An Inflection Point in Cancer Protein Biomarkers: What was and What's Next.

Biomarkers remain the highest value proposition in cancer medicine today-especially protein biomarkers. Despite decades of evolving regulatory frameworks to facilitate the review of emerging technologies, biomarkers have been mostly about promise with very little to show for improvements in human health. Cancer is an emergent property of a complex system, and deconvoluting the integrative and dynamic nature of the overall system through biomarkers is a daunting proposition. The last 2 decades have seen an explosion of multiomics profiling and a range of advanced technologies for precision medicine, including the emergence of liquid biopsy, exciting advances in single-cell analysis, artificial intelligence (machine and deep learning) for data analysis, and many other advanced technologies that promise to transform biomarker discovery. Combining multiple omics modalities to acquire a more comprehensive landscape of the disease state, we are increasingly developing biomarkers to support therapy selection and patient monitoring. Furthering precision medicine, especially in oncology, necessitates moving away from the lens of reductionist thinking toward viewing and understanding that complex diseases are, in fact, complex adaptive systems. As such, we believe it is necessary to redefine biomarkers as representations of biological system states at different hierarchical levels of biological order. This definition could include traditional molecular, histologic, radiographic, or physiological characteristics, as well as emerging classes of digital markers and complex algorithms. To succeed in the future, we must move past purely observational individual studies and instead start building a mechanistic framework to enable integrative analysis of new studies within the context of prior studies. Identifying information in complex systems and applying theoretical constructs, such as information theory, to study cancer as a disease of dysregulated communication could prove to be "game changing" for the clinical outcome of cancer patients.

Changes in Patient-Reported Outcomes Associated with Receiving Whole Health in the Veteran Health Administration (VHA)'s National Demonstration Project.

BACKGROUND: Whole Health (WH) is a patient-centered model of care being implemented by the Veterans Health Administration. Little is known about how use of WH services impacts patients' health and well-being. OBJECTIVE: We sought to assess the association of WH utilization with pain and other patient-reported outcomes (PRO) over 6 months. DESIGN: A longitudinal observational cohort evaluation, comparing changes in PRO surveys for WH users and Conventional Care (CC) users. Inverse probability of treatment weighting was used to balance the two groups on observed demographic and clinical characteristics. PARTICIPANTS: A total of 9689 veterans receiving outpatient care at 18 VA medical centers piloting WH. INTERVENTIONS: WH services included goal-setting clinical encounters, Whole Health coaching, personal health planning, and well-being services. MAIN OUTCOME MEASURES: The primary outcome was change in pain intensity and interference at 6 months using the 3-item PEG. Secondary outcomes included satisfaction, experiences of care, patient engagement in healthcare, and well-being. KEY RESULTS: By 6 months,1053 veterans had utilized WH and 3139 utilized only CC. Baseline pain PEG scores were 6.2 (2.5) for WH users and 6.4 (2.3) for CC users (difference p = 0.028), improving by - 2.4% (p = 0.006) and - 2.3% (p < 0.001), respectively. In adjusted analyses, WH use was unassociated with greater improvement in PEG scores compared to CC - 1.0% (- 2.9%, 1.2%). Positive trends were observed for 8 of 15 exploratory outcomes for WH compared to CC. WH use was associated with greater improvements at 6 months in likelihood to recommend VA 2.0% (0.9%, 3.3%); discussions of goals 11.8% (8.2%, 15.5%); perceptions of healthcare interactions 2.5% (0.4%, 4.6%); and engagement in health behaviors 2.2% (0.3%, 3.9%). CONCLUSION: This study provides early evidence supporting the delivery of WH patient-centered care services to improve veterans' experiences of and engagement in care. These are important first-line impacts towards the goals of better overall health and well-being outcomes for Veterans.

Greater Protein Intake Emphasizing Lean Beef Does Not Affect Resistance Training-Induced Adaptations in Skeletal Muscle and Tendon of Older Women: A Randomized Controlled Feeding Trial.

