Adaptation and implementation of the Batz guide for bedside advocacy in two hospitals

BACKGROUND: The patients’ guide by the Batz Patient Safety Foundation promotes patients’ active participation in healthcare and a safe hospital experience. OBJECTIVE: The aim was to adapt the Spanish version of the guide to the local context and evaluate its acceptability from healthcare professionals’ and patients’ perspectives in two hospitals in Buenos Aires, Argentina. METHODS: This implementation study had a formative research phase to adapt the guide with input from individual interviews and focus group discussions. The intervention comprised training sessions for professionals on patient-centered care and use of the guide, the appointment of coordinators, and distribution of the guide. The adapted guide (section During Admission) was distributed in two hospitals. Before and after intervention, we administered surveys to explore acceptability, utility, and patient satisfaction. RESULTS: Findings from formative research showed that the Batz guide needed to be shortened and adapted to the local healthcare context Although professionals had agreed on the importance of clinical guidelines; after using the Batz guide, they found it complex and difficult to implement. Patients’ satisfaction with healthcare before and after implementing the guide did not differ significantly. Best scores were found in items related to availability of nurses, staff competence and staff kindness. A 78% of patients found the Batz guide useful. CONCLUSION: It is of critical importance to adapt the guide to the local culture, pilot it, and provide training to promote its implementation, improving acceptability and utility.

Antibiotic misuse and improper practices in India: Identifying the scope to improve through a narrative review

BACKGROUND: In India, antibiotic resistance is high and by 2050, two million people will be affected. OBJECTIVE: To review antibiotic practices in India and the variables that impact them. METHODS: For this narrative review, research articles on antibiotic awareness, perception and practices were retrieved from PubMed and Google Scholar using search terms such as ‘India AND antibiotic use AND cross sectional AND awareness’. A total of 1730 results were found on 30 June 2020, of which 35 articles were eligible for summarizing the common antibiotic practices. RESULTS: We found that there are deficiencies in the implementation of existing policies in India. Several issues such as overprescribing of antibiotics, use without prescription and non-adherence to treatment regimens are contributing to irrational antibiotic practices in the country. CONCLUSION: There is a need for policies at the institute level to help curb the problem of antibiotic resistance.

Abortion in Europe: Recent legislative changes and risk of inequality

BACKGROUND: Induced abortion is a medical practice that has always been much discussed all over the world. Abortion is allowed in most European countries at the request of the woman with limitations that are imposed mainly by the gestational age. However, there are legislative differences between European countries which impose stringent limits on the use of induced abortion. OBJECTIVE: This article analyzes the European legislation on abortion, with a particular focus on countries in which there have been recent legislative changes in recent years, and the possible consequent risk of inequality among European women. METHODS: Government and ministerial websites of the countries analyzed have been consulted to investigate abortion laws in Europe. In addition, the Global Abortion Policies Database of the World Health Organization was also consulted for a regulatory comparison. RESULTS: The differences between the various European countries are considerable. Although guaranteed by most legislation, abortion remains a fragile right in some European countries. CONCLUSION: Different legislation in the various countries of Europe causes difficulties for women who want to have an abortion but who reside in states where there are strict limits to abortion. In addressing the issue of induced abortion, we must not forget that the center of this practice is the woman. For this reason, it is essential to apply a reasoning based on respect for women’s rights: freedom, health, and self-determination.

Analysis of the CONKO-001 trial: Is the validity of the study sufficient to recommend adjuvant chemotherapy for pancreatic cancer?

BACKGROUND: Since randomized controlled trials have indicated that adjuvant chemotherapy prolongs survival and reduces recurrence rates after surgical resection of pancreatic adenocarcinoma, a gemcitabine based chemotherapy has become part of the interdisciplinary treatment concept for pancreatic cancer in accordance to current guidelines. OBJECTIVES: The aim of this project was to analyse the validity of the CONKO −001 trial as a basis for the recommendation of adjuvant chemotherapy in many international guidelines. METHODS: We analysed the validity of the CONKO - 001 trial regarding study design, recruitment period, participating institutions, patient selection, randomisation, stratification, standardization of surgical treatment and histological examination, statistical methods and interpretation of results. We additionally analysed the study regarding the risk of bias using the RoB 2 Tool. Finally we reviewed the influence of the pharmaceutical industry and potential conflicts of interest. RESULTS: We identified several shortcomings of the study concerning the study protocol, the participating clinics, the patient recruitment, the randomization pattern, the standardization of surgical treatment and histological examination, the statistical methods, the evaluation of the results and the influence of the pharmaceutical industry. According to the Cochrane RoB 2 Tool the study was judged to raise some concerns in three of the five risk domains for the outcome “overall survival”. CONCLUSIONS: Based on our review, the results of the CONKO-001-study should be revisited and critically reviewed. The recommendation to include adjuvant chemotherapy with gemcitabine deserves a critical appraisal.

