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Rev Esc Enferm USP ; 56: e20210222, 2022.
Article En, Pt | MEDLINE | ID: mdl-34989391

OBJECTIVE: To assess the accuracy measurements for predisposing and precipitating Risk Factors for delirium in an adult Intensive Care Unit. METHOD: Cohort, prospective study with patients over 18 who had been hospitalized for over 24 hours and were able to communicate. The patients were assessed once a day until the onset of delirium or permanence in the Intensive Care Unit. Instruments were employed to track delirium, characterize the sample, and identify the risk factors. Descriptive statistics was employed for sample characterization and accuracy tests for risk factors. RESULTS: The included patients amounted to 102, 31 of which presented delirium. The predisposing predictive risk factors were hypoalbuminemia, American Society of Anesthesiology over three, severity, altered tissue perfusion, dehydration, and being a male, whereas precipitating predictive factors were physical restraint, infection, pharmacological agent, polypharmacy, anemia, altered renal function, dehydration, invasive devices, altered tissue perfusion and altered quality and quantity of sleep. CONCLUSION: An accurate identification of predisposing and precipitating risk factors may contribute to planning preventive measures against delirium.

Delirium , Adult , Delirium/diagnosis , Delirium/epidemiology , Hospitalization , Humans , Intensive Care Units , Male , Prospective Studies , Risk Factors
BMJ Open ; 12(1): e053094, 2022 01 03.
Article En | MEDLINE | ID: mdl-34980617

OBJECTIVES: COVID-19 is having a disproportionate impact on Black, Asian and minority ethnic (BAME) groups and women. Concern over direct and indirect effects may also impact on sleep. We explore the levels and social determinants of self-reported sleep loss among the UK population during the pandemic, focusing on ethnic and gender disparities. SETTING: This prospective longitudinal study analysed data from seven waves of the Understanding Society: COVID-19 Study collected from April 2020 to January 2021 linked to prepandemic data from the 2019 mainstage interviews, providing baseline information about the respondents prior to the pandemic. PARTICIPANTS: The analytical sample included 8163 respondents aged 16 and above who took part in all seven waves with full information on sleep loss, defined as experiencing 'rather more' or 'much more' than usual sleep loss due to worry, providing 57 141 observations. PRIMARY OUTCOME MEASURES: Self-reported sleep loss. Mixed-effects regression models were fitted to consider within-individual and between-individual differences. RESULTS: Women were more likely to report sleep loss than men (OR 2.1, 95% CI 1.9 to 2.4) over the 10-month period. Being female, having young children, perceived financial difficulties and COVID-19 symptoms were all predictive of sleep loss. Once these covariates were controlled for, the bivariate relationship between ethnicity and sleep loss (1.4, 95% CI 1.6 to 2.4) was reversed (0.7, 95% CI 0.5 to 0.8). Moreover, the strength of the association between gender and ethnicity and the risk of sleep loss varied over time, being weaker among women in July (0.6, 95% CI 0.5 to 0.7), September (0.7, 95% CI 0.6 to 0.8), November (0.8, 95% CI 0.7 to 1.0) and January 2021 (0.8, 95% CI 0.7 to 0.9) compared with April 2020, but positively stronger among BAME individuals in May (1.4, 95% CI 1.0 to 2.1), weaker only in September (0.7, 95% CI 0.5 to 1.0). CONCLUSIONS: The pandemic has widened sleep deprivation disparities, with women with young children, COVID-19 infection and BAME individuals experiencing sleep loss, which may adversely affect their mental and physical health.

COVID-19 , Pandemics , Child , Child, Preschool , Communicable Disease Control , Female , Humans , Longitudinal Studies , Male , Prospective Studies , SARS-CoV-2 , Sleep , United Kingdom/epidemiology
Stem Cell Res Ther ; 13(1): 9, 2022 01 10.
Article En | MEDLINE | ID: mdl-35012650

Coronavirus disease 2019 (COVID-19) caused by the novel severe acute respiratory coronavirus 2 is currently spreading throughout the world with a high rate of infection and mortality and poses a huge threat to global public health. COVID-19 primarily manifests as hypoxic respiratory failure and acute respiratory distress syndrome, which can lead to multiple organ failure. Despite advances in the supportive care approaches, there is still a lack of clinically effective therapies, and there is an urgent need to develop novel strategies to fight this disease. Currently, stem cell therapy and stem cell-derived organoid models have received extensive attention as a new treatment and research method for COVID-19. Here, we discuss how stem cells play a role in the battle against COVID-19 and present a systematic review and prospective of the study on stem cell treatment and organoid models of COVID-19, which provides a reference for the effective control of the COVID-19 pandemic worldwide.

