Project EPIC (Empowering People to Independence in COPD): Study protocol for a hybrid effectiveness-implementation pilot randomized controlled trial of telephonic, geriatrics-palliative care nurse-coaching in older adults with COPD and their family caregivers.

BACKGROUND: EPIC (Empowering People to Independence in COPD) is a geriatric-palliative care telephonic, nurse coach intervention informed by Baltes' Theory of Successful Aging and adapted from the ENABLE (Educate, Nurture, Advise, Before Life Ends) intervention. EPIC, focused on improving independence, mobility, well-being, and COPD symptoms, has undergone formative and summative evaluation for adults with COPD. METHODS: The primary study aim is to assess the refined EPIC intervention's feasibility and acceptability via a pilot hybrid effectiveness-implementation randomized control trial in community-dwelling older adults with moderate to severe COPD and their family caregivers. The secondary aim is to explore the impact of EPIC on patient and caregiver outcomes. Older adults with COPD and their family caregivers (target N = 60 dyads) will be randomized to EPIC (intervention) or usual COPD care (control). EPIC includes six patient and four family caregiver weekly, telephone-based nurse coach sessions using a manualized curriculum (Charting Your Course), plus three monthly follow-up calls. Feasibility will be measured as completion of EPIC intervention and trial components (e.g., recruitment, retention, data collection). Acceptability will be evaluated using satisfaction surveys and post-study feedback interviews. A blinded data collector will assess exploratory outcomes (e.g., Life-Space mobility, quality of life, caregiver burden, emotional symptoms, loneliness, cognitive impairment, functional status, healthcare utilization) at baseline, 12, and 24 weeks. DISCUSSION: This intervention fills a gap in addressing the geriatrics and palliative care needs and equity for adults with COPD and their family caregivers. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05040386.

Immunoreactive Trypsinogen in Infants Born to Women with Cystic Fibrosis Taking Elexacaftor-Tezacaftor-Ivacaftor.

Most people with cystic fibrosis (CF) are diagnosed following abnormal newborn screening (NBS), which begins with measurement of immunoreactive trypsinogen (IRT) values. A case report found low concentrations of IRT in an infant with CF exposed to the CF transmembrane conductance regulator (CFTR) modulator, elexacaftor-tezacaftor-ivacaftor (ETI), in utero. However, IRT values in infants born to mothers taking ETI have not been systematically assessed. We hypothesized that ETI-exposed infants have lower IRT values than newborns with CF, CFTR-related metabolic syndrome/CF screen positive, inconclusive diagnosis (CRMS/CFSPID), or CF carriers. IRT values were collected from infants born in Indiana between 1 January 2020, and 2 June 2022, with ≥1 CFTR mutation. IRT values were compared to infants born to mothers with CF taking ETI followed at our institution. Compared to infants identified with CF (n = 51), CRMS/CFSPID (n = 21), and CF carriers (n = 489), ETI-exposed infants (n = 19) had lower IRT values (p < 0.001). Infants with normal NBS results for CF had similar median (interquartile range) IRT values, 22.5 (16.8, 30.6) ng/mL, as ETI-exposed infants, 18.9 (15.2, 26.5). IRT values from ETI-exposed infants were lower than for infants with abnormal NBS for CF. We recommend that NBS programs consider performing CFTR variant analysis for all ETI-exposed infants.

Comparison of Postoperative Outcomes of Laparoscopic vs Open Inguinal Hernia Repair.

