A Personalized Self-Management Rehabilitation System with an Intelligent Shoe for Stroke Survivors: A Realist Evaluation

Background: In the United Kingdom, stroke is the most significant cause of adult disability. Stroke survivors are frequently left with physical and psychological changes that can profoundly affect their functional ability, independence, and social participation. Research suggests that long-term, intense, task- and context-specific rehabilitation that is goal-oriented and environmentally enriched improves function, independence, and quality of life after a stroke. It is recommended that rehabilitation should continue until maximum recovery has been achieved. However, the increasing demand on services and financial constraints means that needs cannot be met through traditional face-to-face delivery of rehabilitation. Using a participatory design methodology, we developed an information communication technology–enhanced Personalized Self-Managed rehabilitation System (PSMrS) for stroke survivors with integrated insole sensor technology within an “intelligent shoe.”. The intervention model was based around a rehabilitation paradigm underpinned by theories of motor relearning and neuroplastic adaptation, motivational feedback, self-efficacy, and knowledge transfer. Objective: To understand the conditions under which this technology-based rehabilitation solution would most likely have an impact on the motor behavior of the user, what would work for whom, in what context, and how. We were interested in what aspects of the system would work best to facilitate the motor behavior change associated with self-managed rehabilitation and which user characteristics and circumstances of use could promote improved functional outcomes. Methods: We used a Realist Evaluation (RE) framework to evaluate the final prototype PSMrS with the assumption that the intervention consists of a series of configurations that include the Context of use, the underlying Mechanisms of change and the potential Outcomes or impacts (CMOs). We developed the CMOs from literature reviews and engagement with clinicians, users, and caregivers during a series of focus groups and home visits. These CMOs were then tested in five in-depth case studies with stroke survivors and their caregivers. Results: While two new propositions emerged, the second importantly related to the self-management aspects of the system. The study revealed that the system should also encourage independent use and the setting of personalized goals or activities. Conclusions: Information communication technology that purports to support the self-management of stroke rehabilitation should give significant consideration to the need for motivational feedback that provides quantitative, reliable, accurate, context-specific, and culturally sensitive information about the achievement of personalized goal-based activities

Toward estimating the impact of changes in immigrants' insurance eligibility on hospital expenditures for uncompensated care

BACKGROUND: The Personal Responsibility and Work Opportunity Reconciliation Act (PRWORA) of 1996 gave states the option to withdraw Medicaid coverage of nonemergency care from most legal immigrants. Our goal was to assess the effect of PRWORA on hospital uncompensated care in the United States. METHODS: We collected the following state-level data for the period from 1994 through 1999: foreign-born, noncitizen population and health uninsurance rates (US Census Current Population Survey); percentage of teaching hospitals (American Hospital Association Annual Survey of Hospitals); and each state's decision whether to implement the PRWORA Medicaid bar for legal permanent residents or to continue offering nonemergency Medicaid coverage using state-only funds (Urban Institute). We modeled uncompensated care expenditures by state (also from the Annual Survey of Hospitals) in both univariate and multivariable regression analyses. RESULTS: When measured at the state level, there was no significant relationship between uncompensated care expenditures and states' percentage of noncitizen immigrants. Uninsurance rates were the only significant factor in predicting uncompensated hospital care expenditures by state. CONCLUSIONS: Reducing the number of uninsured patients would most surely reduce hospital expenditures for uncompensated care. However, data limitations hampered our efforts to obtain a monetary estimate of hospitals' financial losses due specifically to the immigrant eligibility changes in PRWORA. Quantifying the impact of these provisions on hospitals will require better data sources

Systematic review of pre-operative exercise in colorectal cancer patients

The aim of this systematic review was to evaluate the evidence for exercise interventions prior to surgery for colorectal cancer resection. The evidence for use of exercise to improve physical fitness and surgical outcomes is as yet unknown. A systematic search was performed of MEDLINE, EMBASE, CINAHL, AMED and BNI databases for studies involving pre-operative exercise in colorectal cancer patients. Eight studies were included in the review. There is evidence that pre-operative exercise improves functional fitness, and to a lesser extent objectively measurable cardio-respiratory fitness prior to colorectal cancer resection. There is no clear evidence at present that this improvement in fitness translates into reduced peri-operative risk or improved post-operative outcomes. Current studies are limited by risk of bias. This review highlights the common difficulty in transferring promising results in a research setting, into significant improvements in the clinical arena. Future research should focus on which type of exercise is most likely to maximise patient adherence and improvements in cardio-respiratory fitness. Ultimately, adequately powered, randomised controlled trials are needed to investigate whether pre-operative exercise improves post-operative morbidity and mortality

Development of a composite outcome score for a complex intervention - measuring the impact of Community Health Workers.

