Histopathologic regression in patients with primary cutaneous melanoma undergoing sentinel lymph node biopsy is associated with favorable survival and, after metastasis, with improved progression-free survival on immune checkpoint inhibitor therapy: A single-institutional cohort study.

BACKGROUND: Histopathologic regression of cutaneous melanoma is considered a favorable prognostic factor, but its significance in clinical practice remains controversial. OBJECTIVE: To investigate the prognostic importance of regression in patients with primary cutaneous melanoma undergoing sentinel lymph node (SLN) biopsy and to assess its significance in patients progressing to an unresectable stage requiring systemic therapy. METHODS: We retrospectively reviewed patients with newly diagnosed melanoma undergoing SLN biopsy between 2010 and 2015 and available information on histopathologic regression (n = 1179). Survival data and associations of clinical variables with SLN status were assessed. RESULTS: Patients with regressive melanoma showed favorable relapse-free (hazard ratio [HR], 0.52; P = .00013), distant metastasis-free (HR, 0.56; P = .0020), and melanoma-specific survival (HR, 0.35; P = .00053). Regression was associated with negative SLN (odds ratio, 0.48; P = .0077). In patients who progressed to an unresectable stage, regression was associated with favorable progression-free survival under immune checkpoint inhibition (HR, 0.43; P = .031) but not under targeted therapy (HR, 1.14; P = .73) or chemotherapy (HR, 3.65; P = .0095). LIMITATIONS: Retrospective, single-institutional design. CONCLUSIONS: Regression of cutaneous melanoma is associated with improved prognosis in patients eligible for SLN biopsy as well as in patients with unresectable disease receiving systemic therapy with immune checkpoint inhibitors.

Multimodal home-based rehabilitation intervention after discharge from inpatient geriatric rehabilitation (GeRas): study protocol for a multicenter randomized controlled trial.

BACKGROUND: Geriatric rehabilitation aims to maintain the functional reserves of older adults in order to optimize social participation and prevent disability. After discharge from inpatient geriatric rehabilitation, patients are at high risk for decreased physical capacity, increased vulnerability, and limitations in mobility. As a result, ageing in place becomes uncertain for a plethora of patients after discharge from geriatric rehabilitation and effective strategies to prevent physical decline are required. Collaboration between different health-care providers is essential to improve continuity of care after discharge from inpatient geriatric rehabilitation. The aim of this study is to evaluate the effectiveness of a multi-professional home-based intervention program (GeRas) to improve functional capacity and social participation in older persons after discharge from inpatient geriatric rehabilitation. METHODS: The study is a multicenter, three-arm, randomized controlled trial with a three-month intervention period. Two hundred and seventy community-dwelling older people receiving inpatient geriatric rehabilitation will be randomized with a 1:1:1 ratio to one of the parallel intervention groups (conventional IG or tablet IG) or the control group (CG). The participants of both IGs will receive a home-based physical exercise program supervised by physical therapists, a nutritional recommendation by a physician, and social counseling by social workers of the health insurance company. The collaboration between the health-care providers and management of participants will be realized within a cloud environment based on a telemedicine platform and supported by multi-professional case conferences. The CG will receive usual care, two short handouts on general health-related topics, and facultative lifestyle counseling with general recommendations for a healthy diet and active ageing. The primary outcomes will be the physical capacity measured by the Short Physical Performance Battery and social participation assessed by the modified Reintegration to Normal Living Index, three months after discharge. DISCUSSION: The GeRas program is designed to improve the collaboration between health-care providers in the transition from inpatient geriatric rehabilitation to outpatient settings. Compared to usual care, it is expected to improve physical capacity and participation in geriatric patients after discharge from inpatient geriatric rehabilitation. TRIAL REGISTRATION: German Clinical Trials Register (DRKS00029559). Registered on October 05, 2022.

Prevention at home in older persons with (pre-)frailty: analysis of participants' recruitment and characteristics of the randomized controlled PromeTheus trial.

