Methods for causality assessment of idiosyncratic drug-induced liver injury.

The diagnosis of idiosyncratic drug-induced liver injury (DILI) is a challenging task due to the lack of specific features or definitive diagnostic tools. A minimum of clinical and pharmacological information is required, together with laboratory and imaging tests to exclude other causes of liver injury. Several standardized methods have been developed to support clinical judgement and establish causality assessment, the most widely used being the Roussel Uclaf Causality Assessment Method-RUCAM-and structured Expert Opinion. More recently, an evidence-based, revised RUCAM, Electronic Causality Assessment Method-RECAM-has been developed and, although still a work in progress, may replace RUCAM scoring in the future. International collaborative networks and ongoing research efforts are key to advancing biomarker qualification and validation and developing new in vitro patient-based methods that will help improve DILI diagnosis and move towards a personalized medicine approach.

Evaluating methods of detecting and determining the type of urinary incontinence in adults after stroke: A systematic review.

INTRODUCTION: Urinary incontinence (UI) affects over half of people with stroke. It is unclear which methods are accurate in assessing presence and type of UI to inform clinical management. Diagnosis of UI based on inaccurate methods may lead to unnecessary interventions. The aims of this systematic review were to identify, for adults with stroke, clinically accurate methods to determine the presence of UI and type of UI. METHOD: We searched seven electronic databases and additional conference proceedings. To be included, studies had to be primary research comparing two or more methods, or use a reference test. RESULTS: We identified 3846 studies with eight eligible for inclusion. We identified 11 assessment methods within the eight studies. Only five studies had sufficient comparator data for synthesis. Due to heterogeneity of data, results on the following methods were narratively synthesized: Core Lower Urinary Tract Symptom Score (CLSS), clinical history and physical examination, Barthel Activities of Daily Living Index, International Consultation Incontinence Questionnaire Short Form (ICiQ-SF) and urodynamic studies (UDS). Most studies were small and of low to medium quality. All reported differences in sensitivity, and none compared the same assessment methods. CONCLUSION: Current evidence is insufficient to support recommendations on the most accurate UI assessment for adults with stroke. Further research is needed.

Training in robotic-assisted surgery: a systematic review of training modalities and objective and subjective assessment methods.

INTRODUCTION: The variety of robotic surgery systems, training modalities, and assessment tools within robotic surgery training is extensive. This systematic review aimed to comprehensively overview different training modalities and assessment methods for teaching and assessing surgical skills in robotic surgery, with a specific focus on comparing objective and subjective assessment methods. METHODS: A systematic review was conducted following the PRISMA guidelines. The electronic databases Pubmed, EMBASE, and Cochrane were searched from inception until February 1, 2022. Included studies consisted of robotic-assisted surgery training (e.g., box training, virtual reality training, cadaver training and animal tissue training) with an assessment method (objective or subjective), such as assessment forms, virtual reality scores, peer-to-peer feedback or time recording. RESULTS: The search identified 1591 studies. After abstract screening and full-texts examination, 209 studies were identified that focused on robotic surgery training and included an assessment tool. The majority of the studies utilized the da Vinci Surgical System, with dry lab training being the most common approach, followed by the da Vinci Surgical Skills Simulator. The most frequently used assessment methods included simulator scoring system (e.g., dVSS score), and assessment forms (e.g., GEARS and OSATS). CONCLUSION: This systematic review provides an overview of training modalities and assessment methods in robotic-assisted surgery. Dry lab training on the da Vinci Surgical System and training on the da Vinci Skills Simulator are the predominant approaches. However, focused training on tissue handling, manipulation, and force interaction is lacking, despite the absence of haptic feedback. Future research should focus on developing universal objective assessment and feedback methods to address these limitations as the field continues to evolve.

Assessing the Prevalence of Cannabis Use Through a Survey About Criminal Activity Versus One About Alcohol, Tobacco, and Other Drugs.

