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Die vorliegende Arbeit beschäftigt sich mit der außerhäuslichen Alltagsmobilität älterer Menschen, die eine zentrale Schlüsselfunktion in der Erhaltung von Lebensqualität und Gesundheit besonders im höheren Lebensalter einnimmt. Außerhäusliche Alltagsmobilität vollzieht sich stets in einem räumlichen Umweltausschnitt und kann aus ökogerontologischer Perspektive als Ergebnis eines gelungenen Person-Umwelt-Austauschs verstanden werden. Inwiefern psychologische Ressourcen im Sinne mobilitätsspezifischer Einstellungen zum Verständnis von zielgerichteter und habitualisierter Alltagsmobilität älterer Menschen beitragen können, ist Gegenstand der vorliegenden Arbeit. Altersspezifische, mobilitätsrelevante Einstellungen im außerhäuslichen Kontext werden sowohl in der sozialwissenschaftlichen Mobilitäts- und Alternsforschung als auch in der Praxis, etwa im Rahmen einer altersgerechten Stadtgestaltung, bislang noch zu wenig berücksichtigt. Die vorliegende Arbeit reagiert auf dieses Forschungsdesiderat, indem sie mobilitätsspezifische Einstellungen im höheren Lebensalter konzeptuell beschreibt, in den Kontext ökogerontologischer Theorien einbettet und ihre Bedeutung für den Erhalt eines aktiven und gelingenden Alterns untersucht. Im Rahmen der Dissertation wurde zunächst auf der Basis klassischer und neuer ökogerontologischer Modelle das Konstrukt der mobilitätsbezogenen Handlungsflexibilität und Routinen (MBFR) konzeptuell entwickelt. MBFR umfasst einerseits die individuelle Überzeugung, das eigene Mobilitätsverhalten an Herausforderungen außer Haus anpassen zu können (FLEX) und andererseits die Präferenz für mobilitätsbezogene Alltagsroutinen (ROU). Daraufhin wurde ein standardisiertes Messinstrument zur Erfassung des MBFR-Konzepts entwickelt, optimiert und hinsichtlich seiner psychometrischen Qualität untersucht. Die Formulierung der Testitems erfolgte in Anlehnung an bereits existierende Fragebögen zu verwandten Konstrukten. In der vorwiegend online durchgeführten Pilotstudie (Penger & Oswald, 2017) wurden die Items mittels explorativer Faktorenanalysen hinsichtlich ihrer dimensionalen Struktur untersucht. Die Stichprobe umfasste 265 Personen im Alter von 65 Jahren oder älter. Die Analysen des MBFR-Instruments ergaben nach Ausschluss von Items mit niedrigen und nicht eindeutigen Ladungen drei substanzielle Faktoren. Die Items der ersten Dimension bildeten die Überzeugung ab, flexibel mit personenbezogenen, altersassoziierten Herausforderungen (z. B. Schwierigkeiten im Gehen oder auf eine Gehhilfe angewiesen sein) umgehen zu können, um außerhäuslich mobil zu sein. Die Items der zweiten Dimension erfassten die Überzeugung, flexibel mit herausfordernden außerhäuslichen Umweltbedingungen (z. B. eine verlegte Haltestelle oder ein schlechter Zustand der Gehwege) umgehen zu können. Items, die auf den dritten Faktor luden, bildeten die Neigung zu Routinen im Mobilitätsalltag ab, z. B. bekannte Wege beizubehalten oder bei der Ausübung von außerhäuslichen Aktivitäten vertraute Orte aufzusuchen. Während die ersten beiden Faktoren mobilitätsbezogene Handlungsflexibilität (FLEX) messen, werden im dritten Faktor habitualisierte Verhaltensweisen (ROU) erfasst. Alle drei Faktoren wiesen eine akzeptable Reliabilität auf. Auf Basis von Rückmeldungen der Studienteilnehmer:innen wurde das MBFR-Instrument anschließend sprachlich angepasst und gekürzt. Der modifizierte Fragebogen wurde daraufhin in der empirischen Studie „MOBIL bleiben in Stuttgart“ (MBIS) eingesetzt. Dabei sollte die Frage beantwortet werden, ob das finale MBFR-Instrument die zugrundeliegenden Konstrukte valide und reliabel erfasst und die Testwerte somit ausreichende Gültigkeit hinsichtlich faktorieller, Konstrukt- und