Content validity of patient-reported measures evaluating experiences of the quality of transitions in healthcare settings-a scoping review.

No reviews so far have been conducted to define the constructs of patient-experienced quality in healthcare transitions or to identify existing generic measures of patients' experience of the quality within healthcare transitions. Our aim was to identify domains relevant for people experiencing healthcare transitions when evaluating the quality of care they have received, map the comprehensiveness of existing patient-reported experience measures (PREM), and evaluate the PREMs' content validity. The method was guided by the Joanna Briggs Institutes' guidance for scoping reviews. The search was performed on 07 December 2021 and updated 27 May 2024, in the electronic databases Medline (Ovid), Embase (Ovid), and Cinahl (EBSCO). The search identified 20,422 publications, and 190 studies were included for review. We identified 30 PREMs assessing at least one aspect of adults' experience of transitions in healthcare. Summarising the content, we consider a model with two domains, organisational and human-relational, likely to be adequate. However, a more comprehensive analysis and adequate definition of the construct is needed. None of the PREMs were considered content valid.

Effect of In-Person Delivered Behavioural Interventions in People with Multimorbidity: Systematic Review and Meta-analysis.

BACKGROUND: To investigate the effect of in-person delivered behavioural interventions in people with multimorbidity and which behaviour change techniques (BCTs), targeting lifestyle behaviours, are associated with better outcomes. METHODS: Systematic review of randomised controlled trials. We searched MEDLINE, EMBASE, CENTRAL, and CINAHL and screened reference list of reviews including people with multimorbidity, registries, and citation tracking of included studies. Meta-analyses using random-effects model to assess the effect of behavioural interventions and meta-regression analyses and effectiveness ratios to investigate the impact of mediators on effect estimates. Cochrane 'Risk of Bias Tool' 2.0 and the GRADE assessment to evaluate the overall quality of evidence. RESULTS: Fourteen studies involving 1,378 people. Behavioural interventions had little to no effect on physical activity (standardised mean difference 0.38, 95% CI -0.12-0.87) and the effect on weight loss was uncertain (BMI mean difference -0.17, 95% CI -1.1-0.83) at the end-treatment follow-up. Small improvements were seen in health-related quality of life (SMD 0.29, 95% CI 0.17-0.42) and physical function (SMD 0.42, 95% CI 0.12-0.73), and moderate improvements were seen for depression symptoms (SMD -0.70, 95% CI -0.97-0.42). Studies using the BCTs 'action planning' and 'social support (practical)' reported greater physical activity and weight loss. CONCLUSIONS: Behavioural interventions targeting lifestyle behaviours may improve health-related quality of life and physical function, and reduce depression, whereas little to no effect was achieved on physical activity and weight loss in people with multimorbidity. However, the evidence for physical activity and weight loss were of low quality and the end-treatment benefits diminished over time.

Benefits and Harms of Digital Health Interventions Promoting Physical Activity in People With Chronic Conditions: Systematic Review and Meta-Analysis.

BACKGROUND: Digital health interventions for managing chronic conditions have great potential. However, the benefits and harms are still unclear. OBJECTIVE: This systematic review and meta-analysis aimed to investigate the benefits and harms of digital health interventions in promoting physical activity in people with chronic conditions. METHODS: We searched the MEDLINE, Embase, CINAHL, and Cochrane Central Register of Controlled Trials databases from inception to October 2022. Eligible randomized controlled trials were included if they used a digital component in physical activity promotion in adults with ≥1 of the following conditions: depression or anxiety, ischemic heart disease or heart failure, chronic obstructive pulmonary disease, knee or hip osteoarthritis, hypertension, or type 2 diabetes. The primary outcomes were objectively measured physical activity and physical function (eg, walk or step tests). We used a random effects model (restricted maximum likelihood) for meta-analyses and meta-regression analyses to assess the impact of study-level covariates. The risk of bias was assessed using the Cochrane Risk of Bias 2 tool, and the certainty of the evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation. RESULTS: Of 14,078 hits, 130 randomized controlled trials were included. Compared with usual care or minimal intervention, digital health interventions increased objectively measured physical activity (end of intervention: standardized mean difference [SMD] 0.29, 95% CI 0.21-0.37; follow-up: SMD 0.17, 95% CI 0.04-0.31) and physical function (end of intervention: SMD 0.36, 95% CI 0.12-0.59; follow-up: SMD 0.29, 95% CI 0.01-0.57). The secondary outcomes also favored the digital health interventions for subjectively measured physical activity and physical function, depression, anxiety, and health-related quality of life at the end of the intervention but only subjectively measured physical activity at follow-up. The risk of nonserious adverse events, but not serious adverse events, was higher in the digital health interventions at the end of the intervention, but no difference was seen at follow-up. CONCLUSIONS: Digital health interventions improved physical activity and physical function across various chronic conditions. Effects on depression, anxiety, and health-related quality of life were only observed at the end of the intervention. The risk of nonserious adverse events is present during the intervention, which should be addressed. Future studies should focus on better reporting, comparing the effects of different digital health solutions, and investigating how intervention effects are sustained beyond the end of the intervention. TRIAL REGISTRATION: PROSPERO CRD42020189028; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=189028.

