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The Declaration of Helsinki and public health
... Several adaptations and revisions have been made to the DoH over the years but the emphasis on informed consent and the well-being of participants, rather than conducting experimentation on humans in the sole interest of science, has stayed consistent. This emphasis on the public health of a community, as opposed to an individual and their welfare, is a different condition compared to previous documents (Williams, 2008). This shift not only affected how research was approached and how individuals were enrolled, but also affected how research findings could be published. ...
... This shift not only affected how research was approached and how individuals were enrolled, but also affected how research findings could be published. Part of the new revisions made to the DoH outlined policies for publication of research that require a review of the research to be conducted by a committee to ensure the rights of the research participants were upheld and put before the needs of society (Williams, 2008). Amendments made to the DoH prior to 2000 kept this emphasis of the individual over the health of the public (Williams, 2008). ...
... Part of the new revisions made to the DoH outlined policies for publication of research that require a review of the research to be conducted by a committee to ensure the rights of the research participants were upheld and put before the needs of society (Williams, 2008). Amendments made to the DoH prior to 2000 kept this emphasis of the individual over the health of the public (Williams, 2008). In 2000, the updated version of the DoH outlined an emphasis on the benefits of future patients instead of only current participants. ...
... All procedures were carried out in accordance with the Declaration of Helsinki of the World Medical Association (Williams, 2008 ...
... University Health Board (15/AIC/6352) approved the study. All procedures were carried out in accordance with the Declaration of Helsinki of the World Medical Association (Williams, 2008). Written informed consent was obtained from participants in study arm 1. Study arm 2 constituted a retrospective analysis of an anonymized database and thus patient consent was waived. ...
... The Medical Association (Williams, 2008). The study was not registered in a database. ...
Introduction: The aging population is a major concern for healthcare providers and the number of surgical procedures performed is increasing each year. The ‘high-risk’ patient accounts for 13% of surgical cases but contributes to over 80% of postoperative deaths. Evidence suggests that cardiorespiratory fitness (CRF) may be an independent predictor of postoperative outcome. However, this relationship requires further understanding and optimisation to better inform patient care.
Aims: The overarching objective was to explore the ‘potential’ relationship between CRF and post operative outcome (morbidity and survival) in patients undergoing major intra-abdominal surgery. Three aims were established to: 1) Improve the detection and interpretation of CRF, 2) Explore novel thresholds of CRF predictive of postoperative outcome, and 3) Enhance patient management using exercise.
Hypotheses: It was hypothesised that: 1) Natural variation (biological and analytical noise) is present in markers of CRF and thus impacts upon patient fitness stratification, 2) CRF is impaired in diseased patients and can predict postoperative outcomes, 3) Preoperative CRF is lower in females which may translate into inferior postoperative outcomes over males, 4) Preoperative exercise training is well tolerated and associated with objective cardiopulmonary improvement.
Methodology: Study 1 –In a two-armed experiment, natural variation was calculated for CRF in a young, healthy population. Subsequent values of natural variation were retrospectively applied to an anonymised database of patients who underwent preoperative cardiopulmonary exercise testing (PCPET) before colorectal surgery, to re-appraise fitness stratification. Study 2 –A retrospective cross-sectional analysis of patients (n=124) with abdominal aortic aneurysm (AAA) was conducted to compare CRF with that of a matched apparently healthy 3cohort, and to examine the association between impaired CRF and postoperative outcome. Study 3 –In a large cohort of patients (n=640) who underwent PCPET prior to colorectal surgery, firstly, the association between impaired CRF and postoperative outcome was investigated and compared with traditional cardiovascular disease (CVD) risk factors. A subsequent comparative analysis was conducted to investigate sex-differences in preoperative CRF and postoperative outcomes to re-appraise risk stratification. Study 4 –A case-report was conducted describing a 70-year-oldhigh-risk female patient with a complicated medical history, who required major thoraco-abdominal surgery. A preoperative supervised 10-week high intensity interval training (HIIT) exercise intervention was conducted, and its ability to improve perioperative risk stratification evaluated.
Results: Study 1–Natural variation was present in measures of CRF and accounted for up to ± 19%, 13%, and 10% for oxygen consumption at anaerobic threshold (V̇O2-AT),peak oxygen consumption(V̇O2 peak), and ventilatory equivalent of carbon dioxide at anaerobic threshold (V̇E/V̇CO2-AT) respectively. A theoretical potential for up to 60% of patients to have indeterminate fitness existed if natural variation was not considered. Study 2 –Patients with AAA undergoing PCPET highlighted impaired CRF compared to age adjusted/sex-matched sedentary controls. Values of<13.1 mL O2.min-1.kg-1for V̇O2 peak and ≥34 for V̇E/V̇CO2-AT were independent predictors of postoperative mortality at 2-years. Study 3 –Being ‘unfit’ defined by preoperative CRF (V̇O2 peak <14.3mL kg-1 min-1and > 34 for V̇E/V̇CO2-AT) identified a five-fold greater 1-year mortality rate and was a stronger predictor than traditional CVD risk factors in a large cohort of patients undergoing colorectal surgery. Female patients exhibited lower preoperative CRF, and more were stratified ‘high risk’, however postoperative outcomes were equivalent to males. Consequently, females demonstrated lower threshold values of CRF than male counterparts and the application of sex-specific thresholds improved the prediction of postoperative mortality. Study 4 –10 weeks of HIIT proved well tolerated and conferred impressive gain in CRF (27 and 36% for V̇O2-AT and V̇O2 peak respectively) which exceeded sources of variation and positively changed perioperative risk stratification in a high-risk patient prior to major thoraco-abdominal surgery.
Discussion: The overarching premise that CRF is related to postoperative outcome in patients undergoing intra-abdominal surgery is strongly supported. CRF was impaired relative to similarly aged apparently healthy people prior to major surgery and being unfit was a stronger predictor of mortality than traditional CVD risk factors. Furthermore, a 3 to 5-fold greater risk of postoperative mortality occurred in patients undergoing vascular and colorectal surgery if stratified unfit. This work has demonstrated: 1) Improved detection and interpretation of CRF, however unlike previous work the use of V̇O2-AT is not supported, the consequence of experimental ‘noise’ (mostly biological variation) that requires consideration when interpreting PCPET results. 2). Novel threshold values of CRF in specific patient cohorts undergoing surgery improved mortality prediction, and importantly, patients should be stratified by sex as females are more sensitive to CRF, with lower values yet equivalent postoperative outcomes. 3) Preoperative CRF was objectively improved using a short duration HIIT intervention that was well tolerated in the high-risk patient and enabled fitness to transcend stratification boundaries.
Conclusion: Preoperative CRF better predicted postoperative outcome than traditional CVD risk factors, and PCPET should be considered a principal component of surgical risk assessment. This work advances the potential to use CRF to predict postoperative outcome to help clinicians better direct care provision and advance patient outcomes following major surgery.
... Referral by the partner institutions and compliance with organisational procedures served as first consent to participate voluntarily in the study. Information at the screening stage also confirmed that the participation was strictly confidential and in accordance with the applicable data protection law and regulations [66]. Nevertheless, before starting the programme, study participants and/or their care procurators confirmed through a mandatory informed agreement their willingness to participate in the study and acknowledged (i) the ethical terms, and (ii) the inclusion criteria. ...
... The Thereafter, users and/or their care procurators were approached, with the aim of explaining the research components and identifying potentially interested parties. The voluntary nature of participation was also explained, with the possibility of withdrawal at any time without need for justification, as well as data confidentiality, as provided for in the Declaration of Helsinki [66]. ...
Background
As populations age, the prevalence of cognitive impairment is increasing, challenging healthcare systems worldwide. Neurocognitive disorders (NCD) impair cognition and ultimately function. Research shows that cognitive stimulation (CS) is effective as an non-pharmacological intervention to improve cognition and wellbeing in people with NCD. Few programmes, designed to address different mental health problems across a spectrum of cognitive impairment, are available.
Objective
This exploratory study aims (i) to develop a new CS programme for older adults with subjective cognitive complaints (SCC), minor or major NCD, with and without previous mental disorders, and (ii) to assess its effects on cognition, well-being and neuropsychiatric symptoms.
Methods
Different stakeholders in the field of mental health and ageing, using a person-centered consensus approach developed a new programme following a literature review. MentHA COG includes 14 structured thematic CS activities, delivered in facilitated 90-minute sessions, offered twice-weekly for 7 weeks in groups of 5-8. A quasi-experimental study examining the effects of MentHA COG, after 2 and 6 months was conducted. Cognitive performance, subjective well-being, depression, and anxiety were measured using the “Addenbrooke's Cognitive Examination - Revised” and four complementary subtests (Gnosis, Proverbs interpretation and Token orders and nominations) adapted for the "Lisbon Battery for the Assessment of Dementia”, the “Reduced Version of the Positive and Negative Affect Schedule”, and the “Hospital Anxiety and Depression Scale”, respectively.
Results
In total, 47 participants aged 59-94 years were included in three groups: those with Major NCD (ACE-R≤68; n=25), Minor NCD (ACE-R 69-79; n=16) and a group with SCC (ACE-R> 80; n=6). ACE-R scores increased in each group at 6-months with large effect sizes found (Cohen's d≥0.80); the largest relative increase in mean scores was for those with a major NCD (52.71 to 59.00 points). Listening comprehension and immediate auditory memory were the cognitive domains most likely to show statistically significant improvements in those with Major NCD, after 2 (p<0.001) and 6 months (p=0.01). There were also improvements in mean scores with large effect sizes in subjective well-being and neuropsychiatric symptoms for all groups. Pre-existing psychiatric conditions did not influence outcomes.
Conclusions
MentHA COG improved cognition at 6-months for older adults across the cognitive spectrum, improving subjective well-being and anxiety and depression symptoms. This is the first study of this new programme that promotes the inclusion of people with a psychiatric diagnosis, whose pre- existing conditions did not influence their response. Although further research is required, this study suggests that CS programmes such as MentHA COG can offer a low-cost, efficacious, non- pharmacological intervention for patients with cognitive disorders.
... Before a clinical trial is initiated it is imperative to follow international ethical and scientific quality standard for designing, conducting, recording and reporting of clinical trials that involve participation of human subjects. Compliance with this standard provides assurance that the rights, safety and well being of trial subjects are protected, consistent with the principles laid down by Declaration of Helsinki and the data are credible 3,4 . In India, the regulatory framework is governed by these following guidelines i.e. ...
