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ObjectivesTo describe reporting of informed consent in pragmatic trials, justifications for waivers of consent and reporting of alternative approaches to standard written consent. To identify factors associated with (1) not reporting and (2) not obtaining consent.MethodsSurvey of primary trial reports, published 2014–2019, identified using an electronic search filter for pragmatic trials implemented in MEDLINE, and registered in ClinicalTrials.gov.ResultsAmong 1988 trials, 132 (6.6%) did not include a statement about participant consent, 1691 (85.0%) reported consent had been obtained, 139 (7.0%) reported a waiver and 26 (1.3%) reported consent for one aspect (eg, data collection) but a waiver for another (eg, intervention). Of the 165 trials reporting a waiver, 76 (46.1%) provided a justification. Few (53, 2.9%) explicitly reported use of alternative approaches to consent. In multivariable logistic regression analyses, lower journal impact factor (p=0.001) and cluster randomisation (pDiscussionNot obtaining consent seems to be increasing and is associated with the use of cluster randomisation and pragmatic aims, but neither cluster randomisation nor pragmatism are currently accepted justifications for waivers of consent. Rather than considering either standard written informed consent or waivers of consent, researchers and research ethics committees could consider alternative consent approaches that may facilitate the conduct of pragmatic trials while preserving patient autonomy and the public’s trust in research.

All medical interventions need informed consent of the patient, which is obtained after providing all the relevant information to him in a comprehensible form resulting in meaningful decision making. Psychiatric patients, on some occasions, lack the capacity to take decisions on their mental health care and treatment. Utmost care should be taken in dealing with such patients, to proceed for their treatment after obtaining consent from their relatives/friends as per the legal provisions. The recently introduced Mental Health Care Bill – 2013 contains elaborate provisions regarding informed consent, which is to be obtained from persons with mental illness, and/or his nominated representative. Full informed consent is mandatory from all participants before proceeding to carry out any research project. Persons with mental illness who lack capacity to give consent should be included in a research study, only if there is likelihood of benefit for them or if it is intended to promote the health of the population represented by the potential subject.

Background: We carried out a case-control study that examined whether receipt of the inactivated influenza vaccine during the 2019–2020 season impacted on the risk of coronavirus disease 2019 (COVID-19), as there was a concern that the vaccine could be detrimental through viral interference. Methods: A total of 920 cases with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (diagnosed between March and October 2020) and 2,123 uninfected controls were recruited from those who were born in Québec between 1956 and 1976 and who had received diagnostic services at two hospitals (Montréal and Sherbrooke, Québec). After obtaining consent, a questionnaire was administered by phone. Data were analyzed by logistic regression. Results: Among healthcare workers, inactivated influenza vaccine received during the previous influenza season was not associated with increased COVID-19 risk (AOR: 0.99, 95% CI: 0.69–1.41). Among participants who were not healthcare workers, influenza vaccination was associated with lower odds of COVID-19 (AOR: 0.73, 95% CI 0.56–0.96). Conclusion: We found no evidence that seasonal influenza vaccine increased the risk of developing COVID-19.

Background: In inguinal hernia patient post-operative recurrence rate has been decrease due to advancement in prosthetic mesh. The hernia outcome study should concentrate on hernia post-operative quality of life and various complications. Objectives: To study the application of HERQL INSTRUMENT in surgical practice. To study the quality of life pre-operatively & post-operatively. To utilise as HERQL INSTRUMENT in clinical management as a prognostic indicator to improve upon the healthcare system. Methodology: All the patients of inguinal hernia presenting to Acharya Vinoba Bhave Rural Hospital, Sawangi (Meghe), Wardha as an elective/emergency case will be included in the study after obtaining consent. Patient has to go through the HERQL questionnaire pre-operatively and post-operatively or post-operatively only. These patients will be enrolled in the study. Results: We expect a causal relationship between formative symptomatic subscale and the reflective functional status demonstrated by HERQL. The assessment of summative pain in preoperative and immediate postoperative patient shows changes in summative pain and 3 month follow up suggestive of clinical response of HERQL. Conclusion: This study will help to know quality of life in “post-operative” hernia patient with the help of “HERQL instrument”.

There is significant research value in the secondary use of surplus human tissue which has been removed during clinical care and is stored in diagnostic archives. However, this value is limited without access to information about the person from whom the tissue was removed. As the research value of surplus tissue is often not realised until after the patient’s episode of care, it is often the case that no consent has been given for any surplus tissue to be used for research purposes. The Human Tissue Act 2004 does permit research use of surplus tissue without consent, but the researcher must not be in possession of information which could identify the person from whom the tissue was removed. Due to the commonly applied ‘consent or anonymise’ approach, linking tissue and data is challenging and full anonymisation would likely render much research on surplus tissue ineffectual. This article suggests that in recognising the value in surplus tissue linked with information about the person, a ‘share and protect’ approach which considers safeguards other than anonymisation, where obtaining consent for research use would not be feasible, would better balance the public benefit of health research with the protection of individual rights and interests than a requirement for either consent or anonymisation.

Introduction: This cross-sectional survey was conducted to estimate the proportion of participants among health care workers and general population who are willing to get vaccinated against COVID-19 and those who are not, and to identify the reasons for vaccine hesitancy among the participants. Methods: Health care workers of a tertiary care hospital and the general population residing in the nearby areas of the tertiary care hospital were predominantly included in the study. A specific questionnaire was designed, validated, and administered to the participants after obtaining consent. Result: The responses were collected using Google Form and compiled in an excel sheet for analysis. The difference in opinion with regard to acceptance of the COVID-19 vaccine was statistically analysed using Chi-square test. The vaccine acceptance rate was high among the general population (70.2%) as compared to health care workers (56.7%) (p = 0.0006, highly significant). The remaining proportions of participants (43.3% of health care workers and 29.8% of general population) were hesitant to receive the COVID-19 vaccine. Conclusion: The reasons for vaccine hesitancy were fear of harmful effects, doubtful efficacy, lack of transparency in clinical trials, and fast track vaccine development. How to cite this article:Abinaya E, Maignana Kumar R, Ruckmani A, Arunkumar R. Assessment of COVID-19 Vaccine Acceptance among Health Care Workers and General Population - A Cross-Sectional Survey. J Commun Dis. 2021; 53(2): 82-88. DOI: https://doi.org/10.24321/0019.5138.202130

The current study aims to develop a better understanding of university students’ perspectives, expressions, and use of sexual consent in various situations. A sample of 216 undergraduate students responded to a questionnaire about sexual consent. Using qualitative content analysis, the first author created categories from participants’ responses and the third author then re-coded them to ensure adequate interrater reliability. Many students reported sexual consent as always being important, but this sometimes changed in long-term relationships. Most students reported using verbal cues to indicate their own consent to engage in sexual activities and relied on verbal cues from their partners to indicate consent. However, most students reported using both verbal and non-verbal cues to indicate their own unwillingness to engage to sexual activities and relied on those cues from their partners as well. Students rarely explicitly identified the need for consent to be non-coercive and non-violent or for either themselves or their partner to be aware and conscious when providing consent. Although students usually recognize the importance of sexual consent and engage in mostly healthy practices of consent, some problematic attitudes and behaviours still exist among this population. These results can be useful for enhancing current sexual consent education and sexual violence prevention programs for post-secondary students, ensuring that students feel comfortable giving and obtaining consent in healthy ways.

