Co-design of the EMBED-Care Framework as an intervention to enhance shared decision-making for people affected by dementia and practitioners, comprising holistic assessment, linked with clinical decision support tools: A qualitative study.

INTRODUCTION: Shared decision-making intends to align care provision with individuals' preferences. However, the involvement of people living with dementia in decision-making about their care varies. We aimed to co-design the EMBED-Care Framework, to enhance shared decision-making between people affected by dementia and practitioners. METHODS: A theory and evidence driven co-design study was conducted, using iterative workshops, informed by a theoretical model of shared decision-making and the EMBED-Care Framework (the intervention) for person-centred holistic palliative dementia care. The intervention incorporates a holistic outcome measure for assessment and review, linked with clinical decision-support tools to support shared decision-making. We drew on the Medical Research Council (MRC) guidance for developing and evaluating complex interventions. Participants included people with dementia of any type, current or bereaved family carers and practitioners. We recruited via established dementia groups and research and clinical networks. Data were analysed using reflexive thematic analysis to explore how and when the intervention could enhance communication and shared decision-making, and the requirements for use, presented as a logic model. RESULTS: Five co-design workshops were undertaken with participants comprising people affected by dementia (n = 18) and practitioners (n = 36). Three themes were generated, comprising: (1) 'knowing the person and personalisation of care', involving the person with dementia and/or family carer identifying the needs of the person using a holistic assessment. (2) 'engaging and considering the perspectives of all involved in decision-making' required listening to the person and the family to understand their priorities, and to manage multiple preferences. (3) 'Training and support activities' to use the Framework through use of animated videos to convey information, such as to understand the outcome measure used to assess symptoms. CONCLUSIONS: The intervention developed sought to enhance shared decision-making with individuals affected by dementia and practitioners, through increased shared knowledge of individual priorities and choices for care and treatment. The workshops generated understanding to manage disagreements in determining priorities. Practitioners require face-to-face training on the intervention, and on communication to manage sensitive conversations about symptoms, care and treatment with individuals and their family. The findings informed the construction of a logic model to illustrate how the intervention is intended to work.

Airflow rates and breathlessness recovery from submaximal exercise in healthy adults: prospective, randomised, cross-over study.

OBJECTIVES: Facial airflow from a hand-held fan may reduce breathlessness severity and hasten postexertion recovery. Data from randomised controlled trials are limited and the optimal airflow speed remains unknown. We aimed to determine the effect of different airflow speeds on recovery from exercise-induced breathlessness. METHODS: A prospective, randomised, cross-over design. Ten healthy participants (seven male; mean age 29±4 years; height 175±9 cm; body mass 76.9±14.1 kg) completed six bouts of 4 min of exercise. During the first 5 min of a 20 min recovery phase, participants received one of five airflow speeds by holding a fan ~15 cm from their face, or no fan control, administered in random order. Fan A had an internal blade, and fan B had an external blade. Breathlessness was measured using a numerical rating scale (NRS) at minute intervals for the first 10 min, and facial skin temperature was recorded using a thermal imaging camera (immediately postexertion and 5 min recovery). RESULTS: Nine participants completed the trial. A significant main effect for airflow speed (p=0.016, ηp2=0.285) and interaction effect for airflow speed over time (p=0.008, ηp2=0.167) suggest that the airflow speed modifies breathlessness during recovery from exercise. Fan speeds of 1.7 m/s or greater increased the speed of recovery from breathlessness compared with control (p<0.05) with the highest airflow speeds (2.5 m/s and 3.3 m/s) giving greatest facial cooling. CONCLUSION: Higher airflow rates (1.7 m/s or greater) reduced self-reported recovery times from exercise-induced breathlessness and reduced facial temperature .

Measurement equivalence of the paper-based and electronic version of the Integrated Palliative care Outcome Scale (IPOS): A randomised crossover trial.

