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Novel foods by process are a special case in the catalogue of the ten novel food categories according to Article 3 (2) point (a) of the Novel Food Regulation (EU) 2015/2283, since the other nine categories derive their assessment as possible novel foods from their purely substantial properties. In the case of novel foods by process, the problem of dealing with the reference date of 15 May 1997, which is in the end a random reference date, is particularly significant. It would make more sense to have a dynamic reference date that ‘moves along the timeline’ or at least is reset from time to time and is more up-to-date. The characteristic that a process causes ‘significant changes in the composition or structure of the food, affecting its nutritional value, metabolism or level of undesirable substances’ must be understood in such a way that it is only a question of the generation of undesirable substances through the application of the process, but not their reduction, e.g. the reduction of undesirable microorganisms. Finally, the question also arises as to how the assessment of the process technology relates to the assessment of a food in the context of a novel food by composition category. This concerns the exemption for foods that have a history of use as safe foods, which, according to the view taken here, must also be interpreted into the category of novel foods by process.
Stein Backes, Dirce ; Hoffmann Adames, Nathalia ; Schneider Weissheimer, Amanda ; Büscher, Andreas ; Stein Backes, Marli Terezinha ; Lorenzini Erdmann, Alacoque
Objective:
To understand the meaning of entrepreneurial nursing care as inducer of healthy practices in vulnerable communities.
Method:
Grounded theory, whose data collection took place between March and December 2019, from interviews with 19 participants from the central region of Rio Grande do Sul, Brazil and comparative data analysis.
Results:
The phenomenon was delimited: Experiencing small/big transformations in the invisibility of everyday life in promoting healthy practices in vulnerable communities. Conducted by the paradigmatic model, the categories were named based on the components: Condition: Making choices and negotiating non-negotiable exchanges; Action/interaction: Motivating oneself to maintain basic human needs; Consequence: Broadening perspectives and transcending personal and collective boundaries.
Conclusion:
Entrepreneurial nursing care as inducer of healthy practices in vulnerable communities is not reduced to a scientific theory or to the linear and decontextualized apprehension of healthy living, but extends to reach small/big transformations that occur in the invisibility of everyday life.
Hübner, Ursula Hertha ; Saranto, Kaija ; Vieira-Marques, Pedro ; Kinnunen, Ulla-Mari ; Egbert, Nicole ; Babitsch, Birgit ; Kalthoff, Daniel ; Cardosa, Alexandrina ; Sousa, Paulino ; Hüsers, Jens ; Padilha, Miguel ; Mannavaara, Pauleen ; Jokinen, Tiina ; Mansholt, Hilke ; Correia, Ricardo ; Morawski, Toria Shaw ; Wilson, Gabriela Mustata ; Ball, Marion J.
This study describes the eHealth4all@eu course development pipeline that builds upon the TIGER educational recommendations and allows a systematic development grounded on scientific and field requirements of competencies, a case/problem-based pedagogical approach and finally results in the syllabus and the course content. The pipeline is exemplified by the course Learning Healthcare in Action: Clinical Data Analytics.
Meender Schäfer, Axel Georg ; Zalpour, Christoff ; von Piekartz, Harry ; Hall, Toby ; Paelke, Volker
Background
Osteoarthritis of the knee is the most common cause for disability and limited mobility in the elderly, with considerable individual suffering and high direct and indirect disease-related costs. Nonsurgical interventions such as exercise, enhanced physical activity, and self-management have shown beneficial effects for pain reduction, physical function, and quality of life (QoL), but access to these treatments may be limited. Therefore, home therapy is strongly recommended. However, adherence to these programs is low. Patients report lack of motivation, feedback, and personal interaction as the main barriers to home therapy adherence. To overcome these barriers, electronic health (eHealth) is seen as a promising opportunity. Although beneficial effects have been shown in the literature for other chronic diseases such as chronic pain, cardiovascular disease, and diabetes, a systematic literature review on the efficacy of eHealth interventions for patients with osteoarthritis of knee is missing so far.
Objective
The aim of this study was to compare the efficacy of eHealth-supported home exercise interventions with no or other interventions regarding pain, physical function, and health-related QoL in patients with osteoarthritis of the knee.