BACKGROUND: Although experimental research supports that resistance training (RT), especially with greater dietary protein intake, improves muscle mass and strength in older adults, comparable research on tendons is needed. OBJECTIVES: We assessed the effects of a protein-rich diet emphasizing lean beef, compared with 2 control diets, on RT-induced changes in skeletal muscle and tendon size and strength in older women. METHODS: We randomly assigned women [age: 66 ± 1 y, body mass index (BMI): 28 ± 1] to groups that consumed 1) 0.8 g total protein/kg body weight/day from mixed food sources (normal protein control, n = 16); 2) 1.4 g/kg/d protein from mixed food sources (high protein control, n = 17); or 3) 1.4 g/kg/d protein emphasizing unprocessed lean beef (high protein experimental group, n = 16). Participants were provided with all foods and performed RT 3 times/wk, 70% of 1-repetition maximum for 12 wk. We measured quadriceps muscle volume via magnetic resonance imaging (MRI). We estimated patellar tendon biomechanical properties and cross-sectional area (CSA) using ultrasound and MRI. RESULTS: Dietary intake did not influence RT-induced increases in quadriceps strength (P < 0.0001) or muscle volume (P < 0.05). We noted a trend for an RT effect on mean tendon CSA (P = 0.07), with no differences among diets (P > 0.05). Proximal tendon CSA increased with RT (P < 0.05) with no difference between dietary groups (P > 0.05). Among all participants, midtendon CSA increased with RT (P ≤ 0.05). We found a decrease in distal CSA in the 0.8 g group (P < 0.05) but no change in the 1.4 g group (P > 0.05). Patellar tendon MRI signal or biomechanical properties were unchanged. CONCLUSIONS: Our findings indicated that greater daily protein intake, emphasizing beef, did not influence RT-induced changes in quadriceps muscle strength or muscle volume of older women. Although we noted trends in tendon CSA, we did not find a statistically significant impact of greater daily protein intake from beef on tendon outcomes. This trial was registered at clinicaltrials.gov as NCT04347447.

VHA Whole Health Services and Complementary and Integrative Health Therapies: a Gateway to Evidence-Based Mental Health Treatment.

BACKGROUND: Engagement in evidence-based psychotherapy (EBP) among veterans with behavioral health conditions is often low. The Veterans Health Administration (VHA) is implementing a "Whole Health (WH)" system of care, to identify veteran personal health goals, align care with those goals, and offer services designed to engage and empower veterans to achieve well-being. OBJECTIVE: To examine the relationship between veteran WH utilization and subsequent engagement in EBP. DESIGN: Retrospective analysis of VHA administrative records from 18 facilities implementing WH. SUBJECTS: Veterans (n = 265,364) with a diagnosis of depression, post-traumatic stress disorder (PTSD), and/or anxiety who had a mental healthcare encounter but no EBP use in fiscal year (FY) 2018. Among this cohort, 33,146 (12.5%) began using WH in FY2019. MAIN MEASURES: We examined use of an EBP for depression, anxiety, and/or PTSD within 1 year of the index date of WH use compared to use of an EBP anytime during FY2019 for veterans not identified as using WH. We used multiple logistic regression to examine the association between veteran WH use and EBP engagement. KEY RESULTS: Approximately 3.0% (n = 7,860) of the veterans in our overall cohort engaged in an EBP in the year following their index date. Controlling for key demographic, health, and utilization variables, WH users had 2.4 (95% CI: 2.2-2.5) times higher odds of engaging in an EBP the following year than those with no WH utilization. Associations between utilization of specific WH services (vs. no utilization of that service) and engagement in an EBP in the subsequent year ranged from 1.6 (95% CI: 1.0-2.6) to 3.5 (95% CI: 3.2-3.9) across the different types of WH services used. CONCLUSIONS: WH use was associated with increased engagement in EBPs among veterans with depression, anxiety, and/or PTSD. Future interventions intended to promote veteran engagement in EBPs may benefit from leveraging WH services and therapies.

Stakeholder Research Priorities to Promote Implementation of Shared Decision-Making for Lung Cancer Screening: An American Thoracic Society and Veterans Affairs Health Services Research and Development Statement.

Rationale: Shared decision-making (SDM) for lung cancer screening (LCS) is recommended in guidelines and required by Medicare, yet it is seldom achieved in practice. The best approach for implementing SDM for LCS remains unknown, and the 2021 U.S. Preventive Services Task Force calls for implementation research to increase uptake of SDM for LCS. Objectives: To develop a stakeholder-prioritized research agenda and recommended outcomes to advance implementation of SDM for LCS. Methods: The American Thoracic Society and VA Health Services Research and Development Service convened a multistakeholder committee with expertise in SDM, LCS, patient-centered care, and implementation science. During a virtual State of the Art conference, we reviewed evidence and identified research questions to address barriers to implementing SDM for LCS, as well as outcome constructs, which were refined by writing group members. Our committee (n = 34) then ranked research questions and SDM effectiveness outcomes by perceived importance in an online survey. Results: We present our committee's consensus on three topics important to implementing SDM for LCS: 1) foundational principles for the best practice of SDM for LCS; 2) stakeholder rankings of 22 implementation research questions; and 3) recommended outcomes, including Proctor's implementation outcomes and stakeholder rankings of SDM effectiveness outcomes for hybrid implementation-effectiveness studies. Our committee ranked questions that apply innovative implementation approaches to relieve primary care providers of the sole responsibility of SDM for LCS as highest priority. We rated effectiveness constructs that capture the patient experience of SDM as most important. Conclusions: This statement offers a stakeholder-prioritized research agenda and outcomes to advance implementation of SDM for LCS.

