A cross-sectional study on the second victim experience and support at Sarawak General Hospital: A tertiary public hospital in Borneo Island, Malaysia.

Introduction: Second victim experience (SVE) refers to the emotional and psychological impact experienced by healthcare providers who are involved in patient safety incidents (PSIs). Despite growing awareness of patient safety in healthcare organizations, remedial actions often focus only on the first victim, the patient. Therefore, it is important to recognize and address the emotional and physical toll that PSIs to ensure the well-being of and to promote a culture of safety in healthcare settings.

Concurrent Validity Between EQ-5D and HRQ-6D Measures in Patients with Different Primary Diagnoses.

The HRQ-6D is a newly developed instrument to measure Health-related quality of life (HRQOL) and EQ-5D is the gold standard for measuring HRQOL. This study aims to test the concurrent validity between EQ-5D and HRQ-6D measures among patients with different primary diagnoses. : This cross-sectional study uses two HRQOL measurement instruments, EQ-5D-3L and HRQ-6D.

A generic and dynamic measure of health-related quality of life across a variety of health and disease conditions: insights from healthy individuals and patients with a variety of diagnoses.

Objectives: Health-Significant Quality of Life Measure (Health-SigQOLM) provides a generic and dynamic assessment of Health-related quality of life (HRQOL). This study aims to assess the HRQOL among healthy and non-healthy participants with varying chronic diseases.

Results: Comparisons between healthy and non-healthy participants revealed statistically significant differences (p < 0.

Health-Related Quality of Life with Six Domains: A Comparison of Healthcare Providers without Chronic Diseases and Participants with Chronic Diseases.

This study aims to compare the health-related quality of life (HRQOL) between healthcare providers without chronic diseases and participants with chronic diseases presenting with one of the four different primary diagnoses on the health-related quality of life with six domains (HRQ-6D) scale. This is a cross-sectional study to compare the HRQOL between healthcare providers without chronic diseases and participants with chronic diseases. Data collection was performed from May 2022 to May 2023.

Getting the Dose Right in Drug Development for Rare Diseases: Barriers and Enablers.

In the relentless pursuit of optimizing drug development, the intricate process of determining the ideal dosage unfolds. This involves "dose-finding" studies, crucial for providing insights into subsequent registration trials. However, the challenges intensify when tackling rare diseases.

Combination effect of optical defocus and low dose atropine in myopia control: Study protocol for a randomized clinical trial.

Background: Myopia, characterized by excessive axial elongation of the eyeball, increases risks of having sight-threatening diseases and impose a financial burden to healthcare system. Although myopic control interventions showed their effectiveness in slowing progression, the efficacy varies between individuals and does not completely halt progression. The study aims to investigate the efficacy of combining 0.

Health-SigQOLM is a versatile scale for measuring various aspects of health-related quality of life.

Objective: The "Health" element is one of the elements in Significant Quality of Life Measure (SigQOLM) that measures quality of life and well-being of people. This study aims to evaluate the Health element (Health-SigQOLM) as a generic and dynamic scale to measure health-related quality of life (HRQOL) with a broader spectrum of coverage. This study used a secondary data that developed SigQOLM.

Clinical pharmacology considerations for first-in-human clinical trials for enzyme replacement therapy.

Inborn errors of metabolism (IEM) such as lysosomal storage disorders (LSDs) are conditions caused by deficiency of one or more key enzymes, cofactors, or transporters involved in a specific metabolic pathway. Enzyme replacement therapy (ERT) provides an exogenous source of the affected enzyme and is one of the most effective treatment options for IEMs. In this paper, we review the first-in-human (FIH) protocols for ERT drug development programs supporting 20 Biologic License Applications (BLA) approved by the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA) in the period of May 1994 to September 2023.

Sample size determination for conducting a pilot study to assess reliability of a questionnaire.