COVID-19 , Pandemics , Humans , Prospective Studies , SARS-CoV-2 , Stem Cells
Crit Care ; 26(1): 18, 2022 01 10.
Article En | MEDLINE | ID: mdl-35012662

QUESTION: We evaluated whether the time between first respiratory support and intubation of patients receiving invasive mechanical ventilation (IMV) due to COVID-19 was associated with mortality or pulmonary sequelae. MATERIALS AND METHODS: Prospective cohort of critical COVID-19 patients on IMV. Patients were classified as early intubation if they were intubated within the first 48 h from the first respiratory support or delayed intubation if they were intubated later. Surviving patients were evaluated after hospital discharge. RESULTS: We included 205 patients (140 with early IMV and 65 with delayed IMV). The median [p25;p75] age was 63 [56.0; 70.0] years, and 74.1% were male. The survival analysis showed a significant increase in the risk of mortality in the delayed group with an adjusted hazard ratio (HR) of 2.45 (95% CI 1.29-4.65). The continuous predictor time to IMV showed a nonlinear association with the risk of in-hospital mortality. A multivariate mortality model showed that delay of IMV was a factor associated with mortality (HR of 2.40; 95% CI 1.42-4.1). During follow-up, patients in the delayed group showed a worse DLCO (mean difference of - 10.77 (95% CI - 18.40 to - 3.15), with a greater number of affected lobes (+ 1.51 [95% CI 0.89-2.13]) and a greater TSS (+ 4.35 [95% CI 2.41-6.27]) in the chest CT scan. CONCLUSIONS: Among critically ill patients with COVID-19 who required IMV, the delay in intubation from the first respiratory support was associated with an increase in hospital mortality and worse pulmonary sequelae during follow-up.

COVID-19 , Critical Illness , Aged , Humans , Intubation, Intratracheal , Male , Prospective Studies , Respiration, Artificial , SARS-CoV-2
World J Surg Oncol ; 20(1): 14, 2022 Jan 11.
Article En | MEDLINE | ID: mdl-35016693

BACKGROUND: The degree of contamination of healthy tissue with tumor cells during a biopsy in bone or soft tissue sarcomas is clearly dependant on the type of biopsy. Some studies have confirmed a clinically relevant contamination of the biopsy tract after incisional biopsies, as opposed to core-needle biopsies. The aim of our prospective study was to evaluate the risk of local recurrence depending on the biopsy type in extremity and pelvis sarcomas. METHODS: We included 162 patients with a minimum follow-up of 6 months after wide resection of extremity sarcomas. All diagnostic and therapeutic procedures were performed at a single, dedicated sarcoma center. The excision of the biopsy tract after an incisional biopsy was performed as a standard with all tumor resections. All patients received their follow-up after the conclusion of therapy at our center by means of regional MRI studies and, at a minimum, CT of the thorax to rule out pulmonary metastatic disease. The aim of the study was the evaluation of the influence of the biopsy type and of several other clinical factors on the rate of local recurrence and on the time of local recurrence-free survival. RESULTS: One hundred sixty-two patients with bone or soft tissue tumors of the extremities and the pelvis underwent either an incisional or a core-needle biopsy of their tumor, with 70 sarcomas (43.2%) being located in the bone. 84.6% of all biopsies were performed as core-needle biopsies. The median follow-up time was 55.6 months, and 22 patients (13.6%) developed a local recurrence after a median time of 22.4 months. There were no significant differences between incisional and core-needle biopsy regarding the risk of local recurrence in our subgroup analysis with differentiation by kind of tissue, grading of the sarcoma, and perioperative multimodal therapy. CONCLUSIONS: In a large and homogenous cohort of extremity and pelvic sarcomas, we did not find significant differences between the groups of incisional and core-needle biopsy regarding the risk of local recurrence. The excision of the biopsy tract after incisional biopsy in the context of the definitive tumor resection seems to be the decisive factor for this result.

Sarcoma , Soft Tissue Neoplasms , Biopsy , Biopsy, Large-Core Needle , Extremities/surgery , Humans , Neoplasm Recurrence, Local/surgery , Pelvis , Prospective Studies , Retrospective Studies , Sarcoma/surgery , Soft Tissue Neoplasms/surgery
J Refract Surg ; 38(1): 10-20, 2022 Jan.
Article En | MEDLINE | ID: mdl-35020542

