Outcomes Data Collection Research Articles

Co-designing clinical trials alongside youth with chronic pain.

Youth have a right to participate in research that will inform the care that they receive. Engagement with children and young people has been shown to improve rates of enrollment and retention in clinical trials as well as reduce research waste. The aim of the study is to gain practical insight on the design of trials specifically on (1) recruitment and retention preferences, (2) potential barriers to research, and (3) study design optimization. Based on this youth engagement, we will co-design two clinical trials in headaches with youth. Two recruitment strategies were used to recruit 16 youth from across Canada (aged 15-18 years) from an existing youth group, the KidsCan Young Persons' Research Advisory Group (YPRAG) and a new youth group in collaboration with Solutions for Kids in Pain (SKIP). Four virtual, semi-structured discussion groups were held between April and December 2020, which included pre-circulated materials and utilized two distinct upcoming planned trials as examples for specific methods feedback. Individual engagement evaluations were completed following the final group session using the Public and Patient Engagement Evaluation Tool. Descriptive results were shared with participants prior to publication to ensure appropriate interpretation. The discussion was centred around three themes: recruitment and retention preferences, potential barriers to participation, and study design optimization. Youth indicated that they would prefer to be contacted for a potential study directly by their physician (not over social media), that they would like to develop rapport with study staff, and that one of the barriers to participation is the time commitment. The youth also provided feedback on the design of the clinical trial including outcome measurement tools, data collection, and engagement methods. Feedback on the virtual format of the engagement events indicated that participants appreciated the ease of the online discussion and that the open-ended discussion allowed for easy exchange of ideas. They felt that despite a gender imbalance (towards females) it was an overall inclusive environment. All participants reported believing that their engagement will make a difference to the work of the research team in designing the clinical trials. Perspectives from a diverse group of youth meaningfully improved the design and conduct of two clinical trials for headaches in children. This study provides a framework for future researchers to engage youth in the co-design of clinical trials using online engagement sessions.

Clinical functional outcome measures for children with cerebral palsy after gait corrective orthopaedic surgery: A scoping review.

To identify the most frequently reported non-instrumented measures of gait, activity, and participation in children with cerebral palsy (CP) after undergoing gait corrective orthopaedic surgery. Four databases were searched from database inception to the 9th December 2021 for studies that evaluated functional outcomes for children with CP under 18 years undergoing gait corrective orthopaedic surgery. Of 547 citations, 44 publications (n = 3535 participants, n = 1789 males, mean age 10 years 5 months [SD = 3 years 3 months], Gross Motor Function Classification System levels I-III at the time of surgery) were eligible for inclusion. Fourteen different outcome measures were used: one measure of gait, 10 measures of activity, and three measures of participation. Gait was measured with the Edinburgh Visual Gait Scale (EVGS; 4 out of 44). The most common activity and participation measures were the Functional Mobility Scale (FMS; 15 out of 44) and Pediatric Outcomes Data Collection Instrument (11 out of 44) respectively. No studies reported a combination of gait, activity, and participation measures. The EVGS and FMS should be considered as core outcome measures in gait corrective orthopaedic surgery, while a measure of participation is unclear. Additional considerations for developing a comprehensive suite of outcomes include identifying a combination of clinical measures and performance-reflective questionnaires that are standardized for children with CP undergoing surgery and meaningful to clinicians and families.

West Nile virus eco-epidemiology and climate change

West Nile virus (WNV) is an arbovirus with a wide geographical distribution. It is maintained in an enzootic bird-mosquito cycle and exhibits regular zoonotic transmission to humans, to whom it can cause West Nile fever and neuroinvasive disease. Over the last decades, WNV has emerged as a serious health threat with profound impacts on animal and human health. It is broadly accepted that climate change impacts the transmission of WNV through multiple pathways via its impacts on vectors, the pathogen, hosts, and the environment. Although some clarity has been established, the outcomes of these climate-driven processes are yet to be better understood before they can fully benefit tailored prevention and control measures. This review focuses on the eco-epidemiology of WNV and how it is impacted by climate change through an integrative lens. We discuss the role of eco-epidemiological modeling in knowledge generation and highlight the importance of adopting an interdisciplinary and transdisciplinary One Health approach for improved surveillance, data collection, modeling, and translation of outcomes into actionable policy and control.