Background Obtaining informed consent for clinical research in the pediatric emergency department (ED) is challenging. Our objective was to understand the factors that influence parental consent for ED studies. Methods This was a cross-sectional survey assessing parents' willingness to enroll their children into an ED research study. Parents reporting a willingness to enroll in ED studies were presented with two hypothetical scenarios, a low-risk and a high-risk study, and then asked about decision influencers affecting consent. Parents expressing a lack of willingness to enroll were asked which decision influencers impacted their consent decision. Results Among 118 parents, 90 (76%) stated they would be willing to enroll their child into an ED study; of these, 86 (96%) would consent for a low-risk study and 54 (60%) would consent for a high-risk study. Caucasian parents, and those with previous research exposure, were more likely to report willingness to participate. Those who would consent to the high-risk study cited "benefits that research would provide to future children" most strongly influenced their decision to agree. Conclusions ED investigators should highlight the benefits for future children and inquire about parents' previous exposure to research to enhance ED research enrollment. Barriers to consent in non-Caucasian families should be further investigated. Impact Obtaining consent for pediatric emergency research is challenging and this study identified factors influencing parental consent for research in EDs. Benefits for future children and parents' previous research experience were two of the most influential factors in parents' willingness to consent to ED research studies. These findings will help to improve enrollment in ED research studies and better our understanding of how to promote the health and well-being of pediatric patients.

Many high-risk medical devices earn US marketing approval based on limited premarket clinical evaluation that leaves important questions unanswered. Rigorous postmarket surveillance includes registries that actively collect and maintain information defined by individual patient exposures to particular devices. Several prominent registries for cardiovascular devices require enrolment as a condition of reimbursement for the implant procedure, without informed consent. In this article, we focus on whether these registries, separate from their legal requirements, have an ethical obligation to obtain informed consent from enrolees, what is lost in not doing so, and the ways in which seeking and obtaining consent might strengthen postmarket surveillance in the USA.

Intraparietal Hernias are hernias occurring in the anterior abdominal wall at different anatomical planes. An interparietal hernia has a hernial sac that passes between the layers of the anterior abdominal wall. Appendectomy is a very common surgical procedure, and post appendectomy incisional hernia is a very rare complication. Here we present a case of a 24-year-old male with swelling in the right hypochondrium and lumbar region with an open appendectomy scar. He was diagnosed to have an interparietal hernia in the anterior abdominal wall. After obtaining consent patient was taken up for surgery. At surgery, the patient was found to have a defect in the transverse abdominis muscle with a medial leaf far from the incision site. Open repair of the defect along with double breasting of external oblique done. Interparietal hernias are rare in post appendectomy scar and this case is of significance since it Highlights a rare interstitial type incisional hernia, as a complication of post appendectomy scar, and not many cases reports are mentioned in literature.

Consent and assent are important concepts to understand in the care of pediatric neurosurgery patients. Recently it has been recommended that although pediatric patients generally do not have the legal capacity to make medical decisions, they be encouraged to be involved in their own care. Given the paucity of information on this topic in the neurosurgery community, the objective is to provide pediatric neurosurgeons with recommendations on how to involve their patients in medical decision-making. We review the essential elements and current guidelines of consent and assent for pediatric patients using illustrative neurosurgical case vignettes. The pediatric population ranges widely in cognitive and psychological development making the process of consent and assent quite complex. The role of the child or adolescent in medical decision-making, issues associated with obtaining assent or dissent, and informed refusal of treatment are considered. The process of obtaining consent and assent represents a critical yet often overlooked aspect to care of pediatric neurosurgical patients. The pediatric neurosurgeon must be able to distill immensely complex and high-risk procedures into simple, understandable terms. Furthermore, they must recognize when the child’s dissent or refusal to treatment is acceptable. In general, allowing children to be involved in their neurosurgical care is empowering and gives them both identity and agency, which is the vital first step to a successful neurosurgical intervention.

Traditional didactic lectures is one of the commonly followed method of teaching learning in most of the medical colleges to teach undergraduate medical students till now. This method is a passive method of learning in which teacher will be talking and students has to listen, this type of teaching is dominating our MBBS curriculum. Students find these lecture classes very boring. Also after the implementation of new competency based medical education (CBME) by Medical council of India, medical education for undegraduates needs lots of recent improvements to provide satisfactory changing demands in medical practice. Physiology lecture classes was restructured with introduction of pre and post-test, knowledge before and after the lecture were obtained by comparing the test scores before and after to evaluate the enhancement of learning after the lectures. Also feedback regarding the introduction of pre & post -test from the students were taken for evaluating the effectiveness of lectures with the introduction of the test before and after the lecture classes. 1. To provide Pre-test & Post-test questions before lecture and after lecture classes on the topic; 2. To evaluate the enhancement of Learning after lecture based on post-test scores; 3. To evaluate the effectiveness of physiology lecture among students in relation to feedback obtained. The present study was conducted on 150 First year M.B.B.S during Physiology lectures, after obtaining Ethical clearance from the Instituitional Ethical Committee, Adichunchanagiri Institute of Medical Sciences, Adichunchanagiri university.I MBBS(150) students after obtaining consent for voluntary participation were asked to take the pre-test question s containing 20 multiple choice questions on topic “Cardiac cycle & Cardiac output” and the same 20 multiple choice questions were provided to the students at the end of the four hour lecture classes on the topic. Performance of the students with the salient concepts on the topic were assessed by the pre-test & post-test scores. Feedback from all students were obtained regarding perception of students on the use of pre and post-test in learning the salient concepts in physiology were obtained by administering a questionnaire.Pre-test score of the students obtained before the start of the lecture was 5.57±1.29 and the Post-test score of the students obtained after the end of four hour lecture classes on the topic was 15.26±9.7 (p < 0.0001) this was highly significant. Feedback obtained from the students was indicative of that most of the students felt that test was very interesting, innovative, they could focus more on the lecture classes, it helped them to learn the salient concepts in physiology, also most of them felt competitive aspect of the test contributed to their effectiveness and most of them wanted it during lectures. From the present study we would like to conclude that introducing pre and post-test in lectures could enhance learning among students. Also we could evaluate the effectiveness of lectures by introducing pre and post – test based on feedback obtained from the students.