... Its purpose was to provide guidance to physicians engaged in clinical research and its main focus was the responsibilities of researchers for the protection of research subjects. The advancement of medical science and the promotion of public health, although recognized as important objectives of medical research, were clearly subor¬dinate to the well-being of individual research subjects 3,4 . ...
In today's global scientific era, clinical trials are the mainstay for bringing newer and better drugs to market and it has become an indispensable part of the drug discovery process to ensure safety and efficacy of any new drug. According to the Associated Chambers of Commerce and Industry, India is set to grab clinical trials business valued at approximately US$ 1 billion by 2010, up from US$ 200 million last year, making the subcontinent one of the world’s preferred destinations for clinical trials. Drug companies are drawn to India for several reasons, including a techni¬cally competent workforce, patient availability, low costs and a friendly drug-control system which is good news for Indian economy. On the contrary, the booming clinical trial industry is raising concerns because of lack of regulations regarding trials by private drug companies, uneven application of protocol for informed consent and proper ethical review 1.This article tries to give a general overview regarding different steps and criteria of conduction of clinical trials.
... The study took place at the Exercise and Health Laboratory in Faculdade Motricidade Humana, Universidade Lisboa. The study was approved by the Ethics Committee of the Faculty of Human Kinetics, University of Lisbon (Lisbon, Portugal) (CEFMH Approval Number: 7/2020) and was conducted in accordance with the declaration of Helsinki for human studies from the World Medical Association [36]. The study was registered at clinicaltrials.gov ...
... Greater lower leg edema is likely when participants remain seated. Institutional Review Board Statement: The study was approved by the Ethics Committee of the Faculty of Human Kinetics, University of Lisbon (Lisbon, Portugal) (CEFMH Approval Number: 7/2020) and was conducted in accordance with the declaration of Helsinki for human studies from the World Medical Association [36]. The study was registered at clinicaltrials.gov ...
Background:
Sitting or standing during prolonged periods is related to leg swelling. It is unknown if interrupting sedentary behavior can attenuate lower leg swelling. We aimed to examine if adding sit-to-stand transitions prevents lower leg swelling as compared with uninterrupted motionless standing and sitting, using localized bioelectrical impedance raw parameters.
Methods:
Twenty adults participated in this crossover randomized controlled trial and acted out three conditions: (1) uninterrupted, motionless standing; (2) uninterrupted motionless sitting; (3) sit-to-stand transitions (1 min sitting followed by 1 min standing). Localized resistance (R), reactance (Xc), impedance (Z) and phase angle (PhA) were assessed at baseline, at 10 min and at 20 min for each condition.
Results:
For sitting and standing conditions, R and Xc values decreased after 10 and 20 min. Uninterrupted sitting resulted in the highest decrease in R (ΔSit - ΔStand = -9.5 Ω (4.0), p = 0.019; ΔSit - ΔInt = -11.6 Ω (4.0), p = 0.005). For standardized R (R/knee height), sitting was the condition with a greater decrease (ΔSit - ΔStand = -30.5 Ω/m (13.4), p = 0.025; ΔSit - ΔInt = -35.0 Ω/m (13.5), p = 0.011).
Conclusions:
Interrupting sedentary behavior by changing from sit to stand position during short periods may be effective at preventing leg swelling.
... The virtual presentation of the environments with post-processing resolved the problems associated with the variables of the physical experiments and strengthened safety measures. However, these experimental protocols do not involve visually impaired persons, which still raise ethical questions [11]. ...
The inclusion of visually impaired participants in research protocols concerning their perception of space and navigation is essential for the reliability of the results, given the strategies developed by the people concerned in everyday life. However, the diversity of visual impairments, the scarcity of participants and possible safety issues due to obstacles in the physical space induce limitations and prompt researchers to look into alternative methodologies. Simulated low vision is seen as an option. This method involves sighted participants wearing goggles with customized filters or watching processed images in virtual environments. The objective of this study is to investigate the reliability of simulated low vision as a research method to describe the space perception and navigation of people with visual impairment. We conducted a literature review and identified 36 quantitative studies on low vision spatial performance involving multiple user groups. Simulated low vision proved effective in small-scale spatial ability evaluation, such as object detection and distance estimation, but remained challenging regarding large-scale capacity, such as navigation with mobility requirement. Advances in virtual environments suggest that they are a good alternative to goggles and screen displays because of their precision in mimicking ocular problems in simulation settings. Finally, the use of head-mounted-display (HMD) by people with real low vision could open up the possibility of greater testing in safer and controlled conditions, but requires confirmation of the validity of the protocols.
... All patients were counselled about the procedure, and informed consent was obtained. Approval of the Ain Shams University ethical committee was obtained as it conforms to the ethical guidelines of the 1975 Declaration of Helsinki as revised in 2008 [15]. ...
Background
Transcatheter Aortic Valve Implantation (TAVI) has a growing target population after being indicated even in low-surgical-risk patients with severe symptomatic aortic stenosis. However, postoperative outcomes can be compromised due to para-valvular leakage (PVL). A lot of procedural steps have been investigated to decrease this partially avoidable operational hazard. Oversizing is a main technique to decrease the PVL, despite being itself a risky step. Many studies have been conducted to identify the optimum degree of oversizing. However, studies about oversizing by more than 20% are scarce. We aimed to evaluate the safety and efficacy of oversizing equal to or more than 20%.
Results
209 patients who underwent TAVI using the self-expandable valve Evolut R were initially included. 66 patients were excluded because of the baseline conduction disturbance and lack of sufficient data, so 143 patients, 60 females and 83 males, were enrolled in our study as two groups based on the degree of oversizing: Group A included 97 patients with an oversizing index (OI) of less than 20%, and Group B included 46 patients with an OI of 20% or more. We conducted a new technique for more accurate measuring of the OI in the context of the implantation depth, and our patients were categorized using this technique. Our findings have met our primary end point in terms of the safety and efficacy of oversizing by 20% or more. There was no significant difference between both groups in terms of new-onset conduction disturbance (NOCD), with zero cases of annular rupture or coronary encroachment. In terms of efficacy, The incidence of significant PVL (grade 2 or more) in group B was less than in group A ( P value 0.007). The ROC curve found that the minimum depth of implantation-derived oversizing (DIDO) to predict no significant PVL was less than 17%.
Conclusion
Prosthesis oversizing by 20% using the self-expandable Evolut R valve is safe and effective, with no significant effect on the conduction system, coronary encroachment, or annular injury, and warrants a greater reduction in the incidence of significant PVL.
... Every subject who underwent surgery in the entire trunk region and in menopause was excluded. This study was designed according to Ethics Commission approved by Doc103-CE-202 and CAAE:40495120.9.0000.9433, in agreement with the Declaration of Helsinki [19]. ...
Brown adipose tissue (BAT) helps control body weight and is inversely correlated with body fat, but it is unclear whether it is subcutaneous adipose tissue (SAT) or visceral adipose tissue (VAT) that is related to BAT activation. The presented study aimed to verify the relation of SAT and VAT on BAT activation through infrared thermography (IRT) and cold stimulation in adult women. Forty women were evaluated in body composition and skin temperature (Tskin) acquisition by IRT. Student’s independent t-test, Pearson’s correlation, and two-way repeated measures ANOVA with Tukey post-hoc were applied. Women with low amounts of SAT and VAT had a significant increase in supraclavicular Tskin (SCVT). Medium negative degrees of linear variation were found before and after cold stimulation between SCVT, SAT and VAT. A significant effect of the moment factor and the group factor on the SCVT between subjects divided into the groups were pointed out. No difference was found in the relation between SAT, VAT, and BAT in adult women, pointing out that both types of fat are equally related. These results can help clinical practice understand clearly, through IRT, that the high accumulation of SAT and VAT can impair the activation of BAT and hinder the loss of weight in women.
... Before the commencement of the study, all patients provided written consent to participate in the survey and to have the results made public. Tis research was approved by the Shahid Beheshti University of Medical Sciences Ethics Committee and adhered to the ethical principles of the Declaration of Helsinki [16]. ...
Background
Acetabular fracture surgeries are frequently accompanied by protracted and severe perioperative pain, and there is no consensus on optimal pain relief management.
Aim
This study aimed at comparing the analgesic efficacy of fascia iliaca compartment block (FICB) and quadratus lumborum block (QLB) in patients with acetabular fractures undergoing surgery using the Stoppa method.
Methods
In this double-blind, randomized, noninferiority clinical trial, adult patients undergoing spinal anesthesia for acetabular fracture surgery, in Imam Hossein Hospital, Tehran, Iran (IRCT20191114045435N1), were randomly divided into two groups: FICB (n = 22) and QLB (n = 24). The visual analog scale (VAS) was used to assess the pain intensity at different times for all participants. In addition, the dose of fentanyl required to induce the patient to sit for spinal anesthesia and the pain intensity were evaluated. Moreover, the duration of analgesia and the total amount of morphine consumed in the first 24 h following surgery were evaluated, analyzed, and compared between the two study groups.
Results
FICB and QLB demonstrated effective comparative postoperative analgesic profiles following acetabular fracture surgery; however, no significant differences in VAS values were observed between the two groups during the study. FICB experienced reduced cumulative fentanyl consumption during spinal anesthetic placement, whereas QLB had a significantly lower total morphine demand in the initial postoperative 24 h period.
Conclusion
The lateral QLB and FICB can be introduced as effective routes for analgesia in acetabular fracture surgery using the Stoppa method. Clinical Trial Registration. The study was prospectively registered in the clinical trials registry system, on 2021-02-17, with registration number: IRCT20191114045435N1.
... Study design and procedure: This crosssectional study was carried out on 81 Lebanese individuals with SCI over a period of 3 months extending from August 1 st until the end of October 2022. This study was conducted according to the research ethics guidelines of the Declaration of Helsinki 50 and was approved by the Institutional Review Board of HRIR, Beirut, Lebanon. A detailed explanation of the study aims and procedures were presented to the participants during a telephone call interview. ...
Background: Chronic pain is one of the most disabling consequences of spinal cord injury (SCI). Although studies have identified a link between chronic pain and decreased quality of life (QOL) among this population, few studies have looked into the experience of chronic pain in Lebanese individuals with SCI and the impact of pain characteristics on QOL. Thus, the present study evaluated the chronic pain experience and its associated factors among Lebanese individuals with SCI in order to determine the impact of pain on QOL.