Methods
MEDLINE, CENTRAL, CINAHL, and PEDro were systematically searched using the keywords osteoarthritis knee, eHealth, and exercise. An inverse variance random-effects meta-analysis was carried out pooling standardized mean differences (SMDs) of individual studies. The Cochrane tool was used to assess risk of bias in individual studies, and the quality of evidence across studies was evaluated following the Grading of Recommendations, Assessment, Development, and Evaluation approach.
Results
The literature search yielded a total of 648 results. After screening of titles, abstracts, and full-texts, seven randomized controlled trials were included. Pooling the data of individual studies demonstrated beneficial short-term (pain SMD=−0.31, 95% CI −0.58 to −0.04, low quality; QoL SMD=0.24, 95% CI 0.05-0.43, moderate quality) and long-term effects (pain −0.30, 95% CI −0.07 to −0.53, moderate quality; physical function 0.41, 95% CI 0.17-0.64, high quality; and QoL SMD=0.27, 95% CI 0.06-0.47, high quality).
Conclusions
eHealth-supported exercise interventions resulted in less pain, improved physical function, and health-related QoL compared with no or other interventions; however, these improvements were small (SMD<0.5) and may not make a meaningful difference for individual patients. Low adherence is seen as one limiting factor of eHealth interventions. Future research should focus on participatory development of eHealth technology integrating evidence-based principles of exercise science and ways of increasing patient motivation and adherence.
Kempe, Marie ; Grimmelsmann, Sofia ; Oliveira-Souza, Ana Izabela ; Dennett, Liz ; Fuentes, Jorge ; Gülke, Lisa ; Schnepel, Tonia ; Castro-Carletti, Ester ; Von Piekartz, Harry ; Armijo-Olivo, Susan
Background:
Neck pain is one of the most common musculoskeletal pains and among the fourth leading causes of years of life lost due to disability, following back pain, depression, and arthralgia. (1)
In the course of their lives, about 70% of all people will experience a clinically relevant episode of neck pain, (2) so finding a good therapy to treat it is of high interest. Aerobic exercise is associated with pain reduction in patients with different types of MSK pain. Recent studies have shown a positive impact of aerobic exercises on brain function, memory processing, cognition, and motor function. (3, 4)
Therefore, the influence of aerobic exercise on pain modulation seems to be of particular interest for individuals with chronic MSK pain, since brain imaging studies have shown that these patients have structural and functional changes, as well as abnormal brain features in various areas of the brain. The evidence regarding the effectiveness of aerobic exercise for neck pain seems limited and outdated.
Thus, a systematic review evaluating the effects of aerobic exercise in patients with neck pain is needed. Therefore, this review aims to investigate the effectiveness of aerobic exercise interventions when compared to other conservative and non-conservative interventions (e.g., localized exercises, medication, acupuncture, physical agents, manual therapy) to decrease pain intensity in people with neck pain.
Materials and methods:
Electronic literature searches were conducted in a total of six databases such as Medline, Embase, CINAHL, Cochrane Library, Web of Science, and Scopus. The review considered randomised controlled trials (RCTs) including patients over 18 years having musculoskeletal pain in the neck area. The Neck Pain Task Force's classification of pain severity describes four levels of neck pain, with the first three levels considered in this review. (5)These must be clinically diagnosed by a health care provider according to signs and symptoms or based on standardized criteria specific for each disease. Studies involving subjects with any pre-existing conditions, previous surgery, or pain not clearly related to the musculoskeletal system were excluded. No limits were applied in terms of sex, ethnicity, and living country. Data were extracted using a standardized data extraction form.
Methodological quality was determined using the Cochrane Collaboration Risk of Bias Tool (CCRBT) and the strength of the evidence with Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Data were extracted and evaluated by two independent reviewers.
Results:
A total of 21585 records were identified and screened independently for eligibility by two reviewers. A total of six unique studies, reported on ten manuscripts met the specified inclusion criteria. Different types of aerobic exercise were used in the studies. Studies included isolated and combined aerobic exercise using interventions such as cycling on an ergometer or walking outdoors at a moderate intensity. Comparison groups were for example strength training or education. The most common outcome was pain assessed with the Visual Analogue Scale (VAS) or the Nordic questionnaire.
The included studies had a high risk of bias and the overall quality of the evidence for this systematic review was considered low. There was high heterogeneity in the included studies regarding interventions applied and study results.