La enseñanza moral católica afirma que es necesario el consentimiento de los pacientes para autorizar las intervenciones sanitariasque les afectan, pero no especifica las condiciones para obtener dicho consentimiento o evaluar la capacidad de decisión. Aquí se presentan los artículos recogidos en este número que los autores han desarrollado a partir de las presentaciones que hicieron durante un coloquio reciente de la Asociación Internacional de Bioética Católica (IACB) celebrado en Quebec, Canadá. Contribuyen a promover el pensamiento ético sobre la capacidad de toma dedecisiones y el consentimiento. De diversas formas, piden que se respete la dignidad de todos los pacientes y que se promueva su participación tanto como sea posible en la toma de decisiones sobre su salud. Consideran que la toma de decisiones es relacional y abarca una variedad de capacidades. Examinan el papel de los miembros de la familia y de otros partidarios de la toma de decisiones en la promoción de las capacidades de los pacientes, cuya condición de salud mental o discapacidad les impide a menudo cumplir con los estándares clínicos y legales típicos para la capacidad de toma de decisiones.

Üniversite kütüphaneleri hizmet verdiği kullanıcı grubunun bilgi ihtiyaçlarının karşılanmasında sorumlulukları bulunan kurumlardır. Diğer kütüphane türlerinde olduğu gibi üniversite kütüphanelerinde de oluşturulan kullanıcı kayıtları bireyi tanımlayabilecek hatta bilgi arama davranışlarıyla da ilişkilendirilebilecek düzeyde kişisel verilerden oluşabilmektedir. Bu noktada üniversite kütüphanelerindeki kullanıcı verilerinin izinsiz ve yetkisiz kullanıma karşın korunması gerekliliği ortaya çıkmaktadır. Bu çalışmada, üniversite kütüphanelerinin kişisel verilerin korunmasına yönelik uygulamalarının betimlenmesi amaçlanmıştır. Belirlenen amaç çerçevesinde çalışmada öncelikle konuyla ilgili literatürden hareketle 15 üniversite kütüphanesindeki kişisel verilerin yönetimine dönük uygulamaları yöneticilerle yapılan görüşmelerle analiz edilmiştir. Bulgular, kütüphanelerde kayıt altına alınan kullanıcı verilerinin farklılık gösterdiğini ve kütüphanelerin yaklaşık yarısında kullanıcılardan kişisel verilerinin toplanmasına ve işlenmesine yönelik onaylarının alınmadığını ortaya koymuştur. Araştırmanın sonucunda, üniversite kütüphanelerinde kullanıcılara yönelik kişisel verilerin toplanması, kaydedilmesi, sınıflandırılması, işlenmesi, tutulması ve saklanması ve kullanıcılardan kişisel verilerin işlenmesine yönelik onaylarının alınması noktasında eksiklikler olduğu saptanmıştır.

Breast feeding and complementary feeding are known to play a crucial role in the growth and development of an infant. Various Global agencies recommend that Infants should be exclusively breast fed for 6 months and appropriate complementary feeding should be started at the age of six months without discontinuing breastfeeding. Though there are many awareness programmes of the Government, there are still many wrong practices and myths associated with infant feeding. This study aims to evaluate the knowledge about breast feeding and complementary feeding in pregnant women. Material and Methods: A cross sectional study was carried out in the Field Practice area of a Medical College In Maharashtra. There were 80 pregnant women in the 10 adopted villages. 58 women were interviewed for the study by the principal investigator after obtaining consent, with the help of a pretested, IYCF questionnaire formulated by Breast feeding Promotion Network of Results: Out of the 58 women interviewed, all were married and majority 50, (86.20%) were housewives. 46(79.31%) belonged to joint families. 32(55.17%) were primigravida and 26 (44.87%) were multigravida.93% had knowledge of exclusive breastfeeding but only 72% knew the correct time of initiation.57% felt that pre-lacteal foods should be given. 47% knew correct age of giving complementary foods but variety of foods to be given was not known. Myths regarding complementary foods are prevalent. 60% believed that bottle feeding should not be given. Level of education has a positive impact on infant feeding practices. Recommendations: Education regarding infant and young child feeding practices should be given to all pregnant women and also to their family members

Background and Objectives: Adequate knowledge about the number of roots, canals, and morphology of lower first molar teeth is a basic requirement of root canal therapy and any surgical treatment in this region, was carried out to investigate root and canal morphology of permanent mandibular first molars in a sample from Erbil population using cone beam computed tomography (CBCT). Methods: This study carried out during a period from October 2017 till June 2018. The sample selected from patients visited (college of Dentistry, Denta Plus, Hollywood Smile Design) centers in Erbil city according to specific criteria. One hundred patients have been selected from those patients who referred to obtain CBCT for the lower mandibular region, after obtaining consent from these patients and about 141 mandibular first molar teeth were used in this study. Different measurements were done on the CBCT of each patient by investigating the root numbers, the number of canals and root canal configuration which classified by using Wein’s and Vertucci’s classification. The data were analyzed statistically by Pearson’s Chi-square. Results: The result indicated that the first molar tooth had two roots one mesial and one distal, while about the numbers of extra roots the result indicated that only the distal root showed five extra roots (3.5%). The data analysis for the number of canals in study sample indicated that the mesial root had two canals in all sample while in distal root showed that 41 mandibular first molars showed two canals which were about 29.1% and 100 mandibular first molars showed one canal which was about 70.9%. The result indicated that morphology of distal root canal of mandibular first molars according to Wein’s classification, it that 70.9% of the study sample was of type I morphology, both type II and type IV were about 5% of the sample, type III morphology about 12.8%, and about 6.4% of study sample classified according to Vertucci classification which showed type III morphology while for the morphology of mesial root canal of lower first molar tooth the result indicated that 100% of the samples had type III Wein’s morphology. Conclusion: The prevalence of extra root was about 3.5% in distal root. Wein’s type I the most prevalent configurations in distal root and type III Wein’s in the mesial root of the first mandibular molars. CBCT analysis of root canal system provides information and details which is very helpful in different treatment modalities.

