Addressing COVID-19 challenges in a randomised controlled trial on exercise interventions in a high-risk population.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic is a threat to ongoing clinical trials necessitating regular face-to-face, in-person meetings, particularly in participants with a high risk of complications. Guidance on how to handle and safely continue such trials is lacking. Chronically ill elderly individuals require-in addition to protection from infection-regular physical exercise and social contact to remain healthy. Solutions on how to handle these conflicting necessities are needed. The ENTAIER-randomised controlled trial was investigating the influence of mindful movements on fall risk, fear of falling, mobility, balance, life quality, and other outcomes. The study population was planned to comprise of 550 chronically ill elderly individuals with a high risk of falling. The movements were regularly performed in coached groups over 6 months. After the trial began, COVID-19 lockdowns stopped all in-person meetings, and it was expected that the limitations of this pandemic would continue for a long term. Therefore, the exercise programme, which involved complex movements and was typically conducted face-to-face in groups, had to be substituted by a telemedicine programme within a short timeframe. The objectives, therefore, were to identify challenges and tasks that could to be resolved and steps that could to be taken to achieve high-quality, efficacy, safety, and enable human encounter and motivation. METHODS: We proceeded with four steps: 1) A literature review on the quality and feasibility issues of telemedicine in general, and specifically, in exercise training in elderly individuals. 2) Participation in two international telemedicine task forces on integrative medicine, particularly, mind-body medicine. 3) Interviews with study therapists, (for practical purposes, eurythmy therapists and Tai Chi teachers are summarized here as therapists) personnel, and international experts on providing mindful movement exercises and other physiotherapies via live telecommunication technology, and with scientists and patient representatives. 4) Final evaluation by the core trial team and subsequent planning and implementation of changes in the trial organisation. RESULTS: Various tasks and challenges were identified: for the technical equipment for therapists and patients; for the ability of therapists and trial participants to adequately manage the technology and telemedicine intervention; the reservations and concerns about the technology among therapists and participants; safety and data protection in using the technology; and study design. The two major options found on how to continue the trial in the COVID-19 situation were a complete switch to telemedicine and a partial switch in the form of risk management implemented into the former design. CONCLUSIONS: The management of an ongoing clinical trial in a national or international crisis with a minimum of available time and extra financial resources, alongside with two checklists on steps and procedures for trial continuation and telemedicine implementation, may be informative for other researchers or healthcare providers faced with similar challenges and making similar decisions in the current situation or similar future scenarios. TRAIL REGISTRATION: www.drks.de . DRKS00016609. Registered July 30, 2019.

A multi-centre, parallel-group, randomised controlled trial to assess the efficacy and safety of eurythmy therapy and tai chi in comparison with standard care in chronically ill elderly patients with increased risk of falling (ENTAiER): a trial protocol.

BACKGROUND: In elderly poeple, multimorbidity and polypharmacy increase while sensory, motor and cognitive functions decrease. Falls occur in 30% of people aged 65 years and older at least once per year, with injuries at 10-20%. Reducing falls and enhancing physical, emotional and cognitive capacities are essential for healthy aging despite chronic disease. Eurythmy therapy (EYT) and Tai Chi train balance, mobility and concentrative and sensory capacities. METHODS: In eight trial sites (academic or community hospitals), 550 outpatients aged 65 years and older with chronic disease and increased risk of falling (history of imbalance, Berg Balance Scale (BBS) score ≤ 49) will be randomly assigned (1:1:1) to receive either EYT or Tai Chi (each provided in one-hour group sessions, twice, later once per week plus practice at home, for over 24 weeks) added to standard care or standard care alone. Standard care includes a detailed written recommendation on fall prevention and the visit of a primary care doctor. Seniors living a reclusive life or economically disadvantaged elderly will be particularly addressed. A motivation and communication concept supports the trial participants' compliance with trial procedures and practicing. Public and patient representatives are involved in the planning and conduction of the trial. Falls will be documented daily in a diary by the participants. These falls as well as injuries and complications will be ascertained during monthly phone visits. The falls efficacy scale, BBS, cognition (MoCA), Mood (GDS-15), quality of life (SF12), instrumental activities of daily living (IADL), use of medical and non-medical services (FIMA) and adherence will be assessed at months 3, 6, and 12 and inner correspondence with practices (ICPH) at month 6. The trial is funded by the Federal Ministry of Education and Research (BMBF 01GL1805). DISCUSSION: This study will determine whether EYT and Tai Chi reduce falls, injurious falls, fear of falling and healthcare utilisation and improve mobility, cognition, mood, quality of life and functional independence. A reduction of fall risk and fear of falling and an improvement of mobility, autonomy, quality of life, mood, and cognition are highly relevant for older people to cope with aging and diseases and to reduce healthcare costs. TRAIL REGISTRATION: www.drks.de. DRKS00016609. Registered 30th July 2019.

