ResearchPad - medical-devices-and-equipment https://www.researchpad.co Default RSS Feed en-us © 2020 Newgen KnowledgeWorks <![CDATA[Comparability of modern contraceptive use estimates between a face-to-face survey and a cellphone survey among women in Burkina Faso]]> https://www.researchpad.co/article/elastic_article_13849 The proliferation of cell phone ownership in Sub-Saharan Africa (SSA) presents the opportunity to collect public health indicators at a lower cost compared to face-to-face (FTF) surveys. This analysis assesses the equivalence of modern contraceptive prevalence estimates between a nationally representative FTF survey and a cell phone survey using random digit dialing (RDD) among women of reproductive age in Burkina Faso.MethodsWe analyzed data from two surveys conducted in Burkina Faso between December 2017 and May 2018. The FTF survey conducted by Performance Monitoring and Accountability (PMA2020) comprised a nationally representative sample of 3,556 women of reproductive age (15–49 years). The RDD survey was conducted using computer-assisted telephone interviewing and included 2,379 women of reproductive age.ResultsCompared to FTF respondents, women in the RDD sample were younger, were more likely to have a secondary degree and to speak French. RDD respondents were more likely to report using modern contraceptive use (40%) compared to FTF respondents (26%) and the difference remained unchanged after applying post-stratification weights to the RDD sample (39%). This difference surpassed the equivalence margin of 4%. The RDD sample also produced higher estimates of contraceptive use than the subsample of women who owned a phone in the FTF sample (32%). After adjusting for women’s sociodemographic factors, the odds of contraceptive use were 1.9 times higher (95% CI: 1.6–2.2) in the RDD survey compared to the FTF survey and 1.6 times higher (95% CI: 1.3–1.8) compared to FTF phone owners.ConclusionsModern contraceptive prevalence in Burkina Faso is over-estimated when using a cell phone RDD survey, even after adjusting for a number of sociodemographic factors. Further research should explore causes of differential estimates of modern contraceptive use by survey modes. ]]> <![CDATA[Retrospectively ECG-gated helical vs. non-ECG-synchronized high-pitch CTA of the aortic root for TAVI planning]]> https://www.researchpad.co/article/elastic_article_13825 Multidetector computed tomography (MDCT) plays a key role in patient assessment prior to transcatheter aortic valve implantation (TAVI). However, to date no consensus has been established on what is the optimal pre-procedural imaging protocol. Variability in pre-TAVI acquisition protocols may lead to discrepancies in aortic annulus measurements and may potentially influence prosthesis size selection.PurposeThe current study evaluates the magnitude of differences in aortic annulus measurements using max-systolic, end-diastolic, and non-ECG-synchronized imaging, as well as the impact of method on prosthesis size selection.Material and methodsFifty consecutive TAVI-candidates, who underwent retrospectively-ECG-gated CT angiography (CTA) of the aortic root, directly followed by non-ECG-synchronized high-pitch CT of the entire aorta, were retrospectively included. Aortic root dimensions were assessed at each 10% increment of the R-R interval (0–100%) and on the non-ECG-synchronized scan. Dimensional changes within the cardiac cycle were evaluated using a 1-way repeated ANOVA. Agreement in measurements between max-systole, end-diastole and non-ECG-synchronized scans was assessed with Bland-Altman analysis.ResultsMaximal dimensions of the aortic root structures and minimum annulus-coronary ostia distances were measured during systole. Max-systolic measurements were significantly and substantially larger than end-diastolic (p<0.001) and non-ECG-synchronized measurements (p<0.001). Due to these discrepancies, the three methods resulted in the same prosthesis size selection in only 48–62% of patients.ConclusionsThe systematic differences between max-systolic, end-diastolic and non-ECG-synchronized measurements for relevant aortic annular dimensions are both statistically significant and clinically relevant. Imaging strategy impacts prosthesis size selection in nearly half the TAVI-candidates. End-diastolic and non-ECG-synchronized imaging does not provide optimal information for prosthesis size selection. Systolic image acquisition is necessary for assessment of maximal annular dimensions and minimum annulus-coronary ostia distances. ]]> <![CDATA[Is transjugular insertion of a temporary pacemaker a safe and effective approach?]]> https://www.researchpad.co/article/elastic_article_13814 Temporary pacemakers (TPMs) are usually inserted in an emergency situation. However, there are few reports available regarding which route of access is best or what the most preferred approach is currently in tertiary hospitals. This study aimed to compare procedure times, complication rates, and indications for temporary pacing between the transjugular and transfemoral approaches to TPM placement. We analyzed consecutive patients who underwent TPM placement. Indications; procedure times; and rates of complications including localized infection, any bleeding, and pacing wire repositioning rates were analyzed. A total of 732 patients (361 treated via the transjugular approach and 371 treated via the transfemoral approach) were included. Complete atrioventricular block was the most common cause of TPM placement in both groups, but sick sinus syndrome was especially common in the transjugular approach group. Separately, procedure time was significantly shorter in the transjugular approach group (9.0 ± 8.0 minutes vs. 11.9 ± 9.7 minutes; P < 0.001). Overall complication rates were not significantly different between the two groups, and longer duration of temporary pacing was a risk factor for repositioning. The risk of reposition was significantly increased when the temporary pacing was continued more than 5 days and 3 days in the transjugular approach group and the transfemoral approach group, respectively. The transjugular approach should be considered if the TPM is required for more than 3 days.

