What matters in development and sustainment of community dementia friendly initiatives and why? A realist multiple case study.

BACKGROUND: Dementia friendly communities (DFCs) are seen as key to participation of people with dementia and carers. Dementia-friendly initiatives (DFI) are important building blocks for the growth of DFCs. Therefore, it is essential to understand how DFIs are developed and sustained to secure the growth of DFCs. This study identifies contextual factors and mechanisms that influence the development and sustainment of Dutch DFIs. It also explains how these contextual factors and mechanisms are interrelated and the outcomes to which they lead. METHODS: Mixed methods, namely interviews, observations, documentation and focus groups, were used for this realist multiple case study. Participants were professionals (n = 46), volunteers (n = 20), people with dementia (n = 1) and carers (n = 2) who were involved in development and sustainment of DFIs in four Dutch DFCs. RESULTS: This study revealed three middle-range program theories as final outcomes: development of a support base, collaboration, and participation in DFIs by people with dementia and carers. These theories address institutional, organisational, interpersonal and individual levels in the community that are essential in development and sustainment of DFIs. CONCLUSIONS: The development and sustainment of DFIs requires the development of a support base, collaboration, and participation in DFIs by people with dementia and their carers.

Com-mens: a home-based logopaedic intervention program for communication problems between people with dementia and their caregivers - a single-group mixed-methods pilot study.

BACKGROUND: Communication difficulties are common in people with dementia, and often present from an early stage. However, direct treatment options for people with dementia that positively influence their daily communication are scarce. AIMS: To evaluate the potential impact and feasibility of a personalized logopaedic intervention. METHODS & PROCEDURES: A total of 40 community-dwelling persons with dementia and their caregivers were recruited. Five experienced speech and language therapists (SLTs) delivered the six-session Com-mens intervention at home. Com-mens aims to improve positive communication between people with dementia and their primary caregivers and comprises five elements: interactive history-taking, dynamic observational assessment, education about the consequences of dementia on communication, development and use of personalized communication tools, use motivational, and person-centred strategies by the SLT. We conducted a single-group mixed-methods pilot study with five measurements: baseline, directly after intervention, and at 3, 6 and 9 months follow-up. Semi-structured interviews and questionnaires for Experienced Communication in Dementia, quality of life, psychological well-being and caregiver burden were conducted. Process evaluation was performed by interviewing participants, drop-outs, SLTs and other stakeholders. OUTCOMES & RESULTS: A total of 32 dyads completed the intervention. Repeated measures analyses revealed no significant changes over time. In the interviews, participants reported a positive impact on their feelings, increased communication skills and better coping with the diagnosis. Participants would recommend the intervention to others. Facilitators were timely delivery, personalized content and adequate reimbursement. Barriers were unfamiliarity with Com-mens among referrers, an overburdened caregiver or disrupted family relationships. CONCLUSIONS & IMPLICATIONS: This newly developed logopaedic intervention is feasible and has a perceived positive impact on both people with dementia and their caregivers, which is confirmed by a stable pattern over a period of 1 year. Future comparative studies are needed to test the effectiveness of personalized interventions in this patient population. WHAT THIS PAPER ADDS: What is already known on the subject? SLTs are experts in the field of communication, but even though communication problems are common between people with dementia and their caregivers, there is a lack of logopaedic guidelines and materials for the direct treatment for this population. Interventions that are available either focus on (professional) caregivers only or aim to enhance cognitive functioning and do not target on joined communication. What this paper adds to the existing knowledge? A newly developed intervention called Com-mens can be provided by trained SLTs and takes an average of six 1-h sessions. The intervention is perceived to be valuable and feasible for people with dementia and their caregivers, by the participants themselves, as well as by healthcare professionals and other stakeholders. What are the potential or actual clinical implications of this work? Dissemination of this intervention will give SLTs skills, tools and materials to provide meaningful care to home-dwelling persons with dementia and their caregivers. Also, persons with dementia and their caregivers will receive education and materials that can help them increase their understanding of communication problems, enhance their communication skills and better cope with the communication problems that result from dementia. We consider the Com-mens intervention to be a valuable addition to the field of speech language therapy and dementia.

Perceive, Recall, Plan and Perform (PRPP)-Assessment Based on Parent-Provided Videos of Children with Mitochondrial Disorder: Action Design Research on Implementation Challenges.

