Dagmar Lühmann

Falls prevention for the elderly

Background An ageing population, a growing prevalence of chronic diseases and limited financial resources for health care underpin the importance of prevention of disabling health disorders and care dependency in the elderly. A wide variety of measures is generally available for the prevention of falls and fall-related injuries. The spectrum ranges from diagnostic procedures for identifying individuals at risk of falling to complex interventions for the removal or reduction of identified risk factors. However, the clinical and economic effectiveness of the majority of recommended strategies for fall prevention is unclear. Against this background, the literature analyses in this HTA report aim to support decision-making for effective and efficient fall prevention. Research questions The pivotal research question addresses the effectiveness of single interventions and complex programmes for the prevention of falls and fall-related injuries. The target population are the elderly (> 60 years), living in their own housing or in long term care facilities. Further research questions refer to the cost-effectiveness of fall prevention measures, and their ethical, social and legal implications. Methods Systematic literature searches were performed in 31 databases covering the publication period from January 2003 to January 2010. While the effectiveness of interventions is solely assessed on the basis of randomised controlled trials (RCT), the assessment of the effectiveness of diagnostic procedures also considers prospective accuracy studies. In order to clarify social, ethical and legal aspects all studies deemed relevant with regard to content were taken into consideration, irrespective of their study design. Study selection and critical appraisal were conducted by two independent assessors. Due to clinical heterogeneity of the studies no meta-analyses were performed. Results Out of 12,000 references retrieved by literature searches, 184 meet the inclusion criteria. However, to a variable degree the validity of their results must be rated as compromised due to different biasing factors. In summary, it appears that the performance of tests or the application of parameters to identify individuals at risk of falling yields little or no clinically relevant information. Positive effects of exercise interventions may be expected in relatively young and healthy seniors, while studies indicate opposite effects in the fragile elderly. For this specific vulnerable population the modification of the housing environment shows protective effects. A low number of studies, low quality of studies or inconsistent results lead to the conclusion that the effectiveness of the following interventions has to be rated unclear yet: correction of vision disorders, modification of psychotropic medication, vitamin D supplementation, nutritional supplements, psychological interventions, education of nursing personnel, multiple and multifactorial programs as well as the application of hip protectors. For the context of the German health care system the economic evaluations of fall prevention retrieved by the literature searches yield very few useful results. Cost-effectiveness calculations of fall prevention are mostly based on weak effectiveness data as well as on epidemiological and cost data from foreign health care systems. Ethical analysis demonstrates ambivalent views of the target population concerning fall risk and the necessity of fall prevention. The willingness to take up preventive measures depends on a variety of personal factors, the quality of information, guidance and decision-making, the prevention program itself and social support. The analysis of papers regarding legal issues shows three main challenges: the uncertainty of which standard of care has to be expected with regard to fall prevention, the necessity to consider the specific conditions of every single case when measures for fall prevention are applied, and the difficulty to balance the rights to autonomous decision making and physical integrity. Discussion and conclusions The assessment of clinical effectiveness of interventions for fall prevention is complicated by inherent methodological problems (esp. absence of blinding) and meaningful clinical heterogeneity of available studies. Therefore meta-analyses are not appropriate, and single study results are difficult to interpret. Both problems also impair the informative value of economic analyses. With this background it has to be stated that current recommendations regarding fall prevention in the elderly are not fully supported by scientific evidence. In particular, for the generation of new recommendations the dependency of probable effects on specific characteristics of the target populations or care settings should be taken into consideration. This also applies to the variable factors influencing the willingness of the target population to take up and pursue preventive measures. In the planning of future studies equal weight should be placed on methodological rigour (freedom from biases) and transferability of results into routine care. Economic analyses require input of German data, either in form of a “piggy back study“ or in form of a modelling study that reflects the structures of the German health care system and is based on German epidemiological and cost data.

Informative value of Patient Reported Outcomes (PRO) in Health Technology Assessment (HTA).