Background: The prevalence of cannabis use in the United Kingdom might be underestimated using the Crime Survey of England and Wales. The current study examined whether responding to questions about their cannabis use as part of a crime survey would be less likely to report that they use cannabis compared to those responding to the same questions that are part of a survey about health. Methods: Participants were randomized to be told that the items about cannabis use came from a crime survey versus from a health survey. In addition, the sample was recruited using a representative online sampling method and compared to published rates of self-reported cannabis use collected as part of the Crime Survey for England and Wales. Results: There was no significant difference (p > 0.05) in the proportion endorsing cannabis use between those told the items came from a crime survey versus a health survey. However, self-reported rates of cannabis use collected as part of the online panel (51.3% ever use; 11.9% past year; age range 18-64 years) appeared higher than those reported based on results from the Crime Survey for England and Wales (37.2% ever and 5.8% past year; age range 18-59 years). Conclusion: The current study did not find evidence that manipulating whether participants were told that the items asking about cannabis use came from a survey asking about criminal activity versus one about health had an impact on self-reported cannabis use. However, as prevalence estimates generated by the Crime Survey of England and Wales do appear to be an underestimate of actual levels of cannabis use in the United Kingdom, further research is merited on this topic.

Assessment of the Vertical Dimension of Occlusion Using Palm Width and Finger Length.

Background and Objectives: The vertical dimension of occlusion's (VDO) assessment is a highly important issue in the everyday dentist's practice. Patients with unstable occlusion, lost occlusal stops, extensive tooth loss in the lateral area, or complete edentulism need a proper assessment of the VDO before the prosthetic restoration is carried out. Subjective and objective methods were used over time for the restoration of VDO. The study aimed to investigate the possible correlation between finger length, palm width and the vertical dimension of occlusion. Materials and Methods: Assessment of the VDO for 236 subjects, Romanian and French dental students, was performed using the Willis Bite Gauge. The left hand of the subjects was scanned using a flat-bed scanner, and then measurements of palm width and finger length were carried out for each subject. Comparison between VDO values and finger length/palm width was conducted using one-way ANOVA and Student t-Test. Results: Higher VDO average values were found in French subjects compared with Romanian students. The same results were found according to gender; in both female and male subjects, lower values of VDO were found in the Romanian group. Higher values were obtained for women within each group when comparing to men. Statistically significant correlations of the analyzed parameters and VDO values were found. Higher statistical correlations of the studied variables were found for men compared to women in both groups. The highest statistical correlation was obtained between the VDO and the palm width measured at the fingerbase, followed by the middle finger length. Conclusions: The results showed the highest statistical correlation between the vertical dimension of occlusion and the palm width measured at the fingers' base. Statistical correlations were also found between the VDO and the middle finger length. Simple formulas using finger length/palm width can be used for a rapid VDO determination.

Assessment-based management of placenta-mediated pregnancy complications: Pragmatism until a precision medicine approach evolves.

The management of pregnant women with thrombophilia and a history of gestational vascular complications remains debatable. Treatment of the latter is often based on clinical outcome rather than disease mechanism. While the use of venous thromboembolism prophylaxis in pregnancy is recommended for those at increased risk, the ability of anticoagulant and/or antiplatelet agents to lower the risk of placenta-mediated complications in this clinical setting remains controversial. The available guidelines are inconsistent in some situations, which reflects the limited evidence base. This review critically discusses risk assessment models (RAMs) and management strategies of women with thrombophilia and pregnancy complications, using clinical vignettes. RAMs, taking into account obstetric and thrombotic history as well as thrombophilia status, could drive a precision medicine approach, based on disease mechanism, and guide individual therapeutic interventions in high-risk clinical settings.

Exploring the Anemia Ecology: A New Approach to an Old Problem.

Our ability to identify anemia and all its permutations demands an approach that integrates the key elements of a complex "ecology," which intertwines biology and mechanistic aspects of nutrients with both the health status and underlying factors-physical, economic, social, behavioral, demographic, and environmental. The complexity of anemia demands an ecologic approach that appreciates systems biology, translates sensitive and specific assessment methodologies and interventions, and ultimately improves clinical and public health outcomes. This series of technical papers on anemia by the U.S. Agency for International Development (USAID) Advancing Nutrition Anemia Task Force (ATF) is a first step in translating our ecologic approach to anemia with a view toward balancing research with its translation to effective programs, interventions, and policy. This introductory overview describes the components of our ecologic approach-linking the biology of anemia with its assessment and using the learning from that confluence to devise context-specific interventions. This introductory review briefly discusses the topics that underlie the biology and primary etiologies of anemia and presents a framework for public health assessment of anemia, leading to appropriate public health interventions. The other 3 manuscripts in the supplement provide the details of the arguments laid out in the introduction.