Objective To estimate the prevalence of polycystic ovary syndrome (PCOS) among women of reproductive age across educational institutions in the Kashmir valley. Methods A cross-sectional study was conducted from May 2013 to May 2015. Eligible girls and women aged 15-40 years were included using a multistage random selection process from five out of 12 districts in turn housing 14 educational institutions. They were screened through a brief questionnaire in a staged manner. After obtaining consent, women underwent detailed clinical, biochemical, hormonal, and sonographic evaluation to satisfy Rotterdam 2003 criteria. The participants were also evaluated using NIH and AE-PCOS criteria. Results Out of a total of 3300 eligible women, 964 women were evaluated using a structured questionnaire. Among these, 446 (46.4%) were identified as "probable PCOS" cases. Out of 171 probable PCOS women who completed all biochemical, hormonal, and sonographic assessment, 35.3% qualified for a diagnosis of PCOS using Rotterdam criteria. The prevalence of PCOS was 28.9% by NIH criteria and 34.3% by AE-PCOS criteria. Conclusion The prevalence of PCOS is high among Kashmiri women and is probably the highest in a published series globally. A countrywide systematic prevalence study is warranted to reconfirm the findings.

The use of electronic gadgets, especially mobile phones among youth, has been a growing global concern. The worldwide COVID-19 lockdown has only amplified the issue. The extended period of lockdown and virtual classes has increased college students' time on their electronic gadgets. The debilitating health effect of excessive usage of gadgets has been well established. There are an array of effects like headache, nausea, ophthalmological concerns and psychological outcomes associated with gadget use for extended periods. The study aims to understand the difference in time spent using gadgets before and during the lockdown and the associated health impacts. The study included 348 participants (n=348), consisting of 183 female and 165 male participants. Data was collected using a semi-structured questionnaire through Google forms from college students after obtaining consent. The results suggested that the average time spent on gadgets increased from 4.75 hrs/day before lockdown to 11.36 hrs/day during lockdown among participants. Most health complaints like headaches, insomnia, eye complaints, tiredness and restlessness were associated with gadget use during the lockdown. The percentage of participants experiencing these complaints during lockdown was also significantly higher than before lockdown. By understanding the effects of gadget use, it would be possible to create interventions and suggest ways to manage the excessive use of gadgets. It is of prime importance to handle the issue considering the quality of life and wellbeing of students.

Consent must be undertaken prior to any dermatological procedure; however, in doing this, the clinician needs to ensure consent is valid and satisfies the principles of determining material risk. We aimed to assess variations in obtaining consent in the UK and understanding of material risk through a nationally distributed survey to members of the British Society for Dermatological Surgery and British Association of Dermatologists. Of 165 responses, we found that written consent was being obtained for all procedures in 73.9% of cases and typically at the time of procedure in the operating room/theatre (78.8%). Fifty-seven per cent of respondents were not familiar with the term 'material risk' and almost one-third were not aware of the Montgomery vs. Lanarkshire ruling, which replaced the Bolam test in 2015. We would encourage readers to be aware of these changes to consent law in the UK and how it might affect their approach to obtaining consent.

The number of clinical trials in Japan that aim to obtain regulatory approval for new drugs and devices has increased for adults, but not children. The following reasons have been proposed for this discrepancy: the wide range of ages from newborns to adolescents, requirements for many drug formulations, the difficulties associated with obtaining consent, and less profit for companies. The processes required to obtain regulatory approval for drugs and devices, particularly in the pediatric field, differ among Japan, Europe, and the United States (US). While clinical trials are not necessarily required for the development of new drugs or obtaining additional indications in Japan, laws in Europe and the US require clinical trials on children for newly developed drugs; however, pharmaceutical companies are entitled to a 6-mo extension for a patent when pediatric data are added to the attached documents for clinical trials. We herein discuss the current status of and issues associated with pediatric drug development, including clinical trials, in Japan as well as future perspectives.

Some claim that consent requires common knowledge. For a doctor to obtain consent, a doctor must know that her patient has given her permission to perform surgery, and her patient must know the doctor knows that he has given this permission. Some claim that such common knowledge requires communication, and so consent requires communication: the patient must tell the doctor he consents for both to know consent took place, and for both to know the other knows consent took place. I first defend the claim that consent requires common knowledge, responding to recent objections. I then argue that, though consent requires common knowledge, it does not always require communication. It does not require communication when the agent obtaining consent can infer common knowledge based on non-behavioral facts about the world.

Aim: To study the diagnostic accuracy of surgeon performed ultrasound (SPU) in the diagnosis of children presenting with clinical suspicion of intussusception to a tertiary paediatric facility in NSW, Australia. Methods: Children under the age of 16 presenting to the emergency department with clinical features suggestive of intussusception were recruited. After obtaining consent SPU was performed by a Paediatric surgeon. All patients subsequently had an ultrasound performed in radiology department (RPU) on which management was based. Diagnosis and images of SPU were reviewed by an independent radiologist blinded to results of the formal study. Results: Of 7 children enrolled 5 were male. Age ranged from 3 months to 7 years (mean 2.64, SD 2.282), weight from 5.2kgs to 25.2kgs (mean 13.69, SD 6.721). Five out of the 7 children presented during day hours i.e. 8a.m.-5 p.m. (mean 12.72, SD 4.049). Mean time to SPU was 6.3 hours (SD7.1) and RPU was 8.3 hours (SD 7.6). SPU was earlier by 2 hours and correlation between SPU and RPU was 100 percent. Conclusion: SPU for intussusception can be performed early and accurately. Surgeons should train and use ultrasound as a reliable tool in evaluating the child with suspected intussusception.

