreal drug administration has resulted in the detection of silicone oil drops in the vitreous of some patients. This situation derives from the lack of approved syringes for intraocular use in the Spanish market. The aim of this work is to review the use of syringes for intraocular administration, as well as to search for alternatives that meet the legal requirements for these unmet needs.
METHOD
A systematic review was performed following the PRISMA 2020 Guidelines by searching PubMed with the descriptors: "silicone" AND "syringes" AND ("intraocular" OR "intravitreal") and filtering all existing publications from January 2006 to December 2023, including all those articles dealing with silicone oil release in intravitreal injections and analysing the possible consequences.
RESULTS
Sixty-eight results were found, 23 of which were excluded because they did not deal with the subject under study, leaving a total of 45 articles for the systematic review. These were classified according to the conclusions obtained in 4 groups: the adverse reactions produced by silicone, the administration technique, the physicochemical aspects of silicone release, and the characteristics of the medical device. After reviewing the current manufacturers and technical data sheets of commercialized syringes, the existing syringes for this use have been collected, finding two that will probably be commercialized in Spain at the beginning of 2024: Zero Residual™ 0.2 ml SiO-free and VitreJect® Ophthalmic.
CONCLUSIONS
From the results obtained, it can be interpreted that the use of syringes and needles with silicone for intravitreal use is a concern for health professionals due to the implications and consequences that may arise in patients, the most important being adverse reactions, so it is necessary to have silicone-free syringes on the market that are specific for intraocular use. Safety and legality in the use of intraocular syringes and needles is essential to guarantee ocular integrity and patient health.
Topics: Syringes; Humans; Silicone Oils; Intravitreal Injections; Off-Label Use; Spain
PubMed: 38556370
DOI: 10.1016/j.farma.2024.01.008 -
Biomedical Engineering Online Mar 2023Infusion Pumps (IP) are medical devices that were developed in the 1960s and generate fluid flow at pressures higher than that of normal blood pressure. Various hospital... (Review)
Review
BACKGROUND
Infusion Pumps (IP) are medical devices that were developed in the 1960s and generate fluid flow at pressures higher than that of normal blood pressure. Various hospital sectors make use of them, and they have become indispensable in therapies requiring continuity and precision in the administration of medication and/or food. As they are classified Class III (high risk) equipment, their maintenance is crucial for proper performance of the device, as well as patient and operator safety. The principal consideration of the pump is the volume infused, and the device demands great attention to detail when being calibrated. A lack of necessary care with this equipment can lead to uncertainty in volume and precision during the administration of substances. Because of this, it is essential to evaluate its reliability, to prevent possible failures at time of execution. This control aims at the quality of the intended infusion result, becoming an indication of quality.
METHODS
This systematic review summarizes studies done over the last 10 years (2011 to December 2021) that address the reliability and accuracy of hospital infusion pumps, in order to identify planning of maintenance and/or other techniques used in management of the equipment. The Prisma method was applied and the databases utilized were Embase, MEDLINE/Pubmed, Web of Science, Scopus, IEEE Xplore, and Science Direct. In addition, similar reviews were studied in Prospero and the Cochrane Library. For data analysis, softwares such as Mendeley, Excel, RStudio, and VOSviewer were used, and Robvis helped in plotting risk of bias results for studies performed with Cochrane tools.
RESULTS
The six databases selected produced 824 studies. After applying eligibility criteria (inclusion and exclusion), removing duplicates, and applying filters 1 and 2, 15 studies were included in the present review. It was found that the most relevant sources came from the Institute of Electrical and Electronics Engineers (IEEE) and that the most relevant keywords revolved around the terms ("device failure", "infusion pumps", "adverse effects", "complications", etc.). These results made clear that there remains substantial room for improvement as it relates to the study of accuracy and reliability of infusion.
CONCLUSIONS
We verified that the reliability and precision analysis of hospital infusion pumps need to be performed in a more detailed and consistent way. New developments, considering the model and IP specification, are intended, clearly explaining the adopted methodology.