A Technology-Supported Guidance Model to Support the Development of Critical Thinking Among Undergraduate Nursing Students in Clinical Practice: Concurrent, Exploratory, Flexible, and Multimethod Feasibility Study.

There is widespread recognition and acceptance of the need for critical thinking in nursing education, as it is necessary to provide high-quality nursing. The Technology-Supported Guidance Model (TSGM) intervention was conducted during clinical practice among undergraduate nursing students and aimed to support the development of critical thinking. A major element of this newly developed intervention is an app, Technology-Optimized Practice Process in Nursing (TOPP‑N), combined with the daily guidance of nursing students from nurse preceptors and summative assessments based on the Assessment of Clinical Education. The main objective of this study was to assess the feasibility of a newly developed intervention, TSGM, among undergraduate nursing students, nurse preceptors, and nurse educators. Further objectives were to assess the primary and secondary outcome measures, recruitment strategy, and data collection strategy and to identify the potential causes of dropout and barriers to participant recruitment, retention, intervention fidelity, and adherence to the intervention. This study was designed as a concurrent, exploratory, flexible, and multimethod feasibility study of the TSGM intervention that included quantitative and qualitative data from nursing students, nurse preceptors, and nurse educators. The primary outcome measures were the feasibility and acceptability of the intervention. The secondary outcomes included the suitability and acceptance of the outcome measures (critical thinking, self-efficacy, clinical learning environment, metacognition and self-regulation, technology acceptance, and competence of mentors); data collection strategy; recruitment strategy; challenges related to dropouts; and hindrances to recruitment, retention, and intervention fidelity and adherence. Nursing students, nurse preceptors, and nurse educators had varied experiences with the TSGM intervention. We identified factors that make the intervention feasible and challenging and may influence the feasibility, acceptability, dropout rate, adherence, and fidelity of the intervention. We also identified areas for future improvement of the intervention. The use of a newly developed intervention, TSGM, is feasible and accepted by undergraduate nursing students, nurse preceptors, and nurse educators; however, refinement and improvement of the intervention and the TOPP‑N app, improvement in intervention management, and mitigation of negative factors are necessary before a randomized controlled trial can be performed. RR2-10.2196/31646.

The Canadian Registry for Amyloidosis Research: A national multi-disciplinary registry for real-world evidence (P12-8.014)

The Canadian Registry for Amyloidosis Research: A national multi-disciplinary registry for real-world evidence (P12-8.014)

Pendekatan Saintifik Dengan Model Pembelajaran Number Head Together Dapat Meningkatkan Hasil Belajar Roll Belakang

This class action research aims to determine the level of student learning outcomes through a scientific approach with the Number Head Together learning model in grade IV students of SDN 81 Kendari, in the even semester of the 2021/2022 academic year consisting of 20 students. The research was carried out in two cycles with four stages: planning, implementation, observation, and reflection. Data collection of learning outcomes using Attitude Observation, Student Worksheets, and Back Roll Ability Tests. Data analysis was carried out in accordance with standard Benchmark Reference Approach (PAP) 5 and statistical calculations. The results of the study showed that students who completed learning in the first cycle were only 30%. And in cycle II, students who completed learning as much as 85%. The results of the analysis also showed that there was a significant increase in learning outcomes of the back roll technique in grade IV students of SDN 81 Kendari. It can be concluded that the implementation of a scientific approach with the Number Head Together learning model can improve student learning outcomes.