Proactively tailoring implementation: the case of shared decision-making for lung cancer screening across the VA New England Healthcare Network.

BACKGROUND: Shared Decision-Making to discuss how the benefits and harms of lung cancer screening align with patient values is required by the US Centers for Medicare and Medicaid and recommended by multiple organizations. Barriers at organizational, clinician, clinical encounter, and patient levels prevent SDM from meeting quality standards in routine practice. We developed an implementation plan, using the socio-ecological model, for Shared Decision-Making for lung cancer screening for the Department of Veterans Affairs (VA) New England Healthcare System. Because understanding the local context is critical to implementation success, we sought to proactively tailor our original implementation plan, to address barriers to achieving guideline-concordant lung cancer screening. METHODS: We conducted a formative evaluation using an ethnographic approach to proactively identify barriers to Shared Decision-Making and tailor our implementation plan. Data consisted of qualitative interviews with leadership and clinicians from seven VA New England medical centers, regional meeting notes, and Shared Decision-Making scripts and documents used by providers. Tailoring was guided by the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS). RESULTS: We tailored the original implementation plan to address barriers we identified at the organizational, clinician, clinical encounter, and patient levels. Overall, we removed two implementation strategies, added five strategies, and modified the content of two strategies. For example, at the clinician level, we learned that past personal and clinical experiences predisposed clinicians to focus on the benefits of lung cancer screening. To address this barrier, we modified the content of our original implementation strategy Make Training Dynamic to prompt providers to self-reflect about their screening beliefs and values, encouraging them to discuss both the benefits and potential harms of lung cancer screening. CONCLUSIONS: Formative evaluations can be used to proactively tailor implementation strategies to fit local contexts. We tailored our implementation plan to address unique barriers we identified, with the goal of improving implementation success. The FRAME-IS aided our team in thoughtfully addressing and modifying our original implementation plan. Others seeking to maximize the effectiveness of complex interventions may consider using a similar approach.

Interventions to reduce falls in hospitals: a systematic review and meta-analysis.

BACKGROUND: Falls remain a common and debilitating problem in hospitals worldwide. The aim of this study was to investigate the effects of falls prevention interventions on falls rates and the risk of falling in hospital. DESIGN: Systematic review and meta-analysis. PARTICIPANTS: Hospitalised adults. INTERVENTION: Prevention methods included staff and patient education, environmental modifications, assistive devices, policies and systems, rehabilitation, medication management and management of cognitive impairment. We evaluated single and multi-factorial approaches. OUTCOME MEASURES: Falls rate ratios (rate ratio: RaR) and falls risk, as defined by the odds of being a faller in the intervention compared to control group (odds ratio: OR). RESULTS: There were 43 studies that satisfied the systematic review criteria and 23 were included in meta-analyses. There was marked heterogeneity in intervention methods and study designs. The only intervention that yielded a significant result in the meta-analysis was education, with a reduction in falls rates (RaR = 0.70 [0.51-0.96], P = 0.03) and the odds of falling (OR = 0.62 [0.47-0.83], P = 0.001). The patient and staff education studies in the meta-analysis were of high quality on the GRADE tool. Individual trials in the systematic review showed evidence for clinician education, some multi-factorial interventions, select rehabilitation therapies, and systems, with low to moderate risk of bias. CONCLUSION: Patient and staff education can reduce hospital falls. Multi-factorial interventions had a tendency towards producing a positive impact. Chair alarms, bed alarms, wearable sensors and use of scored risk assessment tools were not associated with significant fall reductions.

'It Makes You Sit Back and Think Where You Wanna Go': Veteran experiences in virtual whole health peer-led groups.