BACKGROUND: The "PromeTheus" trial is evaluating a home-based, multifactorial, interdisciplinary prevention program for community-dwelling (pre-)frail older adults. These individuals often suffer from reduced participation, which can complicate the recruitment and enrollment in a clinical trial. AIMS: The aim of this study was to evaluate different recruitment strategies and differences in participant characteristics in relation to these strategies. METHODS: This cross-sectional study used baseline data from the randomized-controlled PromeTheus trial, in which community-dwelling (pre-)frail older persons (Clinical Frailty Scale [CFS] 4-6 pt., ≥ 70 years) were recruited via general practitioners ("GP recruitment") or flyers, newspaper articles, and personalized letters ("direct recruitment"). Differences in the sociodemographic, clinical, physical, functional, mobility-related, psychological and social characteristics were analyzed in relation to the recruitment strategy. RESULTS: A total of 385 participants (mean age = 81.2, SD 5.9 years; women: n = 283, 73.5%) were enrolled, of which 60 (16%) were recruited by GPs and 325 (84%) through direct recruitment. Participants recruited via GPs had significantly higher subjective frailty levels (CFS), were more often physically frail (Fried Frailty Phenotype), and showed lower physical capacity (Short Physical Performance Battery), participation (disability component of the short version of the Late-Life Function and Disability Instrument), and life-space mobility (Life-Space Assessment) compared to those recruited via the direct approach (p = 0.002-0.026). Costs per randomized participant were 94€ for the GP recruitment strategy and €213 for the direct recruitment strategy. CONCLUSION: Different strategies may be required to successfully recruit (pre-)frail home-living older adults into preventive programs. Direct recruitment strategies, in which potential participants are directly informed about the prevention program, seem to be more promising than GP recruitment but may result in enrolment of persons with less functional impairment and higher recruitment costs. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00024638. Registered on March 11, 2021.

"TiC-TUG": technology in clinical practice using the instrumented timed up and go test-a scoping review.

Digitized assessments have a considerable potential to guide clinicial decision making and monitor progress and disease trajectories. The Timed Up and Go test (TUG) has been long established for assessment in geriatric medicine and instrumented versions (iTUG) have been developed and validated. This scoping review includes studies that applied the iTUG and aims to identify use cases to show where and how iTUG assessment could guide interventions and clinical management. The literature search was limited to peer-reviewed studies that performed pre- and post-intervention measurements with a 3-meter TUG instrumented with body-worn technology in samples of at least 20 subjects aged 60+ years. Of 3018 identified articles 20 were included. Four clinical use cases were identified: stratification for subsequent therapy, monitoring of disease or treatment-associated changes and evaluation of interventions in patients with idiopathic normal pressure hydrocephalus (1), and patients with Parkinson's disease (2); monitoring after joint replacement surgery (3), and evaluation after different exercise and rehabilitation interventions (4). The included studies show diversity in terms of iTUG technology and procedures. The identified use cases highlight clinical relevance and high potential for the clinical application of the iTUG. A consensual approach as well as comprehensive reporting would help to further exploit the potential of the iTUG to support clinical management. Future studies should investigate the benefits of segmental iTUG analysis, responsiveness and participants' perspectives on clinically meaningful changes in iTUG.

Measuring health-related quality of life in sarcopenia: summary of the SarQoL psychometric properties.

Patient perspectives are now widely recognized as a key element in the evaluation of health interventions. Therefore, the provision of specific and validated Patient Reported Outcome Measures that emphasize the lived experience of patients suffering from specific diseases is very important. In the field of sarcopenia, the only validated specific health-related quality of life (HRQoL) instrument available is the Sarcopenia Quality of Life questionnaire (SarQoL). This self-administrated HRQoL questionnaire, developed in 2015, consists of 55 items arranged into 22 questions and has currently been translated into 35 languages. Nineteen validation studies performed on SarQoL have consensually confirmed the capacity of SarQoL to detect difference in HRQoL between older people with and without sarcopenia, its reliability and its validity. Two further observational studies have also indicated its responsiveness to change. A short form SarQoL, including only 14 items has further been developed and validated to reduce the potential burden of administration. Research on the psychometric properties of SarQoL questionnaire is still encouraged as the responsiveness to change of SarQoL has not yet been measured in the context of interventional studies, as limited prospective data currently exist and as there is still not cut-off score to define a low HRQoL. In addition, SarQoL has mainly been used in community-dwelling older individuals with sarcopenia and would benefit to be studied in other types of populations. This review aims to provide to researchers, clinicians, regulators, pharmaceutical industries and other stakeholders a clear summary of comprehensive evidence on the SarQoL questionnaire published up to January 2023Query.

