A volunteer-supported walking programme to improve physical function in older people (the POWER Study): study protocol for a randomised controlled trial.

BACKGROUND: Currently 21% of the German population is older than 65 years. Above this age, the risk of suffering from chronic disease and mental disorders increases rapidly. Therefore, physical inactivity is one of the most important public health concerns among older people. To address this issue, we have conceptualised and evaluated a simple and low-threshold intervention, which requires only minimal demand on the participants, targeting older people with inadequate activity levels. The aim of the POWER Study is to investigate whether volunteer-supported outdoor-walking improves physical function and quality of life in older people. METHODS/DESIGN: In a randomised, controlled interventional superiority-trial, individuals older than 65 years of age living in the community or nursing homes will be randomised into two groups. The study will be conducted in two study centres with assessments at baseline, 6 and 12 months. The intervention group will participate in a supported physical activity intervention for 6 months. An assigned volunteer will visit them three times a week for an outdoor walk between 30 and 50 min, or equivalent indoor activity. Persons in the control group will be invited to two lectures covering topics related to health. Primary endpoint is the physical function measured by the Short Physical Performance Battery (SPPB) at baseline, after 6 and 12 months. Secondary and safety endpoints will be quality of life (EQ. 5D), fear of falling (Falls Efficacy Scale), physical activity (activity diary), cognitive executive function (clock drawing test), falls requiring medical attention, hospitalisation and death. Primary analysis will be carried out by intention to treat. DISCUSSION: We expect the intervention to improve the overall health status of the participants in a wide range of health-related outcomes. If effectiveness can be shown, the intervention will close an important gap in current services for older people. We will disseminate our experiences and results in the form of informational documents (training manual) to allow municipalities and health care organisations to implement a similar intervention. TRIAL REGISTRATION: The trial was registered on 31 Aug 2018; German Clinical Trials Register (www.germanctr.de), Deutsches Register Klinischer Studien: DRKS00015188 .

The Optimizing-Risk-Communication (OptRisk) randomized trial - impact of decision-aid-based consultation on adherence and perception of cardiovascular risk.

BACKGROUND: Shared decision-making is a well-established approach to increasing patient participation in medical decisions. Increasingly, using lifetime-risk or time-to-event (TTE) formats has been suggested, as these might have advantages in comparison with a 10-year risk prognosis, particularly for younger patients, whose lifetime risk for some events may be considerably greater than their 10-year risk. In this study, a randomized trial, the most popular 10-year risk illustration in the decision-aid software Arriba (emoticons), is compared with a newly developed TTE illustration, which is based on a Markov model. The study compares the effect of these two methods of presenting cardiovascular risk to patients on their subsequent adherence to intervention. METHODS: A total of 294 patients were interviewed 3 months after they had had a consultation with their GP on cardiovascular risk prevention. Adherence to behavioral change or medication intervention was measured as the primary outcome. The latter was expressed as a generated score. Furthermore, different secondary outcomes were measured, ie, patient perception of risk and self-rated importance of avoiding a cardiovascular event, as well as patient numeracy, which was used as a proxy for patient health literacy. RESULTS: Overall, no significant difference in patient adherence was found depending on risk representation. In the emoticon group, the number of interventions had a significant impact on the adherence score (P=0.025). Perception of risk was significantly higher in patients counseled with the TTE risk display, whereas the importance of avoiding a cardiovascular event was rated equally highly in both groups and actually increased over time. CONCLUSION: The TTE format is an appropriate means for counseling patients. Adherence is a very complex construct, which cannot be fully explained by our findings. The study results support our call for considering TTE illustrations as a valuable alternative to current decision-support tools covering cardiovascular prevention. Nevertheless, further research is needed to shed light on patient motivation and adherence with regard to cardiovascular risk prevention. TRIAL REGISTRATION: The study was registered at the German Clinical Trials Register and at the WHO International Clinical Trials Register Platform (ICTRP, ID DRKS00004933); registered February 2, 2016 (retrospectively registered).

The effect of a new lifetime-cardiovascular-risk display on patients' motivation to participate in shared decision-making.

