Consent For Participation Research Articles

Consent-Related Outcomes in the Alteplase Compared to Tenecteplase Trial.

In recent years, researchers have sought to address the challenges of obtaining informed consent for participation in acute stroke trials. We studied outcomes related to the use of deferral of consent in the phase 3 Alteplase Compared to Tenecteplase (AcT) trial. As part of our protocol, we captured methods of consent, participant withdrawals, door-to-randomization times, and door-to-needle times. Participants at 3 sites were invited to complete a survey of attitudes regarding consent for AcT and for acute stroke trials generally. The AcT trial enrolled 1,600 participants from 22 centers across Canada of whom 1,537 were enrolled through deferral of consent (96.0%) and 63 (4.0%) were enrolled by prospective verbal consent followed by written informed consent. Of those enrolled by deferral of consent, 95% (1,454/1,537) consented to ongoing participation. Door-to-randomization times were similar regardless of method of consent, with an overall median of 30 minutes (interquartile range [IQR] 22-42): 29 minutes (IQR 22-42) in the deferral of consent group vs 32 minutes (IQR 25-44) in the prospective consent group (p = 0.1602). Survey respondents overwhelming agreed or strongly agreed with the use of deferral of consent in AcT (86%) and in any acute stroke trial (76%). Deferral of consent was broadly acceptable to participants in the AcT trial as demonstrated by low rates of withdrawal and by survey results. Door-to-randomization times using deferral of consent in AcT were short, although a system of prospective verbal consent used at 1 center took only slightly longer. These results support the importance of innovation around consent for acute stroke trials.

Effect of a Machine Learning-Derived Early Warning Tool With Treatment Protocol on Hypotension During Cardiac Surgery and ICU Stay: The Hypotension Prediction 2 (HYPE-2) Randomized Clinical Trial.

Cardiac surgery is associated with perioperative complications, some of which might be attributable to hypotension. The Hypotension Prediction Index (HPI), a machine-learning-derived early warning tool for hypotension, has only been evaluated in noncardiac surgery. We investigated whether using HPI with diagnostic guidance reduced hypotension during cardiac surgery and in the ICU. Randomized clinical trial conducted between May 2021 and February 2023. Single-center study conducted in an academic hospital in the Netherlands. Adults undergoing elective on-pump coronary artery bypass grafting, with or without single heart valve surgery, were enrolled if a mean arterial pressure (MAP) greater than or equal to 65 mm Hg was targeted during the surgical off-pump phases and ICU stay. After eligibility assessment, 142 of 162 patients approached gave informed consent for participation. Patients randomized 1:1 received either diagnostic guidance in addition to standard care if HPI reached greater than or equal to 75 (n = 72) or standard care alone (n = 70). The primary outcome was the severity of hypotension, measured as time-weighted average (TWA) of MAP less than 65 mm Hg. Secondary outcomes encompassed hypertension severity and intervention disparities. Of 142 patients randomized, 130 were included in the primary analysis. The HPI group showed 63% reduction in median TWA of hypotension compared with the standard care group, with a median of differences of -0.40 mm Hg (95% CI, -0.65 to -0.27; p < 0.001). In the HPI group, patients spent a median 28 minutes (95% CI, 17-44 min) less in hypotension, with a measurement duration of 322 minutes in the HPI group and 333 minutes in the standard care group. No significant differences were observed in hypertension severity, treatment choice, or fluid, vasopressors, and inotrope amounts. Using HPI combined with diagnostic guidance on top of standard care significantly decreased hypotension severity in elective cardiac surgery patients compared with standard care.

Assessment of the knowledge about blood donation among medical students: Before and after implementing a designed teaching session about blood donation

: Human blood is most important body fluid in saving lives .Evidence indicates that there is a shortage of blood and blood products in many countries. This study aimed at assessing knowledge towards blood donation and its associated factors. With focus on encouraging voluntary blood donation. That’s why stress should be given on voluntary, non - remunerated blood donation. This study aims to determine knowledge about voluntary blood donation, and the objective was to educate undergraduate students about voluntary blood donation. Undergraduates who expressed their consent for participation were enrolled in the study. A pre‑ tested, structured questionnaire was used as a study tool. Baseline information were collected, a brief interactive awareness session, addressing voluntary blood donation was organized for the participants and their willingness to donate blood was again noted at the conclusion of the session. A total of five hundred undergraduate medical students enrolled , out of which 270 (54%) were male and 230 (46%) female. The overall knowledge of voluntary blood donation increased from 67% to 89.90% after educational intervention. Undergraduate medical students had good baseline knowledge about blood donation and this further improved after blood donation educational intervention.