PURPOSE: To compare uniocular and binocular visual acuity, wavefront aberrations, and defocus curves using the TECNIS Eyhance (Johnson & Johnson) and RayOne (Rayner) intraocular lenses (IOLs). METHODS: In this prospective, randomized, comparative study, 50 patients (100 eyes) were randomized to receive the same IOL bilaterally ( Identifier: NCT04175951). Follow-up visits were at 1 and 3 to 9 months postoperatively. Primary outcome measures were uncorrected distance (UDVA) and uncorrected intermediate (UIVA) visual acuity (logMAR) at 66 cm. Secondary outcome measures were corrected distance (CDVA) and distance-corrected intermediate (DCIVA) visual acuity at 66 cm, manifest refraction, spherical (Z40) and vertical coma (Z3-1) aberrations (total, internal eye, and corneal) at normal pupil size, defocus curves, and Catquest 9SF and Glare and Halos questionnaire on Likert scale (1 = no glare and halos and 4 = continuous). RESULTS: Uniocular UDVA (P = .02), UIVA (P = .02), and binocular UIVA (P < .01) and uniocular (P = .01) and binocular (P < .01) DCIVA were better with the TECNIS Eyhance IOL at 3 to 9 months. At 3 to 9 months, both uniocular and binocular defocus curves were significantly broader with the TECNIS Eyhance IOL between -0.50 and -3.00 diopters (D). For total and internal eye, there was a statistically but clinically insignificant difference in Z40 with the TECNIS Eyhance IOL. Rasch scores improved (TECNIS Eyhance: 2.04 ± 1.34 to 2.91 ± 0.81 and RayOne:1.61 ± 1.35 to 2.97 ± 0.16) at 3 to 9 months. Refraction, Z3-1, glare, and halos were not different. CONCLUSIONS: The TECNIS Eyhance IOL provided better DCIVA and broader defocus curves than the RayOne IOL. There was no difference in CDVA or patient-reported outcomes. Although there were some differences in aberrations when measured with normal pupil size, they were not clinically significant. [J Refract Surg. 2022;38(1):10-20.].

Lenses, Intraocular , Phacoemulsification , Humans , Lens Implantation, Intraocular , Patient Satisfaction , Prospective Studies , Prosthesis Design , Refraction, Ocular , Vision, Binocular , Visual Acuity
BMC Infect Dis ; 22(1): 49, 2022 Jan 12.
Article En | MEDLINE | ID: mdl-35022023

BACKGROUND: In Australia, demand for specialist infectious diseases services exceeds capacity to provide timely management of latent tuberculosis infection (LTBI) in areas of high refugee and asylum seeker settlement. A model for treating LTBI patients in primary care has been developed and piloted in a refugee-focused primary health service (Monash Health Refugee Health and Wellbeing [MHRHW]) and a universal primary care clinic. This study reports on the development and evaluation of the model, focusing on the model feasibility, and barriers and enablers to its success. METHODS: A convergent mix-methods design was used to evaluate the model for treating LTBI patients in primary care, where a prospective cohort study of patients commencing treatment either at MHRHW or the universal primary care clinic determined the model feasibility, while focus groups with clinicians directly involved in treating these patients explored barriers and enablers to sustainability and success of the model. RESULTS: From January 2017 to April 2018, 65 patients with confirmed LTBI presented at participating clinics. Treatment was accepted by 31 (48%) patients, of whom 15(48%) were treated at MHRHW and 16 (52%) at the universal primary care clinic. The 6-months' treatment completion rate was higher at MHRHW compared to the universal primary care clinic (14 (93%) compared to 9 (56%) respectively, p = 0.0373). Reasons for non-completion included adverse reaction, opting out and relocation. At the completion of the pilot, 15 clinicians participated in two focus groups. Clinicians identified barriers and enablers for successful LTBI management at patient, provider, organisational and clinical levels. While barriers for treatment completion and adherence were consistent across the two pilot sites, enablers, such as resources to facilitate patient education and follow-up, were available only at MHRHW. CONCLUSION: Screening and management of LTBI patients can be achieved within the primary care setting, considerate of barriers and enablers at patient, provider, organisational and clinical levels. Upscaling of a primary care response to the management of LTBI will require supporting primary care clinics with resources to employ dedicated clinical staff for patient education, follow-up communication and monitoring medication adherence.

Latent Tuberculosis , Refugees , Antitubercular Agents/therapeutic use , Humans , Latent Tuberculosis/diagnosis , Latent Tuberculosis/drug therapy , Mass Screening , Primary Health Care , Prospective Studies
Eur Respir Rev ; 31(163)2022 Mar 31.
Article En | MEDLINE | ID: mdl-35022255

In stark contrast to a few decades ago when lung cancer was predominantly a disease of men who smoke, incidence rates of lung cancer in women are now comparable to or higher than those in men and are rising alarmingly in many parts of the world. Women face a unique set of risk factors for lung cancer compared to men. These include exogenous exposures including radon, prior radiation, and fumes from indoor cooking materials such as coal, in addition to endogenous exposures such as oestrogen and distinct genetic polymorphisms. Current screening guidelines only address tobacco use and likely underrepresent lung cancer risk in women. Women were also not well represented in some of the landmark prospective studies that led to the development of current screening guidelines. Women diagnosed with lung cancer have a clear mortality benefit compared to men even when other clinical and demographic characteristics are accounted for. However, there may be sex-based differences in outcomes and side effects of systemic therapy, particularly with chemotherapy and immunotherapy. Ongoing research is needed to better investigate these differences to address the rapidly changing demographics of lung cancer worldwide.