BACKGROUND: The Integrated Palliative Care Outcome Scale (IPOS) validly and reliably measures symptoms and concerns of those receiving palliative care. AIM: To determine the equivalence of the paper version with an electronic version of the IPOS (eIPOS). DESIGN: Multicentre randomised crossover trial (NCT03879668) with a within-subject comparison of the two modes (washout period 30 min). SETTING/PARTICIPANTS: Convenience sample of specialist inpatient and palliative home care patients aged over 18 years with cancer and non-cancer conditions was recruited. Scores were compared using intraclass correlation coefficients (ICC), Bland-Altman plots and via a mixed-effects analysis of variance. RESULTS: Fifty patients were randomised to complete paper-electronic (n = 24) and electronic-paper (n = 26) IPOS with median age 69 years (range 24-95), 56% male, 16% non-cancer. The ICCs showed very high concordance for the total score (ICC 0.99, 95% CI 0.98-1.00), lowest ICCs being observed for symptoms 'Appetite loss' and 'Drowsiness' (ICC 0.95, 95% CI 0.92-0.97). Nine of seventeen items had ICCs above 0.98, as did all subscales. No statistically significant mode, order, age, and interaction effects were observed for IPOS total score and subscales, except for 'Communication' (Fmode = 5.9, p = 0.019). Fifty-eight percent preferred the electronic version. In the group 75+ years, 53% preferred the paper version. Only three entries in the free-text main problems differed between the versions. CONCLUSION: The very high equivalence in scores and free text between the IPOS and the eIPOS demonstrates that eIPOS is feasible and reliable in an older palliative population.

Development and validation of a clinical prediction model for return to work after arthroscopic anterior crucial ligament reconstruction.

BACKGROUND: Occupational reintegration after anterior cruciate ligament (ACL) rupture is an important clinical issue including economic and health-related perspectives. This study aims to develop and validate a clinical prediction model of return to work in patients with ACL reconstruction surgery considering evidence-based clinical, anthropometric and occupational factors. METHODS: Data of 562 patients with an ACL rupture receiving an arthroscopic ACL reconstruction were used for analysis. A model for the binary outcome of experiencing an inability to work period of less or more than 14 days (model 1), and a model for finding predictor variables that are linearly associated with a continuous longer inability to work period of over 14 days (model 2) was calculated. Pre-operative determinants including patient characteristics and peri-operative factors were used as predictors for both models. RESULTS: For model 1, the highest increase in odds was observed for the occupational type of work, followed by injury of the medial collateral ligament together with partial weight bearing. Small protective effects were observed for female sex, meniscal suture and work with light occupational strain. The type of occupational work, together with revision surgery, a longer duration of limited range of motion and the presence of cartilage therapy were risk factors for longer inability to work. Discrimination and calibration statistics were satisfactory in internal validation. CONCLUSION: Within the framework of clinical consideration, these prediction models will serve as an estimator for patients, their treating physicians and the socioeconomic partners to forecast the individual cost and benefit of ACL injury.

The association between socioeconomic position and the symptoms and concerns of hospital inpatients seen by specialist palliative care: Analysis of routinely collected patient data.

BACKGROUND: Understanding how socioeconomic position influences the symptoms and concerns of patients approaching the end of life is important for planning more equitable care. Data on this relationship is lacking, particularly for patients with non-cancer conditions. AIM: To analyse the association between socioeconomic position and the symptoms and concerns of older adult patients seen by specialist palliative care. DESIGN: Secondary analysis of cross-sectional, routinely collected electronic patient data. We used multivariable linear regression with robust standard errors, to predict scores on the three subscales of the Integrated Palliative care Outcome Scale (IPOS; physical symptoms, emotional symptoms and communication and practical concerns) based on patient level of deprivation, measured using Index of Multiple Deprivation. SETTING/PARTICIPANTS: Consecutive inpatients aged 60 years and over, seen by specialist palliative care at two large teaching hospitals in London between 1st January 2016 and 31st December 2019. RESULTS: Seven thousand eight hundred and sixty patients were included, 38.3% had cancer. After adjusting for demographic and clinical characteristics, patients living in the most deprived areas had higher (worse) predicted mean scores on the communication and practical subscale than patients living in the least deprived areas, 5.38 (95% CI: 5.10, 5.65) compared to 4.82 (4.62, 5.02) respectively. This effect of deprivation diminished with increasing age. Deprivation was not associated with scores on the physical or emotional symptoms subscales. CONCLUSIONS: Targetting resources to address practical and communication concerns could be a strategy to reduce inequalities. Further research in different hospitals and across different settings using patient centred outcome measures is needed to examine inequalities.

