Good Practice Guidelines Research Articles

Budget impact models for lung cancer interventions: A systematic literature review.

Budget impact models (BIMs) forecast the financial implications of adopting new technologies and the potential need for budget reallocation, thus playing a crucial role in reimbursement decisions. Despite the importance of accurate forecasts, studies indicate large discrepancies between estimates and reality. We are developing an artificial intelligence-based clinical decision tool to identify patients with non-small cell lung cancer who are most likely to benefit from immunotherapy. To evaluate the budgetary implications and describe a systematic literature review of published lung cancer BIMs. We searched PubMed and EMBASE for studies published between 2010 and 2023 that include BIMs that describe lung cancer interventions. Forward and backward reference searches were performed for all qualifying studies. We extracted author and publication year, country, interventions, disease stages, time horizon, analytical perspective, modeling methods used, types of costs included, sensitivity analyses conducted, and data sources used. We then evaluated adherence to the Professional Society for Health Economics and Pharmacoeconomics Research best-practice guidelines. A total of 25 BIMs were identified, spanning 14 different countries. Model structure could not be ascertained definitively for nearly half of the models. The cost calculator approach was most common among the others. Time horizons ranged from 1 to 5 years, in line with recommendations. Most models compared drugs, 4 compared nondrug interventions, and 7 compared diagnostic technologies. Assumptions about market uptake were poorly documented and poorly motivated. Inclusion of cancer-related costs was rare. Adherence to best practices was variable and did not appear to improve over time. The number of published BIMs for lung cancer exceeded expectations. There were modest trends toward publication frequency and model quality over time. Our analysis revealed variability across the models, as well as their adherence to best practices, indicating substantial room for improvement. Although none of the models were individually suitable for the purpose of evaluating an artificial intelligence-based treatment selection tool, some models provided valuable insights.

GeoPick ‐ A web application for georeferencing natural history collections following best practices

Georeferencing is a key process in the digitization of natural history collections as it assigns spatial coordinates to preserved specimen collecting locations, facilitating their use in ecological, evolutionary and conservation research. Georeference data in public repositories such as GBIF is often missing or incomplete, jeopardising their use in research and limiting the return on investment made by public institutions. Despite the existence of guidelines for best practices for georeferencing and widely accepted standards for biodiversity data, there is a lack of a simple yet effective software tool that offers the implementation of both concepts. We present GeoPick with the aim to offer the collections community a standards‐compliant tool that eases the georeferencing process, making it more cost‐effective, and which, by applying best practices, contributes to the betterment of the occurrence data in public repositories. GeoPick also offers the possibility of collaboration between users and institutions through the sharing of georeferences. The tool is hosted by GBIF at https://geopick.gbif.org, and is open source. Its code is available at a public GitHub repository (https://github.com/rtdeb/GeoPick).Keywords: Darwin Core, georeferencing, natural history collections, point‐radius method, web application, Well Known Text Format, WKT

A Comparison of ChatGPT and Expert Consensus Statements on Surgical Site Infection Prevention in High-Risk Paediatric Spine Surgery.

Artificial intelligence (AI) represents and exciting shift for orthopaedic surgery, where its role is rapidly evolving. ChatGPT is an AI language model which is preeminent among those leading the mass consumer uptake of AI. Artamonov and colleagues compared ChatGPT with orthopaedic surgeons when considering the diagnosis and management of anterior shoulder instability; they found a limited correlation between them. This study aims to further explore how reliable ChatGPT is compared with orthopaedic surgeons. Twenty-three statements were extracted from the article "Building Consensus: Development of a Best Practice Guideline (BPG) for Surgical Site Infection (SSI) Prevention in High-risk Pediatric Spine Surgery" by Vitale and colleagues. These included 14 consensus statements and an additional 9 statements that did not reach consensus. ChatGPT was asked to state the extent to which it agreed with each statement. ChatGPT appeared to demonstrate a fair correlation with most expert responses to the 14 consensus statements. It appeared less emphatic than the experts, often stating that it "agreed" with a statement, where the most frequent response from experts was "strongly agree." It reached the opposite conclusion to the majority of experts on a single consensus statement regarding the use of ultraviolet light in the operating theatre; it may have been that ChatGPT was drawing from more up to date literature that was published subsequent to the consensus statement. This study demonstrated a reasonable correlation between ChatGPT and orthopaedic surgeons when providing simple responses. ChatGPT's function may be limited when asked to provide more complex answers. This study adds to a growing body of discussion and evidence exploring AI and whether its function is reliable enough to enter the high-accountability world of health care. This article is of high clinical relevance to orthopaedic surgery given the rapidly emerging applications of AI. This creates a need to understand the level to which AI can function in the clinical setting and the risks that would entail.

