The therapeutic use of music is frequently based on active interventions that directly involve the patient through a sonorous-music interaction with the music therapist. In contrast, approaches based on musical listening are characterized by a relationship aimed at promoting an introspective work and processing of one’s emotional experiences. Increasingly, the scientific literature has shown how even listening to music related to the patient’s personal tastes (preferred music listening) and by-passing the direct relationship with the patient, can produce therapeutic effects in different clinical settings. However, in many cases, a clear therapeutic rationale and specific application protocols are still lacking. The paper introduces a novel approach based on music listening: the Therapeutic Music Listening. This approach integrates the subjective component of listening  and structural and parametric characteristics of the music in relation to the therapeutic aims. The article defines theoretical-applicative bases as well as therapeutic and research perspectives of this music listening-based intervention. A careful review of the literature related to the various applications of music in clinical settings, has identified several types of interventions. Music therapy interventions can be divided into relational or rehabilitative approaches, individualized music listening (based on songs chosen by the patient/client with the possible support of a music therapist) or proposed by a therapist . Further interventions are based on a generic use of musical activities (making and/or listening to music without specific therapeutic-rehabilitative aims) . There iListening to music is connected to the sensory processing of the acoustic characteristics of the musical message by the auditory system. The central nervous system has two auditory pathways: the pathway from the internal ear reaching the auditory cortex and another pathway going to the reticular system, with connections to the limbic and autonomic nervous systems . This reThis summary regarding the rationale behind the therapeutic potential of music listening, outlines a positive picture that justifies its use in numerous clinical and preventive settings. Despite the scientific value that emerges from the literature, there is a clear delineation of the need for further research in this regard to adequately connect the specificity of music listening to clinical and application issues. Therefore, greater dialogue and integration between professionals in the clinical, psychological, and neuroscientific fields and music therapy professionals is recommended. This would strengthen the interventions by making them more coherent and rigorous from a scientific and application perspective.Given the above fundamentals, music listening can be used in many clinical settings, including both music therapy receptive techniques and music medicine approaches. Hospital settings is certainly one of the contexts in which music listening can be widely used, especially as music medicine approach. In addition to logistical reasons  and clinical reasons , music listening can be easily implemented during hospital stays. This is in the presence of transient symptoms that characterize the peri-operative setting, pain medicine, sleep medicine, oncological setting, etc., or more widely where the hospital stay is accompanied by psychological symptoms such as anxiety, stress, depression, etc. Often, pharmacological treatment can lead to various side effects. Potentially, music listening can reduce the need for drugs, improve the psychological condition, and, in some cases, even reduce hospitalization time . SpecifiThe approach is applied from a collection of anamnestic data that includes personal and musical information. The questionnaire that precedes the creation of the initial playlist collects information, allowing the creation of a music listening program that combines some fundamental aspects: (a) the preferences of the user; (b) the musical characteristics  of musical choices; and (c) the therapeutic needs. The listening program aims to consider not only musical preferences, but also, to focus attention on the structural and parametric component of the musical pieces, according to three categories that are broadly reflected in the therapeutic needs, regardless of the type of pathological condition, by-passing the more subjective component related to personal emotional referrals and music liking. The three categories that the therapist refers to in the choices of musical parameters are: relaxation/de-activation, activation, and distraction (shifting attention away from the relevant condition). It is important to note that these categories refer to conditions that can be applied to specific musical structures/parameters. In no way does this deny the subjectivity of the listener, but rather attempts to connect therapeutic needs with more objective music parameters. It follows that relaxing/de-activating songs can be traced back to a tendentially slow tempo (40–60 bpm), characterized by regularity, predictability and reduced rhythmic, melodic, and harmonic complexity. To determine a de-activating effect, it is also important that the song does not have a high expressive intensity and potential personal reference . Conversely, potentially activating songs will tend to have opposite characteristics: tempo > 60 bpm with greater parametric and structural irregularities and complexities. Songs with distractive value will need to contain divergent elements, irregularities, and a high number of variations, together with modulable parametric and structural complexity. It is possible to assume a gradualness in defining the above categories. Therefore, it is believed that the TML pathway combines the subjective component with the above parametric and structural characteristics of music .A music therapist relies heavily on anamnesis, music and music therapy skills, and data from the literature (when available).Therapeutic Musical Listening thus constitutes an approach that considers the need to propose listening programs based on the patient’s musical background emphasizing, at the same time, the specificity of musical features.This makes it possible to create a listening program that allows, through the impact of music on the individual, an entrainment mechanism aimed at regulating and modulating psycho-physiological parameters dynamically, reflecting the patient’s needs.The modulation and regulation of stimuli (through the choice of specific parameters and the periodic feedback provided during the therapeutic course) allows for a tailored intervention to be proposed while respecting the subjective musical tastes of the client/patient. Musical parameters and structures can reflect and modulate psychophysical needs in a rewarding and predictable context  see .2.Identification of therapeutic aims and assessment .3.Selection of the most appropriate reference categories  based on the identified therapeutic aims, and definition of music “design” that adequately modulates the trend of music parameters.4.Creation of the individualized listening program (20–40 min).5.Enjoyment test  see .6.Delivery of individualized listening program (definition of listening mode and timing).7.Daily listening by patient/client according to agreed modalities.8.Periodical feedback .9.Confirmation or creation of a new individualized listening program based on the results found and the evolution of the therapeutic treatment.10.Clinical evaluation and subjective assessment (Questionnaire 2) at the end of treatment.This application system ensures the possibility of creating and monitoring a specific listening program that can be varied and modulated based on what emerges during the treatment. In the case of the patient’s lack of autonomy, the support of health care staff is of paramount importance in facilitating the patient’s access to the program. Devices and modes of listening  may vary in relation to specific needs or the clinical or logistical features that connote therapeutic treatment. Clinical experience suggests music listening sessions of 20–40 min in duration (preferably with headphones). The time limit often coincides with possible attention span and patient/client availability. The frequency of music listening  should be assessed based on the need and clinical characteristics of the user.Compared with other receptive music therapy techniques, such as the Bonny Method of Guided Imagery and Music , TML doeThis process integrates aspects of perception and the subjective effects of music (the impact of music on the patient) and aspects given using specific musical parameters chosen to achieve specific effects (the choices of the music therapist).As anticipated, the TML-based approach integrates some basic theoretical assumptions, that are well documented in neuroscience  with the idea that musical structures and parameters also play an important role in determining therapeutic effects. This means giving specificity to musical proposals by-passing the idea that musical pleasure/pleasure alone can determine any therapeutic effect. A generic factor leading to oversimplification would be that any music you like can have a therapeutic effect.In order to study music more closely, we need to isolate those characteristics whose variations can potentially generate very different effects. Identifying these parameters is extremely challenging since perception of music differs from the sum of individual musical factors, which are impossible to separate in their interaction . HoweverThe approach presented is intended to be an attempt to combine the subjective perspective of music listening with a scientifically oriented approach to determine a link between musical stimulus and therapeutic effect. The data that emerged from the studies provide a fundamental starting point for future investigation related to music listening aimed at treatment. Such an approach could ensure a kind of “modeling” of musical listening also characterized by quantitative implications (thus more objectifiable and standardizable) with respect to different clinical problems. In order to accomplish this aim, one could also apply music-therapeutically oriented music feature extraction techniques, which will allow therapeutic repertoires to be developed based on quantitatively defined musical features. With the support of Artificial Intelligence, one could consequently identify songs with similar characteristics given by the presence of the same musical parameters that can be easily identified and quantified. Recent data processing techniques attributable to Machine Learning and artificial neural network can also define target populations in relation to specific music characteristics/structures and discover the hidden relationships among the considered study’s variables , 2021b. I believe that the future of music therapy must consider these multidisciplinary perspectives, trying to combine the music perspective with the scientific perspective, with the aim of consolidating clinical data found in clinical practice.Finally, what is manualized in this article, because it is thought in the context of Western culture, should be studied when applied in other cultural contexts, considering the variables related to different listening habits . In particular, if the cultural aspect can be considered on the anamnestic level, understanding the impact of musical structures and parameters in relation to their potential effect on the individual with different cultural background could be an important point to consider in TML interventions.The original contributions presented in this study are included in this article/AR conceived and designed the study, wrote all sections of the manuscript, and approved the submitted version.