Development of a screening tool for the need of specialist palliative care in oncologic inpatients: study protocol for the ScreeningPALL Study.

INTRODUCTION: A range of referral criteria and scores have been developed in recent years to help with screening for the need of specialist palliative care (SPC) in advanced, incurable cancer patients. However, referral criteria have not yet been widely implemented in oncology, as they usually need to be revised by physicians or nurses with limited time resources. To develop an easily applicable screening for the need for SPC in incurable cancer inpatients, we aim to (a) test inter-rater reliability of multiprofessional expert opinion as reference standard for SPC need (phase I) and (b) explore the diagnostic validity of selected patient-reported outcome measures (PROMs) and routine data for the need of SPC (phase II). METHODS AND ANALYSIS: Inclusion criteria for patients are metastatic or locally advanced, incurable cancer, ≥18 years of age and informed consent by patient or proxy. (Exclusion criteria: malignant haematological disease as main diagnosis). In phase I, three palliative care consultation teams (PCTs) of three German university hospitals assess the SPC need of 20 patient cases. Fleiss' Kappa will be calculated for inter-rater reliability. In phase II, 208 patients are consecutively recruited in four inpatient oncology wards of Freiburg University Hospital. The PCT will provide assessment of SPC need. As potential referral criteria, patients complete PROMs and a selection of routine data on person, disease and treatment is documented. Logistic regression models and ROC analyses are employed to test their utility in screening for SPC need. ETHICS AND DISSEMINATION: Our findings will be published in peer-reviewed journals and presented at national and international scientific meetings and congresses. Ethical approval was granted by the Ethics Committee of Albert-Ludwigs-University Freiburg, Germany (approval no. 20-1103). TRIAL REGISTRATION NUMBER: German Clinical Trials Register, DRKS00021686, registered on 17 December 2020.

Trial-to-trial Variability and Cortical Processing Depend on Recent Outcomes During Human Reinforcement Motor Learning.

The history of our actions and their outcomes represent important information, informing choices and efficiently guiding future behavior. While unsuccessful (S-) outcomes are expected to lead to more explorative motor states and increased behavioral variability, successful (S+) outcomes are expected to reinforce the use of the previous action. Here, we show that humans attribute different values to previous actions during reinforcement motor learning when they experience S- compared to S+ outcomes. Behavioral variability after an S- outcome is influenced more by the previous outcome than after S+ outcomes. Using electroencephalography, we show that theta band oscillations of the prefrontal cortex are most prominent during changes in two consecutive outcomes, potentially reflecting the need for enhanced cognitive control. Our results suggest that S+ experiences 'overwrite' previous motor states to a greater extent than S- experiences and that modulations in neural oscillations in the prefrontal cortex play a potential role in encoding changes in movement variability state during reinforcement motor learning.

Cross-cultural validity of the Death Reflection Scale during the COVID-19 pandemic.

Background: The global COVID-19 pandemic confronts people with their fragility, vulnerability, and mortality. To date, scales to measure death awareness mainly focus on the anxiety-provoking aspect of mortality cues. This study aims to cross-culturally adapt and validate the Death Reflection Scale (DRS), a scale for measuring positive, growth-oriented cognitions of life reflection and prosocial behavior following confrontation with the finiteness of life. Materials and Methods: The Death Reflection Scale was translated and adapted in a multi-step process to the German language. In this anonymous, cross-sectional, online survey at a large university in Germany, students, healthcare professionals (HCP) and other staff completed the DRS alongside comparison measures. Multi-group confirmatory factor analysis was used to assess configural, metric, and scalar measurement equivalence across four age and occupational groups. Convergent/divergent validity testing was done via Spearman correlations. Results: 1,703 participants provided data for a response rate of ∼5%. 24% of respondents were HCP, 22% students. Confirmatory factor analysis showed a higher-order structure of the DRS with a strong general factor and the originally proposed five subscales (CFI 0.945, SRMR 0.045, RMSEA 0.055). Multi-group CFA showed partial metric equivalence across age groups and partial scalar invariance across occupational groups. Non-invariant scales were the Motivation to live, Putting life into perspective, and Legacy subscales. In the convergent validity testing, two hypotheses were fully confirmed, two partially and four were not confirmed. Experiencing a propensity for increased contemplation and life reflection during the pandemic together with spirituality showed correlations of moderate to large size to the DRS and its subscales (Spearman's rho ranging from 0.31 to 0.52). Conclusion: Further conceptual work for death awareness to explore the construct's stability in different population groups needs to be undertaken. However, the DRS can be mostly used to assess positive and growth-oriented aspects of death awareness and death reflection which may be an important avenue when developing counseling and support interventions for groups experiencing a high burden during the pandemic.

