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IntroductionAnaemia is highly prevalent in critical illness and is associated with impaired outcomes during and after hospitalisation. However, the impact of interventions designed to attenuate or treat anaemia during critical illness on post-hospitalisation haemoglobin recovery and functional outcomes is unclear.Methods and analysisThe Practical Anemia Bundle for Sustained Blood Recovery (PABST-BR) clinical trial is a pragmatic, open-label, parallel group, single-centre, randomised clinical trial assessing the impact of a multifaceted anaemia prevention and treatment strategy versus standard care for improvement of haemoglobin concentrations and functional outcomes after critical illness. The intervention, which will be delivered early in critical illness for those with moderate-to-severe anaemia (ie, haemoglobin Ethics and disseminationThe study has been approved by the Institutional Review Board of the Mayo Clinic in Minnesota, USA. A Data Safety Monitoring Plan has been created in accordance with the policies of the Institutional Review Board and the study funder, the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH). The study will comply with NIH data sharing and dissemination policies. Results will be presented at national and international meetings and published in peer-reviewed journals. Designing and testing strategies to optimise haemoglobin recovery and improve functional outcomes after critical illness remain important research gaps. The PABST-BR trial will inform the development of a larger multicentre clinical trial.Trial registration numberNCT05167734.

Although the literature provides guidance regarding patient-reported outcome (PRO) implementation barriers, patients' perspectives are underreported. This study aimed to improve the understanding of patient experiences with PRO tools through examining perceptions of and attitudes toward PROs and expectations of data use after collection.Ethnographic human-centered design approaches were used to conduct free-form interviews. Two case studies of existing PRO use in clinics also were examined. Unstructured thematic analyses were performed using notes taken during these interviews.Patients generally reported a good understanding of the need for PRO collection, both for research and clinical use. Many expected that results would be acted upon by the clinicians promptly. Thematic analyses identified the following patient perception topics: transparency, individualization to patient needs, timely response, different "identities" while accessing care locally compared with at a destination center, and preference for brief PROs.Design and implementation of PRO assessments into patient care should include the patients as key end users. Transparency of the purpose for data collection is critical for broader patient adoption. Ensuring that only necessary and sufficient data are collected for clinical action, and associated research may help minimize burden and maximize patient participation.

Purpose Breast cancer patients are at risk of losing function during and after treatment. Unfortunately, little is known about the individual and additive effects of specific treatment, disease-related, and demographic factors that may contribute to functional decline. This manuscript reports the results of a multi-center study to evaluate the effects of these factors on function. Methods In this cross-sectional study, women with a history of breast cancer referred to cancer rehabilitation clinics were administered the PROMIS Cancer Function Brief 3D Profile to evaluate function in the domains of physical function, fatigue, and social participation. Clinical and demographic information, including treatment history and disease status, was recorded by clinicians. Patients were analyzed in two groups: those with active disease on antineoplastic treatment, and those with no evidence of disease (NED). A multivariable model was constructed to detect associations between clinical and demographic factors. Results In patients with NED, the presence of chemotherapy-induced peripheral neuropathy (CIPN) was strongly associated with reduced function in all three domains. In those with active disease, having brain metastases was significantly associated with reduced function in all domains and CIPN with reduced physical function. Radiation was associated with improved function in both cohorts. Conclusions Among women seeking rehabilitative care, CIPN and the presence of brain metastases were most strongly associated with a decline in function. The effects of radiation on function were unexpected and may be partially explained by the treatment’s role in symptom management. Clinicians who treat breast cancer should consider a patient’s functional status when providing supportive care.

OBJECTIVE: To determine whether patient-reported information, routinely collected in an outpatient setting, is associated with readmission within 30 days of discharge and/or the need for post-acute care after a subsequent hospital admission. DESIGN: Retrospective cohort study. Six domains of patient-reported information collected in the outpatient setting (psychological distress, respiratory symptoms, musculoskeletal pain, family support, mobility, and activities of daily living [ADLs]) were linked to electronic health record hospitalization data. Mixed effects logistic regression models with random intercepts were used to identify the association between the 6 domains and outcomes. SETTING: Outpatient clinics and hospitals in a Midwestern health system. PARTICIPANTS: 7671 patients who were hospitalized 11,445 times between May 2004 and May 2014 (N=7671). INTERVENTION: None. MAIN OUTCOME MEASURES: 30-day hospital readmission and discharge home vs facility. RESULTS: Domains were significantly associated with 30-day readmission and placement in a facility. Specifically, mobility (odds ratio [OR]=1.30; 95% confidence interval [CI], 1.16, 1.46), ADLs (OR=1.27; 95% CI, 1.13, 1.42), respiratory symptoms (OR=1.26; 95% CI, 1.12, 1.41), and psychological distress (OR=1.20; 95% CI, 1.07, 1.35) had the strongest associations with 30-day readmission. The ADL (OR=2.52; 95% CI, 2.26, 2.81), mobility (OR=2.35; 95% CI, 2.10, 2.63), family support (OR=2.28; 95% CI, 1.98, 2.62), and psychological distress (OR=1.38; 95% CI, 1.25, 1.52) domains had the strongest associations with discharge to an institution. CONCLUSIONS: Patient-reported function, symptoms, and social support routinely collected in outpatient clinics are associated with future 30-day readmission and discharge to an institutional setting. Whether these data can be leveraged to guide interventions to address patient needs and improve outcomes requires further research.