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<![CDATA[Incidence and determinants of Implanon discontinuation: Findings from a prospective cohort study in three health zones in Kinshasa, DRC]]> https://www.researchpad.co/article/elastic_article_7634 Kinshasa is Africa's third largest city and one of the continent’s most rapidly growing urban areas. PMA2020 data showed that Kinshasa has a modern contraceptive prevalence of 26.5% among married women in 2018. In Kinshasa’s method mix, the contraceptive implant recently became the dominant method among contraceptive users married and in union. This study provides insight into patterns of implant use in a high-fertility setting by evaluating the 24-month continuation rate for Implanon NXT and identifying the characteristics associated with discontinuation.MethodologyThis community-based, prospective cohort study followed 531 Implanon users aged 18–49 years at 6, 12 and 24 months. The following information was collected: socio-demographic characteristics, Method Information Index (MII) and contraceptive history. The main outcome variable for this study was implant discontinuation. The incidence rate of discontinuation is presented as events per 1000 person/months (p-m), from the date of enrolment. The Cox proportional hazards modelling was used to measure predictors of discontinuation.ResultsA total of 9158.13 p-m were available for analysis, with an overall incidence rate of 9.06 (95% CI: 9.04–9.08) removals per 1000 p-m. Of nine possible co-variates tested, the likelihood of discontinuation was higher among women who lived in military camps, had less than three children, never used injectables or implants in the past, had experienced heavy/prolonged bleeding, and whose MII score was less than 3.ConclusionIn addition to four client characteristics that predicted discontinuation, we identified one programmatic factor: quality of counseling as measured by the Method Information Index. Community providers in similar contexts should pay more attention to clients having less than three children, new adopters, and to clients living military camps as underserved population, where clients have less access to health facilities. More targeted counselling and follow-up is needed, especially on bleeding patterns. ]]> <![CDATA[Effect of moderate elevated intra-abdominal pressure on lung mechanics and histological lung injury at different positive end-expiratory pressures]]> https://www.researchpad.co/article/Nccafa6f6-e83a-4af1-be67-e451f21e0145

Introduction

Intra-abdominal hypertension (IAH) is a well-known phenomenon in critically ill patients. Effects of a moderately elevated intra-abdominal pressure (IAP) on lung mechanics are still not fully analyzed. Moreover, the optimal positive end-expiratory pressure (PEEP) in elevated IAP is unclear.

Methods

We investigated changes in lung mechanics and transformation in histological lung patterns using three different PEEP levels in eighteen deeply anesthetized pigs with an IAP of 10 mmHg. After establishing the intra-abdominal pressure, we randomized the animals into 3 groups. Each of n = 6 (Group A = PEEP 5, B = PEEP 10 and C = PEEP 15 cmH2O). End-expiratory lung volume (EELV/kg body weight (bw)), pulmonary compliance (Cstat), driving pressure (ΔP) and transpulmonary pressure (ΔPL) were measured for 6 hours. Additionally, the histological lung injury score was calculated.

Results

Comparing hours 0 and 6 in group A, there was a decrease of EELV/kg (27±2 vs. 16±1 ml/kg; p<0.05) and of Cstat (42±2 vs. 27±1 ml/cmH2O; p<0.05) and an increase of ΔP (11±0 vs. 17±1 cmH2O; p<0.05) and ΔPL (6±0 vs. 10±1 cmH2O; p<0.05). In group B, there was no significant change in EELV/kg (27±3 vs. 24±3 ml/kg), but a decrease in Cstat (42±3 vs. 32±1 ml/cmH20; p<0.05) and an increase in ΔP (11±1 vs. 15±1 cmH2O; p<0.05) and ΔPL (5±1 vs. 7±0 cmH2O; p<0.05). In group C, there were no significant changes in EELV/kg (27±2 vs. 29±3 ml/kg), ΔP (10±1 vs. 12±1 cmH2O) and ΔPL (5±1 vs. 7±1 cmH2O), but a significant decrease of Cstat (43±1 vs. 37±1 ml/cmH2O; p<0.05). Histological lung injury score was lowest in group B.

