METHODS: The search was performed based on internet search and three main databases: PubMed, SCOPUS and EBSCO. PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation guideline was used to report this work.
RESULTS: Of 34 studies that met the inclusion criteria, 242 essential original constructs were collated, and 7 concepts were derived. Digital content showed the highest percentage of collated original constructs (27%, n = 65) followed by accessibility (24%, n = 56), comprehension engagement (18%, n = 43), autonomy (14%, n = 34), confidentiality (11%, n = 25), language (5%, n = 13), and parental consent (1%, n = 2). Twenty-five new items were synthesized for eConsent criteria which may provide guidance for ethical review of research involving eConsent.
CONCLUSION: The current study adds significant value to the corpus of knowledge in research ethics by providing ethical criteria on electronic informed consent based on evidence-based data. The new synthesized items in the criteria can be readily used as an initial guide by the IRB/REC members during a review process on electronic informed consent and useful to the future preparation of a checklist.
METHODS: Consent was provided by patients or by a relative or an independent doctor in incapacitated patients, using a 1-stage (full written consent) or 2-stage (initial brief consent followed by full written consent post-randomization) approach. The computed tomography-to-randomization time according to consent pathways was compared using the Kruskal-Wallis test. Multivariable logistic regression was performed to identify variables associated with onset-to-randomization time of ≤3 hours.
RESULTS: Of 2325 patients, 817 (35%) gave self-consent using 1-stage (557; 68%) or 2-stage consent (260; 32%). For 1507 (65%), consent was provided by a relative (1 stage, 996 [66%]; 2 stage, 323 [21%]) or a doctor (all 2-stage, 188 [12%]). One patient did not record prerandomization consent, with written consent obtained subsequently. The median (interquartile range) computed tomography-to-randomization time was 55 (38-93) minutes for doctor consent, 55 (37-95) minutes for 2-stage patient, 69 (43-110) minutes for 2-stage relative, 75 (48-124) minutes for 1-stage patient, and 90 (56-155) minutes for 1-stage relative consents (P<0.001). Two-stage consent was associated with onset-to-randomization time of ≤3 hours compared with 1-stage consent (adjusted odds ratio, 1.9 [95% CI, 1.5-2.4]). Doctor consent increased the odds (adjusted odds ratio, 2.3 [1.5-3.5]) while relative consent reduced the odds of randomization ≤3 hours (adjusted odds ratio, 0.10 [0.03-0.34]) compared with patient consent. Only 2 of 771 patients (0.3%) in the 2-stage pathways withdrew consent when full consent was sought later. Two-stage consent process did not result in higher withdrawal rates or loss to follow-up.
CONCLUSIONS: The use of initial brief consent was associated with shorter times to enrollment, while maintaining good participant retention. Seeking written consent from relatives was associated with significant delays.
REGISTRATION: URL: https://www.isrctn.com; Unique identifier: ISRCTN93732214.
METHODS: This is a prospective block randomized, non-blinded study conducted at a single tertiary hospital. Patients undergoing elective laparoscopic cholecystectomy between August 2017 and October 2018 were recruited and randomized into Handout Assisted Consent (HC) and Verbal Consent (VC) group. The HC group was given an adjunct handout on laparoscopic cholecystectomy during consent process in addition to the standard verbal consent. A validated open-ended verbal understanding and recall questionnaire was administered to all patients in both groups at Day 1, 30 and 90 after surgery. Patient satisfaction of the consent process was evaluated with Likert scale.
RESULTS: A total of 79 patients were enrolled, 41 patients and 38 patients in VC and HC groups respectively. Level of understanding among patients were equal and consistent across time in both groups (P > 0.05). There was significant decline (P 0.05).
CONCLUSION: There is good consistent understanding of the surgery in both groups. However, recall of specific surgical consent items decreased significantly over time in both groups. Handouts may have increased satisfaction among patients but did not improve recall in this preliminary study.
TRIAL REGISTRATION: MREC No.:201783-5468.