Methods: A cross-sectional study was conducted on 81 Lebanese individual with SCI between August 1st and October 31, 2022. The collected information included sociodemographic characteristics, SCI-related information, pain-related variables, and the 12-item Short Form Health Survey (SF-12). Factors associated with pain interference were evaluated using a linear regression model. One-way ANOVA and independent sample t-test were used to evaluate the association of different baseline and pain characteristics with QOL.
Results: In the present study, 81.5% of participants reported chronic pain with the majority of them having neuropathic pain type. Employment status (P = 0.034), type of pain (P = 0.009), and pain severity (P = 0.028) were significantly associated with pain interference. Unemployed participants and those with severe chronic pain, particularly neuropathic pain, had lower QOL.
Conclusion: Chronic pain was found to be highly prevalent among Lebanese patients with SCI. Pain interference and QOL were significantly affected by employment status and pain type. Therefore, targeting chronic pain and its associated factors in rehabilitation practice is warranted.
... Ethics. --This research was exempted from Human Ethics Review as no personal data and a Human Ethics Approval was not applicable as per Helsinki Declaration as in this case as we worked with opinion data from individuals who were not identi able in any way 24 . All authors reviewed the themes and commented on them. ...
One health (“OH”) refers to integration of human, animal, and ecosystem health. An OH-based disease surveillance will enable early detection of zoonoses and ecosystem changes, instrumental for pre-empting future pandemics. Telehealth is used for preventive and curative remote care; telehealth can be instrumental for developing OH-surveillance but the barriers and levers in building such systems are unknown. We address this by conducting an innovation sprint with digital health experts at an international conference. We asked the participants how we might build a telehealth-driven OH surveillance system. They identified barriers, opportunities, and needs, and constructed empathy maps. Analyses of their responses revealed that they identified lack of a centralised system as a barrier. Networks, and centralised data systems would facilitate building telehealth-based OH surveillance. These findings are also consistent with existing approaches of OH surveillance without telehealth. This suggests implementing telehealth in OH surveillance will have similar issues to existing approaches.
... Before the commencement of the study, all patients provided written consent to participate in the survey and to have the results made public. This research was approved by the Shahid Beheshti University of Medical Sciences Ethics Committee and adhered to the ethical principles of the Declaration of Helsinki (16). ...
Background: Acetabular fracture surgeries are frequently accompanied by protracted and severe perioperative pain, and there is no consensus on optimal pain relief management.
Aim: This study aimed to compare the analgesic efficacy of fascia iliaca compartment block (FICB) and quadratus lumborum block (QLB) in patients with acetabular fractures undergoing surgery using the Stoppa method.
Methods: In this double-blind, randomized, non-inferiority clinical trial, adult patients undergoing spinal anesthesia for acetabular fracture surgery, in Imam-Hossein Hospital, Tehran, Iran (IRCT20191114045435N1), were randomly divided into two groups: FICB (n = 22) and QLB (n = 24). The visual analog scale (VAS) was used to assess the pain intensity at different times for all participants. In addition, the dose of fentanyl required to induce the patient to sit for spinal anesthesia and the pain intensity was evaluated. Moreover, the duration of analgesia and the total amount of morphine consumed in the first 24 h following surgery were evaluated, analyzed, and compared between the two study groups.
Results: FICB and QLB demonstrated effective comparative postoperative analgesic profiles following acetabular fracture surgery; however, no significant differences in VAS values were observed between the two groups during the study. FICB experienced reduced cumulative fentanyl consumption during spinal anesthetic placement, whereas QLB had a significantly lower total morphine demand in the initial postoperative 24-h period.
Conclusion: The lateral QLB and FICB can be introduced as effective routes for analgesia in acetabular fracture surgery using the Stoppa method.
... This prospective randomized double-blind clinical study received approval from the University of Montreal's ethics committee, and all procedures were conducted in accordance with the tenets of the Declaration of Helsinki. 57 Informed consent was received from all participants before the start of the study. The study was open to participants older than 18 years who had a positive clinical sign of cylindrical dandruff on slit lamp examination. ...
Significance
The advancing age of the population will require increased access to eyecare services to manage eye diseases and vision correction. Optometric education requires a sound financial plan to manage student debt. This study evaluates the financial inequalities of optometric programs in Canada, and how this may impact the provision of eyecare professionals.
Purpose
The objective of this study was to compare the financial inequities in Optometric education in Canada from the 2020 graduating class.
Methods
A cross-sectional study assessed monetary variables related to the study of optometry in Canada, including academic and personal expenses, and overall debt and expenses related to the COVID-19 lockdown for the 2020 graduating class.
Results
108 optometry students from the 2020 graduating classes of the University of Montreal and the University of Waterloo responded, with 68 (53 F:15 M, age 25.66, SD = 2.01) completing the study. Waterloo students spent more years in university ( P < .001); had higher academic fees ( P < .001); spent more on travelling to their family residence (P = .007) and received more provincial ( P = .002) and federal ( P < .001) loans than Montreal students. Overall debt prior to optometry was similar amongst students but differed ( P < .001) at the end of their program, with Waterloo students having a higher debt burden.
Conclusions
There is a financial inequity in optometric education in Canada depending on the chosen program. Cumulative optometry student debt for the 2020 graduating class in Canada ranges from $CAN 0 to 189,000 with an average of $CAN 65,800 and a median of $CAN 50,000. The results of this study can assist financial, government agencies and future optometry students to better understand the financial burdens and establish a financial plan to study optometry in Canada, to respond to the growing eyecare needs of the public.
... The present study is a case-control prospective study carried out during the period from September 2018 till June 2020, and subjected neonates were selected from two neonatal intensive care units (NICUs) (NICU of Obstetric and Gynecological Hospital-Ain Shams University and NICU of Pediatric Hospital-Ain Shams University, Cairo, Egypt). All procedures were following the Helsinki Declaration [15]. Informed written consent was received from the parents of the subjected neonates, and the study was approved by the Research Ethics Committee of Ain Shams University Hospitals, Faculty of Medicine. ...
... The present study is a case-control prospective study carried out during the period from September 2018 till June 2020, and subjected neonates were selected from two neonatal intensive care units (NICUs) (NICU of Obstetric and Gynecological Hospital-Ain Shams University and NICU of Pediatric Hospital-Ain Shams University, Cairo, Egypt). All procedures were following the Helsinki Declaration [15]. Informed written consent was received from the parents of the subjected neonates, and the study was approved by the Research Ethics Committee of Ain Shams University Hospitals, Faculty of Medicine. ...
... This study was performed in accordance with the principles of the Declaration of Helsinki and Good Epidemiological Practices. 19 All participating centers had institutional review board approval or equivalent after the coordinating center's approval of the study protocol. All study participants provided written informed consent before study enrolment and patient consent was securely stored. ...
Background:
The concept of early discharge ≤24 hours after Laparoscopic Cholecystectomy (LC) is still doubted in Italy. This prospective multicentre study aims to analyze the prevalence of patients undergoing elective LC who experienced a delayed discharge >24 hours in an extensive Italian national database and identify potential limiting factors of early discharge after LC.
Methods:
This is a prospective observational multicentre study performed from January 1, 2021 to December 31, 2021 by 90 Italian surgical units.
Results:
A total of 4664 patients were included in the study. Clinical reasons were found only for 850 patients (37.7%) discharged >24 hours after LC. After excluding patients with nonclinical reasons for delayed discharge >24 hours, 2 groups based on the length of hospitalization were created: the Early group (≤24 h; 2414 patients, 73.9%) and the Delayed group (>24 h; 850 patients, 26.1%). At the multivariate analysis, ASA III class (P<0.0001), Charlson's Comorbidity Index (P=0.001), history of choledocholithiasis (P=0.03), presence of peritoneal adhesions (P<0.0001), operative time >60 min (P<0.0001), drain placement (P<0.0001), pain (P=0.001), postoperative vomiting (P=0.001) and complications (P<0.0001) were independent predictors of delayed discharge >24 hours.
Conclusions:
The majority of delayed discharges >24 hours after LC in our study were unrelated to the surgery itself. ASA class >II, advanced comorbidity, the presence of peritoneal adhesions, prolonged operative time, and placement of abdominal drainage were intraoperative variables independently associated with failure of early discharge.
... Informed consent was taken verbally during the phone call and written during the household survey. To ensure confidentiality, ethics, and privacy, the Declaration of Helsinki principles (15) were maintained throughout the research. One of our research team members obtained household screening approval from the Directorate General of Health Services of the Government of the People's Republic of Bangladesh. ...
Musculoskeletal disorders are debilitating conditions that significantly impact on the state of health, especially in elderly people. The study, which employed a cross-sectional design and practical sampling, included 206 participants from all over Bangladesh with musculoskeletal issues of varying severity and impact. The study was carried out between January and June of 2022. The majority of them experienced musculoskeletal pain. It was also common to have limited mobility as a result of arthritic change, which eventually affected daily activities like taking care of oneself. To improve the health of the elderly female population, more study must be conducted to identify the many factors that contribute to musculoskeletal issues. The development of effective prevention and rehabilitation programs must then be based on this knowledge.
... The study protocol was developed according to the Helsinki II declaration [48]. Prior to recruitment of patients and therapists, the study was approved by the independent ethics committee of the Medical Faculty of the Heidelberg University (S-195/2014). ...
Background
Current research has emphasized the role of structural integration of personality and childhood experiences for the understanding of anxiety disorders. In this study, we examined the relationship between anxiety disorders (generalized anxiety disorder vs. panic disorder vs. phobic disorders), the level of structural integration of personality, and negative and protective childhood experiences at the beginning of outpatient psychodynamic psychotherapy treatment. Differences were characterized in comparison to patients with no anxiety disorders.
Methods
The sample included a total of 1646 outpatient psychodynamic psychotherapy treatments, of which 695 treatments included the diagnosis of at least one anxiety disorder. Levels of structural integration of personality were assessed according to the Operationalized Psychodynamic Diagnosis (OPD-2) system. Self-reported negative and protective childhood experiences were examined by using the Questionnaire for the Assessment of Adverse and Protective Childhood Experiences (APC). Associations were tested using single factor ANOVAs.
Results
Patients with anxiety disorders showed lower levels of structural integration of personality and reported more adverse childhood experiences than patients with no anxiety disorders. Regarding the subscales of structural integration of personality, phobic disorders were associated with impaired external communication, whereas for generalized anxiety disorder, an (uncorrected) association with impaired self-regulation was found. Also, generalized anxiety disorder was associated with sexual abuse and other traumatization (accidents etc.) during childhood, while panic disorder and phobic disorders were associated with emotional neglect, abuse, and fewer protective childhood experiences.