[Motivational Reasons and Perceptions about Future Participation of Older People in the Research and Development Process of Health Technologies: a Mixed Methods Study]. / Motivationsgründe und Vorstellungen über eine zukünftige Beteiligung älterer Menschen im Forschungs- und Entwicklungsprozess von Gesundheitstechnologien ­ eine Mixed Methods-Studie.

BACKGROUND: Although digital approaches for disease prevention in older people have a high potential and are being used more often, there are still inequalities in access and use. One reason could be that in technology development future users are insufficiently taken into consideration, or involved very late in the process using inappropriate methods. The aim of this work was to analyze the motivation of older people participating, and their perceptions of future participation in the research and development process of health technologies aimed at health care for older people. METHODOLOGY: Quantitative and qualitative data from one needs assessment and two evaluation studies were analyzed. The quantitative data were analyzed descriptively and the qualitative data were analyzed content-analytically with inductive-deductive category formation. RESULTS: The median age of the 103 participants (50 female) was 75 years (64-90), most of whom were interested in using technology and had prior experience of study participation. Nine categories for participation motivation were derived. A common motivation for participation was to promote and support their own health. Respondents were able to envision participation both at the beginning of the research process and at its end. In terms of technique development, different ideas were expressed, but there was a general interest in technological development. Methods that would enable exchange with others were favored most. CONCLUSIONS: Differences in motivation to participate and ideas about participation were identified. The results provide important information from the perspective of older people and complement the existing state of research.

Dietary protein intake and health-related outcomes: a methodological protocol for the evidence evaluation and the outline of an evidence to decision framework underlying the evidence-based guideline of the German Nutrition Society.

PURPOSE: The present work aimed to delineate (i) a revised protocol according to recent methodological developments in evidence generation, to (ii) describe its interpretation, the assessment of the overall certainty of evidence and to (iii) outline an Evidence to Decision framework for deriving an evidence-based guideline on quantitative and qualitative aspects of dietary protein intake. METHODS: A methodological protocol to systematically investigate the association between dietary protein intake and several health outcomes and for deriving dietary protein intake recommendations for the primary prevention of various non-communicable diseases in the general adult population was developed. RESULTS: The developed methodological protocol relies on umbrella reviews including systematic reviews with or without meta-analyses. Systematic literature searches in three databases will be performed for each health-related outcome. The methodological quality of all selected systematic reviews will be evaluated using a modified version of AMSTAR 2, and the outcome-specific certainty of evidence for systematic reviews with or without meta-analysis will be assessed with NutriGrade. The general outline of the Evidence to Decision framework foresees that recommendations in the derived guideline will be given based on the overall certainty of evidence as well as on additional criteria such as sustainability. CONCLUSION: The methodological protocol permits a systematic evaluation of published systematic reviews on dietary protein intake and its association with selected health-related outcomes. An Evidence to Decision framework will be the basis for the overall conclusions and the resulting recommendations for dietary protein intake.

Nurses' competence in recognition and management of delirium in older patients: development and piloting of a self-assessment tool.