[Comment on the TIDier Checklist]. / Kommentar zur TIDieR Checkliste.

This comment focuses on the need for and possible impact of the TIDieR reporting guideline.

Occupational therapy for elderly. Evidence mapping of randomised controlled trials from 2004-2012.

OBJECTIVE: Previous systematic reviews on occupational therapy for elderly included studies until 2003. The present evidence mapping summarizes recent evidence for the efficacy of occupational therapy with older persons based on randomised controlled trials from 2004-2012. METHOD: An electronic search in Cochrane and Medline databases identified publications of randomised controlled trials on occupational therapy interventions for persons≥65 years old. Two raters independently extracted data and analysed the quality of samples, interventions and outcome evalutations according to PRISMA criteria. RESULTS: In all, 136 abstracts were identified and 48 studies analysed, from these 12 on stroke, 15 on falls and mobility, 7 on dementia, 4 on prevention and 10 on other conditions. Reports of adverse events and evaluations of costs and long-term outcomes are frequently lacking. CONCLUSION: The most promising fields for further research are primary and secondary prevention in persons with stroke, falls or mobility problems and tertiary prevention in persons with dementia. Future trials should be conducted and reported according to consented reporting guidelines of the equator network.

Analysis of Infants Based on Data from the German Perinatal Survey of the Years 1994-2011 in Mecklenburg-Pomerania, Germany. Classification of Infants with regard to their Gestation Duration and Birth Weight.

BACKGROUND: The demographic change in -Germany describes an ongoing process of population development of which the eastern German states tend to be more affected. These ongoing changes have an influence on the reproductive behavior of the population. After twenty-three years of German reunification, the present study has investigated the question to what extent the somatic classification of newborns in Mecklenburg-Pomerania (M-P), Germany, is affected. MATERIAL AND METHODS: Newborn singleton births (n=174,084) were classified from the existing data of the German Perinatal Survey between 1994 and 2011. The rate of premature birth, SGA, and LGA rate as well as the rate of low birth weight ≤2,499 g were determined both gender-dependently and independently. In addition, a combined analysis of the rates has been taken into account. The obtained data material from M-P made it possible for the first time to compare by values. National and international reference studies were considered in this comparison. RESULTS: In M-P, the premature birth rate is 5.2%; the rate of newborns with low birth weight ≤ 2,499 g is 4.4%. Among newborns of ≤2,499 g and SGA newborns, girls compose a higher percentage (4.7%, 12.5%) compared to boys (4.0%, 7.4%). The premature birth rate and LGA newborns appear conversely. For these, the percentage of boys (5.6%, 12.6%) is higher than that of girls (4.8%, 7.0%). 60.6% of the gender non-specific newborns ≤2,499 g are simultaneously premature newborn infants. Only a very small percentage of 0.5% of SGA newborns is at the same time premature infants and newborns with low birth weight. CONCLUSIONS: By getting nationwide country-specific figures, a detailed analysis of the newborns in M-P can be performed. The analysis supports the existing national values and is a helpful addition for practice-oriented advice.

Analysis of infants based on data from the German Perinatal Survey of the years 1994-2011 in Mecklenburg-Pomerania, Germany: new percentile values for anthropometric measures of infants.