Background “Patient-Reported Outcome” (PRO) is used as an umbrella term for different concepts for measuring subjectively perceived health status e. g. as treatment effects. Their common characteristic is, that the appraisal of the health status is reported by the patient himself. In order to describe the informative value of PRO in Health Technology Assessment (HTA) first an overview of concepts, classifications and methods of measurement is given. The overview is complemented by an empirical analysis of clinical trials and HTA-reports on rheumatoid arthritis and breast cancer in order to report on type, frequency and consequences of PRO used in these documents. Methods For both issues systematic reviews of the literature have been performed. The search for methodological literature covers the publication period from 1990 to 2009, the search for clinical trials of rheumatoid arthritis and breast cancer covers the period 2005 to 2009. Both searches were performed in the medical databases of the German Institute of Medical Documentation and Information (DIMDI). The search for HTA-reports and methodological papers of HTA-agencies was performed in the CRD-Databases (CRD = Centre for Reviews and Dissemination) and by handsearching the websites of INAHTA member agencies (INAHTA = International Network of Agencies for Health Technology Assessment). For all issues specific inclusion and exclusion criteria were defined. The methodological quality of randomized controlled trials (RCT) was assessed by a modified version of the Cochrane Risk of Bias Tool. For the methodological part information extraction from the literature is structured by the report’s chapters, for the empirical part data extraction sheets were constructed. All information is summarized in a qualitative manner. Results Concerning the methodological issues the literature search retrieved 158 documents (87 documents related to definition or classification, 125 documents related to operationalisation of PRO). For the empirical analyses 225 RCT (rheumatoid arthritis: 77; breast cancer: 148) and 40 HTA-reports and method papers were found. The analysis of the methodological literature confirms the role of PRO as an umbrella term for a variety of different concepts. The newest classification system facilitates the description of PRO measures by construct, target population and the method of measurement. Steps of operationalisation involve defining a conceptual framework, instrument development, exploration of measurement properties or, possibly, the modification of existing instruments. Seven out of 59 RCT analysing the effects of antibody therapy for rheumatoid arthritis define PRO as the primary endpoint, 38 trials utilize composite measures (ACR, DAS) and ten trials report clinical or radiological parameters as the primary endpoint. Six out of 123 chemotherapy trials for breast cancer define PRO as the primary endpoint, while 98 trials report clinical endpoints (survival, tumour response, progression) in their primary analyses. Discrepancies in the number of trials result from inaccurate specifications of endpoints in the publications. This distribution is reflected in the HTA-reports: while almost all reports on rheumatoid arthritis refer to PRO, this is only the case in about half of the reports on breast cancer. Conclusions As definition and classification of PRO are concerned, coherent concepts are found in the literature. Their operationalisation and implementation must be guided by scientific principles. The type and frequency of PRO used in clinical trials largely depend on the disease analysed. The HTA-community seems to pursue the utilization of PRO proactively – in case of missing data the need for further research is stated.

Medical specialist attendance in nursing homes

The care in nursing homes was examined based on scientific studies. The analysis focuses on dementia and type II diabetes. There is evidence for deficits in the supply of medical specialist attendance to nursing home residents with these diseases in Germany. Compared with corresponding guidelines the medical care for nursing home residents may be too low or inadequate.

Disentangling the complex relation of disability and depressive symptoms in old age - findings of a multicenter prospective cohort study in Germany

BACKGROUND Most of the previous studies attempted to disentangle the relationship between disability and depressive symptoms were limited to observation periods of only few years. Moreover, evidence is missing regarding the complex co-occurrence of disability and depressive symptoms in old age in Germany. In order to close the research gap, we aimed at disentangling the complex co-occurrence of disability and depressive symptoms in old age in Germany over a longer time frame. METHODS Based on data from a representative survey of the German general population aged 75 years and older, the course of disability as well as depressive symptoms was observed every 1.5 years over six waves. While disability was quantified by the Lawton and Brody Instrumental Activities of Daily Living scale, the Geriatric Depression Scale was used to measure depressive symptoms. Taking into account the complex co-occurrence of depressive symptoms and disability, a panel vector autoregressive model was used. By taking the first differences, unobserved heterogeneity was taken into account. RESULTS In the total sample and in both sexes, we revealed a robust positive association between an initial change in depressive symptoms and subsequent changes in disability. No robust association between an initial change in disability and a subsequent change in depressive symptoms was detected. CONCLUSION Our findings highlight the importance of changes in depressive symptoms for future changes in disability in old age.