A narrative review of nutrient based indexes to assess diet quality and the proposed total nutrient index that reflects total dietary exposures.

A priori dietary indices provide a standardized, reproducible way to evaluate adherence to dietary recommendations across different populations. Existing nutrient-based indices were developed to reflect food/beverage intake; however, given the high prevalence of dietary supplement (DS) use and its potentially large contribution to nutrient intakes for those that use them, exposure classification without accounting for DS is incomplete. The purpose of this article is to review existing nutrient-based indices and describe the development of the Total Nutrient Index (TNI), an index developed to capture usual intakes from all sources of under-consumed micronutrients among the U.S. population. The TNI assesses U.S. adults' total nutrient intakes relative to recommended nutrient standards for eight under-consumed micronutrients identified by the Dietary Guidelines for Americans: calcium, magnesium, potassium, choline, and vitamins A, C, D, E. The TNI is scored from 0 to 100 (truncated at 100). The mean TNI score of U.S. adults (≥19 y; n = 9,954) based on dietary data from NHANES 2011-2014, was 75.4; the mean score for the index ignoring DS contributions was only 69.0 (t-test; p < 0.001). The TNI extends existing measures of diet quality by including nutrient intakes from all sources and was developed for research, monitoring, and policy purposes.Supplemental data for this article is available online at https://doi.org/10.1080/10408398.2021.1967872.

Performance of machine learning algorithms for dementia assessment: impacts of language tasks, recording media, and modalities.

OBJECTIVES: Automatic speech and language assessment methods (SLAMs) can help clinicians assess speech and language impairments associated with dementia in older adults. The basis of any automatic SLAMs is a machine learning (ML) classifier that is trained on participants' speech and language. However, language tasks, recording media, and modalities impact the performance of ML classifiers. Thus, this research has focused on evaluating the effects of the above-mentioned factors on the performance of ML classifiers that can be used for dementia assessment. METHODOLOGY: Our methodology includes the following steps: (1) Collecting speech and language datasets from patients and healthy controls; (2) Using feature engineering methods which include feature extraction methods to extract linguistic and acoustic features and feature selection methods to select most informative features; (3) Training different ML classifiers; and (4) Evaluating the performance of ML classifiers to investigate the impacts of language tasks, recording media, and modalities on dementia assessment. RESULTS: Our results show that (1) the ML classifiers trained with the picture description language task perform better than the classifiers trained with the story recall language task; (2) the data obtained from phone-based recordings improves the performance of ML classifiers compared to data obtained from web-based recordings; and (3) the ML classifiers trained with acoustic features perform better than the classifiers trained with linguistic features. CONCLUSION: This research demonstrates that we can improve the performance of automatic SLAMs as dementia assessment methods if we: (1) Use the picture description task to obtain participants' speech; (2) Collect participants' voices via phone-based recordings; and (3) Train ML classifiers using only acoustic features. Our proposed methodology will help future researchers to investigate the impacts of different factors on the performance of ML classifiers for assessing dementia.

Conformities and gaps of clinical audiological data with the international classification of functioning disability and health core sets for hearing loss.

OBJECTIVE: The International Classification of Functioning Disability and Health (ICF) is a classification of health and health-related domains created by the World Health Organization and can be used as a standard to evaluate the health and disability of individuals. The ICF Core Set for Hearing Loss (CSHL) refers to the ICF categories found to be relative to Hearing Loss (HL) and the consequences of it on daily life. This study aimed to adapt the content of a database gathered in Hörzentrum Oldenburg gGmbH that included HL medical assessments and audiological data to the ICF. DESIGN: ICF linking rules were applied to these assessment methods including medical interviews, ear examinations, pure-tone audiometry, Adaptive Categorical Loudness Scaling, and speech intelligibility test. STUDY SAMPLE: 1316 subjects. RESULTS: In total, 44% of the brief and 18% of the comprehensive CSHL categories were addressed. The hearing functions were broadly evaluated. "Activities and Participation" and "Environmental Factors" were poorly examined (17% and 12% of the comprehensive CSHL categories, respectively). CONCLUSIONS: The HL correlation with day-to-day activities limitation, performance restriction, and environmental conditions were poorly addressed. This study showed the essence of incorporating these methodologies with approaches that assess the daily-life challenges caused by HL in rehabilitation.

