Facets of physical function assessed by patient-reported outcome measures in oncology research.

PURPOSE: The U.S. Food & Drug Administration has identified physical functioning (PF) as a core patient-reported outcome (PRO) in cancer clinical trials. The purpose of this study was to identify PF PRO measures (PROMs) in adult cancer populations and classify the PROMs by content covered (facets of PF) in each measure. METHODS: As part of the Patient Reports of Physical Functioning Study (PROPS) research program, we conducted a targeted literature review to identify PROMs that could be used in clinical trials to evaluate PF from the patient perspective. Next, we convened an advisory panel to conduct a modified, reactive, Delphi study to reach consensus on which PF facets are assessed by PROMs identified in the review. The panel engaged in a "card sort" activity to classify PROM items by PF facets. Consensus was reached when 80% of panel members agreed that at least one facet was being measured by each PROM item. RESULTS: The literature review identified 13 PROMs that met inclusion criteria. Eight facets of PF were identified for classification in the Delphi study: ability, completion, difficulty, limitation, quality, frequency, bother, and satisfaction. Through two rounds, the panel documented and classified conceptual approaches for each PRO item presented. The most prevalent PF facets were ability, difficulty, and limitation. CONCLUSION: Classifying PF PROMs by PF facets will promote more consistent communication regarding the aspects of PF represented in each PROM, helping researchers prioritize measures for inclusion in cancer clinical trials.

What facets of physical function are most important to adults diagnosed with cancer?

PURPOSE: Successful patient-focused drug development involves selecting and measuring outcomes in clinical trials that are important to patients. The U.S. Food & Drug Administration's definition of clinical benefit includes how patients feel, function, or survive. Patients are considered the experts in describing how they feel and function. In cancer trials, patient-reported measures of physical function provide insight into how patients function at baseline, benefit from the interventions being studied, and the impact of treatment side effects. We conducted a qualitative study with adults diagnosed with cancer to describe facets of physical function from their perspective and to identify which facets are most important to this patient population. METHODS: Using concept elicitation and cognitive interviewing techniques, we conducted semi-structured interviews with 72 adults ≥ 22 years of age with cancer who received treatment with an anticancer drug or biologic within six months of the interview. We selected participants using purposive sampling with the aim to elicit diverse experiences regarding how they may interpret and respond to questions related to physical function. Participants were presented with patient-reported outcome (PRO) items representative of PRO measures used in cancer and general populations. RESULTS: Five facets of how physical function relates to activities were defined from the patient perspective: ability, difficulty, limitation, satisfaction, and completion. More than half of the participants indicated that ability was the most important facet of physical function. The next most important were satisfaction (18.3%), limitation (14.1%), difficulty (5.6%), and completion (2.8%). CONCLUSION: This study demonstrates that we must be more specific about the facets of physical function that we set out to assess when we use PRO measures to describe the patient experience. These results have implications for the specificity of physical function facets when measured in cancer clinical trials.

Facilitators and barriers to eliciting physical function goals before and after surgery: A qualitative study with clinicians.

OBJECTIVE: Describe clinicians' perspectives of facilitators and barriers to eliciting physical function goals from patients with multiple chronic conditions pre- and post-surgery. METHODS: Semi-structured qualitative interviews were conducted with clinicians, recruited from an academic medical center, who treat adult patients with multiple chronic conditions. Purposive sampling ensured multiple provider types were represented. Interviews were conducted in person or via web conference and were audio recorded. Findings were summarized using descriptive qualitative content analysis. RESULTS: Of the 12 participating clinicians, 92% were female and 83% specialized in geriatrics. Clinicians had a mean of 10.7 (min-max: 1-30) years of experience. Key facilitators to goal-setting conversations were sufficient time, familial support, and patient cognitive ability. Barriers included lack of time, lack of training, patient challenges in choosing realistic and specific actionable goals, emotional barriers, and cognitive challenges. CONCLUSION: Some facilitators and barriers are modifiable, including time, inclusion of family members in the clinical encounter, and clinician training to enable actionable goal setting. These results highlight areas for intervention to facilitate goal elicitation for physical function in clinical care settings. PRACTICE IMPLICATIONS: Clinicians should be aware of the barriers impacting eliciting goals. Healthcare organizations could consider providing effective goal elicitation training and tools to facilitate goal setting conversation.

Multisite Implementation of an American College of Surgeons Geriatric Surgery Quality Improvement Initiative.