The Supporting and Enhancing NICU Sensory Experiences (SENSE) program promotes consistent, age-appropriate, responsive, and evidence-based positive sensory exposures for preterm infants each day of NICU hospitalization to optimize infant and parent outcomes. The initial development included an integrative review, stakeholder input , and feasibility focus groups. To keep the program updated and evidence-based, a review of the recent evidence and engagement with an advisory team will occur every 5 years to inform changes to the SENSE program. Prior to the launch of the 2nd edition of the SENSE program in 2022, information from a new integrative review of 57 articles, clinician feedback, and a survey identifying the barriers and facilitators to the SENSE program’s implementation in a real-world context were combined to inform initial changes. Subsequently, 27 stakeholders  carefully considered the suggested changes, and refinements were made until near consensus was achieved. While the 2nd edition is largely the same as the original SENSE program, the refinements include the following: more inclusive language, clarification on recommended minimum doses, adaptations to allow for variability in how hospitals achieve different levels of light, the addition of visual tracking in the visual domain, and the addition of position changes in the kinesthetic domain. The Supporting and Enhancing NICU Sensory Experiences (SENSE) program was developed following research that identified alterations in the brain structure and function in hospitalized infants in low-stimulation NICU environments . The SENThe SENSE program was developed using a stepwise, rigorous, and scientific process, which included a review of the published literature from the previous 20 years to identify appropriate, evidence-based multisensory interventions for preterm infants in the NICU, along with the timing of when those interventions took place within each study . Expert The SENSE program was also designed to encourage parents to be the providers of positive sensory exposures to their infants. Parents often struggle with role alteration when their young infants are hospitalized in the NICU , and manSince the launch of the initial SENSE program, research has been conducted to understand the impact of the program on infant and parent outcomes. A pilot study identified that, among families who received the SENSE program, mothers demonstrated improved confidence and infants demonstrated improved neurobehavior at the term-equivalent age . SubsequResearch on the implementation of the program has identified that the SENSE program has good reach (was received by the targeted population), is effective and acceptable with minimal costs, and has good fidelity . AnotherThere has been a large demand for the SENSE program among NICU clinicians worldwide since the program materials were made available to other hospitals in 2018. The cost of the program supports only the cost of its distribution, with no direct financial benefit to any person or entity.Due to continuously emerging research on sensory exposures related to improved outcomes, we have committed to a new review of the evidence and engagement with an advisory team to inform changes to the SENSE program every 5 years. The purpose of this manuscript is to define the process for informing revisions, outline the decision-making process as to which changes should be made, and identify the refinements made to the SENSE program in 2022.The original process of the SENSE program’s development has been previously described . A compaAn updated integrative review was conducted through a systematic search for studies published from October 2015 to October 2020 using databases including MEDLINE (via PubMed), CINAHL , the Cochrane Library, and Google Scholar. Studies were included if they imposed a quantifiable environmental sensory exposure during the NICU stay, prior to 36 weeks PMA. The relevant outcomes included infant behavioral outcomes, neurobehavioral outcomes, parent well-being, and other parental outcomes. Studies with outcomes related solely to pain or feeding were excluded. Samples of healthy infants and studies with a sample size of <30 and without an a priori calculation of power were excluded. Two reviewers set the search engine and screened articles for inclusion. One reviewer performed data extraction that was checked for accuracy by a second reviewer. An assessment of study quality was independently performed by two reviewers using the United Kingdom’s National Institute for Health and Care Excellence (NICE). Study findings were summarized qualitatively, with evidence related to each type of sensory intervention defined across PMA. Fifty-seven new articles on sensory-based interventions  were identified that were used to improve outcomes for preterm infants and their parents in the NICU .Clinician input across the previous 5-year period  was compiled. With the increased focus on small baby programs, much of the clinician guidance focused on an interest in further differentiating how to safely tailor SENSE interventions to the small baby.The SENSE Program Implementation Survey was sent out to 211 hospitals who had obtained the SENSE program prior to 11 March 2020, to probe perceptions of the program and better understand implementation, costs, and adaptations made across sites. Among 114 respondents (54% response rate), important insights about acceptability, adoptability, barriers, and facilitators were identified, which informed changes to the parent education materials and administration and implementation manual. Information that guided modifications included that 33% of respondents indicated that they made adaptations to the SENSE program to facilitate implementation, and 64% of them were planned/proactive, while 36% were reactive. Most (64%) of these adaptations were determined by the therapist and had to do with adapting to the NICU context (58%). Some respondents indicated interventions in the SENSE program that their NICU did not endorse, including music (19%), massage (15%), talking to the infant during sleep (4%), use of vestibular stimulation (4%), and any interventions for infants < 26 weeks PMA (4%). There were 88% of respondents who indicated that they use the SENSE parent education materials, with most of them (80%) using the printed materials. There were 80% of respondents who indicated that they assess the tolerance of the infant, with 57% of them using the materials in the SENSE program to do so.Once the new evidence, clinician guidance, and survey had been completed and results carefully considered, a SENSE advisory team  was assembled. All healthcare professionals had a minimum of 5 years of clinical experience working in a NICU. The SENSE advisory team had the goal of ensuring that the SENSE program was evidence-based, incorporated the most current published literature, remained appropriate for different types of families, and was applicable to a variety of NICU settings. A call for members of the SENSE advisory team was made through email and social media groups for those interested in neonatal therapy research and those who were familiar with the original SENSE program. Each member was asked to commit 10 h for a period of up to one year to engage in online meetings, discussions, and individual review of materials. The larger 27-member group was broken into work groups of 2–7 individuals to weigh in on specific components of the program . The work groups reviewed the new evidence and the changes suggested to the program. An iterative and interactive process occurred with the research team until near consensus was achieved on the suggested refinements to each section.All of the findings from the previous systematic and scientific process undertaken to develop the SENSE program, the new integrative review, clinician guidance, the implementation survey, and advisory team feedback were used to refine the SENSE program, which included improvements to the parent education materials and the implementation and administration manual.The new integrative review (2015–2020) identified many interventions that had already been defined in the previous integrative review (1995–2015). However, the new integrative review provided evidence to support some additions, as well as modifications, to the timing and wording of the information contained in the SENSE program. Below, we identify the changes and rationale for the recommendations related to each sensory system, as well as for content in the The previous integrative review identified evidence-based tactile interventions to be gentle human touch, skin-to-skin care, holding, and massage. The new integrative review expanded the evidence base for skin-to-skin holding to include its use as early as in the delivery room ,27. TherThe timing for the introduction of massage received increased attention by the SENSE advisory team following the second integrative review. There is some emerging evidence supporting massage as early as 28 weeks PMA . HoweverThe terminology for “gentle human touch” was changed to “hand hugs” in the 2nd edition of the SENSE program, as this terminology has grown in acceptance and was considered to be more parent-friendly than other terms such as facilitated tuck, containment, and gentle human touch.The previous integrative review identified evidence-based auditory interventions to be live music or singing, recorded sound , and recorded biological sounds. The new integrative review did not add additional interventions but did bring up some needed clarifications, such as the use of different decibel levels, use of headphones (versus not using headphones), type of music (such as pentatonic harp), and type of lullaby (such as Brahms lullaby). The auditory guideline remained the same in the 2nd edition of the SENSE program, with the use of quiet conversations at the bedside at the earliest PMAs, introducing reading and singing at the bedside at 28 weeks PMA, introducing music at 32 weeks if the infant tolerates it, and building up to a minimum of 3 h of intentional auditory exposure per day by term-equivalent age with a focus on an environment rich in language exposure.There were studies from the new integrative review using recorded maternal voice and music prior to 32 weeks. One study using Brahms lullaby between approximately 29 and 34 weeks PMA identified differences in oxygen saturation levels, which was not a primary outcome