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Background Osteoporosis may result from risk factors such as smoking, alcohol, low body mass index, less physical exercise, and dietary calcium deficiency. The risk of osteoporosis fractures can be reduced with lifestyle changes, which include diet, exercise, and preventing falls. The present study is an effort to measure the burden of risk factors of osteoporosis in adult male soldiers in the Armed Forces. Methods The present study was a cross-sectional study among serving soldiers in South-Western part of India, and 400 participants consented to be included in the study. After obtaining informed consent, the questionnaire was distributed. Venous blood samples were collected to measure serum calcium, phosphorus, vitamin D, and parathyroid hormone (PTH). Results The prevalence of vitamin D3 severe deficiency ( 66.5 pg/mL) was seen in 5.5% of the participants. A statistically significant association was found between consumption of milk and milk products and levels of calcium. With a cutoff value of 20 ng/mL for vitamin D3 deficiency, a statistically significant association was found for consumption of fish, physical activity, and sun exposure. Conclusion A remarkably large percentage of otherwise normal healthy soldiers have deficiency or insufficiency of vitamin D and might be prone to osteoporosis. Despite significant advances in our understanding and management options for male osteoporosis, there still remain important gaps in knowledge which needs to be looked into.

Highlights • Mean HBA1c in diabetic patients increased by 0.51% in immediate post lock down period due to COVID 19. • Increased mean HBA1c may significantly increase the annual incidences of complications related to diabetes. • With early identification and multidisciplinary approach which is patient centric good glycemic control can be achieved back. • By achieving good glycemic control, the predicted annual percentage increase in complication rate can be reduced., Background and aims Diabetes is a chronic metabolic condition characterized by hyperglycemia and is associated with several complications. Prevalence of Diabetes in adult population in India ranges from 10.9 to 14.2% in urban area and 3.0–7.8% in rural area. Glycemic control is an important factor in preventing the complications associated with diabetes. HBA1c is the indicator of long-term glycemic control and slight variation in it significantly alters the risk of diabetic complications. Thus, the aim of this study was to study the change in HBA1c levels due to lock down in patients with diabetes. Methods 307 patients with diabetes who had attended our endocrine OPD in last 3 months before nationwide 68 days lockdown from 24 March 2020 to 31 May 2020, and had recent HBA1c report in past and willing to participate were included in the study after informed consent from 2nd June 2020 to 14th June 2020 when first phase of Unlock started, to identify the change in HBA1c levels during the lockdown period in our patients with diabetes. Results The patients were aged between 25–69 years and male to female ratio was 181:126 (1.44: 1). The mean age and mean duration of diabetes in our patients was 55.68 years and 7.95 years respectively. Increment of 0.51% was seen in mean HBA1c levels in our patient from 7.92% mean pre-lockdown HBA1c to mean of 8.43% after release of lock down. Conclusion Glycemic control got deranged during lockdown period with significant increase of mean HBA1c by 0.51% in immediate post lock down period which may significantly increase the annual incidence of complications related to diabetes.

Background Total Ankle Arthroplasty (TAA) is increasingly undertaken for the treatment of end-stage ankle arthritis. For each TAA procedure informed consent is required. The consent process should include discussion of the relevant complications, both systemic and regional. There is a lack of data regarding the systemic complications of TAA. This might cause problems in obtaining valid informed consent. Methods We reviewed and summarised the literature regarding the systemic complications and mortality rate of TAA. Results The average rate of systemic medical complications after TAA was 3% (range: 0–7%). The average mortality rate following TAA was 0.3% (range: 0–0.72%). The following were risk factors for systemic medical complications: obesity, diabetes, systemic co-morbidities, preoperative blood transfusion, revision procedures, and long anaesthetic duration. Conclusions When obtaining informed consent for TAA a systemic complication rate of 3% and a mortality rate of 0.3% ought to be included and documented.

Sedation in palliative care, also called "palliative sedation", is an important treatment option for patients who experience unbearable suffering from treatment-refractory symptoms at the end of life. The aim is to reduce this suffering as far as possible by reduction of the patient's consciousness. Good communication between all people involved is crucial for these clinically and ethically challenging situations. This article presents definitions of key terms and of different types of sedation. It then describes the process of sedation step by step: 0. Pre-emptive discussion of the option of sedation (in the context of advance care planning); 1. indication and decision making; 2. information and informed consent; 3. documentation when starting sedation; 4. start of sedation; 5. monitoring and adaption of sedation; 6. medical and nursing care and documentation during sedation; 7. care and processes after the death of the patient (if applicable).

Objectives: To attain more local corneal donations, awareness of corneal donations must be raised among doctors and medical students. This study aimed to evaluate the knowledge and attitude of medical students regarding corneal donations. Methods: This cross-sectional study was conducted among male fifth- and final-year medical students at the College of Medicine, King Saud bin Abdulaziz University for Health Sciences, Saudi Arabia, between August and October 2019. Non-probability convenience sampling was used and an English-language self-administered questionnaire was administered to evaluate different aspects of the participants’ knowledge regarding and attitudes towards corneal donation. Data were analysed using descriptive statistics, analysis of variance, and independent samples t-test. Results: A total of 141 students participated in this study (response rate: 53%). A mean score of 3.24 ± 1.86 was achieved by the participants on the knowledge test. Approximately 47% of the sample correctly recognised that people who die of AIDS cannot donate an eye. The most common reason for eye donations was to provide vision to a blind person (47%), while a lack of understanding of benefits to others (55%) and religious beliefs (44%) were seen barriers. The internet was identified by 56% as the most common source of information. There was no significant difference in the knowledge of fifth-year and final-year medical students (3.31 ± 1.84 versus 3.17 ± 1.89; P = 0.65). Conclusion: This study showed a low level of knowledge of corneal donations among the participants. Raising awareness among medical students is important to increase donation rates. However, media and the internet are not enough to achieve this. Basic knowledge of corneal donations to students by organising awareness-raising activities and motivating them for voluntary participation is important to fill this knowledge gap. Keywords: Knowledge; Attitude; Cornea; Medical Students; Saudi Arabia.

Objectives Responsive neurostimulation is an innovative modality in the treatment of medication-refractory epilepsy for patients who are not suitable candidates for surgical intervention. While being a potentially life-changing treatment option for many individuals with epilepsy, little is known about the system's complications aside from its performance in initial clinical trials. Therefore, the goal of this study was to characterize all reported complications of the RNS system made to the Food & Drug Administration since its approval. Materials and methods The Manufacturer and User Facility Device Experience (MAUDE) database was queried for entries reported under "implanted brain stimulator for epilepsy" through the dates of November 1, 2013 to March 1, 2020. After correction of duplicate entries, each was sorted into complication types based on the entries' narrative descriptions. Results The searched yielded 241 unique complication events. The most common complications were attributed to infections (40%) and lead breaks (12%). Other reported complications included poor wound healing (10%) and intrinsic device failure (7%). Focal neurological deficits were found in 2%. Over half (67%) of the reported complications required return to the operating room for revision or explant. The remainder of the adverse events were self-resolved or treated with either medication or software adjustment. Conclusions Future research endeavors should attempt to optimize the implantable device for preventing infections. The data of complications provided by this review will also aid physicians in providing the most accurate informed consent for patients when deciding to undergo implantation with the responsive neurostimulation system.