BACKGROUND: The American College of Surgeons (ACS) Coalition for Quality in Geriatric Surgery (CQGS) identified standards of surgical care for the growing, vulnerable population of aging adults in the US. The aims of this study were to determine implementation feasibility for 30 selected standards, identify barriers and best practices in their implementation, and further refine these geriatric standards and verification process. STUDY DESIGN: The CQGS requested participation from hospitals involved in the ACS NSQIP Geriatric Surgery Pilot Project, previous CQGS feasibility analyses, and hospitals affiliated with a core development team member. Thirty standards were selected for implementation. After implementation, site visits were conducted, and postvisit surveys were distributed. RESULTS: Eight hospitals were chosen to participate. Program management (55%), immediate preoperative and intraoperative clinical care (62.5%), and postoperative clinical care (58%) had the highest mean percentage of "fully compliant" standards. Goals and decision-making (30%), preoperative optimization (28%), and transitions of care (12.5%) had the lowest mean percentage of fully compliant standards. Best practices and barriers to implementation were identified across 13 of the 30 standards. More than 80% of the institutions reported that participation changed the surgical care provided for older adults. CONCLUSIONS: This study represents the first national implementation assessment undertaken by the ACS for one of its quality programs. The CQGS pilot testing was able to demonstrate implementation feasibility for 30 standards, identify challenges and best practices, and further inform dissemination of the ACS Geriatric Surgery Verification Program.

Immune Phenotype and Postoperative Complications After Elective Surgery.

OBJECTIVES: To characterize and quantify accumulating immunologic alterations, pre and postoperatively in patients undergoing elective surgical procedures. BACKGROUND: Elective surgery is an anticipatable, controlled human injury. Although the human response to injury is generally stereotyped, individual variability exists. This makes surgical outcomes less predictable, even after standardized procedures, and may provoke complications in patients unable to compensate for their injury. One potential source of variation is found in immune cell maturation, with phenotypic changes dependent on an individual's unique, lifelong response to environmental antigens. METHODS: We enrolled 248 patients in a prospective trial facilitating comprehensive biospecimen and clinical data collection in patients scheduled to undergo elective surgery. Peripheral blood was collected preoperatively, and immediately on return to the postanesthesia care unit. Postoperative complications that occurred within 30 days after surgery were captured. RESULTS: As this was an elective surgical cohort, outcomes were generally favorable. With a median follow-up of 6 months, the overall survival at 30 days was 100%. However, 20.5% of the cohort experienced a postoperative complication (infection, readmission, or system dysfunction). We identified substantial heterogeneity of immune senescence and terminal differentiation phenotypes in surgical patients. More importantly, phenotypes indicating increased T-cell maturation and senescence were associated with postoperative complications and were evident preoperatively. CONCLUSIONS: The baseline immune repertoire may define an immune signature of resilience to surgical injury and help predict risk for surgical complications.

A Multidimensional Bioinformatic Platform for the Study of Human Response to Surgery.

OBJECTIVE: To design and establish a prospective biospecimen repository that integrates multi-omics assays with clinical data to study mechanisms of controlled injury and healing. BACKGROUND: Elective surgery is an opportunity to understand both the systemic and focal responses accompanying controlled and well-characterized injury to the human body. The overarching goal of this ongoing project is to define stereotypical responses to surgical injury, with the translational purpose of identifying targetable pathways involved in healing and resilience, and variations indicative of aberrant peri-operative outcomes. METHODS: Clinical data from the electronic medical record combined with large-scale biological data sets derived from blood, urine, fecal matter, and tissue samples are collected prospectively through the peri-operative period on patients undergoing 14 surgeries chosen to represent a range of injury locations and intensities. Specimens are subjected to genomic, transcriptomic, proteomic, and metabolomic assays to describe their genetic, metabolic, immunologic, and microbiome profiles, providing a multidimensional landscape of the human response to injury. RESULTS: The highly multiplexed data generated includes changes in over 28,000 mRNA transcripts, 100 plasma metabolites, 200 urine metabolites, and 400 proteins over the longitudinal course of surgery and recovery. In our initial pilot dataset, we demonstrate the feasibility of collecting high quality multi-omic data at pre- and postoperative time points and are already seeing evidence of physiologic perturbation between timepoints. CONCLUSIONS: This repository allows for longitudinal, state-of-the-art geno-mic, transcriptomic, proteomic, metabolomic, immunologic, and clinical data collection and provides a rich and stable infrastructure on which to fuel further biomedical discovery.