Conclusions
Our findings emphasize the need of considering structural integration of personality and childhood experiences in order to understand and treat various types of anxiety disorders.
... Verbal and written informed consent were obtained from all participants and anonymity ensured via a random code generator. All experimental procedures conformed to the standards set by the Declaration of Helsinki, except for registration in a database (Williams, 2008). ...
Following retirement from sport, the chronic consequences of prior‐recurrent contact are evident and retired rugby union players may be especially prone to accelerated cognitive decline. The present study sought to integrate molecular, cerebrovascular and cognitive biomarkers in retired rugby players with concussion history. Twenty retired rugby players aged 64 ± 5 years with three (interquartile range (IQR), 3) concussions incurred over 22 (IQR, 6) years were compared to 21 sex‐, age‐, cardiorespiratory fitness‐ and education‐matched controls with no prior concussion history. Concussion symptoms and severity were assessed using the Sport Concussion Assessment Tool. Plasma/serum nitric oxide (NO) metabolites (reductive ozone‐based chemiluminescence), neuron specific enolase, glial fibrillary acidic protein and neurofilament light‐chain (ELISA and single molecule array) were assessed. Middle cerebral artery blood velocity (MCAv, doppler ultrasound) and reactivity to hyper/hypocapnia (/) were assessed. Cognition was determined using the Grooved Pegboard Test and Montreal Cognitive Assessment. Players exhibited persistent neurological symptoms of concussion ( U = 109 (41) , P = 0.007), with increased severity compared to controls ( U = 77 (41) , P < 0.001). Lower total NO bioactivity ( U = 135 (41) , P = 0.049) and lower basal MCAv were apparent in players ( F 2,39 = 9.344, P = 0.004). This was accompanied by mild cognitive impairment ( P = 0.020, 95% CI, −3.95 to −0.34), including impaired fine‐motor coordination ( U = 141 (41) , P = 0.021). Retired rugby union players with history of multiple concussions may be characterised by impaired molecular, cerebral haemodynamic and cognitive function compared to non‐concussed, non‐contact controls.
... An electronic informed consent was taken from the subjects after detailed orientation regarding the survey's objectives, procedures, and possible outcomes. This study was conducted in accordance with the Declaration of Helsinki [13]. The target population was the faculty members of the Doctor of physical therapy program who taught spring course 2020 online, during Coronavirus (COVID- 19) Pandemic. ...
Background: The recent covid-19 pandemic has also displayed a worldwide increase in online education as a method of learning, at an exponential rate. In the wake of the COVID-19 pandemic, the education program of physical therapy abruptly moved from on-campus to remote online medium. Objective: to find out the satisfaction level of the faculty of Doctor of Physical Therapy (DPT) in twin cities of Pakistan. Methodology: A cross-sectional survey was conducted on faculty members of various universities having the Doctor of Physical Therapy program students in Islamabad and Rawalpindi, Pakistan. A total of n=120 participants between 24 to 60 years were recruited through a nonprobability purposive sampling technique. The research team used the Online Faculty Satisfaction Survey (OFSS) which has a total of 34 questions and was designed to quantify and authenticate the satisfaction of faculty regarding the students, teaching mode as well as the institutions. Questionnaires were distributed through emails and other social media applications i.e. Facebook and WhatsApp. Results: The mean age of participants was 29.4± 6.5 years with 63.3 % females & 36.7% males. The Satisfaction levels were different among the participants. A total of n=66(55%) of participants were less satisfied with the online method of teaching whereas n=42 (35%) shows a higher level of satisfaction. The remaining 10% showed various responses regarding satisfaction level i.e. average n=4 (3.3%), moderately satisfied n=4 (3.3%), neutral n=2 (1.7%), satisfied n=2 (1.7%). Conclusion: This study concluded that the faculty of Doctor of Physical Therapy (DPT) was less satisfied with online teaching methods due to the lack of face-to-face interaction and practical components of studies. Keywords: COVID-19; education; faculty satisfaction; pandemic; university teacher.
... While public health is essentially directed toward promoting and protecting the health of populations (Faden, Bernstein, and Shebaya 2022), populations necessarily consist of individuals, who form the locus of decision-making when it comes to medical interventions like getting vaccinated. Determining and maintaining the optimal relationship between individual and public health is a perennial concern and constitutes a major ethical challenge for governments and health care providers (Williams 2008). Individual rights may conflict with, and should be balanced against, public health interests (Hunt 2004;Parmet, Goodman, and Farber 2005). ...
This dissertation explores the idea and ethics of vaccination for the sake of others. It conceptually distinguishes four different kinds of vaccination—self-protective, paternalistic, altruistic, and indirect—based on who receives the primary benefits of vaccination and who ultimately makes the vaccination decision. It describes the results of focus group studies that were conducted to investigate what people who might get vaccinated altruistically think of this idea. It also applies the different kinds of vaccination to ethical issues surrounding COVID-19, such as lockdown measures, routine or mandatory vaccination of healthy children, and the ethical justification of restrictive measures for unvaccinated people. A more general philosophical account of vaccination ethics is ultimately developed, which is based not on moral duties, but on the moral reasons that people may have to get vaccinated for the sake of others. It is argued that such reasons may be stronger or weaker, depending on various factors related to the vaccines in question and the specific epidemiological circumstances.
... The study protocol was developed according to the Helsinki II declaration [47]. Prior to recruitment of patients and therapists, the study was approved by the independent ethics committee of the Medical Faculty of the Heidelberg University (S-195/2014). ...
Background: Current research has emphasized the role of structural integration of personality and childhood experiences for the understanding of anxiety disorders. In this study, we examined the relationship between anxiety disorders (generalized anxiety disorder vs. panic disorder vs. phobic disorders), level of structural integration of personality, and negative and protective childhood experiences. Differences were characterized in comparison to patients with no anxiety disorders.
Methods: The sample included a total of 1646 outpatient psychodynamic psychotherapy treatments, of which 695 treatments included the diagnosis of at least one anxiety disorder. Levels of structural integration of personality were assessed according to the Operationalized Psychodynamic Diagnosis (OPD-2) system. Self-reported negative and protective childhood experiences were examined by using the Questionnaire for the Assessment of Adverse and Protective Childhood Experiences (APC). Associations were tested using single factor ANOVAs.
Results: Patients with anxiety disorders showed lower levels of structural integration of personality and reported more adverse childhood experiences than patients with no anxiety disorders. Regarding the subscales of structural integration of personality, phobic disorders were associated with impaired external communication, whereas for generalized anxiety disorder, an (uncorrected) association with impaired self-regulation was found. Also, generalized anxiety disorder was associated with sexual abuse and other traumatization (accidents etc.) during childhood, while panic disorder and phobic disorders were associated with emotional neglect, abuse, and fewer protective childhood experiences.
Conclusions: Our findings emphasize the need of considering structural integration of personality and childhood experiences in order to understand and treat different types of anxiety disorders.
... El protocolo siguió los estándares éticos de acuerdo con la Ley 1090 de 2006 por la cual se dicta el Código Deontológico y Bioético en materia de investigación para la salud. El contexto en el cual se aplicó el experimento y la escala de evaluación comportamental se enmarca en los parámetros éticos de Helsinki para la investigación con seres humanos (Williams, 2008) y en todos los casos se presentaron las mismas condiciones. Es importante mencionar que la presente investigación contó con la aprobación del comité de ética de la Universidad San Buenaventura Medellín, Colombia. ...
... Written informed consent was waived as this study constituted a service evaluation. Procedures were conducted in accordance with guidelines set forth by the Declaration of Helsinki of the World Medical Association 22 with the exception of registration in a database. ...
Background:
To what extent sex-related differences in cardiorespiratory fitness (CRF) impact postoperative patient mortality and corresponding implications for surgical risk stratification remains to be established.
Methods:
To examine this, we recruited 640 patients (366 males vs. 274 females) who underwent cardiopulmonary exercise testing prior to elective colorectal surgery. Patients were defined high risk if peak oxygen uptake was <14.3 mL kg-1 min-1 and ventilatory equivalent for carbon dioxide at 'anaerobic threshold' >34. Between-sex CRF and mortality was assessed, and sex-specific CRF thresholds predictive of mortality calculated.
Results:
Seventeen percent of deaths were attributed to sub-threshold CRF, which was higher than established risk factors for cardiovascular disease (CVD). The group (independent of sex) exhibited a 5-fold higher mortality (high vs. low risk patients hazard ratio =4.80, 95% confidence interval 2.73 to 8.45, P <0.001). Females exhibited 39% lower CRF (P <0.001) with more classified high risk than males (36 vs. 23%, P=0.001), yet mortality was not different (P =0.544). Upon reformulation of sex-specific CRF thresholds, lower cut-offs for mortality were observed in females, and consequently, fewer (20%) were stratified with sub-threshold CRF compared to the original 36% (P<0.001).
Conclusions:
Low CRF accounted for more deaths than traditional CVD risk factors and when CRF was considered relative to sex, the disproportionate number of females stratified unfit was corrected. These findings support clinical consideration of 'sex-specific' CRF thresholds to better inform postoperative mortality and improve surgical risk stratification.
... This research was carried out in accordance with the ethical principles as defined in the guidance for Good Clinical Practice and the Principles as outlined in the Declaration of Hlsinki [28]. Approval to carry out the study was sought from the Board of Postgraduate Studies, Jaramogi Oginga Odinga University of Science and Technology. ...
Background: Human papillomavirus is the main factor in the etiology of cervical cancer, with over 99.7% of cases being associated with high-risk human papillomavirus infection. Although the majority of HPV infections are asymptomatic and self-limiting, persistent HPV infection can result in genital warts, oropharyngeal cancer, and cervical cancer in women, in addition to various anogenital malignancies and other genital warts in both men and women. Method: This was a cross-sectional descriptive study which employed a convenience sampling technique where both qualitative and quantitative methods were used for data collection. A total of 374 participants were enrolled in the study and a semi structured questionnaire was administered to collect socio-demographic, reproductive and sexual history data. Laboratory analysis involved detection of HPV DNA hybrids with a chemiluminescent substrate, Digene Hybrid Capture 2 technology. Descriptive and inferential (logistic regression) analyses at level of significant (α=0.05) were used to summarize the data, and results illustrated using charts and tables. Results: The study findings reported a significant risk level of human papillomavirus among female of age group 40-49 years (AOR; 0.15, 95% CI: 0.03-0.79; p = 0.026). Furthermore, in bivariate logistic regression the circulating HPV genotypes among the respondents was significantly characterized among women of the same age group (95% CI; 0.09-0.7; p = 0.008) as well as in the multivariate regression (AOR = 0.13; 95% CI: 0.02-0.72; p = 0.019). Conclusion: The study thus concluded that there is 23/94 (25.67%) risk of developing cervical cancer due to high risk level HPV (with the presence of low risk level HPV 71/94 (74.33%) known for causing various forms of warts. Therefore, there is need for combined efforts from the Ministry of health and stakeholders to avail and train health care workers on the usage of HPV DNA kits to ensure timely detection of low and high-risk levels HPV. This will ensure timely identification of women at increased risk for the development of cervical cancer, thereby reducing mortality rate.