Feasibility and Acceptability of a Cognitive Training Study in Individuals with Type 2 Diabetes Mellitus

Individuals with type 2 diabetes mellitus (T2DM) are at an increased risk of cognitive dysfunction. Growing evidence supports the use of cognitive training to target cognitive dysfunction in T2DM, but only limited evidence exists surrounding its feasibility and acceptability. The primary aim of this research is to determine the feasibility and acceptability of a cognitive training study in T2DM. Adults diagnosed with T2DM were randomly allocated to either a 6-week cognitive training group or a usual care control group. Feasibility outcomes (recruitment, adherence, retention, motivation, data collection, and intervention design) were evaluated using a traffic light progression criterion. Qualitative interviews were conducted to explore study acceptability. Cognition was measured at baseline and post-intervention. Forty-one participants completed the study (age 66 ± 9.8 years; HbA1c 54.0 ± 13.3 mmol.mol). Feasibility was shown in the adherence, retention, and motivation of participants, whilst minor amendments were proposed to the study design, recruitment, and data collection. Participants described cognitive training as highly enjoyable, with study components broadly reported as acceptable. Data signalled improvements in cognition, with large improvements observed in executive function. This study provides evidence for the potential feasibility, acceptability, and efficacy for cognitive training in T2DM. Recommendations for future studies are provided.

Protection of haematopoietic progenitor cell donors: an updated overview of the European landscape.

Haematopoietic progenitor cell donation from bone marrow and mobilised peripheral blood obtained from related and unrelated donors is an established procedure. The donation process in general has proven to be safe, but in rare cases severe and even fatal events have been reported. The present study aimed at providing a description of the current situation of donor protection measures in Council of Europe member States. A specific questionnaire was developed to compile information on donation activities, graft sources, legal frameworks, donor protection measures, collection of donor outcome data, and long-term follow-up of paediatric and adult related and unrelated donors. The outcome of this survey served as a basis for elaborating the Recommendation CM/Rec(2020)6 of the Committee of Ministers to member States on establishing harmonised measures for the protection of haematopoietic progenitor cell donors.

509 Developing a Core Outcome Set for hospital deprescribing trials with older people under the care of a geriatrician

Abstract Introduction Half of older people are prescribed unnecessary or harmful medication that are not routinely deprescribed in hospital. There is a need for trials of deprescribing interventions, and for these to adopt consistent measurement and reporting of outcomes(1). Aim To develop a Core Outcome Set (COS) for use in hospital deprescribing trials for older people under the care of a geriatrician. Methods We developed a list of potentially relevant outcomes from the literature. We sought representation from four stakeholder groups: older people and carers, hospital clinicians, hospital managers, and ageing/deprescribing researchers. A gatekeeper at 15 hospitals in England identified and provided study information to hospital staff by email; and older people taking ≥5 medicines, and their carers received printed study information. Academics were recruited worldwide. The number approached was not captured. Using a two-round Delphi survey of participants from all four stakeholder groups scored , each outcome according to Grading of Recommendations Assessment, Development and Evaluation (GRADE)(2). This was followed by two consensus workshops to finalise the COS by discussing the importance, feasibility and acceptability of outcomes. Results In the Delphi survey, 200 people completed Round 1 and 114 completed Round 2. Representing all stakeholder groups, 10 people participated in Workshop 1 and 10 people in Workshop 2. Six outcomes were identified as most important, feasible and acceptable to collect in a trial and were included in the COS for hospital deprescribing trials with older people under the care of a geriatrician. These outcomes were: number of prescribed medicines stopped; number of prescribed medicines with dosage reduced; quality of life; mortality; adverse drug events and number of hospital stays. Three other outcomes were identified as important, but not currently feasible to collect: number of potentially inappropriate medicines prescribed; burden to the patient from their medication; and medication-related admissions to hospital. Conclusion The COS provides the minimum outcomes that should be collected and reported in all hospital deprescribing trials for older people under the care of a geriatrician. This COS builds on three existing COS for: medication reviews in older people with polypharmacy; addressing polypharmacy in older people in primary care; and optimising prescribing in older people in nursing homes. However, it is important when developing a COS to involve all relevant stakeholders that will be affected by a COS, which in this case was older people under the care of a geriatrician and relevant hospital staff. The six outcomes in the COS were agreed as being the most important to be implemented in all hospital deprescribing trials for older people under the care of a geriatrician. The value of considering the feasibility of outcome data collection is demonstrated by the removal of three outcomes that may have compromised COS uptake. Adoption of the COS by hospital deprescribing trials for older people under the care of a geriatrician will enable results from trials to be compared and also allow future aggregation of trial data.