Opioids may be necessary for guideline-concordant acute perioperative pain management, but their use carries risks for unintended prolonged use and addiction. Guidelines recommend use of validated non-pharmacological pain care (NPPC) approaches in conjunction with prescribed opioids and other analgesics. Our protocol outlines a population-level, pragmatic trial that will test a bundled intervention comprised of an electronic health record (EHR) portal-based conversation guide, EHR clinical decision support (CDS), and a suite of self-management educational and support materials to encourage and advance NPPC use.We are conducting a stepped-wedge, cluster-randomized pragmatic trial spanning seven surgical specialties across six geographically diverse locations within the Mayo Clinic Enterprise. Thirty two surgical practices across six locations (Rochester, Minnesota; Mankato, Minnesota; La Crosse, Wisconsin; Eau Claire, Wisconsin; Phoenix, Arizona; Jacksonville, Florida) comprise 22 distinct practice clusters that are randomly assigned to one of five steps using constrained randomization. Steps "go live" by initiating the intervention at 7-month intervals between March 2021 and July 2023. Patients over 18 years of age who are scheduled for qualifying procedures within "live" consenting practices are sent a Healing After Surgery guide via their patient portals pre-operatively, directing them to identify their preferred NPPC modalities among 13 approaches. These selections create CDS options for care teams to support patients with self-management materials that reinforce safe NPPC use.Patients' clinical, demographic, and outcome data will be abstracted from the Epic EHR. Primary outcomes will be the Patient Reported Outcomes Measurement Information System (PROMIS) pain interference and physical functioning computer adaptive tests (CAT) collected at 1, 2, and 3 months postoperatively via the patient portal. We will mail printed versions of the 6-item PROMIS short forms to portal non-responders to minimize bias. Secondary outcomes will include the PROMIS anxiety CAT, opioid consumption, and self-reported NPPC use.ClinicalTrials.gov identifier, NCT04570371.

Cigarette smoking prevalence is higher among rural compared with urban adults, yet access to cessation programming is reduced. The Increasing Digital Equity and Access (IDEA) study aims to evaluate three digital access and literacy interventions for promoting engagement with an online evidence-based smoking cessation treatment (EBCT) program among rural adults.The pilot trial will use a pragmatic, three-arm, randomized, parallel-group design with participants recruited from a Midwest community-based health system in Minnesota, Wisconsin, and Iowa. All participants will receive an online, 12-week, EBCT program, and written materials on digital access resources. Participants will be stratified based on state of residence and randomly assigned with 1:1:1 allocation to one of three study groups: (1) Control Condition-no additional study intervention (n = 30); (2) Loaner Digital Device-Bluetooth enabled iPad with data plan coverage loaned for the study duration (n = 30); (3) Loaner Digital Device + Coaching Support-loaner device plus up to six, 15-20 min motivational interviewing-based coaching calls to enhance participants' digital access and literacy (n = 30). All participants will complete study assessments at baseline and 4- and 12-weeks post-randomization. Outcomes are cessation program and trial engagement, biochemically confirmed smoking abstinence, and patient experience.A rural community advisory committee was formed that fostered co-design of the study protocol for relevance to rural populations, including the trial design and interventions.Study findings, processes, and resources may have relevance to other health systems aiming to foster digital inclusion in smoking cessation and chronic disease management programs and clinical trials in rural communities.