Geriatric Preoperative Optimization: A Review.

This review summarizes best practices for the perioperative care of older adults as recommended by the American Geriatrics Society, American Society of Anesthesiologists, and American College of Surgeons, with practical implementation strategies that can be readily implemented in busy preoperative or primary care clinics. In addition to traditional cardiopulmonary screening, older patients should undergo a comprehensive geriatric assessment. Rapid screening tools such as the Mini-Cog, Patient Health Questionnaire-2, and Frail Non-Disabled Survey and Clinical Frailty Scale, can be performed by multiple provider types and allow for quick, accurate assessments of cognition, functional status, and frailty screening. To assess polypharmacy, online resources can help providers identify and safely taper high-risk medications. Based on preoperative assessment findings, providers can recommend targeted prehabilitation, rehabilitation, medication management, care coordination, and/or delirium prevention interventions to improve postoperative outcomes for older surgical patients. Structured goals of care discussions utilizing the question-prompt list ensures that older patients have a realistic understanding of their surgery, risks, and recovery. This preoperative workup, combined with engaging with family members and interdisciplinary teams, can improve postoperative outcomes.

Identifying high-risk surgical patients: A study of older adults whose code status changed to Do-Not-Resuscitate.

BACKGROUND: There is a paucity of data on older adults (age ≥65 years) undergoing surgery who had an inpatient do-not-resuscitate (DNR) order, and the association between timing of DNR order and outcomes. METHODS: This was a retrospective analysis of 1976 older adults in the American College of Surgeons National Surgical Quality Improvement Program geriatric-specific database (2014-2018). Patients were stratified by institution of a DNR order during their surgical admission ("new-DNR" vs. "no-DNR"), and matched by age (±3 years), frailty score (range: 0-1), and procedure. The main outcome of interest was occurrence of death or hospice transition (DoH) ≤30 postoperative days; this was analyzed using bivariate and multivariable methods. RESULTS: One in 36 older adults had a new-DNR order. After matching, there were 988 new-DNR and 988 no-DNR patients. Median age and frailty score were 82 years and 0.2, respectively. Most underwent orthopedic (47.6%), general (37.6%), and vascular procedures (8.4%). Overall DoH rate ≤30 days was 44.4% for new-DNR versus 4.0% for no-DNR patients (p < 0.001). DoH rate for patients who had DNR orders placed in the preoperative, day of surgery, and postoperative setting was 16.7%, 23.3%, and 64.6%, respectively (p < 0.001). In multivariable analysis, compared to no-DNR patients, those with a new-DNR order had a 28-fold higher adjusted odds of DoH (odds ratio [OR] 28.1, 95% confidence interval: 13.0-60.1, p < 0.001); however, odds were 10-fold lower if the DNR order was placed preoperatively (OR: 5.8, p = 0.003) versus postoperatively (OR: 52.9, p < 0.001). Traditional markers of poor postoperative outcomes such as American Society of Anesthesiologists class and emergency surgery were not independently associated with DoH. CONCLUSIONS: An inpatient DNR order was associated with risk of DoH independent of traditional markers of poor surgical outcomes. Further research is needed to understand factors leading to a DNR order that may aid early recognition of high-risk older adults undergoing surgery.

Perioperative Optimization of Senior Health (POSH): A Descriptive Analysis of Cancelled Surgery.

BACKGROUND: Geriatric collaborative care models improve postoperative outcomes for older adults. However, there are limited data exploring how preoperative geriatric assessment may affect surgical cancellations. METHODS: This is a single-center retrospective cohort analysis. Patients enrolled in the Perioperative Optimization of Senior Health (POSH) program from 2011 to 2016 were included. POSH is a collaborative care model between geriatrics, surgery, and anesthesiology. Baseline demographic and medical data were collected during the POSH pre-op appointment. Patients who attended a POSH pre-op visit but did not have surgery were identified, and a chart review was performed to identify reasons for surgical cancellation. Baseline characteristics of patients who did and did not undergo surgery were compared. RESULTS: Of 449 eligible POSH referrals within the study period, 33 (7.3%) did not proceed to surgery; cancellation rates within the POSH program were lower than institutional cancellation rates for adults over age 65 who did not participate in POSH. Patients who did not have surgery were significantly older, more likely to have functional limitations, and had higher rates of several comorbidities compared with those who proceeded to surgery (P < 0.05). Reasons for surgical cancellations included a similar number of patient- and provider-driven causes. CONCLUSIONS: Many reasons for surgical cancellation were related to potentially modifiable factors, such as changes in goals of care or concerns about rehabilitation, emphasizing the importance of shared decision-making in elective surgery for older adults. These results highlight the important role geriatric collaborative care can offer to older adults with complex needs.