Background/Aim. Growing waiting lists for cardiac surgery have become a real problem in the Republic of Serbia, imposing serious difficulties in patient-surgeon communication. The aim of the study was to determine the current state of the institutional informed consent policy before elective cardiac surgical procedures in light of actual nation-al legislation. Methods. An anonymous, voluntary survey was conducted among 200 consecutive patients at the Clinic for Cardiac Surgery, University Clinical Centre of Serbia, from September to December 2019, after signing an official institutional consent form. A targeted questionnaire was created to determine the quantity and quality of patients? in-formation about general and the most important aspects of cardiac surgical care. Results. The mean age of respondents was 66.2 years, with male predominance (68.0%), homogenous ethnicity, and low-to-middle (84.0%) education levels. A significant percentage had no information on the type of surgery (16.0%), extracorporeal circulation (46.0%), anaesthesia (56.0%) and transfusion (51.5%). Of those having some information, 7.0?20.0% graded them sufficient. The worst situation was recorded concerning risks of disease and surgical treatment, where 88.0% of patients had no information and almost 90.0% had some information and graded them as non-sufficient. Surprisingly, 81.5% of patients signed the consent form without any prior discussion with the operating surgeon. For 56.0% of patients, the information in the actual consent form was clear and sufficient. While 85.5% of patients claimed the importance, the others (14.5%) were not interested to know the most relevant in-formation about their disease and surgery. Conclusion. The results unambiguously indicate an unacceptably low level of our patients? information about the cardiac surgical procedure, extracorporeal circulation, anesthesia, transfusion, and estimated risk. The majority of them (85.5%) comprehends the importance and expects timely and adequate information. An extremely high percentage (81.5%) of patients had no chance to discuss the procedure with the operating surgeon. Both surgical indifference and insufficient knowledge of professional, ethical, and legal importance are the most important reasons for the actual informed consent policy in cardiac surgery.

Background: An increasing number of South Africans utilise primary healthcare services (either in the state or private sector) for mental health concerns; hence, there is a need to objectively assess these doctors’ attitudes and knowledge of mental illness. Aim: To investigate aspects of knowledge and attitudes towards mental illness of a group of private and state-employed non-specialist medical doctors. Method: Doctors in the state sector who were working at a primary healthcare level and who were not working towards, or did not hold, a specialist qualification were considered eligible for the study. Doctors in the private sector who were working as general practitioners and who did not hold a specialist qualification were considered eligible for the study. Data were collected by means of a self-administered questionnaire. A link to the study questionnaire, information about the study, details of the researcher and matters pertaining to informed consent were emailed to potential participants. Results: Of the 140 practitioners who responded to the survey, 51.4% (n = 72) worked in the state sector, 41.4% (n = 58) worked in the private sector and 7.1% (n = 10) worked in both the state and private sectors (χ2 1 = 45.31, p < 0.010). The majority (> 50%) of participants in all three groups had a positive attitude towards mental illness (χ2 2 = 1.52, p = 0.468). Although there were no significant associations between attitude and socio-demographic characteristics (p > 0.05), male SS doctors reported feeling less comfortable when dealing with mentally ill patients (p = 0.015); SS doctors who did not have family contact with mental illness were less likely to feel that mentally ill patients did not pose a risk to others (p = 0.007), and PS doctors under the age of 35 years were more likely to feel adequately trained to treat mental illness (p = 0.026). The majority (> 50%) of participants in all three groups had an adequate level of knowledge of mental illness (modal scores = 10). There were no significant associations between knowledge and socio-demographic characteristics (p > 0.05). Conclusion: Despite the findings of a positive attitude and adequate knowledge of mental illness amongst the participants of this study, it is recommended that more targeted interventions are established to further improve mental health awareness and knowledge of doctors at both undergraduate and postgraduate levels of study.

As the classification of mental disorders advances towards a disease model as promoted by the National Institute of Mental Health (NIMH) Research Domain Criteria (RDoC), there is hope that a more thorough neurobiological understanding of mental illness may allow clinicians and researchers to determine treatment efficacy with less diagnostic variability. This paradigm shift has presented a variety of ethical issues to be considered in the development of psychiatric drugs. These challenges are not limited to informed consent practices, industry funding, and placebo use. The consideration for alternative research models and quality of research design also present ethical challenges in the development of psychiatric drugs. The imperatives to create valid and sound research that justify the human time, cost, risk and use of limited resources must also be considered. Clinical innovation, and consideration for special populations are also important aspects to take into account. Based on the breadth of these ethical concerns, it is particularly important that scientific questions regarding the development of psychiatric drugs be answered collaboratively by a variety of stakeholders. As the field expands, new ethical considerations will be raised with increased focus on genetic markers, personalized medicine, patient-centered outcomes research, and tension over funding. We suggest that innovation in trial design is necessary to better reflect practices in clinical settings and that there must be an emphasized focus on expanding the transparency of consent processes, regard for suicidality, and care in working with special populations to support the goal of developing sound psychiatric drug therapies.

Objective To assess the quality of national cancer screening program leaflets in Japan from the informed-decision perspective. Methods Cross-sectional content analysis of invitation leaflets issued by centralized organizations and used nationwide in Japan was conducted. Three members independently evaluated the materials using International Patient Decision Aids Standards six-item minimum criteria for qualifying patient decision aids. Patient public involvement Co-author KH is a cancer patient himself. We also sought feedbacks from three other cancer survivors and two bereaved family members. Results Inter-rater agreement was substantial (Fleiss’ kappa=0.62). The median score was 2 out of 6 (range: 2–3). All leaflets described the cancer (Q1: 7/7) and screening modality (Q2: 7/7). None stated not undergoing screening as an option. One stated another screening modality (Q3: 1/7). None stated both the positive and negative features of multiple options (Q4: 0/7. Q5: 0/7). One described the psychological and social experience of screening but only its positive side (Q6: 1/7). Conclusions There is room for improvement in the content of the public cancer screening invitation leaflets in Japan from informed-decision perspective. Practice implications Cancer screening leaflets should provide evidence-based, well-balanced, easy-to-understand information to educate people on cancer screening while maintaining people’s autonomy.