BACKGROUND: Delirium is a common condition in elderly inpatients. Health care professionals play a crucial role in recognizing delirium, initiating preventive measures and implementing a multicomponent treatment strategy. Yet, delirium often goes unrecognized in clinical routine. Nurses take an important role in preventing and managing delirium. This study assesses clinical reasoning of nurses using case vignettes to explore their competences in recognizing, preventing and managing delirium. METHODS: The study was conducted as an online survey. The questionnaire was based on five case vignettes presenting cases of acutely ill older patients with different subtypes of delirium or diseases with overlapping symptoms. In a first step, case vignettes were developed and validated through a multidisciplinary expert panel. Scoring of response options were summed up to a Geriatric Delirium Competence Questionnaire (GDCQ) score including recognition and management tasks The questionnaire was made available online. Descriptive analyses and group comparisons explores differences between nurses from different settings. Factors explaining variance in participants' score were evaluated using correlations and linear regression models. RESULTS: The questionnaire demonstrated good content validity and high reliability (kappa = 0.79). The final sample consisted of 115 nurses. Five hundred seventy-five case vignettes with an accuracy of 0.71 for the correct recognition of delirium presence or absence were solved. Nurses recognized delirium best in cases describing hyperactive delirium (79%) while hypoactive delirium was recognized least (44%). Nurses from geriatric and internal medicine departments had significantly higher GDCQ-score than the other subgroups. Management tasks were correctly identified by most participants. CONCLUSIONS: Overall, nurses' competence regarding hypoactive delirium should be strengthened. The online questionnaire might facilitate targeting training opportunities to nurses' competence.

A multifactorial interdisciplinary intervention to prevent functional and mobility decline for more participation in (pre-)frail community-dwelling older adults (PromeTheus): study protocol for a multicenter randomized controlled trial.

BACKGROUND: Age-related decline in physical capacity can lead to frailty, associated with an increased vulnerability to adverse health outcomes and greater healthcare utilization. In an aging population, effective strategies to prevent physical decline and frailty, and preserve independence are needed. Prevention programs for vulnerable community-dwelling older adults are, however, often not yet established and implemented in routine practice. Research on the feasibility, implementation, and (cost-)effectiveness of multifactorial, interdisciplinary intervention programs that take advantage of available services of healthcare providers is also limited. The main aim of this study is to evaluate the effectiveness of such an intervention program (PromeTheus) to prevent functional and mobility decline for more participation in community-dwelling (pre-)frail older adults. METHODS: The study is designed as a three-center, randomized controlled trial with a 12-month intervention period. Four hundred community-dwelling (pre-)frail (Clinical Frailty Scale score 4-6) older adults (≥70 years) will be randomized in a 1:1 ratio to the intervention group (IG) or the control group (CG). The IG will receive the PromeTheus program consisting of obligatory home-based physical exercises (Weight-bearing Exercise for Better Balance) accompanied by physiotherapists and facultative counseling services (person-environment-fit, coping with everyday life, nutrition, group-based activities) delivered via existing healthcare structures (e.g., social workers, nutritionists). The CG will receive usual care and a one-time counseling session on recommendations for physical activity and nutrition. Primary outcomes assessed at months 6 and 12 are the function component of the Late-Life Function and Disability Instrument and the University of Alabama at Birmingham Life-Space Assessment. Secondary outcomes are disability, physical capacity and activity, frailty, nutritional status, falls, fear of falling, health status, and psychosocial components. Process and economic evaluations are also conducted. Primary statistical analyses will be based on the intention-to-treat principle. DISCUSSION: Compared to usual care, the PromeTheus program is expected to result in higher function and mobility, greater independence and lower need for care, and more participation. As the PromeTheus program draws on existing German healthcare structures, its large-scale translation and delivery will be feasible, if evidence of (cost-)effectiveness and successful implementation can be demonstrated. TRIAL REGISTRATION: German Clinical Trials Register, . Registered on March 11, 2021.

Using Sensor Graphs for Monitoring the Effect on the Performance of the OTAGO Exercise Program in Older Adults.