Adoption and maintenance of physical activity: Mediation analysis of a psychological intervention.

OBJECTIVE: To analyze the cognitive mediation processes of an effective psychological group-based intervention promoting physical activity (based on motivational and volitional theories; MoVo-LISA) and to test for different underlying intervention mechanisms in the adoption and maintenance phase of physical activity behavior change. METHOD: In an RCT, N = 202 patients with coronary heart disease were randomly allocated to the group-based MoVo-LISA intervention or a control group (treatment-as-usual). Primary outcome was physical activity (in minutes per week, significant group differences: posttreatment: d = 1.03; 12-months follow-up: d = .57). Potential mediator variables were self-efficacy, outcome expectations, intention strength, self-concordance, action planning and barrier management. A mediation analysis of longitudinal data in SPSS AMOS v.24 was conducted. RESULTS: The intervention was successful in modifying most of the examined cognitive variables in the adoption and/or the maintenance phase, with exception of self-concordance. Intention strength and self-concordance were significant predictors of behavior change in both phases. Findings suggest that the observed intervention effects on physical activity behavior were only partially mediated through the motivational variables self-efficacy and outcome expectation. CONCLUSIONS: The results contribute to opening "the black box" of processes behind an intervention and show that intervention effects of MoVo-LISA are partially mediated through the specified cognitive variables. The relevance of motivational variables (intention strength and self-concordance) in the adoption and maintenance phases is highlighted in this study and leads to relevant intervention design implications. Nevertheless, the differentiation of the two phases might help to improve intervention programs through a stronger focus on those cognitive parameters that are critical at a certain point in the behavior change process. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Concurrent Validity and Prognostic Utility of the Needs Assessment Tool: Progressive Disease Heart Failure.

CONTEXT: People with advanced heart failure have supportive and palliative needs requiring systematic assessment. OBJECTIVES: We aimed to assess the validity of the Needs Assessment Tool: Progressive Disease - Heart Failure (NAT:PD-HF). METHODS: Secondary analysis of routinely collected patient data from a specialist palliative care-heart disease service improvement project. NAT:PD-HF, the Integrated Palliative care Outcome Scale (IPOS), and patient and/or carer-report data were collected. Concurrent validity between NAT:PD-HF items and comparison measures (Kendall's tau; kappa); construct validity via known-group comparisons; predictive utility of NAT:PD-HF for survival (multivariable Cox hazard regression model). RESULTS: Data from 88 patients (50% men; mean age 85; median survival 205 days; 64% left ventricular systolic dysfunction) were analyzed. Prevalence- and bias-adjusted kappa values indicated moderate agreement for physical symptom needs (k: 0.33 for patients, 0.42 for carers). Substantial agreement was observed for patient and/or carer psychological symptoms, and information needs (k ≥ 0.6). NAT:PD-HF distinguished between patients with different survival, comorbidities, functional scores, and palliative Phase of Illness with moderate to high effect sizes. NAT did not predict survival when adjusted for mortality risk score and functional status (2+ needs HR: 1.52, 95% CI: 1.01-1.74). CONCLUSION: The NAT:PD-HF is a valid tool for clinician assessment of physical, psychosocial, and information patient and/or carer needs.

Calculating worldwide needs for morphine for pain in advanced cancer and proportions feasibly met by country estimates of requirements and consumption. Retrospective, time-series analysis (1997-2017).