BACKGROUND: The Veterans Health Administration (VHA) is building a Whole Health system of care that aspires to empower and equip each Veteran to pursue a personally meaningful vision of health and well-being. As part of this effort, VHA has developed Taking Charge of My Life and Health (TCMLH), a peer-led, group-based programme that seeks to support Veterans in setting and pursuing health and well-being goals. Prior research showed TCMLH groups to positively impact Veteran outcomes; yet, little is known about Veterans' own experiences and perspectives. METHODS: We completed semi-structured telephone interviews with 15 Veterans across 8 sites who had participated in TCMLH groups offered by the VHA in the virtual format between Summer 2020 and Fall 2021. Inductive thematic analysis was applied to interview transcripts to generate themes. FINDINGS: We identified five themes regarding Veterans' experiences with TCMLH: (1) navigating the virtual format; (2) internalizing the value of health engagement; (3) making healthy lifestyle changes; (4) forging social connections; and (5) taking on a more active role in healthcare. CONCLUSION: Veterans perceived virtual TCMLH groups as meaningful and beneficial, yet also highlighted several challenges. Their perspectives speak to the need to supplement time-limited programmes like TCMLH with ongoing, community-based support. Virtual group-based well-being programmes are a promising innovation. Other healthcare systems may draw on VHA's experience while tailoring format and content to the needs of their patient populations. PATIENT OR PUBLIC CONTRIBUTION: Veterans were involved as evaluation participants. A Veteran consultant, who is a coauthor on this paper, was engaged through the conceptualization of the evaluation, development of data collection materials (interview guide) and writing.

Once daily 300 mg aspirin with compression versus compression alone in patients with chronic venous leg ulcers (ASPiVLU): A randomised, double-blinded, multicentre, placebo-controlled, clinical trial.

AIM: Venous leg ulcers are lower limb skin ulcers characterised by a cycle of healing and recurrence due to underlying chronic venous insufficiency. While compression improves healing outcomes, many ulcers do not heal. As a daily 300 mg oral dose of aspirin in conjunction with compression may improve healing outcomes, we investigated the effect of adjuvant aspirin on venous leg ulcer healing in participants already receiving compression. MATERIALS AND METHODS: We conducted a prospective, randomised, double-blinded, placebo-controlled, clinical trial (known as ASPiVLU). Participants were recruited from six wound clinics in Australia. We screened 844 participants. Community-dwelling adult participants identified at six hospital outpatient clinics and clinically diagnosed with a venous leg ulcer present for 6+ weeks were eligible between April 13, 2015 to June 30, 2018. We randomised 40 participants (n = 19 aspirin, n = 21 placebo) and evaluated against the primary outcome. There were no dropouts. Ten serious adverse events in six participants were recorded. None were study related. The primary outcome measure was healing at 12 weeks based on blinded assessment. RESULTS: We found no difference in the number of ulcers healed at 12 weeks between the intervention and control groups. CONCLUSION: This study could not detect whether or not aspirin affected VLU healing speed. This is likely because we recruited fewer participants than expected due to the high number of people with venous leg ulcers in Australia who were already taking Aspirin; future research should investigate other adjuvant therapies or different study designs.

Applying the International Classification of Functioning, Disability and Health framework to determine the predictors of falls and fractures in people with osteoarthritis or at high risk of developing osteoarthritis: data from the Osteoarthritis Initiative.

BACKGROUND: Falls are a major cause of injury and death among older people. Evidence suggests that people with osteoarthritis (OA) are at a higher risk of falls and fall-related injuries including fractures. While studies demonstrate a link between OA and falls, little is known about the pathways that link falls with demographic factors, OA impairments, activity limitations and participation restrictions. The aim of this study was to identify risk factors for falls and fractures among people with OA or at high risk of developing OA using the International Classification of Functioning, Disability and Health (ICF) framework. METHODS: A longitudinal analysis of data from the Osteoarthritis Initiative (OAI) dataset was undertaken. Participants were considered to have OA if they reported they had been diagnosed with knee or hip OA by a medical practitioner. Outcomes were self-reported falls and fractures. Potential predictors were classified using the ICF framework. Poisson regression models were used to determine the risk factors for falls and fractures. RESULTS: Of the 4796 participants, 2270 (47%) were diagnosed with knee and/or hip OA. A higher proportion of participants with OA reported having had falls (72% vs 63%; p < 0.0001) and fractures (17% vs 14%; p = 0.012) than those without OA. Personal factors were found to be stronger predictors of falls and fractures compared to OA impairments, activity limitations and participation restrictions in this sample of participants. After adjusting for potential covariates, self-reported history of falls was a significant predictor of both increased falls (incidence rate ratio [IRR] 1.50; 95% confidence interval [CI] 1.40, 4.60) and fracture risk (IRR 1.38; 95% CI 1.13, 1.69). CONCLUSIONS: By applying the ICF framework, we have shown that personal factors were more likely to predict falls and fractures rather than OA impairments, environmental factors, activity limitations and participation restrictions in people with OA or at high risk of developing OA. This highlights the importance of questioning patients about their previous falls and past medical history, and using this information to focus our assessment and clinical decision-making processes.