Effect of Fashion E-Commerce User Experience on Customer Retention in Ghana

Purpose: The aim of the study was to analyze the effect of fashion e-commerce user experience on customer retention in Ghana. Methodology: This study adopted a desk methodology. A desk study research design is commonly known as secondary data collection. This is basically collecting data from existing resources preferably because of its low cost advantage as compared to a field research. Our current study looked into already published studies and reports as the data was easily accessed through online journals and libraries. Findings: Research indicates that positive user experiences, characterized by intuitive website navigation, efficient mobile interfaces, and responsive customer service, greatly enhance customer retention rates. Users who encounter seamless transactions, personalized recommendations, and reliable delivery services are more likely to return and engage with fashion e-commerce platforms repeatedly. Unique Contribution to Theory, Practice and Policy: Theory of planned behavior (TPB), self-determination theory (SDT) & expectation-confirmation theory (ECT) may be used to anchor future studies on effect of fashion e-commerce user experience on customer retention in Ghana. Practically, fashion e-commerce platforms should invest in user-friendly website design and navigation to enhance the overall shopping experience. This includes simplifying the checkout process, ensuring mobile compatibility, and improving site speed. From a policy perspective, e-commerce regulations should include guidelines for user experience best practices. This could involve setting standards for website accessibility, data protection, and user interface design to ensure a positive online shopping experience.

Bayesian Methods for Quality Tolerance Limit (QTL) Monitoring.

In alignment with the ICH guideline for Good Clinical Practice [ICH E6(R2)], quality tolerance limit (QTL) monitoring has become a standard component of risk-based monitoring of clinical trials by sponsor companies. Parameters that are candidates for QTL monitoring are critical to participant safety and quality of trial results. Breaching the QTL of a given parameter could indicate systematic issues with the trial that could impact participant safety or compromise the reliability of trial results. Methods for QTL monitoring should detect potential QTL breaches as early as possible while limiting the rate of false alarms. Early detection allows for the implementation of remedial actions that can prevent a QTL breach at the end of the trial. We demonstrate that statistically based methods that account for the expected value and variability of the data generating process outperform simple methods based on fixed thresholds with respect to important operating characteristics. We also propose a Bayesian method for QTL monitoring and an extension that allows for the incorporation of partial information, demonstrating its potential to outperform frequentist methods originating from the statistical process control literature.

Roughness constant selection for atmospheric boundary layer simulations using a k-ω SST turbulence model within a commercial CFD solver

Transit of an atmospheric boundary layer (ABL) profile within computational fluid dynamics (CFD) simulations is often hindered through unintended streamwise gradients in the flow resulting in ABL inhomogeneity. Within Reynolds-Averaged Navier–Stokes (RANS) turbulence modeling in Ansys Fluent, user-defined wall functions are not available for the k–ω class of RANS models as a remedy to this problem. Instead, the practitioner is required to use the sand–grain roughness property for ground surface roughness calibration, and specify a roughness height and roughness constant, Cs, accordingly. To-date, no clear guidance on their selection is available that can accommodate both high and low roughness terrains. To overcome this, a straightforward and practical calculation is presented for the roughness constant based on the standard wall function implementation. When this calculation is synthesized with other best-practice guidelines, it is possible to reliably model transiting ABL profiles based on wind-tunnel data whilst minimizing effects due to ABL inhomogeneity.

Radiocarbon dating of lipids preserved in pottery vessels: guidelines for best-practice in compound-specific 14C analyses

Radiocarbon dating of lipids preserved in pottery vessels: guidelines for best-practice in compound-specific ¹⁴C analyses

Health Services Research in the Public Health Department - An Explorative Interview Study on Scientific Methodological Competence in the PHS in Baden-Württemberg, Germany