Reconstruction of Type IIIB Thumb Hypoplasia Using a Vascularized Hemi-Metatarsal Composite Tissue Flap.

The aim of this study was to determine the clinical outcomes of vascularized hemi-metatarsal composite tissue transfer for the reconstruction of type IIIB hypoplastic thumbs. Twenty-eight patients with type IIIB hypoplastic thumbs treated with vascularized hemi-metatarsal composite tissue transfer were included in this retrospective study with a mean follow-up of 2.4 years. Preoperative digital subtraction angiography was performed to examine the vessel variance. Clinical measures included grip and pinch strength, scar status, and Kapandji thumb opposition score. Subjective Pediatric Outcomes Data Collection Instrument scores and parent satisfaction were also evaluated. Radial arteries were hypoplastic in 82.1% of the cases, and the common palmar digital artery was chosen as the recipient vessel for the tissue transfer. There was no neurovascular complication. The only donor-site complication was a metatarsal fracture that healed with casting. Key pinch and tripod pinch were 29.5% and 45.8% of the normal side, respectively. The mean grip strength was 51.7% of the unaffected side. The mean Kapandji score was 6. The Pediatric Outcomes Data Collection Instrument scores were high for global function; upper extremity function; transfer; and basic mobility, happiness, and comfort. The Vancouver Scar Scale showed an average score of 2.1. All parents were satisfied with the clinical outcomes. Vascularized hemi-metatarsal composite tissue transfer for type IIIB thumb hypoplasia can provide improved subjective outcomes and is a feasible method for the attainment of a five-digit hand. Therapeutic, IV.

MP06-03 EXTERNAL VALIDATION OF DECREASED ED VISITS AFTER URETEROSCOPY DUE TO QUALITY IMPROVEMENT INITIATIVES OF A STATEWIDE COLLABORATIVE

You have accessJournal of UrologyCME1 Apr 2023MP06-03 EXTERNAL VALIDATION OF DECREASED ED VISITS AFTER URETEROSCOPY DUE TO QUALITY IMPROVEMENT INITIATIVES OF A STATEWIDE COLLABORATIVE Andrew Higgins, Stephanie Daignault-Newton, Russell Becker, Golena Fernandez Moncaleano, Bronson Conrado, John Hollingsworth, Khurshid Ghani, and Casey Dauw Andrew HigginsAndrew Higgins More articles by this author , Stephanie Daignault-NewtonStephanie Daignault-Newton More articles by this author , Russell BeckerRussell Becker More articles by this author , Golena Fernandez MoncaleanoGolena Fernandez Moncaleano More articles by this author , Bronson ConradoBronson Conrado More articles by this author , John HollingsworthJohn Hollingsworth More articles by this author , Khurshid GhaniKhurshid Ghani More articles by this author , and Casey DauwCasey Dauw More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003217.03AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The Michigan Urological Surgery Improvement Collaborative Reducing Operative Complications from Kidney Stones (ROCKS) was created to optimize outcomes after ureteroscopy (URS). Through outcomes data collection, distribution of performance reports, patient educational efforts, and standardization of an opioid-free postoperative pain regimen, emergency department (ED) visits in Michigan have declined. It is unclear, whether this trend is unique to Michigan and thus a reflection of these quality efforts or is similar to national data. We thus sought to understand ED visit rates in Michigan compared to a large national dataset. METHODS: We used data from two sources for this study to understand 30-day ED visits after URS. In Michigan, the ROCKS database, a prospectively maintained registry including more than 90% of participating urologic practices in the state was utilized, capturing patients from 2016-2021. To serve as comparison, we used Optum claims data from 2011 to 2021 (excluding Michigan), which includes commercially insured adults and dependents. We identified patients who underwent URS defined by CPT codes and calculated the proportion who had an ED visit within 30 days of URS. Cohort age and gender were compared with rank and chi-square tests, respectively. ED rates were modeled (logistic) adjusting for age and gender to compare cohorts over time. RESULTS: Overall, we identified 24,163 patients in ROCKS who underwent URS and 162,642 patients in Optum. Significant differences were seen with regards to gender (51% vs 44% female, p<0.01) and median age (58 vs 62 years, p<0.01) between ROCKS and Optum cohorts. The mean ED rate in ROCKS was 7.9% (range 6.3 to 10.5%) with a significant decline over time (p<0.01, Figure 1). The ED rate in Optum was 9.9% (range 9.1 to 10.5%) with an increase over time (p<0.01). Comparing ED visits between the two cohorts after adjusting for observed demographic differences, the ROCKS ED visit rate declined significantly relative to national Optum rates (p<0.01). CONCLUSIONS: ED visit rates in Michigan have declined significantly after URS since establishment of the ROCKS initiative. This decline outpaces national ED rates, which have gradually increased over the past 10 years. This lends credence to systematic quality initiatives seeking to improve urologic care. Source of Funding: Blue Cross Blue Shield of Michigan © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e53 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Andrew Higgins More articles by this author Stephanie Daignault-Newton More articles by this author Russell Becker More articles by this author Golena Fernandez Moncaleano More articles by this author Bronson Conrado More articles by this author John Hollingsworth More articles by this author Khurshid Ghani More articles by this author Casey Dauw More articles by this author Expand All Advertisement PDF downloadLoading ...