AIMS: Performing the Perceive, Recall, Plan and Perform (PRPP)-Assessment, using video material of everyday life, seems sensible to lower the patient burden, enhance ecological validity, and provide care at a distance. However, receipt of adequate video material is not self-evident and assessing videos can be challenging. Therefore, this study aims to optimize the process of gaining video material and to optimize the PRPP-Assessment based on parent-provided videos. METHODS: An action design research method was used, focusing on implementation of the PRPP-Assessment based on parent-provided videos within the care of children with a mitochondrial disorder or similar symptoms. RESULTS: Five cycles were conducted. To receive input, the cycles used videos of nine children performing activities, written feedback, and semi-structured interviews and focus groups comprising parents (n = 13), a teacher (n = 1), occupational therapists (n = 16), and other professionals (n = 2) . This led to successful implementation of the PRPP-Assessment. General lessons were learned on (1) instructing parents; (2) handling video material; (3) PRPP-Assessment based on parent-provided videos; and (4) PRPP-Assessment of children (with limited functional abilities). CONCLUSIONS: Lessons learned should be implemented in practice and are incorporated into a manual to guide the implementation of video-based observations with PRPP-Assessment in practice.

Using PRPP-Assessment for measuring change in everyday activities by home-based videos: An exploratory case series study in children with multiple disabilities.

BACKGROUND: Currently, paediatric health care aims to use a child-centred tailor-made approach. In order to design tailored occupational therapy, the implementation of personalised occupation-based measurements that guide and evaluate goal setting and are responsive to change is necessary. PURPOSE: Primarily, this study explored the potential of the Perceive, Recall, Plan, and Perform (PRPP) assessment to measure the change in the performance of children with multiple disabilities. As a secondary evaluation, the feasibility of the PRPP-Intervention in a home-based program to enable activities was described. The overall aim is to show the potential of the PRPP-Assessment as an outcome measure to use as a base for designing tailor-made person-centred care. METHODS: An exploratory longitudinal multiple case series mixed-methods design was used. The PRPP-Assessment, scored by multiple raters, was conducted based on parent-provided videos. The assessed activities were chosen by the child and/or parents. Responsiveness was evaluated by hypotheses formulated a priori and by comparing measured change with change on concurrent measures: Goal Attainment Scaling (GAS) and Canadian Occupational Performance Measure (COPM). Over a 6-week period, children and their parents (or caregivers) participated in an online home-based video coaching program where parents were coached in the implementation of the training, based on the PRPP-Intervention, by paediatric occupational therapists on a weekly basis. The feasibility of the intervention was explored using semi-structured interviews with children, parents, and the treating occupational therapists and was analysed by directed content analysis. RESULTS: Three out of 17 eligible children agreed to participate and completed post-intervention measurement, of which two completed the intervention. Quantitative results showed that eight out of nine activities improved on the PRPP-Assessment and the COPM, and nine improved on the GAS. In total, 13 out of 15 hypotheses for responsiveness were accepted. Participants experienced the intervention as successful and acceptable. Facilitators and concerns over demand, implementation, practicality, integration, and adaptation were shared. CONCLUSION: The PRPP-Assessment showed the potential to measure change in a heterogeneous group of children. The results indicated a positive tendency for the intervention and also provide directions for further development.

Evidence and consensus-based recommendations for non-pharmacological treatment of fatigue, hand function loss, Raynaud's phenomenon and digital ulcers in patients with systemic sclerosis.

OBJECTIVE: SSc is a complex CTD affecting mental and physical health. Fatigue, hand function loss, and RP are the most prevalent disease-specific symptoms of systemic sclerosis. This study aimed to develop consensus and evidence-based recommendations for non-pharmacological treatment of these symptoms. METHODS: A multidisciplinary task force was installed comprising 20 Dutch experts. After agreeing on the method for formulating the recommendations, clinically relevant questions about patient education and treatments were inventoried. During a face-to-face task force meeting, draft recommendations were generated through a systematically structured discussion, following the nominal group technique. To support the recommendations, an extensive literature search was conducted in MEDLINE and six other databases until September 2020, and 20 key systematic reviews, randomized controlled trials, and published recommendations were selected. Moreover, 13 Dutch medical specialists were consulted on non-pharmacological advice regarding RP and digital ulcers. For each recommendation, the level of evidence and the level of agreement was determined. RESULTS: Forty-one evidence and consensus-based recommendations were developed, and 34, concerning treatments and patient education of fatigue, hand function loss, and RP/digital ulcers-related problems, were approved by the task force. CONCLUSIONS: These 34 recommendations provide guidance on non-pharmacological treatment of three of the most frequently described symptoms in patients with systemic sclerosis. The proposed recommendations can guide referrals to health professionals, inform the content of non-pharmacological interventions, and can be used in the development of national and international postgraduate educational offerings.