The OTAGO exercise program is effective in decreasing the risk for falls of older adults. This research investigated if there is an indication that the OTAGO exercise program has a positive effect on the capacity and as well as on the performance in mobility. We used the data of the 10-months observational OTAGO pilot study with 15 (m = 1, f = 14) (pre-)frail participants aged 84.60 y (SD: 5.57 y). Motion sensors were installed in the flats of the participants and used to monitor their activity as a surrogate variable for performance. We derived a weighted directed multigraph from the physical sensor network, subtracted the weights of one day from a baseline, and used the difference in percent to quantify the change in performance. Least squares was used to compute the overall progress of the intervention (n = 9) and the control group (n = 6). In accordance with previous studies, we found indication for a positive effect of the OTAGO program on the capacity in both groups. Moreover, we found indication that the OTAGO program reduces the decline in performance of older adults in daily living. However, it is too early to conclude causalities from our findings because the data was collected during a pilot study.

Measurement System for Unsupervised Standardized Assessments of Timed Up and Go Test and 5 Times Chair Rise Test in Community Settings-A Usability Study.

Comprehensive measurements are needed in older populations to detect physical changes, initiate prompt interventions, and prevent functional decline. While established instruments such as the Timed Up and Go (TUG) and 5 Times Chair Rise Test (5CRT) require trained clinicians to assess corresponding functional parameters, the unsupervised screening system (USS), developed in a two-stage participatory design process, has since been introduced to community-dwelling older adults. In a previous article, we investigated the USS's measurement of the TUG and 5CRT in comparison to conventional stop-watch methods and found a high sensitivity with significant correlations and coefficients ranging from 0.73 to 0.89. This article reports insights into the design process and evaluates the usability of the USS interface. Our analysis showed high acceptance with qualitative and quantitative methods. From participant discussions, suggestions for improvement and functions for further development could be derived and discussed. The evaluated prototype offers a high potential for early detection of functional limitations in elderly people and should be tested with other target groups in other locations.

[Sarcopenia-what should the orthopedist know?] / Sarkopenie ­ was sollte der Orthopäde wissen?

Sarcopenia - the age-associated loss of muscle function and muscle mass - is of utmost importance for older patients with degenerative and traumatic diseases of the musculoskeletal system, as it closely linked to the loss of independence and quality of life in higher age. Impairments of mobility that are highly present in this patient group accelerate the age-associated decline of muscle function and muscle mass. The diagnosis of sarcopenia relies primarily on tests of strength and function like handgrip, chair-rise test and gait speed. The measurement of muscle mass is desirable, but not mandatory. In the near future the prevention and treatment of sarcopenia has to become part of the clinical routine for older orthopedic patients. Specific modifications of physical exercise like resistance training and optimal nutrition with regard to protein intake (1.0-1.2 g/kg bodyweight per day) in combination with vitamin D supplementation are key components of sarcopenia prevention and therapy.

[Diagnosis of frailty as starting point for training interventions]. / Frailty-Diagnose als Ausgangspunkt einer Trainingsintervention.

The concept of frailty describes an older at-risk population, which has a higher probability for the occurrence of unfavorable health outcomes. It is in the interest of frail individuals as well as the healthcare system to improve the prognosis of these people by targeted interventions. Several systematic reviews and meta-analyses are now available comparing very different interventions in frail older adults. These studies came to the conclusion that training interventions were found to be the most effective. Compared to exercise interventions delivered at participants homes, exercise in groups was found to be more effective. The case finding for such interventions should be carried out with frailty instruments that focus on strength, endurance and/or physical activity. Particularly suitable for this are the frailty criteria of Fried, gait speed or the short physical performance battery (SPPB). From a geriatrics perspective, a comprehensive offer of group training seems to be urgently necessary; however, the implementation requires a large expansion of existing structures and new ways to reach older people with frailty.

Assessing life-space mobility : A systematic review of questionnaires and their psychometric properties.