BACKGROUND: This study investigated the effects of three different risk displays used in a cardiovascular risk calculator on patients' motivation for shared decision-making (SDM). We compared a newly developed time-to-event (TTE) display with two established absolute risk displays (i.e. emoticons and bar charts). The accessibility, that is, how understandable, helpful, and trustworthy patients found each display, was also investigated. METHODS: We analysed a sample of 353 patients recruited in general practices. After giving consent, patients were introduced to one of three fictional vignettes with low, medium or high cardiovascular risk. All three risk displays were shown in a randomized order. Patients were asked to rate each display with regard to motivation for SDM and accessibility. Two-factorial repeated measures analyses of variance were conducted to compare the displays and investigate possible interactions with age. RESULTS: Regarding motivation for SDM, the TTE elicited the highest motivation, followed by the emoticons and bar chart (p < .001). The displays had no differential influence on the age groups (p = .445). While the TTE was generally rated more accessible than the emoticons and bar chart (p < .001), the emoticons were only superior to the bar chart in the younger subsample. However, this was only to a small effect (interaction between display and age, p < .01, η 2 = 0.018). CONCLUSIONS: Using fictional case vignettes, the novel TTE display was superior regarding motivation for SDM and accessibility when compared to established displays using emoticons and a bar chart. If future research can replicate these results in real-life consultations, the TTE display will be a valuable addition to current risk calculators and decision aids by improving patients' participation.

Psychological risk and protective factors for disability in chronic low back pain - a longitudinal analysis in primary care.

BACKGROUND: Utilizing psychological resources when dealing with chronic low back pain might aid the prevention of disability. The observational study at hand examined the longitudinal impact of resilience and coping resources on disability in addition to established risk factors. METHODS: Four hundred eighty four patients with chronic low back pain (>3 months) were recruited in primary care practices and followed up for one year. Resilience, coping, depression, somatization, pain and demographic variables were measured at baseline. At follow-up (participation rate 89%), data on disability was collected. We first calculated bivariate correlations of all the predictors with each other and with follow-up disability. We then used a multiple regression to evaluate the impact of all the predictors on disability together. RESULTS: More than half of the followed up sample showed a high degree of disability at baseline (53.7%) and had suffered for more than 10 years from pain (50.4%). Besides gender all of the predictors were bivariately associated with follow-up disability. However in the main analysis (multiple regression), disability at follow up was only predicted by baseline disability, age and somatization. There was no relationship between resilience and disability, nor between coping resources and disability. CONCLUSIONS: Although it is known that there are cross-sectional relationships between resilience/coping resources and disability we were not able to replicate it in the multiple regression. This can have several reasons: a) the majority of patients in our sample were much more disabled and suffered for a longer time than in other studies. Therefore our results might be limited to this specific population and resilience and coping resources might still have a protective influence in acute or subacute populations. b) We used a rather broad operationalization of resilience. There is emerging evidence that focusing on more concrete sub facets like (pain) self-efficacy and acceptance might be more beneficial. TRIAL REGISTRATION: German Clinical Trial Register, DRKS00003123 (June 28th 2011).

Time-to-event versus ten-year-absolute-risk in cardiovascular risk prevention - does it make a difference? Results from the Optimizing-Risk-Communication (OptRisk) randomized-controlled trial.

BACKGROUND: The concept of shared-decision-making is a well-established approach to increase the participation of patients in medical decisions. Using lifetime risk or time-to-event (TTE) formats has been increasingly suggested as they might have advantages, e.g. in younger patients, to better show consequences of unhealthy behaviour. In this study, the most-popular ten-year risk illustration in the decision-aid-software arribaTM (emoticons), is compared within a randomised trial to a new-developed TTE illustration, which is based on a Markov model. METHODS: Thirty-two General Practitioners (GPs) took part in the study. A total of 304 patients were recruited and counseled by their GPs with arribaTM, and randomized to either the emoticons or the TTE illustration, followed by a patient questionnaire to figure out the degree of shared-decision-making (PEF-FB9, German questionnaire to measure the participation in the shared decision-making process, primary outcome), as well as the decisional conflict, perceived risk, accessibility and the degree of information, which are all secondary outcomes. RESULTS: Regarding our primary outcome PEF-FB9 the new TTE illustration is not inferior compared to the well-established emoticons taking the whole study population into account. Furthermore, the non-inferiority of the innovative TTE could be confirmed for all secondary outcome variables. The explorative analysis indicates even advantages in younger patients (below 46 years of age). CONCLUSION: The TTE format seems to be as useful as the well-established emoticons. For certain patient populations, especially younger patients, the TTE may be even superior to demonstrate a cardiovascular risk at early stages. Our results suggest that time-to-event illustrations should be considered for current decision support tools covering cardiovascular prevention. TRIAL REGISTRATION: The study was registered at the German Clinical Trials Register and at the WHO International Clinical Trials Register Platform ( ICTRP, ID DRKS00004933 ); registered 2 February 2016 (retrospectively registered).