Ethical practice in participant-centred linguistic research

Abstract This article outlines ethical principles for ‘participant-centred linguistic research’ (PCLR), a term we coin to incorporate a range of linguistic research approaches that place importance on the involvement of participants. Linguistics, as a field, has strengthened its focus on participant-centred and socially situated research, recognising the value of better understanding our participants’ practices and linguistic knowledge. However, this also brings ethical challenges for our research practice. Drawing on three differing UK-based case studies from the authors’ own work, the article explores complex issues that can arise during PCLR and establishes four key principles that cut across our varied experiences. Firstly, we address participant consent and confidentiality, establishing the principles: 1. Informed consent and ethics protocols are dialogic processes and 2. Expectations around confidentiality and anonymity can shift during a project. Secondly, we address our research relationships with participants, our key principles being: 3. The researcher-participant relationship is complex and variable and 4. Close attention must be paid to power dynamics within the research setting. Ultimately, we argue that the human interactions and relationships involved in PCLR mean research may inevitably be somewhat unpredictable; researchers therefore need an understanding of the ethical parameters of their practice to navigate these complexities.

Insights from an Experiment Crowdsourcing Data from Thousands of US Amazon Users: The importance of transparency, money, and data use

Data generated by users on digital platforms are a crucial resource for advocates and researchers interested in uncovering digital inequities, auditing algorithms, and understanding human behavior. Yet data access is often restricted. How can researchers both effectively and ethically collect user data? This paper shares an innovative approach to crowdsourcing user data to collect otherwise inaccessible Amazon purchase histories, spanning 5 years, from more than 5,000 U.S. users. We developed a data collection tool that prioritizes participant consent and includes an experimental study design. The design allows us to study multiple important aspects of privacy perception and user data sharing behavior, including how socio-demographics, monetary incentives and transparency can impact share rates. Experiment results (N=6,325) reveal both monetary incentives and transparency can significantly increase data sharing. Age, race, education, and gender also played a role, where female and less-educated participants were more likely to share. Our study design enables a unique empirical evaluation of the 'privacy paradox', where users claim to value their privacy more than they do in practice. We set up both real and hypothetical data sharing scenarios and find measurable similarities and differences in share rates across these contexts. For example, increasing monetary incentives had a 6 times higher impact on share rates in real scenarios. In addition, we study participants' opinions on how data should be used by various third parties, again finding that gender, age, education, and race have a significant impact. Notably, the majority of participants disapproved of government agencies using purchase data yet the majority approved of use by researchers. Overall, our findings highlight the critical role that transparency, incentive design, and user demographics play in ethical data collection practices, and provide guidance for future researchers seeking to crowdsource user generated data.

Field Notes from the Border: Lessons Learned in Conducting Mental Health Research Involving Newly Arrived Latinx Immigrants as Study Participants.

In this paper, we describe a research protocol for surveying and interviewing Latinx immigrants recently arrived at the US southern border, and we raise important and unique issues that need to be considered with this population. The main objective is to share experiences, challenges, opportunities, and essential considerations (which we call lessons learned) that researchers should take into account when working with this vulnerable study population. The six lessons learned focus on: (1) fostering relationships with community partners; (2) participant consent and compensation; (3) linguistic and cultural fluency of researchers; (4) adapting data collection procedures to the environment and conditions; (5) establishing trust with participants and being trustworthy; and (6) addressing the ethical considerations of research with immigrant populations and the positionality of researchers. This paper provides a unique perspective of working with a vulnerable population that is in transit, often coming from circumstances of danger and risk to their lives, who are now headed towards new and uncertain experiences that may include disadvantage, exclusion or other risks. The lessons learned from the field inform best practices for working with recently arrived Latinx immigrants, with implications for public health research that may extend to other immigrant populations.