BACKGROUND: This communication presents precise percentile values for birth weight, birth length and cranial circumference of infants in Mecklenburg-Pomerania, Germany. MATERIAL AND METHODS: Based on data from the German Perinatal Survey of the years 1994-2011 in Mecklenburg-Pomerania, the 3rd, 10th, 25th, 50th, 75th, 90th and 97th percentile values for birth weight, birth length and head circumference are specified. The measurements of a total of 174,084 infants from non-multiple births are shown. RESULTS: The statistically calculated percentile values are presented in tabular and graph forms. The mean birth weight of the infants was 3,437.8 g. The average age of the mothers was 27.9 years. The average duration of pregnancy was 39.4 complete weeks. CONCLUSIONS: The insights gained from many years of data collection are presented as standardised, regional percentile values and curves for Mecklenburg-Pomerania for the first time. The differentiated presentation for the federal state opens the possibility for individually tailored consultations in clinical practice and may provide support for recognised national curves for these values.

The role of selected pre-match covariates on the outcome of One-day International (ODI) cricket matches.

Background: The identification of key factors that systematically influence a team's success is important and has led to the application of statistical models in sport. Predicting the outcome of a One Day International (ODI) cricket match, using only pre-match covariates, has been minimally investigated. Objectives: This research sought to investigate the impact that venue, toss outcome, toss decision, and match type have on the chances of winning an ODI match. Methods: A total of 1228 men's international ODI matches were analysed. A logistic regression model was used to identify the significance of these pre-match covariates on the result of the matches. Results: The results varied across all teams, suggesting that there are individualised factors driving these differences and that generalising the impact pre-match covariates have in every team is unrealistic. New Zealand and India displayed a significant home advantage effect, whereas Australia had a strong tendency towards a significant disadvantage when they won the toss. However, for most teams, toss outcome, toss decision, and match type did not significantly impact the outcome of an ODI match. Conclusion: New Zealand and Australia were the most predictable teams, whereas South Africa and Pakistan were regarded as unpredictable when pre-match covariates were used to forecast the outcome of their ODI matches.

Dementia quality of life instrument--construct and concurrent validity in patients with mild to moderate dementia.

BACKGROUND AND PURPOSE: To translate the Dementia quality of life instrument (DQoL) into German and assess its construct and concurrent validity in community-dwelling people with mild to moderate dementia. METHODS: Dementia quality of life instrument data of two pooled samples (n=287) were analysed regarding ceiling and floor effects, internal consistency, factor reliability and correlations with corresponding scales on quality of life (Quality of Life in Alzheimer's Disease and SF-12), cognition (Mini-Mental State Examination, Alzheimer's Disease Assessment Scale - cognitive), depression (Cornell Scale for Depression in Dementia) and activities of daily living (Interview of Deterioration in Daily Living Activities in Dementia). RESULTS: We found no floor effects (<2%), minor ceiling effects (1-11%), moderate to good internal consistency (Cronbach's α: 0.6-0.8) and factor reliability (0.6-0.8), moderate correlations with self-rated scales of quality of life (Spearman coefficient: 0.3-0.6) and no or minor correlations with scores for cognition, depression or activities of daily living (r<0.3). The original five-factor model could not be confirmed. CONCLUSION: The DQoL can be used in dementia research for assessing positive and negative affect, feelings of belonging and self-esteem. The findings suggest further research to improve the structure of the scales aesthetics, feelings of belonging and self-esteem.

Efficacy and safety of pharmacotherapy for Alzheimer's disease and for behavioural and psychological symptoms of dementia in older patients with moderate and severe functional impairments: a systematic review of controlled trials.