Kriteriumsvalidität bei älteren Menschen im urbanen Raum aufweisen (Penger & Conrad, eingereicht). Es wurden insgesamt 211 privatwohnende Stuttgarter:innen ab 65 Jahren in persönlichen Interviews und mithilfe eines 7-tägigen Wegetagebuchs zu verschiedenen Aspekten ihrer Mobilität im Wohnumfeld befragt. Statistische Analysen auf latenter Ebene erfolgten mittels Strukturgleichungsmodellen. Bivariate Zusammenhänge und Subgruppenanalysen wurden mittels Korrelations- und Regressionsanalysen berechnet. Die dreifaktorielle Struktur des MBFR-Fragebogens konnte im konfirmatorischen Modell empirisch bestätigt werden. Zudem fiel die interne Konsistenz aller drei Faktoren gut aus. Zusammenhänge zu konstruktverwandten Merkmalen – wie allgemeine und mobilitätsspezifische Einstellungen – deuten darauf hin, dass das MBFR-Instrument ausreichend konvergente Validität aufweist. Analysen auf latenter Ebene ergaben, dass Befragte durchschnittlich mehr außerhäusliche Wege zurückzulegten, wenn sie in stärkerem Maße überzeugt waren, flexibel auf mobilitätsbezogene Herausforderungen reagieren zu können (FLEX). Weiterhin ließen sich positive Zusammenhänge zwischen FLEX und der erlebten Selbstständigkeit sowie dem subjektiven Wohlbefinden aufzeigen. Die Befunde belegen somit hinreichende Übereinstimmungsvalidität der Testwerte. Differenzierte Analysen machten darüber hinaus deutlich, dass FLEX vor allem bei Befragten mit Mobilitätseinschränkungen bedeutsam zur Vorhersage des außerhäuslichen Mobilitätsverhaltens beitrug. ...
Investigation of the sympathetic regulation in delayed onset muscle soreness: results of an RCT
(2021)
Sports-related pain and injury is directly linked to tissue inflammation, thus involving the autonomic nervous system (ANS). In the present experimental study, we disable the sympathetic part of the ANS by applying a stellate ganglion block (SGB) in an experimental model of delayed onset muscle soreness (DOMS) of the biceps muscle. We included 45 healthy participants (female 11, male 34, age 24.16 ± 6.67 years [range 18–53], BMI 23.22 ± 2.09 kg/m2) who were equally randomized to receive either (i) an SGB prior to exercise-induced DOMS (preventive), (ii) sham intervention in addition to DOMS (control/sham), or (iii) SGB after the induction of DOMS (rehabilitative). The aim of the study was to determine whether and to what extent sympathetically maintained pain (SMP) is involved in DOMS processing. Focusing on the muscular area with the greatest eccentric load (biceps distal fifth), a significant time × group interaction on the pressure pain threshold was observed between preventive SGB and sham (p = 0.034). There was a significant effect on pain at motion (p = 0.048), with post hoc statistical difference at 48 h (preventive SGB Δ1.09 ± 0.82 cm VAS vs. sham Δ2.05 ± 1.51 cm VAS; p = 0.04). DOMS mediated an increase in venous cfDNA -as a potential molecular/inflammatory marker of DOMS- within the first 24 h after eccentric exercise (time effect p = 0.018), with a peak at 20 and 60 min. After 60 min, cfDNA levels were significantly decreased comparing preventive SGB to sham (unpaired t-test p = 0.008). At both times, 20 and 60 min, cfDNA significantly correlated with observed changes in PPT. The 20-min increase was more sensitive, as it tended toward significance at 48 h (r = 0.44; p = 0.1) and predicted the early decrease of PPT following preventive stellate blocks at 24 h (r = 0.53; p = 0.04). Our study reveals the broad impact of the ANS on DOMS and exercise-induced pain. For the first time, we have obtained insights into the sympathetic regulation of pain and inflammation following exercise overload. As this study is of a translational pilot character, further research is encouraged to confirm and specify our observations.