Multimodal intervention on perception and quality of life of geriatric clients regarding health promotional outcomes at a selected hospitals, Kolar, Karnataka, India

ABSTRACT Background of Study: Old age is a privilege for a second childhood and a new stage of opportunity and strength. Older adults are the most rapidly growing segment of the population. By 2050, 80% of all older people will live in low- and middle-income countries. Purpose: To evaluate the effectiveness of multimodal intervention on perception and quality of life among geriatric clients. Methods: Quantitative approach quasi-experimental interventional controlled study with pre-test, post-test design and follow-up for two months, adopted by using purposive sampling technique among 120 geriatric clients who gave consent for participation in the study at two different settings of hospitals from July 2022 to January 2023, Kolar. After obtaining Central Ethics Committee approval, data was obtained using the structured perception questionnaire and WHO Quality of Life questionnaire, and the Multimodal Intervention package consisting of a snake and ladder health promotion strategies game, educational video, and informational pamphlet distributed to the experimental group, whereas routine care was given to the control group followed by post-test group on the 30th and 60th day. Reinforcement was carried out by the investigator on a fortnightly basis reminders through messages. Data were analyzed by using descriptive and inferential statistics such as repeated measures of ANOVA, independent ‘t’- test, paired ‘t-test, and Chi-square. Results: A perception significant effect was demonstrated in the experimental group with enhanced mean, standard deviation from pre-test to post-test I and Post-test II found to be 35.1 ± 7.9, 46.3 ± 6.1, and 48.3 ± 4.7, respectively, without significant changes in the control group. Concerning quality of life, important variations were demonstrated in the experimental group with enhanced mean, SD from pre-test to post-test I and Post-test II found to be 54.76 ± 10.39, 74.15 ± 6.75 and 77.71 ± 4.99, respectively, without any significant changes in the control group. Conclusion: Geriatric population was the biggest beneficiary, multimodal intervention was proven to be effective and can be implemented in hospitals and community settings in improving the perception and quality of life of senior clients to foster healthy aging. CTRI Trial Reg no: CTRI/2021/07/034632.

Bridging the Gap: Culturally Responsive Strategies for NIH Trial Recruitment

Abstract Objective To enhance recruitment and participation rates of non-Hispanic Black (NHB) and Hispanic adult patients in a NIH-funded clinical trial studying an emerging health technology. Data Sources and Study Setting This study includes primary data collected in Los Angeles, California from November 2020 through November 2023. Study Design To improve the representation of NHB and Hispanic patients in a NIH-funded (NCT04409353) trial on virtual reality for chronic lower back pain (cLBP), we conducted a multi-phase study utilizing a mixed-method approach. First, we conducted focus groups with NHB and Hispanic cohorts aged 18 and older; based on the feedback, we culturally adapted recruitment materials and study correspondences concordantly. Additionally, a cohort builder was used to filter the electronic medical record to isolate non-Hispanic Black (NHB) and Hispanic patients with cLBP for micro-targeted recruitment. These changes were collectively integrated when the parent NIH study had recruited 222 of its 385 final samples (57.7%), creating a pre-post comparison timepoint (May 17, 2022). Quantitative analysis was performed to assess the efficacy of the modified recruitment strategies by comparing the number of recruited and randomized NHB and Hispanic patients pre- and post-intervention. Data Collection/Extraction Methods Semi-structured focus groups were conducted with NHB and Hispanic patients and community members (age 18 and older). The focus groups were conducted online and recorded with participant consent; transcripts of the recording underwent inductive thematic analysis. Emergent themes directed the modification of study materials, including revised language and imagery, targeted outreach, and incorporation of treating physicians, were implemented in the second half of the study. Quantitative analyses were conducted following parent study completion by comparing records added to the screening database following the implementation of new recruiting methods (5/17/2022) to those added before. Principal Findings Thematic analysis of focus groups identified four key themes: mistrust, lack of interest, culture, and communication. Modifications to recruitment methodology resulted in statistically significant increases in the pre- to post-randomization success rate for the overall study population (p &lt; 0.001), the NHB population (p = 0.011), and the Hispanic population (p &lt; 0.015). When looking at each cohort at different points in the recruitment process before and after the intervention, in the Hispanic population, we saw significant increases in the number approached (p &lt; 0.001) and number randomized (p &lt; 0.001) and statistically insignificant increases in the NHB population approached (p = 0.067) and randomized (p = 0.295). Similarly, we saw that the changes in the recruitment letter led to a statistically significant increase in Hispanic recruitment (7.0 to 39.1%, p &lt; 0.001) but not the NHB cohort (19.6 to 35.8%, p &lt; 0.065). Conclusion This study introduces several culturally sensitive considerations and possible approaches for the design of recruitment materials, addressing mistrust, lack of interest, culture, and communication for use in NHB and Hispanic populations. Similarly, the described microtargeting techniques leverage the technological advancements in cohort building to improve the reach and efficiency of the randomization rate of underrepresented groups thereby enhancing clinical trial diversity.