BACKGROUND: Many patients with Alzheimer's disease (AD) are physically frail or have substantial functional impairments. There is growing evidence that such patients are at higher risk for medication-induced adverse events. Furthermore, frailty seems to be more predictive of poor clinical outcomes than chronological age alone. To our knowledge, no systematic review of clinical trials examining drug therapy of AD or behavioural and psychological symptoms of dementia (BPSD) has specifically focused on the topic of physical frailty. Our objective was to evaluate the efficacy and safety of pharmacotherapy in AD patients with frailty or significant functional impairments. METHODS: We performed a systematic literature search in MEDLINE, Embase and the Cochrane Central Register of Controlled Trials (CENTRAL) for randomized controlled trials (RCTs) of drug therapy of AD and BPSD in patients with significant functional impairments according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and Cochrane research criteria. Significant functionally impaired patient populations were identified using the recommendations of the Medication and Quality of Life in frail older persons (MedQoL) Research Group. Screening, selection of studies, data extraction and risk of bias assessment were performed independently by two reviewers. Outcomes including functional status, cognitive function, changes in BPSD symptoms, clinical global impression and quality of life were analysed. For assessing harm, we assessed adverse events, drop-outs as a proxy for treatment tolerability and death. Results were analysed according to Cochrane standards and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. RESULTS: Of 45,045 search results, 38,447 abstracts and 187 full texts were screened, and finally, 10 RCTs were included in the systematic review. Selected articles evaluated pharmacotherapy with acetylcholinesterase-inhibitors (AChEI), anticonvulsants, antidepressants and antipsychotics. Studies of AChEIs suggested that patients with significant functional impairments had slight but significant improvements in cognition and that AChEIs were generally well tolerated. Studies of antidepressants did not show significant improvements in depressive symptoms. Antipsychotics and anticonvulsants showed small effects on some BPSD items but also higher rates of adverse events. However, due to the very small number of identified trials, the quality of evidence for all outcomes was low to very low. Overall, the small number of eligible studies demonstrates that significantly functional impaired older patients have not been adequately taken into consideration in most clinical trials investigating drug therapy of AD and BPSD. CONCLUSION: Due to lack of evidence, it is not possible to give specific recommendations for drug therapy of AD and BSPD in frail older patients or older patients with significant functional impairments. Therefore, clinical trials focussing on frail older adults are urgently required. A standardized approach to physical frailty in future clinical studies is highly desirable.

Wasp hawking induces endothermic heat production in guard bees.

When vespine wasps, Vespa velutina Lepeletier (Hymenoptera: Vespidae), hawk (capture) bees at their nest entrances alerted and poised guards of Apis cerana cerana F. and Apis mellifera ligustica Spinola (Hymenoptera: Apidae) have average thoracic temperatures slightly above 24° C. Many additional worker bees of A. cerana, but not A. mellifera, are recruited to augment the guard bee cohort and begin wing-shimmering and body-rocking, and the average thoracic temperature rises to 29.8 ± 1.6° C. If the wasps persist hawking, about 30 guard bees of A. cerana that have raised their thoracic temperatures to 31.4 ± 0.9° C strike out at a wasp and form a ball around it. Within about three minutes the core temperature of the heat-balling A. cerana guard bees reaches about 46° C, which is above the lethal limit of the wasps, which are therefore killed. Although guard bees of A. mellifera do not exhibit the serial behavioural and physiological changes of A. cerana, they may also heat-ball hawking wasps. Here, the differences in the sequence of changes in the behaviour and temperature during "resting" and "heat-balling" by A. cerana and A. mellifera are reported.

Fast pyrolysis char - Assessment of alternative uses within the bioliq® concept.

Experiments with a process development unit for fast pyrolysis of biomass residues of 10kgh(-1) have been performed to quantify the impact of two different product recovery options. Wheat straw, miscanthus and scrap wood have been used as feedstock. A separate recovery of char increases the organic oil yield as compared to a combined recovery of char and organic condensate (OC). Furthermore, it allows for an alternative use of the byproduct char which represents an important product fraction for the high ash biomass residues under consideration. The char produced shows little advantage over its biomass precursor when considered as energy carrier due to its high ash content. Significant value can be added by demineralizing and activating the char. The potential to increase the economic feasibility of fast pyrolysis is shown by an assessment of the bioliq® process chain.

Effects of ethanol and water extracts of propolis (bee glue) on acute inflammatory animal models.

The anti-inflammatory effects of ethanol (EEP) and water (WSD) extracts in ICR mice and Wistar rats were analyzed. Both WSD and EEP exhibited significant anti-inflammatory effects in animal models with respect to thoracic capillary vessel leakage in mice, carrageenan-induced oedema, carrageenan-induced pleurisy, acute lung damage in rats. The mechanisms for the anti-inflammatory effects probably involve decreasing prostaglandin-E(2) (PGE(2)) and nitric oxide (NO) levels. In rats with Freund's complete adjuvant (FCA) induced arthritis, propolis extracts significantly inhibited the increase of interleukin-6 (IL-6) in inflamed tissues, but had no significant effect on levels of interleukin-2 (IL-2) and interferon-gamma (IFN-gamma). The results are consistent with the interpretation that EEP and WSD may exert these effects by inhibiting the activation and differentiation of mononuclear macrophages.

