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.
Methods: There were 20 healthy participants with normal ears, and all gave an informed consent. After an otoscopy, a baseline pure tone audiogram (PTA) was conducted. If the PTA of the participant was normal, aqueous cream was applied with a syringe via an 18 G cannula, from the tympanic membrane up to the isthmus which corresponds to the bony ear canal. A second PTA was conducted, and subsequently the cream was removed via suction under microscope guidance. The procedure was then repeated with the cream applied from the isthmus to the aperture of the external ear canal using the same cannula followed by a PTA and removal of cream under microscope.
Results: The mean threshold difference of occlusion at both portions of the ear canal were compared and analyzed. The mean threshold difference of hearing loss upon occlusion at the cartilaginous EAC was 37.5 to 48 dB. The mean threshold difference of hearing loss upon occlusion at the bony EAC was less, with a range of 21 to 24.95dB. There was a statistical difference (p<0.05) in the hearing loss between the blockage of the cartilaginous canal versus the blockage of the bony canal with a maximum difference at 2kHz.
Conclusion: Cartilaginous block of the external ear canal causes more hearing loss than block of the bony ear canal. This correlates with the concept and properties of sound waves, resonance and impedance.
METHODS: The local ethics committee approved this retrospective study and for this type of study formal consent is not required. A total of 42 B3 lesions in 40 women aged 41-77 years were included in our study. All patients underwent CESM 2-3 weeks after the biopsy procedure and surgical excision was subsequently performed within 60 days of the CESM procedure. Three radiologists reviewed the images independently. The results were then compared with histologic findings.
RESULTS: The sensitivity, specificity, and positive and negative predictive values for confirmed demonstration of malignancy at CESM were 33.3%, 87.2%, 16.7%, and 94.4% for reader 1; 66.7%, 76.9%, 18.2%, and 96.7% for reader 2; 66.7%, 74.4%, 16.7%, and 96.7% for reader 3. Overall agreement on detection of malignant lesions using CESM among readers ranged from moderate to substantial (κ = .451-.696), for categorization of BPE from moderate to substantial (κ = .562-.711), and for evaluation of lesion intensity enhancement from fair to moderate (κ = .346-.459).
CONCLUSION: In cases of Breast Imaging Reporting and Data System (BI-RADS) 1, BI-RADS 2, or BI-RADS 3 results at CESM, follow-up or VAB rather than surgical biopsy might be performed.
METHODS/DESIGN: This is a randomized, single-blind, two-arm, controlled trial in patients with rheumatoid arthritis visiting outpatient rheumatology clinics in Karachi, Pakistan. We will enroll patients with established diagnosis of rheumatoid arthritis over 3 months. The patients would be randomized through a computer-generated list into the control group, i.e., usual care or into the intervention group, i.e., pharmaceutical care, in a ratio of 1:1, after providing signed written consent. The study will take place in two patient-visits over the course of 3 months. Patients in the intervention group would receive intervention from the pharmacist while those in the control group will receive usual care. Primary outcomes include change in mean score from baseline (week 0) and at follow up (week 12) in disease knowledge, adherence to medications and rehabilitation/physical therapy. The secondary outcomes include change in the mean direct cost of treatment, HRQoL and patient satisfaction with pharmacist counselling.
DISCUSSION: This is a novel study that evaluates the role of the pharmacist in improving treatment outcomes in patients with rheumatoid arthritis. The results of this trial could set the foundation for future delivery of care for this patient population in Pakistan. The results of this trial would be published in a peer-reviewed journal.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT03827148 . Registered on February 2019.
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.
Methods: We described three different surgical techniques for correction of penile paraffinoma based on our single-centre experience. Informed consents were obtained from patients whose photographs were taken during the operation step.
Results: In general, three patients had simple excision biopsy with primary suturing, four patients underwent single stage excision of circumferential granuloma with bilateral scrotal skin flap reconstruction and one patient experienced dual stage procedure. Three of them were injected with paraffin, one with silicone and the remaining four were unable to identify the substance used. All patients successfully underwent the surgical procedure and four of them had minor post-operative surgical site infection and wound gapping.
Conclusion: All patients recovered well and the mean International Index of Erectile Function (IIEF-5) score obtained was 24.25. In our experience, excision biopsy was adequate for focal mass and reconstructive surgery using bilateral scrotal flap was suitable for circumferential mass.
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.
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.
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.