Topics: Humans; Reproducibility of Results; Hospitals; Infusion Pumps
PubMed: 36932393
DOI: 10.1186/s12938-023-01088-w -
Journal of Shoulder and Elbow Surgery May 2022The use of reverse total shoulder arthroplasty and stemless anatomic total shoulder replacement has been increasing in the United States every year. Stemless humeral... (Review)
Review
BACKGROUND
The use of reverse total shoulder arthroplasty and stemless anatomic total shoulder replacement has been increasing in the United States every year. Stemless humeral components in reverse total shoulder arthroplasty are only approved for clinical trials in the United States with an investigational device exception with limited data.
METHODS
A systematic review on stemless reverse total shoulder arthroplasty was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. A search was conducted on November 25, 2020, using the MEDLINE/PubMed, Cochrane, and Embase databases. All articles were reviewed by 2 independent evaluators, with any conflicts or issues resolved by consensus or a final decision by the senior author. The primary outcomes extracted were complications, radiographic results, and outcome scores.
RESULTS
We evaluated 10 studies that used either the Total Evolutive Shoulder System (TESS) or Verso implant. There were 430 total patients and 437 total procedures; 266 patients in the TESS group underwent a total of 272 procedures, and 164 patients in the Verso group underwent a total of 165 procedures. The mean age at the time of surgery was 73.8 years (range, 38-93 years). The mean follow-up period ranged from 6.4 to 101.6 months per study. There was an overall trend of improved clinical outcome scores, a 0.2% humeral component loosening rate, and an 11.2% complication rate.
CONCLUSIONS
This review shows that the clinical and functional outcomes following stemless or metaphyseal reverse total shoulder arthroplasty are quite promising, especially with the low rate of humeral-sided complications. There continues to be a need for additional long-term studies and randomized clinical trials.
Topics: Arthroplasty, Replacement, Shoulder; Humans; Prosthesis Design; Shoulder Joint; Shoulder Prosthesis; Treatment Outcome
PubMed: 35051541
DOI: 10.1016/j.jse.2021.12.017 -
Hellenic Journal of Cardiology : HJC =... 2023The ideal treatment for patent foramen ovale (PFO) in patients with cryptogenic stroke remains controversial and is being evaluated. The objective of this study was to... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The ideal treatment for patent foramen ovale (PFO) in patients with cryptogenic stroke remains controversial and is being evaluated. The objective of this study was to evaluate the net clinical benefit (NCB) between PFO closure and medical treatment.
METHODS
We searched three electronic databases from inception until January 2022. The primary outcomes were the NCB-1, defined as the cumulative incidence of stroke, major bleeding, atrial fibrillation/flutter, and serious procedural or device complications; the NCB-2 and NCB-3 were defined as NCB1 but using a weighted factor of 0.5 and 0.25 for atrial fibrillation/flutter events, respectively. We also evaluated each component outcome of NCB as a secondary outcome. Risk ratios (RR) and 95% confidence intervals (CI) of each outcome were calculated (random-effects model).
RESULTS
Our analysis included six RCTs (n = 3750 patients). The rates of NCB-1, NCB-2, and NCB-3 were not different between PFO closure and medical treatment. The heterogeneity between trials was low to moderate. Stroke showed a significant relative decrease of 44% (95% CI, 21-60%), favoring the PFO closure arm. Atrial fibrillation/flutter increased by 4.04 times (95% CI, 1.57-8.89) in the PFO closure compared with the medical treatment group. In a meta-regression analysis, the reduction in NCB-1 with PFO closure increased as the proportion of patients treated with the Amplatzer device increased (p = 0.02), and the reduction in NCB-1, NCB-2, and NCB-3 with PFO closure increased as the proportion of patients treated with substantial PFO size increased (p = 0.03).
CONCLUSION
The NCB between PFO closure and medical treatment was not different, suggesting individualized treatment to maximize benefit.