Quantitative ultrasound of the calcaneus reflects the mechanical properties of calcaneal trabecular bone.

To provide new information about the potential role of quantitative ultrasound (QUS) in fracture risk prediction, we assessed whether QUS and densitometric variables derived from measurements of intact cadaveric feet were associated with the mechanical properties of calcaneal trabecular bone. We obtained 31 intact cadaveric feet from the local anatomic gifts program, including 13 men and 18 women, with a mean age of 77 years (range 50-91 years). Broadband ultrasound attenuation (BUA) and ultrasound transit velocity (SOS) were assessed in the intact cadaveric feet using a water-based ultrasound system. In addition, we measured the bone mineral density (BMD) of the posterior calcaneus using dual-energy X-ray absorptiometry. Cubes of trabecular bone were then removed from the calcaneus at approximately the same location as the QUS measurements were obtained, and the elastic modulus and ultimate strength of the trabecular bone specimens were measured by compressing them in the mediolateral direction. We found that QUS variables were moderately to strongly correlated with the mechanical properties of calcaneal trabecular bone (r2 = 0.48-0.63, p < 0.001 for all). However, the strongest associations with the mechanical properties trabecular bone were provided by calcaneus BMD and trabecular bone apparent density (r2 = 0.66-0.88). BUA and densitometric measurements were independently associated with elastic modulus, but not with ultimate strength. Our results indicate that QUS measurements of the intact heel are associated with the mechanical properties of calcaneal trabecular bone and, in some cases, provide information in addition to that provided by BMD or density measurements.

First approximation to a phenology of the honeybees (Apis mellifera) and flora of Africa.

Peak flowering by the total flora of Africa coincides with or immediately follows peak rainfall. Flowering intensity of the total flora decreases with distance from the equator, but that of the honeybee plant resource base (±2% of total flora) does not. Flowering in the latter is highly synchronous (months 1-5 north of and 9-11 south of the equator). Both total and honeybee flora are completely incongruent with either the biomes or phytochoria of Africa. There is no significant correspondence between honeybee phenology and the total flora but significant correspondence occurs between honeybees and flowering in honeybee plant genera. A logistic regression model reveals that honeybee plant flowering predicts major honeybee colony events with a probability of 0.81 south of the equator and 0.71 for the whole continent. It is postulated that promiscuity in the bee plant genera and honeybees of Africa have contributed to their continental ubiquity.

The effect of an educational intervention on patients' knowledge about hypertension, beliefs about medicines, and adherence.

BACKGROUND: The burden of chronic noncommunicable diseases continues to rise in South Africa, leading to high rates of morbidity and mortality. The control of hypertension is far from optimal because of factors such as inadequate patient understanding of the condition and its therapy, as well as poor adherence to prescribed regimens. OBJECTIVE: This study investigated the effect of an educational intervention on selected hypertensive participants' levels of knowledge about hypertension, their beliefs about medicines, and adherence to antihypertensive therapy. METHOD: Participants took part in an educational intervention that provided them with information about hypertension and its therapy through presentations, monthly meetings, and a summary information leaflet. The participants' levels of knowledge about hypertension and its therapy as well as their beliefs about medicines were measured using interviews and/or self-administered questionnaires. Levels of adherence were assessed using pill counts, self-reports, and punctuality in collecting medication refills. Paired t tests for dependent samples were performed to compare the participants' levels of knowledge about hypertension and its therapy, beliefs about medicines, and levels of adherence to antihypertensive therapy before and after the educational intervention. RESULTS: There were significant increases in the participants' levels of knowledge about hypertension and its therapy (P<.0001). Most of the parameters used to indicate beliefs about medicines were significantly modified in a positive manner (P<.01 for concerns about medicines, P<.01 for beliefs about the harmful nature of medicines, and P<.01 for the necessity-concerns differential). CONCLUSION: Results of this study show that the educational intervention led to an increase in the participants' levels of knowledge about hypertension and a positive influence on their beliefs about medicines. Despite these positive changes, adequate time is required before anticipated behavioral changes, such as increased adherence, can be observed.