Challenges in setting Permitted Daily Exposure (PDE) Limits for pharmaceuticals: A review

BACKGROUND: When more than one drug is manufactured at a shared facility or equipment in pharmaceutical manufacturing, the potential carry-over of the retained residue of existing drug product on product contact parts of the equipment to the next product can be a source of cross contamination. Permitted daily exposure (PDE) is derived based on the complete nonclinical and clinical data available and is a dose that is unlikely to cause adverse effects if an individual is exposed, by any route, at or below this dose every day over a lifetime. OBJECTIVE: The objective was to present a comprehensive review of available scientific knowledge for derivation of PDE. METHODS: PubMed and ScienceDirect databases were searched using keywords “PDE” and “pharmaceuticals” and all the relevant literature up to March 2021 was reviewed. We have also calculated PDEs for Tobramycin (CAS No. 32986-56-4) and Acetyl Salicylic Acid (ASA, CAS No. 50-78-2). RESULTS: This research will be useful for scientists working in the PDE domain. The given examples emphasize the importance of use of human data in calculating PDE. CONCLUSION: The duty of the risk assessor entrusted with setting PDEs is to derive a data driven, scientifically justified value that is safe for patients, while avoiding unjustified conservativeness that puts unnecessary burden on manufacturing.

Knowledge, attitude and practice towards hepatitis B infection among high school students in Asante Mampong, Ghana

BACKGROUND: Hepatitis B virus (HBV) infection is a serious global public health problem, with significant morbidity and mortality from acute and chronic complications. Increasing awareness and improving knowledge of HBV helps reduce the risk of the disease. Although many studies have been conducted on HBV in Ghana, few have focused on examining knowledge, attitude and preventive practices among adolescents towards the disease. OBJECTIVE: The objective of this study was to assess HBV knowledge, attitude and practice (KAP) among adolescents in high schools in the Asante Mampong Municipality in the Ashanti Region of Ghana. METHODS: A descriptive cross-sectional study was conducted among 398 adolescents from six senior high schools within the Asante Mampong Municipality. Data was collected using a 30-item structured questionnaire. Each item had two response options: “Yes” and “No”. A scoring system was generated and respondents were given a score on each item answered. A positive response to an item was scored 1 point and a negative response was scored 0. Scores were then summed up and averaged to give the mean knowledge, attitude and practice scores. RESULTS: The majority of the respondents were male (60%), between 15 and 17 years (45%), Christian (93%) and in their first year of study. The adolescents had basic knowledge, positive attitude, and poor practices towards HBV. There was no significant relationship between the demographic variables of the respondents and KAP mean scores. CONCLUSION: There is the need to introduce health education and awareness programs in schools within the Asante Mampong Municipality to improve students’ level of knowledge of HBV. Countrywide studies examining KAP towards HBV infection among adolescents are also warranted.

Diagnostic criteria for enduring sexual dysfunction after treatment with antidepressants, finasteride and isotretinoin

BACKGROUND: A set of enduring conditions have been reported in the literature involving persistent sexual dysfunction after discontinuation of serotonin reuptake inhibiting antidepressants, 5 alpha-reductase inhibitors and isotretinoin. OBJECTIVE: To develop diagnostic criteria for post-SSRI sexual dysfunction (PSSD), persistent genital arousal disorder (PGAD) following serotonin reuptake inhibitors, post-finasteride syndrome (PFS) and post-retinoid sexual dysfunction (PRSD). METHODS: The original draft was designed using data from two published case series (Hogan et al., 2014 and Healy et al., 2018), which represent the largest public collections of data on these enduring conditions. It was further developed with the involvement of a multidisciplinary panel of experts. RESULTS: A set of criteria were agreed upon for each of the above conditions. Features of PSSD, PFS and PRSD commonly include decreased genital and orgasmic sensation, decreased sexual desire and erectile dysfunction. Ancillary non-sexual symptoms vary depending on the specific condition but can include emotional blunting and cognitive impairment. PGAD presents with an almost mirror image of unwanted sensations of genital arousal or irritability in the absence of sexual desire. A new term, post-SSRI asexuality, is introduced to describe a dampening of sexual interest and pleasure resulting from a pre-natal or pre-teen exposure to a serotonin reuptake inhibitor. CONCLUSIONS: These criteria will help in both clinical and research settings. As with all criteria, they will likely need modification in the light of developments.