When looking at the effect of aerobic exercise versus control group or other intervention groups measured with VAS, it can be observed, that there was a great heterogeneity between studies results (different magnitudes and directions). Although none of the comparisons showed a statistically significant difference between aerobic exercise and control (MD 6.24 mm, 95% CI [-11.21; 23.96]) or active intervention groups (MD -9.52 mm, 95% CI [-18.48; -0.56]) on pain intensity; it seems that aerobic exercise is slightly better than a control group, and equally effective as other active treatments such as strength exercise or education.
In addition, when combined with other therapeutic modalities, aerobic exercise, could potentially help to reduce pain intensity (MD 7.71 mm, 95% CI [1.07; 14.35]). Especially in the long term, the combination of strength and aerobic exercise showed promising results. Statistically significant differences in favour of aerobic exercise for pre vs. three months follow up (MD 11.20 mm, 95% CI [2.85;19.55]) and pre vs. six moths follow up (MD 15.10 mm, 95% CI [6.99; 23.21]) were found.
Conclusions:
Although there is currently limited evidence on the effectiveness of aerobic exercise in individuals with chronic neck pain, aerobic exercise was found to not only reduce pain intensity, but also to improve disability as well as physical and emotional functioning. However, as the evidence is limited, low quality, and heterogeneous, further research is needed in this area to obtain more accurate results.
Oliveira-Souza, Ana Izabela ; Kempe, Marie ; Grimmelsmann, Sofia ; Tavares, Luiz Felipe ; Viegas Andrade, Angela ; Castro-Carletti, Ester ; Dennett, Liz ; von Piekartz, Harry ; Fuentes Contreras, Jorge ; Armijo-Olivo, Susan
Methods: Systematic review of randomized controlled trials (RCT). Searches were conducted in five electronic databases. Studies were selected if they included patients with NP over 18 years old treated with aerobic exercise (AE) (e.g., cycling, running, hiking, and walking). The main outcome of interest was pain intensity. Qualitative and quantitative data were extracted. The risk of bias (RoB) was determined using the Cochrane RoB Tool-2 and the overall certainty of the evidence with the GRADE recommendations.
Results: Out of 21,585 initial records screened, a total of six individual studies published in ten manuscripts were included. There was a great heterogeneity between protocols, comparisons, and studies’ results (different magnitudes and directions). When looking at the effect of aerobic exercise versus control groups or other interventions on pain intensity measured with the VAS, not statistically (nor clinical) significant differences between aerobic exercise and control groups (MD [95%CI] 5.16 mm [-6.38, 16.70]) were identified. The combined effect of AE plus other interventions seems to be effective. Strength exercise obtained better effects than aerobic exercises (MD [95%CI]: -11.34 mm [-21.6, -1.09]).
Conclusions: Aerobic exercise presented positive results to reduce pain intensity, and improving disability, and physical and emotional functioning. However, the evidence is restricted, low quality, and heterogeneous.
Oliveira-Souza, Ana Izabela ; Gülkner, Lisa ; Dennett, Liz ; Contreras, Jorge F. ; Kempe, Marie ; Grimmelsmann, Sofia ; Castro-Carletti, Ester ; von Piekartz, Harry ; Armijo-Olivo, Susan
Methods: The searches were conducted on five electronic databases. RCTs or CTs with patients over 18 years old of both sexes with OFP diagnoses were targeted. The intervention of interest was AE (i.e., walking, cycling, and running), compared to any other conservative and non-conservative therapy. The primary outcome was pain intensity. Risk of bias (RoB) was done with the Cochrane RoB tool (RoB 2). The overall certainty of the evidence was evaluated with GRADE.
Results: Out of 21,585 initial records found in the initial database search, only one study (reported on three manuscripts) was included. The diagnosis of interest was headache plus temporomandibular disorders (TMD). Three treatment groups (strengthening (Str) exercise + manual therapy (MT) (G1); AE + MT + Str exercises (G2); AE (G3)) were compared. The main outcome was pain; the secondary outcomes included disability, strength, anxiety, and quality of life. The combined treatment (AE+MT+Str exercises) had the strongest effect to decrease pain and headache intensity in patients with OFP (SMD: 9.99 [95%CI: 7.19, 12.80].