Effect of Visual Impairment on Physical and Cognitive Function in Old Age: Findings of a Population‐Based Prospective Cohort Study in Germany

To examine how visual impairment affects physical and cognitive function in old age.

Unmet Care Needs in the Oldest Old Primary Care Patients with Cognitive Disorders: Results of the AgeCoDe and AgeQualiDe Study

Background: In the future, an increase in health care needs in the elderly is expected. Reports on unmet care needs of the oldest old with cognitive disorders are pending. This study aims at exploring unmet needs in the oldest old primary care patients with mild cognitive impairment (MCI) and dementia. Furthermore, the association between sociodemographic and clinical factors and unmet needs ought to be analyzed. Methods: Based on the study “Needs, Health Service Use, Costs and Health-Related Quality of Life in a Large Sample of Oldest-Old Primary Care Patients (85+)” (AgeQualiDe), 749 patients (unimpaired, MCI, and dementia) aged 85 years and older, their relatives (n = 421), and general practitioners (GPs) (n = 607) were assessed. Descriptive, inferential, and regression analyses were run. Results: Most unmet needs were observed in dementia patients, although needs were less frequently rated as unmet by dementia patients themselves as compared to relatives and GPs. Unmet needs were associated with MCI and dementia; other risk factors were age, education, and marital status. Conclusion: This study provides first data on unmet needs according to different perceptions in the elderly with MCI and dementia in Germany. Need assessments should be part of medical examinations to ensure a high-quality health care in the elderly.

Does visual impairment affect social ties in late life? Findings of a multicenter prospective cohort study in Germany

ObjectiveTo investigate how visual impairment affects social ties in late life longitudinally.DesignPopulation-based prospective cohort study.SettingIndividuals in old age were recruited via general practitioners’ offices (at six study centers) in Germany. They were interviewed every 18 months.ParticipantsIndividuals aged 75 years and above at baseline. Follow-up wave 2 (36 months after baseline, n=2,443) and wave 4 (72 months after baseline, n=1,618) were used for the analyses presented here.MeasurementsSocial ties were assessed using the 14-item form of the questionnaire for social support (F-SozU K-14). Visual impairment was self-rated on a three level Likert scale (no impairment, mild visual impairment, or severe/profound visual impairment).ResultsAdjusting for sociodemographic factors, hearing impairment and comorbidity, fixed effects regressions revealed that the onset of mild visual impairment decreased the social support score, in particular the emotional support score. Additionally, the onset of mild hearing impairment decreased the social support score in men. Moreover, increasing age decreased the social support score in the total sample and in both sexes. Loss of spouse and increasing comorbidity did not affect the social support score.ConclusionOur results highlight the importance of visual impairment for social ties in late life. Consequently, appropriate strategies in order to delay visual impairment might help to maintain social ties in old age.

Subjective cognitive decline is longitudinally associated with lower health-related quality of life

BACKGROUND Subjective cognitive decline (SCD), the potentially earliest notable manifestation of preclinical Alzheimers disease and other dementias, was consistently associated with lower quality of life in cross-sectional studies. The aim of this study was to investigate whether such an association persists longitudinally - particularly with health-related quality of life (HRQoL) in older individuals without cognitive impairment. METHODS Data were derived from follow-up 2-6 of the prospective Germany Study on Ageing, Cognition and Dementia in Primary Care (AgeCoDe) covering a total six-year observation period. We used linear mixed effects models to estimate the effect of SCD on HRQoL measured by the EQ-5D visual analogue scale (EQ VAS). RESULTS Of 1,387 cognitively unimpaired individuals aged 82.2 years (SD = 3.2) on average, 702 (50.6%) reported SCD and 230 (16.6%) with SCD-related concerns. Effect estimates of the linear mixed effects models revealed lower HRQoL in individuals with SCD (unadjusted: -3.7 points on the EQ VAS, 95%CI = -5.3 to -2.1; SE = 0.8; p < 0.001; adjusted: -2.9 points, 95%CI = -3.9 to -1.9; SE = 0.5; p < 0.001) than in individuals without SCD. The effect was most pronounced in SCD with related concerns (unadjusted: -5.4, 95%CI = -7.6 to -3.2; SE = 1.1; p < 0.001; adjusted: -4.3, 95%CI = -5.8 to -2.9, SE = 0.7; p < 0.001). CONCLUSION SCD constitutes a serious issue to older cognitively unimpaired individuals that is depicted in persisting lower levels of HRQoL beyond depressive symptoms and functional impairment. Therefore, SCD should be taken seriously in clinical practice.