How do community based dementia friendly initiatives work for people with dementia and their caregivers, and why? A rapid realist review.

OBJECTIVES: To describe and explain the outcomes of community dementia friendly initiatives (DFIs) for people with dementia and their caregivers to inform the development and tailoring of DFIs. METHODS: Literature searches on DFIs were performed through two systematic online database searches of PubMed, Embase, ASSIA, CINAHL and Google scholar. Papers were only included if they evaluated outcomes using empirical data from people with dementia or caregivers. Data collection and analysis were guided by the categorization in the DEM-FACT taxonomy and RAMESES guidelines for realist reviews. RESULTS: Of 7154 records identified, 22 papers were included with qualitative, mixed method and quantitative study designs. The synthesis led to a description of programme theories addressing caring, stimulating and activating communities. Outcomes for people with dementia and caregivers included having contact with others, enjoyment and decrease of stress and, lastly, support. This synthesis also indicated how people with dementia participated in a specific role in DFIs, such as patient, team member or active citizen. CONCLUSIONS: DFIs generate different outcomes for people with dementia and caregivers, depending on the kind of initiative and the specific role for people with dementia. These findings could be a catalyst for initiation and further development of DFIs in a dementia friendly community (DFC). This draws attention to the multiple aspects of DFCs and supports reflection on their essential principles.

Parents' experiences with a home-based upper limb training program using a video coaching approach for infants and toddlers with unilateral cerebral palsy: a qualitative interview study.

BACKGROUND: Although early home-based upper limb training programs are promising, in-depth understanding of parents' experiences with these programs is still limited. We developed an early home-based upper limb training program for infants and toddlers (8-36 months) with or at risk of unilateral cerebral palsy using video coaching for parents. The aim of this qualitative study was to evaluate parents' experiences with the home-based training program using a video coaching approach in order to optimize implementation strategies. METHODS: We held semi-structured interviews with parents of 13 children with unilateral cerebral palsy, who participated in our program in the period from 2014 - 2017. On average, parents had delivered two training periods of the program at the time of the interviews. Interviews were analyzed using inductive thematic content analysis. RESULTS: We identified three overarching interacting themes that shaped the experiences of parents with the program: 1) Parental learning comprising the subthemes parents' training competencies and the facilitative and reinforcing role of video coaching, 2) Parental load comprising the subthemes flexibility of the program, supportive network, competing demands, and child's mood and functional capacities, and 3) Parental perseverance comprising the subthemes beliefs and expectancies and seeing child's functional improvements. CONCLUSIONS: For successful implementation of an early home-based upper limb training program using video coaching, support in delivering home-training from a therapist or from others within parents' social network, is needed to relieve parental load. Seeing functional improvements of their child on the videos increased parents' motivation to continue with the training. Positively phrased feedback from an occupational therapist stimulated parents' perseverance and training competency.

The SLIM study-Shared medical appointments to change lifestyles of overweight people with haemophilia: A randomized multiple baseline (n-of-1) design.

INTRODUCTION: People with haemophilia suffer from haemophilic joint disease that may result in physical inactivity and overweight. Shared medical appointments (SMAs) might help limit the consequences of haemophilic arthropathy. SMAs are group meetings supervised by one or more healthcare professionals that can be utilized to improve lifestyle. AIM: To evaluate the feasibility and efficacy of SMAs in people with haemophilia to improve physical activity and eating habits. METHODS: A multiple baseline single-case design was used. Overweight people with haemophilia were eligible to participate. Seven weekly SMAs were conducted using multiple behavioural change techniques to improve physical activity and eating habits. Feasibility of SMAs was evaluated using (a) dropout rate, (b) occurrence of adverse events (AEs), (c) adherence rate and (d) patient satisfaction. During 13 weeks, physical activity was measured daily and eating habits were measured three times per week. The efficacy of SMAs was determined using randomization tests and visual data inspection. RESULTS: Out of the six men participating in the study, one participant dropped out. No study-related AEs occurred. The adherence rate of SMAs was 80%, and participants reported to be 'very satisfied' with the SMAs. Randomization tests and visual analyses demonstrated (statistical) improvements in physical activity (p = .03). No effect was found in self-reported eating habits (p = .55). CONCLUSION: Shared medical appointments are feasible in people with haemophilia and appear to improve physical activity. The effect on improving eating habits could not be established. Scientific replication of our approach is warranted to confirm or refute the merit of SMAs in people with haemophilia.

Pregnancy- and obstetric-related risk factors for urinary incontinence, fecal incontinence, or pelvic organ prolapse later in life: A systematic review and meta-analysis.