Importance: Advocates of laparoscopic surgery argue that all inguinal hernias, including initial and unilateral ones, should be repaired laparoscopically. Prior work suggests outcomes of open repair are improved by using local rather than general anesthesia, but no prior studies have compared laparoscopic surgery with open repair under local anesthesia. Objective: To evaluate postoperative outcomes of open inguinal hernia repair under general or local anesthesia compared with laparoscopic repair. Design, Setting, and Participants: This retrospective cohort study identified 107 073 patients in the Veterans Affairs Surgical Quality Improvement Program database who underwent unilateral initial inguinal hernia repair from 1998 to 2019. Data were analyzed from October 2021 to March 2022. Exposures: Patients were divided into 3 groups for comparison: (1) open repair with local anesthesia (n = 22 333), (2) open repair with general anesthesia (n = 75 104), and (3) laparoscopic repair with general anesthesia (n = 9636). Main Outcomes and Measures: Operative time and postoperative morbidity were compared using quantile regression and inverse probability propensity weighting. A 2-stage least-squares regression and probabilistic sensitivity analysis was used to quantify and address bias from unmeasured confounding in this observational study. Results: Of 107 073 included patients, 106 529 (99.5%) were men, and the median (IQR) age was 63 (55-71) years. Compared with open repair with general anesthesia, laparoscopic repair was associated with a nonsignificant 0.15% (95% CI, -0.39 to 0.09; P = .22) reduction in postoperative complications. There was no significant difference in complications between laparoscopic surgery and open repair with local anesthesia (-0.05%; 95% CI, -0.34 to 0.28; P = .70). Operative time was similar for the laparoscopic and open general anesthesia groups (4.31 minutes; 95% CI, 0.45-8.57; P = .048), but operative times were significantly longer for laparoscopic compared with open repair under local anesthesia (10.42 minutes; 95% CI, 5.80-15.05; P < .001). Sensitivity analysis and 2-stage least-squares regression demonstrated that these findings were robust to bias from unmeasured confounding. Conclusions and Relevance: In this study, laparoscopic and open repair with local anesthesia were reasonable options for patients with initial unilateral inguinal hernias, and the decision should be made considering both patient and surgeon factors.

A survey assessing the impact of COVID-19 and elexacaftor/tezacaftor/ifavacaftor on both physical and mental health in adults with cystic fibrosis.

In this letter to the editor, we report 82 persons with CF (PwCF) self-reported changes in mental and physical health and potential attribution with either the COVID-19 pandemic and the initiation elexacaftor/tezacaftor/ivacaftor (ETI). Emerging evidence has shown an association with ETI and mental health adverse events. The close proximity of ETI FDA approval and prescribing in PwCF and the COVID-19 pandemic present a challenge in determining the cause of mental health decline. We report 33 (40%) of respondents felt that COVID-19 contributed to a worsening of either their anxiety, depression, or both and 7 (9%) of respondents felt that ETI contributed to a worsening in their anxiety, depression, or both. Eighteen (23%) of respondents felt that ETI had contributed to improvement their mental health. This letter highlights multiple factors that could be impacting mental health beyond ETI. As the COVID-19 pandemic is moving toward an endemic phase, future studies may have more success in deciphering ETI effects on mental health.

Project EPIC (Early Palliative Care In COPD): A Formative and Summative Evaluation of the EPIC Telehealth Intervention.

CONTEXT: Early, concurrent palliative care interventions in chronic obstructive pulmonary disease (COPD) are limited. Project EPIC (Early Palliative Care In COPD) is a multiphase mixed methods study working to fill this gap. OBJECTIVES: To conduct a formative and summative evaluation of EPIC, a telephonic nurse coach-led early palliative care intervention for COPD adapted from the ENABLE© intervention in cancer. METHODS: Phase I Formative Evaluation: Patients with moderate-to-very-severe COPD, family caregivers, and pulmonary and palliative care clinicians rated the acceptability and feasibility of EPIC (≥4 out of five on a Likert-scale survey). Phase II Summative Evaluation: Patients and family caregivers in Phase I participated in a pilot of the three month EPIC prototype to evaluate intervention and data collection feasibility (≥70% completion) and to seek qualitative feedback. RESULTS: Phase I Formative Evaluation: Patients (n=10), family caregivers (n=10), pulmonary clinicians (n=6), and palliative care clinicians (n=6) found EPIC acceptable and feasible to support adaptation, while priority early palliative care needs in COPD from our prior research mapped well to the EPIC prototype. Phase II Summative Evaluation: Patients (n=5; ages 49-72, 40% moderate COPD, 40% Black) and their family caregivers (n=5; ages 51-73, 40% Black) completed 100% of EPIC prototype components, including weekly telephone sessions, a one month follow-up call, Advance Directive, palliative care clinic attendance, and 95% of monthly phone data collection sessions. Feedback from participants about EPIC was all positive. CONCLUSION: EPIC was acceptable and feasible in patients with COPD and their family caregivers. Larger feasibility and effectiveness trials are warranted.