Background: Obtaining informed consent for diagnostic and therapeutic procedures is of great moral and legal importance, which is more important in the field of pediatrics due to its specific issues. Objectives: Obtaining informed consent in the pediatric field is specific because of many factors, including the age of the patients and the necessity of obtaining consent from parents or legal guardians. This study aimed to evaluate the process of obtaining informed consent from the viewpoint of substitute decision-makers (parents or guardians) and physicians. Attention to the differences between the views of these two groups by establishing appropriate and correct communication skills between them can lead to greater satisfaction and increased effectiveness of treatments. Methods: In this descriptive study, the data were collected through questionnaires completed by 188 parents and 23 physicians. Finally, the statistical analysis was conducted using the one-sample t test method in SPSS 16. Results: In 96.3% of the cases, parents believed that where the patient, their relatives, and the medical team disagreed about the kind of treatment, the final decision was made by the medical team. One-third of them did not receive enough information or received no information at all. Informing parents about other possible treatments, complications of the procedures, considering the patients and their relatives’ opinions for the final decision, informing the child about his/her disease and treatment plans, and informing the parents about the possible outcomes were not in the favorable range. Physicians believed that decision about the treatment was made based on the opinion of the parents and the clinical committee, and only in 3.4% of the cases, their opinion was the basis for decision-making. Conclusions: The results showed that there was a gap between the parents and physicians’ opinions about informed consent, as the physicians believed that they act as the patients’ parents wish and the parents believed that their opinion played no important role in the final decision regarding the health of their children. Thus, it seems necessary to institutionalize the culture of participatory decision-making by physicians and parents in decisions related to the diagnosis and treatment of children, and more emphasis should be placed on establishing the right relationship between treatment staff and patients and their relatives.

Introducción: Se hace una correlación entre la osteoatrosis y las condiciones laborales, hábitos y estilos de vida de los trabajadores informales del centro de Medellín, Colombia. Objetivo: Identificar la relación de la osteoartritis y la prevalencia de enfermedades crónicas y degenerativas con las condiciones sociodemográficas, laborales, hábitos y estilos de vida en un grupo de trabajadores informales de Medellín, Colombia. Materiales y métodos: Estudio transversal, con fuente primaria de información de 686 trabajadores informales. Se realizó una encuesta asistida, previa toma de consentimiento. Se seleccionaron 289 trabajadores con diagnóstico de enfermedad crónica o degenerativa, ≥18 años, con ≥5 años en su oficio. Se realizaron análisis exploratorios y de asociación con prueba Chi2, y cálculo de RP con IC del 95%. Resultados: el 79,9% de la población padecía alguna enfermedad crónica. El 3,46% presentaba diagnóstico de osteoartritis, siendo significativamente mayor (p45 años (RP=2,26), mujeres (RP:4,44), trabajadores sedentarios (RP=1,71), obesos (RP=3,40), así como en quienes habían sido obreros (RP=1,30), en aquellos que tenían puestos de venta semiestacionaria (RP=2,21), vendían productos de cosecha y perecederos (RP=1,78), en quienes trabajaban >8 horas diarias (RP:2,77), ≤5días a la semana (RP=3,10), no tenían espacio suficiente para moverse (RP=2,08), y en quienes tenían posturas o movimientos forzados (RP=2,72). Conclusión: En la población de vendedores informales del centro de Medellín, los factores sociodemográficos, laborales, hábitos y estilos de vida modificables se relacionan con una mayor prevalencia de osteoartritis.

Challenges to obtaining consent for clinical research in acute settings are ubiquitous and yet highly specific to clinical context. Dickert and colleagues bring to light the challenges inherent in ...

The optimal care for the transplant candidate is to receive a timely organ transplant. Effective organ donation is critical to this equation. Organ procurement organizations (OPOs) are responsible for: 1) ensuring organ donation occurs by identifying potential donors, obtaining consent, and executing organ allocation/distribution processes, and 2) that organs are recovered safely and efficiently to allow timely transplantation.

Objectives The main purpose of this article is to evaluate the clinical performance of atraumatic restorative treatment (ART) sealant versus Embrace WetBond sealant in terms of retention and fissure caries prevention among a section of school children in the southern Indian state of Karnataka (ClinicalTrials.gov NCT02716558). Materials and Methods After obtaining consent from the parents and screening the children against the inclusion cum exclusion criteria, 90 school children whose mandibular first molars were caries free and with a well-defined pit and fissure system were recruited for this spilt mouth trial. The respective molars were allocated either to the ART sealant or the embrace group after the randomization process. The sealants were applied according to the manufacturer’s instructions and followed up at the end of 3rd, 6th, and 12th month, respectively. The outcome measures assessed were the retention and the caries preventive effects of the materials. Results At the end of the 6th month, about one-fourth of the sealants in either group remained totally intact, without evidence of caries. No significant differences were seen between the sealants either in terms of retention or caries preventive benefits at the end of 12 months. Statistical Analysis The chi-squared test was used to check differences in proportions. The significance value was set at Conclusion The moisture-tolerant resin sealant could not replicate the physical properties usually associated with conventional resin sealants. The usage of ART sealants was deemed to be less cumbersome in an outreach setting as observed in this trial.

Introduction If studies are to be valid, recruitment of representative samples is essential. In 2012, 28% of UK emergency departments met the 80% standard for recruitment to trials set by the National Institute for Health Research. Research nurses play a vital role in the conduct of high-quality research, and it has been argued that dedicated research nurses are needed if clinical trials are to recruit successfully to target. Review question What are research nurses' experiences of obtaining consent from or for patients participating in emergency care research? A qualitative evidence review. Methods A qualitative integrative literature review with a narrative synthesis of the evidence. PRISMA guidelines for reporting systematic qualitative reviews (Appendix S1) were followed. A search of five electronic databases was performed in December 2018 along with a hand search which yielded 125 citations: 10 papers and one PhD thesis met the review eligibility criteria. Methodological quality of the selected studies was evaluated, and data were extracted and synthesised. Results Three themes were identified: Access, Organisation and Timing. Research nurses encountered both general and specific barriers when seeking to obtain consent for participation in research. In particular, it was found there was lack of experience among staff of working in emergency research and with securing deferred consent. The distinction between nurse researchers with a clinical role and those dedicated to solely to research only is often not clear and warrants further investigation. Conclusion Nurse researchers with and without a clinical role can make a positive difference in recruitment to trials in emergency care. The involvement of dedicated research nurses in the consent process can increase recruitment to emergency care research. Experience of recruiting to clinical trials in nonemergency settings does not seem to help when recruiting for trials in emergency care. Relevance to clinical practice There is a need for greater understanding of the experiences of dedicated research nurses in emergency care settings and in particular with regard to deferred consent.