INTRODUCTION: Risk factors for pelvic floor disorders are often related to pregnancy and delivery. Consistent evidence is needed to develop prevention strategies targeting risk factors. The objective of this study is to identify which pregnancy- and/or obstetric-related risk factors can predict urinary incontinence, fecal incontinence, or pelvic organ prolapse later in life by means of a systematic review and meta-analysis. MATERIAL AND METHODS: Systematic review Prospero number: CRD42019131758. Literature searches of PubMed, EMBASE, CINAHL, and Cochrane Library were conducted according to PRISMA guidelines (April 2020). Prospective cohort studies describing more than two pregnancy- and/or obstetric-related risk factors on urinary incontinence, fecal incontinence (including flatal incontinence), or pelvic organ prolapse were eligible. Risk of bias was assessed (using Quality In Prognosis Studies [QUIPS]). Studies with high risk of bias were excluded. Data were extracted and checked for accuracy with the CHARMS checklist. Sub-groups were used to distinguish between a short- and long-term follow-up period: <18 months (shortterm) and >18 months (long-term) postpartum. Odds ratios were calculated from reported prevalence rates. Log odds ratios were calculated using SPSS v.24. Variables were pooled using RevMan5. RESULTS: Data were extracted from nineteen studies for urinary incontinence, nine for fecal incontinence, and two for pelvic organ prolapse. Multivariate analysis was not possible because of the heterogeneity of the population and outcome measures. Pooled univariate risk factors for urinary incontinence were: urinary incontinence during pregnancy, instrumental vaginal delivery, episiotomy, tears, and constipation. Pooled univariate risk factors for fecal incontinence were: fecal incontinence during pregnancy, maternal age over 35 years, prenatal body mass index over 30 kg/m2 , instrumental vaginal delivery, a spontaneous vaginal delivery, oxytocin augmentation, and when the weight of the newborn was more than 4000 g. Both studies for pelvic organ prolapse had a short-term follow-up period and cesarean section was the only risk factor that could be pooled. CONCLUSIONS: Pregnancy- and obstetric-related risk factors predicting pelvic floor disorders postpartum are multifactorial and differ between pelvic floor disorders. The strongest risk factor for incontinence later in life was incontinence during pregnancy. Better quality research with long-term follow up is needed on this topic.

Opening the black box of non-pharmacological care in systemic sclerosis: a cross-sectional online survey of Dutch health professionals.

The objective is to describe the spectrum of the health professional (HP) treatment approach for systemic sclerosis (SSc) from the perspective of Dutch HPs, including alignment of treatment goals set by HPs with self-reported referral reasons, coverage of patient-reported unmet care needs, and quality of communication between HPs and rheumatologists. Dutch HPs were invited through their patients with SSc to complete an anonymous online survey. The survey covered referral reasons, treatment goals, and interventions of the last patient treated, as well as the perceived quality of communication between HPs and rheumatologists. Referral reasons and treatment targets were linked to the International Classification of Functioning, Disability and Health following the refined ICF Linking Rules. Seventy-nine HPs from 8 professions (including 58 physiotherapists, 73%) completed the survey. One hundred and thirty-three different referral reasons were reported, yielding 58 different ICF codes, with 41 (70.7%) being linked to the ICF domain "body structures and functions." The reported interventions focused on body functions/structures (27.9%), training of daily activities (25.6%), education and advice (26.3%), and psychosocial interventions (20.2%). The quality of communication between HPs and rheumatologists was perceived as low. Our findings revealed numerous treatment options offered by Dutch HPs addressing the unmet care needs of patients with SSc. There is an overlap in the content of the various HP disciplines, and HP treatment goals are not sufficiently aligned with referrals of rheumatologists. HP treatment offer seemed inefficiently organized, possibly precluding rheumatologists from making targeted referrals. Communication between rheumatologists and HPs should be improved.

Identifying unmet needs and limitations in physical health in survivors of Head and Neck Cancer.

OBJECTIVE: To gain insight into the level of unmet needs and limitations in physical health experienced by survivors of head and neck cancer, and to evaluate whether unmet needs in physical health and limitations in physical performance are associated. MATERIALS AND METHODS: In this cross-sectional study, unmet needs were measured with Supportive Care Needs Surveys (SCNS-SF34, SCNS-HNC). Limitations in physical health were measured for maximal mouth opening, neck and shoulder function, hand grip strength and lower body strength, level of mobility and walking ability. RESULTS: The SCNSs showed that 48% had a cancer generic unmet need and 46% had at least one HNC-specific unmet need. In total, 76% of sHNC had a cancer generic limitation in physical health and that 58% had an HNC-specific limitation in the mobility of neck and shoulders or maximum mouth opening. The domain of physical and daily living needs showed a weak association with lateral flexion of the neck to the left (R = -0.319; p = 0.024). CONCLUSION: Survivors of HNC might benefit from the use of both SCNSs and physical performance measurements during usual care follow-up for early and optimal identification of unmet needs and limitations in physical health.