Ethical aspects of staff responses when older people with dementia express false beliefs.

Challenging false beliefs are common situations among people living with dementia. They frequently imply time-shifts, that is, situations in which the person re-lives past experiences. Since they have emotional implications and important ethical implications, they are difficult to manage by caregivers, who are faced with the decision of telling or not telling the truth. The study aimed to explore professional staff's perceptions of common and best practices to manage a situation in which a person living with dementia is having a false belief, specifically a time-shift. The study compares technical staff's and assistant carers' responses. Forty-two staff members working in four Spanish long-term care facilities were interviewed. 21 were assistant carers and 21 were technical staff. This study involved a qualitative design, content-analyzing participant's responses to semi-structured interviews. Participants read a vignette about a person living with dementia having a time-shift and were asked (1) how a situation like that is commonly managed and (2) how it should be managed. The principles of informed consent, confidentiality, and assessment of consequences for participants were observed throughout the entire study, which was approved by the University of Barcelona Ethics Committee (IRB 00003099). Written participant's consent was obtained prior to interviews. All the participants mentioned having experienced a situation similar to that described in the vignette. In the case of common practices, lying was the most frequently mentioned strategy. As for best practices, lying and telling the truth were mentioned as well as responses that lie in-between, such as distracting or relaxing. However, most assistant carers reported that they do not know how a challenging false belief should be managed. Our findings stress the importance of organizational guidelines and staff development in the management of challenging false beliefs (and specifically time-shifts) in PLWD.

Exploring Longitudinal Physiological Monitoring: Insights From Utilizing a Commercial Wearable Device Among Older Adults With Mild Cognitive Impairment

Commercial wearable technologies are becoming increasingly prevalent and offer the potential for monitoring physiological changes over time, particularly in older adults with Mild Cognitive Impairment (MCI). While literature suggests the utility of such devices, little evidence exists of their successful deployment among people with MCI. This feasibility study aimed to establish research guidelines, optimize participant training, and identify data collection challenges when collecting longitudinal physiological data using the Oura Ring. Our results indicated that adequate researcher support was crucial for study success and participant engagement. This involves including care partners of participants with MCI and providing appropriate technological training to participants. Care partner support reduced device troubleshooting instances and emotionally encouraged participants with MCI. Lastly, maintaining regular researcher-participant communication fostered rapport and ensured ongoing participant consent and data quality. This research lays the groundwork for future health monitoring studies by emphasizing the importance of tailored support, communication, and researcher involvement.

Patients' & students' perspectives on bedside teaching: A descriptive study.

To assess the student's and patients' perspectives about bedside teaching and to identify possible barriers that delay effective bedside teaching. This cross-sectional study was conducted at two teaching hospitals in Peshawar with 153 participants through non-probability serial sampling from December 2017 to March 2018. Interview-based validated questionnaires were used and pilot tested as well. Ethical approval was taken with the participant's consent. Data were analyzed using SPSS version 19.0 using descriptive statistics. Among the total 79 students, all of them completed the questionnaires with a 100% response rate. However, from the 76 patients only 74 responded with a response rate of 97%. The majority of the patients (n=58; 78%) were satisfied with bedside teaching with no problems faced. During the bedside teaching only (n= 13; 18.2%) felt anxious while others, enjoyed (n= 59; 80.5%) with satisfaction and only 13% (n= 10) thought their privacy was breached. The satisfied students with the time spent on bedside teaching were (n= 52; 65.5%) while (n= 30; 38.7%) thought thirty minutes time was not enough. The hurdles faced were lack of practice (37.3%), fear of embarrassment in front of peers (21.3%), and lack of confidence to approach the patient (16%). The patients showed positive attitude and enjoyed bedside teaching. The students preferred it as a valuable tool for clinical experience. However, time constraints, lack of practice, lack of confidence, confidentiality, and anxiety must be overcome to make bedside teaching a useful method. Effective teaching still requires good teaching methodologies with confidence and competency.