OBJECTIVE: Several European and international consensus statements concerning faecal microbiota transplantation have been issued. While these documents provide overall guidance, we aim to provide a detailed description of all processes that relate to the collection, handling and clinical application of human donor stool in this document.
METHODS: Collaborative subgroups of experts on stool banking drafted concepts for all domains pertaining to stool banking. During a working group meeting in the United European Gastroenterology Week 2019 in Barcelona, these concepts were discussed and finalised to be included in our overall guidance document about faecal microbiota transplantation.
RESULTS: A guidance document for all domains pertaining to stool banking was created. This document includes standard operating manuals for several processes involved with stool banking, such as handling of donor material, storage and donor screening.
CONCLUSION: The implementation of faecal microbiota transplantation by stool banks in concordance with our guidance document will enable quality assurance and guarantee the availability of donor faeces preparations for patients.
DESIGN: Observational study.
SETTING: A single-centre study in which eligible patients were recruited from T2DM clinic. Following consent, patients completed a questionnaire and underwent physical examinations. Patients had blood drawn for laboratory investigations and had a transthoracic echocardiography.
PARTICIPANTS: A total of 305 patients who were not known to have CVD were recruited. Patients with deranged liver function tests and end stage renal failure were excluded.
MAIN OUTCOME MEASURES: Echocardiographic parameters such as left ventricular ejection fraction, left ventricular mass index (LVMI), left ventricular hypertrophy, left atrial enlargement and diastolic function were examined.
RESULTS: A total of 305 patients predominantly females (65%), with mean body mass index of 27.5 kg/m2 participated in this study. None of them had either a history or signs and symptoms of CVD. Seventy-seven percent of patients had a history of hypertension and 83% of this study population had T2DM for more than 10 years. Mean HbA1c of 8.3% was recorded. Almost all patients were taking metformin. Approximately, 40% of patients were on newer anti-T2DM agents such as sodium-glucose cotransporter-2 and dipeptidyl peptidase 4 inhibitors. Fifty-seven percent (n=174) of the study population had SBHF at the time of study: diastolic dysfunction, increased LVMI and increased left atrial volume index (LAVI) were noted in 51 patients (17%), 128 patients (42%) and 98 patients (32%), respectively. Thirty-seven patients (12%) had both increase LVMI and LAVI.
CONCLUSION: Our study has revealed a high prevalence of SBHF in T2DM patients without overt cardiac disease in Malaysia that has one of the highest prevalence of TDM in the world.
Methods: The study was conducted during September 2020 using an online survey form. First to final year undergraduate students provided their consent and signed an integrity pledge electronically. Age, gender, program of study, year of study, whether staying with family or not, method of financing education, and whether they had used any allopathic medicines during the past 6 months were noted. The total knowledge score among different subgroups was compared. The frequency of responses regarding practice items and the free-text comments were also listed. Statistical analysis was performed using Mann-Whitney test and Kruskal-Wallis test.
Results: Altogether 441 of the 668 students (66%) participated. The majority were below 23 years and female. Over 65% had used allopathic medicines during the last 6 months. The median knowledge score was 8 (maximum 10) and was significantly higher among older respondents, females and students in later years of study. Most kept unused medicines at home/hostel till expiry which were disposed of in the household garbage. Over 40% had educated their family members about safe medicine disposal. Knowledge scores were significantly different among subgroups according to respondents' age, gender and year of study.
Conclusion: Respondents were aware of expiry of medicines and knew methods to safely dispose expired medicines. However, they practiced self-medication, stored medications at home and did not practice the safe disposal of medications. Understanding why respondents did not dispose medicines properly is important.
Methods: One hundred and eighty-eight healthy subjects aged between 18 and 50 years with varying oral hygiene status who gave consent to participate were included in this cross-sectional study. The subjects were recruited from primary oral health care of MAHSA University. Oral hygiene of all the participants was measured using Oral Hygiene Index-Simplified (OHI-S). Stimulated saliva collected using paraffin wax was analyzed for salivary statherin, aPRP, and calcium. The relationship between salivary statherin, aPRP, and calcium levels with OHI-S was assessed using Spearman's Rank correlation coefficient; the strength of relationship was assessed by multiple linear regression analysis.