... Retrospective analysis of 7832 respiratory specimens sent from children admitted to our hospital with ARTI from January 2021 to June 2022 were tested for AdV positivity. The study was in accordance with the relevant requirements of the World Medical Association Declaration of Helsinki [9]. Inclusion criteria: all children met the diagnostic criteria for ARTI in Zhu Fu-Tang Practical Pediatrics [10]; all children hospitalized with ARTI in the Department of Respiratory Medicine and the Department of Critical Care Medicine of our hospital; respiratory specimens collected on the day of admission or on day 2 were tested positive for AdV antigen by direct immunofluorescence assay (DFA, Diagnostic Hybrids, USA) or AdV nucleic acid positivity by respiratory pathogen detection kit (RPP, Luminex, USA); informed consent signed by the guardians of the children. ...
Background
The purpose of this study was to investigate the typing of adenovirus (AdV) infection in children hospitalized with acute respiratory tract infection (ARTI) and its clinical characteristics.
Methods
Samples from 7832 hospitalized children with ARTIs from January 2021 to June 2022 were tested by multiplex PCR for AdV. AdV hex neighborhood genes were amplified and sequenced for typing by nested PCR.
Results
Three hundred twenty-eight cases were positive for AdV with rate of 4.48% (328/7832). No statistical difference in the rate of AdV detection was observed in different ages ( P > 0.05). Among the 328 cases, 305 cases underwent amplification and sequence determination of AdV five-neighborhood, six-neighborhood and fibronectin genes. Only 237 cases were sequenced successfully for all 3 genetic fragments. The typing results of 231 cases with 3 genes were consistent, with 49.78% (115/231) of type 3, 41.56% (96/231) of type 7 and 8.66% (20/231) of other types identified. The main clinical symptoms in 231 children hospitalized with ARTI who were AdV positive were cough, sputum not easily coughable, Wheezing or shortness of breath and fever. Clinical diagnoses of 231 cases included: acute bronchitis 3.03% (7/231), capillary bronchitis 16.45% (38/231), pneumonia (mild/severe) 76.62% (177/231) (68.40% (158/231) in mild and 8.23% (19/231) in severe cases), bronchial asthma combined with pulmonary infection 3.46% (8/231). Higher percentage of shortness of breath, multilobar infiltration, and pleural effusion were found in type 7. Calcitoninogen in type 7 were significantly higher than those of type 3 and other types, and the white blood cell count was lower than those of type 3 and other types, and the difference was statistically significant ( P < 0.05).
Conclusion
AdV type 3 and 7 were frequently found in hospitalized children with acute lower respiratory tract involvement. AdV type 7 seems to be associated with more severe outcome.
... The study matches Helsinki's declaration. [6] Patients and their parents were informed that data would be submitted for publication, and they provided consent. ...
Introduction:
Bilateral femoral fractures in children (BFFC) are an uncommon condition. Only a few cases were reported in the literature. The frequency and outcome in low-setting facilities are unknown. This study aims to describe our experience in managing BFFC.
Patients and methods:
A 10-year ongoing study spanning from 2010 to 2020 was held in a level-1 paediatric facility. We included all cases of BFFC on a bone-free disease with at least 10 months of follow-up time. Data were collected and analysed with statistical software.
Results:
A total of eight patients with ten BFFC were collected. It involved mainly boys (n = 7/8) with median age of 8 years. Mechanism of injury were a road traffic accident (n = 4), a fall from height (n = 3), and been crushed by a falling wall (n = 1). Associated injuries were frequent (n = 6/8). Patients were managed nonoperatively with spica cast (n = 5) and by elastic intramedullary nails (n = 3). After 6.11 years of mean follow-up time, all fractures healed. The outcome was excellent and good in 7 cases. One patient sustained knees stiffness.
Conclusion:
Non-operative management of BFFC showed satisfactory outcomes. Early surgical care must be developed in our low-income settings to reduce in-hospital stay and encourage early weight-bearing.
... The authors assert that all procedures contributing to this work comply with the relevant national and institutional committees' ethical standards on human experimentation and with the Helsinki Declaration of 1975, as revised in 2008 (Williams 2008). ...
Background: Dysregulation of circadian rhythms has been thought to be associated with psychiatric disorders such as bipolar disorder (BD) and depression. We aimed to evaluate the relationship between clinical specifiers of BD, mainly seasonal pattern (SP), and the variable number tandem repeat (VNTR) variant of the PERIOD3 (PER3) gene (rs57875989) in BD patients by comparing genotype distributions with healthy controls considering clinical parameters.
Subjects and methods: A sample of 98 BD patients and 97 healthy volunteers were included in the study. The Clinical Interview for DSM-IV Axis-I Disorders (SCID-I) was administered to all participants. The patients were evaluated with some scales (Sociodemographic and Clinical Data Form, The Young Mania Rating Scale (YMRS), the Hamilton Depression Rating Scale (HAMD), and The Clinical Global Impression Scale (CGI)) in terms of clinical features and symptom severity. Blood samples were obtained from participants to isolate their DNA. PCR-RFLP was used to determine the PER3 gene variant.
Results: The PER3 genotype (4/4, 4/5, 5/5) distribution of BD was found to be significantly different from the control group. There was a statistically significant difference in the PER3 genotype distribution between BD patients with SP and BD patients without SP. Again, the PER3 allele (4, 5) distributions of BD patients with the SP were statistically different from the control group. The BD patients' PER3 genotype distributions with a family history of BD were significantly different from the BD patients without family history or control group.
Conclusion: It was found that the VNTR variant of the PER3 gene (rs57875989) may be associated with the SP and family history of BD as well as the BD itself. Further studies with the VNTR variant of the PER3 gene (rs57875989) in different ethnic populations are also required to determine these polymorphisms' exact role in BD.
... All patients provided written consent to participate in the survey and to publish the results before the start of the study. Based on the Declaration of Helsinki (11), the Ethics Committee of the Shahid Beheshti University of Medical Sciences approved this study. ...
Background: Acetabular fracture surgeries are frequently associated with long and severe perioperative pain, and there is no consensus on pain relief management.
Aim: The purpose of this study was to compare the analgesic efficacy of fascia iliaca compartment block (FICB) and quadratus lumborum block (QLB) in patients with acetabular fractures undergoing surgery using the Stoppa method.
Methods: Adult patients undergoing spinal anesthesia for acetabular fracture surgery were divided into two groups of FICB (n = 22) and QLB (n = 24) in this prospective double-blind randomized parallel clinical study. The pain intensity at different times was evaluated in all participants using the visual analog scale (VAS). The dose of fentanyl required to make the patient sit for spinal anesthesia and the pain intensity was evaluated. The duration of analgesia and the total amount of morphine consumed in the first 24 hours after surgery were also evaluated, analyzed, and compared between the two study groups.
Results: Both FICB and QLB showed effective comparative postoperative analgesic profiles after acetabular fracture surgery; However, no significant variation in VAS values was found at any time of the study between the two groups. FICB showed decreased cumulative fentanyl consumption during spinal anesthetic placement, however, QLB had considerably lower total morphine demand in the initial postoperative 24h period.
Conclusion: The lateral QLB and FICB can introduce as effective routes for analgesia in acetabular fracture surgery by the Stoppa approach.
Clinical Trial Registration: The study was retrospectively registered in the clinical trials registry system, on 2021-02-17, with registration number: IRCT20191114045435N1.
... The average amount paid to participants in our online sample for taking part in the research was £3.75/h. The experiment was approved by the Ethics Committee of Cardiff Metropolitan University and was conducted in accordance with the Declaration of Helsinki (Williams, 2008). ...
Prior to the discovery of linear perspective in the fifteenth century, European artists based their compositions more on imagination than the direct observation of nature. Medieval paintings, therefore, can be thought of as ‘mental projections’ of space rather than optical projections, and were sometimes regarded as ‘primitive’ by historians as they lacked the spatial consistency of later works based on the rules of linear perspective.
There are noticeable differences in the way objects are depicted in paintings of the different periods. For example, human figures in pre-linear perspective works often vary greatly in size in ways that are not consistent with the laws of optics. Some art historians have attributed this to ‘hierarchical scaling’ in which larger figures have greater narrative significance. But there are examples of paintings that contradict this explanation.
In this paper we will consider an alternative to the hierarchical scaling hypothesis: that medieval artists used relative size to elicit empathy and to reflect the perceptual structure of imagination. This hypothesis was first proposed by the art historian Oskar Wulff, but has largely been dismissed since. We argue that artists of this period, far from being naïve, used sophisticated techniques for directing the attention of the viewer to a particular figure in a painting and encouraging them to ‘see’ the depicted space from that figure’s point of view. We offer some experimental evidence in support of this hypothesis and suggest that the way artists have depicted space in paintings has an important bearing on how we imagine and perceive visual space.
... The study will be conducted in accordance with the appropriate data protection legislation and the Declaration of Helsinki. 33 ...
Background
Insomnia is a prevailing health problem among older adults. Tai Chi, a popular mind-body exercise practiced by older people in various oriental communities, has been shown to improve sleep. However, Tai Chi has not been directly compared to cognitive behavioral therapy for insomnia (CBT-I), which is the first-line non-pharmacological treatment for insomnia in older adults. This study aims to examine whether Tai Chi is non-inferior to CBT-I as a treatment for insomnia in older adults.