Paediatric Emergency Nurses' Perception of Medication Errors: A Qualitative Study.

To explore paediatric emergency nurses' perceptions of medication administration errors. A qualitative, ethnomethodological, descriptive study. The participants were nurses working in the paediatric emergency department. Data were collected through in-depth individual interviews with paediatric emergency nurses. The study excluded nurses employed for less than six months. Ten individual interviews were carried out. All interviews were face-to-face and audio-recorded with the participant's consent. Interviews took between 52 min and 1 h 25 min. A questions guide was followed during the interviews. The analysis of the data was carried out according to the scheme proposed by Taylor and Bogdan. The participants' discourse revealed three main categories: Safety culture, transmitted by supervisors and safety groups. Teamwork, with good communication and a positive relationship. Error management, the lack of formal support and negative feelings despite an understanding of the multifactorial nature of errors. The study identifies several challenges in the healthcare system. Emphasis was placed on the perception of errors in terms of patient harm, while near misses or dose delays or omissions are not treated as errors. Although institutions have implemented safety culture strategies, nurses have not fully embraced them. There is a need to promote a positive safety culture and a safe working environment that encourages communication within the team. The hospital should provide training in safe management and patient safety and develop effective protocols. This study was not registered.

Patient and family aftercare enhance interactions between Helicopter Emergency Medicine Services and former patients and families

BackgroundHelicopter Emergency Medical Services (HEMS) in the United Kingdom (UK) deliver enhanced care to high-acuity, critically ill and injured patients. To enable patients to meet the HEMS team who treated them, many services within the UK have developed or are in the process of developing a Patient and Family Aftercare Service (PFAS). This study aims to evaluate whether the introduction of PFAS mitigates anxiety associated with patient aftercare visits.MethodsA service evaluation of anxiety in HEMS team members before and after patient aftercare visits were conducted. The study was carried out between 1 September 2023, and 31 October 2023, and patient visits were undertaken between March 2022 and July 2023. An electronic survey was distributed to the respondents who provided informed consent for participation. The survey comprised the validated generalised anxiety disorder anxiety scale (GAD-7) and five additional contextualised statements developed through the wider PFAS. Anonymised data were collected using REDCap, a secure electronic database and was analysed in R programming. Free-text comments were reported by content analysis, placed into themes, and discussed with a narrative to complement the quantitative analysis.ResultsOf the 33 recipients, 25 completed the questionnaire. Between the pre- and post-aftercare visits, a statistically significant difference was found between scores for GAD-7 (0.004, p < 0.05) and contextualised statements (0.001, p < 0.05). In addition, six broad themes were identified through content analysis. These include the emotional impact of patient interaction, coping strategies and structural changes in the aftercare system, challenges in patient and family expectations, anxieties relating to operational commitments, memory and recall of the incident, and a positive impact on personal growth.ConclusionAnxiety related to patient aftercare visits was reduced when measured before and after the patient visits. Following this service evaluation, we can hypothesise that within pre-hospital care, PFAS plays an important structural role. Future research should focus on affirming the correct tool to measure anxiety in multi-disciplinary teams and prospectively evaluating these methods collaboratively across multiple pre-hospital services.

Advance Consent for Participation in Acute Stroke Trials: A Focus Group Study with People with Lived Experience of Stroke.

Advance consent could address many of the limitations traditional consenting methods pose to participation in acute stroke trials. We conducted a series of five focus groups with people with lived experience of stroke. Using an inductive thematic approach, two themes were developed: factors in favour of, and against, advance consent. Participants supported the idea of advance consent and highlighted trust, transparent communication and sufficient time as major factors that would positively affect their decision to provide advance consent. The results will be used to finalise a model of advance consent suitable for testing the feasibility in stroke prevention clinics.