Veteran Perspectives on Phantom Limb Pain and Non-Drug Interventions.

Phantom limb pain (PLP) commonly occurs post-amputation and can negatively affect the daily functioning of persons with amputation. Best practices for medication and non-drug management remain unclear. To better understand the PLP experience and patients' familiarity with treatments, phone interviews were conducted at the Minneapolis Veterans Affairs Regional Amputation Center in Veterans with amputations. Fifty Veteran participants (average age 66, 96% male) with lower limb amputation were recruited for phone-based data collection of patient-reported outcomes (ie, demographics using the Trinity Amputation and Prosthesis Experience Scales-Revised (TAPES-R) and pain experience using the Phantom Phenomena Questionnaire) to characterize the population and a semi-structured interview. Notes taken during interviews were analyzed using the Krueger and Casey constant comparison analysis method. Participants had an average of 15 years since amputation, and 80% reported PLP as identified with the Phantom Phenomena Questionnaire. Investigators identified several core themes from the qualitative interviews including 1) high variability in the experience of PLP, 2) acceptance and resilience, and 3) PLP treatment perceptions. The majority of participants reported trying common non-drug treatments with none endorsed consistently as highly effective. More research is needed to inform identification and implementation of clinical best practices for non-drug interventions for PLP and understand the factors that influence engagement in non-drug interventions. The participants in this study were largely male, so these results may not be generalizable to females.

Feasibility pilot trial for the Trajectories of Recovery after Intravenous propofol versus inhaled VolatilE anesthesia (THRIVE) pragmatic randomised controlled trial

IntroductionMillions of patients receive general anaesthesia for surgery annually. Crucial gaps in evidence exist regarding which technique, propofol total intravenous anaesthesia (TIVA) or inhaled volatile anaesthesia (INVA), yields superior patient...