Lack of access to therapeutic opioids continuing causes global health inequalities. Access to morphine for symptom control is regulated under the terms of the Single Convention on Narcotics, countries must submit annual morphine requirement estimates and report consumption to the International Narcotics Control Board (INCB). INCB indicates access to morphine is increasing, however, estimated needs are unreported so changing proportions of needs feasibly met by requirements and consumption are unknown. Retrospective time series-analysis taking cross-sections every five years of gaps between calculated needs for morphine for people who die from cancer and total treatable using estimates of requirements and consumption (1997, 2002, 2007, 2012, 2017). We calculated need using INCB-recommended methods (80% of people who die from cancer require 67.5mg of morphine daily for 90 days (6.075g)) for countries reporting estimates and consumption using Global Burden of Disease cancer deaths by country. Gaps between calculated need and total treatable population using estimates and consumption were calculated. We report proportions of need feasibly met by estimates and consumption for included countries, by World Bank Income group. Global availability of morphine increased, from estimates sufficient to treat 86% of calculated needs in 1997, to 701% in 2017. However, proportion of countries estimating requirements feasibly meeting >100% of calculated needs rose only from 16% to 30%. Almost all Low-and-Middle-Income Countries submitted inadequate estimates with little change in 20 years. Consumption was lower than calculated needs at all time-points. Very few countries reported consumption greater than their estimate of requirement. Most countries submitted morphine estimates insufficient to meet analgesic needs of people who died from cancer. Estimates of requirements contextualise future Consumption, and increases in adequacy of estimates and consumption were minimal over 20 years. Annual publication of calculated morphine needs alongside estimates and consumption may be a key step to drive countries' accountabilities.

A questionnaire to assess eating behavior: Structure, validity and responsiveness of a new German eating behavior scale (SEV).

Numerous weight-loss interventions promoting healthy and weight-reducing eating behavior have been developed over the past years. To evaluate the effectiveness of such interventions for eating behavior change, short, validated and sensitive instruments are needed. In this study series, we developed and validated a new outcome measure to assess health-conscious and weight-controlling eating behavior for the evaluation of weight-loss interventions. The preliminary version of the German eating behavior scale (Skala zumErnährungsverhalten [SEV]) included 40 items. Three studies were conducted to (a) reduce the preliminary item pool, (b) investigate structural validity and internal consistency using exploratory and confirmatory factor analyses (EFA, CFA), as well as McDonald's ω, and (c) test construct validity with physiological and behavioral parameters. Responsiveness to change was also assessed after a 12-week weight-loss intervention. EFA indicated a two-factor solution with health-conscious (hc-EB) and weight-controlling eating behavior (wc-EB) as subscales, CFA confirmed the two-factor solution with acceptable model fit. Internal consistencies of both subscales were also acceptable to good (hc-EB: ω = 0.88; wc-EB: ω = 0.78). Significantly small to moderate correlations to the Healthy Eating Index (r = 0.51) as well as blood glucose (r = 0.31), blood lipids (r = 0.23), and vascular age (r = 0.31) were found, supporting the construct validity of the SEV and its subscales. Both subscales detected intervention-related changes in eating behavior among subjects of a weight-loss intervention with Standardized Response Means of 0.52 and 0.67, indicating good responsiveness of the SEV. In sum, findings provide evidence that the SEV is a valid and responsive measure to assess health-conscious and weight-controlling eating behavior.

Mind your step: predicting maximum ankle inversion during cutting movements in soccer.

The objective of this investigation was to identify parameters at initial contact that would predict the subsequent maximum ankle inversion angle during cutting movements. We conducted a secondary data analysis and calculated kinematics of 1,400 cuttings performed by 46 male soccer athletes. The movement task consisted of an approach run, followed by a pre-planned cutting movement. A linear mixed regression model was applied to predict the maximum ankle inversion angle during the first 100 ms of ground contact. The prediction was made based on six predictors that describe change-of-direction intensity and foot placement as found to be relevant in the literature. The model explained 62% of the variance of maximum ankle inversion angles. A change of the main predictors (foot rotation, cutting angle and initial ankle inversion) by 1 SD caused a reduction of the subsequent maximum ankle inversion angle by 2.6-4.4°. Regarding the intensity of a change-of-direction movement, cutting angle seems to have a higher influence on maximum ankle inversion angle than approach velocity. With respect to the individual foot positioning, the maximum ankle inversion angle can be reduced by increasing exorotation and eversion of the foot while shifting towards forefoot landing.