A cross-sectional observational study of suicidal behavior among people in prison at Lajpore Central district jail, India

ABSTRACT Suicidal ideation assessment can help reduce the suicide rate among people in prison. Studies for the assessment of suicidal ideation and risk factors for suicide among inmates have been done in Western countries, but in India, data is lacking regarding the assessment of suicidal ideation among the people in prison. 1. To assess the prevalence of suicidal ideationin people in prison. 2. To identify aggravating factors for suicidal behavior. It was a cross Sectional Observational Study at a district jail, Lajpore, Surat, Gujarat. After permission from the jail authority, people in prison with or without conviction, who were willing to give consent for participation, were enrolled in the study. Semi-structured questionnaires are used to assess socio-demographic profiles. Modified Suicide Ideation scale (MSSI) and General Health Questionnaire (GHQ) and PatientHealth Questionnaire (PHQ) scales were used as materials to assess suicidal ideation and psychiatric comorbidity. Frequency analysis and Pearson correlation among various factors with the use of appropriate statistical methods. Descriptive and qualitative analysis of data was done on 140 incarcerated persons in prison. Analysis showed that 10 (7.1%) people in prison had moderate suicidal ideation in the last 48 hours while 58 (41.4%) people in prison had suicidal ideation at any point in their life. The prevalence of depressive symptoms was high among people in prison. 57.9% had minimal depressive symptoms, while 9.3% had moderate to severe symptoms. Non-convicted inmates from urban areas were having significantly more psychological distress and depressive symptoms than other inmates. Advanced ageof the inmates, negative impact of imprisonment on life, depressive symptoms, and psychosocial distress emerged as risk factors correlated with suicidal ideation. During suicide risk assessment, inmate’s age, the impact of imprisonment, psychosocial distress, and depressive symptoms should be considered as risk factors among people in prison.

Advance Consent for participation in Acute Stroke Trials (ACTION): protocol for a feasibility study

IntroductionObtaining informed consent for research from patients in medical emergencies remains a challenge, particularly in acute stroke care as treatment must be administered quickly and patients often arrive in the...

Program Reach and Motivational Correlates of Exercise Behavior among Program Participants with Visual Impairment

ABSTRACT Introduction Adults with visual impairments (VI) experience unique barriers to exercise. Targeted exercise programming can eliminate barriers, but little is known about who engages in such programs. This cross-sectional study a) describes program reach and motivational correlates of exercise behavior among members of specialized exercise programs offered to adults with VI; b) examines demographic, psychological, and behavioral differences according to VI severity; and c) assesses the interrelationships between motivational characteristics and exercise behavior. Methods Data for program participants were provided to researchers by the partnered organization with participant consent. A total of 118 participants also completed a post-program survey on motivational characteristics and exercise behavior. Reach was assessed with descriptive statistics. T-tests and chi-squared tests were used to analyze respondent representativeness compared to the population of program participants (demographically) and normative values (motivationally). Analysis of variance examined differences according to VI severity. Pearson’s correlations and multiple regression assessed strength and independence of relationships between motivational variables and exercise. Results Programs attracted mostly equivalent groups of individuals across gender and varying severity of VI. Survey respondents were representative of program participants but were significantly more approach motivated and less avoidance motivated than published norms, and mostly exhibited autonomous forms of motivational regulation for exercise. Differences according to VI severity were not significant. Relationships between approach motivation and exercise were no longer significant when modeled with motivational regulation for exercise. Identified regulation was the lone significant predictor of exercise in the multivariate model. Conclusion This study presents a novel understanding of the demographic and motivational reach of specialized programming for adults with VI, as well as the motivational correlates of exercise behavior among existing program participants. Motivational characteristics were related to exercise behavior in a way that was consistent with theory, such that contextualized motivational regulation demonstrated stronger associations with exercise behavior than motivational dispositions.

How Much is Too Much? Evaluation of the Clinical Relevance of Routine Preoperative Investigations in American Society of Anaesthesiologist (ASA) Grades I and II Patients Undergoing Minor to Intermediate Elective Surgeries at Tertiary Care Teaching Hospital - Influence on Change in the Surgical Plan and Outcome