Evaluation of RESPOND, a patient-centred program to prevent falls in older people presenting to the emergency department with a fall: A randomised controlled trial.

BACKGROUND: Falls are a leading reason for older people presenting to the emergency department (ED), and many experience further falls. Little evidence exists to guide secondary prevention in this population. This randomised controlled trial (RCT) investigated whether a 6-month telephone-based patient-centred program-RESPOND-had an effect on falls and fall injuries in older people presenting to the ED after a fall. METHODS AND FINDINGS: Community-dwelling people aged 60-90 years presenting to the ED with a fall and planned for discharge home within 72 hours were recruited from two EDs in Australia. Participants were enrolled if they could walk without hands-on assistance, use a telephone, and were free of cognitive impairment (Mini-Mental State Examination > 23). Recruitment occurred between 1 April 2014 and 29 June 2015. Participants were randomised to receive either RESPOND (intervention) or usual care (control). RESPOND comprised (1) home-based risk assessment; (2) 6 months telephone-based education, coaching, goal setting, and support for evidence-based risk factor management; and (3) linkages to existing services. Primary outcomes were falls and fall injuries in the 12-month follow-up. Secondary outcomes included ED presentations, hospital admissions, fractures, death, falls risk, falls efficacy, and quality of life. Assessors blind to group allocation collected outcome data via postal calendars, telephone follow-up, and hospital records. There were 430 people in the primary outcome analysis-217 randomised to RESPOND and 213 to control. The mean age of participants was 73 years; 55% were female. Falls per person-year were 1.15 in the RESPOND group and 1.83 in the control (incidence rate ratio [IRR] 0.65 [95% CI 0.43-0.99]; P = 0.042). There was no significant difference in fall injuries (IRR 0.81 [0.51-1.29]; P = 0.374). The rate of fractures was significantly lower in the RESPOND group compared with the control (0.05 versus 0.12; IRR 0.37 [95% CI 0.15-0.91]; P = 0.03), but there were no significant differences in other secondary outcomes between groups: ED presentations, hospitalisations or falls risk, falls efficacy, and quality of life. There were two deaths in the RESPOND group and one in the control group. No adverse events or unintended harm were reported. Limitations of this study were the high number of dropouts (n = 93); possible underreporting of falls, fall injuries, and hospitalisations across both groups; and the relatively small number of fracture events. CONCLUSIONS: In this study, providing a telephone-based, patient-centred falls prevention program reduced falls but not fall injuries, in older people presenting to the ED with a fall. Among secondary outcomes, only fractures reduced. Adopting patient-centred strategies into routine clinical practice for falls prevention could offer an opportunity to improve outcomes and reduce falls in patients attending the ED. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN12614000336684).

Multifactorial falls prevention programmes for older adults presenting to the emergency department with a fall: systematic review and meta-analysis.

OBJECTIVE: To determine whether multifactorial falls prevention interventions are effective in preventing falls, fall injuries, emergency department (ED) re-presentations and hospital admissions in older adults presenting to the ED with a fall. DESIGN: Systematic review and meta-analyses of randomised controlled trials (RCTs). DATA SOURCES: Four health-related electronic databases (Ovid MEDLINE, CINAHL, EMBASE, PEDro and The Cochrane Central Register of Controlled Trials) were searched (inception to June 2018). STUDY SELECTION: RCTs of multifactorial falls prevention interventions targeting community-dwelling older adults ( ≥ 60 years) presenting to the ED with a fall with quantitative data on at least one review outcome. DATA EXTRACTION: Two independent reviewers determined inclusion, assessed study quality and undertook data extraction, discrepancies resolved by a third. DATA SYNTHESIS: 12 studies involving 3986 participants, from six countries, were eligible for inclusion. Studies were of variable methodological quality. Multifactorial interventions were heterogeneous, though the majority included education, referral to healthcare services, home modifications, exercise and medication changes. Meta-analyses demonstrated no reduction in falls (rate ratio = 0.78; 95% CI: 0.58 to 1.05), number of fallers (risk ratio = 1.02; 95% CI: 0.88 to 1.18), rate of fractured neck of femur (risk ratio = 0.82; 95% CI: 0.53 to 1.25), fall-related ED presentations (rate ratio = 0.99; 95% CI: 0.84 to 1.16) or hospitalisations (rate ratio = 1.14; 95% CI: 0.69 to 1.89) with multifactorial falls prevention programmes. CONCLUSIONS: There is insufficient evidence to support the use of multifactorial interventions to prevent falls or hospital utilisation in older people presenting to ED following a fall. Further research targeting this population group is required.