Introduction Dry powder inhalers (DPIs), a commonly prescribed inhaler type for respiratory diseases, require patients to generate sufficient peak inspiratory flow (PIF) to ensure optimal drug delivery to the airways. Effectiveness of therapy also requires a good inhalation technique and adequate medication adherence. For patients with chronic obstructive pulmonary disease (COPD), recent studies conducted in tertiary care suggest that DPI users with suboptimal PIF have poorer COPD-related health status and increased exacerbation risk versus those with optimal PIF. The PIFotal study will investigate the impact of PIF, inhalation technique and medication adherence on patient-reported outcomes in patients with COPD in primary care using a DPI for their maintenance therapy. Methods and Analysis This cross-sectional observational study will assess 1200 patients (aged ≥ 40 years, diagnosed with COPD and using a DPI for COPD maintenance therapy for ≥ 3 months) from the Netherlands, Spain, Portugal, Poland, Greece and Australia. Assessments will consist of (1) PIF measurements (usual patient inhalation manoeuvre, maximal PIF against resistance of own inhaler, and maximal PIF against low resistance); (2) Clinical COPD Questionnaire (CCQ), COPD Assessment Test and Test of Adherence to Inhalers scores; and (3) video recordings of patient inhalation technique. Dependent variables include health status (CCQ score), number of self-reported exacerbations in previous 12 months, and healthcare resource utilisation in previous 6 months. Independent variables include PIF values, inhalation technique errors, medication adherence, and demographic and clinical characteristics. In the primary analysis, the mean difference in CCQ score between patients (1) with optimal/suboptimal PIF, (2) exhibiting/not exhibiting inhalation technique errors, and (3) adhering/not adhering to medication will be examined in a multivariable linear mixed model. Ethics The study protocol was approved by ethics committees/institutional review boards of all participating sites prior to enrolment; written informed consent was obtained from all study participants. Trial Registration Number ClinicalTrials.gov: NCT04532853. Supplementary Information The online version contains supplementary material available at 10.1007/s41030-021-00172-7.

Inguinal hernias represent one of the most common pathologic conditions presenting to the general surgeon. In surgical practice, several controversies persist: when to operate, the utility of a laparoscopic versus open approach, the applicability of robotic surgery, the approach to bilateral hernias, management of athletic-related groin pain ("sports hernia"), and the role of tissue-based repairs in modern hernia surgery. Ideally, surgeons should approach each patient individually and tailor their approach based on patient factors and preferences. The informed consent process is critical, especially given increasing recognition of the risk of long-term chronic pain following hernia repair.

Background: Chlamydia trachomatis(CT) and Neisseria gonorrhoeae (NG) are the most common bacterial sexually transmitted infections (STIs) worldwide. In the absence of affordable point-of-care STI tests, WHO recommends STI testing based on risk factors. This study aimed to develop a prediction tool with a sensitivity of >90% and efficiency (defined as the percentage of individuals that are eligible for diagnostic testing) of

Background: Given the high sensitivity of the D-dimer assessment when ruling out pulmonary embolism, the present study was conducted to investigate the D-dimer levels in patients with CKD based on their related GFR. Methods: The present cross-sectional study included 98 patients with CKD who presented to the nephrology clinic of the Shahid Beheshti Hospital in Hamadan, Iran. The patients gave informed consent before enrollment. The data of each patient was recorded in the form of a checklist. The data analysis was performed using the SPSS software at a significance level of 0.05%. Results: There was found to be a negative correlation between GFR and D-dimer levels in the study participants. However, there was no evidence of thromboembolic events during the 1-year follow-up. Moreover, we found a direct relationship between patient age and the serum levels of the D-dimer, in that the D-dimer levels were higher in the participants who were older. Conclusion: We concluded that serum D-dimer level has a positive correlation with age, while it has a negative correlation with GFR in CKD patients. However, no evidence of thromboembolic events was found.

Introduction: Telephysiotherapy (TPT) is provision of physiotherapy services using telecommunication technology such as audio call or video call to facilitate the physiotherapy management of patients within their own homes. In the absence of which the patients may have to discontinue physiotherapy treatment that may result into poor motor outcomes leading to deterioration of the quality of life (QoL). Methodology: This is a study protocol designed to study the effectiveness of TPT intervention in Stroke patients. The objective is to study whether TPT is effective for Stroke Rehabilitation in improving motor function and quality of life. An exercise protocol will be administered to patients suffering from mild to moderate stroke those grading less than or equal to 4 on a Modified Rankin Scale (mRS=

Purpose Breast cancer survivors take vitamins and supplements to bolster their general health and to decrease the risk of cancer recurrence. Healthcare providers are frequently unaware of their patients non-prescription supplement use. The aim of this study was to study the type and the documentation of patients’ dietary supplements and vitamins in the electronic medical record (EMR). Methods 50/51 female breast cancer survivors seen over a 7 week period consented to the study. Mean age was 70 and mean years since diagnosis was 13.9. Informed consent and documentation of supplement and vitamin use was obtained by the nurse practitioner the day before the visit. Study data were collected and managed using REDCap electronic data capture tools hosted at Weill Cornell Medicine. Results Of the 50 study patients, 90% were taking one or more vitamins and/or supplements (mean = 2.4, range = 1–9). The most common were Vitamin D, calcium, and vitamin C. Reasons for vitamin and supplement use included the recommendation by their physician or friend and prevention of bone loss or catching a cold. Five patients mentioned immunity or prevention of COVID-19. The patient reported list was compared with the medication list used by multiple providers in the electronic medical record (EMR). None of the 50 study patients had an accurate list of their vitamins and supplements in the EMR. Conclusion 90% of the breast cancer survivors in our study were taking dietary supplements for a variety of reasons. None had an accurate list in the EMR. We strongly recommend more attention to accurate and easily accessed vitamin and supplement recording by providers.

Objective: To evaluate and compare the effectiveness of zinc and B-Complex supplementation to prevent the recurrence of nephrotic syndrome in the cases priory responsive to corticosteroid therapy. Methodology It is a randomized controlled trial conducted at OPD Pediatric medicine, Shaheed Zulfiqar Ali Bhutto University, PIMS Children Hospital Islamabad from October 3, 2016 to April 2, 2017. 192 patients (96 in each group) were included in the study after obtaining informed consent from parents or guardians taken before determining the population. Patients were randomly assigned to two groups (Group 1: Zinc and Group 2: B-Complex) to receive oral zinc sulphate (10 mg / day) or B-Complex using a random number table. The patients were followed up after 4 months. All data were collected by the researchers themselves in a structured form. Results: The age of 192 participants of the trial averaged 6.38±3.42 years of age ranging from 1-12 years. There were 88 (45.8%) men and 104 (54.2%) women cases. In group 1, there were 22 (22.9%) and in group 2, there were 47 (49%) cases that had been pardoned. The recurrence of nephrotic syndrome was significantly higher in group 1 than group 2 (p =

Background Hodgkin lymphoma survivors (HLS) are at excess risk of lung cancer as a consequence of HL treatment. HLS without a heavy smoking history are currently unable to access lung cancer screening (LCS) programmes aimed at ever smokers, and there is an unmet need to develop a targeted LCS programme. In this study we prospectively explored HLS perspectives on a future LCS programme, including motivating factors and potential barriers to participation, with the aim of identifying ways to optimise uptake in a future programme. Methods Semistructured telephone interviews were conducted with HLS, aged 18–80 and lymphoma‐free for ≥5 years, selected from a clinical database (ADAPT). Participants provided informed consent. Data were analysed using inductive thematic analysis. Results Despite awareness of other late effects, most participants were unaware of their excess risk of lung cancer. Most were willing to participate in a future LCS programme, citing the potential curability of early‐stage lung cancer and reassurance as motivating factors, whilst prior experience of healthcare was a facilitator. Whilst the screening test (a low dose CT scan) was considered acceptable, radiation risk was a concern for some and travel and time off work were potential barriers to participation. Conclusions Our results suggest that most HLS would participate in a future LCS programme, motivated by perceived benefits. Their feedback identified a need to develop educational materials addressing lung cancer risk and concerns about screening, including radiation risk. Such materials could be provided upon an invitation to LCS. Uptake in a future programme may be further optimized by offering flexible screening appointments close to home.

