Exploring data reduction strategies in the analysis of continuous pressure imaging technology.

BACKGROUND: Science is becoming increasingly data intensive as digital innovations bring new capacity for continuous data generation and storage. This progress also brings challenges, as many scientific initiatives are challenged by the shear volumes of data produced. Here we present a case study of a data intensive randomized clinical trial assessing the utility of continuous pressure imaging (CPI) for reducing pressure injuries. OBJECTIVE: To explore an approach to reducing the amount of CPI data required for analyses to a manageable size without loss of critical information using a nested subset of pressure data. METHODS: Data from four enrolled study participants excluded from the analytical phase of the study were used to develop an approach to data reduction. A two-step data strategy was used. First, raw data were sampled at different frequencies (5, 30, 60, 120, and 240 s) to identify optimal measurement frequency. Second, similarity between adjacent frames was evaluated using correlation coefficients to identify position changes of enrolled study participants. Data strategy performance was evaluated through visual inspection using heat maps and time series plots. RESULTS: A sampling frequency of every 60 s provided reasonable representation of changes in interface pressure over time. This approach translated to using only 1.7% of the collected data in analyses. In the second step it was found that 160 frames within 24 h represented the pressure states of study participants. In total, only 480 frames from the 72 h of collected data would be needed for analyses without loss of information. Only ~ 0.2% of the raw data collected would be required for assessment of the primary trial outcome. CONCLUSIONS: Data reduction is an important component of big data analytics. Our two-step strategy markedly reduced the amount of data required for analyses without loss of information. This data reduction strategy, if validated, could be used in other CPI and other settings where large amounts of both temporal and spatial data must be analysed.

Alignment of patient-centredness definitions with real-life patient and clinician experiences: A qualitative study.

INTRODUCTION: Patient-centred care (PCC) has come to the forefront for many institutions, funding agencies and clinicians, and is integrated into care. Does a disconnect in understanding still exist between patients, healthcare organizations and clinicians in what PCC means and how outstanding issues might be addressed? METHODS: We conducted interviews and focus groups with self-reported chronic care patients and clinicians providing care to these patients exploring PCC experiences, expectations and practices. These data were initially analysed using inductive thematic analysis. This paper reports on the findings of a secondary analysis examining the alignment between patients and clinicians on five key predetermined dimensions of PCC. RESULTS: Eighteen patients participated, representing a range of chronic conditions. Thirty-eight clinicians participated. One thousand and three hundred patient and 1800 clinician codes were identified and grouped into 5 main topics with 140 unique themes (patients) and 9 main topics with 54 unique themes (clinicians). A total of 166 quotes (patient = 93, clinician = 73) were identified for this PCC definition alignment analysis. Partial or complete alignment of patient and clinician perspectives was seen on most dimensions. Key disconnects were observed in patient involvement, patient empowerment and clinician-patient communication. Only 18% of patients reported experiencing patient-centred communication, whereas 57% of clinicians reported using patient-focused communication approaches. CONCLUSION: Overall, study patients and clinicians endorse that many PCC elements occur. This study highlights key differences between patients and clinicians, suggesting persistent challenges. Clinician participants relayed their PCC approaches of informing and educating patients; however, patients often perceive these approaches as didactic, role-diminishing and noncollaborative. Collaborative approaches, such as shared decision-making, hold promise to bridge persistent PCC gaps and should be integrated into medical education programmes. PATIENT OR PUBLIC CONTRIBUTION: This project was conceived and executed with a co-design approach wherein patients with chronic conditions who are trained in research (i.e., see descriptions of Patient and Community Engagement Research in the text) were involved in all stages of the research project alongside other researchers on the project team. Healthcare providers were involved as participants and as principal investigators in the project.

Implementation strategies for hospital-based probiotic administration in a stepped-wedge cluster randomized trial design for preventing hospital-acquired Clostridioides difficile infection.