An Implementation Assessment of the Virtual Acute Care for Elders Program From the Perspective of Key Stakeholders.

OBJECTIVE: The aim of this study was to obtain feedback from key stakeholders and end users to identify program strengths and weaknesses to plan for wider dissemination and implementation of the Virtual Acute Care for Elders (Virtual ACE) program, a novel intervention that improves outcomes for older surgical patients. BACKGROUND: Virtual ACE was developed to deliver evidence-based geriatric care without requiring daily presence of a geriatrician. Previous work demonstrated that Virtual ACE increased mobility and decreased delirium rates for surgical patients. METHODS: We conducted semi-structured interviews with 30 key stakeholders (physicians, nurses, hospital leadership, nurse managers, information technology staff, and physical/occupational therapists) involved in the implementation and use of the program. RESULTS: Our stakeholders indicated that Virtual ACE was extremely empowering for bedside nurses. The program helped nurses identify older patients who were at risk for a difficult postoperative recovery. Virtual ACE also gave them skills to manage complex older patients and more effectively communicate their needs to surgeons and other providers. Nurse managers felt that Virtual ACE helped them allocate limited resources and plan their unit staffing assignments to better manage the needs of older patients. The main criticism was that the Virtual ACE Tracker that displayed patient status was difficult to interpret and could be improved by a better design interface. Stakeholders also felt that program training needed to be improved to accommodate staff turnover. CONCLUSIONS: Although respondents identified areas for improvement, our stakeholders felt that Virtual ACE empowered them and provided effective tools to improve outcomes for older surgical patients.

Pre-treatment neutrophil to lymphocyte ratio as a biomarker of frailty and predictor of survival among older adults with multiple myeloma.

INTRODUCTION: Neutrophil to Lymphocyte Ratio (NLR) combines a marker of inflammation and reduced cell turnover to reflect age related alterations in the immune system. Whether NLR can serve as a biomarker of frailty and predict survival among older adults with Multiple Myeloma (MM) is unknown. MATERIALS AND METHODS: We used an electronic health record-derived database to identify older adults (age ≥ 60y) with incident MM diagnosed between 1/2011 and 2/2020, with known pre-treatment absolute neutrophil and lymphocyte count up to 90 days before the start of therapy. The calculated NLR values were stratified into quartiles (Q1-Q4). We constructed a previously validated, simplified frailty index combining age, comorbidity and ECOG performance status. We measured the association between NLR quartiles and this frailty index using a logistic regression, adjusted for age, sex and race/ethnicity. We used Kaplan Meier methods and multivariable Cox regression to assess the impact of NLR on overall survival adjusting for potential confounders. RESULTS: We identified 1729 older adults with newly diagnosed MM, at a median age of 73y (IQR: 67-78y). The median NLR was 2.13 (IQR: 1.44 to 3.31). Of the 1135 evaluable patients, 55% met criteria for frailty. Multivariable analysis revealed a 2.1-fold higher odds of frailty (95%CI = 1.42-3.10, p < 0.001) for patients in the NLR Q4 group vs. NLR Q1 group. In a multivariable analysis, adjusting for age, sex, race/ethnicity, M-protein type, stage, high risk cytogenetics, baseline creatinine, LDH and type of first line therapy, patients in NLR Q4 group had a 1.51 times increased hazards of death (95%CI = 1.15-1.98, p 0.002) when compared to those in NLR Q1 group. CONCLUSION: NLR, a readily available laboratory biomarker, is associated with frailty measured using a simplified frailty index as well as inferior overall survival among older adults with MM. Future studies should explore its value as a screening tool to identify frail older adults with MM.

Opportunity for pharmacogenomic testing in patients with cystic fibrosis.