Background: Diabetes mellitus (DM) is a clinical syndrome characterized by hyperglycaemia due to absolute or relative insulin deficiency. Autonomic neuropathy invokes potentially life threatening outcomes especially in poorly controlled diabetic patients. Objectives: The objective of this study is to assess the incidence of autonomic neuropathy in patients with type 2 diabetes mellitus. Materials and Methods: The Study was conducted on 80 Type 2 Diabetes Mellitus patients in Pre Anesthetic Clinic of Department of Anesthesiology, Saveetha Medical College and Hospital during the period of March 2021 to August 2021. Informed consent was obtained from all those who met the inclusion criteria and their BP and Heart Rate variability to various manoeuvres were assessed. Results: According to our study 40% and 30% had borderline and definite autonomic neuropathy respectively. Conclusion: Autonomic neuropathy is common in patients with poorly controlled Diabetes Mellitus, especially those on oral hypoglycemic agents. As nowadays no therapy is able to effectively reverse this process, prevention with strict glycemic control, multifactorial intervention, and lifestyle modification remains essential.

Urine drug screens (UDSs) are often performed in the emergency department (ED) as part of a standard ED order set in patients with significant altered mental status, trauma, or seizures usually without the patient’s knowledge or specified informed consent. In the ED the UDS has been included in the standard consent to treatment for routine testing along with blood studies, EKG, urinalysis and radiology. Many technical factors are known to effect UDS results.There is a lack of education among physicians regarding the clinical pitfalls of UDS interpretation. This article discusses the current state and issues associated with the UDS, and presents three clinical vignettes that illustrate the impact of false-positive UDS results on patient care and the potential for a patient becoming unknowingly and unfairly stigmatized. The article also offers suggestions including a requirement for either formal informed consent or an “opt out” screening process, as recommended by the CDC in HIV testing, designed to protect patient autonomy and confidentiality.

The lower urinary tract (LUT), in particular the prostate, has been theoretically recognized as a target for SARS-CoV-2. Moreover, common pathophysiological mechanisms have been described for BPE/LUTS and COVID-19, including RAS dysregulation, androgen receptors, and MetS-related factors. These factors raise concerns about the possibility of worse urological outcomes due to BPE/LUTS progression in COVID-19 patients. The available results suggest a correlation between SARS-CoV-2 infection, exacerbation or new onset of LUTS, and semen impairment. BPE patients’ care and management have been deeply affected by COVID-19. In the midst of the pandemic, the main urological guidelines suggested postponement of BPH-related deferrable medical examinations and surgery. Telemedicine, therefore, gained attention and interest. Clinical evidence of impaired QoL or complications expedited surgical intervention. An informed consent covering the risk of COVID-19 and a negative molecular PCR within 72 hours of surgery were mandatory. A reduction in procedures under general anaesthesia was recommended. Long waiting lists accrued worldwide during the pandemic, leading to regular review of the BPE waiting lists and patients’ clinical status, encouraging the increase of minimally invasive office-based procedures, even in the post-COVID-19 era, and the improvement of telemedicine. Prospective studies are still needed to assess the course of LUTS/BPE patients after COVID-19.

Introduction: Hospital-acquired pressure injuries are one of the most important indicators of quality patient care. It is important to identify high-risk patients to guide the implementation of appropriate prevention strategies. This can be done by using an assessment tool that covers the main risk factors for pressure injuries. Aim: The purpose of the study was to describe the incidence of pressure injuries and the associated risk factors among patients assessed with the Prevent Pressure Injury (PPI) risk assessment tool developed by the Helsinki University Hospital. Method: The study was conducted by selecting six wards from medical, surgical and neurological units. The target group were the patients being treated in the study units who gave their informed consent. The research data were retrieved from electronic patient records. Results: From the target group, 332 patients were eligible to participate in the study. The pressure injury risk was found to increase with longer hospital stays and older age. Surgical patients had an increased risk of pressure injuries compared to other specialty fields. A primary diagnosis of musculoskeletal or connective tissue disease, and secondary diagnoses of hypertension and cerebral haemorrhage, were linked with an increased pressure injury risk. A total of nine pressure injuries occurred in nine patients, with an incidence of 2.5% (stages II−IV). Conclusion: The observation and recording of pressure injuries in specialised medical care remain insufficient. Longer hospital stays, older age and surgery increase pressure injury risk. Also, patients' primary and secondary diagnoses may increase the pressure injury risk. Declaration of interest: The authors have no conflicts of interest to declare.

Retinit is pigmentosa is an incurable degenerative disease that causes loss of light-sensitive cells in the retina and leads to severe vision impairment. The development of optogenetics has created great hype around its potential to treat retinitis pigmentosa by the introduction of light-sensitive proteins into other neural cells in the retina. The first-in-human studies of optogenetic treatment for this disease have recently been reported (NCT02556736 and NCT03326336). The treatment involves irreversible gene therapy and requires access to specially designed goggles to deliver light to the treated eye. These highly innovative and high-profile clinical trials raise numerous ethical issues that must be addressed during the early phases of research and clinical testing to ensure trial participants are treated fairly and can provide appropriate informed consent.

Teprotumumab was the first and only medication approved by the US Food and Drug Administration for the treatment of thyroid eye disease in January 2020. Thyroid eye disease is a complex autoimmune inflammatory disease that can be sight-threatening, debilitating, and disfiguring to affected patients. Although biologic therapies are a preferred treatment option for many complex immunologic and oncologic conditions, their use in ophthalmology and endocrinology may be more novel. The goals of this article are to introduce this new therapeutic option; discuss its mechanism of action, indications for use, administration protocol, infusion precautions, and informed consent; and review common side effects and management.

Objectives The objective of this study was to estimate the possible number of cancer cases produced during 2019 in US dental offices from radiography, estimate the possible reduction in those rates resulting from use of intraoral rectangular collimation and selection criteria, and determine the frequency and quality of website radiation risk information and informed consent forms. Study Design An analysis of dental radiation examinations in 2014 to 2015 US national survey data, Nationwide Evaluation of X-ray Trends, and National Council on Radiation Protection and Measurements surveys was performed, in addition to an analysis of 2008 to 2020 Journal of Clinical Orthodontics national orthodontic surveys for radiographic examination frequencies. Lifetime attributable cancer risk estimates from US and European studies were used to generate the total dental and orthodontic office cancer totals. In total, 150 offices were examined online for the quality and frequency of risk information in websites and consent forms. Results The 2019 estimate for all office cancers is 967. Collimation and selection criteria could reduce this to 237 cancer cases. Most cancers arise from intraoral and cone beam computed tomography examinations, with 135 orthodontic cancers over 21 months (average treatment time). Collimation and selection criteria could reduce this to 68. Only 1% of offices use collimators or informed consent for radiography. The website and consent information were of poor quality. Conclusions Dentists are not following selection criteria or using collimators according to guidelines. Up to 75% of cancer cases could be avoided.