BACKGROUND: Clostridioides difficile infection (CDI) is associated with considerable morbidity and mortality in hospitalized patients, especially among older adults. Probiotics have been evaluated to prevent hospital-acquired (HA) CDI in patients who are receiving systemic antibiotics, but the implementation of timely probiotic administration remains a challenge. We evaluated methods for effective probiotic implementation across a large health region as part of a study to assess the real-world effectiveness of a probiotic to prevent HA-CDI (Prevent CDI-55 +). METHODS: We used a stepped-wedge cluster-randomized controlled trial across four acute-care adult hospitals (n = 2,490 beds) to implement the use of the probiotic Bio-K + ® (Lactobacillus acidophilus CL1285®, L. casei LBC80R® and L. rhamnosus CLR2®; Laval, Quebec, Canada) in patients 55 years and older receiving systemic antimicrobials. The multifaceted probiotic implementation strategy included electronic clinical decision support, local site champions, and both health care provider and patient educational interventions. Focus groups were conducted during study implementation to identify ongoing barriers and facilitators to probiotic implementation, guiding needed adaptations of the implementation strategy. Focus groups were thematically analyzed using the Theoretical Domains Framework and the Consolidated Framework of Implementation Research. RESULTS: A total of 340 education sessions with over 1,800 key partners and participants occurred before and during implementation in each of the four hospitals. Site champions were identified for each included hospital, and both electronic clinical decision support and printed educational resources were available to health care providers and patients. A total of 15 individuals participated in 2 focus group and 7 interviews. Key barriers identified from the focus groups resulted in adaptation of the electronic clinical decision support and the addition of nursing education related to probiotic administration. As a result of modifying implementation strategies for identified behaviour change barriers, probiotic adherence rates were from 66.7 to 75.8% at 72 h of starting antibiotic therapy across the four participating acute care hospitals. CONCLUSIONS: Use of a barrier-targeted multifaceted approach, including electronic clinical decision support, education, focus groups to guide the adaptation of the implementation plan, and local site champions, resulted in a high probiotic adherence rate in the Prevent CDI-55 + study.

Economic Evaluations of Strategies to Prevent Hospital-Acquired Pressure Injuries.

GENERAL PURPOSE: To provide information from a review of literature about economic evaluations of preventive strategies for pressure injuries (PIs). TARGET AUDIENCE: This continuing education activity is intended for physicians, physician assistants, nurse practitioners, and nurses with an interest in skin and wound care. LEARNING OBJECTIVES/OUTCOMES: After participating in this educational activity, the participant should be better able to:1. Identify the purpose and methods used for this study.2. Compare costs and effectiveness related to preventative strategies for PIs. ABSTRACT: BACKGROUND: Pressure injuries (PIs) are a common and resource-intensive challenge for acute care hospitals worldwide. While a number of preventive strategies have the potential to reduce the cost of hospital-acquired PIs, it is unclear what approach is the most effective. OBJECTIVE: The authors performed a narrative review of the literature on economic evaluations of preventive strategies to survey current findings and identify important factors in economic assessments. DATA SOURCES: Ovid, MEDLINE, NHS Economic Evaluation Databases, and the Cochrane Database of Systematic ReviewsSELECTION CRITERIA: Potentially relevant original research articles and systematic reviews were considered. DATA EXTRACTION: Selection criteria included articles that were written in English, provided data on cost or economic evaluations of preventive strategies of PIs in acute care, and published between January 2004 and September 2015. Data were abstracted from the articles using a standardized approach to evaluate how the items on the Consolidated Health Economic Evaluation Reporting Standards checklist were addressed. DATA SYNTHESIS: The searches identified 192 references. Thirty-three original articles were chosen for full-text reviews. Nineteen of these articles provided clear descriptions of interventions, study methods, and outcomes considered. CONCLUSIONS: Limitations in the available literature prevent firm conclusions from being reached about the relative economic merits of the various approaches to the prevention of PIs. The authors' review revealed a need for additional high-quality studies that adhere to commonly used standards of both currently utilized and emerging ways to prevent hospital-acquired PIs.

Effectiveness of Bio-K+ for the prevention of Clostridioides difficile infection: Stepped-wedge cluster-randomized controlled trial.