One aim of the pact for the Public Health Service ("Pakt für den ÖGD") is to increase scientific activity in the Public Health Service (PHS). This study deals with the question, which methods related to health services research are known and applied in the PHS and which methods are needed by PHS employees in the federal state Baden-Württemberg in Germany. Guideline-based interviews (focus group and individual interviews) were conducted with 12 persons at different hierarchy levels from public health departments in Baden-Württemberg. The interviews were subjected to content analysis acording to Kuckartz. The interviewees described their heterogeneous needs as well as their methodological competences. Staff members expressed existing competences more frequently than leaders. These competencies included those used in everyday work such as literature research in routinely collected data (e. g., school entry examination), or different methods for data analysis. Needs seemed to exist primarily in the area of data analysis and collection, but were also expressed in the area of basic scientific methods. Topics relating to guidelines for good scientific practice (e. g., ethics proposals) and publications were also rather less known. A need for a support from research institutions or higher authorities was frequently mentioned. In addition, motivation and barriers for research in public health departments were mentioned. This study shows that existing methodological competencies and needs are heterogeneous and can be attributed to the heterogeneous backgrounds and fields of activity of the interviewees. Competencies are indicated, for example, in literature research and analysis of existing data. There is a need in methods, for example, of data collection/analysis as well as in basic scientific methods and deepening of existing skills. Furthermore support offers regarding scientific methodological competence for public health departments are required. There is also a lack of research infrastructure (e. g. software, access to literature) and a legal basis. The results can serve as a basis for the design of demand-oriented methodological programs for employees of the PHS in Baden-Württemberg.

A Study in Wad Madani, Sudan: Are We Documenting Operation Notes Effectively?

Operative notes represent the critical record of a surgical procedure, encompassing comprehensive details encountered throughout the operation. Recognizing the importance of comprehensive documentation, the Royal College of Surgeons (RCS) developed the Good Surgical Practice guidelines, which emphasize accurately recording every procedure and specifying the necessary parameters for each operative note. These guidelines help maintain high standards of surgical care and patient safety. A retrospective review of 88 orthopaedic surgery operative notes for fracture neck of femurs was conducted at Gezira Centre for Orthopedic Surgery and Traumatology (GCOST) from March 12 to May 28, 2022. The review assessed 18 parameters against RCS guidelines.Statistical analysis was performed using Statistical Product and Service Solutions (SPSS,version 25.0; IBM SPSS Statistics for Windows, Armonk, NY), which facilitated comprehensive data examination. In 37 cases (42.05%), the operation notes were written by a medical officer. In 29 cases (32.95%), an orthopaedic resident authored the notes. A specialist documented the notes in 21 cases (23.86%), and a consultant wrote the notes in one case (1.14%). Over 90% of the notes included surgeon and assistant names, procedure names, operative diagnoses, operative procedures, prosthesis details, deep vein thrombosis (DVT) and antibiotic prophylaxis, and signatures. The name of the theatre anaesthetist, elective/emergency details, and additional procedures with reasons were absent in all notes. Less than 50% of the notes documented the time of the procedure, type of incision, operative findings, anticipated blood loss, closure technique specifics, and complications. The study emphasizes the shortcomings in the operating notes, underscoring the necessity for training initiatives to enhance the recording by medical officers and orthopaedic trainees. Implementing structured templates that adhere to RCS standards can improve the comprehensiveness and consistency of operating notes, effectively resolving existing discrepancies. Regular audits and feedback sessions are essential for identifying and rectifying persistent issues. It is recommended to arrange workshops and seminars to educate medical officials and trainees on the skills of efficient note-taking and thorough documentation procedures.

Providing the Tools to Facilitate Quality Care for Children with Sickle Cell Disease

Summary: Meeting best-practice guidelines can significantly enhance quality of life and longevity for those with sickle cell disease (SCD). However, many clinical settings lack the necessary resources for optimal care. We present an integrated suite of tools and collaborative actions designed to enhance SCD care.

Bringing Care Close to Home: Remote Management of Heart Failure In Partnership with Indigenous Communities In Northern Ontario, Canada

BackgroundThe Weeneebayko Area Health Authority (WAHA) is a regional, community-based Indigenous health authority in Northern Ontario, Canada. From September 2022 to March 2023, the WAHA and University Health Network engaged in a partnership that designed a collaborative model of care to address inequities in cardiology specialist access in Northern Ontario. This model implemented a digital therapeutic for heart failure, (the Medly program) and in-person cardiology clinics in the region. MethodsA WAHA-based Medly program clinical coordinator worked closely with the University Health Network team to deliver care and support patient self-management of HF. The use and effectiveness of the Medly program were tracked through app usage and rules-based algorithm alerts, based on patient self-reported data. Distribution of relevant equipment (a scale, a blood pressure cuff, and a mobile device) for the Medly program was recorded. Surveys to assess patient and provider satisfaction with the Medly program also were administered. A retrospective chart audit of electronic medical records and administrative databases was conducted. ResultsA total of 33 patients in the WAHA were enrolled in the Medly program during a 7-month period, surpassing the enrollment goal of 25 patients. A total of 93% of eligible patients were on optimized guideline-directed medical therapy or were being titrated for it. Of 15 surveyed patients, 100% agreed or strongly agreed that the Medly program facilitated delivery of care close to home, and 86% of surveyed clinicians (n = 7) agreed or strongly agreed that the Medly program addresses a gap in available care in the region. ConclusionsThe implementation of the Medly program in partnership with the WAHA has demonstrated success in terms of the volume of referrals, the quality of care, adherence to evidence-based best-practice guidelines, and satisfaction with the program.