BACKGROUND: Patients with cystic fibrosis (CF) are exposed to many drugs in their lifetime and many of these drugs have Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines that are available to guide dosing. Contemporary CF treatments are targeted to specific mutations in the CF transmembrane conductance regulator (CFTR) gene, and thus, require patients to have genetic testing before initiation of modulator therapy. However, aside from CFTR genetic testing, pharmacogenomic testing is not standard of care for CF patients. AIM: The aim of this study is to determine the number of non-CFTR modulator medications with CPIC guidelines that are prescribed to patients with CF. MATERIALS & METHODS: We identified all patients with a diagnosis of CF and queried our hospital electronic medical records (EMR) for all orders, including inpatient and prescriptions, for all drugs or drug classes that have CPIC actionable guidelines for drug-gene pairs that can be used to guide therapy. RESULTS: We identified 576 patients with a diagnosis of CF that were treated at our institution during this 16-year period between June 2005 and May 2021. Of these patients, 504 patients (87.5%) received at least one drug that could have been dosed according to CPIC guidelines if pharmacogenomic results would have been available. CONCLUSIONS: Patients with CF have high utilization of drugs with CPIC guidelines, therefore preemptive pharmacogenomic testing should be considered in CF patients at the time of CFTR genetic testing.

Racial and Ethnic Disparities in Access to Local Anesthesia for Inguinal Hernia Repair.

BACKGROUND: Many studies have identified racial disparities in healthcare, but few have described disparities in the use of anesthesia modalities. We examined racial disparities in the use of local versus general anesthesia for inguinal hernia repair. We hypothesized that African American and Hispanic patients would be less likely than Caucasians to receive local anesthesia for inguinal hernia repair. MATERIALS AND METHODS: We included 78,766 patients aged ≥ 18 years in the Veterans Affairs Surgical Quality Improvement Program database who underwent elective, unilateral, open inguinal hernia repair under general or local anesthesia from 1998-2018. We used multiple logistic regression to compare use of local versus general anesthesia and 30-day postoperative complications by race/ethnicity. RESULTS: In total, 17,892 (23%) patients received local anesthesia. Caucasian patients more frequently received local anesthesia (15,009; 24%), compared to African Americans (2353; 17%) and Hispanics (530; 19%), P < 0.05. After adjusting for covariates, we found that African Americans (OR 0.82, 95% CI 0.77-0.86) and Hispanics (OR 0.77, 95% CI 0.69-0.87) were significantly less likely to have hernia surgery under local anesthesia compared to Caucasians. Additionally, local anesthesia was associated with fewer postoperative complications for African American patients (OR 0.46, 95% CI 0.27-0.77). CONCLUSIONS: Although local anesthesia was associated with enhanced recovery for African American patients, they were less likely to have inguinal hernias repaired under local than Caucasians. Addressing this disparity requires a better understanding of how surgeons, anesthesiologists, and patient-related factors may affect the choice of anesthesia modality for hernia repair.

Local Anesthesia is Associated with Fewer Complications in Umbilical Hernia Repair in Frail Veterans.

BACKGROUND: The optimal anesthesia modality for umbilical hernia repair is unclear. We hypothesized that using local rather than general anesthesia would be associated with improved outcomes, especially for frail patients. METHODS: We utilized the 1998-2018 Veterans Affairs Surgical Quality Improvement Program to identify patients who underwent elective, open umbilical hernia repair under general or local anesthesia. We used the Risk Analysis Index to measure frailty. Outcomes included complications and operative time. RESULTS: There were 4958 Veterans (13%) whose hernias were repaired under local anesthesia. Compared to general anesthesia, local was associated with a 12%-24% faster operative time for all patients, and an 86% lower (OR 0.14, 95%CI 0.03-0.72) complication rate for frail patients. CONCLUSIONS: Local anesthesia may reduce the operative time for all patients and complications for frail patients having umbilical hernia repair.

Long-term safety and efficacy of tezacaftor-ivacaftor in individuals with cystic fibrosis aged 12 years or older who are homozygous or heterozygous for Phe508del CFTR (EXTEND): an open-label extension study.