BACKGROUND: Life-space mobility (LSM), as the extent of mobility within one's environment, is a key for successful aging and has become a relevant concept in gerontology and geriatric research. Adequate assessment instruments are needed to identify older persons with LSM restrictions, and to initiate, adapt or evaluate intervention strategies. OBJECTIVE: To systematically identify, describe and analyze the psychometric properties of LSM questionnaires, with a special focus on their availability in the German language. METHODS: A systematic literature search was conducted in PubMed, PsycINFO, Cochrane Library, CINAHL, and Web of Science. Studies that examined at least one psychometric property of LSM questionnaires published up to August 2021 were included and evaluated based on the consensus-based standards for the selection of health measurement instruments (COSMIN) guidelines. RESULTS: This study included 37 validation studies describing 13 different LSM questionnaires. Methodological quality and comprehensiveness of validations were heterogeneous. Based on comprehensive and high-quality results, four LSM questionnaires stood out: the University of Alabama at Birmingham life-space assessment (UAB-LSA), life-space assessment in persons with cognitive impairment (LSA-CI), interview-based and proxy-based versions of the life-space assessment in institutionalized settings (LSA-IS), all of them available in the German language. CONCLUSION: This systematic review provides a concise overview of available LSM questionnaires and their psychometric properties to facilitate the selection for use in clinical practice and research. The UAB-LSA and LSA-CI for community settings and the interview-based or proxy-based LSA-IS for institutional settings were found to be the most appropriate LSM questionnaires.

[Digital geriatric self-assessment-A narrative review]. / Digitales geriatrisches Self-Assessment ­ ein narratives Review.

BACKGROUND: Digital health apps have a large potential for autonomous screening and monitoring of older people with respect to maintaining their independence. Due to demographic change and the shortage of specialized personnel in medicine, these premedical self-assessment apps could be of great value in the future. OBJECTIVE: This narrative review enables the assessment of whether a digital geriatric self-assessment for older people ≥ 70 years is feasible using currently available apps. MATERIAL AND METHODS: A search was carried out for apps that enable a self-assessment in the following domains: physical capacity, cognition, emotion, nutrition, sensory perception and context factors. Based on predefined criteria apps were selected and presented. RESULTS: Self-assessment apps could be identified in four of the six domains: physical capacity, cognition, emotion and sensory perception. In total five apps are presented as examples. No apps were identified regarding nutrition and context factors. Numerous self-assessment apps were identified for the field of physical activity. CONCLUSION: The presented results indicate that digital self-assessment can currently be realized for certain domains of the comprehensive geriatric assessment. New promising apps are currently under development. More research is needed to verify test quality criteria and usability of available apps. Furthermore, there is a need for a platform that integrates individual assessment apps to provide users with an overview of the results and recommendations.

The COVID rehabilitation paradox: why we need to protect and develop geriatric rehabilitation services in the face of the pandemic.

Older multi-morbid persons often fall seriously ill due to COVID-19. To be able to participate in a social life again, they often need special rehabilitation measures. Geriatric rehabilitation is a multi-professional service geared to these needs. Paradoxically, however, capacities in geriatric rehabilitation are currently being reduced despite increasing demand. The reasons are manifold and are not only due to the current situation. This article highlights the current situation leading to the COVID rehabilitation paradox and shows ways to learn from it for the future.

Experts' preferences for sarcopenia outcomes: a discrete-choice experiment from a working group of the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) in collaboration with the European Union of Geriatric Medicine Society (EUGMS).

BACKGROUND AND AIMS: To assess experts' preference for sarcopenia outcomes. METHODS: A discrete-choice experiment was conducted among 37 experts (medical doctors and researchers) from different countries around the world. In the survey, they were repetitively asked to choose which one of two hypothetical patients suffering from sarcopenia deserves the most a treatment. The two hypothetical patients differed in five pre-selected sarcopenia outcomes: quality of life, mobility, domestic activities, fatigue and falls. A mixed logit panel model was used to estimate the relative importance of each attribute. RESULTS: All sarcopenia outcomes were shown to be significant, and thus, important for experts. Overall, the most important sarcopenia outcome was falls (27%) followed by domestic activities and mobility (24%), quality of life (15%) and fatigue (10%). DISCUSSION AND CONCLUSION: Compared to patient's preferences, experts considered falls as a more important outcome of sarcopenia, while the outcomes fatigue and difficulties in domestic activities were considered as less important.

