Methods for the Watch the Spot Trial. A Pragmatic Trial of More- versus Less-Intensive Strategies for Active Surveillance of Small Pulmonary Nodules.

Small pulmonary nodules are most often managed by surveillance imaging with computed tomography (CT) of the chest, but the optimal frequency and duration of surveillance are unknown. The Watch the Spot Trial is a multicenter, pragmatic, comparative-effectiveness trial with cluster randomization by hospital or health system that compares more- versus less-intensive strategies for active surveillance of small pulmonary nodules. The study plans to enroll approximately 35,200 patients with a small pulmonary nodule that is newly detected on chest CT imaging, either incidentally or by screening. Study protocols for more- and less-intensive surveillance were adapted from published guidelines. The primary outcome is the percentage of cancerous nodules that progress beyond American Joint Committee on Cancer seventh edition stage T1a. Secondary outcomes include patient-reported anxiety and emotional distress, nodule-related health care use, radiation exposure, and adherence with the assigned surveillance protocol. Distinctive aspects of the trial include: 1) the pragmatic integration of study procedures into existing clinical workflow; 2) the use of cluster randomization by hospital or health system; 3) the implementation and evaluation of a system-level intervention for protocol-based care; 4) the use of highly efficient, technology-enabled methods to identify and (passively) enroll participants; 5) reliance on data collected as part of routine clinical care, including data from electronic health records and state cancer registries; 6) linkage with state cancer registries for complete ascertainment of the primary study outcome; and 7) intensive engagement with a diverse group of patient and nonpatient stakeholders in the design and execution of the study

Co-designing new tools for collecting, analysing and presenting patient experience data in NHS services: working in partnership with patients and carers

Background The way we collect and use patient experience data is vital to optimise the quality and safety of health services. Yet, some patients and carers do not give feedback because of the limited ways data is collected, analysed and presented. In this study, we worked together with researchers, staff, patient and carer participants, and patient and public involvement and engagement (PPIE) contributors, to co-design new tools for the collection and use of patient experience data in multiple health settings. This paper outlines how the range of PPIE and research activities enabled the co-design of new tools to collect patient experience data. Methods Eight public contributors represented a range of relevant patient and carer experiences in specialist services with varied levels of PPIE experience, and eleven members of Patient and Participation Groups (PPGs) from two general practices formed our PPIE group at the start of the study. Slide sets were used to trigger co-design discussions with staff, patient and carer research participants, and PPIE contributors. Feedback from PPIE contributors alongside verbatim quotes from staff, patient and carer research participants is presented in relation to the themes from the research data. Results PPIE insights from four themes: capturing experience data; adopting digital or non-digital tools; ensuring privacy and confidentiality; and co-design of a suite of new tools with guidance, informed joint decisions on the shaping of the tools and how these were implemented. Our PPIE contributors took different roles during co-design and testing of the new tools, which supported co-production of the study. Conclusions Our experiences of developing multiple components of PPIE work for this complex study demonstrates the importance of tailoring PPIE to suit different settings, and to maximise individual strengths and capacity. Our study shows the value of bringing diverse experiences together, putting patients and carers at the heart of improving NHS services, and a shared approach to managing involvement in co-design, with the effects shown through the research process, outcomes and the partnership. We reflect on how we worked together to create a supportive environment when unforeseen challenges emerged (such as, sudden bereavement)

Co-designing new tools for collecting, analysing and presenting patient experience data in NHS services: working in partnership with patients and carers

From Springer Nature via Jisc Publications RouterHistory: received 2021-07-12, accepted 2021-11-15, registration 2021-11-17, pub-electronic 2021-11-27, online 2021-11-27, collection 2021-12Publication status: PublishedFunder: health services and delivery research programme; doi: http://dx.doi.org/10.13039/501100002001; Grant(s): 14/156/16Abstract: Background: The way we collect and use patient experience data is vital to optimise the quality and safety of health services. Yet, some patients and carers do not give feedback because of the limited ways data is collected, analysed and presented. In this study, we worked together with researchers, staff, patient and carer participants, and patient and public involvement and engagement (PPIE) contributors, to co-design new tools for the collection and use of patient experience data in multiple health settings. This paper outlines how the range of PPIE and research activities enabled the co-design of new tools to collect patient experience data. Methods: Eight public contributors represented a range of relevant patient and carer experiences in specialist services with varied levels of PPIE experience, and eleven members of Patient and Participation Groups (PPGs) from two general practices formed our PPIE group at the start of the study. Slide sets were used to trigger co-design discussions with staff, patient and carer research participants, and PPIE contributors. Feedback from PPIE contributors alongside verbatim quotes from staff, patient and carer research participants is presented in relation to the themes from the research data. Results: PPIE insights from four themes: capturing experience data; adopting digital or non-digital tools; ensuring privacy and confidentiality; and co-design of a suite of new tools with guidance, informed joint decisions on the shaping of the tools and how these were implemented. Our PPIE contributors took different roles during co-design and testing of the new tools, which supported co-production of the study. Conclusions: Our experiences of developing multiple components of PPIE work for this complex study demonstrates the importance of tailoring PPIE to suit different settings, and to maximise individual strengths and capacity. Our study shows the value of bringing diverse experiences together, putting patients and carers at the heart of improving NHS services, and a shared approach to managing involvement in co-design, with the effects shown through the research process, outcomes and the partnership. We reflect on how we worked together to create a supportive environment when unforeseen challenges emerged (such as, sudden bereavement)