BACKGROUND: Tezacaftor-ivacaftor is an approved cystic fibrosis transmembrane conductance regulator (CFTR) modulator shown to be efficacious and generally safe and well tolerated over 8-24 weeks in phase 3 clinical studies in participants aged 12 years or older with cystic fibrosis homozygous for the Phe508del CFTR mutation (F/F; study 661-106 [EVOLVE]) or heterozygous for the Phe508del CFTR mutation and a residual function mutation (F/RF; study 661-108 [EXPAND]). Longer-term (>24 weeks) safety and efficacy of tezacaftor-ivacaftor has not been assessed in clinical studies. Here, we present results of study 661-110 (EXTEND), a 96-week open-label extension study that assessed long-term safety, tolerability, and efficacy of tezacaftor-ivacaftor in participants aged 12 years or older with cystic fibrosis who were homozygous or heterozygous for the Phe508del CFTR mutation. METHODS: Study 661-110 was a 96-week, phase 3, multicentre, open-label study at 170 clinical research sites in Australia, Europe, Israel, and North America. Participants were aged 12 years or older, had cystic fibrosis, were homozygous or heterozygous for Phe508del CFTR, and completed one of six parent studies of tezacaftor-ivacaftor: studies 661-103, 661-106, 661-107, 661-108, 661-109, and 661-111. Participants received oral tezacaftor 100 mg once daily and oral ivacaftor 150 mg once every 12 h for up to 96 weeks. The primary endpoint was safety and tolerability. Secondary endpoints were changes in lung function, nutritional parameters, and respiratory symptom scores; pulmonary exacerbations; and pharmacokinetic parameters. A post-hoc analysis assessed the rate of lung function decline in F/F participants who received up to 120 weeks of tezacaftor-ivacaftor in studies 661-106 (F/F) and/or 661-110 compared with a matched cohort of CFTR modulator-untreated historical F/F controls from the Cystic Fibrosis Foundation Patient Registry. Primary safety analyses were done in all participants from all six parent studies who received at least one dose of study drug during this study. This study was registered at ClinicalTrials.gov (NCT02565914). FINDINGS: Between Aug 31, 2015, to May 31, 2019, 1044 participants were enrolled in study 661-110 from the six parent studies of whom 1042 participants received at least one dose of study drug and were included in the safety set. 995 (95%) participants had at least one TEAE; 22 (2%) had TEAEs leading to discontinuation; and 351 (34%) had serious TEAEs. No deaths occurred during the treatment-emergent period; after the treatment-emergent period, two deaths occurred, which were both deemed unrelated to study drug. F/F (106/110; n=459) and F/RF (108/110; n=226) participants beginning tezacaftor-ivacaftor in study 661-110 had improvements in efficacy endpoints consistent with parent studies; improvements in lung function and nutritional parameters and reductions in pulmonary exacerbations observed in the tezacaftor-ivacaftor groups in the parent studies were generally maintained in study 661-110 for an additional 96 weeks. Pharmacokinetic parameters were also similar to those in the parent studies. The annualised rate of lung function decline was 61·5% (95% CI 35·8 to 86·1) lower in tezacaftor-ivacaftor-treated F/F participants versus untreated matched historical controls. INTERPRETATION: Tezacaftor-ivacaftor was generally safe, well tolerated, and efficacious for up to 120 weeks, and the safety profile of tezacaftor-ivacaftor in study 661-110 was consistent with cystic fibrosis manifestations and with the safety profiles of the parent studies. The rate of lung function decline was significantly reduced in F/F participants, consistent with cystic fibrosis disease modification. Our results support the clinical benefit of long-term tezacaftor-ivacaftor treatment for people aged 12 years or older with cystic fibrosis with F/F or F/RF genotypes. FUNDING: Vertex Pharmaceuticals Incorporated.

Using local rather than general anesthesia for inguinal hernia repair may significantly reduce complications for frail Veterans.

BACKGROUND: Frailty predisposes patients to poor postoperative outcomes. We evaluated whether using local rather than general anesthesia for hernia repair could mitigate effects of frailty. METHODS: We used the Risk Analysis Index (RAI) to identify 8,038 frail patients in the 1998-2018 Veterans Affairs Surgical Quality Improvement Program database who underwent elective, open unilateral inguinal hernia repair under local or general anesthesia. Our outcome of interest was the incidence of postoperative complications. RESULTS: In total, 5,188 (65%) patients received general anesthesia and 2,850 (35%) received local. Local anesthesia was associated with a 48% reduction in complications (OR 0.52, 95%CI 0.38-0.72). Among the frailest patients (RAI≥70), predicted probability of a postoperative complication ranged from 22 to 33% with general anesthesia, compared to 13-21% with local. CONCLUSIONS: Local anesthesia was associated with a ∼50% reduction in postoperative complications in frail Veterans. Given the paucity of interventions for frail patients, there is an urgent need for a randomized trial comparing effects of anesthesia modality on postoperative complications in this vulnerable population.