A mixed methods process evaluation of a person-centred falls prevention program.

BACKGROUND: RESPOND is a telephone-based falls prevention program for older people who present to a hospital emergency department (ED) with a fall. A randomised controlled trial (RCT) found RESPOND to be effective at reducing the rate of falls and fractures, compared with usual care, but not fall injuries or hospitalisations. This process evaluation aimed to determine whether RESPOND was implemented as planned, and identify implementation barriers and facilitators. METHODS: A mixed-methods evaluation was conducted alongside the RCT. Evaluation participants were the RESPOND intervention group (n = 263) and the clinicians delivering RESPOND (n = 7). Evaluation data were collected from participant recruitment and intervention records, hospital administrative records, audio-recordings of intervention sessions, and participant questionnaires. The Rochester Participatory Decision-Making Scale (RPAD) was used to evaluate person-centredness (score range 0 (worst) - 9 (best)). Process factors were compared with pre-specified criteria to determine implementation fidelity. Six focus groups were held with participants (n = 41), and interviews were conducted with RESPOND clinicians (n = 6). Quantitative data were analysed descriptively and qualitative data thematically. Barriers and facilitators to implementation were mapped to the 'Capability, Opportunity, Motivation - Behaviour' (COM-B) behaviour change framework. RESULTS: RESPOND was implemented at a lower dose than the planned 10 h over 6 months, with a median (IQR) of 2.9 h (2.1, 4). The majority (76%) of participants received their first intervention session within 1 month of hospital discharge with a median (IQR) of 18 (12, 30) days. Clinicians delivered the program in a person-centred manner with a median (IQR) RPAD score of 7 (6.5, 7.5) and 87% of questionnaire respondents were satisfied with the program. The reports from participants and clinicians suggested that implementation was facilitated by the use of positive and personally relevant health messages. Complex health and social issues were the main barriers to implementation. CONCLUSIONS: RESPOND was person-centred and reduced falls and fractures at a substantially lower dose, using fewer resources, than anticipated. However, the low dose delivered may account for the lack of effect on falls injuries and hospitalisations. The results from this evaluation provide detailed information to guide future implementation of RESPOND or similar programs. TRIAL REGISTRATION: This study was registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12614000336684 (27 March 2014).

Patient-Centered Care in Primary Care Scale: Pilot Development and Psychometric Assessment.

BACKGROUND: Nurse contributions to patient-centered care in primary care clinics are all but ignored in standard patient experience surveys. PURPOSE: The purpose was to conduct a pilot study to develop and psychometrically assess a scale measuring nurses' and other providers' patient-centered care in Veteran Affairs primary care clinics. METHOD: We developed a patient experience survey composed of original items and previous studies' items and scales. The survey was field tested online with patients who had a recent clinic appointment. The nonrandom analytic sample comprised 221 patients. RESULTS: Exploratory factor analyses yielded a 36-item, 4-factor solution explaining 76% of the variance. The factors were: (1) Provider Knowing the Person/Individualizing Care (18 items; α = 0.98); (2) Nurse Knowing the Person (8; 0.95); (3) Nurse Individualizing Care (7; 0.94); and (4) Continuity of Care (3; not calculated). A short form with 23 items was created using stepwise regression. It had the same 4 factors as the long form with 76% of the variance explained. CONCLUSIONS: Patients reported distinctive nurse contributions that have not been routinely measured.

Interventions to Reduce the Incidence of Hospital-Onset Clostridium difficile Infection: An Agent-Based Modeling Approach to Evaluate Clinical Effectiveness in Adult Acute Care Hospitals.