Objectives: Current treatments for chronic depression have focused on reducing interpersonal problems and negative affect, but paid little attention to promoting prosocial motivation and positive affect. Following this treatment focus, the objective of the present study was to examine whether the combination of metta (Loving Kindness) group meditation and subsequent tailored individual therapy focusing on kindness towards oneself and others (metta-based therapy, MBT) shows greater improvements in depressive symptoms than a wait list control group in patients with chronic depression. Methods: Forty-eight patients with DSM-5 persistent depressive disorder were randomly assigned to MBT or a wait list control condition. Outcome was assessed after group meditation, after subsequent individual therapy, and at 6-month follow-up. The primary outcome measure was an independent blind rating of depressive symptoms at post-test. Secondary outcome included changes in self-reported depression, behavioral activation, rumination, social functioning, mindfulness, compassion, and clinician-rated emotion regulation. Results: Mixed-design analyses showed significant differences between MBT and WLC in changes from pre- to post-test in clinician-rated and self-rated depression, behavioral activation, rumination, social functioning, mindfulness, and emotion regulation. Most of the changes occurred during group meditation and were associated with large effect sizes. Improvements were maintained at 6-month follow-up. Conclusions: The results provide preliminary support for the effectiveness of MBT in treating chronic depression. Trial Registration: ISRCTN, ISRCTN97264476.
Although researchers and practitioners increasingly focus on health promotion in organizations, research has been mainly fragmented and fails to integrate different organizational levels in terms of their effects on employee health. Drawing on organizational climate and social identity research, we present a cascading model of organizational health climate and demonstrate how and when leaders' perceptions of organizational health climate are linked to employee well-being. We tested our model in two multisource studies (NStudy 1 = 65 leaders and 291 employees; NStudy 2 = 401 leader–employee dyads). Results showed that leaders' perceptions of organizational health climate were positively related to their health mindsets (i.e., their health awareness). These in turn were positively associated with their health-promoting leadership behavior, which ultimately went along with better employee well-being. Additionally, in Study 1, the relationship between perceived organizational health climate and leaders' health mindsets was moderated by their organizational identification. High leader identification strengthened the relationship between perceived organizational health climate and leaders' health mindsets. These findings have important implications for theory and practice as they show how the dynamics of an organizational health climate can unfold in organizations and how it is related to employee well-being via the novel concept of health-promoting leadership.
Strenuous and unaccustomed exercise frequently lead to what has been coined “delayed onset muscle soreness” (DOMS). As implied by this term, it has been proposed that the associated pain and stiffness stem from micro-lesions, inflammation, or metabolite accumulation within the skeletal muscle. However, recent research points towards a strong involvement of the connective tissue. First, according to anatomical studies, the deep fascia displays an intimate structural relationship with the underlying skeletal muscle and may therefore be damaged during excessive loading. Second, histological and experimental studies suggest a rich supply of algogenic nociceptors whose stimulation evokes stronger pain responses than muscle irritation. Taken together, the findings support the hypothesis that DOMS originates in the muscle-associated connective tissue rather than in the muscle itself. Sports and fitness professionals designing exercise programs should hence consider fascia-oriented methods and techniques (e.g., foam rolling, collagen supplementation) when aiming to treat or prevent DOMS.
Korrektur zu: Roth C, Rettenmaier L and Behringer M (2021) High-Protein Energy-Restriction: Effects on Body Composition, Contractile Properties, Mood, and Sleep in Active Young College Students. Front. Sports Act. Living 3:683327. https://doi.org/10.3389/fspor.2021.683327
Background: The promotion of healthy aging is one of the major challenges for healthcare systems in current times. The present study investigates the effects of a standardized physical activity intervention for older adults on cognitive capacity, self-reported health, fear of falls, balance, leg strength and gait under consideration of movement biography, sleep duration, and current activity behavior. Methods: This single-blinded, randomized controlled trial included 49 community-dwelling older adults (36 women; 82.9 ± 4.5 years of age (Mean [M] ± SD); intervention group = 25; control group = 24). Movement biography, sleep duration, cognitive capacity, self-reported health status, and fear of falls were assessed by means of questionnaires. Leg strength, gait, and current activity levels were captured using a pressure plate, accelerometers, and conducting the functional-reach and chair-rising-test. The multicomponent intervention took place twice a week for 45 min and lasted 16 weeks. Sub-cohorts of different sleep duration were formed to distinguish between intervention effects and benefits of healthy sleep durations. Change scores were evaluated in univariate analyses of covariances (ANCOVAs) between groups and sub-cohorts of different sleep duration in both groups. Changes in cognitive capacity, self-reported health, fear of falls, balance, leg strength, and gait were investigated using the respective baseline values, movement biography, and current activity levels as covariates. Analysis was by intention-to-treat (ITT). Results: We found sub-cohort differences in cognitive capacity change scores [F(3,48) = 5.498, p = 0.003, ηp2 = 0.287]. Effects on fear of falls [F(1,48) = 12.961, p = 0.001, ηp2 = 0.240] and balance change scores F(1,48) = 4.521, p = 0.040, ηp2 = (0.099) were modified by the level of current activity. Effects on gait cadence were modified by the movement biography [F(1,48) = 4.545; p = 0.039, ηp2 = 0.100]. Conclusions: Unlike for functional outcomes, our multicomponent intervention in combination with adequate sleep duration appears to provide combinable beneficial effects for cognitive capacity in older adults. Trainability of gait, fear of falls, and flexibility seems to be affected by movement biography and current physical activity levels. Trial registration: This study was registered at the DRKS (German Clinical Trials Register) on November 11, 2020 with the corresponding trial number: DRKS00020472.