of interest for our integrative review . HoweverDecibel levels have also been a focus of attention. While the American Academy of Pediatrics and the World Health Organization recommendation for sound exposure is an average of 45 decibels, few NICUs meet this requirement ,39. The The previous integrative review identified maternal scent and breast milk as the only evidence-based olfactory exposures. Clarifications about the use of breast milk scent were added to the 2nd edition, as the original program largely focused on the smell of the parent. A discussion occurred regarding the addition of an assigned time recommendation for olfactory exposure, as it is one of the only senses in the program that did not have a time target. This idea of a time target also heightened discussions about the use of a constant smell and whether infants might habituate to it. In addition, there was discussion about the potential impact and associated learning if a scent was placed by an infant and then they had multiple noxious stimuli that occurred. Based on evidence supporting the use of the scent of the parent and breast milk for 3 h , this miIn the previous integrative review, interventions largely focused on the light environment, specifically on the use of cycled light, starting at 32 weeks PMA. There was also some evidence on the use of the parent’s face for visual exposure closer to term-equivalent age. The new integrative review identified positive outcomes associated with having infants fix and follow a toy or human face starting at 34 weeks PMA . TherefoThere is not strong evidence to support cycled light prior to 32 weeks ,46, whicFor cycled light, a specific time  has been replaced with “during the day” and “during the night” in the 2nd edition to allow NICU staff to find a pattern that works for them . Another important factor discussed was the benefit of gradual light transitions as in normal day/night rhythms. This is important, because sudden changes in light can impact sleep ,47,48. SAnother important discussion point was light intensity. The literature identifying the impact of cycled light has variable lux levels ranging from 75 to 500 lux during the daytime , with moThe previous integrative review included interventions described as physical therapy, but with outcomes largely focused on bone health. The new integrative review expanded the repertoire of evidence-based kinesthetic interventions to include guided movement and position changes. There is also emerging evidence to support passive range of motion (PROM), but since the positive outcomes in these studies were related only to bone health and weight gain (and not to neurobehavior), PROM was not added to the SENSE program at this time. The guideline continues to include opportunities for free movement and supporting the infant’s smooth movements when appropriate . Clarifications were added that infants at low PMA may not tolerate free movement, and that such free movement can be contained and/or occur within the confines of positioning devices or by allowing movement of one extremity at a time, especially when performed with the 23–28 week PMA population.The 2nd edition of the SENSE program also now includes recommendations that the infant experience at least two different positions each day for a minimum of 10 min each  at the earliest PMAs. By 34 weeks PMA, the recommendation is for infants to experience being in at least three different positions each day, with tummy time being one of them. These positions may occur at any time throughout the course of a 24 h period and may already be encouraged based on position change recommendations that are part of standard care. Tummy time is important throughout infancy , and encParent education materials for the 2nd edition of the SENSE program consist of an 88-page booklet written at a 5th to 8th grade reading level that includes a glossary of common NICU terms along with chapters that detail the importance of parents and why their involvement matters, development of the senses, specific guidelines for how to provide sensory experiences, guidance on when to interact based on their baby’s cues, a “how to” guide with recommendations for sensory experiences to share with their baby each day of hospitalization with “doses” to target that evolve across PMA, and detailed instructions and videos for how to share sensory experiences (such as massage or gentle rocking) with their baby. This parent booklet is now available in English, Spanish, Arabic, French, Korean, Hindi, Chinese, and Hebrew, with additional translations ongoing. In addition to a print version of the booklet, these materials are also accessible electronically via a QR code to enable easy access on smart phones and/or tablets.General changes were made to the wording in the 2nd edition of the SENSE program based on the results of the integrative review, advisory team feedback, survey responses, and informal clinician feedback. The chapters of the parent education booklet were re-organized and modified for inclusion, clarity, and promotion of parent engagement. Minor formatting changes were made to improve the aesthetics of the program and enhance the clarity of the content.In recognition of evidence regarding gender-affirming care , the lanThe weekly infant assessment of tolerance is included as an optional component of the SENSE program to allow clinicians to formally evaluate whether infants are tolerating the interventions as described. In a large level IV NICU, it was found that 95% of infants tolerated the original SENSE program as described, but 5% required temporary adaptations based on a medical status that typically lasted a few days to a few weeks before returning to the program recommendations . ExperieThe implementation and administration manual is a supplemental resource that serves as a “user manual” for clinicians to implement and support the program, with information regarding the development of the program, strategies for implementation, and adaptations that can be made to the program. Changes to the implementation and administration manual of the SENSE program were made based on the SENSE implementation survey, clinician guidance, and the advisory team’s feedback. A definition of the SENSE program was added, along with a rationale for the program and a detailed description of the process of developing the SENSE program. The ongoing commitment to evidence-based programming was emphasized, with the intention to update it every 5 years. The manual was reorganized to guide clinicians in three main subsections: components of the program, necessary personnel, and materials to assist in implementation. The added items to assist with implementation were a map of an implementation strategy, an implementation checklist, and examples of adaptations that can be made based on individual and organizational factors. It was also clarified that the process of implementation can be an iterative process of implementation, assessment of progress, and then adaptation. Specific lux levels and decibel levels to go along with the program recommendations were added to the manual for clinicians to have quantifiable targets, with suggested tools to aid clinicians in assessing light and sound in their NICUs. Additional factors surrounding the first 72 h were added to aid clinicians in evidence-based practice and determine choices of sensory exposures that align with their hospital’s policies and culture. The manual was also updated to include strategies for engaging families, provide applause for small progress toward positive sensory exposures, and outline recommendations to integrate the program into the context of daily life in the NICU.This manuscript discusses changes to the SENSE program that were made in 2022. The goal was, and will continue to be, to keep the SENSE program aligned with the latest evidence. The refinements made ensure that the program stays evidence-based and meets the needs of infants, families, and healthcare providers worldwide. The program will continue to be updated every 5 years using a similar process of an integrative review of new evidence, advisory team input, and survey feedback from hospitals that have obtained the program.While the research to date has identified associations of the SENSE program with parent confidence, as well as infant neurobehavior and outcomes ,18,21, mWhile a systematic and rigorous process was used to refine the SENSE program, there were some limitations. The integrative reviews that now encompass 25 years of research were limited based on the inclusion and exclusion criteria, and many of the studies lacked clarity of when the interventions were conducted. This led to assumptions being made with the available information. The informal feedback from clinicians that was compiled over the previous 5 years was not formally analyzed using qualitative techniques, and it could be subject to bias based on receiving responses only from individuals who reached out. The implementation survey is limited by being a survey, rather than a direct observation of the SENSE program implementation. The timing of this survey was also challenging due to the impact of the COVID-19 pandemic on medical care in the NICU. The SENSE advisory team was made up of parents and healthcare professionals who were willing to volunteer their time to aid this process and may not reflect all the views of parents and healthcare professionals. When combining all the information through these processes, choices and decisions were not always clear, and discussions had to occur until near consensus was achieved. Despite the limitations, we have confidence that the 2nd edition of the SENSE program is evidence-based, incorporates stakeholder feedback, and is best practice in terms of sensory exposures for preterm infants in the NICU.There has been a high demand for the SENSE program, especially in the United States, but also extending to other countries including Canada, Italy, Malta, Mexico, Chile, Switzerland, Spain, Taiwan, the United Arab Emirates, Qatar, Australia, South Africa, Argentina, New Zealand, Costa Rica, Turkey, the United Kingdom, Singapore, India, and Israel. More than 400 hospitals have obtained the program worldwide. Updates to the program will ensure that the thousands of infants and families who are reached by the program are receiving sensory experiences that have the power to improve hospital, family, and infant outcomes.