Background: Despite intensified efforts to reduce hospital-onset Clostridium difficile infection (HO-CDI), its clinical and economic impacts continue to worsen. Many institutions have adopted bundled interventions that vary considerably in composition, strength of evidence, and effectiveness. Considerable gaps remain in our knowledge of intervention effectiveness and disease transmission, which hinders HO-CDI prevention. Methods: We developed an agent-based model of C. difficile transmission in a 200-bed adult hospital using studies from the literature, supplemented with primary data collection. The model includes an environmental component and 4 distinct agent types: patients, visitors, nurses, and physicians. We used the model to evaluate the comparative clinical effectiveness of 9 single interventions and 8 multiple-intervention bundles at reducing HO-CDI and asymptomatic C. difficile colonization. Results: Daily cleaning with sporicidal disinfectant and C. difficile screening at admission were the most effective single-intervention strategies, reducing HO-CDI by 68.9% and 35.7%, respectively (both P < .001). Combining these interventions into a 2-intervention bundle reduced HO-CDI by 82.3% and asymptomatic hospital-onset colonization by 90.6% (both, P < .001). Adding patient hand hygiene to healthcare worker hand hygiene reduced HO-CDI rates an additional 7.9%. Visitor hand hygiene and contact precaution interventions did not reduce HO-CDI, compared with baseline. Excluding those strategies, healthcare worker contact precautions were the least effective intervention at reducing hospital-onset colonization and infection. Conclusions: Identifying and managing the vast hospital reservoir of asymptomatic C. difficile by screening and daily cleaning with sporicidal disinfectant are high-yield strategies. These findings provide much-needed data regarding which interventions to prioritize for optimal C. difficile control.

Effect of Lactobacillus rhamnosus HN001 on carriage of Staphylococcus aureus: results of the impact of probiotics for reducing infections in veterans (IMPROVE) study.

BACKGROUND: Infection by Staphylococcus aureus (S. aureus) is a major cause of morbidity and mortality. Colonization by S. aureus increases the risk of infection. Little is known about decolonization strategies for S. aureus beyond antibiotics, however probiotics represent a promising alternative. A randomized controlled trial was conducted to determine the efficacy of Lactobacillus rhamnosus (L. rhamnosus) HN001 in reducing carriage of S. aureus at multiple body sites. METHODS: One hundred thirteen subjects, positive for S. aureus carriage, were recruited from the William S. Middleton Memorial Medical Center, Madison, WI, USA, and randomized by initial site of colonization, either gastrointestinal (GI) or extra-GI, to 4-weeks of oral L. rhamnosus HN001 probiotic, or placebo. Nasal, oropharyngeal, and axillary/groin swabs were obtained, and serial blood and fecal samples were collected. Differences in prevalence of S. aureus carriage at the end of the 4-weeks of treatment were assessed. RESULTS: The probiotic and placebo groups were similar in age, gender, and health history at baseline. S. aureus colonization within the stool samples of the extra-GI group was 15% lower in the probiotic than placebo group at the endpoint of the trial. Those in the probiotic group compared to the placebo group had 73% reduced odds (OR 0.27, 95% CI 0.07-0.98) of methicillin-susceptible S. aureus presence, and 83% reduced odds (OR 0.17, 95% CI 0.04-0.73) of any S. aureus presence in the stool sample at endpoint. CONCLUSION: Use of daily oral L. rhamnosus HN001 reduced odds of carriage of S. aureus in the GI tract, however it did not eradicate S. aureus from other body sites. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01321606 . Registered March 21, 2011.

Predictors of inpatient rehabilitation after total knee replacement: an analysis of private hospital claims data.

OBJECTIVE: To investigate inpatient rehabilitation rates after private total knee replacements (TKRs) in Australia since 2009; to quantify the contributions of hospital-, surgeon- and patient-related factors to predicting inpatient rehabilitation. DESIGN: Retrospective cohort study; multivariate linear regression analysis of linked, de-identified Medibank administrative claims data and hospital casemix protocol data, adjusted for patient-related characteristics. Setting, participants: 35 389 patients undergoing Medibank-funded TKRs in 170 private hospitals in Australia, 2009-2016. MAIN OUTCOME MEASURES: Hospital inpatient rehabilitation rate; relative contributions of patient- and provider-related characteristics to variation in inpatient rehabilitation rates. RESULTS: The overall inpatient rehabilitation rate increased from 31% in 2009 to 45% in 2016, but varied between hospitals (range, 0-100%). The reduction in mean acute length of stay during this period explained about 15% of this increase, and about 30% was explained by patient-related factors; more than half of the increase was explained by neither reduced length of stay or patient-related factors. Patient-related characteristics explained little of the variation in rates between hospitals. Rates at 27% of hospitals lay above the 95% confidence limit for the mean inpatient rehabilitation rate in private hospitals (38%), both before and after adjusting for patient-related factors. Provider characteristics explained three times as much of the variation as patient characteristics (75% v 25%); hospital-related factors made the largest contribution to variation (47%). CONCLUSION: Inpatient rehabilitation after TKR has increased in private health care during the past 8 years. Substantial variation in inpatient rehabilitation rates is not explained by patient-related factors, suggesting that some inpatient rehabilitation is low value care.

Do patients have a say? A narrative review of the development of patient-reported outcome measures used in elective procedures for coronary revascularisation.