Topics: Humans; Atrial Fibrillation; Neoplasm Recurrence, Local; Stroke; Ischemic Stroke; Foramen Ovale, Patent; Secondary Prevention; Cardiac Catheterization; Atrial Flutter; Treatment Outcome; Septal Occluder Device; Recurrence
PubMed: 36584788
DOI: 10.1016/j.hjc.2022.12.010 -
Sensors (Basel, Switzerland) Jul 2022In general, the adoption of IoT applications among end users in healthcare is very low. Healthcare professionals present major challenges to the successful... (Review)
Review
In general, the adoption of IoT applications among end users in healthcare is very low. Healthcare professionals present major challenges to the successful implementation of IoT for providing healthcare services. Many studies have offered important insights into IoT adoption in healthcare. Nevertheless, there is still a need to thoroughly review the effective factors of IoT adoption in a systematic manner. The purpose of this study is to accumulate existing knowledge about the factors that influence medical professionals to adopt IoT applications in the healthcare sector. This study reviews, compiles, analyzes, and systematically synthesizes the relevant data. This review employs both automatic and manual search methods to collect relevant studies from 2015 to 2021. A systematic search of the articles was carried out on nine major scientific databases: Google Scholar, Science Direct, Emerald, Wiley, PubMed, Springer, MDPI, IEEE, and Scopus. A total of 22 articles were selected as per the inclusion criteria. The findings show that TAM, TPB, TRA, and UTAUT theories are the most widely used adoption theories in these studies. Furthermore, the main perceived adoption factors of IoT applications in healthcare at the individual level are: social influence, attitude, and personal inattentiveness. The IoT adoption factors at the technology level are perceived usefulness, perceived ease of use, performance expectancy, and effort expectations. In addition, the main factor at the security level is perceived privacy risk. Furthermore, at the health level, the main factors are perceived severity and perceived health risk, respectively. Moreover, financial cost, and facilitating conditions are considered as the main factors at the environmental level. Physicians, patients, and health workers were among the participants who were involved in the included publications. Various types of IoT applications in existing studies are as follows: a wearable device, monitoring devices, rehabilitation devices, telehealth, behavior modification, smart city, and smart home. Most of the studies about IoT adoption were conducted in France and Pakistan in the year 2020. This systematic review identifies the essential factors that enable an understanding of the barriers and possibilities for healthcare providers to implement IoT applications. Finally, the expected influence of COVID-19 on IoT adoption in healthcare was evaluated in this study.
Topics: COVID-19; Delivery of Health Care; Health Personnel; Humans; Telemedicine; Wearable Electronic Devices
PubMed: 35891056
DOI: 10.3390/s22145377 -
Sensors (Basel, Switzerland) Aug 2023Smart wearable devices enable personalized at-home healthcare by unobtrusively collecting patient health data and facilitating the development of intelligent platforms... (Review)
Review
Smart wearable devices enable personalized at-home healthcare by unobtrusively collecting patient health data and facilitating the development of intelligent platforms to support patient care and management. The accurate analysis of data obtained from wearable devices is crucial for interpreting and contextualizing health data and facilitating the reliable diagnosis and management of critical and chronic diseases. The combination of edge computing and artificial intelligence has provided real-time, time-critical, and privacy-preserving data analysis solutions. However, based on the envisioned service, evaluating the additive value of edge intelligence to the overall architecture is essential before implementation. This article aims to comprehensively analyze the current state of the art on smart health infrastructures implementing wearable and AI technologies at the far edge to support patients with chronic heart failure (CHF). In particular, we highlight the contribution of edge intelligence in supporting the integration of wearable devices into IoT-aware technology infrastructures that provide services for patient diagnosis and management. We also offer an in-depth analysis of open challenges and provide potential solutions to facilitate the integration of wearable devices with edge AI solutions to provide innovative technological infrastructures and interactive services for patients and doctors.