Effective science communication is fundamental to closing the gap from research and innovation to clinical implementation. Existing paradigms of science communication are often challenged by a lack of skill and engagement, particularly from those who progress the science. Currently, a standardized curriculum on science communication, with global applicability, does not exist. The purpose of this project is to address the gap in training by health professionals and clinical researchers through the development of a globally relevant curriculum for science communication. The nominal group technique (NGT) was used whereby a convenience sample of eleven science communication experts from across the globe generated, discussed, and arrived at a consensus on topics that should be included in a standardized science communication curriculum. Experts represented diverse backgrounds within the health sciences. Due to the COVID-19 pandemic and geographical constraints, the NGT was conducted virtually. The consensus-building methodology allowed for each expert to equally present ideas and collaborate with one another to create a robust and comprehensive curriculum for effective science communication. Expert panelists reached a consensus on 10 essential components of a standardized global science communication curriculum. Following the refinement of the curriculum topic areas, a virtual meeting with project co-investigators was held to review the topics and discuss relevance, applicability, and appeal to the local contexts. A standardized science communication curriculum is needed for health professionals and clinical researchers. The NGT achieved expert consensus on the core topics. The next steps are to develop the course ensuring optimal participation from learners across the globe. Globally there is a profound inequality in access to cancer care and these gaps are projected to increase in the next decade. The causes of these gaps are multifactorial, including health human resource shortages, lack of access to cancer medicines, radiotherapy, diagnostic tools, and health systems infrastructure gaps. The know-do gap , 2, or tThe current paradigms of science communication are often challenged by a lack of skill and/or engagement from those progressing in science. One cause for this is certainly that science communication modules for a long time have not been part of the educational programs for researchers and clinicians. However, we slowly see increasing interest and progress in certain countries and specific institutions where these elements are being introduced to complement the individual training portfolios for these target groups. Another reason might be that traditional venues for science communication steeped in Western values and priorities fail to address the global cancer control agenda, and in addition, there is a lack of attention to digital and social mechanisms for information diffusion. To realize success on a global scale, one must also address issues of neo-colonialism, which permeate medical science, education, and clinical practice . CurricuThis curriculum development work employed a qualitative method, the nominal group technique (NGT). Since its development in 1960, the NGT has been used in education and health, among other fields, as a consensus development method –12. It cThe NGT is composed of five consecutive steps see Fig.  11, 13], 1311, 1This work was conducted in June 2021, and due to the COVID-19 pandemic and geographical constraints, the NGT was conducted virtually. Science communication experts were identified through convenience informed by snowball sampling through the co-investigators who were familiar with the expert’s work through personal networks. In order to obtain a sample of participants with global representation, seven geographical regions were targeted: Asia, Africa, North America, South America, Antarctica, Europe, and Australia. The co-investigators’ home countries included Canada, Brazil, Germany, and India, and therefore, several participants were invited from these countries within the respective seven regions. The Internet was searched to help identify science communications experts from regions where the co-investigators did not have contacts. For example, the co-investigators were not familiar with science communication experts from Antarctica and thus used the Internet to search for and identify individuals with suitable expertise. Science communication experts had diverse backgrounds within the health sciences such as education, journalism, biomedical research, and medicine. The ranges of expertise in the science communication field varied from advanced to moderate expertise. For example, advanced participants included professors and directors of university graduate programs in science communication, and participants with moderate expertise included clinician-scientists with a passion for communication and expertise in their local setting . A total of thirteen science communication experts from six of the seven regions, representing ten countries , were invited via email to participate in the NGT session and eleven accepted the invitation. Unfortunately, participants from Singapore and Zambia were unable to attend.The NGT was conducted virtually over 3 h, and consent was obtained from participants to record the session. After the session, participants were provided with an honorarium (CAD $150). Following the NGT protocol steps, the session started with the moderator welcoming participants and inviting them to introduce themselves. The moderator is an education scientist and experienced facilitator with 15 years of experience in teaching and training. Once introductions were completed, the moderator gave a brief introduction on the nominal group technique steps, the rules that had to be followed, and the time allotted for each step. The moderator presented the aim of the NGT session: to develop curriculum topics for a science communication training course. The second step was the silent generation of ideas. In this step, participants were presented with one question: “What topics should be covered in a science communication course for health professionals and clinical researchers”? Participants were asked to consider science communication in the context of scholarship, public communication, policymakers, patients and families, scientist-clinicians, decision-makers, advocacy, and philanthropy. No definition of science communication was provided as NGT participants had expertise in the subject, and project investigators wished to avoid confining the breadth of ideas. There were no constraints on the number of curriculum topics. The moderator requested participants to turn off their cameras and microphones and to write down all the answers they could think of, and they were instructed to refrain from communicating with each other. Experts were given 10 min to complete this step.Step 3 consisted of participants sharing their ideas one by one in a multiple rounds (round-robin) format. If the expert did not have any ideas to share, they could pass the opportunity to share to the next expert. A research analyst and a research associate transcribed each idea presented by the experts. Approximately ten rounds of idea sharing occurred until experts had no further ideas to share. The intention of this step was to allow participants to share the ideas they came up with during the silent generation of ideas and by listening to the other experts share their ideas and trigger the conception of more ideas. This step lasted 90 min. After this step, participants were given a 15-min break period while the research analyst and the session moderator organized the information obtained from the idea sharing in a PowerPoint slide, so the experts were able to visualize the curriculum topics and conduct the next step.Once participants returned from break, they were presented with the slide and the moderator asked participants if any ideas were unclear or required any clarification and further discussion. The experts spent 20 min discussing and clarifying ideas while the facilitator moderated the discussion. When the idea discussion was completed, the group proceeded to the final step of voting and ranking ideas. The research assistant sent a link to Slido, an online platform for voting and ranking, where the curriculum topics were shown in no particular order. Participants were asked to rank their choice of ideas from most important to least important in relation to the original question. This step lasted 15 min and concluded once all participants had submitted their votes.Knowledge user engagement Basic psychology Education science Social determinants of health The art of persuasion and rhetoric  and types of appeal in terms of pathos , ethos , logos (thoughtful reflection with data/facts))Communication strategies Equity diversity inclusivity and accessibility (EDIA) Communicating with the media Social media Empathy and compassion in science communication Ethics in science communication Design principles Uses of science communication Sixty-five curriculum topics were generated during the round-robin. Several curriculum topics overlapped, and the research analyst and moderator thematically organized and condensed topics together into thirteen main curriculum topics with thirty-six sub-topics. The main curriculum topics were as follows:Engaging knowledge usersCommunication strategiesBasics of psychologyUses of science communicationSocial determinants of healthEquity diversity inclusivity and accessibilityEthics of science communicationArt of persuasion and rhetoricEmpathy and compassion in science communicationEducation scienceNominated curriculum topics were ranked by participants, and consensus was achieved with ten curriculum topics being selected as core components of a global science communications curriculum:Introduction to science communicationKnowledge user engagementEducation science