Therapists' experiences and needs with regard to providing work-focused care: a focus group study.

BACKGROUND: Musculoskeletal disorders (MSDs) can create a temporary or permanent disability that reduce a person's ability to work. Physiotherapists (PTs), occupational therapists (OTs) and exercise therapists (ETs) are often involved in the early management of MSDs. There is a need for additional insights into therapists' experiences, barriers and needs to work-focused care. Moreover, there is no evidence on how OTs and ETs address work participation. Therefore, the aim of this qualitative study was 1) to investigate how generalist PTs, OTs and ETs provide work-focused healthcare and 2) to obtain insight into their perceived barriers and needs that affect their ability to address occupational factors. METHODS: An exploratory qualitative study using three focus groups. Generalist PTs, OTs and ETs were eligible to participate if they treated working patients with MSDs. A semi-structured interview guide with open-ended questions was developed. Two moderators facilitated each focus group using the interview guide, and all the groups were audio recorded. Data were analysed using inductive thematic analysis. RESULTS: Sixteen therapists (mean age 44 years, range 25-59) participated in this study. Participants were aware of the importance of taking occupational factors into account. Whether they address occupational factors is largely dependent on the patient's request for help. However, ETs and OTs consider it normal to ask about occupational factors during the diagnostic process, while PTs often address this in later consultations. Almost all participants were unaware of the existence of PTs, OTs or ETs who are specialised in occupational health. Moreover, almost all participants struggled with when to refer a patient to other (occupational) healthcare professionals. This study identified several needs of therapists. These included knowledge about laws and legislation and skills for identifying and addressing work-related or work-relevant complaints. CONCLUSIONS: Participants in this qualitative study were aware of the importance of taking occupational factors into account. However, how PTs, OTs and ETs address work participation and the extent to which they do so can be improved. There was a lack of knowledge about and cooperation with occupational health professionals, including PTs, OTs or ETs specialised in occupational health.

Reliability of recommendations to reduce a fracture of the distal radius.

Background and purpose - It is unclear what degree of malalignment of a fracture of the distal radius benefits from reduction. This study addressed the following questions: (1) What is the interobserver reliability of surgeons concerning the recommendation for a reduction for dorsally displaced distal radius fractures? (2) Do expert-based criteria for reduction improve reliability or not?Methods - We sent out 2 surveys to a group of international hand and fracture surgeons. On the first survey, 80 surgeons viewed radiographs of 95 dorsally displaced (0° to 25°) fractures of the distal radius. The second survey randomized 68 participants to either receive or not receive expert-based criteria for when to reduce a fracture and then viewed 20 radiographs of fractures with dorsal angulation between 5° and 15°. All participants needed to indicate whether they would advise a reduction or not.Results - In the 1st study, the interrater reliability of advising a reduction was fair (kappa 0.31). Multivariable linear regression analyses indicated that each additional degree of dorsal angulation increased the chance of recommending a reduction by 3%. In the 2nd study, reading criteria for reduction did not increase interobserver reliability for recommending a reduction.Interpretation - There is notable variation in recommendations for reduction that is not accounted for by surgeon or patient factors and is not diminished by exposure to expert criteria. Surgeons should be aware of their biases and develop strategies to inform patients and share the decision regarding whether to reduce a fracture of the distal radius.

The decline in physical activity in aging people is not modified by gender or the presence of cardiovascular disease.

BACKGROUND: A physically active lifestyle decreases the progression of atherosclerosis and consequently reduces cardiovascular mortality. However, activity levels are hampered by aging. The association between aging and physical inactivity might be gender-specific or be modified by the presence of cardiovascular disease (CVD). In this study, we investigated if the association between aging and physical inactivity was different between men and women and between primary and secondary prevention patients. METHODS: We performed a cross-sectional analysis of three primary care samples including primary and/or secondary prevention patients (total n = 4726). Baseline data for sample 1 were collected in the years 2013-14, for sample 2 in 2009-10 and for sample 3 in 2009. Activity levels were measured by the patient reported Rapid Assessment of Physical Activity questionnaire. A multilevel regression analysis was used to explore the association between aging and physical inactivity, adjusted for confounders. We examined potential effect modification by gender and the presence of CVD on the association between aging and physical inactivity. RESULTS: Multilevel regression revealed that aging was consistently associated with physical inactivity in three out of three samples. This association was, however, not modified by gender or the presence of CVD. CONCLUSIONS: Cardiovascular risk management interventions should aim at increasing or maintaining physical activity levels in aging primary care population. This study does not support the notion that extra emphasis should be put in targeting men or women, or people with or without the presence of CVD.