Using local rather than general anesthesia for inguinal hernia repair is associated with shorter operative time and enhanced postoperative recovery.

BACKGROUND: Inguinal hernia repair is the most common general surgery procedure and can be performed under local or general anesthesia. We hypothesized that using local rather than general anesthesia would improve outcomes, especially for older adults. METHODS: This is a retrospective review of 97,437 patients in the Veterans Affairs Surgical Quality Improvement Program who had open inguinal hernia surgery under local or general anesthesia. Outcomes included 30-day postoperative complications, operative time, and recovery time. RESULTS: Our cohort included 22,333 (23%) Veterans who received local and 75,104 (77%) who received general anesthesia. Mean age was 62 years. Local anesthesia was associated with a 37% decrease in the odds of postoperative complications (95% CI 0.54-0.73), a 13% decrease in operative time (95% CI 17.5-7.5), and a 27% shorter recovery room stay (95% CI 27.5-25.5), regardless of age. CONCLUSIONS: Using local rather than general anesthesia is associated with a profound decrease in complications (equivalent to "de-aging" patients by 30 years) and could significantly reduce costs for this common procedure.

Using Local Anesthesia for Inguinal Hernia Repair Reduces Complications in Older Patients.

BACKGROUND: Inguinal hernia repair is the most common general surgery operation in the United States. Nearly 80% of inguinal hernia operations are performed under general anesthesia versus 15%-20% using local anesthesia, despite the absence of evidence for the superiority of the former. Although patients aged 65 y and older are expected to benefit from avoiding general anesthesia, this presumed benefit has not been adequately studied. We hypothesized that the benefits of local over general anesthesia for inguinal hernia repair would increase with age. MATERIALS AND METHODS: We analyzed 87,794 patients in the American College of Surgeons National Surgical Quality Improvement Project who had elective inguinal hernia repair under local or general anesthesia from 2014 to 2018, and we used propensity scores to adjust for known confounding. We compared postoperative complications, 30-day readmissions, and operative time for patients aged <55 y, 55-64 y, 65-74 y, and ≥75 y. RESULTS: Using local rather than general anesthesia was associated with a 0.6% reduction in postoperative complications in patients aged 75+ y (95% CI -0.11 to -1.13) but not in younger patients. Local anesthesia was associated with faster operative time (2.5 min - 4.7 min) in patients <75 y but not in patients aged 75+ y. Readmissions did not differ by anesthesia modality in any age group. Projected national cost savings for greater use of local anesthesia ranged from $9 million to $45 million annually. CONCLUSIONS: Surgeons should strongly consider using local anesthesia for inguinal hernia repair in older patients and in younger patients because it is associated with significantly reduced complications and substantial cost savings.

Association of peripheral artery disease with life-space mobility restriction and mortality in community-dwelling older adults.

OBJECTIVE: Symptomatic peripheral artery disease (PAD) impairs walking, but data on the impact of PAD on community mobility is limited. Life-space mobility measures the distance, frequency, and assistance needed as older adults move through geographic areas extending from their bedroom (life-space mobility score: 0) to beyond their town (life-space mobility score: 120). We evaluated the association of PAD with longitudinal life-space mobility trajectory. METHODS: Participants were part of the University of Alabama at Birmingham Study of Aging, a longitudinal study of community-dwelling older adults who were observed from 2001 to 2009. We limited our analysis to those who survived at least 6 months (N = 981). PAD was based on self-report with verification by physician report and hospital records. Our primary outcome was life-space mobility score assessed every 6 months. A multilevel change model (mixed model) was used to determine the association between PAD and life-space mobility trajectory during a median 7.9 years of follow-up. RESULTS: Participants had a mean age of 75.7 (standard deviation, 6.7) years; 50.5% were female, and 50.4% were African American. PAD prevalence was 10.1%, and 57.1% of participants with PAD died. In participants with both PAD and life-space restriction, defined as life-space mobility score <60, we observed the highest mortality (73.1%). In a multivariable adjusted mixed effects model, participants with PAD had a more rapid decline in life-space mobility by -1.1 (95% confidence interval [CI], -1.9 to -0.24) points per year compared with those without PAD. At 5-year follow-up, model-adjusted mean life-space mobility was 48.1 (95% CI, 43.5-52.7) and 52.4 (95% CI, 50.9-53.8) among those with and without PAD, respectively, corresponding to a restriction in independent life-space mobility at the level of one's neighborhood. CONCLUSIONS: Life-space mobility is a novel patient-centered measure of community mobility, and PAD is associated with significant life-space mobility decline among community-dwelling older adults. Further study is needed to mechanistically confirm these findings and to determine whether better recognition and treatment of PAD alter the trajectory of life-space mobility.