Lung Neoplasms , Female , Humans , Incidence , Lung Neoplasms/diagnosis , Lung Neoplasms/epidemiology , Lung Neoplasms/therapy , Male , Prospective Studies , Risk Factors , Smoke
Saudi Med J ; 43(1): 45-52, 2022 Jan.
Article En | MEDLINE | ID: mdl-35022283

OBJECTIVES: To investigate the possible effects of wet-cupping therapy (hijama) on autoimmune activity and thyroid hormonal profiles of Hashimoto's disease (HD) patients. METHODS: A prospective pilot controlled trial was carried out among adult females following HD at the Endocrinology Clinic of King Abdulaziz University Hospital, Jeddah, Saudi Arabia, from February 2014 until March 2017. A total of 13 patients (intervention group) underwent 3 hijama sessions at 3-week interval with a 6-month follow-up. Blood tests were carried out for both pre- and post-hijama, including: thyroid peroxidase antibody (TPO), thyroglobulin antibody (TG), thyroid stimulating hormone (TSH), thyroxine-4 (T4), and prolactin. Control group included 13 randomly selected HD patients following usual care with 2 consecutive measurements of TPO and TG at 2-3 months interval. RESULTS: Changes in anti-TPO and anti-TG showed a decrease in hijama group versus an increase in control group, and intervention group comparison was statistically significant. On a fixed thyroxine supplement for each patient, significant decrease in levels of anti-TPO, anti-TG, TSH, prolactin, and erythrocyte sedi-mentation rate (ESR) occurred. CONCLUSION: These findings are presumptive to the efficacy of hijama on the pathogenesis of HD in modulating the immune inflammatory process demonstrated by the reduction in ESR, TPO, and TSH levels on a fixed thyroxin supplementation dose, along with patient-reported clinical improvement and positive changes in ultrasound including regaining of gland physiological size, echogenicity, and vascularity.

Cupping Therapy , Hashimoto Disease , Adult , Autoantibodies , Female , Hashimoto Disease/drug therapy , Humans , Prospective Studies , Thyroxine
Acta Orthop ; 93: 198-205, 2022 01 03.
Article En | MEDLINE | ID: mdl-34984481

Background and purpose - Facemasks play a role in preventing the respiratory spread of SARS-CoV-2, but their impact on the physician-patient relationship in the orthopedic outpatient clinic is unclear. We investigated whether the type of surgeons' facemask impacts patients' perception of the physician-patient relationship, influences their understanding of what the surgeon said, or affects their perceived empathy. Patients and methods - All patients with an appointment in the orthopedic outpatient clinic of a tertiary university hospital during the 2-week study period were included. During consultations, all surgeons wore a non-transparent (first study week) or transparent facemask (second study week). Results of 285 of 407 eligible patients were available for analysis. The doctor-patient relationship was evaluated using the standardized Patient Reactions Assessment (PRA) and a 10-point Likert-scale questionnaire ranging from 0 (strongly disagree) to 10 (strongly agree). Results - A non-transparent facemask led to more restrictions in the physician-patient communication and a worse understanding of what the surgeon said. Patients' understanding improved with a transparent facemask with greatest improvements reported by patients aged 65 years and older (non-transparent: 6 [IQR 5-10] vs. transparent: 10 [IQR 9-10], p < 0.001) and by patients with a self-reported hearing impairment (non-transparent: 7 [IQR 3-7] vs. transparent: 9 [IQR 9-10], p < 0.001). The median PRA score was higher when surgeons wore a transparent facemask (p= 0.003). Interpretation - Surgeons' non-transparent facemasks pose a new communication barrier that can negatively affect the physician-patient relationship. While emotional factors like affectivity and empathy seem to be less affected overall, the physician-patient communication and patients' understanding of what the surgeon said seem to be negatively affected.

COVID-19/prevention & control , Equipment Design , Masks , Orthopedic Surgeons , Pandemics/prevention & control , Physician-Patient Relations , Adult , Aged , Cohort Studies , Female , Hospitals, University , Humans , Male , Middle Aged , Prospective Studies , SARS-CoV-2 , Surveys and Questionnaires
Crit Care ; 26(1): 16, 2022 01 07.
Article En | MEDLINE | ID: mdl-34996496

BACKGROUND: In patients with COVID-19-related acute respiratory failure (ARF), awake prone positioning (AW-PP) reduces the need for intubation in patients treated with high-flow nasal oxygen (HFNO). However, the effects of different exposure times on clinical outcomes remain unclear. We evaluated the effect of AW-PP on the risk of endotracheal intubation and in-hospital mortality in patients with COVID-19-related ARF treated with HFNO and analyzed the effects of different exposure times to AW-PP. METHODS: This multicenter prospective cohort study in six ICUs of 6 centers in Argentine consecutively included patients > 18 years of age with confirmed COVID-19-related ARF requiring HFNO from June 2020 to January 2021. In the primary analysis, the main exposure was awake prone positioning for at least 6 h/day, compared to non-prone positioning (NON-PP). In the sensitivity analysis, exposure was based on the number of hours receiving AW-PP. Inverse probability weighting-propensity score (IPW-PS) was used to adjust the conditional probability of treatment assignment. The primary outcome was endotracheal intubation (ETI); and the secondary outcome was hospital mortality. RESULTS: During the study period, 580 patients were screened and 335 were included; 187 (56%) tolerated AW-PP for [median (p25-75)] 12 (9-16) h/day and 148 (44%) served as controls. The IPW-propensity analysis showed standardized differences < 0.1 in all the variables assessed. After adjusting for other confounders, the OR (95% CI) for ETI in the AW-PP group was 0.36 (0.2-0.7), with a progressive reduction in OR as the exposure to AW-PP increased. The adjusted OR (95% CI) for hospital mortality in the AW-PP group ≥ 6 h/day was 0.47 (0.19-1.31). The exposure to prone positioning ≥ 8 h/d resulted in a further reduction in OR [0.37 (0.17-0.8)]. CONCLUSION: In the study population, AW-PP for ≥ 6 h/day reduced the risk of endotracheal intubation, and exposure ≥ 8 h/d reduced the risk of hospital mortality.