and behavioral psychology basicsArt of persuasion and rhetoricHealth literate communication strategiesEquity diversity inclusivity and accessibilityMedia engagementStrategic communicationScience visualization and presentation skillsDissemination of research evidenceFollowing the NGT session, the moderator and a co-investigator who is an instructional designer, both of whom have expertise in science communication, further refined the curriculum topics in terms of flow, redundancy, and expansion of some topic areas. The revised curriculum included ten major topics:The next step in the curriculum development process was a meeting of project co-investigators  to review the nominated curriculum topics and discuss, to the best of their ability, the relevance, applicability, and appeal to their local contexts to plan for course development. The meeting was held virtually, 1 month following the NGT session. It was structured using a framework for curriculum planning called the “3Ws and an H” . Using tThrough this meeting, the project investigators agreed that the course should be targeted toward clinician-scientists, healthcare professionals, and health researchers. The project investigators cited motivations for these individuals to participate in the course as promoting their research, writing applications for funding including writing lay summaries, sharing their research with non-experts, and communicating complex information to patients, family, and the public. When asked which curriculum topics would be most useful to learners, project investigators differed in the order of importance of subjects but agreed that all ten of the refined topics would appeal to learners in each of their country contexts. When discussing how the course should be delivered to optimize participation from learners across the globe, project investigators shared advantages and disadvantages of synchronous and asynchronous courses. The advantages of a synchronous course delivery included real-time feedback from course instructors and opportunities for networking among learners. Disadvantages of synchronous course delivery included temporal limitations given divergent time zones and limitations of transmission speeds (bandwidth) in rural settings. These important disadvantages held force to sway all project investigators to agree to develop a curriculum for asynchronous delivery.Effective training in science communications is becoming more important as health professionals and researchers recognize the importance of closing the know-do gap. While the NGT process has successfully been used in curricula development –18, to oThe authors invited science communication experts who participated in the NGT to aid in the development of a new global science communications course specifically targeted to health professions and clinical researchers. The topics identified during the NGT did not differ significantly from the extant science communication literature. The major difference between the published science communication literature and the topics that emerged from the NGT is context and the way that the various topics are appreciated within different global contexts. The science communication course that we are developing as a result of this work includes case studies from across the globe that are meant to share diverse perspectives on common science communication topics.In terms of how the topics identified through the NGT compare to the CanMEDS framework, the topics differ fairly significantly. The CanMEDS role of “communicator” is the role within the framework where we would most expect to see elements of science communication competency. The communicator role has 24 key concepts associated with it and when we examine the ten topics identified for a priority through the NGT, there is only minor overlap. Two topics from the NGT specifically overlap with CanMEDS key concepts. The NGT topic, “Health literate communication strategies” overlaps with three key concepts in the CanMED communicator role, Active listening, Effective oral and written communication, and Patient-centered approach to communication. The NGT topic, “Equity diversity inclusivity and accessibility,” has some overlap with two of the CanMEDS key concepts, Respect for diversity and Trust in physician/patient relationships.Currently, several experts are working collaboratively to develop the course with plans to launch a free, online globally applicable science communication course in the fall of 2023. Developing the curriculum with experts from several countries may support the creation of learning experiences that are applicable to learners living in different contexts in various parts of the world, in contrast to content developed locally by faculty living in the same region as learners.In addition, the curriculum developers asked NGT participants to identify local science communicators that would be invited to participate in a single interview to support the development of case studies. The case studies are meant to provide a sampling of different approaches to communicating science based on available media channels and cultures. Science communicators from Chile, Colombia, Japan, the Philippines, and Kenya have been invited to interview and they are scheduled to take place in the near future. Neo-colonialism pervades global discourses where the Global North is often narrating stories and setting standards for the Global South. An epistemological change is emerging where the Global South is valued for novel approaches to solving complex problems, and teaching and learning are more reciprocal. Our effort to include case studies demonstrating novel approaches from the Global South is one way that the co-investigators are endeavoring to address this challenge.The opportunity to create a course with broad applicability is increasingly significant for many reasons including the impact of free online courses in reducing barriers associated with affordability and access, and the growing appreciation for the value of community engagement and tailored implementation of evidence for best outcomes. This project has yielded a basic science communication curricular framework for health professionals and clinical researchers with global applicability. Science communication skills are fundamental to closing the research and innovation to clinical implementation gap. The authors support that all health professionals and clinical researchers require training in this area. Currently, communication skills outlined in training frameworks such as CanMEDS  focus on


Co-ordinated, evidence-based policy and programmatic efforts are needed to respond to complex drowning prevention problems. Comprehensive, current, and robust data are vital for agenda setting, burden and risk factor identification, intervention design and evaluation, as well as setting policy. We aim to record methods used in, and identify impacts of, the development of a national fatal drowning database (NFDD) in Australia, including lessons learned across research, policy, and practice.We employ a case study method using process mapping and document review to explore the evolution, drivers and impacts of the NFDD. We analyse methodological approaches including those relating to data definitions, drowning case collection, and management, as well as tracking the various outputs of the NFDD. We describe a development timeline that presents impact of drowning prevention policy, and research agendas on database development, and research investments more specifically.Our study identified that the collected variables grew 20-fold from 2002 to 2022, reaching 259 variables, and 5,692 unique cases of fatal drowning. The NFDD employs data triangulation methodology, combining keyword and targeted searches of coronial files, media report monitoring, and organisational data provision. Database development is influenced by the Australia Water Safety Strategy, policymaker and practitioner-initiated research agendas, and identification of knowledge gaps. We identified numerous outputs spanning publications, media, intervention development, and legislative submissions.A comprehensive and robust NFDD informed by policymaker and practitioner input can enhance surveillance, policy, and intervention development for drowning prevention. Employing mixed data collection and validation methods can supplement weaknesses in official data sources. There is a need for the NFDD to continue to evolve in its application while maintaining rigorous case identification and data quality assurance processes. Despite significant investment, the outputs and influence on drowning prevention practice in Australia has been extremely valuable and contributed to sizeable reductions in Australia’s fatal drowning rate.The online version contains supplementary material available at 10.1186/s12889-023-16392-2. Drowning is a significant cause of injury-related mortality and morbidity . GloballThe World Health Organization (WHO) recommends advancing drowning prevention through data collection and well-designed studies, as one of four strategies, alongside six selected interventions to prevent drowning at a community or national level . ComprehAlthough there is a long history of drowning prevention and water safety in Australia, Australia is not the only country working on a National Drowning Database which includes detailed information about the drowning incident, with some cross country analysis using national databases having been published in the last few years, such as the Australia, Canada, and New Zealand collaboration –8. One oTo address this gap in the literature, we focus on the National Fatal Drowning Database (NFDD) of the Royal Life Saving Society – Australia (RLSSA) which has been collating, analysing, and communicating cases of unintentional fatal drowning for 20 years. Data are collated and analysed in the annual Royal Life Saving National Drowning Report, to increase