OBJECTIVE: To evaluate the impact of administering probiotics to prevent Clostridioides difficile infection (CDI) among patients receiving therapeutic antibiotics. DESIGN: Stepped-wedge cluster-randomized trial between September 1, 2016, and August 31, 2019. SETTING: This study was conducted in 4 acute-care hospitals across an integrated health region. PATIENTS: Hospitalized patients, aged ≥55 years. METHODS: Patients were given 2 probiotic capsules daily (Bio-K+, Laval, Quebec, Canada), containing 50 billion colony-forming units of Lactobacillus acidophilus CL1285, L. casei LBC80R, and L. rhamnosus CLR2. We measured hospital-acquired CDI (HA-CDI) and the number of positive C. difficile tests per 10,000 patient days as well as adherence to administration of Bio-K+ within 48 and 72 hours of antibiotic administration. Mixed-effects generalized linear models, adjusted for influenza admissions and facility characteristics, were used to evaluate the impact of the intervention on outcomes. RESULTS: Overall adherence of Bio-K+ administration ranged from 76.9% to 84.6% when stratified by facility and periods. Rates of adherence to administration within 48 and 72 hours of antibiotic treatment were 60.2% -71.4% and 66.7%-75.8%, respectively. In the adjusted analysis, there was no change in HA-CDI (incidence rate ratio [IRR], 0.92; 95% confidence interval [CI], 0.68-1.23) or C. difficile positivity rate (IRR, 1.05; 95% CI, 0.89-1.24). Discharged patients may not have received a complete course of Bio-K+. Our hospitals had a low baseline incidence of HA-CDI. Patients who did not receive Bio-K+ may have differential risks of acquiring CDI, introducing selection bias. CONCLUSIONS: Hospitals considering probiotics as a primary prevention strategy should consider the baseline incidence of HA-CDI in their population and timing of probiotics relative to the start of antimicrobial administration.

Effect of a Continuous Bedside Pressure Mapping System for Reducing Interface Pressures: A Randomized Clinical Trial.

Importance: Continuous bedside pressure mapping (CBPM) technology can assist in detecting skin areas with excessive interface pressure and inform efficient patient repositioning to prevent the development of pressure injuries (PI). Objective: To evaluate the efficacy of CBPM technology in reducing interface pressure and the incidence of PIs. Design, Setting, and Participants: This parallel, 2-group randomized clinical trial was performed at a tertiary acute care center. The study started to enroll participants in December 2014 and was completed in May 2018. Participants included adults partially or completely dependent for bed mobility. Statistical analysis was performed from September 2018 to December 2022. Intervention: Nursing staff using visual feedback from CBPM technology for 72 hours. Main Outcomes and Measures: Absolute number of sensing points with pressure readings greater than 40 mm Hg, mean interface pressure across all sensing points under a patient's body, proportion of participants who had pressure readings greater than 40 mm Hg, and pressure-related skin and soft tissue changes. Results: There were 678 patients recruited. After attrition, 260 allocated to the control group (151 [58.1%] male; mean [SD] age, 61.9 [18.5] years) and 247 in the intervention group (147 [59.5%] male; mean [SD] age, 63.6 [18.1] years) were included in analyses. The absolute number of sensing points with pressures greater than 40 mm Hg were 11 033 in the control group vs 9314 in the intervention group (P = .16). The mean (SD) interface pressure was 6.80 (1.63) mm Hg in the control group vs 6.62 (1.51) mm Hg in the intervention group (P = .18). The proportion of participants who had pressure readings greater than 40 mm Hg was 99.6% in both the control and intervention groups. Conclusions and Relevance: In this randomized clinical trial to evaluate the efficacy of CBPM technology in the reduction of interface pressure and the incidence of PIs in a tertiary acute care center, no statistically significant benefit was seen for any of the primary outcomes. These results suggest that longer duration of monitoring and adequately powered studies where CBPM feedback is integrated into a multifaceted intervention to prevent PI are needed. Trial Registration: ClinicalTrials.gov Identifier: NCT02325388.

Healthcare provider and patient/family perceptions of continuous pressure imaging technology for prevention of pressure injuries: A secondary analysis of patients enrolled in a randomized control trial.