Topics: Humans; Artificial Intelligence; Awareness; Chronic Disease; Heart Failure; Wearable Electronic Devices
PubMed: 37571678
DOI: 10.3390/s23156896 -
Journal of the Academy of... 2022Chronic cerebral hypoperfusion is a potential mechanism that causes cognitive impairment in patients with heart failure. Cognitive impairment in this population is... (Review)
Review
BACKGROUND
Chronic cerebral hypoperfusion is a potential mechanism that causes cognitive impairment in patients with heart failure. Cognitive impairment in this population is associated with an increased mortality and poorer quality of life. Understanding the etiopathogenesis of cognitive impairment is crucial to developing effective treatment. A left ventricular assist device (LVAD) is a durable mechanical circulatory support device that restores systemic perfusion in patients with heart failure, potentially reversing cerebral hypoperfusion and cognitive impairment.
OBJECTIVE
This case series and systematic review examines the effect of LVAD implantation on cognition in patients with heart failure.
METHODS
We report a case series of 4 LVAD recipients at a tertiary academic center who underwent preimplant and postimplant cognitive testing. We also conducted a systematic review of studies with adult recipients of a continuous-flow LVAD whose cognition was measured before and after implantation. We searched Medline, EMBASE, SCOPUS, and the Cochrane library (start of database to July 16, 2021) for longitudinal, peer-reviewed studies written in English.
RESULTS
Cognitive improvement after LVAD implantation was observed in the case series, with improvement on phonemic fluency and digit symbol coding assessments. Two out of 4 cases in the case series improved on Clinical Dementia Rating: one from moderate dementia to mild cognitive impairment and another from mild cognitive impairment to unimpaired. Seven studies were included in the systematic review and were heterogeneous regarding cognitive tests employed, follow-up period, and measured outcomes. Montreal Cognitive Assessment and Trail-Making Test Part B were used most commonly. Cognitive improvement was reported in all 7 studies with at least 1 study reporting statistically significant improvements in each the following cognitive domains: delayed and immediate recall, executive function, visuospatial function, verbal function, attention, and processing speed. Most studies had small sample sizes and lacked a control group.
CONCLUSIONS
LVAD implantation appears to be associated with improved cognition. Adequately powered, prospective studies are needed to examine the effect of LVAD on cognitive function in patients with heart failure. Additionally, studies that directly examine cerebral blood flow in conjunction with cognitive assessment are needed to establish the relationship between the reversal of cerebral hypoperfusion and improved cognition.
Topics: Adult; Humans; Heart-Assist Devices; Quality of Life; Heart Failure; Treatment Outcome; Cognition
PubMed: 36116764
DOI: 10.1016/j.jaclp.2022.09.003 -
Journal of Medical Internet Research Apr 2022There are a range of wearable transdermal alcohol sensors that are available and are being developed. These devices have the potential to monitor alcohol consumption... (Review)
Review
BACKGROUND
There are a range of wearable transdermal alcohol sensors that are available and are being developed. These devices have the potential to monitor alcohol consumption continuously over extended periods in an objective manner, overcoming some of the limitations of other alcohol measurement methods (blood, breath, and urine).
OBJECTIVE
The objective of our systematic review was to assess wearable transdermal alcohol sensor accuracy.
METHODS
A systematic search of the CINAHL, Embase, Google Scholar, MEDLINE, PsycINFO, PubMed, and Scopus bibliographic databases was conducted in February 2021. In total, 2 team members (EB and SH) independently screened studies for inclusion, extracted data, and assessed the risk of bias. The methodological quality of each study was appraised using the Mixed Methods Appraisal Tool. The primary outcome was transdermal alcohol sensor accuracy. The data were presented as a narrative synthesis.
RESULTS
We identified and analyzed 32 studies. Study designs included laboratory, ambulatory, and mixed designs, as well as randomized controlled trials; the length of time for which the device was worn ranged from days to weeks; and the analyzed sample sizes ranged from 1 to 250. The results for transdermal alcohol concentration data from various transdermal alcohol sensors were generally found to positively correlate with breath alcohol concentration, blood alcohol concentration, and self-report (moderate to large correlations). However, there were some discrepancies between study reports; for example, WrisTAS sensitivity ranged from 24% to 85.6%, and specificity ranged from 67.5% to 92.94%. Higher malfunctions were reported with the BACtrack prototype (16%-38%) and WrisTAS (8%) than with SCRAM (2%); however, the former devices also reported a reduced time lag for peak transdermal alcohol concentration values when compared with SCRAM. It was also found that many companies were developing new models of wearable transdermal alcohol sensors.