awareness of drowning risk and communicate risk reduction strategies . Data alWithin a period of rapid transition in the technology and media landscape, as well as the growth of the field of drowning prevention , the datThis paper takes a case study approach  to descrThe NFDD was first developed in 2002 to address the paucity of detailed drowning data in Australia. Originally the Australian Bureau of Statistics (ABS) had a drowning flag  that was added to the annual cause of death data they produced. However, this ceased in 2002 . In 2000We mapped the processes employed and identified a range of activities such as case identification, verification, collation, and analysis. In many cases overlapping and developed iteratively over the database’s 20-year lifespan.There are a range of data sources which feed into the NFDD Fig. . Each haYear-round media monitoring is conducted using an external media monitoring company. This company searches for pre-defined keywords across print, broadcast (radio and television) and online media reports and social media posts. Daily digest emails of relevant media coverage are sent to RLSSA staff. Preliminary data on a relevant case that is believed to fit the inclusion criteria are entered by RLSSA researchers into an SPSS media monitoring database. Preliminary free text data fields comprise age (or age range if specific age unknown), sex, date of incident, date of death, geographical location of incident, aquatic location of incident, activity prior to drowning, outcome  notes and a link to the media article for future reference). Cases of non-fatal drowning are initially entered into the media monitoring database to monitor regarding reporting of patient outcome in the media and to cross-reference in case of a fatality against the NCIS.Keywords used to identify cases of drowning reported in the media can be found in Table Data are sourced from drowning prevention organisations across Australia at the national and sub-national level, such as Royal Life Saving, Surf Life Saving and maritime safety organisations. Surf Life Saving provide additional data on coastal incidents  through their Incident Rescue Database (IRD) and their own media monitoring and NCIS searches . MaritimChild Death Review Teams at the sub-national level are a governmental function which reviews the deaths of children (that is young people aged 0–17 years) . This inThe NCIS is an online repository of all sudden and unexpected deaths investigated by a coroner in the eight states and territories of Australia and in New Zealand. Drowning is considered a sudden and unexpected death and therefore must be investigator by a coroner. The NCIS, accessible to researchers via ethical approval, comprises information from the investigation conducted by a coroner into the death of an individual . This inA police report will detail the narrative circumstances leading up to the incident. Toxicology provides blood and urine testing results for illicit and prescription medications including type and concentration, as well as alcohol content. Autopsy report will detail characteristics of the individual such as sex, heigh and weight, as well as the presence of acute injury or medical condition which occurred during the drowning incident, as well as any evidence of pre-existing disease or injury. An internal autopsy can be opposed, resulting in findings from an external examination only.RLSSA researchers gained access to the NCIS in 2001. This allowed the identification and collation of drowning cases from all jurisdictions via the one portal. Prior to this, cases were captured from individual state and territory coroners’ courts. NCIS access allows drowning cases from all states and territories in Australia to be identified through a mix of searches on fields or attachments (should the case be closed and documentation attached)  or non-fatal drowning (with or without morbidity) . There iThe NFDD includes cases where drowning is determined to be either the primary or a contributory case of death by a coroner, as reported by the NCIS. Cases are included based on a combination of cause of death text and ICD coding . By not limiting case inclusion to those coded with ICD codes W65-74, this allows for the identification and inclusion of drowning deaths due to water transport and disasters incidents. Cases of suspected drowning, where the body is unrecovered, are included if the coroner rules the cause of death is likely to be drowning given the circumstances of the incident, however this is rare. Each person who drowned in a multiple fatality event  is included as a separate case.The NFDD includes cases of drowning of Australian residents or international visitors to Australia, provided the drowning incident occurred in Australia, including in Australia’s territorial sea which extends up to 12 nautical miles offshore . DrowninDrowning case data identified from the above sources are transferred to the NFDD which is housed within an SPSS database . Each yeData are entered manually, using pre-defined sub-categories for variables wherever possible to reduce typographical inconsistencies which impact analyses. Other free text fields allow for the inclusion of a short narrative sentence detailing key points. The core variables, i.e., those checked and collected (if available) for each case, are shown in Table Strict data governance and security measures are in place given the sensitive nature of this data. Every five years, RLSSA revises and confirms an ethics approval process with the Victorian Department of Justice and Community Safety Human Research Ethics Committee (JHREC) . As part of the process of gaining national ethics approval via the JHREC, a separate ethics approval process is undertaken with the state of Western Australia. In accordance with ethical agreements, data must be reported in aggregate format to minimise identification. In a practical sense, this typically precludes data counts of < 5 from being reported. De-identified data are stored on a password protected remote server housed internally at RLSSA which is backed up daily. Only limited numbers of pre-approved researchers from RLSSA have access to the NCIS and the NFDD. Media and researchers can make enquiries of the database via email which allows for the NFDD to be used for information and advocacy purposes while maintaining the accuracy and ethical constraints around data usage via aggregate reporting.The NFFD was developed and maintained by staff at RLSSA. Tasks associated with the NFFD are included in work plans and tasks descriptions of research staff. IT staff assist with data security and stability of the software used. Funding for the NFDD is received from the Australian Government by RLSSA as one of a range of projects and ongoing functions of the organisation.The NFDD has grown over time, both in number of cases included but also in number of variables recorded. At the time of writing, the NFDD is in its 21st year of data collation for the 2022/23 financial year (July to June). As such we report 20 years of data in the following section. At the present time, the NFDD spans 20 complete financial years and 5,692 cases, 83% of which are closed in the NCIS. Cases which have occurred more recently are more likely to be open  and thus details subject to change pending the outcome of the coronial process increases.With respect to data variables these have grown in tandem with an expanded research focus. Variables have morphed from a core minimum set of variables n = 12) used in early annual drowning reports to a possible 259 variables in 2022. Pivot points in the NFDD’s development have occurred based on specific research needs or questions which have necessitated the addition of new variables. These pivot points based on different research agendas, and the resultant expansion in variables recorded within the NFDD are depicted in Fig.  used in There are a range of outputs the NFDD has contributed to. These include annual national drowning reports and associated media coverage, National Water Safety Strategies, industry reports, peer reviewed publications, advocacy campaigns, and the provision of information in response to requests and formal submissions. We have collated the categories of outputs and associated impacts in Table Drowning is a significant cause of injury-related harm in Australia . InvestmIn this study, we have outlined the rigorous data triangulation method used in case identification and documentation, as well as the expansion of the database in response to emerging research priorities. Finally, we have tracked the many and varied direct outputs, and impact of those outputs, since the NFDD’s inception. We reflect here on some of the lessons learned across the first 20 years of the NFDD, a period which has seen rapid change in information provision, the media landscape, and technology.Coronial data, via ethical access to the NCIS, is the data gold standard and in large part, underpins the NFDD. The NCIS is a rich source of data geared towards prevention, although the speed with which data become available is subject to the pace of processes within the coronial system. While core demographic details such as a person’s age and sex (as well as the state or territory of the death) are recorded almost immediately when a death is entered on the NCIS, other information, such as location and activity, are often not updated until a coronial investigation is completed and the case is closed. As such, using media reports as part of a data triangulation approach, can fill these gaps and provide an immediacy of data useful for advocacy purposes, such as the RLSSA Summer Drowning Toll  website From the other direction, this triangulation approach addresses some of the known weaknesses with the use of media reports, such as a bias towards child drowning and emotive cases such as rescuer drowning and multiple fatality events, to the detriment of the identification