PURPOSE: Patient-reported outcome measures (PROMs) capture health information from the patient's perspective that can be used when weighing up benefits, risks and costs of treatment. This is important for elective procedures such as those for coronary revascularisation. Patients should be involved in the development of PROMs to accurately capture outcomes that are important for the patient. The aims of this review are to identify if patients were involved in the development of cardiovascular-specific PROMs used for assessing outcomes from elective coronary revascularisation, and to explore what methods were used to capture patient perspectives. METHODS: PROMs for evaluating outcomes from elective coronary revascularisation were identified from a previous review and an updated systematic search. The studies describing the development of the PROMs were reviewed for information on patient input in their conceptual and/or item development. RESULTS: 24 PROMs were identified from a previous review and three additional PROMs were identified from the updated search. Full texts were obtained for 26 of the 27 PROMs. The 26 studies (11 multidimensional, 15 unidimensional) were reviewed. Only nine studies reported developing PROMs using patient input. For eight PROMs, the inclusion of patient input could not be judged due to insufficient information in the full text. CONCLUSIONS: Only nine of the 26 reviewed PROMs used in elective coronary revascularisation reported involving patients in their conceptual and/or item development, while patient input was unclear for eight PROMs. These findings suggest that the patient's perspective is often overlooked or poorly described in the development of PROMs.

Exploring patient-reported outcomes following percutaneous coronary intervention: A qualitative study.

BACKGROUND: Percutaneous coronary intervention (PCI) is a common cardiac procedure used to treat obstructive coronary artery disease. Patient-centred care is a priority in cardiovascular health having been shown to increase patient satisfaction, engagement with rehabilitation activities and reduce anxiety. Evidence indicates that patient-centred care is best achieved by routine collection of patient-reported outcomes (PROs). However, existing patient-reported outcome measures (PROMs) have limited the patient involvement in their development. AIMS: To identify and explore outcomes, patients perceive as important following PCI. METHODS: A qualitative design was adopted. Eight focus groups and five semi-structured interviews were conducted with 32 patients who had undergone PCI in the previous 6 months. Outcomes were identified and mapped under the U.S. Food and Drug Administration (FDA) patient-reported outcome (PROs) domains of feeling (physical and psychological outcomes), function and evaluation. Inductive and deductive analysis methods were used with open, axial and thematic coding. RESULTS: Consistent with prior studies, patients identified feeling and function outcomes such as reductions in physical and psychological symptoms and the ability to perform usual activities as important. Participants also identified a range of new outcomes, including confidence to return to usual activities and evaluation domains such as adverse effects of medications and the importance of patient communication. CONCLUSION: The findings of this research should be considered in the design of a cardiac PROM for PCI patients. A PROM which adequately assesses these outcomes can provide clinicians and hospital staff with a foundation in which to address these concerns or symptoms.

How can healthcare organizations implement patient-centered care? Examining a large-scale cultural transformation.

BACKGROUND: Healthcare organizations increasingly are focused on providing care which is patient-centered rather than disease-focused. Yet little is known about how best to transform the culture of care in these organizations. We sought to understand key organizational factors for implementing patient-centered care cultural transformation through an examination of efforts in the US Department of Veterans Affairs. METHODS: We conducted multi-day site visits at four US Department of Veterans Affairs medical centers designated as leaders in providing patient-centered care. We conducted qualitative semi-structured interviews with 108 employees (22 senior leaders, 42 middle managers, 37 front-line providers and 7 staff). Transcripts of audio recordings were analyzed using a priori codes based on the Consolidated Framework for Implementation Research. We used constant comparison analysis to synthesize codes into meaningful domains. RESULTS: Sites described actions taken to foster patient-centered care in seven domains: 1) leadership; 2) patient and family engagement; 3) staff engagement; 4) focus on innovations; 5) alignment of staff roles and priorities; 6) organizational structures and processes; 7) environment of care. Within each domain, we identified multi-faceted strategies for implementing change. These included efforts by all levels of organizational leaders who modeled patient-centered care in their interactions and fostered willingness to try novel approaches to care amongst staff. Alignment and integration of patient centered care within the organization, particularly surrounding roles, priorities and bureaucratic rules, remained major challenges. CONCLUSIONS: Transforming healthcare systems to focus on patient-centered care and better serve the "whole" patient is a complex endeavor. Efforts to transform healthcare culture require robust, multi-pronged efforts at all levels of the organization; leadership is only the beginning. Challenges remain for incorporating patient-centered approaches in the context of competing priorities and regulations. Through actions within each of the domains, organizations may begin to truly transform to patient-driven care.