Higher Pain Catastrophizing and Preoperative Pain is Associated with Increased Risk for Prolonged Postoperative Opioid Use

BACKGROUND: Prolonged postoperative opioid use (PPOU) is considered an unfavorable post-surgical outcome. Demographic, clinical, and psychosocial factors have been associated with PPOU, but methods to prospectively identify patients at increased risk are lacking. OBJECTIVES: Our objective was to determine whether an individual or a combination of several psychological factors could identify a subset of patients at increased risk for PPOU. STUDY DESIGN: Observational cohort study with prospective baseline data collection and passive outcomes data collection. SETTING: A single VA medical center in the United States. METHODS: Patients were recruited from a preoperative anesthesia clinic where they were undergoing evaluation prior to elective surgery, and they completed a survey before surgery. The primary outcome was PPOU, defined as outpatient receipt of a prescribed opioid 31 to 90 days after surgery as determined from pharmacy records. Primary covariates of interest were pain catastrophizing, self-efficacy, and optimism. Additional covariates included social and demographic factors, pain severity, medication use, depression, anxiety, and surgical fear. RESULTS: Of 123 patients included in the final analyses, 30 (24.4%) had PPOU. In bivariate analyses, preoperative opioid use and preoperative nonsteroidal anti-inflammatory drug use were significantly associated with PPOU. The combination of high pain catastrophizing and high preoperative pain (OR 3.32, 95% CI 1.41 - 7.79) was associated with higher odds of PPOU than either alone, and the association remained significant after adjusting for preoperative opioid use (OR 2.56, 95% CI 1.04 - 6.29). LIMITATIONS: Patients were recruited from a single site, and the sample was not large enough to include potentially important variables such as procedure type. CONCLUSIONS: A combination of high pain catastrophizing and high preoperative pain has the potential to be a clinically useful means of identifying patients at elevated risk of PPOU. KEY WORDS: Postoperative pain, postoperative opioids, opioid prescribing, preoperative evaluation, pain catastrophizing

IMPLEMENTATION OF SSCS LEARNING MODEL IN IMPROVING STUDENTS’ MATHEMATICS LEARNING MOTIVATION AT CLASS VII.C OF SMPN 4 TAMBANG KAMPAR

This paper discusses the students’ low mathematics learning outcomes of Class VII.C at SMPN 4 Tambang Kampar Regency. It aims to improve mathematics learning outcomes through the application of the Search Solve Create Share learning model (SSCS) for students at Class VII.C of SMPN 4 Tambang Kampar Regency, which was conducted for 2 months. The research subjects were 32 students at Class VII.C of SMPN 4 Tambang in Kampar Regency. The type of research was classroom action research. The research instrument consisted of learning outcome tests and data collection instruments, which were observation sheets of teacher and student activities. Based on the results of data analysis, the average score of students’ learning motivation in the pre-cycle was 45.0, while the percentage was 35.2%. The average score increased in the first cycle to 60, while the percentage was 46.7%. And the average score increased significantly in cycle II to 100.4, while the percentage was 78.5%. It can be concluded that the application of Search Solve Create Share learning (SSCS) could increase students' learning motivation in mathematics at class VII.C of SMPN 4 Tambang in Kampar Regency.

Patient-Reported Outcomes Collection at an Urban HIV Clinic Associated With a Historically Black Medical College in the Southern United States: Qualitative Interview Study Among Patients With HIV.