CONCLUSIONS
As shown, there is a lack of consistency in the studies on wearable transdermal alcohol sensor accuracy regarding study procedures and analyses of findings, thus making it difficult to draw direct comparisons between them. This needs to be considered in future research, and there needs to be an increase in studies directly comparing different transdermal alcohol sensors. There is also a lack of research investigating the accuracy of transdermal alcohol sensors as a tool for monitoring alcohol consumption in clinical populations and use over extended periods. Although there is some preliminary evidence suggesting the accuracy of these devices, this needs to be further investigated in clinical populations.
TRIAL REGISTRATION
PROSPERO CRD42021231027; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=231027.
Topics: Alcohol Drinking; Blood Alcohol Content; Ethanol; Humans; Monitoring, Physiologic; Wearable Electronic Devices
PubMed: 35436239
DOI: 10.2196/35178 -
Journal of Clinical Monitoring and... Feb 2022The objective of this systematic review and meta-analysis was to analyze the effectiveness of contactless vital sign monitors that utilize a consumer-friendly camera... (Meta-Analysis)
Meta-Analysis Review
The objective of this systematic review and meta-analysis was to analyze the effectiveness of contactless vital sign monitors that utilize a consumer-friendly camera versus medical grade instruments. A multiple database search was conducted from inception to September 2020. Inclusion criteria were as follows: studies that used a consumer-grade camera (smartphone/webcam) to examine contactless vital signs in adults; evaluated the non-contact device against a reference medical device; and used the participants' face for measurement. Twenty-six studies were included in the review of which 16 were included in Pearson's correlation and 14 studies were included in the Bland-Altman meta-analysis. Twenty-two studies measured heart rate (HR) (92%), three measured blood pressure (BP) (12%), and respiratory rate (RR) (12%). No study examined blood oxygen saturation (SpO). Most studies had a small sample size (≤ 30 participants) and were performed in a laboratory setting. Our meta-analysis found that consumer-grade contactless vital sign monitors were accurate in comparison to a medical device in measuring HR. Current contactless monitors have limitations such as motion, poor lighting, and lack of automatic face tracking. Currently available consumer-friendly contactless monitors measure HR accurately compared to standard medical devices. More studies are needed to assess the accuracy of contactless BP and RR monitors. Implementation of contactless vital sign monitors for clinical use will require validation in a larger population, in a clinical setting, and expanded to encompass other vital signs including BP, RR, and SpO.
Topics: Adult; Heart Rate; Humans; Monitoring, Physiologic; Oximetry; Respiratory Rate; Vital Signs
PubMed: 34240262
DOI: 10.1007/s10877-021-00734-9 -
The Cochrane Database of Systematic... Dec 2021Endometriosis is a condition characterised by the presence of ectopic deposits of endometrial-like tissue outside the uterus, usually in the pelvis. The impact of... (Review)
Review
BACKGROUND
Endometriosis is a condition characterised by the presence of ectopic deposits of endometrial-like tissue outside the uterus, usually in the pelvis. The impact of laparoscopic treatment on overall pain is uncertain and a significant proportion of women will require further surgery. Therefore, adjuvant medical therapies following surgery, such as the levonorgestrel-releasing intrauterine device (LNG-IUD), have been considered to reduce recurrence of symptoms. OBJECTIVES: To determine the effectiveness and safety of post-operative LNG-IUD in women with symptomatic endometriosis.