Social complexity negatively influences lung function in cystic fibrosis after transfer to adult care.

BACKGROUND: Several nongenetic factors, such as socioeconomic status, environmental exposures, and adherence have been described to have an impact on outcomes in cystic fibrosis (CF). OBJECTIVE: To determine the effect of social complexity on the % predicted forced expiratory volume (ppFEV1 ) before and after transfer to adult care among adolescents with CF. METHODS: Retrospective, single center, cohort study included all patients with CF who were transitioned into adult care between 2005 and 2015 at Indiana University. Social complexity (Bob's level of social support, [BLSS]) was collected at transfer. Linear mixed regression models assessed the relationship between ppFEV1 decline over time and BLSS with other covariates. RESULTS: The median age of the patients (N = 133) at the time of transfer was 20 years (interquartile range: 19-23). Overall, there was a decline in lung function over time in our population (ppFEV1 at 24 months pretransfer 77 ± 20%, ppFEV1 at 24 months, posttransfer 66 ± 24%; P < .001). The relationship between BLSS and ppFEV1 became more negative over time, even after adjusting for other covariates. CONCLUSION: Social complexity is strongly associated with lung function decline after transfer to adult care.

A Qualitative Study of Pulmonary and Palliative Care Clinician Perspectives on Early Palliative Care in Chronic Obstructive Pulmonary Disease.

Background: Guidelines recommend that pulmonary clinicians involve palliative care in chronic obstructive pulmonary disease (COPD); however, integration before advanced stage, that is, early palliative care, is rare. Objective: To explore and compare pulmonary and palliative care clinician perspectives on barriers, facilitators, and potential referral criteria for early palliative care in COPD. Design: Qualitative descriptive formative evaluation study. Setting/Subjects: Pulmonary and palliative care clinicians at a tertiary academic medical center. Measurements: Transcribed interviews were thematically analyzed by specialty to identify within- and across-specialty perspectives on barriers, facilitators, and referral criteria. Results: Twelve clinicians (n = 6 pulmonary, n = 6 palliative care) participated. Clinicians from both specialties agreed that early palliative care could add value to disease-focused COPD care. Perspectives on many barriers and facilitators were shared between specialties along broad educational, clinical, and operational categories. Pulmonary and palliative care clinicians shared concerns about the misconception that palliative care was synonymous to end-of-life care. Pulmonologists were particularly concerned about the potential risks of opioids and benzodiazepines in COPD. Both specialties stressed the need for clearly defined roles, consensus referral criteria, and novel delivery models. Although no single referral criterion was discussed by all, frequent hospitalizations and emotional symptoms were raised by most across disciplines. Multimorbidity and poor prognosis were discussed only by palliative care clinicians, whereas medication adherence was discussed only by pulmonary clinicians. Conclusions: Pulmonary and palliative care clinicians supported early palliative care in COPD. Continued needs include addressing pulmonologists' misconceptions of palliative care, establishing consensus referral criteria, and implementing novel early palliative care models.

A Surgeon's Guide to Treating Older Patients with Colorectal Cancer.