Methods
This is a single-center, assessor-blinded, non-inferiority randomized controlled trial comparing Tai Chi and CBT-I in 180 older adults aged ≥50 years with chronic insomnia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Participants will be randomly assigned to either the Tai Chi or CBT-I group. Interventions will last for 3 months with a 12-month follow-up. The primary outcome is self-perceived insomnia severity measured by Insomnia Severity Index (ISI) at 3 months and at 15 months. The secondary outcomes include the remission rate of chronic insomnia, insomnia treatment response, subjective sleep quantity and quality, 7-day actigraphy, 7-day sleep diary, sleep medication, health-related quality of life, mental health, body balance and lower extremity function, adverse events, habitual physical activity, and dietary intake. Measurements will be conducted at baseline, 3 months, and 15 months by outcome assessors who are blinded to the group allocation.
Discussion
This will be the first non-inferiority randomized controlled trial to compare the efficacy and long-term outcomes of Tai Chi versus CBT-I for treating insomnia in older adults. This study will be of clinical importance as it supports the use of Tai Chi as an alternative non-pharmacological approach for insomnia treatment and sustainable management.
... They voluntarily participated in the research and signed the written consent. The research was carried out in accordance with the conditions of the declaration of Helsinki, recommendations guiding physicians in biomedical research involving human subjects [25], and with the ethical approval number 484-2 of the ethical board of the faculty. ...
Wrestling combat causes the body to respond by increased heart rate (HR) and accumulation of blood lactates (La) to near maximum or maximum. The evidence to whether higher proficiency wrestlers perform better and recover faster due to more efficient cardio-metabolic system is scarce. This study aimed to investigate the difference in HR and La response during an initial five minutes of recovery after specific wrestling performance test (SWPT). The sample of male competitive wrestlers of different proficiency were allocated into three groups Level 1 (highest), Level 2, and Level 3 (lowest). Wrestlers performed SWPT and number throws (Tn Throws) was recorded, while HR and La were collected during recovery. HR was measured at the end of the test and after five minutes into recovery and relative (%) change (∆HR5min) was recorded. La level was collected three (La3min) and five (La5min) minutes into recovery and used for the analyses. Relative La change (∆La3-5min) was calculated as difference between La3min and La5min. Multiple analysis of variance with the Bonferroni post-hoc (p<0.05) calculated the between-group difference. Level 1 wrestlers performed better (p<0.01) in Tn Throws than Level 2 and 3. Level 2 performed better (p<0.01) than Level 3. Level 1 wrestlers had larger (p<0.01) ∆HR5min than the Level 2 and Lever 3. In addition, small to moderate difference occurred in La3min and La5min, with Level 1 having lower values. Wrestlers of higher proficiency had advanced specific adaptation of cardio-metabolic system to perform better and recover faster than the wrestlers of lower proficiency.
... The study was carried out according to The International Council for Harmonization (ICH) guidelines for Good Clinical Practice (GCP) and the declaration of Helsinki provisions [5,6]. Each subject was given the informed consent form during the screening phase before starting the study. ...
Cefixime is a broad-spectrum oral antibiotic used for treating a wide variety of bacterial infections. Study Objective: The objective of this study was to find out whether bioequivalence study of Cefixime 200 mg, Profim® capsule manufactured by PT Promedrahardjo Farmasi Industri in comparison with Cefixime 100 mg, Cefspan® capsule manufactured by PT Dankos Farma, For PT Kalbe Farma Tbk, under license by Astellas Pharma Inc., Osaka – Japan. Methods: The study was conducted using an open-label, randomized, single-dose, two-periods, two-treatments, crossover study under fasting conditions with 8 (eight) days washed-out period between each period. According to the random design, a single oral dose of the test drug or reference drug was administered to 30 healthy male subjects after overnight fasting. The number of subjects who finished the study was twenty-eight (28) healthy male subjects. Serial plasma samples were obtained over a 32 hours period. Plasma concentrations of the drug were determined by LC-MS/MS method. From the Cefixime concentration vs. time curves, the following pharmacokinetic parameters were obtained: AUC0-32h, AUC0-∞, and Cmax, while the statistical interval proposed was 80.00 - 125.00% for AUC0-32h and Cmax with 90% Confidence Interval (CI) with α = 5.00%. The estimation of Tmax and T1/2 in the bioequivalence study was based on a nonparametric statistical procedure on the original data using Wilcoxon Sign Test. Results: The main pharmacokinetic parameters of the test drug Profim® (BN: B051A21P-1)/ reference drug, Cefspan® (BN: KCEFB00038) ratio were as follows: AUC0-32h: 105.86 (95.41 - 117.44) with CV Intra Subjects was 22.72% and Cmax: 105.63 (95.33 - 117.03) with CV Intra Subjects was 22.43 %. Whilst TMAX of the test drug Profim® (BN: B051A21P-1)/ reference drug, Cefspan® (BN: KCEFB00038) were respectively 4.50 (3.50 – 6.00) h and 4.50 (3.00 – 6.00) h; mean T1/2 were respectively 4.18 ± 0.78 h and 4.14 ± 0.56 h; and mean Slope were respectively (-0.17) ± 0.03 h and (-0.17) ± 0.02 h. There is no adverse event that occurred during this study. Conclusion: The present study demonstrated that the evaluated test drug Profim® (BN: B051A21P-1) were bioequivalence in term of both rate and extent of absorption to the reference drug Cefspan® (BN: KCEFB00038).
... All the volunteers gave informed consent to participate and adhere to the Declaration of Helsinki. 17 All volunteers were healthy, and none suffered from heart diseases. HR between 60 and 100 bpm was considered SR, ≥100 bpm was considered ST and <60 bpm was considered SB. ...
Introduction: In an Electrocardiogram (ECG), QT Interval (QTI) has gained a major role as an indicator; its prolongation leads to ventricular arrhythmias. QTI varies with RR Interval (RRI) as the Heart Rate (HR) changes which motivate to measure corrected QT (QTc) interval for different HR.
Objective: To develop a new QTc formula optimal for different HRs and compare its performance with previously developed QTc formulas.
Methods: ECGs were recorded from 220 volunteers (110 females) in Sinus Rhythm (SR), Sinus Tachycardia (ST) and Sinus Bradycardia (SB) conditions. HR, RRI and QTI were extracted from the lead II. A New QTc formula was developed by taking the mean value of slopes between RRI and QTI in SR, ST, and SB. The QTc values were calculated using a newly developed formula, and the performance was compared with previously developed QTc formulas.
Results: In SR, ST, and SB, the QTI mean values for lead II were 358 ms, 316 ms, and 440 ms and the mean slope values between RRI and QTI were 0.132, 0.214, and 0.137, respectively. The new QTc (QTcN) formula was developed by taking the mean of the above slope values as 0.161 and mentioned as QTcN[Formula: see text]QT[Formula: see text]0.161(1000−RRI).
Conclusion: The least slope value of the QTI/RRI plot gave the best correction formula. Using statistical analysis, it was noted that Frederica QTc formula showed the best results for SR and SB and Hodge’s formula in ST. To overcome the limitation of QTc formulas for different HR, a QTcN formula was developed to reduce over/under estimation of QTI.
... The GDPR established in May 2018 has emphasised the potential value and challenges of managing e-health data, especially in terms of security and privacy issues. Respecting patients' privacy and confidentiality are increasingly becoming more critical, and they represent two of the core values in health care [28]. A key to adopting such technologies is the security and privacy of data, considering the highly sensitive nature of medical data (confidentiality, availability, integrity). ...
Medical consultations for chronic diseases form an arena to provide information from health personnel to patients. This information is necessary for patients to understand how to deal with the possible lifelong symptoms and needed self-management activities. The amount of patient-generated health data is increasing. Today’s patients gather an increasing amount of personalised health-related information. Meanwhile, the health personnel get more patients to care for and fewer resources. This paper summarises information and communication technologies possibilities for improved diabetes consultations. It aims to inform how the medical consultation for chronic diseases needs to change drastically to meet today and future’s challenges.
... Während sich medizinische Studien, insbesondere in Europa, häufi g auf die Deklaration von Helsinki (Williams, 2008) stützen, kann Forschung im sonderpädagogischen Bereich auf den ethischen Rahmen von Beauchamp und Childress (2008) aufgebaut werden (Calveley, 2012;Dederich, 2017 und für Menschen mit komplexer Behinderung gesehen und im Folgenden zunächst allgemein diskutiert. Die Umsetzung der wichtigsten Aspekte im Forschungsprojekt EmEx (Hammann et al., in Vorbereitung;Krämer & Zentel, 2020) werden abschließend an diesen Absatz jeweils kurz erläutert. ...
Empirische Forschungsbemühungen mit und für Menschen mit komplexer Behinderung haben sich sukzessive intensiviert. Im Spannungsfeld zwischen Forschungsfreiheit und -verantwortung hat dies zu einem gestiegenen Bedarf an forschungsethischer Reflexion geführt. Die existierenden Herausforderungen beim Einbezug dieser Zielgruppe werden orientiert an dem Forschungsprojekt EmEx und anhand von vier weiterführenden Leitfragen diskutiert: Warum wird zu einem Thema geforscht? Was sind Möglichkeiten der Einwilligung? Wie werden Schutz und Wohlergehen sichergestellt? Wie werden Ergebnisse bewertet und kommuniziert? In der Auseinandersetzung werden Umsetzungsansätze dargestellt, die die Partizipation dieser vulnerablen Gruppe an Forschung und deren Erkenntnissen unter Wahrung forschungsethischer Grundsätze unterstützen.
... All procedures were carried out in accordance with the Declaration of Helsinki of the World Medical Association. 10 ...
Background:
Initial clinical evaluation (ICE) is traditionally considered a useful screening tool to identify frail patients during the preoperative assessment. However, emerging evidence supports the more objective assessment of cardiorespiratory fitness (CRF) via cardiopulmonary exercise testing (CPET) to improve surgical risk stratification. Herein, we compared both subjective and objective assessment approaches to highlight the interpretive idiosyncrasies.
Methods:
As part of routine preoperative patient contact, patients scheduled for major surgery were prospectively "eyeballed" (ICE) by two experienced clinicians before more detailed history taking that also included the American Society of Anesthesiologists score classification. Each patient was subjectively judged to be either "frail" or "not frail" by ICE and "fit" or "unfit" from a thorough review of the medical notes. Subjective data were compared against the more objective validated assessment of postoperative outcomes using established CPET "cut-off" metrics incorporating peak pulmonary oxygen uptake, V̇O2PEAK at the anaerobic threshold (V̇O2 -AT), and ventilatory equivalent for carbon dioxide that collectively informed risk stratification. These data were retrospectively extracted from a single-center prospective National Health Service database. Data were analyzed using the Chi-square automatic interaction detection decision tree method.