Conclusions

A moderate elevated IAP of 10 mmHg leads to relevant changes in lung mechanics during mechanical ventilation. In our study, a PEEP of 10 cmH2O was associated with a lower lung injury score and was able to overcome the IAP induced alterations of EELV.

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<![CDATA[Polymer-fiber-coupled field-effect sensors for label-free deep brain recordings]]> https://www.researchpad.co/article/N12f161cb-ce31-436b-989e-fa44b0a6dffa

Electrical recording permits direct readout of neural activity but offers limited ability to correlate it to the network topography. On the other hand, optical imaging reveals the architecture of neural circuits, but relies on bulky optics and fluorescent reporters whose signals are attenuated by the brain tissue. Here we introduce implantable devices to record brain activities based on the field effect, which can be further extended with capability of label-free electrophysiological mapping. Such devices reply on light-addressable potentiometric sensors (LAPS) coupled to polymer fibers with integrated electrodes and optical waveguide bundles. The LAPS utilizes the field effect to convert electrophysiological activity into regional carrier redistribution, and the neural activity is read out in a spatially resolved manner as a photocurrent induced by a modulated light beam. Spatially resolved photocurrent recordings were achieved by illuminating different pixels within the fiber bundles. These devices were applied to record local field potentials in the mouse hippocampus. In conjunction with the raster-scanning via the single modulated beam, this technology may enable fast label-free imaging of neural activity in deep brain regions.

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<![CDATA[Ser96Ala genetic variant of the human histidine-rich calcium-binding protein is a genetic predictor of recurrence after catheter ablation in patients with paroxysmal atrial fibrillation]]> https://www.researchpad.co/article/5c897742d5eed0c4847d2858

Background

Atrial fibrillation (AF) recurrence after radiofrequency catheter ablation (RFCA) still remains a serious issue. Ca2+ handling has a considerable effect on AF recurrence. The histidine-rich calcium-binding protein (HRC) genetic single nucleotide polymorphism (SNP), rs3745297 (T>G, Ser96Ala), is known to cause a sarcoplasmic reticulum Ca2+ leak. We investigated the association between HRC Ser96Ala and AF recurrence after RFCA in paroxysmal AF (PAF) patients.

Methods and results

We enrolled PAF patients who underwent RFCA (N = 334 for screening and N = 245 for replication) and were genotyped for HRC SNP (rs3745297). The patient age was younger and rate of diabetes and hypertension lower in the PAF patients with Ser96Ala than in those without (TT/TG/GG, 179/120/35; 64±10/60±12/59±13 y, P = 0.001; 18.5/ 9.2/8.6%, P = 0.04 and 66.1/50.0/37.1%, P = 0.001, respectively). During a mean 19 month follow-up, 57 (17.1%) patients suffered from AF recurrences. The rate of an Ser96Ala was significantly higher in patients with AF recurrence than in those without in the screening set (allele frequency model: odds ratio [OR], 1.80; P = 0.006). We also confirmed this significant association in the replication set (OR 1.74; P = 0.03) and combination (P = 0.0008). A multivariate analysis revealed that the AF duration, sinus node dysfunction, and HRC Ser96Ala were independent predictors of an AF recurrence (hazard ratio [HR], 1.04, P = 0.037; HR 2.42, P = 0.018; and HR 2.66, P = 0.007, respectively).

Conclusion

HRC SNP Ser96Ala is important as a new genetic marker of AF recurrence after RFCA.

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<![CDATA[Utilization of modern contraceptives and predictors among women in Shimelba refugee camp, Northern Ethiopia]]> https://www.researchpad.co/article/5c897721d5eed0c4847d2504