Defining Suicidal Thought and Behavior Phenotypes for Genetic Studies.

Standardized definitions of suicidality phenotypes, including suicidal ideation (SI), attempt (SA), and death (SD) are a critical step towards improving understanding and comparison of results in suicide research. The complexity of suicidality contributes to heterogeneity in phenotype definitions, impeding evaluation of clinical and genetic risk factors across studies and efforts to combine samples within consortia. Here, we present expert and data-supported recommendations for defining suicidality and control phenotypes to facilitate merging current/legacy samples with definition variability and aid future sample creation. A subgroup of clinician researchers and experts from the Suicide Workgroup of the Psychiatric Genomics Consortium (PGC) reviewed existing PGC definitions for SI, SA, SD, and control groups and generated preliminary consensus guidelines for instrument-derived and international classification of disease (ICD) data. ICD lists were validated in two independent datasets (N = 9,151 and 12,394). Recommendations are provided for evaluated instruments for SA and SI, emphasizing selection of lifetime measures phenotype-specific wording. Recommendations are also provided for defining SI and SD from ICD data. As the SA ICD definition is complex, SA code list recommendations were validated against instrument results with sensitivity (range = 15.4% to 80.6%), specificity (range = 67.6% to 97.4%), and positive predictive values (range = 0.59-0.93) reported. Best-practice guidelines are presented for the use of existing information to define SI/SA/SD in consortia research. These proposed definitions are expected to facilitate more homogeneous data aggregation for genetic and multisite studies. Future research should involve refinement, improved generalizability, and validation in diverse populations.

Relationships, risks and remuneration: Australian directors “doing” corporate governance

Purpose This paper aims to examine how directors operationalise Australian corporate governance guidelines to follow their self-regulatory responsibilities. Design/methodology/approach This study consists of semi-structured, in-depth interviews with 41 directors of ASX200 companies. Findings This study sheds light on how directors behave when grappling with the challenges they face as they work within a non-mandatory governance code. It adds to the literature by finding that while most of the good practice guidelines detailed by the ASXCG are well understood and enacted, in practice directors focus on ensuring strong relationships, minimising risk and managing the tensions they face in responsibly managing remuneration. Practical implications This study highlights the three R’s and the workings of the code, it also reveals the dynamics of managing uncertainty at the board level. At the implementation level, these insights will help board members to reflect on where attention is focused within guiding principles. Originality/value This study contributes to corporate governance studies by filling the gap between what should happen – as per governance guidelines – and what does happen in practice in top level Australian corporations. In making visible what exercises directors most as they operationalise their responsibilities in Australia, a country with a non-mandatory “if not, why not” governance code, the authors demonstrate how self-regulation plays out.

Consensus panel recommendations for the optimization of EPIDIOLEX® treatment for seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex.

Following the approval of Epidiolex® (cannabidiol; CBD) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), and tuberous sclerosis complex (TSC), healthcare professionals (HCPs) have had substantial experience in treating patients with Epidiolex. However, confusion still remains among HCPs, caregivers, and patients regarding dosing, drug interactions, safety monitoring, and differentiation between Epidiolex and nonapproved CBD products. To establish consensus recommendations for Epidiolex treatment optimization in LGS, DS, and TSC, a panel of seven HCPs with expertise in epilepsy was convened. Panelists participated in a premeeting survey based on a literature review of Epidiolex for the treatment of LGS, DS, and TSC, and survey responses were compiled for discussion. A modified Delphi method was used to assess agreement among panelists regarding recommendation statements following two rounds of discussion. Panelists identified two broad themes - overcoming barriers to initiation and optimization of treatment for seizures associated with LGS, DS, and TSC - for consensus guidelines. Accurate identification of patients with these rare epilepsies is critical for optimization of Epidiolex treatment. Providers should differentiate Epidiolex from nonapproved CBD products and set expectations for the therapeutic effect and safety/tolerability of Epidiolex. Initial target dose and titration rate should be individualized by baseline variables, prior response to antiseizure medications, and therapeutic goals. Awareness of strategies to manage adverse events and concomitant medications, including drug-drug interactions, is critical. Tracking response to the maximum tolerated dose is an important measure of effectiveness. These consensus recommendations provide real-world experience from neurology HCPs with experience in prescribing Epidiolex and can inform optimal use of Epidiolex for the treatment of seizures associated with LGS, DS, and TSC. PLAIN LANGUAGE SUMMARY: Epidiolex® (cannabidiol) is approved for treating seizures in Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex. Although healthcare professionals have experience in treating patients with Epidiolex, there is a need for better understanding of dosing, drug interactions, and safety of this drug. Therefore, a group of epilepsy experts developed guidelines for best practices in Epidiolex treatment. Two main areas were identified: overcoming barriers to starting Epidiolex and considerations related to Epidiolex dosing. Within these areas, topics, including correct disease identification, managing adverse events, and determining individualized dose, were discussed. These guidelines provide real-world experience to inform optimal Epidiolex use.