Objectives Primary objectives were to discover current practices of informed consent for bedside procedures in the PICU and neonatal ICU and how trainees learn to obtain consent. We also attempted to gauge if program directors felt that one method of consent was subjectively superior to another in the way it fulfilled established ethical criteria for informed consent. Design An online anonymous survey. Participants were asked about how and by whom informed consent is currently obtained, training practices for fellows, and attitudes about how different consent methods fulfill ethical criteria. Setting All U.S. fellowship programs for neonatology (n = 98) and pediatric critical care (n = 66) in the fall of 2017. Subjects Neonatal and pediatric critical care fellowship program directors. Interventions None. Measurements and main results The overall response rate was 50% (82 of 164). The most common method for obtaining consent in both ICU types was via a written, separate (procedure-specific) consent (63% neonatal ICUs, 83% PICUs); least common was verbal consent (8% neonatal ICUs and 6% PICUs). Fellows were reported as obtaining consent most often (91%), followed by mid-level practitioners (71%) and residents (66%). Residents were one-fifth as likely to obtain consent in the PICU as compared with the neonatal ICU. Sixty-three percent of fellowship directors rated their programs as "strong" or "very strong" in preparing trainees to obtain informed consent. Twenty-eight percent of fellowship directors reported no formal training on how to obtain informed consent. Conclusions Most respondents' ICUs use separate procedure-specific written consents for common bedside procedures, although considerable variability exists. Trainees reportedly most often obtain informed consent for procedures. Although most fellowship directors report their program as strong in preparing trainees to obtain consent, this study reveals areas warranting improvement.

Swina Santhirakumaran, Harkaran Singh Kalkat, Vinay Jamnadas Sonagara Department of Undergraduate Medicine, Faculty of Medicine, Imperial College London, London, UK Abstract: Student-led clinical examinations, including pelvic floor examinations, are an integral part of clinical training and can be beneficial to both students and patients alike. However, our experience and previous literature catalog numerous obstacles in obtaining consent for student-led pelvic floor examinations. Although some of these factors may not be modifiable, it is evident that efforts can be made to overcome those that are. An examination of these obstacles can help to provide a clear and succinct template to overcoming them: we propose a “5-Rs” framework that may bridge the apparent gap between the students’ need to practice and obtain valid consent. Keywords: consent, teaching, pelvic floor examination

Background: Bullying is a common violence in school and has become a major public health and global concern. Bullying influences mental health and is identified as a leading factor of depression. Therefore, this study aimed to identify bullying prevalence and its association toward psychological disturbances (stress, anxiety, and depression). Methods: This cross-sectional study was conducted in three secondary schools in Kuantan. After obtaining consent from parents/guardians, participants were asked to answer a self-administered questionnaire, including School Climate Bullying Survey, Depression Anxiety Stress Questionnaire-21, Patient Depression Questionnaire, and Generalized Anxiety Disorder. Demographic data were self-reported. Data were analyzed using SPSS version 20.0, and chi-square and correlation tests were conducted for variables. Results: A total of 207 students were included in this study. Of respondents, 50.7% were boys and 49.3% girls, and the majority (92.8%) were Malays. Of students, 63.2% were involved in bullying problems through the school years, with verbal bullying as the highest (55.1%). Bullying is significantly associated with stress (p = 0.045), anxiety (p = 0.018), and depression (p = 0.012). Conclusions: School children in Kuantan continue to be involved in bullying. The current study supported that involvement with any bullying activity was associated with psychological disturbances including anxiety, stress, and depression.

Induction of labour is experienced by up to one third of women and can be a negative experience, in relation to both the decision about whether to have an induction of labour (IoL) and the experience of the process of IoL. This paper reviews the limited evidence of women's views on and experiences of: information provision; shared decision-making; preferences for method and location of IoL; indications for IoL; pain management; and effective communication and support. Healthcare professionals' views are reviewed, but are underrepresented, and further research is needed to understand experiences of gaining consent for IoL. Systematic review evidence is drawn on where possible, but reviews often found small numbers of papers for inclusion, and provide insights rather than conclusive evidence. Future research would benefit from using validated measures to assess the experience of IoL.

Background In many countries, a forensic medical examination by a trained professional is offered to people who have experienced recent sexual assault. The consultation may include a vaginal speculum examination to visualise injuries and collect forensic evidence, but not all patients will consent to the examination. Clinicians’ attitudes to a speculum examination in a sexual assault context and the consequent wording when obtaining consent may influence uptake rates and ultimately health outcomes for sexual assault survivors. Objectives This survey study identifies (i) factors affecting clinician attitudes towards the use of speculum examinations in sexual assault forensic medical examinations; (ii) situations in which they would offer a speculum examination; and (iii) approaches to seeking consent. Methods An online survey was sent to all eligible forensic examiners working in sexual assault services across New South Wales (NSW), Australia (n = 100), between August and September 2019. The survey recorded demographic data, experience with speculum examinations, opinions regarding the main purpose of the speculum examination, circumstances in which clinicians would offer a speculum examination, and the wording of their consent process based upon two detailed clinical scenarios (differing only in the hours elapsed since the assault (24 h vs 72 h)). A mixed method approach was used to analyse the data and was completed using SPSS and NVivo. Results Of the 100 invited participants, there were 32 respondents. Twenty-eight respondents (87.5%) stated that the main purpose of a speculum examination is to both check for injuries and collect evidence. Clinicians were more likely to offer a speculum examination to patients presenting with symptoms (i.e., pelvic pain, bleeding) or presenting more than 24 h after the event. Twenty-seven participants (84.4%) stated that patient-centred factors (i.e., time of presentation, patient comfort with speculum examination) were the main influences in whether they would/would not offer a speculum examination. Clinicians felt more comfortable performing speculum examinations in a forensic setting if they felt comfortable performing speculum examinations in a non-forensic setting (p = 0.004) and less comfortable as time increased from introductory sexual assault training (p = 0.0029). Eight participants (26.7%) would not offer a speculum examination acutely ( Conclusions This study is the first to explore clinicians’ attitudes towards the speculum examination component of the adult sexual assault forensic medical examination and provides foundations for future research. Current guidelines should be reviewed and updated to ensure that speculum examinations are routinely offered, rather than only when endocervical samples are being considered, to ensure potential injuries are not missed.

ObjectivesTo evaluate the knowledge of corneal donation and the new opt-out system among junior doctors in the East Midlands, UK.MethodsThis was a cross-sectional study performed during June-September 2020. A 26-item questionnaire-based survey was disseminated to all 340 junior doctors working in the East Midlands, UK. Relevant data, including participants background, knowledge of corneal donation and the new opt-out system introduced in England, were analysed.ResultsA total of 143 responses were received (response rate=42.1%). Nineteen (13.3%) junior doctors had previously discussed about corneal donation. The majority (100, 69.9%) of them perceived the importance of obtaining consent for corneal donation as junior doctors, but only 24 (16.8%) felt comfortable in discussing corneal donation. The knowledge of corneal donation was low, with a mean correct response rate of 33.3+/-20.8%. Only 28 (19.6%) doctors were aware of the 24-hour death-to-enucleation time limit. The majority (116, 81.1%) of doctors would consider certifying a death on the ward quicker if they knew it could potentially compromise the quality of corneas. Most (103, 72%) doctors were aware of the new opt-out system but only 56 (39.2%) doctors correctly stated that donation can only proceed with family consent.ConclusionJunior doctors working at the frontline services serve as valuable members in contributing to the process of obtaining consent for organ/tissue donation. Our study highlights the lack of knowledge of corneal donation and the opt-out system amongst junior doctors in the UK. Targeted postgraduate training during the induction process may potentially enhance the donation rate.