BACKGROUND: In health services research, composite scores to measure changes in health-seeking behaviour and uptake of services do not exist. We describe the rationale and analytical considerations for a composite primary outcome for primary care research. We simulate its use in a large hypothetical population and use it to calculate sample sizes. We apply it within the context of a proposed cluster randomised controlled trial (RCT) of a Community Health Worker (CHW) intervention. METHODS: We define the outcome as the proportion of the services (immunizations, screening tests, stop-smoking clinics) received by household members, of those that they were eligible to receive. First, we simulated a population household structure (by age and sex), based on household composition data from the 2011 England and Wales census. The ratio of eligible to received services was calculated for each simulated household based on published eligibility criteria and service uptake rates, and was used to calculate sample size scenarios for a cluster RCT of a CHW intervention. We assume varying intervention percentage effects and varying levels of clustering. RESULTS: Assuming no disease risk factor clustering at the household level, 11.7% of households in the hypothetical population of 20,000 households were eligible for no services, 26.4% for 1, 20.7% for 2, 15.3% for 3 and 25.8% for 4 or more. To demonstrate a small CHW intervention percentage effect (10% improvement in uptake of services out of those who would not otherwise have taken them up, and additionally assuming intra-class correlation of 0.01 between households served by different CHWs), around 4,000 households would be needed in each of the intervention and control arms. This equates to 40 CHWs (each servicing 100 households) needed in the intervention arm. If the CHWs were more effective (20%), then only 170 households would be needed in each of the intervention and control arms. CONCLUSIONS: This is a useful first step towards a process-centred composite score of practical value in complex community-based interventions. Firstly, it is likely to result in increased statistical power compared with multiple outcomes. Second, it avoids over-emphasis of any single outcome from a complex intervention

Response shift in patient-reported outcomes:definition, theory, and a revised model

International audiencePurpose The extant response shift definitions and theoretical response shift models, while helpful, also introduce predicaments and theoretical debates continue. To address these predicaments and stimulate empirical research, we propose a more specific formal definition of response shift and a revised theoretical model. Methods This work is an international collaborative effort and involved a critical assessment of the literature. Results Three main predicaments were identified. First, the formal definitions of response shift need further specification and clarification. Second, previous models were focused on explaining change in the construct intended to be measured rather than explaining the construct at multiple time points and neglected the importance of using at least two time points to investigate response shift. Third, extant models do not explicitly distinguish the measure from the construct. Here we define response shift as an effect occurring whenever observed change (e.g., change in patient-reported outcome measures (PROM) scores) is not fully explained by target change (i.e., change in the construct intended to be measured). The revised model distinguishes the measure (e.g., PROM) from the underlying target construct (e.g., quality of life) at two time points. The major plausible paths are delineated, and the underlying assumptions of this model are explicated. Conclusion It is our hope that this refined definition and model are useful in the further development of response shift theory. The model with its explicit list of assumptions and hypothesized relationships lends itself for critical, empirical examination. Future studies are needed to empirically test the assumptions and hypothesized relationships

Does Prehabilitation modify muscle mass in patients with rectal cancer undergoing neoadjuvant therapy?:A subanalysis from the REx Randomised Controlled Trial

Background: Patients with rectal cancer who present with sarcopenia (low muscle mass) are at significantly greater risk of postoperative complications and reduction in disease-free survival. We performed a subanalysis of a randomised controlled study [the REx trial; www.isrctn.com; 62859294] to assess the potential of prehabilitation to modify muscle mass in patients having neoadjuvant chemoradiotherapy (NACRT). Methods: Patients scheduled for NACRT, then potentially curative surgery (August 2014–March 2016) had baseline physical assessment and psoas muscle mass measurement (total psoas index using computed tomography-based measurements). Participants were randomised to either the intervention (13–17-week telephone-guided graduated walking programme) or control group (standard care). Follow-up testing was performed 1–2 weeks before surgery. Results: The 44 patients had a mean age of 66.8 years (SD 9.6) and were male (64%); white (98%); American Society of Anesthesiologists class 2 (66%); co-morbid (58%); overweight (72%) (body mass index ≥ 25 kg/m2). At baseline, 14% were sarcopenic. At follow-up, 13 (65%) of patients in the prehabilitation group had increased muscle mass versus 7 (35%) that experienced a decrease. Conversely, 16 (67%) controls experienced a decrease in muscle mass and 8 (33%) showed an increase. An adjusted linear regression model estimated a mean treatment difference in Total Psoas Index of 40.2mm2/m2 (95% CI − 3.4 to 83.7) between groups in change from baseline (p = 0.07). Conclusions: Prehabilitation improved muscle mass in patients with rectal cancer who had NACRT. These results need to be explored in a larger trial to determine if the poorer short- and long-term patient outcomes associated with low muscle mass can be minimised by prehabilitation