Conclusions: a multimodal treatment strategy achieved the greatest positive effects on pain and other outcomes in the short/medium term. AE seems to be an important component of this strategy. However, the scientific evidence supporting AE’s isolated effect is limited, indicating a research gap in this scientific field.
Introduction: Hamstring injuries are among the most common injuries in soccer players. Especially the danger of hamstring injuries increases in the final third of each half, with the biceps femoris muscle being highly susceptible, but currently there is no supporting evidence in soccer players. It is important to investigate to provide a basis for further clinical investigations in order to reduce the risk of hamstring injuries.
Objective: To investigate a soccer-specific muscle fatigue protocol has an effect on the activation patterns of the biceps and semitendinosus muscles and correlates with the subjectively perceived exertion of the soccer players.
Methods: 19 healthy soccer players aged 19 - 35 years were included and underwent a standardized procedure that included: (1) performance of the nordic hamstring curls (NHC) and a 10m sprint (pre-test), (2) a soccer-specific muscle fatigue loading protocol for 30 minutes with subsequent rating of perceived exertion (RPE), (3) re-assessed like pre-assessment (post- test). Electromyography (EMG) data were recorded the biceps and
semitendinosus muscles of both legs. Two parameters were analyzed: the peak amplitude during the NHC and the mean amplitude during the 10m sprint.
Results: The RPE score (9.5, p<0.001) and 10m sprint shows significant differences between pre- and post- test for the biceps (standing leg: -82.45, kicking leg: -81.77; p<0.01) and semitendinosus muscle (standing leg: -60.08, p=0.001); kicking leg: -65.30, p=0.03). Significant correlation exists between RPE score and biceps muscles at posttest (standing leg: r=-0.54, kicking leg: r=-0.51; p<0.05).
Conclusion: Muscle fatigue leads to significant changes in the activation behavior of the hamstring muscles. In particular, the biceps muscle shows a correlation with perceived exertion, the higher the exertion, the lower the muscle activity. This may help explain the higher prevalence of the biceps muscle in hamstring injuries and offers a basis for further clinical investigations
Background:
Large health organizations often struggle to build complex health information technology (HIT) solutions and are faced with ever-growing pressure to continuously innovate their information systems. Limited research has been conducted that explores the relationship between organizations’ innovative capabilities and HIT quality in the sense of achieving high-quality support for patient care processes.
Objective:
The aim of this study is to explain how core constructs of organizational innovation capabilities are linked to HIT quality based on a conceptual sociotechnical model on innovation and quality of HIT, called the IQHIT model, to help determine how better information provision in health organizations can be achieved.
Methods:
We designed a survey to assess various domains of HIT quality, innovation capabilities of health organizations, and context variables and administered it to hospital chief information officers across Austria, Germany, and Switzerland. Data from 232 hospitals were used to empirically fit the model using partial least squares structural equation modeling to reveal associations and mediating and moderating effects.
Results:
The resulting empirical IQHIT model reveals several associations between the analyzed constructs, which can be summarized in 2 main insights. First, it illustrates the linkage between the constructs measuring HIT quality by showing that the professionalism of information management explains the degree of HIT workflow support (R²=0.56), which in turn explains the perceived HIT quality (R²=0.53). Second, the model shows that HIT quality was positively influenced by innovation capabilities related to the top management team, the information technology department, and the organization at large. The assessment of the model’s statistical quality criteria indicated valid model specifications, including sufficient convergent and discriminant validity for measuring the latent constructs that underlie the measures of HIT quality and innovation capabilities.
Conclusions:
The proposed sociotechnical IQHIT model points to the key role of professional information management for HIT workflow support in patient care and perceived HIT quality from the viewpoint of hospital chief information officers. Furthermore, it highlights that organizational innovation capabilities, particularly with respect to the top management team, facilitate HIT quality and suggests that health organizations establish this link by applying professional information management practices. The model may serve to stimulate further scientific work in the field of HIT adoption and diffusion and to provide practical guidance to managers, policy makers, and educators on how to achieve better patient care using HIT.