Monitoring of Palliative Care Symptoms and Concerns in Specialized Palliative Home Care Using an Electronic Version of the Integrated Palliative care Outcome Scale (Palli-MONITOR): protocol for a mixed-methods study.

INTRODUCTION: Over the last decades, patient-reported outcome (PRO) measures have been developed to better understand the patient's perspective and enable patient-centred care. In palliative care, the Integrated Palliative care Outcome Scale (IPOS) is recommended as a PRO tool. Its implementation in specialised palliative home care (SPHC) would benefit from an electronic version validated for the setting.Following the Medical Research Council (MRC) guidance, the study Palli-MONITOR is developing (phase 1) and testing the feasibility (phase 2) of implementing the electronic version of IPOS (eIPOS) in the SPHC setting to inform a cluster-randomised phase 3 trial. METHODS AND ANALYSIS: Palli-MONITOR is a multicentre, sequential mixed-methods, two-phase development and feasibility study. The study consists of four substudies. In phase 1 (MRC development phase), qualitative patient interviews and focus groups with SPHC professionals are used to identify barriers and facilitators of eIPOS (substudy I). Substudy II tests the equivalence of eIPOS and IPOS in a crossover randomised controlled trial. Phase 2 (MRC feasibility/piloting phase) includes a quasi-experimental study with two control groups (substudy III), and qualitative interviews as well as focus groups to explore the feasibility and acceptability of the developed intervention (substudy IV).Qualitative data will be analysed with thematic analysis following the framework approach. Quantitative analysis uses a two-way intraclass correlation coefficients model for the equivalence testing. Quantitative analysis of the quasi-experimental study will focus on the primary outcomes, recruitment rates and completeness of eIPOS. Secondary outcomes will include intraindividual change in palliative symptoms and concerns, quality of life and symptom burden. ETHICS AND DISSEMINATION: Approval of the ethics committee of the Ludwig Maximilian University Munich was received for all study parts. Results and experiences will be presented at congresses and in written form. Additionally, participating SPHC teams will receive summarised results. TRIAL REGISTRATION NUMBER: NCT03879668.

Effects of Incentives on Adherence to a Web-Based Intervention Promoting Physical Activity: Naturalistic Study.

BACKGROUND: Despite many advantages of web-based health behavior interventions such as wide accessibility or low costs, these interventions are often accompanied by high attrition rates, particularly in usage under real-life conditions. It would therefore be helpful to implement strategies such as the use of financial incentives to motivate program participation and increase adherence. OBJECTIVE: This naturalistic study examined real-life usage data of a 12-week web-based physical activity (PA) intervention (Fitness Coach) among insurants who participated in an additional incentive program (incentive group) and those who did not (nonincentive group). Users in the incentive group had the perspective of receiving €30 (about US $33) cash back at the end of the intervention. METHODS: Registration and real-life usage data as part of routine data management and evaluation of the Fitness Coach were analyzed between September 2016 and June 2018. Depending on the duration of use and the weekly recording of tasks, 4 adherence groups (low, occasional, strong, and complete adherence) were defined. Demographic characteristics were collected by a self-reported questionnaire at registration. We analyzed baseline predictors and moderators of complete adherence such as participation in the program, age, gender, and BMI using binary logistic regressions. RESULTS: A total of 18,613 eligible persons registered for the intervention. Of these, 15,482 users chose to participate in the incentive program (incentive group): mean age 42.4 (SD 14.4) years, mean BMI 24.5 (SD 4.0) kg/m2, median (IQR) BMI 23.8 (21.7-26.4) kg/m2; 65.12% (10,082/15,482) female; and 3131 users decided not to use the incentive program (nonincentive group): mean age 40.7 (SD 13.4) years, mean BMI 26.2 (SD 5.0) kg/m2, median BMI 25.3 (IQR 22.6-28.7) kg/m2; 72.18% (2260/3131) female. At the end of the intervention, participants in the incentive program group showed 4.8 times higher complete adherence rates than those in the nonincentive program group (39.2% vs 8.1%), also yielding significantly higher odds to complete the intervention (odds ratio [OR] 12.638) for the incentive program group. Gender significantly moderated the effect with men in the incentive group showing higher odds to be completely adherent than women overall and men in the nonincentive group (OR 1.761). Furthermore, older age and male gender were significant predictors of complete adherence for all participants, whereas BMI did not predict intervention completion. CONCLUSIONS: This is the first naturalistic study in the field of web-based PA interventions that shows the potential of even small financial incentives to increase program adherence. Male users, in particular, seem to be strongly motivated by incentives to complete the intervention. Based on these findings, health care providers can use differentiated incentive systems to increase regular participation in web-based PA interventions.