Measuring HRQoL following heart valve surgery: the HeartQoL questionnaire is a valid and reliable core heart disease instrument.

PURPOSE: Patient-reported health-related quality of life is a complementary healthcare outcome and important when assessing treatment efficacy. Using COSMIN methodological recommendations, this study evaluates the validity and reliability of a core heart disease-specific health-related quality of life questionnaire, the HeartQoL questionnaire (Danish version) in a sample of patients following heart valve surgery. DESIGN: This project involved a cross-sectional validity study and a test-retest reliability study. METHODS: Eligible patients completed the HeartQoL, the SF-36 health survey questionnaire, and the Hospital Anxiety and Depression Scale following heart valve surgery. Construct validity was tested using a priori hypotheses. Internal consistency reliability was assessed with Cronbach's alpha. An independent sample of patients participated in the test-retest study and reproducibility was determined with relative [intra-class correlation coefficient (ICC)] and absolute reliability [standard error of measurement (SEM) and smallest detectable change (SDC)]. RESULTS: Internal consistency was high with Cronbach's alpha ≥ 0.87. ICC was 0.86-0.92. SEM ranged from 0.17 to 0.26 points and SDC ranged from 0.5 to 0.7 points. Construct validity was confirmed with 87% of all a priori hypotheses for predicted variables. CONCLUSIONS: The HeartQoL questionnaire demonstrates acceptable construct validity, internal consistency, and test-retest reproducibility in patients following heart valve surgery. Future studies should focus on assessing the responsiveness of the HeartQoL questionnaire over time and following heart valve surgery.

Danish translation, cultural adaption and initial psychometric evaluation of the patient feedback form.

AIM: No suitable Danish questionnaire exists to evaluate patient satisfaction with various patient reported outcome measures. Thus, the aim of this research project was to conduct a study on the translation and cultural adaption of an American patient reported experience measures questionnaire, "Patient Feedback Form", among Danish patients, and to examine selected psychometric properties within reliability. MATERIAL AND METHODS: In the first phase of the study, the Patient Feedback Form was forward and backward translated following the methodology of existing guidelines. Subsequently, cognitive interviewing was performed with seven cancer patients and seven healthy persons (19-86 years old/6 men and 8 women) to ensure that questions were easy to understand and made sense to Danish interviewees. In the second phase, phone interviews were carried out with 95 prostate cancer patients after they had responded to the same Patient Feedback Form. Missing data was imputed using the Expectation-Maximization technique. To examine the structure of the questionnaire, an exploratory factor analysis was conducted. Cronbach's alpha was calculated to investigate internal consistency. RESULTS: There were only minor disagreements in the translation process, and the reconciliation went smoothly (phase 1). With regard to one item, however, it was difficult to reach a consensus. Through the qualitative validation process, the right solution was found. The results from the psychometric testing (phase 2) showed that four factors had an Eigen value > 1, but only one factor was extracted as the Scree plot had a clear "elbow", showing a one factor structure that explained 46.1% of the variance. The internal consistency was high as Cronbach's alpha was 0.89. CONCLUSION: The translated, culturally adapted, and validated version of the Patient Feedback Form seems to be suitable for measuring satisfaction with patient reported outcome measures in a Danish setting. While the results should be treated with caution due to the small sample size, psychometric testing indicates that the questionnaire is a valid instrument. However, additional psychometric testing such as hypotheses testing, responsiveness, and test-retest on a larger and more diverse sample size is required to further verify the validity of the instrument.