Women living in refugee camps, in addition to the common hardships, such as drought, and famine, are also prone to another peculiar problem: an unintended pregnancy. The impact of unintended pregnancy is so severe that the rate of women who die or suffer an injury while giving birth in crisis settings is almost double the world average death rate. Thus, this study was aimed to investigate the utilization of modern contraceptive and associated factors among women in the reproductive age group in Shimelba refugee camp, Northern Ethiopia. A community-based cross-sectional study was employed and 329 study subjects were selected using simple random sampling technique with a face-to-face interview. The prevalence of using modern contraceptive was 47.7% and the study showed that being older [AOR = 0.017, 95%CI: 0.001, 0.467], being single [AOR = 0.17, 95%CI:0.031,0.914], being unemployed [AOR = 0.21, 95% CI:0.001,0.392], having no partner support [AOR = 0.006, 95% CI:0.001,0.044], and inconvenient service site AOR = 0.089,95% CI:0.013, 0.595] were factors that contributed to women not using modern contraceptive methods. Receipt of counseling on family planning utilization was more likely to helps women to use it [AOR = 3.37, 95% CI: 1.1095, 10.236]. Our study concluded that the current prevalence rate of contraceptive use is fairly good. However, much effort has to be made to improve this result. The situations in refugee can exacerbate the existing barriers to the use of contraceptives. Given its grave consequence on the livelihood of women, the contraceptive issue should be given due emphasis using several techniques including education to expand the awareness on modern contraceptive so as to augment access to family planning.

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<![CDATA[Efficacy of liposomal amphotericin B and anidulafungin using an antifungal lock technique (ALT) for catheter-related Candida albicans and Candida glabrata infections in an experimental model]]> https://www.researchpad.co/article/5c75ac7dd5eed0c484d088b2

Objective

The aims of this study were as follows. First, we sought to compare the in vitro susceptibility of liposomal amphotericin B (LAmB) and anidulafungin on Candida albicans and Candida glabrata biofilms growing on silicone discs. Second, we sought to compare the activity of LAmB versus anidulafungin for the treatment of experimental catheter-related C. albicans and C. glabrata infections with the antifungal lock technique in a rabbit model.

Methods

Two C. albicans and two C. glabrata clinical strains were used. The minimum biofilm eradication concentration for 90% eradication (MBEC90) values were determined after 48h of treatment with LAmB and anidulafungin. Confocal microscopy was used to visualize the morphology and viability of yeasts growing in biofilms. Central venous catheters were inserted into New Zealand rabbits, which were inoculated of each strain of C. albicans and C. glabrata. Then, catheters were treated for 48h with saline or with antifungal lock technique using either LAmB (5mg/mL) or anidulafungin (3.33mg/mL).

Results

In vitro: anidulafungin showed greater activity than LAmB against C. albicans and C. glabrata strains. For C. albicans: MBEC90 of anidulafungin versus LAmB: CA176, 0.03 vs. 128 mg/L; CA180, 0.5 vs. 64 mg/L. For C. glabrata: MBEC90 of anidulafungin versus LAmB: CG171, 0.5 vs. 64 mg/L; CG334, 2 vs. 32 mg/L. In vivo: for C. albicans species, LAmB and anidulafungin achieved significant reductions relative to growth control of log10 cfu recovered from the catheter tips (CA176: 3.6±0.3 log10 CFU, p≤0.0001; CA180: 3.8±0.1 log10 CFU, p≤0.01). For C. glabrata, anidulafungin lock therapy achieved significant reductions relative to the other treatments (CG171: 4.8 log10 CFU, p≤0.0001; CG334: 5.1 log10 CFU, p≤0.0001)

Conclusions

For the C. albicans strains, both LAmB and anidulafungin may be promising antifungal lock technique for long-term catheter-related infections; however, anidulafungin showed significantly higher activity than LAmB against the C. glabrata strains.

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<![CDATA[Population dynamics and entrainment of basal ganglia pacemakers are shaped by their dendritic arbors]]> https://www.researchpad.co/article/5c65dcf2d5eed0c484dec628

The theory of phase oscillators is an essential tool for understanding population dynamics of pacemaking neurons. GABAergic pacemakers in the substantia nigra pars reticulata (SNr), a main basal ganglia (BG) output nucleus, receive inputs from the direct and indirect pathways at distal and proximal regions of their dendritic arbors, respectively. We combine theory, optogenetic stimulation and electrophysiological experiments in acute brain slices to ask how dendritic properties impact the propensity of the various inputs, arriving at different locations along the dendrite, to recruit or entrain SNr pacemakers. By combining cable theory with sinusoidally-modulated optogenetic activation of either proximal somatodendritic regions or the entire somatodendritic arbor of SNr neurons, we construct an analytical model that accurately fits the empirically measured somatic current response to inputs arising from illuminating the soma and various portions of the dendritic field. We show that the extent of the dendritic tree that is illuminated generates measurable and systematic differences in the pacemaker’s phase response curve (PRC), causing a shift in its peak. Finally, we show that the divergent PRCs correctly predict differences in two major features of the collective dynamics of SNr neurons: the fidelity of population responses to sudden step-like changes in inputs; and the phase latency at which SNr neurons are entrained by rhythmic stimulation, which can occur in the BG under both physiological and pathophysiological conditions. Our novel method generates measurable and physiologically meaningful spatial effects, and provides the first empirical demonstration of how the collective responses of SNr pacemakers are determined by the transmission properties of their dendrites. SNr dendrites may serve to delay distal striatal inputs so that they impinge on the spike initiation zone simultaneously with pallidal and subthalamic inputs in order to guarantee a fair competition between the influence of the monosynaptic direct- and polysynaptic indirect pathways.