PURPOSE/OBJECTIVE Compare the effects of an adapted Screening, Education, and Brief Intervention (Adapted SBI) for alcohol misuse following traumatic brain injury (TBI) to a Screening and Education with Attention Control (SEA) condition. STUDY DESIGN A single-masked, parallel group, randomized controlled trial was conducted with 58 participants who were 18 and older, sustained a TBI requiring inpatient rehabilitation, had a history of alcohol misuse, were English-speaking, cleared posttraumatic amnesia, were free of language impairments precluding participation in the intervention, and who provided informed consent. Outcomes were collected at 3, 6, and 12 months postdischarge. The primary outcome was drinks per week at 12 months postdischarge. RESULTS Participants in both conditions reduced alcohol use following their injury. The number of drinks per week at 12 months did not differ between the treatment conditions; the number of drinks consumed across the entire sample was very low (median = 0). A lower percentage of participants in the Adapted SBI condition resumed alcohol use by 12 months postdischarge (32% vs. 62% in the SEA condition, p < .05). No significant differences were found on other outcomes (binging, facts recalled about the negative effects of alcohol, drug use). The inclusion of a booster session did not appear to alter the intervention effects. The interventions did not impact other healthy behaviors, however healthy eating and stress management practices were associated with abstaining from alcohol use at the 12-month follow-up. CONCLUSIONS/IMPLICATIONS While alcohol misuse generally declines postinjury, by 12 months postdischarge many individuals resume alcohol use. Adapted SBI may slow the resumption of alcohol use. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Background As patients with severe mental illness are at increased risk for COVID-19 mortality, the issue of willingness to be vaccinated is of extreme importance. Methods During February 2021 Shalvata Mental Health hospital provided Covid-19 vaccines to its patients. Fifty one patients suffering from severe mental illness, out of 196 patients hospitalized in closed, open or day wards during that period, signed the informed consent and were assessed for their clinical condition (OQ-45), fear of Covid-19 (FCV-19S) and approach to the vaccine (C19-VHS). All patients who were not vaccinated in February 2021 (baseline) were re-approached a month later to assess whether they had gotten vaccinated since. Results Patients who were not vaccinated at baseline had an oppositional approach to the vaccine, and did not significantly differ in their fear of Covid-19 levels or in levels of clinical severity (t(49) = 2.51, p = 0.02) from those who were vaccinated. From the 29 patients who were not vaccinated at baseline approach to the vaccine was a good predictor to getting vaccinated after one month (79% positive predictive value). Conclusions The majority of patients suffering from a severe mental illness are willing to get vaccinated, and their decision of whether or not to get vaccinated is based on their viewpoint on the vaccine rather than being an outcome of their level of distress (OQ-45). It is important to allow vaccine accessibility to hospitalized patients, to consider their opinions and to provide useful information to lower vaccine hesitancy and improve vaccination rates.

When performed appropriately and safely, esophagogastroduodenoscopy (EGD) is an invaluable tool for diagnosing and monitoring a range of upper gastrointestinal disorders and cancers. With more than 6 million EGDs being performed in the United States and reports of missed upper GI (UGI) lesions, both experienced and budding endoscopists should keep a number of essential considerations in mind when performing an EGD, and that starts with obtaining a thorough patient medical history and ensuring that informed consent has been obtained. The right approach, including good posture, appropriate intubation, and proper use of torque, as well as slow endoscope insertion and withdrawal, helps make for a smooth and effective procedure. A clean mucosa, achieved using water and de-foaming and mucolytic agents, ensures clear visibility. Meticulous inspection of the mucosa will allow the endoscopist to detect all lesions and abnormalities. Adherence to established and indication-specific biopsy protocols and use of validated classification criteria should help histopathologists confirm a diagnosis. Maintaining vigilance after an endoscopy and informing our patients of symptoms and signs of procedure-related adverse events is essential for the early recognition and management of these possible adverse events. Finally, an evidence-based schedule of follow-up endoscopy built on endoscopic and histologic findings and risk factors for disease progression will help avoid overutilization of endoscopies.

ZusammenfassungZiel der Studie „Real world“-Daten aus der ambulanten Gesundheitsversorgung sind in Deutschland nur schwer systematisch und longitudinal zu erlangen. Unsere Vision ist eine permanente Datenablage mit repräsentativen, de-identifizierten Patienten- und Versorgungsdaten, längsschnittlich, fortwährend aktualisiert und von verschiedenen Versorgern, mit der Möglichkeit zur Verknüpfung mit weiteren Daten, etwa aus Patientenbefragungen oder biologischer Forschung, zugänglich für andere Forscher. Wir berichten methodische Vorgehensweisen und Ergebnisse aus dem RADAR Projekt.Methodik Untersuchung des Rechtsrahmens, Entwicklung prototypischer technischer Abläufe und Lösungen, mit Machbarkeitsstudie zur Evaluation von technischer und inhaltlicher Funktionalität sowie Eignung für Fragestellungen der Versorgungsforschung.Ergebnisse Ab 2016 entwickelte ein interdisziplinäres Wissenschaftlerteam ein Datenschutzkonzept für Exporte von Versorgungsdaten aus elektronischen Praxisverwaltungssystemen. Eine technische und organisatorische Forschungsinfrastruktur im ambulanten Sektor wurden entwickelt und im Anwendungsfall „Orale Antikoagulation“ (OAK) umgesetzt. In 7 niedersächsischen Hausarztpraxen wurden 100 Patienten gewonnen und nach informierter Einwilligung ihre ausgewählten Behandlungsdaten, reduziert auf 40 relevante Datenfelder, über die Behandlungsdatentransfer-Schnittstelle extrahiert, unmittelbar vor Ort in identifizierende bzw. medizinische Daten getrennt und verschlüsselt zur Treuhandstelle (THS) bzw. an den Datenhalter übertragen. 75 Patienten, die die Einschlusskriterien erfüllten (mind. 1 Jahr Behandlung mit OAK), erhielten einen Lebensqualitäts-Fragebogen über die THS per Post. Von 66 Rücksendungen wurden 63 Fragebogenergebnisse mit den Behandlungsdaten in der Datenablage verknüpft.Schlussfolgerung Die rechtskonforme Machbarkeit der Gewinnung von pseudonymisierten hausärztlichen Routinedaten mit expliziter informierter Patienteneinwilligung und deren wissenschaftliche Nutzung einschließlich Re-Kontaktierung und Einbindung von Fragebogendaten konnte nachgewiesen werden. Die Schutzkonzepte Privacy by design und Datenminimierung (Artikel 25 mit Erwägungsgrund 78 DSGVO) wurden systematisch in das RADAR Projekt integriert und begründen wesentlich, dass der Machbarkeitsnachweis rechtskonformer Primärdatengewinnung und sekundärer Nutzung für Forschungszwecke gelang. Eine Nutzung hinreichend anonymisierter, aber noch sinnvoller hausärztlicher Gesundheitsdaten ohne individuelle Einwilligung ist im bestehenden Rechtsrahmen in Deutschland schwerlich umsetzbar.