A group- and smartphone-based psychological intervention to increase and maintain physical activity in patients with musculoskeletal conditions: study protocol for a randomized controlled trial ("MoVo-App").

BACKGROUND: Interventions designed to increase the level of physical activity are crucial in the treatment of patients with musculoskeletal conditions. The psychological group-based intervention MoVo-LISA based on the Motivation-Volition (MoVo) Process Model has been shown to effectively promote physical activity. The aim of this study is to evaluate whether a MoVo-based app (MoVo-App) subsequent to MoVo-LISA during orthopedic inpatient care can support people to increase and maintain their amount of physical activity. METHODS/DESIGN: In this parallel-group randomized controlled trial, patients with musculoskeletal disorders will be randomized to either (a) a combination of the group-based intervention program MoVo-LISA to promote physical activity plus the MoVo-App or (b) the group-based intervention program alone without the app. The intervention group will receive the MoVo-App after discharge from inpatient rehabilitation. They receive help to increase and maintain their level of physical activity (initiated by the group program) by tracking their health goals, activity plans, major barriers, and barrier management that were developed during the group-based program. We will recruit 224 initially minimally active participants during orthopedic rehabilitation care. Outcomes are assessed at clinic admission; discharge; 6 weeks; and 3 (post-treatment), 6, and 12 months after discharge (follow-up). The primary outcome is sport activity (active/inactive and minutes of activity) at 6-month follow-up. Secondary outcomes are movement activity, cognitive mediators of behavioral change (e.g., self-efficacy, action planning), and health-related variables (e.g., pain intensity, depression). To evaluate intervention effects, linear mixed effects models (both on intention-to-treat basis with an additional per-protocol analysis) will be conducted with each outcome variable and with time as the within-subjects factor and group as the between-subjects factor, along with all two-way interactions and accounting for covariates as fixed effects. DISCUSSION: This is the first evaluation of the effectiveness of an app in combination with a face-to-face group intervention to promote physical activity. The approach of using an app in addition to an effective face-to-face intervention program, both based on the MoVo model, might sustain positive intervention effects introduced in routine health care. TRIAL REGISTRATION: The trial "A group- and smartphone-based psychological intervention to increase physical activity in patients with musculoskeletal conditions: A randomized controlled trial" is registered at the World Health Organization International Clinical Trials Registry Platform via the German Clinical Studies Trial Register (DRKS), DRKS00014814. Registered on 18 October 2018; URL: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00014814.

Challenges in the cultural adaptation of the German Myeloma Patient Outcome Scale (MyPOS): an outcome measure to support routine symptom assessment in myeloma care.

BACKGROUND: Patients with multiple myeloma report more problems with quality of life (QoL) than other haematological malignancies over the course of their incurable illness. The patient-centred Myeloma Patient Outcome Scale (MyPOS) was developed to assess and monitor symptoms and supportive care factors in routine care. Our aim was to translate and culturally adapt the outcome measure to the German context, and to explore its face and content validity. METHODS: Translation and cultural adaptation following established guidelines used an exploratory, sequential mixed method study design. Steps included: (1) forward translation to German; (2) backward translation to English; (3) expert review; (4) focus groups with the target population (patients, family members, healthcare professionals) to achieve conceptual equivalence; (5) cognitive interviews using Tourangeau's model with think-aloud technique to evaluate comprehension and acceptability; (6) final review. Results were analysed using thematic analysis. RESULTS: Cultural and linguistic differences were noted between the German and English original version. The focus groups (n = 11) and cognitive interviews (n = 9) both highlighted the need for adapting individual items and their answer options to the German healthcare context. Greater individuality regarding need for information with the right to not be informed was elaborated by patients. While the comprehensive nature of the tool was appreciated, item wording regarding satisfaction with healthcare was deemed not appropriate in the German context. Before implementation into routine care, patients' concerns about keeping their MyPOS data confidential need to be addressed as a barrier, whereas the MyPOS itself was perceived as a facilitator/prompt for a patient-centred discussion of QoL issues. CONCLUSION: With adaptations to answer options and certain items, the German version of the MyPOS can help monitor symptoms and problems afflicting myeloma patients over the course of the disease trajectory. It can help promote a model of comprehensive supportive and patient-centred care for these patients.