The effectiveness of exercise-based rehabilitation to patients with myeloproliferative neoplasms-An explorative study.

The aim of the study was to determine the impact of an interdisciplinary exercise-based rehabilitation intervention on fatigue and quality of life (QOL) in patients with Philadelphia-negative myeloproliferative neoplasms (MPNs). At the Danish Knowledge Centre for Rehabilitation and Palliative Care, a 5-day interdisciplinary exercise-based rehabilitation intervention was carried out on 48 patients with MPN. It was followed by 12 weeks of self-exercising prior to follow-up. Initially and at follow-up, participants filled out validated questionnaires; Brief Fatigue Inventory, Multidimensional Fatigue Inventory, European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire, Myeloproliferative Neoplasm Symptom Assessment Form and Hospital Anxiety and Depression Scale. Maximal oxygen uptake and muscular strength were tested as well. Paired t test was used to compare scores between baseline and follow-up. In total, 45 participants (94%) completed the follow-up. No significant differences were observed on fatigue or QOL when comparing baseline and follow-up. Mean maximal oxygen uptake increased from 27.2 to 33.6 ml O2 · kg-1  ·min-1 (p < 0.001). Handgrip strength (p = 0.01) and the 30-s chair-stand test (p < 0.001) improved as well. No changes were found regarding levels of fatigue and QOL. However, we observed a significant increase in the physical capacity. Our observations call for further studies investigating the effects of non-pharmacological approaches in patients with MPN.

Local and Systemic Changes in Pain Sensitivity After 4 Weeks of Calf Muscle Stretching in a Nonpainful Population: A Randomized Trial.

BACKGROUND: Stretching is often used in clinical practice for a variety of purposes, including pain therapy. The possible mechanism behind the effect of stretching remains to be clarified. AIM: To investigate whether 4 weeks of unilateral stretching of the calf muscles would affect local and central pain sensitivity. METHOD: This study was a randomized assessor-blinded clinical study. Healthy participants (age 18 to 40) were included and randomized. Participants in the intervention group were instructed to perform 2 stretching exercises targeting the calf muscles; 3 times 30 seconds, 7 days a week for 4 weeks on the dominant leg. Participants in the control group were instructed not to do any stretching for 4 weeks. Pressure pain threshold (PPT) and temporal summation (TS) of pressure pain were measured on the stretched calf, the contra-lateral calf, and contra-lateral lower arm using a computerized cuff algometer. Analyses of variance on the per-protocol population (defined as participants that adhered to the protocol) were used to assess group differences in the changes from baseline. RESULT: Forty healthy volunteers were included, of which 34 participants adhered to the protocol (15 intervention group/19 control group). No statistically significant group differences in the changes from baseline were found regarding PPT and TS measurements for the stretched calf, the contra-lateral calf, and the arm. CONCLUSION: Four weeks of regular stretching of the calf muscles does not affect pressure pain sensitivity, suggesting that pressure pain sensitivity is unaffected by stretching in a healthy population. The mechanisms underlying any benefits of regular stretching remain to be explained.

Association between digital health literacy and physical activity levels among individuals with and without long-term health conditions: Data from a cross-sectional survey of 19,231 individuals.