Adult spinal deformity (ASD) surgeries are complex, involving long operative times and surgical morbidity. It is currently unclear how the invasiveness of ASD surgery compares to other major operations.To: (1) develop a quantitative score of surgical morbidity and invasiveness, and (2) compare this score between ASD surgery and other major operations.Retrospective review of prospectively collected data.A prospective surgical registry was used to identify all patients undergoing ASD surgery involving ≥ 7 segments. Seventeen additional procedures were included: coronary artery bypass grafting (CABG), pancreatectomy, and esophagectomy, among others.Perioperative factors (operative time, transfusions, ventilation) and complications were collected and combined with a previously validated Postoperative Morbidity Survey to create a Surgical Invasiveness and Morbidity Score (SIMS).Computed scores were compared across surgeries using Welch's t-test. Multiple linear regression modeling was used to compare the SIMS of major surgeries relative to ASD while controlling for patient demographics and comorbidities.A total of 1,245,282 surgical patients were included, 4,656 of which underwent ASD surgery. After multiple regression modeling controlling for patient demographics and comorbidities, ASD surgery ranked fourth in SIMS. ASD surgery had a significantly greater SIMS than 13 other major procedures including 6th esophagectomy (adjusted mean difference=-0.05, 95%CI -0.01-0.09, p.001), 8th pancreatectomy (-0.40, 0.37-0.44, p.001), 11th craniotomy for tumor (-1.01, 0.98-1.04, p.001), and 12th sacral chordoma resection (-1.31, 1.26-1.37, p.001).ASD surgery was associated with significantly greater SIMS than many other major operations, even when controlling for important perioperative factors. These data have implications for patient counseling, resource allocation, and informed consent.

Aims: This study aims to assess knowledge and attitude of guardians in management of dental avulsion of the children. Materials and Methods: This cross-sectional study was carried out at Altamash Institute of Dental Medicine, Pakistan, from April to May 2021. A total of 400 parents were recruited. An online self-administered questionnaire was circulated to the parents after taking the informed consent. 17 questions regarding demographics, knowledge and attitude were included. Chi-square test was used for association between demographics and responses of the participants. Results: Of the 400 participants, there were 140 (35%) males and 260 (65%) females. Most of the 180 (45%) participants belonged to 18-30 years age bracket. About 63% of the children did not have past dental trauma history. Predominantly, 80% chose dentists being most appropriate of emergency treatment. 33% believed to visit the dentist within 30minutes for treatment. About 50% participants agreed avulsed teeth can be placed back into its original position. More than half knew different transport mediums, with milk (21%) and Hanks Balanced Salt Solution (19%) being commonly selected. Younger age group and females were more knowledgeable regarding emergency management. Conclusion: Dental avulsion is a common finding in childhood, which mandates proper knowledge for the guardians. There is still a gap present in adequate knowledge for management of such emergencies which mandates organizations of education and awareness programs for both children and adults.

Background: Hypotheses defend BCG being able to have an impact on the course of COVID-19 disease, decreasing the rate of infections and their severity. Objective: To determine if the incidence and severity of COVID-19 are less in patients who receive adjuvant treatment with intravesical BCG for non-muscle invasive bladder cancer and if the number of instillations are influential. Methods: All the participants treated with intravesical BCG between January and June-2020 were analysed, researching if they had been infected, and comparing them with the infection rate in the general reference population of our Hospital. Ethical Aspects: The Healthcare Ethics Committee of the Hospital approved the study and informed consent forms were delivered to patients treated with BCG in order to authorize the use of their data in this study. Statistical Analysis: OpenEpi (Link) statistical analysis was carried out by means of 2×2 tables applying the chi-square statistic and Fisher test for qualitative variables. Results: 117 patients, 23 women (19.7%) and 94 men (80.3%), received treatment with BCG. The mean age was 72.12 years; all ≥50 years. Seven in induction phase, 6 weeks, and 110 in 1-year maintenance, 3 weeks to 3, 6 and 12 months, excluding those that had

In the principle of informed consent, doctors were obliged to establish communication with patients before carrying out medical treatments. Information from the doctor became a guideline or consideration for patients in making a choice (freedom to choose) and gave approval to the doctor to carry out medical action to them. The obligation of doctors to effectively communicate has been regulated in Article 35 and Article 45 of Law No. 29 of 2004 concerning Medical Practice and further strengthened by Regulation of the Minister of Health of the Republic of Indonesia No. 290/ Menkes/ Per/ III/ 2008 concerning Approval of Medical Measures. The effectiveness of communication in health services was an act of caution in medical treatments. Before the medical treatment was carried out, the patient should already knew about the disease, the chances of healing, the risk of medical treatment and the patients were also given alternative methods of other treatments so that the patients has information about the illness and therapy that doctors would do. If communication between patients and doctors is effective, it could prevent medical malpractice.

The increasing dementia prevalence worldwide is driving the testing of novel therapeutic approaches, such as invasive brain technologies, despite limited clinical evidence and the risk of accelerating cognitive decline. Our manuscript (a) reviews the NIH Clinicaltrials.gov database for deep brain stimulation, stem cell implantation, and gene therapy trials on people with dementia; (b) discusses issues on beneficence, nonmaleficence, and autonomy associated with these trials; and (c) proposes nine recommendations that build on elements from the Declaration of Helsinki. We found 49 preregistered high-risk trials from nine countries planning to or involving 11,801 people with Alzheimer's or Lewy body dementia or dementia secondary to Parkinson's or Huntington's disease. Most of the people with Alzheimer's who are in these trials are from North America and East Asia. There is substantial heterogeneity in the enrolment criteria, even for trials recruiting only those with Alzheimer's disease. Although most trials enrol people in mild to moderate stages of Alzheimer's disease, trials in China enrol people who have severe Alzheimer's. Our findings highlight a pressing need to review and refine the enrolment criteria for invasive neural trials in people with dementia, considering risks, potential benefits, and capacity for informed consent. As a multidisciplinary team from Australia, the USA, Canada, and Germany with expertise in neurology, neuroscience, and ethics, we examine how it is essential to balance the risks of invasive neural research in a vulnerable population with limited capacity to provide informed consent to help advance the body of knowledge regarding a disease with limited therapeutic options.

Research ethics is a fundamental part of the entire research. Patients with rheumatoid arthritis are sensitive group of research participants because their long-term health problems cause significant changes in their foot health. In foot health research, data are usually collected through a clinical assessment of the foot or questionnaires. However, there is limited evidence of the reported research ethics of empirical studies on foot health in patients with rheumatoid arthritis. Therefore this review aimed to analyze the reported research ethics of peer-reviewed empirical studies focusing on foot health in patients with rheumatoid arthritis as research participants. This systematic review used the Medline/PubMed, CINAHL, and Embase databases. A total of 1,653 records were identified, and 32 articles were included in the final analysis. Reporting research ethics in studies of patients with rheumatoid arthritis is fragmented, focusing predominantly on ethical approval and informed consent and lacking a broader discussion about research ethics.

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.