Strategies to Obtain Reliable Energy Landscapes from Embedded Multireference Correlated Wavefunction Methods for Surface Reactions.

Embedded correlated wavefunction (ECW) theory is a powerful tool for studying ground- and excited-state reaction mechanisms and associated energetics in heterogeneous catalysis. Several factors are important to obtaining reliable ECW energies, critically the construction of consistent active spaces (ASs) along reaction pathways when using a multireference correlated wavefunction (CW) method that relies on a subset of orbital spaces in the configuration interaction expansion to account for static electron correlation, e.g., complete AS self-consistent field theory, in addition to the adequate partitioning of the system into a cluster and environment, as well as the choice of a suitable basis set and number of states included in excited-state simulations. Here, we conducted a series of systematic studies to develop best-practice guidelines for ground- and excited-state ECW theory simulations, utilizing the decomposition of NH3 on Pd(111) as an example. We determine that ECW theory results are relatively insensitive to cluster size, the aug-cc-pVDZ basis set provides an adequate compromise between computational complexity and accuracy, and that a fixed-clean-surface approximation holds well for the derivation of the embedding potential. Additionally, we demonstrate that a merging approach, which involves generating ASs from the molecular fragments at each configuration, is preferable to a creeping approach, which utilizes ASs from adjacent structures as an initial guess, for the generation of consistent potential energy curves involving open-d-shell metal surfaces, and, finally, we show that it is essential to include bands of excited states in their entirety when simulating excited-state reaction pathways.

Complex issues in vocational rehabilitation with functional capacity evaluation results

BACKGROUND: The American Physical Therapy Association (APTA) conducted a two-year process of literature review, writing, discussion, and debate within a panel of four subject matter experts in design, administration, and interpretation of Functional Capacity Evaluations (FCE). This process resulted in a Best Practice Guidelines document which was then adopted by the APTA. OBJECTIVE: This article provides additional clarification regarding best practices and standard methodology for functional capacity evaluations including standard terminology for use by physical therapists and vocational rehabilitation professionals in determining the types of work a patient has the capacity of performing. METHODS: The clarification of the role of the FCE, who is qualified to conduct an FCE, complexities such as ‘good effort’ and pain in the evaluation process, clarification of terms from different government agencies, and the implications for disability determination are discussed. RESULTS: Specific guidelines for best practice with FCE are suggested and demonstrated through case studies. CONCLUSION: The best practice guidelines are detailed here to set forth qualification standards for FCE examiners and to promote clinical excellence, accountability, and consistency in the design, administration, and interpretation of FCEs.

An Integrated DAIDS Laboratory Oversight Framework: Application of the DAIDS GCLP Guidelines.