Results:
A total of 127 patients were examined that comprised 58% male and 42% female patients aged 69 ± 10 years with a body mass index of 29 ± 7 kg/m2 . Patients were poorly conditioned with a V̇O2PEAK almost 20% lower than predicted for age, sex-matched healthy controls with 35% exhibiting a V̇O2 -AT < 11 ml/kg/min. Disagreement existed between the subjective assessments of risk with ∼34% of patients classified as not frail on ICE were considered unfit by notes review (p < .0001). Furthermore, ∼35% of patients considered not frail on ICE and ∼31% of patients considered fit by notes review exhibited a V̇O2 -AT < 11 ml/kg/min, and of these, ∼28% and ∼19% were classified as intermediate to high risk.
Conclusions:
These findings highlight the interpretive limitations associated with the subjective assessment of patient frailty with surgical risk classification underestimated in up to a third of patients compared to the validated assessment of CRF. They reinforce the benefits of a more objective and integrated approach offered by CPET that may help us to improve perioperative risk assessment and better direct critical care provision in patients scheduled for "high-stakes" surgery including open thoracoabdominal aortic aneurysm repair.
Background
Usage of Youth Friendly Health Services (YFHSs) remains unsatisfactory in sub-Saharan Africa despite global agreements on the utilisation of these services among the youths.
Aim
The aim of the study was to identify factors that influence the utilisation of YFHSs in Blantyre, Malawi.
Setting
Four health centres in Blantyre, Malawi.
Methods
A descriptive quantitative research design using multistage sampling was used to randomly sample (N = 293) unmarried youths and collect data using a structured questionnaire. Data were analysed using a computerised statistical package for social sciences (SPSS) version 26. Chi-square (χ²) was used to test the significance of the association between variables, and the p-value (p < 0.05) was considered significant. Regression analysis was used to examine the influence of independent variables on the utilisation of the services.
Results
Less than half of the respondents have ever accessed YFHSs (43%). The Chi-square test showed that the following variables had a significant association with utilisation of the services (p < 0.05): gender, age, knowledge, signage, printed health education materials, provider attitudes and being shy or fear of being seen at the services.
Conclusion
Age, knowledge, signpost, printed health education materials, provider attitudes and being shy or fear of being seen at the YFHSs are factors that influenced the utilisation of the services. Working on these factors would help to increase utilisation.
Contribution
The study findings will help to fill the gap in the provision of YFHSs and thus increase utilisation of the services.
Background
Occupational stress is increasing globally and affecting all workplaces and countries' health professionals. There is, however, a paucity of literature on the issue in Ghana. Besides, policymakers have not given it the needed much attention. We, therefore, examined the prevalence and causes of occupational stress among nurses working in a secondary care and tertiary hospitals in Ghana.
Methods
We conducted health facility-based cross-sectional study among 248 nurses from two hospitals (Volta Regional Hospital [VRH] and Ho Teaching Hospital [HTH]). The Perceived stress scale (PSS) and Weiman Occupational Stress Scale (WOSS) were used to measure the stress level and occupational stressors among the nurses. Descriptive analyses and t-test were performed, and statistical significance as measured at the 0.05 level.
Results
Majority of nurses 77.8% of experienced a moderate level of stress. The total individual mean score of the nurses from the two hospitals (VRH = 3.02 and HTH = 3.09) were 25% higher than the established WOSS. Nursing difficult patients (t=-1.1196, p = 0.037), Unfriendly relationship with superiors, colleagues, and subordinates (t=-2.3333, p = 0.020), working with incompetent staff (t=-1.3129, p = 0.037) were the statistically significant stressors among nurses in the HTH. However, long work hours (t = 2.0841, p = 0.038) and needle-stick injuries (t = 2.6669, p = 0.008) were the statistically significant stressors among nurses from the VRH. Headache (VRH = 73.8% and HTH = 97.9%), Fatigue (VRH = 68.9% and HTH = 83.5%), Frustration VRH = 50.5% and HTH = 68.3%) and Lack of Concentration (VRH = 81.6% and HTH = 80.0%) were the effects of occupational stress reported.
Conclusion
The study demonstrated increasing levels of occupational stress among nurses. To accelerate progress towards achieving the sustainable development goal (SDG) 3.4 of promoting mental health and wellbeing by 2030, the 2012 Mental Health Act of Ghana and the Occupation Health and safety regulations, should fully and effectively be implemented by health facilities across the country.
Background
Adverse childhood experiences were previously identified to be important risk factors for the development of anxiety disorders. Furthermore, anxiety disorders were shown to be associated with impairments of personality functioning. The aim of the present study was to investigate the effects of adverse and protective childhood experiences on symptom improvement of patients with anxiety disorders during outpatient psychotherapy. Personality functioning, according to the Operationalized Psychodynamic Diagnosis system, was examined as a potential predictor.
Methods
The sample consisted of n = 312 completed psychotherapies. The symptom improvement rate was calculated using a two-stage hierarchical linear model. Direct and indirect effects of adverse and protective childhood experiences on the symptom improvement rate during psychotherapy were then examined using a structural equation model.
Results
The presence of adverse childhood experiences predicted a slower improvement rate during psychotherapy. In addition, a higher number of adverse childhood experiences was associated with greater impairments in the abilities of perception and regulation as dimensions of personality functioning. A higher number of protective childhood experiences was associated with fewer impairments in the communication and attachment dimensions. Impairments in personality functioning in patients with anxiety disorders did not predict symptom improvement rate during psychotherapy.
Conclusions
Among patients with anxiety disorders, adverse childhood experiences lead to slower symptom improvement in psychotherapy. Therefore, childhood adversity should be regularly assessed before starting psychotherapy in patients with anxiety disorders.
Background
Although metabolic syndrome (MetS) is intended to identify people at risk for diabetes and cardiovascular disease, it is not a reliable predictor of diabetes. Studies have demonstrated that evaluating blood glucose is as effective as MetS in predicting diabetes. Therefore, refining the MetS definition to include other diabetes risk factors may increase its efficacy.
Methods
Two thousand individuals, aged 20 to 74, were followed over a period of 9.9 years. Multivariate Cox proportional hazard models were used to examine the association between serum uric acid (SUA) and diabetes incidence. Random forest was developed for predicting diabetes based on MetS components and SUA. We explained how each component in the machine learning model affects diabetes prediction using Shaply Additive exPlanation (SHAP), mean decrease in impurity (MDI), Ceteris Paribus (CP) profiles and the drop-out-loss method. Diabetes-predicting SUA cutoff points were calculated.
Results
The fourth quartile of SUA had a hazard ratio of 1.80 (1.03–3.24) for diabetes incidence compared to the lowest quartile. The revised definition of metabolic syndrome based on random forest reached an area under the curve (AUC) of 86.0 ± 3.32 and an F1-score of 86.48 ± 3.16 after 10-fold cross-validation. According to this machine learning model, adding SUA to the metabolic syndrome criteria can increase the AUC of diabetes prediction by 4.2 percent, just as it can be decreased by eliminating TG and blood pressure. Although FBS and waist circumference were found to be the two main predictors of diabetes, SUA had nearly the same impact as other variables, such as triglyceride (TG), high-density-lipoprotein (HDL) and blood pressure. Higher SUA does not necessarily predict diabetes better; the prediction starts increasing at 3 mg/dl and reaches a plateau at approximately 5 mg/dl. Our study suggests that SUA levels above 4 mg/dl in women and 5.1 mg/dl in men have the highest sensitivity and specificity for the prediction of T2DM.
Conclusion
SUA was as effective as TG, HDL, and blood pressure at predicting diabetes. The MetS definition's ability to predict diabetes can be improved slightly by incorporating SUA. Moreover, current hyperuricemia cutoffs require revision.
Ensemble representations are efficient codes that the brain generates effortlessly even under noisy conditions. However, the role of visual awareness for computing ensemble rep- resentations remains unclear. We present two psychophysical experiments (N=15x2) using a bias-free paradigm to investigate the contribution of conscious and unconscious processing to ensemble perception. Here we show that ensemble perception can unfold without awareness of the relevant features that define the ensemble. Computational modeling of the type-1 and type-2 drift-rates further suggest that awareness lags well behind the categorization pro- cesses that support ensemble perception. Additional evidence indicates that the dissociation between type-1 from type-2 sensitivity, was not driven by type-2 inefficiency or a system- atic disadvantage in type-2 decision making. The present study demonstrates the utility of robust measures for studying the role of visual consciousness and metacognition in stimuli and tasks of increasing complexity, crucially, without underestimating the contribution of unconscious processing in an otherwise visible stimulus.
Background:
The co-occurrence of depression among individuals with type 2 diabetes is a recognised global health problem and can lead to poorer health outcomes for both conditions. Behavioural activation is an evidence-based brief, low-cost psychological therapy which can be delivered by trained non-specialists, and is useful in treating depression, particularly in low-resource settings. The aim of this study is to test the effectiveness and cost-effectiveness of culturally adapted behavioural activation for depression in people with both depression and type 2 diabetes in two South Asian countries - Bangladesh and Pakistan.
Methods:
A parallel arm, multi-country randomised controlled trial will be conducted in urban health care facilities providing diabetes services. We will recruit 604 adults in total, and randomise them using a 1:1 allocation ratio to receive culturally adapted behavioural activation (DiaDeM), or optimised usual care. DiaDeM comprises six sessions of behavioural activation with a trained non-mental health facilitator, conducted face-to-face and/or remotely. Optimised usual care includes information on depression, pharmacological and non-pharmacological treatment options for depression and details for accessing help locally. Participants in both arms will be followed up at 6- and 12-months post-randomisation. The primary outcome is the severity of depressive symptoms at 6 months, measured using the 9-item Patient Health Questionnaire (PHQ-9). Secondary outcomes include diabetes control, measured using glycosylated haemoglobin. An embedded process evaluation will evaluate the quality of intervention delivery and explore mechanisms of change and the contextual factors associated with the implementation and observed outcomes of DiaDeM. An economic evaluation will gauge DiaDeM’s cost-effectiveness and estimate the impact of diabetes and depression on economic outcomes.
Conclusion:
There is an urgent need to address the rising burden of depression and chronic physical illnesses, such as type 2 diabetes. Interventions such as DiaDeM, which are culturally relevant and rely on a task-sharing approach, offer a potentially low-cost treatment within existing health services. If found to be effective and cost-effective, DiaDeM may be scaled up to address the mental health ‘treatment gap’ and improve mental and physical health outcomes for people with diabetes in South Asia.