Background: Primary dysmenorrhea is chronic pain during menstruation without the presence of a pelvic pathologic complication. Objectives: The aim this research was comparison of the effect of stretching exercises and combination of massage - stretching exercises on primary dysmenorrhea of female students of Razi University of Kermanshah. Methods: This semi-experimental study was statistical population all female students of Razi University of Kermanshah. 90 students were selected through purposive and convenient sampling method. After obtaining consent and justification of the subjects from the research stages, they were randomly divided into three groups of 30 to practice the protocol. The research instrument consisted of two primary dysmenorrhea and McGill pain questionnaires as well as stretching exercise and massage protocol. The validity of the questionnaires was obtained formally using Cronbach's test. Exercise program for groups was performed in 8 sessions for 3 weeks. Data were analyzed by dependent t-test, one-way ANOVA and Kolmogorov-Smirnov test, to check the normality of the data distribution. Results: The results showed that there were significant differences between the three methods of exercise (stretching, massage and massage- stretching movements) on pain severity (P = 0.938), duration of pain (P = 0.095) and the nature of pain (P = 0.664) There was no significant difference. Conclusions: According to the results of the present study, massage and stretching exercise and massage-stretching combinations are almost as effective and effective as noninvasive methods in reducing the symptoms of sensory pain caused by primary dysmenorrhea. Assistance to girls with dysmenorrhea Selection and application of one of these methods will depend on the individual's abilities and circumstances.

Anemia is one of the major problems among female adolescents in Indonesia. Weekly iron-folic acid supplementation was a cost-effective measure to tackle adolescent anemia. However, adherence to the supplementation is low. This study was aimed to explore the determinants of t highschool females' adherence to consume iron-folic acid tablets. Using cross sectional design with 274 subjects. After obtaining consent the data were collected, coded and analysed using SPSS23. The inclusion criteria were high school female from 18 schools which had iron tablets program. The majority of subjects was 14-16 y old (73.7%). The majority of schools gave iron tablets to students without organizing taking iron tablets together (63.5%). The adherence to consume iron and folic acid tablets in this study was 45.6% (n=125). Almost half of highschool female (36.1%) cited they did not think that iron tablets are necessary while 12.4% cited experiencing side effects. Factors that were correlated (p

BACKGROUND Heart-type Fatty Acid-Binding Protein (H-FABP) has been used in the diagnosis of myocardial damage. In this study, we assessed the relationships between serum H-FABP as a marker of cardiac injury and right ventricle (RV) echocardiographic indices in patients with stable COPD. MATERIALS AND METHODS In this case-control study, 84 participants were investigated (50 COPD patients and 34 healthy subjects). After obtaining consent, 3 mL of fasting whole blood sample was collected from each of the participants to test their serum H-FABP. Echocardiography was performed on all participants by cardiologists. RESULTS Serum H-FABP was found to be significantly correlated with smoking history (P

This article contains quantitative and qualitative patient-reported outcome measures (PROMs) collected from nine dental patients, with a single-implant in the maxillary anterior region of the mouth, recruited after obtaining consent documents. The quantitative data were obtained from participants’ demographics, frontal extraoral digital photographs, intraoral scans (IOS) of the maxillary arch, and self-administered questionnaires (where patients judged the overall, appearance, function, and comfort of their single-implant-supported crowns). Objective single-implant aesthetic index mean scores (Pink Esthetic Score/White Esthetic Score [PES/WES]) were obtained after two experienced calibrated clinicians analyzed the photographs and the three-dimensional models generated from the IOS. The self-administered questionnaires used a visual analogue scale (VAS) to obtain the patients’ subjective perceptions. The qualitative data were obtained from in-depth, semi-structured one-to-one interviews. The transcriptions from audio-recorded interview data were managed and coded, with the aid of a Computer-Assisted Qualitative Data Analysis Software (CAQDAS). These data were stored in a public repository that can be easily downloaded from a Mendeley data repository (DOI: 10.17632/sv8t6tkvjv.1).

Parent involvement in their college student’s mental health has increased, perhaps in light of the growing number and complexity of mental health problems on campuses. Parents are more aware of mental health problems in the college population and expect campuses to provide services for their students. College psychiatrists and other psychiatric providers may find themselves collaborating with parents, after obtaining consent from the student, in a variety of situations: the student is experiencing suicidal thoughts; has been psychiatrically hospitalized; or has a serious substance use disorder that puts their life at risk. Even in non-emergent situations, parents can provide valuable information to the psychiatric provider regarding developmental and family history, and also serve as a source of support for the student. This chapter provides examples of how best to work with parents to promote safety and obtain the right level of treatment for the student. It also covers studies regarding parent involvement in college mental health, and reviews the changing laws and policies regarding communicating with parents with and without a student’s consent. Psychiatrists and other psychiatric providers should consider parent collaboration as part of the treatment plan when it will be clinically beneficial to student.

Background GOSH Sample Bank is a key Research Hospital initiative, enabling patients’ leftover samples to be stored and potentially used for child health research. It was launched to staff, patients and families in 2019, following extensive piloting to determine acceptability, feasibility and resource requirements. Initial recruitment was slow, with 83 patients recruited between September 2017 and April 2020. As all patients should have the opportunity to participate, we investigated different methods to reach more patients and increase recruitment. Aim To increase inpatient recruitment to Sample Bank, raise awareness of the initiative amongst ward staff, deliver training to staff and develop a model for sustainability to help achieve the Research Hospital vision for this initiative. Method To drive engagement, especially at an extremely busy time clinically, Research and Innovation (R&I) staff worked with nursing staff to identify wards to visit to seek consent. The training needs of R&I staff, who are familiar with seeking research consent and are GCP compliant, were determined and a training plan was implemented to ensure familiarity with the initiative and competency in obtaining informed consent. Results Over a 5 month period from April 2020, 308 patients were consented to Sample Bank, across 4 wards (Sky, Koala, Pelican and Panther). Of all patients identified or approached, 65% consented, 13% declined, 6% were ineligible, 13% were discharged before consent could be taken and 3% were eligible but not approached. In total, 24 clinical and 18 non-clinical staff were trained to obtain consent. Conclusion Although resource intensive, this method of obtaining consent proved highly effective at increasing recruitment. We will now investigate opportunities for embedding obtaining consent for Sample Bank into routine clinical practice, including providing training for clinical staff and amending the clinical consent process, providing all GOSH patients with the opportunity to participate.