Even Worse - Risk Factors and Protective Factors for Transition from Chronic Localized Low Back Pain to Chronic Widespread Pain in General Practice: A Cohort Study.

STUDY DESIGN: Prospective cohort study with patients with chronic low back pain (CLBP) at primary care setting. OBJECTIVE: The aim of our study was to identify predictors for transition from localized CLBP to chronic widespread pain in general practice. In contrast to the typically investigated risk factors, this study also focuses intensively on protective factors, which decrease the probability of chronic widespread pain. For this, we investigated the resources resilience and coping strategies, which are suspected as potential protective factors for incident chronic pain syndromes. SUMMARY OF BACKGROUND DATA: In primary care, about a quarter of patients with CLBP experience chronic widespread pain (CWP). METHODS: Patients experiencing localized CLBP were included and evaluated after a 6- and 12-month follow-up period regarding the development of CWP. Potential risk factors (sociodemographic data, pain characteristics, depression, anxiety, somatization), protective factors (resilience, coping strategies), and sample characteristics were assessed at baseline. Predictor identification was done by multivariate logistic regression analysis. RESULTS: The 1-year incidence for the onset of CWP among patients with CLBP was 23.8%. We identified the 3 risk factors, female sex, long duration of back pain, and a high rate of psychosomatic symptoms, for the onset of CWP among patients with CLBP. Coping resources and resilience had no impact on the transition from CLBP to CWP. CONCLUSION: The results suggest that CWP is no independent entity but rather a particularly negative occurrence on a continuum of chronic pain. Processes of somatization play a major role in the development of this extreme. LEVEL OF EVIDENCE: 2.

Differences between patients with chronic widespread pain and local chronic low back pain in primary care--a comparative cross-sectional analysis.

BACKGROUND: Chronic pain is a common reason for consultation in general practice. Current research distinguishes between chronic localized pain (CLP) and chronic widespread pain (CWP). The aim of this study was to identify differences between CWP and chronic low back pain (CLBP), a common type of CLP, in primary care settings. METHODS: Fifty-eight German general practitioners (GPs) consecutively recruited all eligible patients who consulted for chronic low back pain during a 5-month period. All patients received a questionnaire on sociodemographic data, pain characteristics, comorbidities, psychosomatic symptoms, and previous therapies. RESULTS: GPs recruited 647 eligible patients where of a quarter (n = 163, 25.2%) met the CWP criteria according to the American College of Rheumatology. CWP patients had significantly more comorbidities and psychosomatic symptoms, showed longer pain duration, and suffered predominantly from permanent pain instead of distinguishable pain attacks. CWP patients were more often females, are less working and reported a current pension application or a state-approved grade of disability more frequently. We found no other differences in demographic parameters such as age, nationality, marital status, number of persons in household, education, health insurance status, or in health care utilization data. CONCLUSIONS: This project is the largest study performed to date which analyzes differences between CLBP and CWP in primary care settings. Our results showed that CWP is a frequent and particularly severe pain syndrome. TRIAL REGISTRATION: German Clinical Trial Register, DRKS00003123.

Chronic low back pain patient groups in primary care--a cross sectional cluster analysis.