[Nonmedical treatment of dementia]. / Nichtpharmakologische Behandlungsmethoden bei Demenzen.

Dementia is a highly prevalent condition. While randomized clinical trials of high quality provide strong evidence for newly developed drugs for dementia, nonpharmacological treatments are investigated mostly in smaller, lower-quality studies although they show promise and are being intensively studied in Europe and the USA. There are indications that programmes based on psychotherapy and neuropsychology can be effective in the early stages of dementia. Ergotherapy during the early and middle stages can delay the loss of abilities for daily living. Validation can ease problems presented by "challenging" behaviour for family members and care personnel. Education of family members has great potential for delaying insitutionalisation and should be integral to every treatment for dementia.

Dancing to different tunes: heterospecific deciphering of the honeybee waggle dance.

Although the structure of the dance language is very similar among species of honeybees, communication of the distance component of the message varies both intraspecifically and interspecifically. However, it is not known whether different honeybee species would attend interspecific waggle dances and, if so, whether they can decipher such dances. Using mixed-species colonies of Apis cerana and Apis mellifera, we show that, despite internal differences in the structure of the waggle dances of foragers, both species attend, and act on the information encoded in each other's waggle dances but with limited accuracy. These observations indicate that direction and distance communication pre-date speciation in honeybees.

Honeybee (Apis cerana) foraging responses to the toxic honey of Tripterygium hypoglaucum (Celastraceae): changing threshold of nectar acceptability.

To investigate honeybee foraging responses to toxic nectar, honey was collected from Apis cerana colonies in the Yaoan county of Yunnan Province, China, during June, when flowers of Tripterygium hypoglaucum were the main nectar source available. Pollen analysis confirmed the origin of the honey, and high-performance liquid chromatography showed the prominent component triptolide to be present at a concentration of 0.61 mug/g +/- 0.11 SD. In cage tests that used young adult worker bees, significantly more of those provided with a diet of T. hypoglaucum honey mixed with sugar powder (1:1) died within 6 d (68.3%) compared to control groups provided with normal honey mixed with sugar powder (15.8%). Honeybees were trained to visit feeders that contained honey of T. hypoglaucum (toxic honey) as the test group and honey of Vicia sativa or Elsholtzia ciliata as control groups (all honeys diluted 1:3 with water). Bees preferred the feeders with normal honey to those with toxic honey, as shown by significantly higher visiting frequencies and longer imbibition times. However, when the feeder of normal honey was removed, leaving only honey of T. hypoglaucum, the foraging bees returned to the toxic honey after a few seconds of hesitation, and both visiting frequency and imbibition time increased to values previously recorded for normal honey. Toxic honey thus became acceptable to the bees in the absence of other nectar sources.

Bee-hawking by the wasp, Vespa velutina, on the honeybees Apis cerana and A. mellifera.

The vespine wasps, Vespa velutina, specialise in hawking honeybee foragers returning to their nests. We studied their behaviour in China using native Apis cerana and introduced A. mellifera colonies. When the wasps are hawking, A. cerana recruits threefold more guard bees to stave off predation than A. mellifera. The former also utilises wing shimmering as a visual pattern disruption mechanism, which is not shown by A. mellifera. A. cerana foragers halve the time of normal flight needed to dart into the nest entrance, while A. mellifera actually slows down in sashaying flight manoeuvres. V. velutina preferentially hawks A. mellifera foragers when both A. mellifera and A. cerana occur in the same apiary. The pace of wasp-hawking was highest in mid-summer but the frequency of hawking wasps was three times higher at A. mellifera colonies than at the A. cerana colonies. The wasps were taking A. mellifera foragers at a frequency eightfold greater than A. cerana foragers. The final hawking success rates of the wasps were about three times higher for A. mellifera foragers than for A. cerana. The relative success of native A. cerana over European A. mellifera in thwarting predation by the wasp V. velutina is interpreted as the result of co-evolution between the Asian wasp and honeybee, respectively.