The effects of integrating work-related factors and improving cooperation in musculoskeletal physical therapy practice: protocol for the 'WORK TO BE DONE' cluster randomised controlled trial.

BACKGROUND: Musculoskeletal disorders (MSDs) are the primary cause of disability worldwide and a major societal burden. Recent qualitative research found that although a patient's work is considered important, physical therapists take work participation insufficiently into account as a determining factor in the treatment of patients with MSDs. Therefore, the aim of this study is to improve the effectiveness of physical therapy (in primary healthcare) with respect to the work participation of employees with MSDs by increasing the knowledge and skills of generalist physical therapists and by improving the collaboration between generalist physical therapists and physical therapists specialised in occupational health. METHODS/DESIGN: This trial is a two-arm non-blinded cluster randomised controlled trial. Working patients with MSDs visiting a physical therapy practice are the target group. The control group will receive normal physical therapy treatment. The intervention group will receive treatment from a physical therapist with more knowledge about work-related factors and skills in terms of integrating work participation into the patients' care. Data are gathered at baseline (T0), at four months (T1) and eight months (T2) follow-up. Most outcomes will be assessed with validated patient-reported questionnaires. Primary outcomes are the limitations in specific work-related activities and pain during work. Secondary outcomes include limitations in general work-related activities, general pain, quality of life, presenteeism, sick leave (absenteeism), estimated risk for future work disability, work-related psychosocial risk factors, job performance, and work ability. Based on a sample size calculation we need to include 221 patients in each arm (442 in total). During data analysis, each outcome variable will be analysed independently at T1 and at T2 as a dependent variable using the study group as an independent variable. In addition to the quantitative evaluation, a process evaluation will be performed by interviewing physical therapists as well as patients. DISCUSSION: The trial is expected to result in a more effective physical therapy process for working patients with MSDs. This will lead to a substantial reduction of costs: lower costs thanks to a more effective physical therapy process and lower costs due to less or shorter sick leave and decreased presenteeism. TRIAL REGISTRATION: Netherlands Trial Register, registration number: NL8518, date of registration 9 April 2020, URL registration: https://www.trialregister.nl/trial/8518.

Evaluation of a Web-Based Self-Management Program for Patients With Cardiovascular Disease: Explorative Randomized Controlled Trial.

BACKGROUND: Web-based self-management programs have the potential to support patients with cardiovascular disease (CVD) in their self-management (eg, by focusing on behavior change and improving physical activity). The intervention mapping framework was used to develop a web-based program called Vascular View. The Vascular View program contained 6 modules (coping with CVD, setting boundaries, lifestyle, healthy nutrition, being physically active, interaction with health professionals) aiming to increase self-management behavior by tailoring to the perceived problems and (support) needs of patients after CVD. OBJECTIVE: The aim was to test the effectiveness of Vascular View before embarking on a full-scale randomized clinical trial (RCT) by evaluating the potential effectiveness and effect sizes of the Vascular View program and identifying outcome measures most likely to capture the potential benefits. METHODS: An explorative RCT was performed. Both control and intervention groups received care as usual and, in addition, the intervention group received 12 months of access to a web-based self-management program. Assessment occurred at baseline, 6 months, and 12 months. Outcome measures included general patient-reported outcome measurements: Illness Perception Questionnaire (IPQ), Rand-36, Patient Activation Measure, and patient self-efficacy. Module-specific patient-reported outcome measurements were Beliefs about Medicines Questionnaire, International Physical Activity Questionnaire, Dutch Healthy Diet Index, Fagerström Test for Nicotine Dependence (FTND), Alcohol Use Disorders Identification Test, and Perceived Efficacy in Patient-Physician Interaction. Linear mixed models for repeated measures using intention-to-treat and per-protocol analysis were applied to study differences between the patients in the intervention and control groups. Floor and ceiling effects were explored to give insight into the outcome measures most likely to capture the potential benefits. RESULTS: A total of 105 patients in the control group and 103 patients in the intervention group participated in the study. A positive direction of change between baseline and 12 months was shown for most outcome measurements in favor of the intervention group, of which 2 out of 10 outcomes showed a significant effect: attribution of cause of the disease to risk factors and immunity factors (IPQ) and dependency of nicotine (FTND). Floor and ceiling effects were seen in the IPQ, Rand-36, and the self-efficacy questionnaire. CONCLUSIONS: No conclusion for the efficacy of the Vascular View program or selection of outcome measurements can be taken yet. A process evaluation will be conducted to gain thorough insight into the working elements of the program, patient needs in eHealth, and the use of the program by patients. This can determine for whom web-based self-management programs will work and help to adapt the program. TRIAL REGISTRATION: Dutch Trial Register NTR5412; https://www.trialregister.nl/trial/5303. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/resprot.6352.