INTRODUCTION: Despite the availability of various pressure injury (PI) prevention strategies (e.g., risk identification, use of pressure re-distribution surfaces, frequent repositioning), they persist as a significant issue for healthcare systems worldwide. Continuous pressure imaging (CPI) is a novel technology that could be integrated within a comprehensive approach to the prevention of PIs. We studied the perceptions of healthcare providers and patients/families to identify facilitators and barriers to the use of this technology. METHODS: Hospitalized patients/family members from a randomized controlled trial assessing the efficacy of CPI in preventing PIs completed a survey after 72 hours (or upon discharge from hospital) of CPI monitoring. They were asked questions about prior and current experience with CPI technology. For healthcare providers, perceptions on the use of the device and its impact on care were explored through a survey distributed by email or hard copies. RESULTS: A total of 125 healthcare providers and 525 patients/family members completed the surveys. Of the healthcare providers, 95% either agreed/strongly agreed that the CPI technology was easy to use and 65% stated that the device improved how they provided pressure relief for patients. Identified issues with the device were cost, the fitting of the mattress cover, and the fixation of the patients/families on the device. Over a quarter of the patient/family respondents agreed/strongly agreed that the device influenced how pressure relief was provided. This response was statistically associated with whether the monitor was turned on (intervention arm; 52.7%) or off (control arm; 4.2%). DISCUSSION AND CONCLUSION: CPI technology was positively perceived by healthcare providers. Most patients/families felt it influenced care when the CPI monitor was turned on. Concerns raised around cost and the ease of use of these devices by healthcare providers may affect the decisions of healthcare system administrators to adopt and implement this technology.

Human-centred design processes for clinical decision support: A pulmonary embolism case study.

BACKGROUND: Clinical Decision Support Systems (CDSS) can make patient care more efficient, cost-effective, and guideline-concordant. Many are created by clinicians who understand the challenges, but may publish concepts before considering subtle but important design details. Human-Centred Design (HCD) approaches provide necessary methods ensuring solid CDSS design. This article highlights HCD approaches in a pulmonary embolism CDSS case study context. METHODS: This pulmonary embolism CDSS results from collaborative work between computer science, psychology, and medicine. HCD methods used include: evaluations of pre-clinical prototype recordings, iterative usability expert reviews with software refinement, formative usability testing, and (separately-published) clinical pilot study. RESULTS: HCD methods were instrumental in iteratively creating an easy to use and functionally-sound CDSS. Retrospective evaluations revealed that participants spent considerable time on items that were out of order from natural cognitive diagnostic workflows. Features missing between original and study version were noted, confusing interface elements reworked, and currently-active decision tree branches were visually emphasized. From iterative usability reviews, positioning of information within the decision tree was radically reworked, information separated into levels of support for different user groups, and supportive versus directive language issues addressed. Formative studies identified issues such as interface adjustments and hospital workflow integration. CONCLUSIONS: Human-centred design approaches provide methods for integrating the skills and knowledge of many disciplines, illustrated by example in this pulmonary embolism CDSS creation. Advantages of leveraging many design guidelines as well as revealing new design considerations that would otherwise have remained hidden are described. The findings reported here support future CDSS design through HCD inclusion.

A Mixed-methods Study to Assess Interrater Reliability and Nurse Perception of the Braden Scale in a Tertiary Acute Care Setting.

Research regarding the reliability of the Braden Scale and nurses' perspectives on the instrument for predicting pressure ulcer (PU) risk in acute care settings is limited. A mixed-methods study was conducted in a tertiary acute care facility to examine interrater reliability (IRR) of the Braden Scale and its subscales, and a qualitative survey using semi-structured interviews was conducted among nurses caring for patients in acute care units to gain nurse perspective regarding scale usability. Data were extracted from a previous retrospective, randomized, controlled trial involving adult patients with compromised mobility receiving care in a tertiary acute care hospital in Canada. One-way, intraclass correlation coefficients (ICCs) were calculated on item and total scores, and kappa statistics were used to determine reliability of categorizing patients on their risk. Interview results were categorized by common themes. Reliability was assessed on 64 patients, where nurses and research staff independently assessed enrolled participants at baseline and after 72 hours using the Braden Scale as it appeared on an electronic medical record. IRR for the total score was high (ICC = 0.807). The friction and shear item had the lowest reliability (ICC = 0.266). Reliability of categorizing patients' level of risk had moderate agreement (κ = 0.408). Three (3) major and 12 subthemes emerged from the 14 nurse interviews; nurses were aware of the scale's purpose but were uncertain of its effectiveness, some items were difficult to rate, and questions were raised as to whether using the scale enhanced patient care. Aspects identified by nurses to enhance usability included: 1) changes to the electronic version (incorporating the scale into daily assessment documents with readily available item descriptions), 2) additional training, and 3) easily available resource material to improve reliability and usability of scale. These findings need to be considered when using the Braden Scale in clinical practice. Further study of the value of the total Braden Scale and its subscales is warranted.