COVID-19 , Oxygen Inhalation Therapy , Respiratory Insufficiency , Administration, Intranasal , COVID-19/complications , Humans , Oxygen/administration & dosage , Oxygen Inhalation Therapy/methods , Prone Position , Prospective Studies , Respiratory Insufficiency/therapy , Respiratory Insufficiency/virology , Time Factors , Treatment Outcome , Wakefulness
Crit Care ; 26(1): 10, 2022 01 04.
Article En | MEDLINE | ID: mdl-34983614

BACKGROUND: Research on the duration of infectivity of ICU patients with COVID-19 has been sparse. Tests based on Reverse Transcriptase polymerase chain reaction (RT-PCR) detect both live virus and non-infectious viral RNA. We aimed to determine the duration of infectiousness based on viral culture of nasopharyngeal samples of patients with COVID-19. METHODS: Prospective observational study in adult intensive care units with a diagnosis of COVID-19 Pneumonia. Patients had repeated nasopharyngeal sampling performed after day 10 of ICU admission. Culture positive rate (based on viral culture on Vero cells in a level 4 lab) and Cycle threshold from RT-PCR were measured. RESULTS: Nine patients of the 108 samples (8.3%, 95% CI 3.9-15.2%) grew live virus at a median of 13 days (interquartile range 11-19) after their initial positive test. 74.1% of patients were RT-PCR positive but culture negative, and the remaining (17.6%) were RT-PCR and culture negative. Cycle threshold showed excellent ability to predict the presence of live virus, with a Ct < 25 with an AUC of 0.90 (95% CI 0.83-0.97, p < 0.001). The specificity of a Ct > 25 to predict negative viral culture was 100% (95% CI 70-100%). CONCLUSION: 8.3% of our ICU patients with COVID-19 grew live virus at a median of 13 days post-initial positive RT-PCR test. Severity of illness, use of mechanical ventilation, and time between tests did not predict the presence of live virus. Cycle threshold of > 25 had the best ability to determine the lack of live virus in these patents.

COVID-19 , SARS-CoV-2 , Adult , COVID-19/therapy , COVID-19/virology , COVID-19 Nucleic Acid Testing , Critical Illness , Humans , Intensive Care Units , Nasopharynx/virology , Prospective Studies , SARS-CoV-2/isolation & purification
Environ Int ; 158: 107018, 2022 01.
Article En | MEDLINE | ID: mdl-34991270

In 2011, phthalates, mainly di-(2-ethylhexyl) phthalate (DEHP), were found to have been added to a variety of foods in Taiwan, increasing the risk of microalbuminuria in children. Exposure to melamine perhaps modifies that risk. This prospective cohort study investigates whether renal injury resulting from exposure to DEHP-tainted foods from the 2011 Taiwan Food Scandal is reversed over time. The temporal and interactive effects of past daily DEHP intake, current daily DEHP intake, and urinary melamine levels on oxidative stress and renal injury were also examined. Two hundred possibly DEHP-affected children (aged < 18 years) were enrolled in the first survey wave (August 2012-January 2013), with 170 and 159 children in the second (July 2014-February 2015) and third waves (May 2016-October 2016), respectively. The first wave comprised questionnaires that were used to collect information about possible past daily DEHP intake from DEHP-tainted foods. One-spot first morning urine samples were collected to measure melamine levels, phthalate metabolites, and markers indicating oxidative stress (malondialdehyde and 8-oxo-2'-deoxyguanosine), and renal injury (albumin/creatinine ratio (ACR) and N-acetyl-beta-D-glucosaminidase) in all three waves. Generalized estimating equation (GEE) modeling revealed that both past daily DEHP intake and time might affect urinary ACR. However, most interactions were negative and significant correlation was observed only during the second wave (P for interaction = 0.014) in the group with the highest past daily DEHP intake (>50 µg/kg/day). Urinary melamine levels were found to correlate significantly with both urinary ACR and oxidative stress markers. The highest impact associated with exposure to DEHP-tainted foods in increasing urinary ACR of children was observed during the first wave, and the effect may partially diminish over time. These results suggest that continuous monitoring of renal health and other long-term health consequences is required in individuals who were affected by the scandal in 2011.

