Good Practice Guidelines Research Articles

Synovitis and joint health in patients with haemophilia: Statements from a European e-Delphi consensus study.

Synovitis, a common feature in haemophilia, is triggered by the presence of blood in joints, and represents the first step towards the development of chronic arthropathy. Synovitis may be detected early by means of ultrasound or magnetic resonance imaging scan; clinical joint scores are less sensitive in this setting. Regular long-term prophylaxis with clotting factor concentrates, as primary prophylaxis and tailored to individual needs, has high efficacy in preventing synovitis. In general, higher factor levels lower bleeding risk, but no direct correlation between factor levels and synovitis incidence has been demonstrated. This study aimed to develop an expert consensus relating to the definition, pathophysiology, diagnosis, prevention, follow-up and treatment of synovitis, recognising its relevance for joint health and taking into account existing knowledge gaps. A Delphi consensus study was designed and performed. An expert group prepared 22 statements based on existing literature; a wider expert panel subsequently voted on these. Retention of panellists was high. Four statements required amending and consensus on all statements was achieved after three rounds of voting. This e-Delphi consensus study addressed the importance of synovitis in joint health of people with haemophilia and highlighted knowledge gaps in this field. Studies on the natural course of synovitis are lacking and the biological mechanisms underlying this process are not yet fully elucidated. While basic and clinical research proceeds in this field, expert consensus can help guide clinicians in their routine clinical practice, and Delphi methodology is often used to produce best-practice guidelines.

Validated French translation of the ESIT-SQ standardized tinnitus screening questionnaire

ObjectivesThe heterogeneity of tinnitus in terms of etiology, presentation and sometimes severe impact on quality of life hinders treatment and clinical research. The European School for Interdisciplinary Tinnitus Research Screening Questionnaire (ESIT-SQ) collects standardized tinnitus characteristics for patient subtyping. A validated French translation of the ESIT-SQ is presented here. MethodOn the initiative of the French Interdisciplinary Tinnitus Association (AFREPA), 3 translators (1 professional translator, 1 clinician and 1 researcher) were missioned to translate the English version of the ESIT-SQ into French, adhering to good practice guidelines. Nine patients were recruited with the help of the France-Acouphènes patient association, to test and validate the translation. Lastly, an exploratory survey of responses to the French questionnaire was conducted online via the Siopi mobile phone application. ResultsThe French translation of the ESIT-SQ was successfully validated. 105 patients responded to the exploratory survey, and their characteristics are presented here. ConclusionThis new validated French translation of the ESIT-SQ will enable epidemiological and clinical data to be collected in French-speaking populations, and thus compiled and compared with data collected with other versions of this questionnaire already published in other languages.

Lipid Extraction and Sample Preservation Techniques for Stable Isotope Analysis and Ecological Assays.

Lipid extraction is an important component of many ecological and ecotoxicological measurements. For instance, percent lipid is often used as a measure of body condition, under the assumption that those individuals with higher lipid reserves are healthier. Likewise, lipids are depleted in 13C compared with protein, and it is consequently a routine to remove lipids prior to measuring carbon isotopes in ecological studies so that variation in lipid content does not obscure variation in diet. We provide detailed methods for two different protocols for lipid extraction: Soxhlet apparatus and manual distillation. We also provide methods for polar and non-polar solvents. Neutral (non-polar) solvents remove some lipids but few non-lipid compounds whereas polar solvents remove not only most lipids but also many non-lipid compounds. We discuss each of the methods and provide guidelines for best practices. We recommend that for stable isotope analysis, researchers test for a relationship between the change in the carbon stable isotope ratio and the amount of lipid extracted to see if the degree of extraction has an impact on isotope ratios. Stable isotope analysis is widely used by ecologists, and we provide a detailed methodology that minimizes known biases.

Experiencia de implantación de la Guía de Buenas Prácticas de RNAO «Prevención de caídas y lesiones derivadas de las caídas» en Atención Primaria de Tenerife

Falls are a public health problem with worldwide relevance and are considered the second cause of death due to involuntary trauma. Nurses have a central role in preventing falls by implementing evidence-based recommendations. Good practice guidelines (GBP) allow care to be provided based on the best and most current evidence. The Nurses Association of Ontario (RNAO) develops GBP that it expands worldwide thanks to the Program of Centers Committed to Excellence in Care, BPSO®, in which the Primary Care Management of Tenerife participates, as a candidate center, implementing the Guide «Preventing falls and reducing injury resulting from falls». The objectives of this study were to describe the profile of the patient included in «Home Health Care Service» in the ZBS of the Tenerife Health Area where the GBP is implemented.