of drowning among the elderly and in more geographically isolated locations . Being aOne of the key impacts of the NFDD has been the anecdotal increase in reporting of drowning incidents by the Australian media, due in part to the NFDD providing the ability to quickly and easily respond to media requests for information, coupled with timely media-facing advocacy activities such as the Summer Drowning Toll. Systematic collation of media coverage of drowning incidents afforded by media monitoring, as used in data triangulation for the NFDD, can also provide an opportunity to audit the manner in which drowning incidents are being reported, including the provision of water safety and drowning prevention information to readers, which has yet to be done on a national basis .More broadly, the impacts of the NFDD are wide ranging and, at times, hard to quantify. One of the key lessons learned over the lifespan of the NFDD has been the need to track outputs and impacts from the start. Not only is this useful from an organisational perspective, but it can be helpful as a means of justifying resourcing and securing additional investment. Conversely, the increased investment in the NFDD corresponded with an uplift in investment in research within the organisation. As the NFDD grew, so too did its uses, with additional research questions able to be asked of the database to support emerging research agendas.Another lesson across the lifespan of the NFDD has been the technology required to support an ever-expanding database, both sadly in the number of cases added each year, and the number of variables potentially recorded for each case. As variables grew, a focus on the core minimum dataset required to annual analysis in the National Drowning Report has been key. Ensuring consistency in application of coding of variables has been an important part of the NFDD development. Having tools for training staff in the integrity of the database as staff change over the years has been a core part of this approach.Intentional drowning is an issue which has been growing in prominence among the drowning prevention community , 31. AltAs the NFDD continues to expand, investment in data storage and technology solutions will be an important consideration. Similarly, in a contested landscape, including the speed with which media operate, it will be important to develop a means for those outside of the organisation to interrogate the database in an ethically appropriate way themselves. This will improve responsiveness, with caveats regarding data accuracy, and also likely further enhance the reach and impact of the database. Sharing of data is a core benefit of the NFDD and an important role that RLSSA plays in data stewardship.This study reflects the processes undertaken and impacts from the 20-year development and evolution of the NFDD. It must be noted that these reflect the experiences of one organisation, and potentially may differ from the experiences and processes applied by other organisations in Australia. The NFDD benefits from wider and long-term investment in the health and justice systems, specifically through coronial processes, health data capture and the NCIS itself. Therefore, the processes adopted by the NFDD may not be entirely transferable to other country contexts. It is also not an exhaustive documentation of all outputs and impacts of the NFDD which are too numerous to list and difficult to fully track.Timely and accurate data on drowning are important for a range of reasons, including research, advocacy, to influence policy change and as a mechanism for monitoring progress against stated goals in drowning reduction. Creating and maintaining high quality databases such as the NFDD, require a rigorous approach to case identification, validation and coding, as well as significant and ongoing resourcing. However, the outputs and impacts can be wide-ranging and highly impactful. In future, revitalisation of technology may be required to house an expanding dataset, as well as innovative ways of using, and allowing others, to use the data.Below is the link to the electronic supplementary material.Supplementary Material 1


This was an “intercontrol test”, i.e., all subjects under the same conditions acted as controls but also as cases whilst wearing the clear aligners. Patients were asked to chew an almond for 20 s, once with aligners and once without aligners. The material was then dried, sieved, and weighted. Statistical analysis was performed to investigate any significative differences. In all our subjects, the efficiency of chewing with clear aligners was found to be comparable to the efficiency of chewing without clear aligners. In detail, the average weight after drying was 0.62 g without aligners and 0.69 g with aligners, while after sieving at 1 mm, the average weight was 0.08 g without aligners and 0.06 g with aligners. The average variation after drying was of 12%, and after sieving at 1 mm, it was 25%. In summary, there was no substantial difference between chewing with or without clear aligners. Despite some discomfort in chewing, the clear aligners were well tolerated by most subjects, who wore them without difficulty even during meals.The aim of this study was to evaluate the masticatory function of subjects with clear aligners and to propose a simple and repeatable method for the clinical and experimental evaluation of masticatory function. For the testing we used almonds, a natural substance that can be easily found and stored, has intermediate consistency and hardness, is insoluble in saliva, and has the ability easily lose the moisture absorbed in the mouth. Thirty-four subjects using the Invisalign In orthodontics, functionality and aesthetics are the key factors in treatment with clear aligners. To ensure patient satisfaction, the orthodontist has to ensure that functional issues are solved while simultaneously paying attention to aesthetics during treatment . Clear aClear aligners, unlike other aesthetic orthodontic techniques, are removable, which aids the frequent cleaning of the devices, home hygiene measures, and eating. According to the manufacturers, they should be worn about 20–22 h a day. Orthodontic treatment, to be as effective as possible, should be continuous and constant over 24 h. Ideally, in order to achieve the highest efficiency, orthodontic pressure should be delivered constantly. However, clear aligners tend to be frequently removed from the mouth for meal consumption and oral hygiene practices, causing repeated interruptions in the efficiency of the devices. The manufacturer of the aligners used in this study suggests removing them only to eat and to brush and wear them for the rest of the day, because they are not supposed to create discomfort during daily life ,4.The evaluation of masticatory function should be carried out through standardized tests for every patient that receives dental treatment, especially when the occlusion is modified. It is also a factor that allows clinicians to check the success of a treatment ,4,5. ManThe assessment of masticatory function may involve subjective evaluation by the patient (masticatory ability) or objective test procedures (masticatory efficiency).Surveys and interviews are useful to estimate subjective ability, but in order to obtain a quantifiable value, an objective test procedure must be used .Various tests have been described in the literature that allow clinicians to evaluate the efficiency of the masticatory system. These tests can be performed using sieving techniques or by optical scanning, and both these approaches are considered adequate .Regarding the sieving test, the use of multiple sieves evaluates the particle size obtained with high sensitivity: the smaller the size of the particles, the better the masticatory performance. In the past, a single sieve technique was adopted, but the multiple sieves approach is considered more detailed and reliable.One of the most challenging aspects in the use of masticatory tests is to find and use appropriate specimens, i.e., choosing between mechanically degradable test foods or fragmenting tests that involve silicon cubes or wax and laboratory equipment .Every solution has advantages and disadvantages; our proposal is a food test using almonds, since it is an easily stored and available material, sufficiently soft to be crushed even by patients with reduced chewing capacity, insoluble in saliva, and easily loses the moisture absorbed in the mouth during the test. Furthermore, the loss of material during the tests is modest and easily measurable.The aim of this study was to evaluate the masticatory function of subjects with clear aligners and to propose a simple and repeatable method for the clinical and experimental evaluation of masticatory function. A test, therefore, was developed to evaluate the chewing effectiveness of patients.® . Patients were selected randomly among those in active treatment, with the following inclusion and exclusion criteria. Inclusion criteria: subjects aged 12 to 60 years, in complete permanent dentition , treated with transparent aligners on both arches, and with a physiological chewing function. Exclusion criteria: subjects with an almond allergy, TMJ diseases, muscular issues that may affect chewing capacity, systemic diseases, and dental or periodontal decay.This study was performed in accordance with the ethical standards established in the Declaration of Helsinki of 1975 and the Code of Ethics of the World Medical Association for experiments involving humans. Approval from the Ethics Committee  was obtained. The informed consent of the participant was obtained prior to experimentation and the privacy rights of human subjects was always observed. A sample of 34 subjects was required in order to detect an effect size of 0.05 . The sample of this study consisted of 34 subjects being treated with InvisalignThe subjects were asked to introduce a single almond (previously weighed) into the oral cavity and to chew it for 20 s. A trained operator calculated the time and counted the chewing cycles. The procedure was repeated with and without the aligners, allowing 5 min to pass between one measurement and the next. The patient was then asked to spit into a funnel with a fabric filter at the bottom. Before proceeding with the following step, the subject rinsed several times, and the oral cavity was carefully inspected by the operator to verify that no residues were left .