Diethylhexyl Phthalate , Phthalic Acids , Child , Diethylhexyl Phthalate/toxicity , Environmental Exposure/adverse effects , Food Contamination , Humans , Kidney/chemistry , Oxidative Stress , Prospective Studies , Taiwan , Triazines
BMC Gastroenterol ; 22(1): 8, 2022 Jan 06.
Article En | MEDLINE | ID: mdl-34991464

BACKGROUND: Undesirable outcomes may appear for elderly patients undergoing esophagogastroduodenoscopy (EGD) under sedation, such as hypoxia and hypotension. The aim of our study was to investigate the ability of the innovative endoscopic oropharyngeal airway to reduce the frequency of hypoxia during EGD under sedation in elderly patients. METHODS: In this trial, aged patients undergoing EGD were randomized into airway group and mouthpiece group. The primary outcome was the incidence of the minimum pulse oxygen saturation < 90% and minimum pulse oxygen saturation. In addition, sedation dose, recovery time, emergency management and adverse reactions were recorded. RESULTS: 360 patients completed the study (180 in each groups). The minimum pulse oxygen saturation during EGD was significantly higher in airway group (97.66 ± 2.96%) than in mouthpiece group (95.52 ± 3.84%, P < 0.001). The incidence of pulse oxygen saturation of 85-89% of airway group (5.0%, 9/180) was lower than mouthpiece group (10.6%, 19/180, P = 0.049). The endoscopy entry time in airway group was 3 (2, 4) seconds and in mouthpiece group was 5 (4, 6) (P < 0.001). Propofol total dose and awakening time were significantly lower in the airway group than in the mouthpiece group (P = 0.020 and P = 0.012, respectively). Furthermore, the incidence rate of hypotension was significantly higher in mouthpiece group (12.2%) than in airway group (5.0%) (P = 0.015). By comparison with the mouthpiece group, the satisfaction of endoscopists was higher in airway group (P = 0.012). CONCLUSION: Elderly patients undergoing EGD, Endoscopy Protector was associated with a significantly lower incidence of hypoxia, shortened endoscopy entry time and more stable hemodynamics. TRIAL REGISTRATION: ChiCTR, ChiCTR2000031998, 17/04/2020.

Outpatients , Propofol , Aged , Conscious Sedation/adverse effects , Endoscopy, Digestive System , Endoscopy, Gastrointestinal , Humans , Hypnotics and Sedatives/adverse effects , Propofol/adverse effects , Prospective Studies
BMC Gastroenterol ; 22(1): 10, 2022 Jan 06.
Article En | MEDLINE | ID: mdl-34991489

BACKGROUND: Endoscopic submucosal dissection (ESD) is technically difficult and requires considerable training. The authors have developed a multi-loop traction device (MLTD), a new traction device that offers easy attachment and detachment. We aimed to evaluate the utility of MLTD in ESD. METHODS: This ex vivo pilot study was a prospective, block-randomized, comparative study of a porcine stomach model. Twenty-four lesions were assigned to a group that undertook ESD using the MLTD (M-ESD group) and a group that undertook conventional ESD (C-ESD group) to compare the speed of submucosal dissection. In addition, the data of consecutive 10 patients with eleven gastric lesions was collected using electronic medical records to clarify the inaugural clinical outcomes of gastric ESD using MLTD. RESULTS: The median (interquartile range) speed of submucosal dissection in the M-ESD and C-ESD groups were 141.5 (60.9-177.6) mm2/min and 35.5 (20.8-52.3) mm2/min, respectively; submucosal dissection was significantly faster in the M-ESD group (p < 0.05). The rate of en bloc resection and R0 resection was 100% in both groups, and there were no perforation in either group. The MLTD attachment time was 2.5 ± 0.9 min and the MLTD extraction time was 1.0 ± 1.1 min. Clinical outcomes of MLTD in gastric ESD were almost the same as those of ex vivo pilot study. CONCLUSIONS: MLTD increased the speed of submucosal dissection in ESD and was similarly effective when used by expert and trainee endoscopists without perforation. MLTD can potentially ensure a safer and faster ESD.