SEGURANÇA DO PACIENTE PEDIÁTRICO NA ADMINISTRAÇÃO DE HEMOCOMPONENTES

ABSTRACT Objective: to analyze pediatric patient safety in the administration of blood components. Method: a documentary and retrospective study, developed at a hospital in the Brazilian Midwest region. Data collection took place through medical records and 234 transfusions were identified, performed in 90 patients aged from zero to twelve years old, hospitalized between July and December 2020. An instrument based on good practice guidelines about blood components was used. Descriptive and inferential statistics were used for data analysis. Results: the transfusions were predominantly performed in breastfeeding infants (71.1%). Blood transfusions in critical sectors stood out (86.3%), as well as with indication of a clinical order (87.2%) and prescription of packed red blood cells (75.3%). The Nursing reports identified adverse events (n=05) and incidents (n=13) that were associated with inadequacies between the prescribed and infused volumes and the request and administration time (p<0.001), although no notification was formalized in the institution during the period. Conclusion: the administration of blood components presented nonconformities, which results in risk situations for pediatric patients.

Best-practice recommendations to inform general practice nurses in the provision of dementia care: a Delphi study.

Worldwide, responsibility for dementia diagnosis and management is shifting to primary care, in particular to the general practitioner (GP). It has been acknowledged that primary care nurses, working collaboratively with GPs, have a role in dementia care by utilising their unique knowledge and skills. However, there are no best-practice guidelines or care pathways to inform nurses in general practice on what best-practice dementia care comprises and how to implement this into their practice. This study identified the recommendations in the Australian guidelines for dementia management most relevant to the role of the nurse working in general practice. Seventeen experts active in clinical practice and/or research in primary care nursing in general practice participated in an online three-round Delphi study. All 17 participants were female with a nursing qualification and experienced in general practice clinical nursing and/or general practice nursing research. Five recommendations were identified as the most relevant to the role of the nurse in general practice. These recommendations all contained elements of person-centred care: the delivery of individualised information, ongoing support, including the carer in decision-making, and they also align with the areas where GPs want support in dementia care provision. This novel study identified best-practice dementia care recommendations specific to nurses in general practice. These recommendations will inform a model of care for nurses in the provision of dementia care that supports GPs and better meets the needs of people living with dementia and their carer(s).

Intergenerational Day Centers: A New Wave in Adult and Child Day Care.

Intergenerational Day Centers (IDCs) are an innovation that addresses two important societal challenges, the continuing need for childcare and the emerging demand for older-adult supportive services that help them remain independent in their homes. These facilities provide care, and specialized resources and activities for both older adults and children in one location. While the importance and benefits of these programs have been proven, there is scant information in the literature and best-practice guidelines on the planning and development of these programs. This qualitative study focuses on the research, planning, and building development for new IDCs in metropolitan areas. It is based on a case example of the process of establishing an IDC in the City of Austin, which was an element of the Age-Friendly Austin Plan. It examines the applicable literature and the extensive involvement of experts in architecture, community planning, and public health policy as well as data collected from community engagement workshops to facilitate the IDC's creation and operation. This study offers a developmental strategy method that can be adopted and utilized by other cities, developers, and designers who are interested in building IDCs.

Elektronska komunikacija u porodičnoj medicini

Traditional communication between physicians and patients consists of verbal and non-verbal communication. Non-verbal communication can emphasize, modify, or supplement a message that is verbally conveyed and reduce the possibility of misunderstanding. Web applications offer the ability to communicate with physicians and patients outside the healthcare facility. E-mail communication of the selected physician and patient is defined as electronic communication of doctors and patients in a contractual relationship in which the health information provider bears responsibility for the patient's health as his or her chosen physician. A literature review was conducted based on European and American studies reports to determine whether the use of electronic communication in family medicine could contribute to improving the quality of health care. The search for PUBMED, BMJ, JMIR and OVID was performed using the terms: electronic communication, family medicine, email, physician, patient. The most important benefits of electronic communication in family medicine are the simplicity and increased efficiency of communication, the expansion of resources and the ability to communicate, saving time and the ability to print electronic messages. The disadvantages lie in the potential compromise of confidentiality, the lack of monetary compensation and overload of the doctors, the potential for miscommunication, diagnostic error and unrealistic user expectations. Information technology must not replace traditional physician-patient communication. Although the results of the available studies have not provided strong enough evidence to broaden the introduction of electronic communications into everyday practice, adhering to the guidelines of good clinical practice, email and other forms of internet communication could contribute to improving the quality of primary care.