Reliability and Responsiveness of the Observable Movement Quality Scale for Children with Mild to Moderate Motor Impairments.

AIM: The Observable Movement Quality (OMQ) scale measures generic movement quality and is used alongside standardized age-adequate motor performance tests. The scale consists of 15 items, each focusing on a different aspect; together, the entire construct of movement quality is assessed. This study aimed to determine interrater and intrarater reliability, and responsiveness of the OMQ scale. METHODS: A prospective intervention study with pre-post design in pediatric physical therapy practices. For interrater reliability, 3 physical therapists observed video-recorded motor assessments of 30 children with mild to moderate motor impairments -aged 4 to 12 years-using the OMQ scale. One therapist scored baseline assessment a second time for intrarater reliability, and to calculate smallest detectable change (SDC). Responsiveness (n = 28) was tested by comparing outcomes before and after intervention. RESULTS: Interrater reliability was moderate to good (ICC2,1: 0.79); intrarater reliability was high (ICC2,1: 0.97). Responsiveness results revealed an SDC of 2.4 and a minimal important change of 2.5; indicating sufficient validity in differentiating groups of children showing improved versus unchanged movement quality. CONCLUSION: The OMQ scale is reliable and responsive to change when used to assess movement quality in clinical practice for children with mild to moderate motor impairments, aged 4-12 year.

The effect of a programme to improve men's sedentary time and physical activity: The European Fans in Training (EuroFIT) randomised controlled trial.

BACKGROUND: Reducing sitting time as well as increasing physical activity in inactive people is beneficial for their health. This paper investigates the effectiveness of the European Fans in Training (EuroFIT) programme to improve physical activity and sedentary time in male football fans, delivered through the professional football setting. METHODS AND FINDINGS: A total of 1,113 men aged 30-65 with self-reported body mass index (BMI) ≥27 kg/m2 took part in a randomised controlled trial in 15 professional football clubs in England, the Netherlands, Norway, and Portugal. Recruitment was between September 19, 2015, and February 2, 2016. Participants consented to study procedures and provided usable activity monitor baseline data. They were randomised, stratified by club, to either the EuroFIT intervention or a 12-month waiting list comparison group. Follow-up measurement was post-programme and 12 months after baseline. EuroFIT is a 12-week, group-based programme delivered by coaches in football club stadia in 12 weekly 90-minute sessions. Weekly sessions aimed to improve physical activity, sedentary time, and diet and maintain changes long term. A pocket-worn device (SitFIT) allowed self-monitoring of sedentary time and daily steps, and a game-based app (MatchFIT) encouraged between-session social support. Primary outcome (objectively measured sedentary time and physical activity) measurements were obtained for 83% and 85% of intervention and comparison participants. Intention-to-treat analyses showed a baseline-adjusted mean difference in sedentary time at 12 months of -1.6 minutes/day (97.5% confidence interval [CI], -14.3-11.0; p = 0.77) and in step counts of 678 steps/day (97.5% CI, 309-1.048; p < 0.001) in favor of the intervention. There were significant improvements in diet, weight, well-being, self-esteem, vitality, and biomarkers of cardiometabolic health in favor of the intervention group, but not in quality of life. There was a 0.95 probability of EuroFIT being cost-effective compared with the comparison group if society is willing to pay £1.50 per extra step/day, a maximum probability of 0.61 if society is willing to pay £1,800 per minute less sedentary time/day, and 0.13 probability if society is willing to pay £30,000 per quality-adjusted life-year (QALY). It was not possible to blind participants to group allocation. Men attracted to the programme already had quite high levels of physical activity at baseline (8,372 steps/day), which may have limited room for improvement. Although participants came from across the socioeconomic spectrum, a majority were well educated and in paid work. There was an increase in recent injuries and in upper and lower joint pain scores post-programme. In addition, although the five-level EuroQoL questionnaire (EQ-5D-5L) is now the preferred measure for cost-effectiveness analyses across Europe, baseline scores were high (0.93), suggesting a ceiling effect for QALYs. CONCLUSION: Participation in EuroFIT led to improvements in physical activity, diet, body weight, and biomarkers of cardiometabolic health, but not in sedentary time at 12 months. Within-trial analysis suggests it is not cost-effective in the short term for QALYs due to a ceiling effect in quality of life. Nevertheless, decision-makers may consider the incremental cost for increase in steps worth the investment. TRIAL REGISTRATION: International Standard Randomised Controlled Trials, ISRCTN-81935608.