Endoscopic Mucosal Resection , Animals , Endoscopic Mucosal Resection/adverse effects , Humans , Pilot Projects , Prospective Studies , Stomach , Swine , Traction , Treatment Outcome
BMC Infect Dis ; 22(1): 39, 2022 Jan 06.
Article En | MEDLINE | ID: mdl-34991507

BACKGROUND: Inappropriate antibiotics use in lower respiratory tract infections (LRTI) is a major contributor to resistance. We aimed to design an algorithm based on clinical signs and host biomarkers to identify bacterial community-acquired pneumonia (CAP) among patients with LRTI. METHODS: Participants with LRTI were selected in a prospective cohort of febrile (≥ 38 °C) adults presenting to outpatient clinics in Dar es Salaam. Participants underwent chest X-ray, multiplex PCR for respiratory pathogens, and measurements of 13 biomarkers. We evaluated the predictive accuracy of clinical signs and biomarkers using logistic regression and classification and regression tree analysis. RESULTS: Of 110 patients with LRTI, 17 had bacterial CAP. Procalcitonin (PCT), interleukin-6 (IL-6) and soluble triggering receptor expressed by myeloid cells-1 (sTREM-1) showed an excellent predictive accuracy to identify bacterial CAP (AUROC 0.88, 95%CI 0.78-0.98; 0.84, 0.72-0.99; 0.83, 0.74-0.92, respectively). Combining respiratory rate with PCT or IL-6 significantly improved the model compared to respiratory rate alone (p = 0.006, p = 0.033, respectively). An algorithm with respiratory rate (≥ 32/min) and PCT (≥ 0.25 µg/L) had 94% sensitivity and 82% specificity. CONCLUSIONS: PCT, IL-6 and sTREM-1 had an excellent predictive accuracy in differentiating bacterial CAP from other LRTIs. An algorithm combining respiratory rate and PCT displayed even better performance in this sub-Sahara African setting.

Pneumonia, Bacterial , Respiratory Tract Infections , Algorithms , Biomarkers , C-Reactive Protein/analysis , Humans , Outpatients , Pneumonia, Bacterial/diagnosis , Prospective Studies , Respiratory Tract Infections/diagnosis , Tanzania
BMC Infect Dis ; 22(1): 38, 2022 Jan 06.
Article En | MEDLINE | ID: mdl-34991508

BACKGROUND: Influenza A virus (IAV) remains an important global public health threat with limited epidemiological information available from low-and-middle-income countries. The major objective of this study was to describe the proportions, temporal and spatial distribution, and demographic and clinical characteristics of IAV positive patients with influenza like illness (ILI) and severe acute respiratory illness (SARI) in Lahore, Pakistan. METHODS: Prospective surveillance was established in a sentinel hospital from October 2015 to May 2016. All eligible outpatients and inpatients with ILI or SARI were enrolled in the study. Nasal and/or throat swabs were collected along with clinico-epidemiological data. Samples were tested by real-time RT-PCR (rRT-PCR) to identify IAV and subtype. The descriptive analysis of data was done in R software. RESULTS: Out of 311 enrolled patients, 284 (91.3%) were ILI and 27 (8.7%) were SARI cases. A distinct peak of ILI and SARI activity was observed in February. Fifty individuals (16%) were positive for IAV with peak positivity observed in December. Of 50 IAV, 15 were seasonal H3N2, 14 were H1N1pdm09 and 21 were unable to be typed. The majority of IAV positive cases (98%) presented with current or history of fever, 88% reported cough and 82% reported sore throat. The most common comorbidities in IAV positive cases were hepatitis C (4%), obesity (4%) and tuberculosis (6%). The highest incidence of patients reporting to the hospital was seen three days post symptoms onset (66/311) with 14 of these (14/66) positive for IAV. CONCLUSION: Distinct trends of ILI, SARI and IAV positive cases were observed which can be used to inform public health interventions (vaccinations, hand and respiratory hygiene) at appropriate times among high-risk groups. We suggest sampling from both ILI and SARI patients in routine surveillance as recommended by WHO.

Influenza A virus , Influenza, Human , Humans , Infant , Influenza A Virus, H3N2 Subtype , Influenza, Human/epidemiology , Pakistan/epidemiology , Prospective Studies , Seasons , Sentinel Surveillance
Reprod Health ; 19(1): 4, 2022 Jan 06.
Article En | MEDLINE | ID: mdl-34991651

BACKGROUND: The hormonal Intrauterine Device (IUD) is a highly effective contraceptive option growing in popularity and availability in many countries. The hormonal IUD has been shown to have high rates of satisfaction and continuation among users in high-income countries. The study aims to understand the profiles of clients who choose the hormonal IUD in low- and middle-income countries (LMICs) and describe their continuation and satisfaction with the method after 12 months of use. METHODS: A prospective longitudinal study of hormonal IUD acceptors was conducted across three countries-Madagascar, Nigeria, and Zambia-where the hormonal IUD had been introduced in a pilot setting within the of a broad mix of available methods. Women were interviewed at baseline immediately following their voluntary hormonal IUD insertion, and again 3 and 12 months following provision of the method. A descriptive analysis of user characteristics and satisfaction with the method was conducted on an analytic sample of women who completed baseline, 3-month, and 12-month follow-up questionnaires. Kaplan-Meier time-to-event models were used to estimate the cumulative probability of method continuation rates up to 12 months post-insertion. RESULTS: Each country had a unique demographic profile of hormonal IUD users with different method-use histories. Across all three countries, women reported high rates of satisfaction with the hormonal IUD (67-100%) and high rates of continuation at the 12-month mark (82-90%). CONCLUSIONS: Rates of satisfaction and continuation among hormonal IUD users in the study suggest that expanding method choice with the hormonal IUD would provide a highly effective, long-acting method desirable to many different population segments, including those with high unmet need.