Abstract Background: In recent decades, experts have questioned the necessity of routine preoperative investigations due to their limited influence on perioperative management, higher expenses, postponed surgical procedures, patient anxiety resulting from false-positive results for minor operations and increased workload for laboratories. Objective: Our objective was to systematically evaluate the impact of pre-operative investigations on the treatment of patients opting for elective procedures. The study aimed to evaluate the impact of pre-operative investigations and peri-operative management on elective surgeries of the American Society of Anesthesiologists (ASA) physical status classification grades I and II, identifying common inappropriate investigations and assessing the impact of abnormal results on patient management. Materials and Methods: We conducted a prospective, cross-sectional, clinical, observational, single-centre study from February 2020 to March 2021 on 500 cases in the General Surgery Department of Tertiary Care Teaching Hospital. This study assessed the importance of pre-operative investigations in low-risk patients undergoing low-grade elective general surgical procedures. We recruited consecutive patients from the surgery wards of the institute, who fulfilled the inclusion criteria and obtained informed written consent for anaesthesia, surgery and participation in the study. Demographic data, the type of investigation conducted and test results were noted. We followed up with patients who had abnormal test results to record the consequences of the abnormality, such as the postponement of surgery and the requirement for additional investigations. Pre-operative transfusion, change in the management plan and change in the anaesthesia plan were recorded. Results: In the current study, the age of the patients ranged from 20 years to 45 years, and the mean age of the patients was 32.208 ± 9.16. The age group of 20–30 years was the commonest, being 158 (31.6%) patients. Out of 500 patients, 296 (59.2%) patients were males and the remaining 204 (40.8%) were female patients. Out of 500 tests, 44 (8.8%) had abnormal results. Most of the changes in our study were based on abnormal ECG findings. Out of a total of 500 surgical procedures performed, 497 (99.4%) were carried out without any difficulty, with two (0.4%) postponed due to abnormality in the pre-operative investigations and one (0.2%) cancelled. A total of 490 (98%) patients did not have any post-operative complications. Only ten (2%) patients developed post-operative complications, and out of those, only one (0.1%) had some abnormality in the pre-operative investigations. Conclusion: Preoperative laboratory investigations do not significantly influence the surgical outcome of the patients belonging to ASA grades I and II.

Clinical Variables among Egyptian Patients with Opioid Use Disorder Only versus with comorbid Gabapentin Use Disorder

Abstract Background Like the increased clinical use of gabapentin, these trends appear to chronologically align with the opioid overdose crisis and particularly with the increased restrictions on opioid prescription. Among the published literature, the prevalence of gabapentin misuse has been estimated at 1.6% to 6.6% in the general population and 3% to 68% among individuals with a substance use disorder. Gabapentin is well tolerated when consumed at or below the FDA maximum recommended dose of 3600 mg/day. Objective the study aims to assess and compare between clinical variables, rate of relapses, Overdose symptoms, pain quality and severity, among patients with OUD only and Opioid with comorbid GUD. Furthermore, this study was conducted to assess clinical correlates in relation to socio-demographics, personality disorders and degree of addiction severity in patient with OUD only and Opioid with comorbid GUD. Patients and Methods The study was carried out at Okasha Institute of Psychiatry, Ain Shams University, particularly the outpatient clinic and inpatient unit of addiction medicine. Participants were selected as sample sizes of 30 and 30 according to those meeting, the inclusion Criteria for participants: diagnosed with opioid use disorder/ opioid use disorder with comorbid gabapentin use disorder according to DSM-V, both genders, aged between (18 – 45) years old, Egyptian nationality, and Agreement for written informed consent for participation in this study. Results In our study, dose of oral opioid was found to be more than 225mg in 46.7% of the opioid group and less than 225 mg in 33.3% of the gabapentin group with an evident statistically high significant difference between both groups and a P-value of 0.004,while heroin sniffing was 76.7% in the opioid group and 33.3% in the gabapentin group with an evident statistically high significant difference between both groups and a P-value of 0.001 and regarding dose of sniffed heroin, it was &amp;gt;1gm in 70% of the opioid group and in 10% of the gabapentin group with an evident statistically high significant difference between both groups and a P-value of 0.000. In addition, heroin IV route was 70% in the opioid group and 20% in the gabapentin group with an evident statistically high significant difference between both groups and a P-value of 0.000 and regarding dose of IV heroin, it was &amp;gt;1gm in 63.3% of the opioid group and in 13.3% of the gabapentin group with an evident statistically high significant difference between both groups and a P-value of 0.000. Euphoria was found to be the desirable effect in 86.7% of the opioid group and 23% of the gabapentin group, meanwhile, pain relief was the desirable effect in 3.3% in the opioid group and 66.2%in the Gabapentin group with an evident statistically high significant difference between both groups and a P-value of 0.000. Regarding overdose, it was found to be 16.7% of the opioid group and 56.7%% of the Gabapentin group with statistical significance between both groups and a P-value of 0.018. Respiratory complications were found to be 20% of Gabapentin group statistical significance between both groups and a P-value of 0.049. Moreover, regarding history of pain, the percentage was 16.7% in the opioid group and 83.3% % in the gabapentin group with high significance between both groups and a P-value of 0.000. Also, the presence of significant neuropathic pain was 3.3% in the opiod group versus 80% in the Gabapentin group. There was a high significance between both groups with a P-value of 0.000. Regarding addiction severity, the percentage of very severe medical problems was 36.7%% in the opioid group and 13.3% % in the gabapentin group with high significance between both groups and a P-value of 0.025,inaddition, the percentage of mild psychiatric problems was 23.3%% in the opioid group and 10% % in the gabapentin group with high significance between both groups and a P-value of 0.023. Finally, the current study showed that the incidence of abstinence was 83.3% in the opioid group and 56.7% in the gabapentin group with statistical significance between both groups and a P-value of 0.024. Conclusion The current study showed that patients with opioid with comorbid GUD were associated with higher incidence overdose, history of pain and presence of significant neuropathic pain. The incidence of pain relief as a desirable effect higher in patients with opioid with comorbid GUD compared to patients with OUD. While, the incidence of euphoria as a desirable effect was higher in patients with OUD compared to patients with opioid with comorbid GUD. The patients with OUD have higher incidence of abstinence compared to patients with opioid with comorbid GUD. The patients with OUD have higher doses of oral, Sniffed, and IV opioids compared to patients with opioid with comorbid GUD. OUD patients have more severe medical and psychiatric problems than with comorbid GUD.