Results: The study found a weak positive correlation (r = 0.179, p = 0.014) between salivary statherin and OHI-S; weak negative correlation (r = -0.187, p = 0.010) between salivary aPRP and OHI-S; and moderate negative correlation between salivary statherin and salivary aPRP levels (r = -0.50, p
OBJECTIVE: To determine the parents'/patients' perception on the informed consent process prior to posterior spinal fusion (PSF) for adolescent idiopathic scoliosis (AIS) patients.
SUMMARY OF BACKGROUND DATA: Understanding parents/patients perspective on the process is important in order to achieve the goal of consent and prevent medico-legal implications.
METHODS: Fifty AIS patients operated between August 2019 and November 2019 were prospectively recruited. Parents'/patients' perceptions on three sections were evaluated: the process of the informed consent, specific operative risk which they were most concerned with and the accountability of surgeons for the surgical risks. These data were ranked and scored using a 5-point Likert Scale. Preferences were reported in mean and standard deviation. Differences in terms of preferences were studied using One-way analysis of variance (ANOVA) analysis and deemed significant when P consent to be explained more than once (P = 0.021), once during clinic consultation and once during admission (4.2 ± 1.0). Consent taking by both attending surgeons was preferred (4.5 ± 0.6) compared with other healthcare providers, P consent and they felt that surgeons were directly responsible for screw-related injuries (3.9 ± 0.9), neurological injury (3.8 ± 0.9), and intraoperative bleeding (3.7 ± 0.9).
CONCLUSION: Parents/patients preferred the attending surgeons to personally explain the informed consent, more than once with the use of visual aid. They would still hold the surgeons accountable when complications occur despite acceptance of the informed consent.
LEVEL OF EVIDENCE: 2.
Materials and Methods: An unblinded randomized controlled trial was undertaken at the dermatology clinic of a tertiary care hospital. Consent from the patients fulfilling inclusion criteria were obtained, and they were included in this study. They were randomized into two groups, namely Gp-1 (C and P labeling) and Gp-2 (conventional labeling). Both groups were assessed at week 0, 6, and 12 (visit 1, 2, and 3) using knowledge assessment list and psoriasis severity assessment score. For visit 2 (week 6), reinforcement of their understanding of topical treatment was performed.
Results: A total of 101 patients were recruited. Only 91 of them completed the study. The mean ages were 44.52 (±16.61) and 45.49 (±15.84) years, with 70.3% males and approximately half Malay ethnics. The changes of knowledge and comparison of Topical Application Assessment Score between the groups showed an incremental raise of significance with every visit (P = 0.006 [week 1], 0.004 [week 6], and 0.002 [week 12]). Psoriasis Area and Severity Index 75 could not draw any conclusion as patients who achieved >75% improvement were inadequate.
Conclusion: C and P labeling was effective in improving the understanding and knowledge of patients with psoriasis. Both groups showed improvement in body surface area and Dermatology Life Quality Index for every visit; however, it was statistically insignificant.
Patients and Methods: The data were collected from 35 experts by using a bipolar questionnaire. The study applied an analytical hierarchal process (AHP) for prioritization factors contributing to willingness to donate and then selection of a suitable organ donation system based on prioritized factors.
Results: Based on the AHP results, it is evident that donation perception (0.36) has the highest priority in influencing organ donation rates, followed by socioeconomic status (0.32), demographic factors (0.23), and financial incentives (0.09). Further, our results challenge the existing opt-in donation system in Malaysia and present a presumptive approach as a suitable system for increasing deceased donation rate in Malaysia. Presumptive approach promotes the role of health-care professionals in securing the family consent.
Conclusion: This approach is a person-oriented rather than process-oriented strategy and it relies on designated requesters' skills to evoke altruism among bereaved families. Based on results, the authors recommended that relevant government agencies focus on training nurses to discuss donation with bereaved families and raising public awareness.