OBJECTIVE Fetal tissue research has driven significant medical advances but remains publicly contentious in the United States. The views of pregnant individuals in the United States regarding the donation of fetal tissue offer an important and previously unexplored perspective on this issue. METHODS We conducted a secondary analysis of data from two separate, broader qualitative studies. Pregnant and recently pregnant individuals (N=79) from clinical sites at the University of North Carolina at Chapel Hill, Johns Hopkins University, and Massachusetts General Hospital were interviewed individually using a semi-structured guide addressing a range of issues related to infectious disease research and pregnancy, including the acceptability of fetal tissue research. Interviews were transcribed, coded, and analyzed for emergent themes. RESULTS Among this sample of predominantly Black (61%), reproductive-aged pregnant and recently pregnant participants, the majority (72%) generally supported fetal tissue research. The following three themes were identified: choice, respect, and meaning. Respondents discussed the deeply personal nature of decisions surrounding fetal tissue research, emphasizing the importance of informed consent and respect for the person's emotional state when approaching for consent. The ways in which participants regarded how to respectfully handle fetal tissue also shaped views about the acceptability of donation, both for and against. For many participants, fetal tissue donation to research represented one way of ascribing meaning to pregnancy termination or loss. CONCLUSION Among this diverse sample of pregnant and recently pregnant individuals, most were supportive of fetal tissue donation for research. A better understanding of pregnant individuals' views on this topic may lead to policies and practices that are congruent with the needs and values of people facing decisions regarding the disposition of fetal remains.

To study the efficacy and safety of uterine artery embolization in treatment of obstetric hemorrhage. This ethically approved prospective study was conducted between November 2017 and October 2019, and written informed consent was obtained from all patients. Consecutive patients presenting with uncontrolled obstetric hemorrhage were evaluated. Fifty-three patients with uncontrolled bleeding underwent uterine artery embolization (UAE) and were followed up. Spectrum of patients encountered in this study was arteriovenous malformations (AVMs) (n = 25), retained products of conception (RPOC) (n = 16), RPOC with secondary AVMs (n = 5), ectopic pregnancy (n = 5) and iatrogenic trauma to cervix or vagina (n = 2). A total of 57 UAE procedures were performed in these 53 patients as repeat sessions were required in four patients. Most common embolic agent used was polyvinyl alcohol (PVA) particles with gelfoam followed by cyanoacrylate glue as second most common agent. Technical success was achieved in 57 (100%) of 57 UAE procedures. Primary clinical success was achieved in 49 (92%) of 53 patients and secondary clinical success in 52 (98%) patients. Clinical failure was observed in one patient who underwent hysterectomy. Uterine artery embolization is a safe and effective procedure in the management of uncontrolled obstetric hemorrhage.

To the Editor, Radical Prostatectomy (RP) is one of the preferred treatments for localized prostatic cancer and although surgical complications have been reduced over the years, urinary incontinence and erectile dysfunction are still common and significantly impact the patient’s life. Therefore, adequate patient education and counselling before RP is essential. Informed Consent (IC) is a crucial element of doctor-patient interaction, and it must ensure that patients receive and understand all the information regarding their diseases and treatments. Implicit in providing IC is assessing the patient’s understanding, since accessible communication enables them to make informed decisions consciously and autonomously about their health status [...].

Resumen Introducción: El síndrome de manguito rotador es una de las principales patologías limitantes y discapacitantes en la población de edad media, las técnicas de terapia manual como el método Kaltenborn se proponen como alternativa de tratamiento para tratar su sintomatología y poder mejorar su funcionalidad. Objetivo: Determinar la efectividad del método Kaltenborn en el síndrome de manguito rotador, en pacientes adultos para mejorar su funcionalidad. Material y métodos: Se realizó una investigación con diseño prospectivo de intervención cuasiexperimental, longitudinal, en 30 pacientes adultos de entre 40 a 59 años con síndrome de manguito rotador, se evaluó la intensidad de dolor, rango de movilidad articular y discapacidad antes y después de la intervención, mediante los test de Eva, goniométrico y test de Spadi. Se intervino con cuatro técnicas del método Kaltenborn durante diez días, cinco veces por semana, con una duración de 20 minutos cada intervención. Criterios de inclusión­: Presencia de dolor y limitación del rango de movilidad articular de al menos 3 meses. Criterios de exclusión; Discapacidad intelectual, cirugía en el hombro afecto, traumatismos graves. El estudio fue aprobado por el Comité de Bioética de la Universidad Técnica de Ambato, los participantes firmaron el consentimiento informado. Resultados: Con los resultados obtenidos, se afirma la efectividad de la aplicación del método Kaltenborn en el síndrome de manguito rotador respecto al dolor, ROM y funcionalidad, el Test EVA con la prueba de Wilcoxon P29=0.00, Test goniométrico en todos los rangos de movimiento analizados con T de Student P29=0.00 y el test de Spadi con T de student P29=0.00. Conclusiones: La aplicación del método Kaltenborn, mejoro la intensidad de dolor, el rango de movilidad articular y la funcionalidad en la articulación del hombro en los pacientes adultos con síndrome de manguito rotador.

Introducción: En el año 2020 la OMS lo reconoce como pandemia la presencia del virus SARS-Cov-2, las entidades gubernamentales adoptaron medidas de confinamiento para salvaguardar la salud de los adultos mayores (AM), el aislamiento social se relaciona con el deterioro de las funciones cognitivas, siendo necesario implementar la ritmo terapia (RT) para mejorar su estilo de vida. Objetivo: Establecer la efectividad de la ritmo terapia en las funciones cognitivas de los adultos mayores durante el confinamiento por Covid-19. Material y métodos: Se realizó una investigación con enfoque cuantitativo y cuasi-experimental, la intervención fue aprobada por el comité de bioética de la Universidad Técnica de Ambato. Participaron 20 adultos entre 65 años o más, quienes firmaron el consentimiento informado; se aplicó 12 sesiones de ritmo terapia de 45 minutos una vez por semana; evaluando el deterioro mediante el test de Minimental antes y después de la intervención. Para el análisis estadístico se utilizó el sistema informático SPSS versión 25.0 y se aplicó la prueba estadística de Chi cuadrado y Wilcoxon. Resultados: En la evaluación inicial presentaron los AM funciones cognitivas normales (30-27) con el 45%, el 25% con sospecha patológica (26-24), 25% deterioro (23-12) y solo el 5% demencia (9-11). Sin embargo en la post-intervención se observó efectos positivos en las funciones cognitivas representando un 85% normal, el 10% sospecha patológica y el 5% deterioro. Se observa que la técnica de RT fue efectiva para el deterioro cognitivo en la post intervención con una diferencia significativa del 5%, P=0.004. Conclusión: La intervención mejoró las funciones cognitivas en la población adulta mayor, permitiéndoles un envejecimiento activo y saludable.