Barriers to access to clinical trial data: Obstruction of a RIAT reanalysis of the treatment for adolescents with depression study

BACKGROUND: Public access to data has been a major step in attempting to reduce bias in scientific literature. OBJECTIVE: Data to verify efficacy outcomes are now more accessible; however, little has been done to ensure public access to harms data from RCTs, which are equally important in ascertaining possible misreporting and protecting safety. METHODS: The treatment for adolescents with depression study (TADS) has influenced most international practice guidelines for treating children and adolescents with depression, supporting first-line prescription of fluoxetine in combination with cognitive behavioural therapy (CBT). However, after over 30 publications by the TADS team, reporting on harms remains highly deficient. RESULTS: In undertaking a restoring invisible and abandoned trials (RIAT) reanalysis of TADS’ effectiveness and safety outcomes, we sought access to de-identified serious adverse events (SAE) data. This paper describes our unsuccessful efforts to obtain more detailed SAE data from TADS’ data custodians, highlighting several problematic blocks to comprehensive safety reporting. CONCLUSION: Comprehensive access to clinical trial data is necessary to ensure safe and fully informed guidelines for treating children and adolescents with depression.

Knowledge of community pharmacists in the Kathmandu Valley, Nepal about the risks associated with medication use during pregnancy

BACKGROUND: Community pharmacists are among the most accessible health care providers. OBJECTIVE: This study evaluates the knowledge of community pharmacists about the risks associated with medication use during pregnancy. METHODS: A cross-sectional study was carried out in March 2021 among the 344 community pharmacies in the Kathmandu Valley, Nepal. Convenience sampling was used for data collection using a structured and validated questionnaire. RESULTS: The majority of participants were male: 264 (76.7%), 94.2% were between the age of 21 to 30 years, and 53.1% had work experience of less than one year. Over half had completed diploma in pharmacy. Less than 10 medicines were dispensed to pregnant women daily in 61.6% of the pharmacies. Only 28.8% of the community pharmacists always inquired about pregnancy status from women in the reproductive age group. The mean knowledge score was significantly different among individuals with different work experience and qualifications (p < 0.001). There was also difference in mean scores according to average number of medicines dispensed daily (p = 0.006). The knowledge score also differed according to average number of medicines dispensed to pregnant woman and inquiry by the pharmacist about pregnancy status (p < 0.001). CONCLUSION: Our study revealed that the mean knowledge scores need improvement.

Social distance capacity to control the COVID-19 pandemic: A systematic review on time series analysis

BACKGROUND: Reducing interpersonal contact has been one of the least expensive and most widely used COVID-19 control strategies. OBJECTIVE: This systematic review has been conducted with the aim of identifying social distancing strategies and policies and their impact on the COVID-19 pandemic. METHODS: In order to compile this systematic review, Google Scholar, PubMed, Scopus, Web of Science, Science Direct, Magiran, SID, and Irandoc databases were searched from the COVID-19 outbreak until March 2021. Keywords included “social”, “physical”, “distance”, “outbreak”, “incidence”, “prevalence”, “spread”, “new case”, “death*”, “mortality*”, “morbidity*” , “covid-19”, “coronavirus”, “sars-cov-2” and “time series*”. The articles were qualitatively evaluated by two researchers using the STROBE tool. Finally, the study data were divided into three conceptual categories by three researchers, who then agreed on one category. The practical suggestions were also categorized in the same way. RESULTS: The policies and strategies adopted to implement social distancing were included in five categories of restrictions, prohibitions, closures, incentives, and punishments. Transportation and travel restrictions, crowded places and schools closure, use of telecommunications and virtual communications, and financial and psychological support to society members were the main policies in this area. CONCLUSION: Rapid and complete vaccination of all people around the world is out of reach, therefore social distancing and the implementation of physical restraints, especially in crowded and densely populated environments, should be done extensively until COVID-19 is eradicated.