Update on the ESCEO recommendation for the conduct of clinical trials for drugs aiming at the treatment of sarcopenia in older adults.

BACKGROUND: In 2016, an expert working group was convened under the auspices of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) and formulated consensus recommendations for the conduct of clinical trials for drugs to prevent or treat sarcopenia. AIMS: The objective of the current paper is to provide a 2020 update of the previous recommendations in accordance with the evidence that has become available since our original recommendations. METHODS: This paper is based on literature reviews performed by members of the ESCEO working group and followed up with face to face meetings organized for the whole group to make amendments and discuss further recommendations. RESULTS: The randomized placebo-controlled double-blind parallel-arm drug clinical trials should be the design of choice for both phase II and III trials. Treatment and follow-up should run at least 6 months for phase II and 12 months for phase III trials. Overall physical activity, nutrition, co-prescriptions and comorbidity should be recorded. Participants in these trials should be at least 70-years-old and present with a combination of low muscle strength and low physical performance. Severely malnourished individuals, as well as bedridden patients, patients with extremely limited mobility or individuals with physical limitations clearly attributable to the direct effect of a specific disease, should be excluded. Multiple outcomes are proposed for phase II trials, including, as example, physical performance, muscle strength and mass, muscle metabolism and muscle-bone interaction. For phase III trials, we recommend a co-primary endpoint of a measure of functional performance and a Patient Reported Outcome Measure. CONCLUSION: The working group has formulated consensus recommendations on specific aspects of trial design, and in doing so hopes to contribute to an improvement of the methodological robustness and comparability of clinical trials. Standardization of designs and outcomes would advance the field by allowing better comparison across studies, including performing individual patient-data meta-analyses, and different pro-myogenic therapies.

[Clinical importance of the detection of frailty]. / Klinische Bedeutung der Erfassung von Frailty.

Frailty is a multidimensional geriatric syndrome characterized by the loss of the individual reserve capacity and increased vulnerability to internal and external stressors. Frailty in older adults is associated with an increased risk for falls and loss of autonomy as well as an increased mortality. The identification of patients who suffer from frailty can trigger a comprehensive geriatric assessment and justify targeted treatment options. Furthermore, by the detection of frailty each patient with an increased risk of an unfavorable treatment outcome can be identified. There are a confusing number of instruments available for the detection of frailty but only a limited number of these instruments are available in a German version. The choice of an appropriate instrument is largely dependent on the clinical setting and the available resources.

Evidence gap on antihyperglycemic pharmacotherapy in frail older adults : A systematic review.

BACKGROUND: Although antihyperglycemic pharmacotherapy in frail older adults with type 2 diabetes mellitus (T2DM) is challenging, recommendations from international guidelines are mainly based on indirect evidence from trials not including frail participants. OBJECTIVE: This systematic review investigated the effectiveness and safety of pharmacotherapy in frail older adults with T2DM. MATERIAL AND METHODS: Randomized (RCT) and non-randomized prospective clinical trials (non-RCT) were searched in three electronic databases (Medline, Embase, Central) up to October 2018. Trials in older adults with T2DM who were assessed as significantly or severely impaired by defined cut-off scores of assessment instruments on frailty, activities of daily living or physical functional impairment were included. RESULTS: Two reviewers independently screened 17,391 references for inclusion and assessed risk of bias with ROBINS­I. Five non-RCTs and no RCT were identified. Treatment of T2DM without insulin compared to insulin could be associated with increased improvement in cardiac functions in patients with cardiac resynchronization therapy and with decreased falls in frail older women. While better glycemic control with low variability and low HbA1c (hemoglobin A1c) values (<7%) was associated with better maintenance of physical function in community-dwelling older persons, higher HbA1c values (8-8.9%) were associated with a reduction in the composite outcome of death or functional decline in community-dwelling diabetic older adults with need for skilled assistance. Due to serious risk of bias in all studies, results should be considered with caution. CONCLUSION: Well-designed, large-scale RCTs including this important group of patients are required to assess the effectiveness and safety of pharmacotherapy and HbA1c targets.