This study examined the relation between employees' perceived extent of change and adaptive performance, focusing on the roles of expressive suppression (i.e. the habit of suppressing overt expressions of emotion) at work and perceived strain. Analysing survey data of 153 employees in Germany with different occupational backgrounds via bootstrapping, the conceptual moderated indirect effect scheme was supported. As hypothesized, greater changes were associated with higher strain. Strain, in turn, was negatively related to adaptive performance. Although extent of change did not directly affect adaptive performance, the data supported the expected indirect relationship via strain. Finally, expressive suppression at work acted as a buffer of this indirect effect: extent of change was only negatively related to strain for employees low in suppression. In line with newer evidence, our results indicate that the suppression of overt emotional expressions at work can have positive effects under certain circumstances.
Tietze, Anna L. ; Zernikow, Boris ; Otto, Michael ; Hirschfeld, Gerrit ; Michel, Erik ; Koh, Michelle ; Blankenburg, Markus R.
Background:
Children with severe psychomotor impairment (SPMI) often experience sleep disturbances that severely distress both the child and his or her parents. Validated questionnaires for the assessment of parents’ distress related to their child’s sleep disturbances are lacking.
Methods:
We developed and validated a new questionnaire, the HOST (holistic assessment of sleep and daily troubles in parents of children with SPMI) to assess the effect of the sleep disturbances in children with SPMI on their parents. The questionnaire was developed based on published data and expert opinion, and it was refined via direct consultation with affected parents. Its psychometric characteristics were assessed in a sample of parents of 214 children with SPMI. It was retested using a random subsample of the participants.
Results:
Explorative factor analysis revealed that the HOST was composed of four scales. Fit indices, item analysis, and convergent validity (coherence with preexisting instruments of sleep disturbances and health status) were adequate. Retest analysis (n = 62) revealed high stability of the HOST questionnaire and adequate replication validity.
Conclusion:
Sleep-related difficulties significantly impact the sociomedical characteristics of the parents of children with complex neurologic diseases. Typically, parents are severely affected in various aspects of daily life (i.e., medical health, social life, professional life). The HOST proved to be a valid, reliable and economical assessment tool of sleep-related difficulties in parents and relatives of children with SPMI. The HOST is capable of identifying individuals and specific areas requiring intervention.
The ability of film stars to attract viewers is a widely accepted rationale for hiring expensive actors. However, the precise mechanisms behind this ‘drawing power’ remain unclear. By reviewing the existing literature, six possible antecedents of drawing power are identified. Artists with high acting abilities (i) increase a film’s artistic appeal, (ii) function as markers of quality and (iii) facilitate the matching process with the right audiences. Widely popular, commonly perceived as beautiful/handsome but often less talented actors, on the other hand, rather (iv) facilitate the marketing campaigns of films, (v) offer entertaining interactions with famous personalities and (vi) provide manifold opportunities for gossiping. Based on a discussion of the implications for theory and a preliminary analysis of a sample of Hollywood actors, managerial recommendations for those who have and those who depend on star drawing power are developed.
Functional foods are still of increasing interest among the scientific community. Based on the extensive literature about functional foods, four main research areas can be identified: functional food innovation (1); the scientific background of the health benefits of functional foods (2); the regulation of functional foods (3); and consumer acceptance of functional foods (4). These research areas are not detached from each other, and each presents a consumer perspective. Although multifaceted studies focus on consumer acceptance of functional foods, literature regarding a structured framework of the determinants of functional food acceptance is limited. The aim of this review is to provide the reader with an overview of the recent literature on consumer attitudes towards functional foods and with an extensive structured framework of the determinants of functional food acceptance and their intertwined relationships. The scientific literature discusses a plethora of determinants of consumer acceptance of functional foods. These determinants can be categorized into consumer and market attributes, which show interwoven relationships with each other. On the one hand, consumer attributes are widely discussed in the literature, while on the other hand structured analyses of the market perspective are inadequately represented. Additionally, the ongoing development of new scientific findings regarding health benefits of different functional ingredients leads to a large amount of new functional food products in the market. Consequently, the research area of functional foods and in particular consumer acceptance of functional food innovation will remain an important research field in the coming years.