BACKGROUND: Due to the heterogeneous nature of chronic low back pain (CLBP), it is necessary to identify patient groups and evaluate treatments within these groups. We aimed to identify groups of patients with CLBP in the primary care setting. METHODS: We performed a k-means cluster analysis on a large data set (n = 634) of primary care patients with CLBP. Variables of sociodemographic data, pain characteristics, psychological status (i.e., depression, anxiety, somatization), and the patient resources of resilience and coping strategies were included. RESULTS: We found three clusters that can be characterized as "pensioners with age-associated pain caused by degenerative diseases", "middle-aged patients with high mental distress and poor coping resources", and "middle-aged patients who are less pain-affected and better positioned with regard to their mental health". CONCLUSIONS: Our results supported current knowledge concerning groups of CLBP patients in primary care. In particular, we identified a group that was most disabled and distressed, and which was mainly characterized by psychological variables. As shown in our study, pain-related coping strategies and resilience were low in these patients and might be addressed in differentiating treatment strategies. Future studies should focus on the identification of this group in order to achieve effective treatment allocation. TRIAL REGISTRATION: German Clinical Trial Register DRKS00003123.

Study protocol: Transition from localized low back pain to chronic widespread pain in general practice: identification of risk factors, preventive factors and key elements for treatment--a cohort study.

BACKGROUND: Chronic localized pain syndromes, especially chronic low back pain (CLBP), are common reasons for consultation in general practice. In some cases chronic localized pain syndromes can appear in combination with chronic widespread pain (CWP). Numerous studies have shown a strong association between CWP and several physical and psychological factors. These studies are population-based cross-sectional and do not allow for assessing chronology. There are very few prospective studies that explore the predictors for the onset of CWP, where the main focus is identifying risk factors for the CWP incidence. Until now there have been no studies focusing on preventive factors keeping patients from developing CWP. Our aim is to perform a cross sectional study on the epidemiology of CLBP and CWP in general practice and to look for distinctive features regarding resources like resilience, self-efficacy and coping strategies. A subsequent cohort study is designed to identify the risk and protective factors of pain generalization (development of CWP) in primary care for CLBP patients. METHODS/DESIGN: Fifty-nine general practitioners recruit consecutively, during a 5 month period, all patients who are consulting their family doctor because of chronic low back pain (where the pain is lasted for 3 months). Patients are asked to fill out a questionnaire on pain anamnesis, pain-perception, co-morbidities, therapy course, medication, socio demographic data and psychosomatic symptoms. We assess resilience, coping resources, stress management and self-efficacy as potential protective factors for pain generalization. Furthermore, we raise risk factors for pain generalization like anxiety, depression, trauma and critical life events. During a twelve months follow up period a cohort of CLBP patients without CWP will be screened on a regular basis (3 monthly) for pain generalization (outcome: incident CWP). DISCUSSION: This cohort study will be the largest study which prospectively analyzes predictors for transition from CLBP to CWP in primary care setting. In contrast to the typically researched risk factors, which increase the probability of pain generalization, this study also focus intensively on protective factors, which decrease the probability of pain generalization. TRIAL REGISTRATION: German Clinical Trial Register DRKS00003123.

Situational factors, conditions and individual variables which can determine ultrasonic vocalizations in male adult Wistar rats.

The fact that rats emit different types of ultrasonic vocalizations in a variety of contexts has received increasing experimental attention, since such calls might serve as indices of the animal's subjective state, and/or as social signals in various types of interactions with other rats. Here, we present two experiments in adult male Wistar rats where we tested several different situations and conditions with respect to the occurrence of high-frequency (50-kHz) and low-frequency (22-kHz) calls. These experiments showed that rats emitted high-frequency calls when tested singly in a housing cage, which was situated in a room with no other rats present. Calling did not habituate with repeated testing, and occurred in the animal's own home cage, or a fresh housing cage, and irrespective of whether the animal's motivational status was high or low, that is, irrespective of whether they were food-deprived or fed ad libitum. Furthermore, high- and low-frequency calls were observed when applying a standardized new tickling procedure, which provided evidence for effective types of tickling. Most, but not all, young adult rats still accepted this stimulation as play. Therefore, this procedure might be a useful method to elicit high-frequency calls in adult rats. Overall, substantial evidence for inter-individual variability and intra-individual stability in vocalization was provided both, within and between housing cage and tickle tests. This variability seems to depend at least partly on dispositions or traits, which can be gauged by specific screening tests, like measuring risk-assessment in the elevated plus-maze, since animals with more risk-assessment were more likely to emit high-frequency calls during cage and tickle tests. These findings are discussed with respect to the major hypotheses concerning the functional significance of ultrasonic vocalizations, namely the social/communicatory and the motivational/emotional hypothesis.