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<![CDATA[Pressure redistributing in-seat movement activities by persons with spinal cord injury over multiple epochs]]> https://www.researchpad.co/article/5c6dc9fdd5eed0c48452a665

Pressure ulcers, by definition, are caused by external forces on the tissues, often in the regions of bony prominences. Wheelchair users are at risk to develop sitting-acquired pressure ulcers, which occur in the regions of the ischial tuberosities, sacrum/coccyx or greater trochanters. As a means to prevent pressure ulcers, instruction on performing pressure reliefs or weight shifts are a part of the rehabilitation process. The objective of this study was to monitor the weight shift activity of full-time wheelchair users with acute spinal cord injury over multiple epochs of time in order to determine consistency or routine within and across epochs. A second objective was to evaluate the accuracy of self-reported pressure relief frequency within each measurement epoch. A wheelchair in-seat activity monitor was used to measure weight shifts and other in-seat movement. The data was classified into multiple in-seat activity metrics using machine learning. Seventeen full-time wheelchair users with spinal cord injury were measured within multiple epochs, each lasting more than 1 week. Across all in-seat activity metrics, no consistent pattern of activity changes emerged. None of the in-seat activity metric changed in any one direction across a majority of subjects. Subjects tended to over-estimate their frequency of performing pressure reliefs. Self-reported pressure relief behaviors are not reliable, and therefore, cannot be used to evaluate preventative behaviors either clinically or within research. This study had the capability of fully investigating in-seat movements of wheelchair users. The results indicated that in-seat movement does not reflect a routine, either in pressure reliefs, weight shifts or other functional in-seat movements. This study has illustrated the complexity of assigning causation of pressure ulcer occurrence to seated behaviors of wheelchair users and identifies the need for improved clinical techniques designed to develop routine behaviors to prevent pressure ulcers.

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<![CDATA[Isolated diastolic potentials as predictors of success in ablation of right ventricular outflow tract idiopathic premature ventricular contractions]]> https://www.researchpad.co/article/5c648cdbd5eed0c484c8196e

Background and aims

Discrete potentials, low voltage and fragmented electrograms, have been previously reported at ablation site, in patients with premature ventricular contractions (PVCs) originating in the right ventricular outflow tract (RVOT). The aim of this study was to review the electrograms at ablation site and assess the presence of diastolic potentials and their association with success.

Methods

We retrospectively reviewed the electrograms obtained at the radiofrequency (RF) delivery sites of 48 patients subjected to ablation of RVOT frequent PVCs. We assessed the duration and amplitude of local electrogram, local activation time, and presence of diastolic potentials and fragmented electrograms.

Results

We reviewed 134 electrograms, median 2 (1–4) per patient. Success was achieved in 40 patients (83%). At successful sites the local activation time was earlier– 54 (-35 to -77) ms vs -26 (-12 to -35) ms, p<0.0001; the local electrogram had lower amplitude 1 (0.45–1.15) vs 1.5 (0.5–2.1) mV, p = 0.006, and longer duration 106 (80–154) vs 74 (60–90) ms, p<0.0001. Diastolic potentials and fragmented electrograms were more frequently present, respectively 76% vs 9%, p <0.0001 and 54% vs 11%, p<0.0001. In univariable analysis these variables were all associated with success. In multivariable analysis only the presence of diastolic potentials [OR 15.5 (95% CI: 3.92–61.2; p<0.0001)], and the value of local activation time [OR 1.11 (95% CI: 1.049–1.172 p<0.0001)], were significantly associated with success.

Conclusion

In this group of patients the presence of diastolic potentials at the ablation site was associated with success.

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<![CDATA[The benefits of sensation on the experience of a hand: A qualitative case series]]> https://www.researchpad.co/article/5c5ca2abd5eed0c48441e844

Background

The experience of upper limb loss involves loss of both functional capabilities and the sensory connection of a hand. Research studies to restore sensation to persons with upper limb loss with neural interfaces typically measure outcomes through standardized functional tests or quantitative surveys. However, these types of metrics cannot fully capture the personal experience of living with limb loss or the impact of sensory restoration on this experience. Qualitative studies can demonstrate the viewpoints and priorities of specific persons or groups and reveal the underlying conceptual structure of various aspects of their experiences.