The Division of AIDS (DAIDS) Good Clinical Laboratory Practice (GCLP) Guidelines establish a framework to guide the oversight of laboratories supporting DAIDS-sponsored clinical research or trials. Compliance with these guidelines promotes data reliability, consistency, and validity, and the safety of the clinical research or trial participants and laboratory staff, as well as ensures adherence to regulatory requirements. This article describes the application of the DAIDS GCLP Guidelines, the DAIDS Integrated Laboratory Oversight Framework, and the coordinated efforts of the collaborative oversight team of laboratory experts to support and monitor the performance of over 175 participating laboratories worldwide. Data from two self-administered online surveys conducted in 2017 and 2023 assessed the laboratory staff's experience implementing the GCLP Guidelines. The results of the 2017 survey were instrumental in informing changes to GCLP audit activities and promoting harmonization in the approach to laboratory oversight. A key finding from the 2023 survey results is the preference for hybrid GCLP training, encompassing face-to-face and online modules. Overall, both surveys acknowledged satisfaction with applying and implementing GCLP Guidelines. The need to effectively disseminate information about DAIDS laboratory oversight requirements to support the improved implementation of GCLP Guidelines was notable from both survey results. The collaborative team of laboratory experts and the integrated oversight approach promote knowledge-sharing and accountability to support the application of the GCLP Guidelines and compliance monitoring. The systematic implementation of the integrated laboratory oversight activities helped identify valuable lessons for improving laboratory performance and opportunities to strengthen quality oversight for laboratories participating in clinical research or trials.

Cognitive Factors Leading to Human Error: A Major Contributing Factor for Quality Deviations in Pharmaceutical Industry

The pharmaceutical sector is one of the top research-based sectors in the world which continuously produces new medications that improve and save human lives. Patients, as well as healthcare professionals depend on pharmaceutical companies for the treatment of ailments, so it is very important to develop a good quality product following Good manufacturing practices guidelines that ensure the quality, safety, and efficacy of the product. Human cognitive errors are a major cause of quality deviations. These quality deviations result in product recalls, a ban on products by regulators where the company’s reputation will be tarnished which can result in loss of sales and revenue. Human errors can be identified and mitigated by various techniques. In this paper, we discuss the factors contributing to cognitive errors, the impact of cognitive errors on the pharmaceutical industry, the identification of the cognitive errors causing current good manufacturing practices (cGMP) deviations, and challenges in the mitigation of cognitive errors. A survey questionnaire and the form human error assessment and reduction technique (HEART) tool were also developed and discussed in the manuscript.

Qualitative Analysis of Inquiries Received by FDA Regarding Conduct of Clinical Trials during the Covid-19 Public Health Emergency

BackgroundThis report describes the U.S. Food and Drug Administration (FDA) experience in establishing a dedicated mailbox, and in publishing related guidance, to address concerns among interested parties regarding the conduct of clinical trials during the COVID-19 public health emergency (PHE).MethodsSix hundred and thirty-four mailbox inquiries were received from March 2020 through February 2022. Qualitative methods were used to provide a structured description of, and identify common themes among, these inquiries.ResultsMost inquiries came from U.S.-based interested parties, including sponsors, industry trade associations, academic institutions, hospitals, clinics, research sites, trial participants, and individual persons. Approximately one-fifth of questions were related directly to COVID-19 (e.g., proposals for treatment); other inquiries were related to conduct of routine trial-related activities, and concerns were often focused on maintaining compliance with good clinical practice. In March 2020, FDA published a guidance titled Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency; the document was subsequently revised eight times based in part on issues raised in mailbox inquiries.ConclusionsThe dedicated mailbox enabled expedited communication among invested parties during the COVID-19 PHE; FDA also provided updates of the aforementioned guidance. These efforts supported the continuance of ongoing trials and the initiation of new trials during the PHE in accordance with good clinical practice guidelines, thereby helping to ensure the safety of trial participants while maintaining the quality of trial data. By soliciting and responding to trial-related inquiries and addressing corresponding needs and concerns, FDA improved transparency and communication.

Lights on music cognition: A systematic and critical review of fNIRS applications and future perspectives

Research investigating the neural processes related to music perception and production constitutes a well-established field within the cognitive neurosciences. While most neuroimaging tools have limitations in studying the complexity of musical experiences, functional Near-Infrared Spectroscopy (fNIRS) represents a promising, relatively new tool for studying music processes in both laboratory and ecological settings, which is also suitable for both typical and pathological populations across development. Here we systematically review fNIRS studies on music cognition, highlighting prospects and potentialities. We also include an overview of fNIRS basic theory, together with a brief comparison to characteristics of other neuroimaging tools. Fifty-nine studies meeting inclusion criteria (i.e., using fNIRS with music as the primary stimulus) are presented across five thematic sections. Critical discussion of methodology leads us to propose guidelines of good practices aiming for robust signal analyses and reproducibility. A continuously updated world map is proposed, including basic information from studies meeting the inclusion criteria. It provides an organized, accessible, and updatable reference database, which could serve as a catalyst for future collaborations within the community. In conclusion, fNIRS shows potential for investigating cognitive processes in music, particularly in ecological contexts and with special populations, aligning with current research priorities in music cognition.