This article is a narrative review that discusses the recommended sample size requirements to design a pilot study to assess the reliability of a questionnaire. A list of various sample size tables that are based on the kappa agreement test, intra-class correlation test and Cronbach's alpha test has been compiled together. For all calculations, type I error (alpha) was set at a maximum value of 0.

Measuring population health and quality of life: Developing and testing of the significant quality of life measure (SigQOLM).

Quality of life (QOL) should ideally be determined by a broader spectrum of measurable parameters. This study aims to develop and validate a study instrument that is designed to determine a holistic measure of health and non-health aspects of QOL, and it is called the 'Significant Quality of Life Measure' (SigQOLM). This study involves five phases which aim to (i) explore and understand the subject matter content, (ii) develop a questionnaire, (iii) assess its content validity and face validity, (iv) conduct a pilot study, and lastly (v) perform a field-test by using the questionnaire.

Dose selection for biological enzyme replacement therapy indicated for inborn errors of metabolism.

This paper summarizes key features of the dose-finding strategies used in the development of 11 approved new molecular entities that are first-in-class enzyme replacement therapy (ERT), with a goal to gain insight into the dose exploration approaches to inform efficient dose-finding in future development of biological products for Inborn Errors of Metabolism (IEM). Dose exploration should preferably begin in in vitro studies, followed by testing multiple doses in an appropriate animal disease model, when available, which can provide important information for dose assessment in humans. Performing adequate dose-finding in early phase clinical studies in a well-defined study population, including pediatric subjects, is generally critical to inform dose selection for pivotal trials; alternatively, additional dose exploration can be incorporated as part of a pivotal trial.

Impact of Organ Impairment on the Pharmacokinetics of Therapeutic Peptides and Proteins.

The kidneys and liver are major organs involved in eliminating small-molecule drugs from the body. Characterization of the effects of renal impairment (RI) and hepatic impairment (HI) on pharmacokinetics (PK) have informed dosing in patients with these organ impairments. However, the knowledge about the impact of organ impairment on therapeutic peptides and proteins is still evolving.

Development of a Quality-of-Life Instrument to Measure Current Health Outcomes: Health-Related Quality of Life with Six Domains (HRQ-6D).

Health-related quality of life (HRQOL) is one of the most important outcome measures to be assessed by medical research. This study aims to develop and validate an instrument called the "health-related quality of life with six domains" (HRQ-6D), which aims to measure an individual's health-related quality of life within a 24 h period of time. This is a questionnaire development study involving five phases, which are (i) to explore the subject matter content for gaining a better understanding of the topic, (ii) to develop the questionnaire, (iii) to assess both its content validity and face validity, (iv) to conduct a pilot study, and finally, (v) to undertake a field testing of the questionnaire.

A systematic review of cost and well-being in hip and knee replacements surgical site infections.

This systematic review examined peer-reviewed literature published from 2010 to 2020 to investigate the health care system costs, hidden out-of-pocket expenses and quality of life impact of surgical site infections (SSIs) and to develop an overall summary of the burden they place on patients. SSI can significantly impact patients' treatment experience and quality of life. Understanding patients' SSI-related burden may assist in developing more effective strategies aimed at lessening the effects of SSI in financial and well-being consequences.

Research landscape on 3D printing applications in healthcare within Southeast Asian countries: a systematic scoping review protocol.

Introduction: Three-dimensional (3D) printing plays a significant role as a promising technological advancement in modern healthcare settings. 3D printing has been incorporated by many sectors worldwide including in Southeast Asian countries. However, there is a paucity of research, especially in the healthcare pertaining to 3D printing activity in the Southeast Asian region.

Experience, decision-making and information needs around parenteral nutrition among people with advanced cancer, and their carers: A scoping review.

Background: The present study aims to summarise current knowledge and identify gaps in knowledge and research regarding experience, decision-making and information needs around parenteral nutrition, among people with advanced cancer, and their carers.