We investigated whether dichotomous data showed the same latent structure as the interval-level data from which they originated. Given constancy of dimensionality and factor loadings reflecting the latent structure of data, the focus was on the variance of the latent variable of a confirmatory factor model. This variance was shown to summarize the information provided by the factor loadings. The results of a simulation study did not reveal exact correspondence of the variances of the latent variables derived from interval-level and dichotomous data but shrinkage. Since shrinkage occurred systematically, methods for recovering the original variance were fleshed out and evaluated.
The sudden impact of the COVID-19 pandemic challenged universities to provide students with online teaching and learning settings that were both immediately applicable and supportive of quality learning. This resulted in a broad variety of synchronous and asynchronous online settings of teaching and learning. While some courses balanced both kinds, others offered either predominantly synchronous or asynchronous teaching and learning. In a survey study with students (N=3,056) and teachers (N=396) from a large German university, we explored whether a predominance of synchronous or asynchronous teaching and learning settings in higher education was associated with certain student experiences and outcomes. Additionally, we examined how well these two types of teaching and learning settings support students’ basic psychological needs for autonomy, competence, and relatedness proposed by self-determination theory (SDT). Data were collected after the first online semester due to the COVID-19 pandemic. The results imply that from the students’ perspective, the teaching methods involved in the two settings of teaching and learning differ with regard to their potential to support social interaction and to support basic psychological needs as proposed by SDT. Students who studied mostly in synchronous settings reported more peer-centered activities such as feedback in comparison to students in mostly asynchronous settings. In contrast, teachers perceived fewer differences between teaching methods in synchronous and asynchronous settings, especially regarding feedback activities. Further, students in mostly synchronous settings reported greater support of their basic psychological needs for competence support and relatedness as well as a greater overall satisfaction with the online term compared to students in mostly asynchronous settings. Across all students, greater fulfillment of psychological needs and higher technology acceptance coincided with outcomes that are more favorable. Implications for the post-pandemic classroom are drawn.
Muscular fatigue can affect postural control processes by impacting on the neuromuscular and somatosensory system. It is assumed that this leads to an increased risk of injury, especially in sports such as alpine skiing that expose the body to strong and rapidly changing external forces. In this context, posture constraints and contraction-related muscular pressure may lead to muscular deoxygenation. This study investigates whether these constraints and pressure affect static and dynamic postural control. To simulate impaired blood flow in sports within a laboratory task, oxygen saturation was manipulated locally by using an inflatable cuff to induce blood flow restriction (BFR). Twenty-three subjects were asked to stand on a perturbatable platform used to assess postural-related movements. Using a 2 × 2 within-subject design, each participant performed postural control tasks both with and without BFR. BFR resulted in lower oxygenation of the m. quadriceps femoris (p = 0.024) and was associated with a significantly lower time to exhaustion (TTE) compared to the non-restricted condition [F(1,19) = 16.22, p < 0.001, ηp2 = 0.46]. Perturbation resulted in a significantly increased TTE [F(1,19) = 7.28, p = 0.014, ηp2 = 0.277]. There were no significant effects on static and dynamic postural control within the saturation conditions. The present data indicate that BFR conditions leads to deoxygenation and a reduced TTE. Postural control and the ability to regain stability after perturbation were not affected within this investigation.