Development of a meta-algorithm for guiding primary care encounters for patients with multimorbidity using evidence-based and case-based guideline development methodology

Objective The study aimed to develop a comprehensive algorithm (meta-algorithm) for primary care encounters of patients with multimorbidity. We used a novel, case-based and evidence-based procedure to overcome methodological difficulties in guideline development for patients with complex care needs. Study design Systematic guideline development methodology including systematic evidence retrieval (guideline synopses), expert opinions and informal and formal consensus procedures. Setting Primary care. Intervention The meta-algorithm was developed in six steps:1. Designing 10 case vignettes of patients with multimorbidity (common, epidemiologically confirmed disease patterns and/or particularly challenging health care needs) in a multidisciplinary workshop.2. Based on the main diagnoses, a systematic guideline synopsis of evidence-based and consensus-based clinical practice guidelines was prepared. The recommendations were prioritised according to the clinical and psychosocial characteristics of the case vignettes.3. Case vignettes along with the respective guideline recommendations were validated and specifically commented on by an external panel of practicing general practitioners (GPs).4. Guideline recommendations and experts’ opinions were summarised as case specific management recommendations (N-of-one guidelines).5. Healthcare preferences of patients with multimorbidity were elicited from a systematic literature review and supplemented with information from qualitative interviews.6. All N-of-one guidelines were analysed using pattern recognition to identify common decision nodes and care elements. These elements were put together to form a generic meta-algorithm. Results The resulting meta-algorithm reflects the logic of a GPs encounter of a patient with multimorbidity regarding decision-making situations, communication needs and priorities. It can be filled with the complex problems of individual patients and hereby offer guidance to the practitioner. Contrary to simple, symptom-oriented algorithms, the meta-algorithm illustrates a superordinate process that permanently keeps the entire patient in view. Conclusion The meta-algorithm represents the back bone of the multimorbidity guideline of the German College of General Practitioners and Family Physicians. This article presents solely the development phase; the meta-algorithm needs to be piloted before it can be implemented.

Regional variation of patient behaviour and reasons for consultation in the general practice of Northern Germany: protocol for an observational study

Introduction Inappropriate supply and an increasing demand on the healthcare system have been of concern for health policy in Germany for at least 15 years. In the primary care setting, this especially relates to an undersupply of general practitioners (GPs) in the countryside. In addition, there seem to be other regional differences, for example, a difference in accessing primary and secondary care between rural and urban areas. Despite these findings, regional differences in health services have not been studied extensively in Germany. Therefore, this study aims to explore regional variations of patient populations and reasons for accessing primary medical care. Methods and analysis We will conduct a cross-sectional observational study based on standardised interviews with 240 GPs and ∼1200 patients. Data collection started on 10 June 2015 and will probably be completed by 31 October 2016. We will include all districts and cities within 100 km from Hamburg and assign them according to the type of regions: rural, urban and environs. All eligible GPs will be invited to participate. Each practice will recruit up to 15 patients, aged 18 years or older. Questionnaires are based on a preliminary qualitative study and were pretested. Data will be analysed with descriptive statistics and regression modelling strategies adjusted for confounders and the GP-induced cluster structure. Ethics and dissemination Our study was approved by the Ethics Committee of the Medical Association of Hamburg and is conducted in accordance with the Declaration of Helsinki. Study participants give written informed consent before data collection and data is pseudonymised. Survey data and person identifiers are stored separately in locked cabinets and have restricted availability. The results of our study will be presented at conferences and published in peer-reviewed journals. Trial registration number NCT02558322; Pre-results.