Objectives: This study explored associations between digital health literacy and physical activity levels and assessed potential interactions of long-term health conditions. Methods: A cross-sectional survey was sent to 34,000 inhabitants in Region Zealand, Denmark. The survey included items on physical activity levels and three electronic Health Literacy Questionnaire (eHLQ) scales (1, 4, and 5). Associations were assessed by logistic regression and adjusted for confounders. Results: A total of 19,231 participated in the survey. Positive associations were found between higher digital health literacy and being active >30 min./week at moderate-to-vigorous intensity (eHLQ 1: OR 1.24, p < 0.001; eHLQ 4: OR 1.13, p = 0.012; eHLQ 5: OR 1.25, p < 0.001), compliance with the World Health Organization minimum recommendations for physical activity (eHLQ 1: OR 1.33 p < 0.001; eHLQ 4: OR 1.08 p = 0.025; eHLQ 5: OR 1.32, p < 0.001), and self-reported physical active (eHLQ 1: OR 1.50 p < 0.001; eHLQ 4: OR 1.24 p < 0.001; eHLQ 5: OR 1.54 p < 0.001), even when fully adjusted for covariates. No significant interaction was found for long-term health conditions. However, individuals with more long-term health conditions exhibited the lowest digital health literacy scores (9% to 19% scored <2.0). Conclusion: A higher digital health literacy is positively associated with higher physical activity levels. This highlights the importance of screening and promoting digital health literacy in managing digital health and digital physical activity interventions. Future research should explore strategies and targeted interventions to enhance digital health literacy and improve health outcomes.

Mapping interventional components and behavior change techniques used to promote self-management in people with multimorbidity: a scoping review.

Ageing populations and improved survival, have contributed to a rise in the number of people living with multimorbidity, raising issues related to polypharmacy, treatment burden, competing priorities and poor coordination of care. Self-management programs are increasingly included as an essential component of interventions to improve outcomes in this population. However, an overview of how interventions supporting self-management in patients with multimorbidity is missing. This scoping review focused on mapping the literature on patient-centered interventions for people living with multimorbidity. We searched several databases, clinical registries, and grey literature for RCTs published between 1990-2019 describing interventions that supported self-management in people with multimorbidity. We included 72 studies that were found to be very heterogeneous when it comes to the population, delivery modes and modalities, intervention elements and facilitators. The results pointed to an extensive use of cognitive behavioral therapy as a basis for interventions, as well as behavior change theories and disease management frameworks. The most coded behavior change techniques stemmed from the categories Social Support, Feedback and monitoring and Goals and Planning. To allow for implementation of effective interventions in clinical practice, improved reporting of intervention mechanisms in RCTs is warranted.

The effectiveness of digital health interventions for the maintenance of physical activity following cardiac rehabilitation: A systematic review and meta-analysis.

Objective: To summarise the effectiveness of digital health maintenance interventions for subjectively and objectively measured physical activity level (PA) and physical function, fitness and health-related quality of life (HRQoL) after completion of phase II cardiac rehabilitation (CR). Methods: We conducted a search for studies in MEDLINE, Embase, CENTRAL, and CINAHL (inception to May 2024). Independent reviewers selected and included randomised controlled trials (RCTs) using digital health interventions to maintain PA in patients with cardiovascular disease after phase II CR. Independent reviewers conducted data extraction, assessed the risk of bias using the Cochrane Risk of Bias 2 tool and rated the certainty of evidence using Grading of Recommendations Assessment, Development and Evaluation - registered at PROSPERO: CRD42023396629. Results: From 17,455 hits, 20 RCTs with 1801 participants were included. Risk of bias for most studies reporting on PA outcomes was rated as 'some concerns'. Comparing digital health intervention with minimal intervention/usual care showed no effect of objective PA (standardised mean difference (SMD) 0.85, 95% CI: -0.07 to 1.77) and a small effect of subjective PA (SMD 0.37, 95% CI: 0.05 to 0.69) at the end of intervention both graded as very low certainty of evidence. We found very low certainty of evidence for moderate effects on physical function (SMD 0.63, 95% CI: 0.03 to 1.24), and low certainty of evidence for no effect on physical fitness (SMD 0.19, 95% CI: 0.05 to 0.34) and HRQoL (SMD 0.13, 95% CI: -0.02 to 0.28), I 2= 0.00%) at the end of intervention. Conclusion: Digital health interventions showed a small effect on subjectively measured PA, and no effect on objective PA, physical fitness and HRQoL, but may increase physical function after CR completion. Yet, the certainty of evidence is low and higher quality studies with longer follow-up duration are needed to guide this area further.

mHealth intervention including text messaging and behaviour change techniques to support maintenance of physical activity after cardiac rehabilitation: A single-arm feasibility study.