Methodology for a preliminary assessment of water use sustainability in industries at sub-basin level.

The sustainability of industrial production, especially for highly water-demanding processes, is strictly related to water resource availability and to the dynamic interactions between natural and anthropogenic requirements over the spatial and temporal scales. The increase in industrial water demand raises the need to assess the related environmental sustainability, facing the occurrence of global and local water stress issues. The identification of reliable methodologies, based on simple indices and able to consider the impact on local water basins, may play a basilar role in water sustainability diagnosis and decision-making processes for water management and land use planning. The present work focalized on the definition of a methodology based on the calculation of indicators and indices in the view of providing a synthetic, simple, and site-specific assessment tool for industrial water cycle sustainability. The methodology was built starting from geo-referenced data on water availability and sectorial uses derived for Italian sub-basins. According to the data monthly time scale, the proposed indices allowed for an industrial water-related impacts assessment, able to take into account the seasonal variability of local resources. Three industrial factories, located in northern (SB1, SB2) and central (SB3) Italian sub-basins, were selected as case studies (CS1, CS2, CS3) to validate the methodology. The companies were directly involved and asked to provide some input data. The methodology is based on the calculation of three synthetic indexes: the Withdrawal and Consumption water Stress Index (WCSI) allowed for deriving a synthetic water stress level assessment at the sub-basin scale, also considering the spatial and temporal variations; the industrial water use sustainability assessment was achieved by calculating the Overall Factory-to-Basin Impact (OFBI) and the Internal Water Reuse (IWR) indices, which allowed a preliminary evaluation of the factories' impacts on the sub-basin water status, considering the related water uses and the overall pressures on the reference territorial context. The WCSI values highlighted significant differences between the northern sub-basins, characterised by limited water stress (WCSISB1 = 0.221; WCSISB2 = 0.047), and the central ones, more subjected to high stress (WCSISB3 = 0.413). The case studies CS1 and CS3 showed to exert a more significant impact on the local water resource (OFBICS1 = 0.18%; OFBICS2 = 0.192%) with respect to CS2 (OFBI = 0.002%), whereas the IWR index revealed the different company's attitude in implementing water reuse practices (IWRCS1 = 40%; IWRCS1 = 27%; IWRCS1 = 99%). The proposed methodology and the indices may also contribute to assessing the effectiveness of river basin management actions to pursue sustainable development goals.

Musculoskeletal disorders risk assessment methods: a scoping review from a sex perspective.

The evidence points to differences in the impact of musculoskeletal disorders (MSD) in males and females due to different exposure to risk factors and inherent characteristics. To identify risks associated with MSDs, ergonomic assessment is carried out by applying various methods. The aim of this scoping review was to determine to what extent ergonomic assessment methods consider sex-related factors and if they were found to do so, to determine the extent of this consideration. A total of 31 papers on 32 ergonomic assessment methods were analysed in the review. Of these 32 methods, only 6 considered sex as an assessment parameter or when interpreting the results. The results revealed that the limited consideration given to the sex factor in ergonomic methods, together with the different impacts of MSDs and their consequences according to a person's sex, supports the importance of including sex factors in ergonomic assessment methods. Practitioner summary: This scoping review determined to what extent ergonomic assessment methods consider sex-related factors and if they do so, to establish the extent of such consideration. Of the 32 methods analysed, only 6 considered a person's sex. The results revealed that only a limited consideration is given to the sex factor in ergonomic methods.

An Overview of Taste-Masking Technologies: Approaches, Application, and Assessment Methods.