The diagnostic accuracy of headache measurement instruments: A systematic review and meta-analysis focusing on headaches associated with musculoskeletal symptoms.

AIM: To systematically review the available literature on the diagnostic accuracy of questionnaires and measurement instruments for headaches associated with musculoskeletal symptoms. DESIGN: Articles were eligible for inclusion when the diagnostic accuracy (sensitivity/specificity) was established for measurement instruments for headaches associated with musculoskeletal symptoms in an adult population. The databases searched were PubMed (1966-2018), Cochrane (1898-2018) and Cinahl (1988-2018). Methodological quality was assessed with the Quality Assessment of Diagnostic Accuracy Studies tool (QUADAS-2) and COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist for criterion validity. When possible, a meta-analysis was performed. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) recommendations were applied to establish the level of evidence per measurement instrument. RESULTS: From 3450 articles identified, 31 articles were included in this review. Eleven measurement instruments for migraine were identified, of which the ID-Migraine is recommended with a moderate level of evidence and a pooled sensitivity of 0.87 (95% CI: 0.85-0.89) and specificity of 0.75 (95% CI: 0.72-0.78). Six measurement instruments examined both migraine and tension-type headache and only the Headache Screening Questionnaire - Dutch version has a moderate level of evidence with a sensitivity of 0.69 (95% CI 0.55-0.80) and specificity of 0.90 (95% CI 0.77-0.96) for migraine, and a sensitivity of 0.36 (95% CI 0.21-0.54) and specificity of 0.86 (95% CI 0.74-0.92) for tension-type headache. For cervicogenic headache, only the cervical flexion rotation test was identified and had a very low level of evidence with a pooled sensitivity of 0.83 (95% CI 0.72-0.94) and specificity of 0.82 (95% CI 0.73-0.91). DISCUSSION: The current review is the first to establish an overview of the diagnostic accuracy of measurement instruments for headaches associated with musculoskeletal factors. However, as most measurement instruments were validated in one study, pooling was not always possible. Risk of bias was a serious problem for most studies, decreasing the level of evidence. More research is needed to enhance the level of evidence for existing measurement instruments for multiple headaches.

Effectiveness of Supervised Home-Based Exercise Therapy Compared to a Control Intervention on Functions, Activities, and Participation in Older Patients After Hip Fracture: A Systematic Review and Meta-analysis.

OBJECTIVE: The aim of this review was to investigate whether supervised home-based exercise therapy after hospitalization is more effective on improving functions, activities, and participation in older patients after hip fracture than a control intervention (including usual care). Furthermore, we aimed to account the body of evidence for therapeutic validity. DATA SOURCES: Systematic searches of Medline, Embase, and CINAHL databases up to June 30, 2016. STUDY SELECTION: Randomized controlled trials studying supervised home-based exercise therapy after hospitalization in older patients (≥65y) after hip fracture. DATA EXTRACTION: Two reviewers assessed methodological quality (Physiotherapy Evidence Database) and therapeutic validity (Consensus on Therapeutic Exercise Training). Data were primary analyzed using a best evidence synthesis on methodological quality and meta-analyses. DATA SYNTHESIS: A total of 9 articles were included (6 trials; 602 patients). Methodological quality was high in 4 of 6 studies. One study had high therapeutic validity. We found limited evidence in favor of home-based exercise therapy for short- (≤4mo) and long-term (>4mo) performance-based activities of daily living (ADL) and effects at long-term for gait (fast) and endurance. Evidence of no effectiveness was found for short- and long-term effects on gait and self-reported (instrumental) ADL and short-term effects on balance, endurance, and mobility. Conflicting evidence was found for strength, long-term balance, short-term gait (comfortable), long-term self-reported ADL, and long-term mobility. CONCLUSIONS: Research findings show no evidence in favor of home-based exercise therapy after hip fracture for most outcomes of functions, activities, and participation. However, trials in this field have low therapeutic validity (absence of rationale for content and intensity and reporting of adherence), which results in interventions that do not fit patients' limitations and goals.