Roadmap for Transforming Preoperative Assessment to Preoperative Optimization.

Preoperative assessment typically equates to evaluating and accepting the presenting condition of the patient (unless extreme) and commonly occurs only a few days before the planned surgery. While this timing enables a preoperative history and examination and mitigates unexpected findings on the day of surgery that may delay throughput, it does not allow for meaningful preoperative management of modifiable medical conditions. Evidence is limited regarding how best to balance efforts to mitigate modifiable risk factors versus the timing of surgery. Furthermore, while the concept of preoperative risk modification is not novel, evidence is lacking for successful and sustained implementation of such an interdisciplinary, collaborative program. A better understanding of perioperative care coordination and, specifically, implementing a preoperative preparation process can enhance the value of surgery and surgical population health. In this article, we describe the implementation of a collaborative preoperative clinic with the primary goal of improving patient outcomes.

Delaying Elective Surgery in Geriatric Patients: An Opportunity for Preoperative Optimization.

Deciding whether to pursue elective surgery is a complex process for older adults. Comprehensive geriatric assessment (CGA) can help refine estimates of benefits and risks, at times leading to a delay of surgery to optimize surgical readiness. We describe a cohort of geriatric patients who were evaluated in anticipation of elective abdominal surgery and whose procedures were delayed for any reason. Themes behind the reasons for delay are described, and a holistic framework to guide preoperative discussion is suggested.

Randomized Trial of Medical versus Surgical Treatment for Refractory Heartburn.

BACKGROUND: Heartburn that persists despite proton-pump inhibitor (PPI) treatment is a frequent clinical problem with multiple potential causes. Treatments for PPI-refractory heartburn are of unproven efficacy and focus on controlling gastroesophageal reflux with reflux-reducing medication (e.g., baclofen) or antireflux surgery or on dampening visceral hypersensitivity with neuromodulators (e.g., desipramine). METHODS: Patients who were referred to Veterans Affairs (VA) gastroenterology clinics for PPI-refractory heartburn received 20 mg of omeprazole twice daily for 2 weeks, and those with persistent heartburn underwent endoscopy, esophageal biopsy, esophageal manometry, and multichannel intraluminal impedance-pH monitoring. If patients were found to have reflux-related heartburn, we randomly assigned them to receive surgical treatment (laparoscopic Nissen fundoplication), active medical treatment (omeprazole plus baclofen, with desipramine added depending on symptoms), or control medical treatment (omeprazole plus placebo). The primary outcome was treatment success, defined as a decrease of 50% or more in the Gastroesophageal Reflux Disease (GERD)-Health Related Quality of Life score (range, 0 to 50, with higher scores indicating worse symptoms) at 1 year. RESULTS: A total of 366 patients (mean age, 48.5 years; 280 men) were enrolled. Prerandomization procedures excluded 288 patients: 42 had relief of their heartburn during the 2-week omeprazole trial, 70 did not complete trial procedures, 54 were excluded for other reasons, 23 had non-GERD esophageal disorders, and 99 had functional heartburn (not due to GERD or other histopathologic, motility, or structural abnormality). The remaining 78 patients underwent randomization. The incidence of treatment success with surgery (18 of 27 patients, 67%) was significantly superior to that with active medical treatment (7 of 25 patients, 28%; P = 0.007) or control medical treatment (3 of 26 patients, 12%; P<0.001). The difference in the incidence of treatment success between the active medical group and the control medical group was 16 percentage points (95% confidence interval, -5 to 38; P = 0.17). CONCLUSIONS: Among patients referred to VA gastroenterology clinics for PPI-refractory heartburn, systematic workup revealed truly PPI-refractory and reflux-related heartburn in a minority of patients. For that highly selected subgroup, surgery was superior to medical treatment. (Funded by the Department of Veterans Affairs Cooperative Studies Program; ClinicalTrials.gov number, NCT01265550.).