Objective: To evaluate the feasibility of a mobile health-supported intervention in patients with cardiovascular diseases after completion of a cardiac rehabilitation programme. Methods: The feasibility study was performed in two hospitals and one municipality in Region Zealand, Denmark. Eligible participants were ≥18 years old, participated in a supervised cardiac rehabilitation programme, had access to a mobile phone, and could walk 3 m independently. Participants received a 12-week intervention utilizing behaviour change techniques, consisting of action planning, text messages, and phone support. Feasibility was assessed using pre-defined progression criteria, which included recruitment (≥75%), retention (≥80%), accelerometer data completeness (≥80%), coordinator (phone support) time (≤30 min), the response rate on patient-reported outcomes (≥90%), adherence (≥75% respond to ≥75% of messages), and acceptability (≥75%). The secondary outcome of objective physical activity was assessed with accelerometers. Results: Ten women and 30 men with cardiovascular diseases aged 63.5 (±9.8 SD) participated. The progression criteria for retention (90%), accelerometer data completeness (83%), coordinator time (9.9 min), adherence (83%), and acceptability (82%) were at acceptable levels, exceptions were progression criteria for recruitment (35%) being below acceptable levels for recruitment, and response rate on patient-reported outcomes (75%). High satisfaction (92.6%) with the intervention was found. All objectively measured physical activity levels remained unchanged from baseline to follow-up. No serious adverse events related to the intervention were reported. Conclusion: Mobile health-supported maintenance of physical activity after cardiac rehabilitation completion was feasible, safe, and acceptable. Yet, changes to improve recruitment and response rate are needed before conducting a large-scale effect evaluation.

The Quality of Health Apps and Their Potential to Promote Behavior Change in Patients With a Chronic Condition or Multimorbidity: Systematic Search in App Store and Google Play.

BACKGROUND: Mobile apps offer an opportunity to improve the lifestyle of patients with chronic conditions or multimorbidity. However, for apps to be recommended in clinical practice, their quality and potential for promoting behavior change must be considered. OBJECTIVE: We aimed to investigate the quality of health apps for patients with a chronic condition or multimorbidity (defined as 2 or more chronic conditions) and their potential for promoting behavior change. METHODS: We followed the Cochrane Handbook guidelines to conduct and report this study. A systematic search of apps available in English or Danish on App Store (Apple Inc) and Google Play (Google LLC) for patients with 1 or more of the following common and disabling conditions was conducted: osteoarthritis, heart conditions (heart failure and ischemic heart disease), hypertension, type 2 diabetes mellitus, depression, and chronic obstructive pulmonary disease. For the search strategy, keywords related to these conditions were combined. One author screened the titles and content of the identified apps. Subsequently, 3 authors independently downloaded the apps onto a smartphone and assessed the quality of the apps and their potential for promoting behavior change by using the Mobile App Rating Scale (MARS; number of items: 23; score: range 0-5 [higher is better]) and the App Behavior Change Scale (ABACUS; number of items: 21; score: range 0-21 [higher is better]), respectively. We included the five highest-rated apps and the five most downloaded apps but only assessed free content for their quality and potential for promoting behavior change. RESULTS: We screened 453 apps and ultimately included 60. Of the 60 apps, 35 (58%) were available in both App Store and Google Play. The overall average quality score of the apps was 3.48 (SD 0.28) on the MARS, and their overall average score for their potential to promote behavior change was 8.07 (SD 2.30) on the ABACUS. Apps for depression and apps for patients with multimorbidity tended to have higher overall MARS and ABACUS scores, respectively. The most common app features for supporting behavior change were the self-monitoring of physiological parameters (eg, blood pressure monitoring; apps: 38/60, 63%), weight and diet (apps: 25/60, 42%), or physical activity (apps: 22/60, 37%) and stress management (apps: 22/60, 37%). Only 8 out of the 60 apps (13%) were completely free. CONCLUSIONS: Apps for patients with a chronic condition or multimorbidity appear to be of acceptable quality but have low to moderate potential for promoting behavior change. Our results provide a useful overview for patients and clinicians who would like to use apps for managing chronic conditions and indicate the need to improve health apps in terms of their quality and potential for promoting behavior change.