Validation of two short versions of the Zarit Burden Interview in the palliative care setting: a questionnaire to assess the burden of informal caregivers.

PURPOSE: Several validated outcome measures, among them the Zarit Burden Interview (ZBI), are valid for measuring caregiver burden in advanced cancer and dementia. However, they have not been validated for a wider palliative care (PC) setting with non-cancer disease. The purpose was to validate ZBI-1 (ultra-short version and proxy rating) and ZBI-7 short versions for PC. METHODS: In a prospective, cross-sectional study with informal caregivers of patients in inpatient (PC unit, hospital palliative support team) and outpatient (home care team) PC settings of a large university hospital, content validity and acceptability of the ZBI and its structural validity (via confirmatory factor analysis (CFA) and Rasch analysis) were tested. Reliability assessment used internal consistency and inter-rater reliability and construct validity used known-group comparisons and a priori hypotheses on correlations with Brief Symptom Inventory, Short Form-12, and Distress Thermometer. RESULTS: Eighty-four participants (63.1% women; mean age 59.8, SD 14.4) were included. Structural validity assessment confirmed the unidimensional structure of ZBI-7 both in CFA and Rasch analysis. The item on overall burden was the best item for the ultra-short version ZBI-1. Higher burden was recorded for women and those with poorer physical health. Internal consistency was good (Cronbach's α = 0.83). Inter-rater reliability was moderate as proxy ratings estimated caregivers' burden higher than self-ratings (average measures ICC = 0.51; CI = 0.23-.69; p = 0.001). CONCLUSION: The ZBI-7 is a valid instrument for measuring caregiver burden in PC. The ultra-short ZBI-1 can be used as a quick and proxy assessment, with the caveat of overestimating burden.

Acupuncture for Breathlessness in Advanced Diseases: A Systematic Review and Meta-analysis.

CONTEXT: Nonpharmacological approaches are effective strategies for difficult to palliate breathlessness. Although acupuncture is effective for dyspnea in early-stage chronic obstructive pulmonary disease (COPD), little is known about its effects in patients with advanced (non)malignant diseases. OBJECTIVES: The objective of this study was to identify and examine the evidence of acupuncture on breathlessness in advanced malignant and nonmalignant diseases. METHODS: Systematic literature review of randomized controlled trials of acupuncture and acupressure searched in five databases. Included were adult participants with at least 25% having advanced diseases such as cancer or COPD with severe breathlessness. Primary outcome was severity of dyspnea on Visual Analogue Scale or Borg Scale. Secondary outcomes included quality of life, function, and acceptability. Data were pooled using a random effects model of standardized mean differences. RESULTS: Twelve studies with 597 patients (347 COPD, 190 advanced cancer) were included. For breathlessness severity, significant differences were obtained in a meta-analysis (10 studies with 480 patients; standardized mean difference (SMD) = -1.77 [95% CI -3.05, -0.49; P = 0.007; I2 = 90%]) and in a subgroup analysis of using sham acupuncture control groups and a treatment duration of at least three weeks (6 studies with 302 patients; SMD = -2.53 [95% CI -4.07, -0.99; P = 0.001; I2 = 91%]). Exercise tolerance (6-minute walk test) improved significantly in the acupuncture group (6 studies with 287 patients; SMD = 0.93 [95% CI 0.27, 1.59; P = 0.006; I2 = 85%]). In four of six studies, quality of life improved in the acupuncture group. CONCLUSION: Acupuncture improved breathlessness severity in patients with advanced diseases. The methodological heterogeneity, low power, and potential morphine-sparing effects of acupuncture as add-on should be further addressed in future trials.