It is well-known that plenty of active pharmaceutical ingredients (API) inherently possess an unpleasant taste, which influences the acceptance of patients, especially children. Therefore, manufacturing taste-masked dosage forms has attracted a lot of attention. This review describes in detail the taste-masking technologies based on the difference in the taste transmission mechanism which is currently available. In particular, the review highlights the application of various methods, with a special focus on how to screen the appropriate masking technology according to the properties of API. Subsequently, we overviewed how to assess taste-masking efficacy, guiding researchers to rationally design taste-masking formulations.

New Exponential Scoring Functions for Diet Quality Indexes Solve Problems Caused by Truncation.

BACKGROUND: Diet quality indexes, including the Healthy Eating Index, assess diets based on usual dietary intakes and a scoring function. Nearly all diet quality indexes use scoring functions that have floors and ceilings, thereby truncating the scores and losing information about intakes outside the scoring range. This score truncation has 2 important impacts: 1) the index does not reflect all intakes; and 2) the assumption that measurement error in intake reporting has a neutral impact on the diet quality score cannot be upheld. OBJECTIVES: Our main objective was to devise new diet quality scoring functions that eliminate truncation and its attendant problems. METHODS: Seven desirable properties of a new scoring function were identified: 1) avoid truncations in component scoring to prevent information loss and to provide scoring sensitivity in the currently truncated regions; 2) reduce dependency on the accuracy of dietary standards; 3) minimize measurement error bias and subsequent misclassification; 4) relate plausibly to biological processes; 5) possess desirable mathematical and statistical properties; 6) have simple representations that are easy to calculate and add minimum artifacts of their own; and 7) otherwise closely mimic existing scoring functions. RESULTS: The recommended replacement for piecewise-linear scoring is a family of scoring functions based on exponentials. For components where higher intakes are better, the function is a single exponential. For components where lower intakes are better, the function is a concave-convex mirrored pair of exponentials. The proposed exponential scoring functions have all 7 desired properties. CONCLUSIONS: The proposed exponential scoring functions will improve the usefulness of dietary scoring indexes by eliminating truncations. Compared to existing scoring functions, the use of exponentials makes the scores more inclusive of very high and very low intakes, reduces measurement error bias, and is less sensitive to the exact placement of the scoring standards.

New Exponential Scoring Functions for Diet Quality Indexes Solve Problems Caused by Truncation.

BACKGROUND: Diet quality indexes, including the Healthy Eating Index, assess diets based on usual dietary intakes and a scoring function. Nearly all diet quality indexes use scoring functions that have floors and ceilings, thereby truncating the scores and losing information about intakes outside the scoring range. This score truncation has 2 important impacts: 1) the index does not reflect all intakes; and 2) the assumption that measurement error in intake reporting has a neutral impact on the diet quality score cannot be upheld. OBJECTIVES: Our main objective was to devise new diet quality scoring functions that eliminate truncation and its attendant problems. METHODS: Seven desirable properties of a new scoring function were identified: 1) avoid truncations in component scoring to prevent information loss and to provide scoring sensitivity in the currently truncated regions; 2) reduce dependency on the accuracy of dietary standards; 3) minimize measurement error bias and subsequent misclassification; 4) relate plausibly to biological processes; 5) possess desirable mathematical and statistical properties; 6) have simple representations that are easy to calculate and add minimum artifacts of their own; and 7) otherwise closely mimic existing scoring functions. RESULTS: The recommended replacement for piecewise-linear scoring is a family of scoring functions based on exponentials. For components where higher intakes are better, the function is a single exponential. For components where lower intakes are better, the function is a concave-convex mirrored pair of exponentials. The proposed exponential scoring functions have all 7 desired properties. CONCLUSIONS: The proposed exponential scoring functions will improve the usefulness of dietary scoring indexes by eliminating truncations. Compared to existing scoring functions, the use of exponentials makes the scores more inclusive of very high and very low intakes, reduces measurement error bias, and is less sensitive to the exact placement of the scoring standards.

Objective sleep assessments for healthy people in environmental research: A literature review.