PURPOSE OF REVIEW: Review strategies to improve outcomes of colorectal cancer treatment in older patients. RECENT FINDINGS: Older colorectal patients face many barriers to recovery during their initial inpatient stay following surgery and after leaving the hospital. In addition to the risk of inpatient morbidity and mortality, older patients are more likely to require post-acute care services, to face nutritional deficits, and to experience complications of chemoradiation. SUMMARY: In order to improve outcomes for older patients with colorectal cancer, it is important for surgeons to recognize their unique needs and to develop plans to address them. The involvement of a multidisciplinary team with geriatric experience can guide planning for surgery, the immediate postoperative recovery, and long-term survivorship.

High-dose Cholecalciferol Supplementation in Adults with Cystic Fibrosis.

INTRODUCTION: Despite the availability of consensus guidelines for the treatment of vitamin D deficiency, prospective trials are lacking to examine alternative dosing strategies for adult patients with cystic fibrosis (CF) who do not meet therapeutic goals with standard regimens. OBJECTIVES: The primary objective of this study was to determine the efficacy of high-dose cholecalciferol supplementation in increasing serum vitamin D (25-OHD) levels in adult patients with CF. METHODS: Patients were eligible for inclusion if they were 18 years or older, had baseline 25-OHD levels lower than 30 ng/ml, and were diagnosed with CF and pancreatic insufficiency. Patients were given a single dose of cholecalciferol 300,000 or 500,000 IU based on baseline 25-OHD levels. Response was defined by 25-OHD and ionized calcium levels at 3 months. At 6 months, responders received a second dose of the same strength, and nonresponders were given a weekly supplement of cholecalciferol 50,000 IU in addition to cholecalciferol 500,000 IU. A second 25-OHD level was obtained at 9 months. RESULTS: Of the 46 patients enrolled, 32 patients (70%) completed the study. Baseline levels of 25-OHD significantly increased over time in the per protocol population at 3 and 9 months. A total of 16 patients (50%) were considered nonresponders and required weekly supplementation. CONCLUSION: A protocol using high-dose cholecalciferol or high-dose plus weekly cholecalciferol is safe and effective in treating adult patients with CF and pancreatic insufficiency.

A Formative Evaluation of Patient and Family Caregiver Perspectives on Early Palliative Care in Chronic Obstructive Pulmonary Disease across Disease Severity.

Rationale: Little direction exists on how to integrate early palliative care in chronic obstructive pulmonary disease (COPD).Objectives: We sought to identify patient and family caregiver early palliative care needs across stages of COPD severity.Methods: As part of the Medical Research Council Framework developmental phase for intervention development, we conducted a formative evaluation of patients with moderate to very severe COPD (forced expiratory volume in 1 s [FEV1]/FVC < 70% and FEV1 < 80%-predicted) and their family caregivers. Validated surveys on quality of life, anxiety and depressive symptoms, and social isolation quantified symptom severity. Semi-structured interviews were analyzed for major themes on early palliative care and needs in patients and family caregivers and across COPD severity stages.Results: Patients (n = 10) were a mean (±SD) age of 60.4 (±7.5) years, 50% African American, and 70% male, with 30% having moderate COPD, 30% severe COPD, and 40% very severe COPD. Family caregivers (n = 10) were a mean age of 58.3 (±8.7) years, 40% African American, and 10% male. Overall, 30% (n = 6) of participants had poor quality of life, 45% (n = 9) had moderate-severe anxiety symptoms, 25% (n = 5) had moderate-severe depressive symptoms, and 40% (n = 8) reported social isolation. Only 30% had heard of palliative care, and most participants had misconceptions that palliative care was end-of-life care. All participants responded positively to a standardized description of early palliative care and were receptive to its integration as early as moderate stage. Five broad themes of early palliative care needs emerged: 1) coping with COPD; 2) emotional symptoms; 3) respiratory symptoms; 4) illness understanding; and 5) prognostic awareness. Coping with COPD and emotional symptoms were commonly shared early palliative care needs. Patients with very severe COPD and their family caregivers prioritized illness understanding and prognostic awareness compared with those with moderate-severe COPD.Conclusions: Patients with moderate to very severe COPD and their family caregivers found early palliative care acceptable and felt it should be integrated before end-stage. Of the five broad themes of early palliative care needs, coping with COPD and emotional symptoms were the highest priority, followed by respiratory symptoms, illness understanding, and prognostic awareness.