Marketing Regulatory Oversight of Advanced Therapy Medicinal Products in Europe.

Advanced therapy medicinal products (ATMP) in the European Union (EU) are regulated by Regulation 1394/2007 and comprise gene and cell therapy and tissue-engineered products. Under this framework, ATMP are authorised by the centralised procedure, coordinated by the European Medicines Agency (EMA), whereas clinical trial authorisations remain at the remit of each National Competent Authority. The Committee for Advanced Therapies is responsible for the scientific evaluation of the marketing authorisation applications and for generating a draft opinion that goes to the Committee for Human Medicinal Products for a final opinion. For every application, data and information relating to manufacturing processes and quality control of the active substance and final product have to be submitted for assessment together with data from non-clinical and clinical safety and efficacy studies. Technical requirements for ATMP are defined in the legislation, and guidance for different products is available through several EMA/CAT guidelines.Due to the diverse and complex nature of ATMP, a need for some regulatory flexibility was recognised. Thus, a risk-based approach was introduced in Regulation 1394/2007 allowing adapted regulatory requirements. This has led, for instance, to the development of good manufacturing practice (GMP) guidelines specific for ATMP. This, together with enhanced regulatory support, has allowed an increasing number of successful marketing authorisation applications resulting in 25 licensed ATMP in the EU, mainly gene therapy medicinal products. The promise of messenger RNA and genome editing technologies as therapeutic tools make the future for these innovative medicinal products look even brighter.This chapter reviews the regulatory landscape together with some of the support initiatives developed for ATMP in the EU.

Adherence to Good Pharmacy Practices by Community Pharmacies in Lebanon and Opportunities for Quality Improvement: It is Time to Act.

Good pharmacy practice is an important standard that highlight the quality of services in community pharmacies. In 2018, The Order of Pharmacists in Lebanon (OPL) published their own good pharmacy practices (GPP) guidelines. The need exists for investigational studies to assess GPP implementation status and the professional conduct of on-site staff towards these standards. Data collection was carried out between February and August 2020 using a questionnaire covering: Socio-demographic variables; Indicator A (Attitude of the Community Pharmacists); Indicator B (Services and Facilities); Indicator C (Dispensing); Indicator D (Storage). Data analysis were performed on SPSS version 25, T-Test and ANOVA were used. A significant p value of <0.001, 95% confidence interval and variables with missing data counting less than 10% were considered. A total of 211 staffers from pharmacies were enrolled in the study, each representing one community pharmacy. The mean percent of adherence to GPP standards by community pharmacies in the South of Lebanon was below the recommended threshold of 75%. Only 65.09% adhered to all tested indicators (27% to Indicator A, 56.91% to Indicator B, 68.61% to Indicator C, 66.31% to Indicator D). Higher indicators were seen among providers who were aware of OPL standards (OR = 4.021), female (OR= 2.011) and being a licensed pharmacist (OR=3.506). Cronbach alpha of the overall score was 0.615. Further steps shall be taken to improve the compliance to GPP standards. Steps shall include, identification of the core standards, such as dispensing, provision of adequate information, monitoring of storage conditions, and ensuring the presence of a licensed pharmacist. It is highly recommended that the OPL and the Ministry of Public Health develop a "Self-assessment tool" and an efficient training program to increase community Pharmacists' awareness status. Regular assessment shall be carried to monitor the progress overtime.

The revamped Good Clinical Practice E6(R3) guideline: Profound changes in principles and practice!

The International Council for Harmonisation has released a draft version E6(R3) of the Good Clinical Practice Guideline for public consultation. The objective of the revamped guideline is to make the new provisions applicable across diverse clinical trial types and settings and to remain relevant as technological and methodological advances occur. E6(R3) includes profound changes in the structure and content of E6(R2) version, which will impact all the trial conduct processes from planning to reporting. This guideline's focus on principles, digital technology, ethics, and quality will increase the responsibilities of the ethics committees, the investigator, and the sponsor. This brief review discusses the impact of the guideline on trial conduct and the challenges of implementation in India.