Personalised exercise therapy and self-management support for people with multimorbidity: Development of the MOBILIZE intervention.

BACKGROUND: To our knowledge, there is no intervention which includes personalised exercise therapy and self-management support for people with multimorbidity, although these interventions may be as effective as for people with single chronic conditions. Therefore, we developed a novel intervention, including personalised exercise therapy and self-management support for people with multimorbidity. METHODS: We followed the Medical Research Council framework and conducted one scoping review, five systematic reviews, two registry-based studies, one qualitative interview study and a mixed-methods feasibility study. Following an iterative approach, together with feedback from people with multimorbidity and relevant stakeholders, we developed the MOBILIZE intervention. RESULTS: The intervention included 24 (60 minutes) sessions of personalised exercise therapy and 24 (30 minutes) sessions of self-management support twice a week for 12 weeks, delivered in small groups by specifically trained physiotherapists. The intervention targets physiological, psychosocial, behavioural, and contextual factors to improve health-related quality of life and physical function in people living with multimorbidity. CONCLUSIONS: We developed a personalised exercise therapy and self-management support programme for people with multimorbidity. The intervention will be tested for its safety and effectiveness in a randomised controlled trial.

Maintenance of physical activity after cardiac rehabilitation (FAIR): study protocol for a feasibility trial.

INTRODUCTION: To enhance health and prevent secondary consequences for patients with cardiovascular disease (CVD), maintenance of an active lifestyle following participation in cardiac rehabilitation (CR) is important. However, levels of physical activity often decrease after completion of a structured CR programme. Models that support long-term behaviour change with a sustained level of physical activity are imperative. The aim of this study is to evaluate the feasibility of a mobile health intervention based on the Health Action Process Approach theoretical model of behaviour change in patients with CVD for 3 months after completion of a CR programme. METHODS AND ANALYSIS: In a feasibility trial design, we will recruit 40 participants from CR programmes at Slagelse Hospital, the City of Slagelse (municipality), or Holbæk Hospital. After completing the standard structured CR programme, each participant will create an action plan for physical activity together with a physiotherapist. Following that, participants are sent 2 weekly text messages for 3 months. The first text message prompts physical activity, and the second will check if the action plan has been followed. If requested by participants, a coordinator will call and guide the physical activities behaviour. The feasibility of this maintenance intervention is evaluated based on predefined progression criteria. Physical activity is measured with accelerometers at baseline and at 3 months follow-up. ETHICS AND DISSEMINATION: Study approval was waived (EMN-2021-00020) by the Research Ethics Committee of Region Zealand, Denmark. Study results will be made public and findings disseminated to patients, health professionals, decision-makers, researchers and the public. TRIAL REGISTRATION NUMBER: NCT05011994.

Preliminary validation of the insomnia severity index in Danish outpatients with a medical condition.

PURPOSE: Insomnia is a frequent sleeping disorder in the general and clinical population. With an increasing proportion of health care services being provided as outpatient care, a short, valid and reliable tool is needed to identify insomnia in medical patients under outpatient care in Denmark. The Insomnia Severity Index (ISI) could be the needed tool if found valid and reliable. Hence, the aim of this study is to evaluate elements of the psychometric properties of the Danish version of ISI (ISI-DK). METHODS: Outpatients from three hospital wards and one rehabilitation center were asked to complete the ISI-DK twice, 2 weeks apart. Internal consistency, discriminative validity, test-retest reliability, and measurement error was assessed. RESULTS: The ISI-DK was completed by 249 (79.0%) participants the first time, and 163 (65.5%) the second time. Respondents had a mean age of 58.2 years (SD 13.5) and 63.5% were women. All but one of the discriminative hypotheses was accepted. Internal consistency was high in the global scale at 0.90 and good with Cronbach's alpha at 0.75-0.88 in the proposed subscales. The test-retest reliability was good, as the intraclass correlation was 0.90 (95% CI: 0.87; 0.93). Ceiling and floor effects were low < 4.4%. Standard error of measurement was 2.52 and smallest detectable change 6.99. CONCLUSION: This preliminary assessment showed encouraging results supporting the ISI-DK as a valid and reliable tool for screening insomnia severity in Danish outpatients with a medical condition, but further assessments are needed.