® 300 g/0.01 g) with a sensitivity of 0.01 g was used to weigh the residue in order to evaluate any loss of material due to the patient’s ingestion or any leak during the analysis procedure. Subsequently, the remaining particles were sieved through filters with meshes of decreasing size , and the filtrates were weighed. The Shapiro–Wilk test was used to assess the normal distribution of the variables. A paired t-test was run to report any significant changes between the patients chewing with and without clear aligners . All measurements were calculated as average and standard deviations.The material was then dried in the oven at 130° for 30 min to allow the almond to regain its initial hygrometry. A precision balance , as shown in The statistical analysis showed no statistically significant difference between the two groups . The test led to an index of chewing efficiency and consisted of chewing a round tablet of Optosil®, 5 mm thick and 20 mm in diameter, for 20 chewing cycles, after which the subject had to spit the chewed part into a plastic container and rinse and empty their mouth into the same container. The contents were then filtered through sieves with 2.8, 1.9, and 1 mm diameter meshes and weighed. The efficiency was considered high if the weight of the material passing through the 1 mm filter was higher in percentage compared to the weight of the material which had passed through the other two filters.Regarding the materials developed specifically for tests, in 1980, Edlund et al.  used a sIn 1983, Gunne  developeIn 1989, Nakasima et al.  developeShi et al.  used soyIn 1994, Mowlana et al.  comparedIn 2007, Schimmel et al.  developeIn 2010, Nokubi et al.  based a In 2012, Ikebe et al.  also devA 2014 study by Oliveira et al. reviewed all the methodologies for assessing masticatory efficiency . The mosIn 2018, Shala et al. [In 2019, in a pediatric study that aimed to evaluate the chewing function of patients with anterior open bite, Correa et al. [In the Glossary of Prosthodontic Terms, masticatory performance is described as “a measure of the comminution of food attainable under standardised testing settings”, while “masticatory efficiency” is described as “the effort necessary to obtain a standard degree of comminution of food”.That being said, a proper definition of masticatory performance is still unclear and poorly supported by scientific evidence.According to Bates et al., while chewing efficiency refers to the number of chewing cycles required to achieve a specific chewing outcome, chewing performance refers to the status of the chewing outcome after a specific number of chewing cycles. In other words, whereas masticatory efficiency refers to the number of chewing cycles required to achieve half the original particle size, masticatory performance refers to the ability of the individual to grind or pulverize a specimen of test food after a predetermined number of mastication cycles .Although there is disagreement among scholars on the precise meaning of each phrase, related names are occasionally used to denote other approaches. This could result in comparisons between various test methodologies, endangering the validity of scientific data of physiological or therapeutic treatments .So far, no author has studied the chewing function of patients with and without clear aligners.In this study, a simple and repeatable clinical and experimental method was proposed for the evaluation of the chewing function and, at the same time, to assess the chewing function of subjects with clear aligners. The aim of the study was to investigate whether this type of device can also be worn during meals, which would then increase the time of use of these devices and, therefore, the effectiveness of the treatment.The need for aesthetic orthodontic procedures, such as clear aligners, is rising today in both adults and adolescents. Numerous studies have underlined the higher aesthetic and comfort provided by clear aligners when compared to traditional fixed orthodontics. In recent years, phase one treatment is also starting to be performed with clear aligners.Compared with traditional fixed orthodontic appliances, clear aligners are considered a more aesthetic and comfortable alternative . In addiComfort surely represents one of the most important aspects of clear aligners techniques: even though the need for removing aligners for meal consumption is a limit in this perspective, the comfort of chewing with aligners still has to be evaluated.In line with the findings of Oliveira et al. , almondsAlthough techniques using optical scanners can test many variables and conditions more quickly, a food test with the sieving of the chewed food was utilized in this study. This was because previous studies have shown that food tests entail using less expensive equipment and are easier to use in clinical practice , but at In this research, in all 34 subjects, the difference between the weighed values of the chewed almonds with and without aligners was slight, with no statistically significant differences between the two groups analyzed.In our study, a sample of patients who presented a complete set of teeth was selected. As reported by Alves et al., the number of remaining teeth needs specific consideration, since tooth loss influences the sensory and motor components of the masticatory process. Mechanoreceptor loss has been documented along with tooth loss. Periodontal mechanoreceptors are neural receptors that help the masticatory muscles contract and work together. Therefore, the loss of sensory feedback and subsequent muscle atrophy following tooth loss reduced the ability to masticate .In this study, almonds were chosen as the brittle food for the comminution test. Other options are raw carrots or nuts. When chewed, food breaks up into smaller pieces, creating the food bolus. Sieving or optical scanning can be used to analyze the food particles. The distribution of particle sizes in the chewed food sample is typically described in terms of the median particle size. Masticatory performance is the outcome of chewing food for a predetermined number of chewing cycles. After spitting and drying the bolus into a different sizes sieves, the remaining particles were counted and evaluated with a statistical analysis.There are several reasons why a comminution test was chosen. The human masticatory system has evolved to allow the chewing of both tough foods, such as meat, and brittle solid foods, such as almonds and carrots. A person’s ability to chew a brittle solid food is correlated with their ability to chew a variety of foods that are either harder or less tough. Additionally, multiple research projects have effectively used comminution tests to quantify masticatory function. These tests make it possible to assess both chewing effectiveness and performance. Comminution tests are an accurate approach to measuring how well an individual or a group can chew. More in-depth data about the chewing process was obtained for the masticatory efficiency as a result of multiple tests carried out after varying the number of chewing cycles, providing a comparison of inter-subjects at the same stage of food comminution and constant intra-subject and inter-subject ratios between and within samples, respectively .According to this study, the capability to chew food while wearing aligners is valid and shows encouraging results, which highlight the possibility of wearing aligners continuously throughout the day.Various aspects still need to be investigated in a more detailed way, such as the quantification of the effective therapeutic advantage derived from the continuous use of the clear aligners in 24 h, and the properties of resistance and deformability of the material that make up the clear aligners themselves. If the clear aligners are worn during meals, they should be able to resist the sudden changes in temperature caused by the ingestion of food and should also be non-deformable under the subjected chewing forces.Moreover, the implications that the aligner worn 24 h could have should be investigated, since it would further reduce the natural cleansing of the saliva on the tooth .Some limitations of the study are that patients were not asked to report their level of annoyance while chewing with the clear aligners. Further studies should also evaluate whether the swallowing function and the masticatory pattern can be influenced by wearing aligners during meals. Additionally, the small sample size and the possible variability in almond size and weight could affect the conclusions of this study.The results highlighted no substantial difference between chewing with and without clear aligners from a chewing point of view.With regard to the food test used, this was found to be quick and simple to perform and equally fast to analyze and was tolerated even by the youngest subjects. The almond was also suitable for this type of experiment, considering its intermediate consistency and hardness, its availability, low cost, its ability easily loses the moisture absorbed in the mouth, and its good level of tolerance by the subjects.Clear aligners could be worn during meals to maximize the therapeutic effect, since this could lead to an increase in aligner wearing time, but furthers studies are needed to investigate and confirm these hypotheses. Researchers should also investigate any variation in aligner fit or advantages and comfort during meals.