Articular Cartilage Repair After Implantation of Hyaline Cartilage Beads Engineered From Adult Dedifferentiated Chondrocytes: Cartibeads Preclinical Efficacy Study in a Large Animal Model

Background: Chondrocyte-based cell therapy to repair cartilage has been used for >25 years despite current limitations. This work presents a new treatment option for cartilage lesions. Hypothesis: High-quality hyaline cartilage microtissues called Cartibeads are capable of treating focal chondral lesions once implanted in the defect, by complete fusion of Cartibeads among themselves and their integration with the surrounding native cartilage and subchondral bone. Study Design: Controlled laboratory study. Methods: Cartibeads were first produced from human donors and characterized using histology (safranin O staining of glycosaminoglycan [GAG] and immunohistochemistry of collagen I and II) and GAG dosage. Cartibeads from 6 Göttingen minipigs were engineered and implanted in an autologous condition in the knee (4 or 5 lesions per knee). One group was followed up for 3 months and the other for 6 months. Feasibility and efficacy were measured using histological analysis and macroscopic and microscopic scores. Results: Cartibeads revealed hyaline features with strong staining of GAG and collagen II. High GAG content was obtained: 24.6-µg/mg tissue (wet weight), 15.52-µg/mg tissue (dry weight), and 35 ± 3-µg GAG/bead (mean ± SD). Histological analysis of Göttingen minipigs showed good integration of Cartibeads grafts at 3 and 6 months after implantation. The Bern Score of the histological assay comparing grafted versus empty lesions was significant at 3 months (grafted, n = 10; nongrafted, n = 4; score, 3.3 and 5.3, respectively) and 6 months (grafted, n = 11; nongrafted, n = 3; score, 1.6 and 5.1). Conclusion: We developed an innovative 3-step method allowing, for the first time, the use of fully dedifferentiated adult chondrocytes with a high number of cell passage (owing to the extensive amplification in culture). Cartibeads engineered from chondrocytes hold potential as an advanced therapy medicinal product for treating cartilage lesions with established efficacy. Clinical Relevance: This successful preclinical study, combined with standardized manufacturing of Cartibeads according to good manufacturing practice guidelines, led to the approval of first-in-human clinical trial by the ethics committee and local medical authority. The generated data highlighted a promising therapy to treat cartilage lesions from a small amount of starting biopsy specimen. With our innovative cell amplification technology, very large lesions can be treated, and older active patients can benefit from it.

The growing role of telemedicine - possibilities and regulations concerning teleradiology in Poland.

In recent years, imaging studies have become increasingly used at various stages in the management of patients with various conditions and disorders. This process results in a necessity to provide an increasing number of exams, which involves a growing role of radiologists in assessing and reporting those exams. The article discusses tele-radiology as a method that can improve access to radiology services, presenting its potential benefits, as well as the risks involved. It analyses access to radiology healthcare services in Poland in the context of the international and Polish legal provisions concerning the right to healthcare. While funding for imaging studies for patients is widely available and imaging equipment in Poland is improving despite some shortages, the main barrier is identified in the number of specialists capable of assessing the exams. Teleradiology can alleviate this shortage, so the article presents legal provisions and international good practice guidelines in this area, focusing on documents issued by the European Society of Radiology, the American College of Radiology, and the British Royal College of Radiologists. The guidelines concerning such aspects as patients' rights, teleradiologists' qualifications, communication and reporting, responsibility, and technical requirements may help make teleradiology a safe and valuable component of the healthcare system in Poland.

Impact of a syndrome-specific antibiotic stewardship intervention on antipseudomonal antibiotic use in inpatient diabetic foot infection management.

To demonstrate that a syndromic stewardship intervention can safely reduce antipseudomonal antibiotic use in the treatment of inpatient diabetic foot infections (DFIs). From November 2017 through March 2018, we performed an antimicrobial stewardship intervention that included creation of a DFI best-practice guideline, implementation of an electronic medical record order set, and targeted education of key providers. We conducted a retrospective before-and-after study evaluating guideline adherent antipseudomonal antibiotic use 1 year before and after the intervention using interrupted time-series analysis. University of Nebraska Medical Center, a 718-bed academic medical center in Omaha, Nebraska. The study included 193 adults aged ≥19 years (105 in the preintervention group and 88 in the postintervention group) admitted to non-intensive care units whose primary reason for antibiotic treatment was diabetic foot infection (DFI). Guideline-adherent use of antipseudomonal antibiotics increased from 39% before the intervention to 68% after the intervention (P ≤ .0001). Antipseudomonal antibiotic use decreased from 538 days of therapy (DOT) per 1,000 DFI patient days (PD) before the intervention to 272 DOT per 1,000 DFI PD after the intervention (P < .0001), with a statistically significant decrease in both level of use and slope of change. We did not detect any changes in length of stay, readmission, amputation rate, subsequent positive Clostridioides difficile testing, or mortality. Our 3-component intervention of guideline creation, implementation of an order set, and targeted education was associated with a significant decrease in antipseudomonal antibiotic use in the management of inpatient DFIs. DFIs are common and should be considered as opportunities for syndromic stewardship intervention.