Methods: This review was informed by previous methods and guidance on conducting and reporting scoping reviews. A literature search was conducted in March 2021 using Embase, Medline, CINAHL, Google and Web of Science to identify studies that examined the experience, decision-making process and information needs of adults with advanced cancer, and their carers, who were making decisions around commencing and discontinuing parenteral nutrition.

An unusual cause of pulmonary infiltrates mimicking pulmonary edema: metastatic calcifications.

Metastatic calcification is an uncommon condition with underlying abnormal bone and calcium metabolism, leading to ectopic deposition of calcium in soft tissues. The lung is a common site of involvement, and can mimic pulmonary edema in radiographic findings, especially in clinical context of end-stage renal failure. Recognition of such condition is important to avoid unnecessary diuretic therapy and extra dialysis sessions and guides correct treatment of underlying metabolic disorder.

Are radiographers suffering from symptoms of compassion fatigue due to occupational stress: A systematic review.

Introduction: Repeated exposure to challenging or traumatic situations can lead to a phenomenon called compassion fatigue (CF). This can present as increased stress and anxiety in staff and a reduced patient relationship. If untreated it can lead to sickness and attrition from the profession.

Physiologically Based Pharmacokinetic Modeling of Metformin in Children and Adolescents With Obesity.

Childhood obesity continues to rise in the United States and, with it, the off-label use of metformin for weight loss. The influence of age and obesity on the drug's disposition and exposure has not previously been studied using a mechanistic framework. Here, an adult physiologically based pharmacokinetic (PBPK) model of metformin was scaled to pediatric populations without obesity, with overweight/obesity, and with severe obesity; a published virtual population of children and adolescents with obesity was leveraged during model evaluation.

A Technique for Minimizing the Need for Hemotransfusion in Non-Syndromic Craniosynostosis Surgery.

Surgery for craniosynostosis is associated with excessive blood loss, as well as morbidity and mortality risks. This study investigated the effectiveness of a surgical technique for nonsyndromic craniosynostosis intervention in controlling bleeding, assessed based on the volume of blood transfused. The cohort included 73 children who underwent nonsyndromic craniosynostosis surgery during a 3-year period.

Pediatric minor head trauma in Brazil and external validation of PECARN rules with a cost-effectiveness analysis.

Background: Pediatric minor head trauma approaches aim to ensure the absence of traumatic brain lesions, minimize ionizing radiation, and enhance cost control. We evaluated the applicability and cost-effectiveness of the Pediatric Emergency Care Applied Research Network (PECARN) rules after head trauma and rationalize the use of head computed tomography (CT) scans.

Methods: We retrospectively divided patients <18 years old who presented at a single institution in Brazil with minor head trauma into four groups: Group I (skull X-ray only), Group II (head CT only), Group III (X-ray and CT), and Group IV (observation only).

Hypofractionated Stereotactic Ablative Radiotherapy for Recurrent or Oligometastatic Tumours in Children and Young Adults.

Aims: Cancer remains a leading cause of death in children and adolescents in the developed world. Despite advances in oncological management, rates of primary treatment failure remain significant. Radiation of recurrent or metastatic disease improves survival in adults but there is little data to support clinical decision making in the paediatric/teenage and young adult population.

Association between long-term orthokeratology responses and corneal biomechanics.

Myopia is very prevalent worldwide, especially among Asian populations. Orthokeratology is a proven intervention to reduce myopia progression. The current study investigated association between baseline corneal biomechanics and orthokeratology responses, and changes of corneal biomechanics from long-term orthokeratology.

Healthy eating interventions in adults living with and beyond colorectal cancer: a systematic review.

Background: Rates of cancer survival are increasing, with more people living with and beyond cancer. Lifestyle recommendations for cancer survivors are based largely on extrapolation from cancer prevention recommendations. The present study aimed to systematically review the literature on randomised controlled trials (RCTs) focusing on healthy eating interventions in people with colorectal cancer (CRC).