Black Americans, particularly in the southern United States, are disproportionately affected by the US HIV epidemic. Patient-reported outcome (PRO) data collection can improve patient outcomes and provide oft-overlooked data on mental health, substance use, and patient adherence to antiretroviral therapy. We piloted the use of an electronic tablet to collect PRO data on social and behavioral determinants of health among people with HIV at the Meharry Community Wellness Center, an HIV clinic affiliated with a Historically Black Medical College in Nashville, Tennessee. Our primary objective was to better understand patients' experiences and comfort with using an electronic PRO tool through patient interviews. We enrolled 100 people with HIV in care at the Meharry Community Wellness Center consecutively to completely validate PRO tools using the Research Electronic Data Capture platform on a hand-held tablet. Using a purposive sampling strategy, we enrolled 20 of the 100 participants in an in-depth interview (IDI). Interview guide development was grounded in the cognitive-behavioral model, in which thoughts, feelings, and behaviors are interrelated. IDIs were audio recorded, transcribed, deidentified, and formatted for coding. A hierarchical coding system was developed and refined using an inductive-deductive approach. Among the 100 people with HIV enrolled, the median age was 50 (IQR 42-54) years; 89% (n=89) were Black, 60% (n=60) were male, and 82% (n=82) were living below 100% of the federal poverty level in 2016. Five major interview themes emerged: overall experience, question content, sensitive topics, clinic visit impact, and future recommendations. IDI participants felt that the tablet was easy to use and that the question content was meaningful. Question content related to trauma, sexual and drug use behaviors, mental health, stigma, and discrimination elicited uncomfortable or distressing feelings in some participants. Patients expressed a strong desire to be truthful, and most would complete these surveys without compensation at future visits if offered. The use of an electronic tablet to complete PRO data collection was well received by this cohort of vulnerable persons in HIV care in the southern United States. Despite some discomfort related to question content, our cohort overwhelmingly believed this was a meaningful part of their medical experience and expressed a high desire for truthfulness. Future research will focus on scaling up the implementation and evaluation of PRO data collection in a contextually appropriate manner while obtaining input from providers and staff to ensure that the collected data are both applicable and actionable.

An intervention to support stroke survivors and their carers in the longer term: results of a cluster randomised controlled feasibility trial (LoTS2Care)

BackgroundTo address the limited provision of longer-term stroke care, we conducted a programme of research (LoTS2Care) to develop and test an intervention to form part of a replicable longer-term care strategy. New Start, a programme of facilitated self-management, was developed to be delivered at 6 months post-stroke by trained facilitators. Here, we report the findings from the final workstream of this programme, which aimed to evaluate the feasibility and acceptability of implementing a future definitive cluster randomised controlled trial of the developed intervention (New Start) to support stroke survivors and their carers in the longer term.MethodsA feasibility cluster randomised controlled trial was conducted in English and Welsh NHS stroke services. Stroke services (clusters) were randomised on a 1:1 basis to implement New Start or continue with usual care only. Community-dwelling stroke survivors between 4 and 6 months post-stroke were invited to participate in the trial by post. Outcome measures were collected via post at 3, 6 and 9 months after recruitment. Recruitment and follow-up rates, delivery and uptake of the intervention, data collection feasibility (including postal outcome measures of health and disability, mental well-being at 3, 6, and 9 months post-recruitment) and safety were assessed.ResultsTen stroke services were recruited. A total of 1127 stroke survivors were screened for participation, and 269 were registered (New Start, n = 145; usual care, n = 124). Retention was high with 239 (89%) stroke survivors being available for follow-up at 9 months, and high return rates of postal questionnaires were achieved (80.3% at 9 months). Intervention training was successfully delivered, and New Start was offered to 95.2% of trial participants in the intervention arm. Uptake was variable, however, ranging from 11.8 to 75.0%. There were no safety concerns.ConclusionsStroke service recruitment and longer-term stroke survivor postal recruitment and outcome data collection are feasible; however, refinement of intervention targeting and delivery is required prior to undertaking a definitive trial.Trial registrationISRCTN38920246. Registered 22 June 2016 (http://www.isrctn.com/ISRCTN38920246).

Lower extremity proprioception and its association with activity and participation in children with unilateral spastic cerebral palsy

ObjectiveThis cross-sectional study aimed to assess lower extremity proprioception and investigate its relationship to activity and participation levels in children with unilateral spastic cerebral palsy (USCP). MethodsA total of 22 children with USCP between the ages of 5 and 16 years participated in this study. Lower extremity proprioception was evaluated with a protocol that consisted of verbal and location identification, unilateral and contralateral limb matching, and static and dynamic balance tests performed with the impaired and less impaired lower extremities under eyes-open and eyes-closed conditions. Furthermore, the Functional Independence Measure (WeeFIM) and Pediatric Outcomes Data Collection Instrument (PODCI) were used to evaluate the independence levels in daily living activities and participation levels. ResultsChildren demonstrated proprioceptive loss, as evidenced by an increase in matching errors under the eyes-closed condition compared to the eyes-open condition (p<0.05). Also, the impaired extremity had greater proprioceptive loss than the less impaired extremity (p<0.05). The 5–6-year age group experienced greater proprioceptive deficits than did the 7–11 and 12–16 age groups (p<0.05). Children's lower extremity proprioceptive deficit was moderately associated with their activity and participation levels (p<0.05). ConclusionsOur findings suggest that treatment programs based on comprehensive assessments, including proprioception, may be more effective in these children.