Reachable workspace in facioscapulohumeral muscular dystrophy (FSHD) by kinect

IntroductionA depth-ranging sensor (Kinect) based upper extremity motion analysis system was applied to determine the spectrum of reachable workspace encountered in facioscapulohumeral muscular dystrophy (FSHD).MethodsReachable workspaces were obtained from 22 individuals with FSHD and 24 age- and height-matched healthy controls. To allow comparison, total and quadrant reachable workspace relative surface areas (RSAs) were obtained by normalizing the acquired reachable workspace by each individual's arm length.ResultsSignificantly contracted reachable workspace and reduced RSAs were noted for the FSHD cohort compared with controls (0.473 ± 0.188 vs. 0.747 ± 0.082; P < 0.0001). With worsening upper extremity function as categorized by the FSHD evaluation subscale II + III, the upper quadrant RSAs decreased progressively, while the lower quadrant RSAs were relatively preserved. There were no side-to-side differences in reachable workspace based on hand-dominance.ConclusionsThis study demonstrates the feasibility and potential of using an innovative Kinect-based reachable workspace outcome measure in FSHD

Resting-state oscillatory activity in children born small for gestational age: a magnetoencephalographic study

Growth restriction in utero during a period that is critical for normal growth of the brain, has previously been associated with deviations in cognitive abilities and brain anatomical and functional changes. We measured magnetoencephalography (MEG) in 4-7 year old children to test if children born small for gestational age (SGA) show deviations in resting-state brain oscillatory activity. Children born SGA children with postnatally spontaneous catch-up growth (SGA+; 6 boys, 7 girls; mean age 6.3 y (SD=0.9) and children born appropriate for gestational age (AGA; 7 boys, 3 girls; mean age 6.0 y (SD=1.2) participated in a resting-state MEG study. We calculated absolute and relative power spectra and used nonparametric statistics to test for group differences. SGA+ and AGA born children showed no significant differences in absolute and relative power except for reduced absolute gamma band power in SGA children. At time of MEG investigation, SGA+ children showed was significantly lower head circumference (HC) and a trend toward lower IQ, however there was no association of HC or IQ with absolute or relative power. Except for reduced absolute gamma band power, our findings suggest normal brain activity patterns at school age in a group of children born SGA in which spontaneous catch-up growth of bodily length after birth occurred. Although previous findings suggest that being born SGA alters brain oscillatory activity early in neonatal life, we show that these neonatal alterations do not persist at early school age when spontaneous postnatal catch-up growth occurs after birth

Upper extremity 3‐dimensional reachable workspace analysis in dystrophinopathy using Kinect

IntroductionAn innovative upper extremity 3-dimensional (3D) reachable workspace outcome measure acquired using the Kinect sensor is applied toward Duchenne/Becker muscular dystrophy (DMD/BMD). The validity, sensitivity, and clinical meaningfulness of this novel outcome measure are examined.MethodsUpper extremity function assessment (Brooke scale and NeuroQOL questionnaire) and Kinect-based reachable workspace analyses were conducted in 43 individuals with dystrophinopathy (30 DMD and 13 BMD, aged 7-60 years) and 46 controls (aged 6-68 years).ResultsThe reachable workspace measure reliably captured a wide range of upper extremity impairments encountered in both pediatric and adult, as well as ambulatory and non-ambulatory individuals with dystrophinopathy. Reduced reachable workspaces were noted for the dystrophinopathy cohort compared with controls, and they correlated with Brooke grades. In addition, progressive reduction in reachable workspace correlated directly with worsening ability to perform activities of daily living, as self-reported on the NeuroQOL.ConclusionThis study demonstrates the utility and potential of the novel sensor-acquired reachable workspace outcome measure in dystrophinopathy

Reachable workspace reflects dynamometer‐measured upper extremity strength in facioscapulohumeral muscular dystrophy

IntroductionIt is not known whether a reduction in reachable workspace closely reflects loss of upper extremity strength in facioscapulohumeral muscular dystrophy (FSHD). In this study we aimed to determine the relationship between reachable workspace and quantitative upper extremity strength measures.MethodsMaximal voluntary isometric contraction (MVIC) testing of bilateral elbow flexion and shoulder abduction by hand-held dynamometry was performed on 26 FSHD and 27 control subjects. In addition, Kinect sensor-based 3D reachable workspace relative surface areas (RSAs) were obtained. Loading (500-g weight) effects on reachable workspace were also evaluated.ResultsQuantitative upper extremity strength (MVIC of elbow flexion and shoulder abduction) correlated with Kinect-acquired reachable workspace RSA (R = 0.477 for FSHD, P = 0.0003; R = 0.675 for the combined study cohort, P < 0.0001). Progressive reduction in RSA reflected worsening MVIC measures. Loading impacted the moderately weak individuals the most with additional reductions in RSA.ConclusionsReachable workspace outcome measure is reflective of upper extremity strength impairment in FSHD