Efficacy of a pressure-sensing mattress cover system for reducing interface pressure: study protocol for a randomized controlled trial.

BACKGROUND: Interface pressure is a key risk factor in the development of pressure ulcers. Visual feedback of continuous interface pressure between the body and support surface could inform clinicians on repositioning strategies and play a key role in an overall strategy for the prevention and management of pressure ulcers. METHODS/DESIGN: A parallel two-group randomized controlled clinical trial will be conducted to study the effect of continuous pressure imaging on reducing interface pressure and on the incidence of pressure ulcers in vulnerable hospital patients. A total of 678 eligible consenting inpatients at risk of pressure ulcer development in a tertiary acute care institution will be randomly allocated to either having the ForeSite PT™ system with the liquid-crystal display monitor turned on to provide visual feedback to the clinicians while also collecting continuous interface pressure data (intervention group) or to having the ForeSite PT™ system with monitor turned off (that is, not providing visual feedback) but still collecting continuous interface pressure data (control group), in a ratio of 1:1. Continuous interface pressure data will be collected in both groups for 3 days (72 h). Data collection will continue until discharge for a subset of approximately 60 patients. The primary outcome will be the differences in the two groups' interface pressure analysis. Interface pressure readings will be collected through hourly samplings of continuous interface pressure recordings. Secondary outcomes will be the differences between the two groups in pressure-related skin and soft tissue changes in areas at risk of pressure ulcer (obtained at baseline within 24 h of admission) and on the third day of the trial or at discharge and perceptions of the intervention by patients and clinicians (obtained on the third day or at discharge). DISCUSSION: This will be the first randomized controlled trial to investigate the effect of visual feedback with continuous interface pressure of vulnerable hospital patients across different care settings, and the association between interface pressure and development of pressure-related skin and soft tissue changes. The results could provide important information to guide clinical practice in the prevention and management of pressure ulcers. TRIALS REGISTRATION: ClinicalTrials.gov NCT02325388 (date of registration: 24 December 2014).

Effects of mesalamine (5-aminosalicylic acid) on bacterial gene expression.

BACKGROUND: 5-Aminosalicylic acid (5-ASA) is a well-established treatment for inflammatory bowel disease (IBD) and may reduce the risk of colon cancer in patients with chronic colitis, but the mechanisms underlying these effects have not been fully elucidated. Although 5-ASA delivery is targeted to the distal gut, little is known about its effects on the luminal bacteria that reside there. Intestinal bacteria are believed play a role in causing or perpetuating IBD, and bioremediation has been studied as a therapeutic strategy. In an effort to better understand the bacteriological effects of 5-ASA, we examined the role of this compound at the level of bacterial gene expression. METHODS: 5-ASA was screened for its effects on a random promoter library representing the genome of Salmonella enterica serovar Typhimurium as a model enteric bacterium. Forty-five constructs representing 38 unique promoters were found to be responsive to 5-ASA, and included genes involved in bacterial invasion, cellular metabolism, and stress resistance. Several genes of unknown function were also identified. These effects occurred at 5-ASA concentrations that are relevant to those achieved in the distal intestinal tract in patients with IBD but did not inhibit bacterial growth. RESULTS: Bacterial invasiveness was decreased by 5-ASA. Some of the identified genes had homologs among commensal Gram-negative enteric bacteria. CONCLUSIONS: This study demonstrates that 5-ASA has potent effects on bacterial gene expression. These novel findings implicate intestinal bacteria as pharmacological targets of 5-ASA, perhaps contributing to the therapeutic action of this important class of IBD drugs.