Comparison of Psychiatric Disorders in a Sample of Egyptian Patients with Methamphetamine versus Opioid Use Disorder: Rate and Addiction Severity

Abstract Background Methamphetamine use is markedly increasing worldwide. That widespread isn’t limited to high income countries, it's also evidently in developing and low-income countries, including Africa. According to a United States study, the prevalence of psychiatric disorders in patients with methamphetamine dependence is (34%-48.1%). Clinical effect of methamphetamine is done by increasing monoamine centrally therefore potentiate sympathetic system, causing both psychiatric and physical manifestations. While opioid effect is done by activation opioid receptors as μ, δ, κ and nociceptin opioid peptide (NOP) receptors. Objective the study aims to compare rate of psychiatric disorders between methamphetamine and opioid use disorder. Also, it was used to assess the rate of personality disorders in patients with methamphetamine in comparison to opioid use disorder. Furthermore, this study was conducted to assess clinical correlates in relation to socio-demographics, personality disorders and degree of addiction severity in patient with methamphetamine and/or opioid use disorder. Patients and Methods The study was carried out at Okasha Institute of Psychiatry, Ain Shams University, particularly the outpatient clinic. Participants were selected as sample sizes of 45 and 45according to those meeting, the inclusion Criteria for participants: diagnosed with methamphetamine/ opioid dependence according to DSM-IV, both genders, aged between (18 – 45) years old, Egyptian nationality, and Agreement for written informed consent for participation in this study). Results In our study, the percentage of psychosis was found to be 42.2% in the methamphetamine group and 13.3% in the opioid group with an evident statistically high significance difference between both groups and a P-value of 0.002. Regarding bipolar affective disorder, it was found to be 15.56% of the methamphetamine group and 2.22% of the opioid group with statistical significance between both groups and a P-value of 0.026. Moreover, regarding depression, the percentage was 2.22% in the methamphetamine group and 40 % in the opioid group with high significance between both groups and a P-value of &amp;lt; 0.001. Finally, the anxiety rate was 26.6% in the methamphetamine group versus 0% in the opioid group. There was a high significance between both groups with a P-value of &amp;lt; 0.001. the current study showed that the borderline personality disorder in methamphetamine use disorder patients’ percentage was found to be 66.6% in the methamphetamine group and 26.6% in the opioid group with evident statistical high significance difference between both groups and a P-value of &amp;lt; 0.001. Conclusion The current study showed that the substance use disorders were associated with higher incidence of mental disorders and poor physical health. The patients with MUD have higher rates of Psychosis, BAD and Anxiety and lower rate of Depression compared to patients with OUD. The patients with MUD have higher rates of borderline personality disorders and lower rate of Avoidant compared to patients with OUD. The patients with OUD have higher addiction severity index compared to patients with MUD. Opioid use disorder patents have poorer physical health, more severe alcohol use, and more severe family and psychiatric problems than MUD.