In 2019, some restrictions for use of valproic acid in women with reproductive potential by regulatory authorities and the original drug manufacturer based on the results of studies in real clinical practice were introduced. During 2019–2021, there were a further clinical data accumulation and labeling changes. The review presents a critical analysis of the changes in prescribing information and product label. There is a long lead time from the moment when safety data become known to the moment when changes are made to the medicinal product label and patient brochures. Some of the changes, including the need for high doses of folic acid to prevent neural tube defects, are debatable. Repealing the provision for mandatory archiving of informed consent forms for valproic acid use in girls and women raises legal risks. Improvements in pregnancy prevention programs and further research on the safety of valproic acid in real-world clinical settings are needed.

Summary Background Aging is associated with physical impairment and functional disability, mainly assessed in terms of activities of daily living (ADL). Assessment using this tool is one of the best ways to evaluate the health status of the elderly. Earlier studies have considered different variables such as those linked to functional disabilities, but psychiatric morbidity has been very little explored in the existing literature. Aims and objectives To estimate the prevalence of functional disability in terms of restriction in the activities of daily living (ADL) and the factors associated with it among elderly subjects attending a geriatric psychiatry clinic. Materials and methods Hospital-based cross sectional study. One hundred and fifty patients over sixty years old attending a geriatric psychiatry clinic in a tertiary care specialty hospital in eastern India were enrolled in the study after their informed consent, using a purposive sampling method. After clinical diagnosis, the activities of daily living were assessed using Barthel's 10-item index, and patients were graded accordingly. The data was analyzed on SPSS version 25.0. Results On the basis of Barthel's 10-item Index score, 72% of the subjects exhibited dependency, among whom 4% were totally dependent. Patients aged over 66 years and those with dementia, psychosis or other psychiatric diseases exhibited significantly higher levels of impairment. Impairments were mostly in the self-care domain. Conclusion The high prevalence of functional disability among elderly subjects with psychiatric morbidity in this study suggests the need for a comprehensive geriatric assessment for these patients, in particular for autonomy, to improve their functional status and promote speedy recovery.

Background: Blood cultures are indispensable for detecting life-threatening bacteremia. Blood cultures can become contaminated, which increases health care costs and antimicrobial resistance. Little is known about associations between contamination rates and topical disinfectants for blood collection in adults. Objective: We sought to determine whether a change in topical disinfectants was associated with the rates of contaminated blood cultures in the emergency department of a single institution. Methods: This single-center, retrospective observational study of consecutive patients aged 20 years or older was conducted in the emergency department (ED) of a university hospital in Japan between August 1, 2018 and September 30, 2020. Pairs of blood samples were collected for aerobic and anaerobic culture from the patients in the ED. Physicians selected topical disinfectants according to their personal preference before September 1, 2019; alcohol/chlorhexidine gluconate (ACHX) was mandatory thereafter, unless the patient was allergic to alcohol. Regression discontinuity analysis was used to detect the effect of the mandatory usage of ACHX on rates of contaminated blood cultures. Results: We collected 2,141 blood culture samples from 1097 patients and found 164 (7.7%) potentially contaminated blood cultures. Among these, 445 (20.8%) were true bacteremia and 1,532 (71.6%) were true negatives. Puncture site disinfection was performed with ACHX for 1,345 (62.8%) cases and with povidone-iodine (PVI) for 767 (35.8%) cases. The regression discontinuity analysis showed that mandatory ACHX usage significantly reduced the blood culture contamination rate by 9.6% (95% confidence interval (CI): 5.0%–14.2%, P

Background Informed consent forms consist of large blocks of written information that may be difficult for patients to understand. Visual teaching aids are promising, however, they have not been studied as a pre-operative educational tool for common surgical procedures. We pilot tested the use of a visual teaching aid during the informed consent process for a colectomy. Methods A randomized pilot study was performed. Participants were randomized into the visual teaching aid group or standard care. Following the consent process, participants were questioned about potential surgical complications, anxiety, satisfaction, and understanding. Results 30 participants were enrolled. Potential complication recall and patient-reported understanding were improved in the visual group (p = 0.01, p = 0.03). Anxiety levels were reduced in the visual group (p = 0.02). No statistically significant data were found for satisfaction (p = 0.75). Conclusions Utilizing a visual teaching aid during the consent process for colectomy increases patient recall of risks, reduces anxiety, and improves understanding.

Aim of the work To assess knowledge of Egyptian family physicians about the diagnostic criteria and treatment modalities of fibromyalgia. Subjects and methods A questionnaire and an informed consent were sent by email to family physicians working in primary health care centers in Egypt. The questionnaire assessed 3 areas: sociodemographic and professional data; knowledge about diagnosis; and knowledge about treatment modalities. Scoring system was used to categorize levels of knowledge into very low, low, moderate, high and very high. Results A total of 108 family physicians responded, with a response rate of 60%.The respondents were 27 consultants, 54 specialists and 27 residents, with a median age of 33 years and a median experience of 12 years. Very low, low and moderate levels of familiarity with fibromyalgia were perceived by 28.7%, 30.6% and 28% respectively. Close to half of participants (46.2%) gained their knowledge about fibromyalgia through self-study. According to the scoring system, 39.8% had low level of knowledge about clinical presentation and 37% had the same level of knowledge about treatment modalities. About three quarters (76%) of participants agreed that patients with fibromyalgia should be referred to rheumatologists. The most common selected clinical presentations were widespread pain (94.4%) and excessive fatigue (91.7%), while the most selected treatment modalities were non-steroidal anti-inflammatory drugs (89.8%) and selective serotonin reuptake inhibitors (47.2%). Conclusion Knowledge about clinical presentation and treatment modalities of fibromyalgia among Egyptian family physicians is low. Continuing medical education about fibromyalgia is needed to improve quality of health care.

There is an urgent unmet need in the Parkinson’s disease community—advanced therapies to modify the inevitable decline that occurs in those affected by this progressive neurodegenerative disease for which there is no cure. This will require collaboration from all stakeholders and central to those partnerships are patients themselves. But participation in clinical trials and clinical use of advanced therapies have their own risk profile above and beyond standard therapeutics as evidenced by past invasive procedures. Therefore, it is of utmost importance that clear, evidence-based information about these potential treatments be clearly communicated by those exploring their use to ensure safe and informed participation from the patient community. Likewise, patients must weigh the benefits of these treatments their limitations and risks in order to truly give informed consent to participate in bringing these treatments to the clinic. Here we explore these issues from the patient perspective.

Advanced therapies for Parkinson’s disease (PD) constitute a broad range of treatments, each presenting specific ethical challenges. Some of these therapies are established and in clinical use, like device-aided therapies, and others, based on advanced therapeutic medicinal products (ATMPs), are still in early stage of clinical trials. This paper focuses on some common ethical issues arising in these two categories of advanced therapies, especially challenges arising when advanced therapies are proposed to PD patients in the form of advanced care, under a clinical trial, or, in case of ATMPs, under the “hospital exemption” rule. The ethical issues covered here relate mainly to ensuring informed consent in these different contexts, to the stakeholder role of patient’s non-professional caretakers, such as family, and to patient safety in treatments under “hospital exemption”. To illustrate the points discussed in connection with “hospital exemption” rule, the example of the EU has been chosen. This paper does not claim completeness of ethical issues raised by bringing advanced therapies for PD to the clinic, but rather presents examples of ethical challenges in this context.