To date, although many studies had focused on the impact of environmental factors on sleep, how to choose the proper assessment method for objective sleep quality was often ignored, especially for healthy subjects in bedroom environment. In order to provide methodological guidance for future research, this paper reviewed the assessments of objective sleep quality applied in environmental researches, compared them from the perspective of accuracy and interference, and statistically analyzed the impact of experimental type and subjects' information on method selection. The review results showed that, in contrast to polysomnography (PSG), the accuracy of actigraphy (ACT), respiratory monitoring-oxygen saturation monitoring (RM-OSM), and electrocardiograph (ECG) could reach up to 97%, 80.38%, and 79.95%, respectively. In terms of sleep staging, PSG and ECG performed the best, ACT the second, and RM-OSM the worst; as compared to single methods, mix methods were more accurate and better at sleep staging. PSG interfered with sleep a great deal, while ECG and ACT could be non-contact, and thus, the least interference with sleep was present. The type of experiment significantly influenced the choice of assessment method (p < 0.001), 85.3% of researchers chose PSG in laboratory study while 82.5% ACT in field study; moreover, PSG was often used in a relatively small number of young subjects, while ACT had a wide applicable population. In general, researchers need to pay more attention at selection of assessments in future studies, and this review can be used as a reliable reference for experimental design.

Digital Assessment Tools Using Animation Features to Quantify Alcohol Consumption: Systematic App Store and Literature Review.

BACKGROUND: Accurate and user-friendly assessment tools for quantifying alcohol consumption are a prerequisite for effective interventions to reduce alcohol-related harm. Digital assessment tools (DATs) that allow the description of consumed alcoholic drinks through animation features may facilitate more accurate reporting than conventional approaches. OBJECTIVE: This review aims to identify and characterize freely available DATs in English or Russian that use animation features to support the quantitative assessment of alcohol consumption (alcohol DATs) and determine the extent to which such tools have been scientifically evaluated in terms of feasibility, acceptability, and validity. METHODS: Systematic English and Russian searches were conducted in iOS and Android app stores and via the Google search engine. Information on the background and content of eligible DATs was obtained from app store descriptions, websites, and test completions. A systematic literature review was conducted in Embase, MEDLINE, PsycINFO, and Web of Science to identify English-language studies reporting the feasibility, acceptability, and validity of animation-using alcohol DATs. Where possible, the evaluated DATs were accessed and assessed. Owing to the high heterogeneity of study designs, results were synthesized narratively. RESULTS: We identified 22 eligible alcohol DATs in English, 3 (14%) of which were also available in Russian. More than 95% (21/22) of tools allowed the choice of a beverage type from a visually displayed selection. In addition, 36% (8/22) of tools enabled the choice of a drinking vessel. Only 9% (2/22) of tools allowed the simulated interactive pouring of a drink. For none of the tools published evaluation studies were identified in the literature review. The systematic literature review identified 5 exploratory studies evaluating the feasibility, acceptability, and validity of 4 animation-using alcohol DATs, 1 (25%) of which was available in the searched app stores. The evaluated tools reached moderate to high scores on user rating scales and showed fair to high convergent validity when compared with established assessment methods. CONCLUSIONS: Animation-using alcohol DATs are available in app stores and on the web. However, they often use nondynamic features and lack scientific background information. Explorative study data suggest that such tools might enable the user-friendly and valid assessment of alcohol consumption and could thus serve as a building block in the reduction of alcohol-attributable health burden worldwide. TRIAL REGISTRATION: PROSPERO International Prospective Register of Systematic Reviews CRD42020172825; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020172825.

Feasibility and reliability of the Functional Movement Screen battery in adults with intellectual disability.