Feasibility and first results of the ‘Trials-within-Cohorts’ (TwiCs) design in patients undergoing radiotherapy for lung cancer

Background: ‘Trials-within-Cohorts’ (TwiCs), previously known as ‘cohort multiple randomized controlled trials’ is a pragmatic trial design, supporting an efficient and representative recruitment of patients for (future) trials. To our knowledge, the ‘COhort for Lung cancer Outcome Reporting and trial inclusion’ (COLOR) is the first TwiCs in lung cancer patients. In this study we aimed to assess the feasibility and first year results of COLOR.Material and Methods: All patients diagnosed with lung cancer referred to the Radiotherapy department were eligible to participate in the ongoing prospective COLOR study. At inclusion, written informed consent was requested for use of patient data, participation in patient-reported outcomes (PROs), and willingness to participate in (future) trials. Feasibility was studied by assessing participation and comparing baseline PROs to EORTC reference values. First-year results of PROs at baseline and 3 months after inclusion were evaluated separately for stereotactic body radiotherapy (SBRT) and conventional radiotherapy patients.Results: Of the 338 eligible patients between July 2020 and July 2021, 169 (50%) participated. Among these, 127 (75%) gave informed consent to PROs participation and 110 (65%) were willing to participate in (future) trials. The inclusion percentage dropped from 77% to 33% when the information procedure was switched from in-person to by phone (due to COVID-19 pandemic measures). Baseline PROs for physical and cognitive functioning were comparable in COLOR patients compared to the EORTC reference values. No significant changes in PROs were observed 3 months after inclusion, except for a slight increase in pain scores in the SBRT group (n = 97).Conclusions: The TwiCs-design appears feasible in lung cancer patients with fair participation rates (although negatively impacted by the COVID-19 pandemic). With a planned expansion to other centers, the COLOR-study is expected to enable multiple (randomized) evaluations of experimental interventions with important advantages for recruitment, generalizability, and long-term outcome data collection.

Feasibility of Family-Centered Workshops for Children Aged 18-36 Months with Language Developmental Delay

BackgroundFamily-centered workshops' effects on children with language developmental delay remain unknown. This study assessed the feasibility of workshops for children with language developmental delay. MethodsA total of 122 children aged 18-36 months with language developmental delays and their parents participated in six sessions of 2-h family-centered multidisciplinary workshops for 6 weeks. The Mandarin-Chinese Communicative Development Inventory, Peabody Developmental Motor Scale, Emotional Competency Rating Scales, Pediatric Outcomes Data Collection Instrument, Child Health Questionnaire, Pediatric Quality of Life Inventory, Caregiver Strain Index, Impact on Family Scale, PedsQL Family Impact Module, and World Health Organization Quality of Life (QOL) were administered to the children and their parents before and after the workshop. ResultsWe found improvement of emotion (P = 0.037), upper extremity and physical function (P = 0.038), and transfer and basic mobility (P = 0.019) in children and parental QOL related to children's conditions (P = 0.049), with no effect on communication ability and QOL in children and family strain and function. We also noted more significant improvement in children with pure developmental language delay than in children with nonpure developmental language delay concerning the success rates (from delayed to normal development) for expressive vocabulary (P < 0.001) and word combination (P = 0.002). Satisfaction levels toward the workshop were high. ConclusionsFamily-centered workshops improved children's emotions, functional performance, and parental QOL. Although the samples were too small to test different conditions of the developmental delay, the workshops for children with language developmental delays are acceptable and feasible.