Methods and findings

Following a home use trial of a neural-connected, sensory-enabled prosthesis, two persons with upper limb loss were interviewed about their experiences using the sensory restoration system in unsupervised, unconstrained settings. We used grounded theory methodology to examine their experiences, perspectives, and opinions about the sensory restoration system. We then developed a model to describe the impact of sensation on the experience of a hand for persons with upper limb loss.

Conclusions

The experience of sensation was complex and included concepts such as the naturalness of the experience, sensation modality, and the usefulness of the sensory information. Sensation was critical for outcome acceptance, and contributed to prosthesis embodiment, confidence, reduced focus and attention for using the prosthesis, and social interactions. Embodiment, confidence, and social interactions were also key determinants of outcome acceptance. This model provides a unified framework to study and understand the impact of sensation on the experience of limb loss and to understand outcome acceptance following upper limb loss more broadly.

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<![CDATA[The stability of long-segment and short-segment fixation for treating severe burst fractures at the thoracolumbar junction in osteoporotic bone: A finite element analysis]]> https://www.researchpad.co/article/5c61e8dbd5eed0c48496f278

The majority of compressive vertebral fractures in osteoporotic bone occur at the level of the thoracolumbar junction. Immediate decompression is often required in order to reduce the extent of neurological damage. This study evaluated four fixation methods for decompression in patients with thoracolumbar burst fractures, and presented the most suitable method for osteoporotic patients. A finite element model of a T7–L5 spinal segment was created and subjected to an L1 corpectomy to simulate a serious burst fracture. Five models were tested: a) intact spine; 2) two segment fixation (TSF), 3) up-three segment fixation (UTSF), below-three segment fixation (BTSF), and four segment fixation (FSF). The ROM, stiffness and compression ratio of the fractured vertebra were recorded under various loading conditions. The results of this study showed that the ROM of the FSF model was the lowest, and the ROMs of UTSF and BTSF models were similar but still greater than the TSF model. Decreasing the BMD to simulate osteoporotic bone resulted in a ROM for the four instrumented models that was higher than the normal bone model. Of all models, the FSF model had the highest stiffness at T12-L2 in extension and lateral bending. Similarly, the compression ratio of the FSF model at L1 was also higher than the other instrumented models. In conclusion, FSF fixation is suggested for patients with osteoporotic thoracolumbar burst fractures. For patients with normal bone quality, both UTSF and BTSF fixation provide an acceptable stiffness in extension and lateral bending, as well as a favorable compression ratio at L1.

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<![CDATA[Reporting of “dialysis adequacy” as an outcome in randomised trials conducted in adults on haemodialysis]]> https://www.researchpad.co/article/5c633962d5eed0c484ae65b8

Background

Clinical trials are most informative for evidence-based decision-making when they consistently measure and report outcomes of relevance to stakeholders, especially patients, clinicians, and policy makers. However, sometimes terminology used is interpreted differently by different stakeholders, which might lead to confusion during shared decision making. The construct dialysis adequacy is frequently used, suggesting it is an important outcome both for health care professionals as for patients.

Objective

To assess the scope and consistency of the construct dialysis adequacy as reported in randomised controlled trials in hemodialysis, and evaluate whether these align to the insights and understanding of this construct by patients.

Methods

To assess scope and consistency of dialysis adequacy by professionals, we performed a systematic review searching the Cochrane Central Register of Controlled Trials (CENTRAL) up to July 2017. We identified all randomised controlled trails (RCT) including patients on hemodialysis and reporting dialysis adequacy, adequacy or adequacy of dialysis and extracted and classified all reported outcomes. To explore interpretation and meaning of the construct of adequacy by patients, we conducted 11 semi-structured interviews with HD patients using thematic analysis. Belgian registration number B670201731001.

Findings

From the 31 included trials, we extracted and classified 98 outcome measures defined by the authors as adequacy of dialysis, of which 94 (95%) were biochemical, 3 (3%) non-biochemical surrogate and 2 (2%) patient-relevant. The three most commonly reported measures were all biochemical. None of the studies defined adequacy of dialysis as a patient relevant outcome such as survival or quality of life. Patients had a substantially different understanding of the construct dialysis adequacy than the biochemical interpretation reported in the literature. Being alive, time spent while being on dialysis, fatigue and friendliness of staff were the most prominent themes that patients linked to the construct of dialysis adequacy.