With our research, we contribute to the research on proactive work behavior in two ways. First, we examine a person's gender as a boundary condition for proactive behavior at work. Based on social role theory, we argue that women are less likely to receive credit for showing personal initiative (PI) than men. Second, we examine agency and communion as underlying mechanisms that translate PI into a person's evaluation and drive backlash effects. The hypotheses were tested in two complementary experimental studies (Study 1; N = 114, Study 2: N = 163) using simulated job interviews. Our results show that PI relates to better evaluations (likeability, perceived competence, performance evaluations, expected success and hireability) of the job applicant and that these effects are mediated by agency and communion. Further, we find backlash effects for women high in agency and men high in communion on likeability (Study 2). The implications of these results for organizations and future research are discussed.
Individual differences in general cognitive ability (i.e., intelligence) have been linked to individual variations in the modular organization of functional brain networks. However, these analyses have been limited to static (time-averaged) connectivity, and have not yet addressed whether dynamic changes in the configuration of brain networks relate to general intelligence. Here, we used multiband functional MRI resting-state data (N = 281) and estimated subject-specific time-varying functional connectivity networks. Modularity optimization was applied to determine individual time-variant module partitions and to assess fluctuations in modularity across time. We show that higher intelligence, indexed by an established composite measure, the Wechsler Abbreviated Scale of Intelligence (WASI), is associated with higher temporal stability (lower temporal variability) of brain network modularity. Post-hoc analyses reveal that subjects with higher intelligence scores engage in fewer periods of extremely high modularity — which are characterized by greater disconnection of task-positive from task-negative networks. Further, we show that brain regions of the dorsal attention network contribute most to the observed effect. In sum, our study suggests that investigating the temporal dynamics of functional brain network topology contributes to our understanding of the neural bases of general cognitive abilities.
Positive psychological coaching (PPC) has emerged as a popular “paradigm” for practitioners interested in the professional development of people. A recent review consolidated the literature on PPC and produced a 5-phase positive psychological coaching model aimed at facilitating professional growth. However, little is known about practically operationalizing each phase of the coaching process (i.e., how to facilitate each phase and which underlying tools and techniques could be employed to do so). As such, the purpose of this systematic review was to address this limitation by (a) determining which coaching tools and techniques are proposed within the coaching literature and (b) classifying the identified tools and techniques into the respective phases of PPC model. The investigation used a two-step approach by conducting a systematic literature review (to identify various PPC tools/techniques) followed by an iterative heuristic classification process (to assign these PPC tools/techniques to a known PPC model). The systematic literature review resulted in 24 peer-reviewed publications on positive psychological coaching, providing 117 different coaching tools that could be condensed into 18 overarching coaching techniques. The iterative classification process showed that most techniques and tools are useful in at least two phases. Interestingly, experts still vary in opinion on the timing and application of these specific techniques and tools within the positive psychological coaching process. This study provides researchers and practitioners with practical guidelines to facilitate a positive psychological coaching process.
In sports and clinical settings, roller massage (RM) interventions are used to acutely increase range of motion (ROM); however, the underlying mechanisms are unclear. Apart from changes in soft tissue properties (i.e., reduced passive stiffness), neurophysiological alterations such as decreased spinal excitability have been described. However, to date, no study has investigated both jointly. The purpose of this trial was to examine RM’s effects on neurophysiological markers and passive tissue properties of the plantar flexors in the treated (ROLL) and non-treated (NO- ROLL) leg. Fifteen healthy individuals (23 ± 3 years, eight females) performed three unilateral 60-s bouts of calf RM. This procedure was repeated four times on separate days to allow independent assessments of the following outcomes without reciprocal interactions: dorsiflexion ROM, passive torque during passive dorsiflexion, shear elastic modulus of the medial gastrocnemius muscle, and spinal excitability. Following RM, dorsiflexion ROM increased in both ROLL (+19.7%) and NO-ROLL (+13.9%). Similarly, also passive torque at dorsiflexion ROM increased in ROLL (+15.0%) and NO-ROLL (+15.2%). However, there were no significant changes in shear elastic modulus and spinal excitability (p > 0.05). Moreover, significant correlations were observed between the changes in DF ROM and passive torque at DF ROM in both ROLL and NO-ROLL. Changes in ROM after RM appear to be the result of sensory changes (e.g., passive torque at DF ROM), affecting both rolled and non-rolled body regions. Thus, therapists and exercise professionals may consider applying remote treatments if local loading is contraindicated.