BACKGROUND: The feasibility and reliability of the Functional Movement Screen (FMS) battery for predicting injury risk have been widely studied in athletic, military, public service and healthy populations. However, scant research has been carried out in people with disabilities. This study aimed at identifying the feasibility and reliability of the FMS battery when administered to adults with intellectual disability (ID). METHODS: Adults from a residential and day care centre over 18 years of age, diagnosed with ID and able to follow simple instructions, were included in the study. All participants with behavioural or health problems that prevented the completion of the FMS battery were excluded. All exercises were video recorded to assure proper scoring. Three assessors (one trained and two novices) scored each of the FMS subtests performed separately from the videos. Feasibility was based on completion rates. Reliability of the composite test scores was analysed using intraclass correlation coefficients (ICCs). RESULTS: A total of 30 people with ID (mean age: 35.5 ± 7.12 years; 33.3% women) completed all assessments. The battery showed to be feasible, although difficulties when performing two of the subtests were observed among those with moderate and severe ID. Mean total scores from the three assessors ranged from 7.83 to 8.90. An inverse trend was observed indicating that the higher the ID level, the lower the total FMS score. Test-retest reliability was good for the trained assessor (ICC = 0.89) and mostly moderate for both novice assessors (ICC range: 0.60 to 0.76). Moderate to good inter-rater reliability was observed (ICC range: 0.65 to 0.80). CONCLUSION: The FMS battery is a reliable tool that can be performed by people with ID, albeit with certain difficulties, especially in those with moderate to severe impairment. The battery does not seem to be useful for identifying people with ID at risk of suffering a sport injury. Adequately powered, well-designed studies are required to determine if the FMS battery is appropriate for identifying changes in functional performance in this population.

What funders are doing to assess the impact of their investments in health and biomedical research.

As pressures to maximize research funding grow, biomedical research funders are increasingly tasked with demonstrating the long-term and real-world impacts of their funded research investments. Over the past three decades, research impact assessments (RIA) have emerged as an important tool for analysing the impacts of research by incorporating logic models, frameworks and indicators to track measures of knowledge production, capacity-building, development of research products, adoption of research into clinical guidelines and policies, and the realization of health, economic and social benefits. While there are currently several models for RIA within the literature, less attention has been paid to how funders can practically select and implement a RIA model to demonstrate the impacts of their own research portfolios. In this paper, a literature review was performed to understand (1) which research funders have performed RIAs of their research portfolios to date; (2) how funders have designed their assessments, including the models and tools they have used; (3) what challenges to and facilitators of success have funders found when adopting the RIA model to their own portfolio; and (4) who participates in the assessments. Forty-four papers from both published and grey literature were found to meet the review criteria and were examined in detail. There is a growing culture of RIA among funders, and included papers spanned a diverse set of funders from 10 countries or regions. Over half of funders (59.1%) used a framework to conduct their assessment, and a variety of methods for collecting impact data were reported. Issues of methodological rigour were observed across studies in the review, and this was related to numerous challenges funders faced in designing timely RIAs with quality impact data. Over a third of articles (36.4%) included input from stakeholders, yet only one article reported surveying patients and members of the public as part of the assessment. To advance RIA among funders, we offer several recommendations for increasing the methodological rigour of RIAs and suggestions for future research, and call for a careful reflection of the voices needed in an impact assessment to ensure that RIAs are having a meaningful impact on patients and the public.

Patient-based benefit-risk assessment of medicines: development, refinement, and validation of a content search strategy to retrieve relevant studies.

Introduction: Poor indexing and inconsistent use of terms and keywords may prevent efficient retrieval of studies on the patient-based benefit-risk assessment (BRA) of medicines. We aimed to develop and validate an objectively derived content search strategy containing generic search terms that can be adapted for any search for evidence on patient-based BRA of medicines for any therapeutic area. Methods: We used a robust multistep process to develop and validate the content search strategy: (1) we developed a bank of search terms derived from screening studies on patient-based BRA of medicines in various therapeutic areas, (2) we refined the proposed content search strategy through an iterative process of testing sensitivity and precision of search terms, and (3) we validated the final search strategy in PubMed by firstly using multiple sclerosis as a case condition and secondly computing its relative performance versus a published systematic review on patient-based BRA of medicines in rheumatoid arthritis. Results: We conceptualized a final search strategy to retrieve studies on patient-based BRA containing generic search terms grouped into two domains, namely the patient and the BRA of medicines (sensitivity 84%, specificity 99.4%, precision 20.7%). The relative performance of the content search strategy was 85.7% compared with a search from a published systematic review of patient preferences in the treatment of rheumatoid arthritis. We also developed a more extended filter, with a relative performance of 93.3% when compared with a search from a published systematic review of patient preferences in lung cancer.