Conclusion

Adequacy of dialysis as reported in the literature refers to biochemical outcome measures, most of which are not related with patient relevant outcomes. For patients, adequate dialysis is a dialysis that enables them to spend as much quality time in their life as possible.

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<![CDATA[Predicting ambulatory energy expenditure in lower limb amputees using multi-sensor methods]]> https://www.researchpad.co/article/5c5ca28cd5eed0c48441e5dd

Purpose

To assess the validity of a derived algorithm, combining tri-axial accelerometry and heart rate (HR) data, compared to a research-grade multi-sensor physical activity device, for the estimation of ambulatory physical activity energy expenditure (PAEE) in individuals with traumatic lower-limb amputation.

Methods

Twenty-eight participants [unilateral (n = 9), bilateral (n = 10) with lower-limb amputations, and non-injured controls (n = 9)] completed eight activities; rest, ambulating at 5 progressive treadmill velocities (0.48, 0.67, 0.89, 1.12, 1.34m.s-1) and 2 gradients (3 and 5%) at 0.89m.s-1. During each task, expired gases were collected for the determination of V˙O2 and subsequent calculation of PAEE. An Actigraph GT3X+ accelerometer was worn on the hip of the shortest residual limb and, a HR monitor and an Actiheart (AHR) device were worn on the chest. Multiple linear regressions were employed to derive population-specific PAEE estimated algorithms using Actigraph GT3X+ outputs and HR signals (GT3X+HR). Mean bias±95% Limits of Agreement (LoA) and error statistics were calculated between criterion PAEE (indirect calorimetry) and PAEE predicted using GT3X+HR and AHR.

Results

Both measurement approaches used to predict PAEE were significantly related (P<0.01) with criterion PAEE. GT3X+HR revealed the strongest association, smallest LoA and least error. Predicted PAEE (GT3X+HR; unilateral; r = 0.92, bilateral; r = 0.93, and control; r = 0.91, and AHR; unilateral; r = 0.86, bilateral; r = 0.81, and control; r = 0.67). Mean±SD percent error across all activities were 18±14%, 15±12% and 15±14% for the GT3X+HR and 45±20%, 39±23% and 34±28% in the AHR model, for unilateral, bilateral and control groups, respectively.

Conclusions

Statistically derived algorithms (GT3X+HR) provide a more valid estimate of PAEE in individuals with traumatic lower-limb amputation, compared to a proprietary group calibration algorithm (AHR). Outputs from AHR displayed considerable random error when tested in a laboratory setting in individuals with lower-limb amputation.

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<![CDATA[Mutation screening in non-syndromic hearing loss patients with cochlear implantation by massive parallel sequencing in Taiwan]]> https://www.researchpad.co/article/5c79b005d5eed0c4841e3c60

Objectives

To explore the molecular epidemiology of rare deafness genes in Taiwanese sensorineural hearing impairment (SNHI) patients with cochlear implantation (CI) by performing massive parallel sequencing (MPS) and correlating genetic factors and CI outcomes.

Methods

We enrolled 41 Taiwanese non-syndromic deafness patients with CI that lacked known mutations in common deafness genes. All probands were screened by a targeted exon amplification method that used massively parallel sequencing to screen a customized panel that included 40 relatively rare non-syndromic deafness genes.

Results

Thirteen candidate variants in nine relatively rare deafness genes (MYO15A, TMC1, MYH14, MYO3A, ACTG1, COL11A2, DSPP, GRHL2, and WFS1) were identified in 24.4% (10/41) of the non-syndromic deafness probands with CI. According to the ACMG Standards and Guidelines, five variants in MYO15A and ACTG1 were classified as likely pathogenic variants. Two of three multi-generational pedigrees exhibiting deafness were analyzed for the segregation of the disorder with the possible disease-causing variants. Patients with variants detected in most of the identified variant-bearing genes showed relatively good CI outcomes.

Conclusions

We successfully identified candidate variants in partially deaf Taiwanese probands who lacked the known mutations in common deafness genes. Comparing the progress of hearing rehabilitation in CI patients with their apparent causative variants and the expression profiles of their altered genes allowed us to speculate on how alterations in specific gene sets may influence outcomes in hearing rehabilitation after CI.