Sleep Disturbances in Patients With Coronary Heart Disease: A Systematic Review.

STUDY OBJECTIVES: Investigation into sleep and coronary heart disease (CHD) has predominantly been focused on sleep disturbances as a risk factor for developing CHD. Objectively measured and self-reported sleep at a patient level has only been sparsely and not systematically reported. Therefore, we set out to review the literature for studies using objectively measured and self-reported sleep in patients with CHD. The review focuses on patients with acute coronary syndrome (ACS) and stable CHD. METHODS: A systematic review performed in four databases adhering to the PRISMA guidelines applying a qualitative synthesis of evidence. RESULTS: Following ACS, we found sleep architecture to be significantly disturbed with changes normalizing over a period of up to 6 months. With increasing severity of CHD, sleep disturbances were more pronounced; however, the modulating effects of sleep-disordered breathing and ejection fraction on sleep in patients with CHD are conflicting. Overall, studies were predominantly cross-sectional in design and of low methodological quality. Polysomnography was the predominant outcome assessment tool and validated self-reported assessment tools were limited. CONCLUSIONS: Future investigations in sleep and CHD applying both a longitudinal design and investigating objective and self-reported sleep assessments are warranted. SYSTEMATIC REVIEW REGISTRATION: Registry: PROSPERO, Title: Sleep measures in relation to coronary heart disease: a systematic review, Identifier: CRD42017056377, URL: https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=56377.

Psychometric properties of HeartQoL, a core heart disease-specific health-related quality of life questionnaire, in Danish implantable cardioverter defibrillator recipients.

Background Patient-reported health-related quality of life is increasingly used as an outcome measure in clinical trials and as a performance measure to evaluate quality of care. The objective of this study was to assess the psychometric properties of the Danish HeartQoL questionnaire, a core heart disease-specific health-related quality of life questionnaire, in implantable cardioverter defibrillator recipients. Design This study involved cross-sectional and test-retest study designs. Method Implantable cardioverter defibrillator recipients in the cross-sectional study completed the HeartQoL, the Short-Form 36 Health Survey, and the Hospital Anxiety and Depression Scale. The HeartQoL structure, construct-related validity (convergent and discriminative) and reliability (internal consistency) were assessed. HeartQoL reproducibility (test-retest) was assessed in an independent sample of implantable cardioverter defibrillator recipients. Results Mokken scale analysis supported the bi-dimensional structure of HeartQoL among 358 implantable cardioverter defibrillator recipients. Convergent ( r > 0.72) and discriminative validity were confirmed. The HeartQoL scales demonstrated satisfactory internal consistency (Cronbach's alpha > 0.90). Test-retest reliability (two weeks interval) was assessed in 89 implantable cardioverter defibrillator recipients and found to be acceptable for each scale (intra-class correlation > 0.90). Conclusion The Danish HeartQoL questionnaire demonstrated satisfactory key psychometric attributes of validity and reliability in this implantable cardioverter defibrillator population. This study adds support for the HeartQoL as a core heart-specific health-related quality of life questionnaire in a broad group of patients with heart disease including implantable cardioverter defibrillator recipients.

Validating the HeartQoL questionnaire in patients with atrial fibrillation.