A Clinical Audit of Orthopaedic Operation Note Documentation and Digitalization of the Operative Note Template: A Quality Improvement Project.

Background Good communication between a surgical team and other colleagues is vital, and the medium of communication is often the operative note. It is essential to ensure continuity of care between the operating team and other colleagues; also, it provides a medicolegal record of patientcare. It checks all the four main domains of good surgical practice guidelines set by the Royal College of Surgeons (RCS) of England. The aims of this project wereto evaluate the quality of operation notes against the set parameters by the RCS and to improve qualityof the operative notes using information technology (IT) service software update to provide operative note digitalization. Methods This was a retrospective andprospective closed-loop audit, in which the operative notes were analysed for the Trauma and Orthopaedics speciality. Three separate cycles of audits were completed. In the the first cycle, data were collected retrospectively from all the operative notes, from June 1, 2020, to June 15, 2020; then, data were collected prospectively after making interventionsto establish digitalization of the operative notes. The secondcycle was completed from February 14 to 21, 2021, and from March 1 to 7, 2021. The third cycle was completed from August 1 to 31, 2021.All data were collected in Excelusing a checklist that evaluated 34 parameters. These parameters were based on the recommendations of RCSGood Surgical Practice guidelines.All trauma and orthopaedic patients were included regardless of the type of procedure. There were no exclusion criteria in place. Results An overall increase from 9.5% to 66.7% in typed operative notes was achieved with the introduction of the templated operative note documentation service. There was a 40% reduction in the use of handwritten operative notes. Concerns regarding legibility were reduced in view of the digitalization of the operative notes. The firstcycle of the audit, in terms of the parameters yielded, found that the operative notes were missing 10 important parameters, independent of the author grade; these were recorded in less than 10% of the operative notes. The secondcycle, in terms of the parametersyielded, found that the operative notes were missing four important parameters, independent of the author grade; these were recorded in less than 10% of the operative notes. The thirdcycle of the audit, in terms of the parameters yielded, found that the operative notes were missing three important parameters.Specific documentation for 12 different parameters improved over the course of the three Plan-Do-Study-Act (PDSA) cycles. Conclusion Royal College of Surgeons guidelines and integration withITservices significantly improved the quality and legibility of operative notes that were being documented in the trauma and orthopaedics department. Structured document standards and good integration with a computer-based IT servicehelpprompt surgeons to document in a better and easy way, thereby leading to improved clinical documentation.

Diseño y validación de 2 instrumentos para analizar y evaluar la calidad formal en el proceso de consentimiento informado de ensayos clínicos con medicamentos

ObjectiveThe activity of sponsors and Ethics Committees for Research with medicines has increased in recent years. The objective was to design and validate 2 instruments to analyze and evaluate the formal quality of the patient information sheet and the informed consent form of clinical trials with drugs, in accordance with the legislation. MethodDesign (Guideline for good clinical practice and European and Spanish regulations); validation (Delphi method and expert consensus: concordance ≥ 80%); reliability (inter-observer method, Kappa index). 40 patient information sheets/informed consent forms were evaluated. ResultsVery good concordance was obtained in both checklists (k ≥ 0.81, p < 0.001). The final versions consisted of checklist-patient information sheet: 5 sections, 16 items and 46 sub-items; and checklist-informed consent form: 11 items. ConclusionThe instruments developed are valid, reliable and facilitate the analysis, evaluation, and decision-making on the patient information sheets/informed consent forms of clinical trials with drugs.

Simulation-based summative assessment in healthcare: an overview of key principles for practice