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<![CDATA[Intraoperative loading of calcium phosphate-coated implants with gentamicin prevents experimental Staphylococcus aureus infection in vivo]]> https://www.researchpad.co/article/5c5df36bd5eed0c48458127d

Orthopedic device-related infection (ODRI) is a potentially devastating complication arising from the colonization of the device with bacteria, such as Staphylococcus aureus. The aim of this study was to determine if intraoperative loading of a clinically approved calcium phosphate (CaP) coating with gentamicin can protect from ODRI in vivo. First, CaP-coated titanium aluminium niobium (TAN) discs were used to investigate the adsorption and release kinetics of gentamicin in vitro. Gentamicin loading and subsequent release from the coating were both rapid, with maximum loading occurring following one second of immersion, and >95% gentamicin released within 15 min in aqueous solution, respectively. Second, efficacy of the gentamicin-loaded CaP coating for preventing ODRI in vivo was investigated using a CaP-coated unicortical TAN screw implanted into the proximal tibia of skeletally mature female Wistar rats, following inoculation of the implant site with S. aureus. Gentamicin-loading prevented ODRI in 7/8 animals, whereas 9/9 of the non-gentamicin treated animals were infected after 7 days. In conclusion, gentamicin can be rapidly and simply loaded onto, and released from, CaP-based implant coatings, and this is an effective strategy for preventing peri-operative S. aureus-induced ODRI in vivo.

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<![CDATA[Patient Transfer Decision Difficulty Scale: Development and psychometric testing of emergency department visits by long-term care residents]]> https://www.researchpad.co/article/5c5df351d5eed0c48458114b

Background and objectives

Nurses serve as gatekeepers of the health of long-term care facility (LTCF) residents and are key members deciding whether residents should visit an emergency department (ED). Inappropriate decisions as to ED visits may result in ED overcrowding, excessive medical expenses, and nosocomial infections. Currently, there is a lack of effective tools for assessing the barriers and level of difficulty experienced by LTCF nurses. The purposes of this study were to develop a Patient Transfer Decision Difficulty Scale (PTDDS) and test its effectiveness.

Methods

This study randomly sampled LTCFs in Taiwan and surveyed two or three nurses in every institution selected. Registered return envelopes were provided for participants to return self-completed questionnaires. Three steps were used to develop the scale and items: in step I, the instrument was developed; in step II, psychometric testing was conducted, which entailed performing an exploratory factor analysis (EFA) to verify the construct validity and reliability of the developed items; and in step III, a confirmation study was conducted using a confirmatory factor analysis (CFA) and structural equation modeling to cross-validate the factors and items.

Results

The cumulative sum of variance explained by the measurement models of the three factors in the PTDDS was 63.54%.When deciding whether to transfer LTCF residents to EDs, the most pronounced barrier experienced by nurses were for judging the severity of “clinical episodes”, which had an explanatory power of 37.49%. The second and third pronounced barriers and decision difficulty experienced by nurses were “communication and information” and “timing of the residents’ emergency visits,” which explained 16.81% and 9.24% of the variance, respectively.

Conclusions

The cross-validation results obtained using the EFA and CFA showed favorable reliability and validity of the PTDDS. For future studies, this study recommends performing large-scale investigations of the level of decision difficulty and related factors experienced by nurses in LTCFs of varying levels and types.

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<![CDATA[Quality of family planning services in Mexico: The perspective of demand]]> https://www.researchpad.co/article/5c5b52f0d5eed0c4842bd2c6

Introduction

Family planning (FP) is one of the key services provided by health care systems. Extending beyond matters of sexual and reproductive health, its area of influence impacts directly on the development of individuals and nations. After 60 years of intense FP activities in Mexico, and in light of recent restructuring of health service supply and financing, services need to be assessed from a user perspective.

Objective

Based on a comprehensive conceptual framework, this article assesses the quality of the FP services provided by the Mexican Ministry of Health (MoH). Analysis considers not only accessibility and availability but also the users’ perceptions of the care process, particularly as regards the interpersonal relations they experience with staff and the type of information they are provided.

Material and methods

This study used a descriptive, qualitative design based on maximum variation sampling in six Mexican states. It included visits to 12 clinics in urban and rural areas. Thematic analysis was performed on 86 semi-structured interviews administered to FP service users.

Results

While access was described by users as “easy,” their experiences revealed normalized barriers. One of our key findings referred to inverse availability, meaning that the contraceptive methods available were generally not the ones preferred by users, with their selection therefore being shaped by shortage of supplies. Challenges included disrespect for the free choice of FP users and coercion during consultations for contraception post obstetric event. Finally, information provided to users left considerable room for improvement.

Conclusions

After six decades of FP service supply, results indicate a series of quality issues that may lie at the heart of the unmet demand reported in the literature. Based on a comprehensive conceptual scheme, the present study analyzes the quality of services, highlighting areas for improvement that should be considered by the MoH in future efforts.

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