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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.