Contraceptive Agents, Female , Intrauterine Devices, Copper , Intrauterine Devices , Female , Humans , Levonorgestrel , Longitudinal Studies , Madagascar , Nigeria , Pilot Projects , Prospective Studies , Zambia
Trials ; 23(1): 16, 2022 Jan 06.
Article En | MEDLINE | ID: mdl-34991689

BACKGROUND: Currently, the population with myopia climbs steadily, and is developing toward younger age, posing a great concern to the health of adolescents. Myopia in severe cases can cause irreversible consequences such as glaucoma, blindness, and other complications. At present, the solutions for myopia are glasses, medication, and surgery. This study aims to investigate the role of a physiotherapy category based on guided meditation for vision acuity training on adolescent myopia. METHODS: This is a prospective, randomized, multicenter clinical trial. One thousand one hundred forty primary and secondary school students aged 8-18 years old from 27 schools will be recruited and randomly divided into an experimental and a control group at a ratio of 2:1 in two phases, with a training period of 30 days in each phase and a follow-up period of 3 months. No interventions will be conducted during the follow-up period, nor will other interventions employed. Inclusion criteria will meet the diagnostic criteria for simple myopia and -6.00D ≤ spherical lenses ≤ -0.50D and cylindrical lenses ≤1.50D. The primary observation index will be to compare the statistical differences in distant visual acuity between the two groups; the secondary observation indexes will be ocular symptoms (mainly including eye fatigue, dryness, pain, double vision, neck pain, thought disorders, and lags in response), diopter, and astigmatism. DISCUSSION: The purpose of this two-phase trial is to compare the clinical effectiveness of focused vision-guided meditation with Chinese eye exercises that are also non-pharmacological, non-invasive interventions for myopia, and to maximize the benefit to the subjects. The results will indicate whether the training based on focused vision-guided meditation has the ability to improve distant visual acuity, relieve ocular symptoms, and ameliorate diopter. In addition, this trial will provide clinical efficacy of the training, which is expected to provide meaningful data for vision rehabilitation. At the same time, the vision acuity training method, which is permeated with the concept of Traditional Chinese Medicine (TCM) rehabilitation and health maintenance, will be applied to achieve the goal of preventing or alleviating myopic development and reducing myopia rate. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2000038642 . Registered on 26 September 2020.

Meditation , Myopia , Adolescent , Blindness , Child , Humans , Multicenter Studies as Topic , Myopia/diagnosis , Myopia/therapy , Prospective Studies , Randomized Controlled Trials as Topic , Visual Acuity
Trials ; 23(1): 20, 2022 Jan 06.
Article En | MEDLINE | ID: mdl-34991706

BACKGROUND: Structural impairment of the lumbar multifidus muscle, such as reduced cross-sectional area, is evident among individuals with chronic low back pain. Real-time ultrasound imaging (RUSI) biofeedback has been reported to improve preferential activation of as well as retention in the ability to activate the lumbar multifidus muscle during lumbar stabilization exercises (LSE). However, evidence of the effectiveness of this treatment approach in individuals with non-specific chronic low back pain (NCLBP) is still limited. The purpose of this study is, therefore, to determine the effectiveness of LSE with RUSI biofeedback on lumbar multifidus muscle cross-sectional area in individuals with NCLBP. METHODS/DESIGN: This study is a prospective, single-center, assessor-blind, three-arm, parallel randomized controlled trial to be conducted at National Orthopedic Hospital, Kano State, Nigeria. Ninety individuals with NCLBP will be randomized in a 1:1:1: ratio to receive LSE, LSE with RUSI biofeedback, or minimal intervention. All participants will receive treatment twice weekly for 8 weeks. The primary outcome will be the lumbar multifidus muscle cross-sectional area. The secondary outcomes will include pain (Numerical Pain Rating Scale), functional disability (Roland-Morris Disability Questionnaire), and quality of life (12-Item Short-Form Health Survey). All outcomes will be assessed at baseline, 8 weeks post-intervention,  and 3 months follow-up. DISCUSSION: To our knowledge, this study will be the first powered randomized controlled trial to compare the effectiveness of LSE training with and without RUSI biofeedback in individuals with NCLBP. The outcome of the study may provide evidence for the effectiveness of LSE with RUSI biofeedback on enhancing the recovery of the lumbar multifidus muscle in individuals with NCLBP. TRIAL REGISTRATION: Pan African Clinical Trials Registry ( PACTR201801002980602) . Registered on January 16, 2018.

Low Back Pain , Biofeedback, Psychology , Humans , Low Back Pain/diagnostic imaging , Low Back Pain/therapy , Nigeria , Paraspinal Muscles/diagnostic imaging , Prospective Studies , Quality of Life , Randomized Controlled Trials as Topic , Ultrasonography