Hintergrund: Das Kindesalter wurde bei der Entwicklung von wirksamen Präventions- und Interventionsprogrammen bei Computerspiel- und Internetabhängigkeit bisher kaum berücksichtigt. PROTECTdissonanz wurde daher als 1-stündiges dissonanzbasiertes universelles Primärpräventionsprogramm für die Klassenstufe 5 konzipiert. Die vorliegende Pilotstudie überprüft die unmittelbaren Effekte der Dissonanzinduktion auf die Einstellung zum Gaming. Methodik: In einem einarmigen A+B-Design mit drei Messzeitpunkten (T0, T1, T2) wurde die Einstellung zum Gaming anhand des Gaming Attitude Test (GAT) erfasst. In die Baselinesequenz (Sequenz A, T0 bis T1, Teilstichprobe) wurden N = 83 Schüler_innen eingeschlossen (Alter: M = 10.27; SD = 0.48) und in die Interventionssequenz (Sequenz B, T1 bis T2, Gesamtstichprobe) N = 200 Schüler_innen (Alter: M = 10.24; SD = 0.47). Akzeptanz und Zufriedenheit wurden nach der Intervention erfasst. Ergebnisse: Hierarchisch lineare Wachstumsmodelle zeigten eine signifikante Reduktion der GAT-Symptome durch die Intervention, sowohl im Gesamtwert des GAT als auch auf der Subskala „Bagatellisierung negativer Konsequenzen“. Im natürlichen Verlauf (Baselinesequenz A) zeigten sich keine Veränderungen. Die Schüler_innen bewerteten PROTECTdissonanz zudem mit einer hohen Zufriedenheit. Schlussfolgerungen: Eine kurze, gezielte übung zur Dissonanzinduktion zeigt unmittelbare Effekte auf ein Einstellungsmaß zum Gaming. Zur Weiterverfolgung dieses vielversprechenden Ansatzes sollte in künftigen Studien untersucht werden, ob sich eine verringerte Bagatellisierung negativer Konsequenzen von Gaming im Sinne der kognitiven Dissonanztheorie auch tatsächlich in einer Verhaltensänderung widerspiegelt.
The strengths use scale: psychometric properties, longitudinal invariance and criterion validity
(2021)
Strengths use is an essential personal resource to consider when designing higher-educational programs and interventions. Strengths use is associated with positive outcomes for both the student (e.g., study engagement) and the university (e.g., academic throughput/performance). The Strengths Use Scale (SUS) has become a popular psychometric instrument to measure strengths use in educational settings, yet its use has been subjected to limited psychometric scrutiny outside of the U.S. Further, its longitudinal stability has not yet been established. Given the wide use of this instrument, the goals of this study were to investigate (a) longitudinal factorial validity and the internal consistency of the scale, (b) its equivalence over time, and (c) criterion validity through its relationship with study engagement over time. Data were gathered at two-time points, 3 months apart, from a sample of students in the Netherlands (n = 360). Longitudinal confirmatory factor analyses showed support for a two-factor model for overall strengths use, comprised of Affinity for Strengths and Strengths Use Behaviors. The SUS demonstrated high levels of internal consistency at both the lower- and upper bound limits at both time points. Further, strict longitudinal measurement invariance was established, which confirmed the instrument's temporal stability. Finally, criterion validity was established through relating strengths use to study engagement at different time stamps. These findings support the use of the SUS in practice to measure strengths use and to track the effectiveness of strengths use interventions within the higher education sector.
It is increasingly recognized that neuroscience has not delivered the revolutionary clinical possibilities for psychiatry that had been promised. Explanations differ, however: some proponents emphasize the divide between biopsychosocial psychiatry and mechanistic neurology. Others rely on further basic experimental neuroscience as only the most elementary level of explanation will allow us to fully understand and treat mental disorders. From a clinical-neuropsychological perspective, I shall argue that both views are mistaken. Diagnosis and treatment of neurological diseases demands a biopsychosocial perspective similar to psychiatry. Acknowledging this might help to bring both disciplines together and improve clinical outcome.