We developed a video and an app for obtaining consent about allowing newborn blood spots (NBS) to be used as biospecimen resources for biobanking. Newborn screening programs test for treatable diseases and leave residual biospecimens that can be used in future research activities. We conducted focus groups and interviews with three diverse communities to determine (a) how well the consent tools worked and (b) participant familiarity with NBS. Participants preferred the video and noted that they were unaware that NBS could be used for future research. Providing information about how biospecimens could be used was a key issue.

Introduction Sleep plays a vital role in good health, growth and well-being. Sleep disorders manifest with disturbance in quantity and quality. Previous studies have shown that sleep disorders are increasing in pediatric age group, which is attributed to increased usage of smartphones and also associated with lifestyle changes. Aim To assess quality and quantity of sleep in children aged 3-15 years. Methodology Institutional Ethics Committee approval was obtained. 52 children were recruited for the study from Meenakshi Medical College Hospital, Kanchipuram, India. After obtaining consent, Pediatric Sleep Questionnaire (PSQ) was administered after collecting clinical history. History of duration of smartphone usage, TV Screen time, history of hospitalizations, time spent outdoors was also collected. Anthropometry and clinical examination was done. Data was tabulated and analysed using SPSS V17.0. Results 4 out of 52 children (7.69%) in the study had poor quality sleep (PSQ Score ≥ 5). 24 out of 52 children (46.1%) had deficient quantity of sleep as per WHO recommendations. Children born with low birth weight had comparatively poorer quality of sleep (r=0.331 p=0.015). Conclusion Quality and quantity of sleep was affected in children aged 3–15 years. Low birth weight children are at a greater risk of suffering from poor sleep quality. However, this finding is to be confirmed in larger study.

Frequent use of psychotropic medicines in people with dementia is a significant concern globally, doing this without informed consent is a violation of human rights, ethics and law. Capacity Australia piloted an intervention to address several hypothetical barriers to obtaining consent for psychotropic use in aged care and has developed a suite of resources to improve rights and health literacy for clinicians, patients and community alike.

Online ahead of print; International audience; Having the means to share research data openly is essential to modern science. For human research, a key aspect in this endeavor is obtaining consent from participants, not just to take part in a study, which is a basic ethical principle, but also to share their data with the scientific community. To ensure that the participants' privacy is respected, national and/or supranational regulations and laws are in place. It is, however, not always clear to researchers what the implications of those are, nor how to comply with them. The Open Brain Consent (https://open-brain-consent.readthedocs.io) is an international initiative that aims to provide researchers in the brain imaging community with information about data sharing options and tools. We present here a short history of this project and its latest developments, and share pointers to consent forms, including a template consent form that is compliant with the EU general data protection regulation. We also share pointers to an associated data user agreement that is not only useful in the EU context, but also for any researchers dealing with personal (clinical) data elsewhere.

Purpose The aim of this study was to investigate the effect of preoperative and postoperative anxiety on the state of recovery in patients undergoing abdominal surgery. Design This research is a descriptive and cross-sectional study. Methods The study included a total of 82 patients undergoing elective abdominal surgery. Demographic data were collected. State-Trait Anxiety Inventory was the measure for anxiety. The quality of recovery (QoR) was assessed using Quality of Recovery Scale (QoR-40). Both have known validity and reliability and valid translations into Turkish. After obtaining consent from patients, 82 patients completed their demographic profile and State-Trait Anxiety Inventory before surgery, and after 24 hours of surgery completed the state anxiety and QoR. Findings Patients who received general anesthesia had higher anxiety before and after surgery (P = .004 and P = .022). Patients who were not informed about the surgery had higher preoperative trait anxiety (P = .01). The QoR scores of the patients were negatively related to preoperative and postoperative state anxiety (P = .01 and P = .000). Preoperative state anxiety was positively related to preoperative trait and postoperative state anxiety (P = .000 and P = .000). Conclusions The results provided more evidence that patients need education before surgery as to what to expect both in the surgical suite and immediately after surgery to alleviate anxiety. This should also improve QoR.

Tissue donation is important to reverse cornea-related blindness. Unfortunately, the willingness to make a decision concerning organ and tissue donation while still alive remains low despite all efforts. By analyzing anonymized archived data from 25 654 next-of-kin interviews from our database over a period of 5 years (2013-2018), it was found that only 20.8% of all potential cornea donors have declared their own wishes. While still alive, refusal was communicated more often than consent by potential donors. Overall consent rates were 39.2%, with parents and siblings consenting more often than other relatives and females refusing more often than male family members. Personal interviews and interviews via telephone handled by staff known to the family resulted in better consent rates (up to 75.6%) with male interviewers receiving higher consent rates in general. The gender of the approached relatives in relation to a male/female interviewer was of low importance. The results also show that it is important to allow discussion about that topic between family members-the more relatives that were involved the higher the probability of consent.

Background Examination of serum lactate level and its changes, as an indicator of tissue oxygenation, as well as level of creatine kinase (CK) inhibitors, as a factor of mortality which partially expresses heart, brain, and muscle damage, may be considered as tools to determine prognosis in critically ill patients. We aimed to evaluate these two factors as potential prognostic factors in critically poisoned patients admitted to our toxicology ICU. Method This is a cross-sectional descriptive-analytic study that was performed on poisoned patients referred to emergency department of Loghman Hakim Hospital. One-hundred critically poisoned patients who had been admitted to ICU were conveniently chosen using a random number table and included into the study after obtaining consent forms from their next of kin. Their serum lactate and CK levels were checked on admission. These levels were compared subsequently between survivors and non-survivors to seek for their potential prognostic role. Results In a total of 100 patients enrolled, 61 were male. Serum level of lactate (with a cut off of 26 mg/dL) and serum CK with a cutoff point of 169 U/L could have prognosticated death with sensitivity and specificity of 78 and 77% (for lactate) and 74 and 62% (for serum CK), respectively. Conclusions In poisoned patients, serum lactate and CK can be used as possible prognostic factors because they rapidly increase in the serum and are easily detectable.