SEARCH METHODS
We searched the following databases from inception to January 2021: The Specialised Register of the Cochrane Gynaecology and Fertility Group, CENTRAL (which now includes records from two trial registries), MEDLINE, Embase, PsycINFO, LILACS and Epistemonikos. We handsearched citation lists of relevant publications, review articles, abstracts of scientific meetings and included studies. We contacted experts in the field for information about any additional studies.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) comparing women undergoing surgical treatment of endometriosis with uterine preservation who were assigned to LNG-IUD insertion, versus control conditions including expectant management, post-operative insertion of placebo (inert intrauterine device), or other medical treatment such as gonadotrophin-releasing hormone agonist (GnRH-a) drugs.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected studies for inclusion, and extracted data to allow for an intention-to-treat analysis. For dichotomous data, we calculated the risk ratio (RR) and 95% confidence interval (CI) using the Mantel-Haenszel fixed-effect method. For continuous data, we calculated the mean difference (MD) and 95% CI using the inverse variance fixed-effect method.
MAIN RESULTS
Four RCTs were included, with a total of 157 women. Two studies are ongoing. The GRADE certainty of evidence was very low to low. The certainty of evidence was graded down primarily for serious risk of bias and imprecision. LNG-IUD versus expectant management Overall pain: No studies reported on the primary outcome of overall pain. Dysmenorrhoea: We are uncertain whether LNG-IUD improves dysmenorrhoea at 12 months. Data on this outcome were reported on by two RCTs; meta-analysis was not possible (RCT 1: delta of median visual analogue scale (VAS) 81 versus 50, P = 0.006, n = 55; RCT 2: fall in VAS by 50 (35 to 65) versus 30 (25 to 40), P = 0.021, n = 40; low-certainty evidence). Quality of life: We are uncertain whether LNG-IUD improves quality of life at 12 months. One trial demonstrated a change in total quality of life score with postoperative LNG-IUD from baseline (mean 61.2 (standard deviation (SD) 14.8) to 12 months (mean 70.3 (SD 16.2) compared to expectant management (baseline 55.1 (SD 17.0) to 57.0 (SD 33.2) at 12 months) (n = 55, P = 0.014, very low-certainty evidence). Patient satisfaction: Two studies found higher rates of satisfaction with LNG-IUD compared to expectant management; however, combining the studies in meta-analysis was not possible (n = 95, very low-certainty evidence). One study found 75% (15/20) of those given post-operative LNG-IUD were "satisfied" or "very satisfied", compared to 50% (10/20) of those in the expectant management group (RR 1.5, 95% CI 0.90-2.49, 1 RCT, n=40, very low-certainty evidence). The second study found that fewer were "very satisfied" in the expectant management group when compared to LNG, but there were no data to include in a meta-analysis. Adverse events: One study found a significantly higher proportion of women reporting melasma (n = 55, P = 0.015, very low-certainty evidence) and bloating (n = 55, P = 0.021, very low-certainty evidence) following post-operative LNG-IUD. There were no differences in other reported adverse events, such as weight gain, acne, and headaches. LNG-IUD versus GnRH-a Overall pain: No studies reported on the primary outcome of overall pain. Chronic pelvic pain: We are uncertain whether LNG-IUD improves chronic pelvic pain at 12 months when compared to GnRH-a (VAS pain scale) (MD -2.0, 95% CI -20.2 to 16.2, 1 RCT, n = 40, very low-certainty evidence). Dysmenorrhoea: We are uncertain whether LNG-IUD improves dysmenorrhoea at six months when compared to GnRH-a (measured as a reduction in VAS pain score) (MD 1.70, 95%.CI -0.14 to 3.54, 1 RCT, n = 18, very low-certainty evidence). Adverse events: One study suggested that vasomotor symptoms were the most common adverse events reported with patients receiving GnRH-a, and irregular bleeding in those receiving LNG-IUD (n = 40, very low-certainty evidence) AUTHORS' CONCLUSIONS: Post-operative LNG-IUD is widely used to reduce endometriosis-related pain and to improve operative outcomes. This review demonstrates that there is no high-quality evidence to support this practice. This review highlights the need for further studies with large sample sizes to assess the effectiveness of post-operative adjuvant hormonal IUD on the core endometriosis outcomes (overall pain, most troublesome symptom, and quality of life).
Topics: Dysmenorrhea; Endometriosis; Endometrium; Female; Humans; Intrauterine Devices, Medicated; Levonorgestrel
PubMed: 34928503
DOI: 10.1002/14651858.CD005072.pub4