BACKGROUND: Atrial fibrillation (AF) is associated with impaired health-related quality-of-life (HRQL). When assessing HRQL, disease-specific and generic instruments are used, which may hinder outcome comparisons across studies. A newly developed core ischaemic heart disease-specific HRQL questionnaire, the HeartQoL, offers a single measurement instrument which may allow outcome comparisons across cardiac diseases. The aim of the study was to evaluate the psychometric properties of HeartQoL in an AF population treated with ablation by assessing its factor structure, construct validity, internal consistency, and test-retest reliability. DESIGN AND METHODS: Data were collected in two phases: (a) a cross-sectional study including 462 patients with AF/atrial flutter who completed the HeartQoL and the Short-Form 36 (SF-36), allowing for the evaluation of internal consistency, factor structure and construct validity; and (b) a longitudinal study including 55 patients completing HeartQoL twice to evaluate test-retest reliability. RESULTS: The two-factor structure of HeartQoL was largely confirmed in patients with AF. Internal consistency was high (Cronbach's alpha (α) ≥ 0.90) and test-retest reliability good (intra-class correlation ≥ 0.90). The construct validity was supported, as subscales of HeartQoL correlated strongly with similar (r ≥ 0.78) and weakly (r ≤ 0.47) with dissimilar subscales of SF-36. The HeartQoL demonstrated ability to distinguish between different clinical subgroups of patients, indicating sensitivity. CONCLUSION: The HeartQoL showed overall satisfactory psychometric properties, demonstrating it to be a valid instrument in the evaluation of HRQL in patients with AF treated with ablation. This suggests that HeartQoL may be a valuable instrument for making HRQL comparisons across the spectrum of cardiac diseases.

Self-rating level of perceived exertion for guiding exercise intensity during a 12-week cardiac rehabilitation programme and the influence of heart rate reducing medication.

OBJECTIVES: To investigate whether self-rating level of perceived exertion can adequately guide exercise intensity during a 12-week cardiac rehabilitation programme. DESIGN: Linear regression analysis using rehabilitation data from two randomised controlled trials. METHODS: Patients undergoing radiofrequency ablation for atrial fibrillation or following heart valve surgery and participating in exercise-based rehabilitation were included. The 12-week rehabilitation outpatient programme comprised three weekly training sessions, each consisting of 20min aerobic exercise divided into three steps. Patients were asked to base their exercise intensity for each step on a predefined rating of perceived exertion specified in a training diary. Exercise intensity was objectively measured by heart rate during the last 2min for each exercise step. Comparative analysis and linear regression of the rating of perceived exertion and heart rate were performed. RESULTS: A total of 2622 ratings of perceived exertion were collected from 874 training sessions in 97 patients. Heart rate and rating of perceived exertion were associated both across all three exercise steps and individually for each step, with a mean of 6 to7bpm per 1-point difference in the rating of perceived exertion (p<0.001). Adjusting for rate-reducing medication slightly improved the strength of the association. CONCLUSIONS: The association between change in the rating of perceived exertion and change in heart rate indicates that a diary-led and self-regulated model using rating of perceived exertion can help guide exercise intensity in everyday clinical practice among patients with heart disease, irrespective if they are taking heart rate-reducing medication.

Improved gait in persons with knee related mobility limitations by a rosehip food supplement: A randomized, double-blind, placebo-controlled trial.

PURPOSE: To evaluate the efficacy of a specialized rosehip powder nutraceutical on the biomechanical function of the knee joint during walking in individuals with knee-related walking limitations. METHODS: Randomized, participant and outcome assessor blinded trial. Participants with self-reported knee-related walking limitations were randomized (1:1) to receive three capsules/day of either rosehip powder or identically appearing placebo capsules for 12 weeks. At baseline and the 12 weeks follow-up, 3-dimensional gait analyses were performed from which the peak resultant knee moment was selected as primary outcome. Secondary outcomes included sagittal and frontal plane knee joint moments, knee joint kinematics, peaks in the vertical ground reaction forces, and self-selected walking speeds. Analyses were based on ANCOVA with the 'Intention-To-Treat' (ITT) population, defined as all randomized participants using last observation carried forward imputation for missing data. RESULTS: 100 participants were randomized to rosehip (n=50) or placebo (n=50) and defined the ITT population. Of these 94 completed the study (47 in each group). There were statistically significant group differences in the change from baseline in the primary outcome: the resultant knee moment (0.06 nm/kg, 95%CI: 0.00-0.12; P=0.039) and in the peaks in the sagittal plane moments and kinematics during the stance phase of walking with the rosehip group exhibiting greater joint moments and more knee joint flexion during walking than the placebo group. CONCLUSION: A daily intake of rosehip powder for 12 weeks improved important indices of knee joint function and dynamics during walking compared to placebo in persons with knee-related walking limitations.