BackgroundHealthcare curricula need summative assessments relevant to and representative of clinical situations to best select and train learners. Simulation provides multiple benefits with a growing literature base proving its utility for training in a formative context. Advancing to the next step, “the use of simulation for summative assessment” requires rigorous and evidence-based development because any summative assessment is high stakes for participants, trainers, and programs. The first step of this process is to identify the baseline from which we can start.MethodsFirst, using a modified nominal group technique, a task force of 34 panelists defined topics to clarify the why, how, what, when, and who for using simulation-based summative assessment (SBSA). Second, each topic was explored by a group of panelists based on state-of-the-art literature reviews technique with a snowball method to identify further references. Our goal was to identify current knowledge and potential recommendations for future directions. Results were cross-checked among groups and reviewed by an independent expert committee.ResultsSeven topics were selected by the task force: “What can be assessed in simulation?”, “Assessment tools for SBSA”, “Consequences of undergoing the SBSA process”, “Scenarios for SBSA”, “Debriefing, video, and research for SBSA”, “Trainers for SBSA”, and “Implementation of SBSA in healthcare”. Together, these seven explorations provide an overview of what is known and can be done with relative certainty, and what is unknown and probably needs further investigation. Based on this work, we highlighted the trustworthiness of different summative assessment-related conclusions, the remaining important problems and questions, and their consequences for participants and institutions of how SBSA is conducted.ConclusionOur results identified among the seven topics one area with robust evidence in the literature (“What can be assessed in simulation?”), three areas with evidence that require guidance by expert opinion (“Assessment tools for SBSA”, “Scenarios for SBSA”, “Implementation of SBSA in healthcare”), and three areas with weak or emerging evidence (“Consequences of undergoing the SBSA process”, “Debriefing for SBSA”, “Trainers for SBSA”). Using SBSA holds much promise, with increasing demand for this application. Due to the important stakes involved, it must be rigorously conducted and supervised. Guidelines for good practice should be formalized to help with conduct and implementation. We believe this baseline can direct future investigation and the development of guidelines.

Adherence to Best Practices for Stated Preference Valuation within the U.S. Marine Ecosystem Services Literature

Non-market economic values derived from stated preference (SP) methods are often of interest for policy analysis and evaluation, program design, green accounting, and damage assessments and are increasingly in demand with adoption of ecosystem-based management approaches that emphasize accounting for ecosystem services and their values. A recent guidance prescribes a set of twenty-three best practices guidelines (BPGs) to follow when conducting a SP study to ensure the validity of the results and maximize its ability to provide reliable economic value information. In this article, we evaluate adherence to these guidelines within the U.S. SP marine ecosystem service valuation literature. Our results suggest adherence by the literature to the guidelines is heterogeneous with none of the studies examined adhering to all guidelines and some guidelines being adhered to better than others. Evidence points to adherence differences between older and more recent studies, between studies using different SP valuation methods, and between studies valuing recreation ecosystem services and ones valuing other ecosystem services. Furthermore, a citation analysis suggests studies addressing elements embodied in the BPGs tend to have more citations all else being equal. We discuss several challenges to valuing marine ecosystem services and areas for improvement and inquiry.

Economic analyses of behavioral health intervention implementation: Perspective on stakeholder engagement.

To provide full potential benefits to patients, behavioral health interventions often require comprehensive and systematic implementation efforts. The costs of these efforts should therefore be included when organizations decide to fund or adopt a new intervention. However, existing guidelines for conducting economic analyses like cost-effectiveness analyses and budget impact analyses are not well-suited to the complexity of the behavioral healthcare pathway and its many stakeholders. Stakeholder engagement, when used effectively with recent innovations in economic analysis, advance more equitable access to interventions for individuals living with behavioral health conditions. But early and ongoing stakeholder engagement has not yet been incorporated into best-practice guidelines for economic evaluation. We discuss our perspective, as researchers and clinicians in a large integrated health system, on how the integration of stakeholder engagement with existing economic analysis methods could improve decision-making about implementation of behavioral health interventions.

Best Practices for Ethical Conduct of Misinformation Research

Abstract: Misinformation can have noxious impacts on cognition, fostering the formation of false beliefs, retroactively distorting memory for events, and influencing reasoning and decision-making even after it has been credibly corrected. Researchers investigating the impacts of real-world misinformation are therefore faced with an ethical issue: they must consider the immediate and long-term consequences of exposing participants to false claims. In this paper, we first present an overview of the ethical risks associated with real-world misinformation. We then report results from a scoping review of ethical practices in misinformation research. We investigated (1) the extent to which researchers report the details of their ethical practices, including issues of informed consent and debriefing, and (2) the specific steps that researchers report taking to protect participants from the consequences of misinformation exposure. We found that fewer than 30% of misinformation papers report any debriefing, and almost no authors assessed the effectiveness of their debriefing procedure. Building on the findings from this review, we evaluate the balance of risk versus reward currently operating in this field and propose a set of guidelines for best practices. Our ultimate goal is to allow researchers the freedom to investigate questions of considerable scientific and societal impact while meeting their ethical obligations to participants.