The way in which brands are economically represented in the context of financial reporting is controversial in theory and practice. This holds especially against the background of the ever- increasing importance of intangible assets. Brands and the economic success associated with them are thus regarded as a key variable for overall corporate success: cash flows can be accelerated and expanded through the use of brand-strategic options, while existing risks may be mitigated. In addition to a large number of theoretical definitions, the determination of brand value from both a marketing and an accounting perspective is also characterized by a complex interaction of numerous influencing factors. This is where the International Accounting Standards IAS 38: "Intangible Assets" (isolated acquisition of a brand) and IFRS 3: "Business Combinations" (acquisition of a brand as part of a business combination) take effect: These are intended to ensure a comparable and reliable "true and fair view" for the presentation of intangible assets in international accounting. In addition to various recognition criteria, the accounting regulation here also includes the accounting valuation of intangible assets and thus also of brands. In principle, valuation in accordance with IAS 38 is based on acquisition costs. The determination of the operating life for impact evaluation is highly controversial both in literature and in practice. Under IFRS 3, acquisition costs are to be replaced by the fair value. Regardless of the method used, possible subjectivity is one of the central issues. The current discussion approach of the International Accounting Standards Board also clearly shows the need for simplification and concretization that still exists for practice: In particular, the accounting distinction between goodwill and intangible assets is the subject of discussions with the Global Preparers Forum, among others. The interests of users, preparers and auditors of corporate financial reporting must be taken into account equally. In particular, the prohibition on recognizing self-created brands in the balance sheet makes it difficult to assess their value. Furthermore, it creates a weak point in the presentation of the true and fair view of a company's financial position and financial performance that is generally required. Regardless of the previous, the current rules provide preparers and users with a basic overview of existing intangible assets. Irrespective of how valuation is determined individually, the IASB's rules thus help to create a fundamental structure. In which approach the future discussion will result in remains open.
Speck (geb. Lukas), Melanie ; Wagner, Lynn ; El Mourabit, Xenia ; Scharp, Michael ; Reinhardt, Guido ; Wagner, Tobias ; Schulz-Brauckhoff, Sabine ; Engelmann, Tobias ; Bartels, Ruth
Der Konsumbereich „Ernährung“ verantwortet in Deutschland rund 15 % der Treibhausgasemissionen (THG). Aufgrund der hohen Nachfrage hat die Außer-Haus-Verpflegung eine starke Hebelwirkung, um eine klimaeffiziente Ernährung voranzutreiben – so auch Schulküchen. Aktuell sind der Verpflegung jedes Schulkindes, welches ganzjährig an der Mittagsverpflegung teilnimmt, pro Jahr etwa 264 kg THG-Emissionen zuzuschreiben.
Im Projekt KEEKS „Klima- und energieeffiziente Küche in Schulen” wurden deshalb in 22 Schulküchen von Ganztagsschulen mit täglich insgesamt 5 000 Mittagessen der Status Quo ermittelt. Dies geschah mittels Energiemessungen, Analyse von Ausstattung, Technik und Prozessen der Küchen sowie leitfadengestützten Interviews mit den Küchenleitungen. Treibhausgasemissionen von Menüs und Küchenprozessen wurden bilanziert, Einsparpotenziale identifiziert sowie Handlungsempfehlungen entwickelt und erprobt. Die effektivsten Maßnahmen – die Reduktion und Substitution von Fleisch und Fleischprodukten sowie der Aufbau eines effizienten Abfallmanagements – sparen rund 10 % des Treibhausgasausstoßes einer Schulküche ein. Die erarbeiteten Handlungsempfehlungen können Küchenpersonal dabei unterstützen, eine klimafreundliche, kindgerechte, gesunde und bezahlbare Schulküche zu gestalten.
Innovations are typically characterised by their relative newness for the user. In order for new eHealth applications to be accepted as innovations more criteria were proposed including “use” and “usability”. The handoverEHR is a new approach that allows the user to translate the essentials of a clinical case into a graphical representation, the so-called cognitive map of the patient. This study aimed at testing the software usability. A convenience sample of 23 experienced nurses from different healthcare organisations across the country rated the usability of the handoverEHR after performing typical handover tasks. All usability scales of the IsoMetricsL questionnaire showed positive values (4 “I agree”) with the exception of “error tolerance” (3 “neutral statement”). A significant improvement was found in self-descriptiveness as compared to an initial usability testing prior to this study. Different subgroups of users tended to rate the usability of the system differently. This study demonstrated the benefits of formative evaluations in terms of improving the usability of an entirely new approach. It thus helps to transform a novel piece of software towards becoming a real innovation. Our findings also hint at the importance of user characteristics that could affect the usability ratings.