Background: Personal protective equipment (PPE) adversely affects pulmonary gas exchange and may result in systemic hypercapnic hypoxaemia and headache. This study aimed to determine what extent PPE affects cerebral symptoms, global cerebral blood flow, and cognitive functional performance.
Background:
Personal protective equipment (PPE) adversely affects pulmonary gas exchange and may result in systemic hypercapnic hypoxaemia and headache. This study aimed to determine what extent PPE affects cerebral symptoms, global cerebral blood flow, and cognitive functional performance.
Methods:
Higher surgical trainees participated in a randomized, repeated-measures, crossover study, completing 60 min of laparoscopic surgical simulation in both standard operating attire and type 3 PPE. Measurements were collected at baseline and after 60 min of simulation. The primary outcome measure was headache. Headache was examined using the validated visual analogue scale (VAS) and Environmental Symptoms Questionnaire C (ESQ-C), global cerebral blood flow with duplex ultrasonography, and visuospatial and executive gross/fine motor function with grooved peg board (GPB) and laparoscopic bead (LSB) board tasks.
Results:
Thirty-one higher surgical trainees (20 men, 11 women) completed the study. Compared with standard operating attire, PPE increased headache assessment scores (mean(s.d.) VAS score 3.5(5.6) versus 13.0(3.7), P < 0.001; ESQ-C score 1.3(2.0) versus 5.9(5.1), P < 0.001) and was associated with poorer completion times for GPB-D (61.4(12.0) versus 71.1(12.4) s; P = 0.034) and LSB (192.5(66.9) versus 270.7(135.3) s; P = 0.025) tasks. Wearing PPE increased heart rate (82.5(13.6) versus 93.5(13.0) beats/min; P = 0.022) and skin temperature (36.6(0.4) versus 37.1(0.5)°C; P < 0.001), but decreased peripheral oxygen saturation (97.9(0.8) versus 96.8(1.0) per cent; P < 0.001). Female higher surgical trainees exhibited higher peripheral oxygen saturation across all conditions. No differences were observed in global cerebral blood flow as a function of attire, time or sex.
Conclusion:
Despite no marked changes in global cerebral blood flow, type 3 PPE was associated with increased headache scores and cerebral symptoms (VAS and ESQ-C) alongside impaired executive motor function highlighting the clinical implications of PPE-induced impairment for cognitive-clinical performance.
Background and aim:
Management of genotype 4 hepatitis C virus (HCV) has shifted to interferon-free regimens with a high sustained virological response (SVR-12), especially with NS5B/NS5A inhibitor combinations such as sofosbuvir and ledipasvir (Sof-Led). The guidelines have recommended the combination of sofosbuvir and another NS5A inhibitor, daclatasvir, to manage HCV genotypes 1-3. However, its use was extended to genotype 4 HCV based on extrapolating evidence. Our aim is to assess the efficacy of generic sofosbuvir + branded daclatasvir (Sof-Dac) compared to the Sof-Led combination in treating genotype 4 HCV.
Methods:
This study is an open-label, 2-period, noninferiority study that compared patients receiving a combination of generic sofosbuvir 400 mg and daclatasvir 60 mg orally daily (Group 2) prospectively to a historical control (Group 1) that included patients who received a combination of sofosbuvir/ledipasvir 400/90 mg orally daily. The primary endpoint is the proportion of patients who achieved SVR-12.
Results:
The study included 111 patients in the (Sof-Led) Group 1 and 109 patients (Sof-Dac) Group 2. For the primary outcome, SVR-12 was achieved in 106 (95.5%) of the patients in Group 1 versus 108 (99.1%) in Group 2 (p = 0.2). In addition, all patients who achieved SVR-12 also achieved SVR-24.
Conclusion:
Generic sofosbuvir combined with branded daclatasvir was safe and effective for treating genotype 4 HCV compared to Sof-Led. This combination may significantly reduce the cost burden, enabling a larger pool of treated patients. Office of research affairs at KFSHRC RAC# 2171 036.
This proceeding presents the papers presented at the 18th Scandinavian Conference on Health Informatics - SHI 2022 in Tromsø, Norway on August 22-24, 2022.
The SHI conference is an annual scientific event attended by scientist and practitioners working in the field of Health Informatics. The area of Health informatics is driven by development in technologies and informatics research that are advancing in parallel and for the integration of information and communication of health and social care. The area includes issues related to EHR, eHealth services and systems, intelligent systems, mobile health applications, telemedicine, assistive technology, artificial intelligence, and Internet of Things.
The field of Health Informatics in this conference is examined from a very broad perspective with participants presenting research outcomes and with focus on eHealth, informatics, Assistive technologies, machine learning, gaming, Internet of the Things, Implementation of eHealth services, EHR, Artificial Intelligence, management and organizational aspects, legal and social issues. More than 40 manuscripts were received with a total of 32 accepted as full papers and 11 as extended abstracts after peer-review. The Editorial Board selected publications with relevance and quality of the field to provide a state-of-the-art of the area. Authors of these communications are researchers of 35 different affiliations, and 13 countries (in alphabetic order: Czech Republic, Denmark, Finland, Germany, India, Italy, Luxembourg, Netherlands, Norway, Pakistan, Sweden, Switzerland, and USA).
All contributions are peer reviewed. The Editorial board expect this proceeding will be of interest for researchers and practitioners working in the field of Health Informatics.
Among many other things, 2022 made us aware of the value of networking. The past years , due to the Covid pandemic, demonstrated the necessity for access to information to improve health and healthcare, and the need for professionals to use and apply that information to transform healthcare. At the same time, the past years made us aware of different approaches and of the importance of Health informatics for renew and innovation of health and social care to improve the delivery of health and social care services to benefit citizens and patients, as we were forces to adapt to a “new normal” in many areas.
The Editors would like to thank the members of the Scientific Program Committee, the Organizing Committee, and all reviewers, who carried out the very professional, through and objective refereeing of the scientific work in order to achieve a high-quality publishing achievement for this scientific event.
The Editors would like to thank Linköpings University press, Sweden for the publication of the processing as an Open access Book. We expect the SHI 2022 provides a forum for research and researchers in Health Informatics, as well as to facilitate scientific discussion, share experiences, and promote collaboration and networking between researchers and practitioners across all countries.
In addition to the delegates presentations, SHI 2022 had the following keynote speakers: Prof. Sabine Koch from Karolinska Institutet (Sweden), Dr. Morten Hasselstrøm Jensen from Aalborg University (Denmark), Prof. and chief physician Audny Anke from the University Hospital of North-Norway (Norway), and research scholar & psychologist Henriette Michalsen, University Hospital of North-Norway (Norway).
Background:
The relevance of closing the platysma muscle layer after open thyroidectomy has received little interest in terms of research. The objective was to determine whether non-closure of the platysma muscle layer after open thyroidectomy impacts significantly on the cosmetic outcome of the resulting collar scar.
Methods:
In this prospective randomised controlled clinical trial, patients were assigned randomly to have the platysma muscle layer closed or not closed. The primary endpoint was the cosmesis of the collar scar six weeks after surgery assessed using the patient and observer scar assessment scale (POSAS). Additional endpoints included operation time and early postoperative wound complications.
Results:
Ninety-two patients were recruited, with 46 randomised to each group. The patient scar assessment subscale(PSAS) of the POSAS showed no significant difference in the scar cosmesis between the two groups six weeks after surgery (median PSAS: 16.5 vs 17.5; p = 0.514). The observer scar assessment subscale (OSAS) showed that the platysma muscle layer closure group had marginally better scars (median OSAS: 15 vs 17; p = 0.045). The size of the goitre did not make any significant difference in the scar cosmesis. There was no significant difference in the incidence of early postoperative wound complications as well as the median operation time.
Conclusion:
Not closing the platysma muscle layer had no significant impact on the scar cosmesis six weeks after open thyroidectomy, with no significant difference in the incidence of early postoperative wound complications and the operation time.
Later this year, the US Food and Drug Administration (FDA; Rockville, MD, USA) plans to rewrite its regulations to eliminate any reference to the Declaration of Helsinki (DoH), a document from the World Medical Association (WMA; Ferney‐le‐Voltaire, France) that many consider to be the hallmark of medical ethics (WMA, 2004). This decision, triggered by the 2000 update to the DoH, is the latest move in an increasingly heated debate over medical research ethics. The FDA is reacting in particular to the addition of two controversial paragraphs, which, if adopted in their own regulations, would limit the use of placebos in drug trials and increase the responsibilities of trial sponsors towards research participants.
> Unhappy with revisions made to the DoH between 2000 and 2004, the FDA now refers to the 1989 version of the Declaration, which the WMA itself considers invalid
Since 1975, the FDA, which decides what medicines are marketed in the USA and therefore influences similar decisions elsewhere, had cited the DoH in its rules for new drug applications from studies conducted outside the USA. Unhappy with revisions made to the DoH between 2000 and 2004, the FDA now refers to the 1989 version of the Declaration, which the WMA itself considers invalid. In the future, the FDA plans instead to refer to the Good Clinical Practice: Consolidated Guidance —a joint effort by drug approval agencies from Europe, the USA and Japan, and pharmaceutical trade organizations (ICH, 1996)—which honours the spirit, but not necessarily the wording, of the DoH. The European Commission (EC), which sets the pace on national drug laws and ethical standards in Europe, is also reluctant to adopt the latest version of the DoH and instead refers to the 1996 version in its 2001 clinical trials directive (EC, 2001) and its 2005 directive on good clinical …
The World Medical Association's Declaration of Helsinki was first adopted in 1964. In its 40-year lifetime the Declaration has been revised five times and has risen to a position of prominence as a guiding statement of ethical principles for doctors involved in medical research. The most recent revision, however, has resulted in considerable controversy, particularly in the area of the ethical requirements surrounding placebo-controlled trials and the question of responsibilities to research participants at the end of a study. This review considers the past versions of the Declaration of Helsinki and asks the question: How exactly has the text of the Declaration changed throughout its lifetime? Regarding the present form of the Declaration of Helsinki we ask: What are the major changes in the most recent revision and what are the controversies surrounding them? Finally, building on the detailed review of the past and present versions of the Declaration of Helsinki, we give consideration to some of the possible future trajectories for the Declaration in the light of its history and standing in the world of the ethics of medical research.