Lower extremity lymphedema (LEL) is associated with decreased physical functioning (PF) and activities of daily living (ADLs) limitations. However, the prevalence of LEL in older survivors of cancer is unknown.To examine LEL among older female survivors of colorectal, endometrial, or ovarian cancer and investigate the association of LEL with PF and ADLs.This secondary analysis of the Women's Health Initiative (WHI) Life and Longevity After Cancer (LILAC) study was conducted using data from postmenopausal women enrolled at 40 US centers. Participants were women who had a prior diagnosis of endometrial, colorectal, or ovarian cancer and who had completed the WHI LILAC baseline and year 1 follow-up questionnaires as of September 2017.The 13-item Lower Extremity Lymphedema Screening Questionnaire in Women was used to determine LEL (ie, score ≥5).Validated surveys were used to assess PF and ADLs.Among 900 older women diagnosed with endometrial, colorectal, or ovarian cancer, the mean (SD) age was 78.5 (5.9) years and the mean (range) time since cancer diagnosis was 8.75 (1.42-20.23) years. Overall, 292 women (32.4%) reported LEL, with the highest LEL prevalence among survivors of ovarian cancer (38 of 104 women [36.5%]), followed by survivors of endometrial cancer (122 of 375 women [32.5%]) and colorectal cancer (132 of 421 women [31.4%]). Compared with women without LEL, women with LEL had a PF score that was lower by a mean (SE) 16.8 (1.7) points (P .001) and higher odds of needing help with ADLs (odds ratio [OR], 2.45; 95% CI, 1.64-3.67). In the association of LEL with PF, the mean (SE) decrease in PF score was greatest among survivors of colorectal cancer (-21.8 [2.6]) compared with survivors of endometrial cancer (-13.3 [2.7]) and ovarian cancer (-12.8 [5.2]). Additionally, among survivors of colorectal cancer, LEL was associated with increased odds of needing help with ADLs (OR, 3.59; 95% CI, 1.94-6.66), while there was no such association among survivors of endometrial cancer or ovarian cancer. However, there were no interaction associations between LEL and cancer type for either outcome. Additionally, the overall mean (SE) difference in PF between women with and without LEL was greater among those aged 80 years and older (-19.4 [2.6] points) vs those aged 65 to 79 years (-14.9 [2.2] points). However, among survivors of colorectal cancer, the mean (SE) difference in PF score was greater among women aged 65 to 79 years (-22.9 [3.7] points) vs those aged 80 years or older (-20.8 [3.7] points) (P for 3-way interaction = .03).This study found that nearly one-third of older female survivors of colorectal, endometrial, or ovarian cancer experienced LEL and that LEL was associated with decreased PF and increased odds of needing help with ADLs. These findings suggest that clinicians may need to regularly assess LEL among older survivors of cancer and provide effective interventions to reduce LEL symptoms and improve PF for this population.

To examine the effect of skilled nursing facility (SNF) use on hospitalizations in patients with heart failure (HF) and to examine predictors of hospitalization in patients with HF admitted to a SNF.Olmsted County, Minnesota, residents with first-ever HF from January 1, 2000, through December 31, 2010, were identified, and clinical data were linked to SNF utilization data from the Centers for Medicare and Medicaid Services. Andersen-Gill models were used to determine the association between SNF use and hospitalizations and to determine predictors of hospitalization.Of 1498 patients with incident HF (mean ± SD age, 75±14 years; 45% male), 605 (40.4%) were admitted to a SNF after HF diagnosis (median follow-up, 3.6 years; range, 0-13.0 years). Of those with a SNF admission, 225 (37%) had 2 or more admissions. After adjustment for age, sex, ejection fraction, and comorbidities, SNF use was associated with a 50% increased risk of hospitalization compared with no SNF use (adjusted hazard ratio, 1.52; 95% CI, 1.31-1.76). In SNF users, arrhythmia, asthma, chronic kidney disease, and the number of activities of daily living requiring assistance were independently associated with an increased risk of hospitalization.Approximately 40% of patients with HF were admitted to a SNF at some point after diagnosis. Compared with SNF nonusers, SNF users were more likely to be hospitalized. Characteristics associated with hospitalization in SNF users were mostly noncardiovascular, including reduced ability to perform activities of daily living. These findings underscore the effect of physical functioning on hospitalizations in patients with HF in SNFs and the importance of strategies to improve physical functioning.

Reliance on "as-needed" analgesia following total knee arthroplasty may lead to inadequate control of pain and delayed recovery of function. Preemptive use of controlled-release opioids may improve pain control, accelerate recovery, and reduce the need for inpatient rehabilitative services. This study was designed to determine whether controlled-release opioids enhance post-arthroplasty pain control and facilitate functional recovery during rehabilitation.Fifty-nine patients admitted for inpatient rehabilitation following unilateral total knee arthroplasty were randomized to receive OxyContin (controlled-release oxycodone) (twenty-nine patients) or a placebo (thirty patients) every twelve hours. Both groups could receive on-request, immediate-release oxycodone (5 mg every four hours). The dose of study medication was increased on the basis of the frequency of requests for immediate-release oxycodone. Measures of interest included pain ratings as determined with a visual-analog scale, changes in the range of motion of the knee and quadriceps strength, and improvements in selected Functional Independence Measure scores during the first eight physical therapy sessions. The duration of the hospital stay for rehabilitation also was compared between the two groups.Baseline demographic, clinical, and functional characteristics were similar between the OxyContin and placebo groups. Compared with the placebo group, the patients who received OxyContin reported significantly less pain as well as significantly greater range of motion of the knee (passive motion, p = 0.036; active motion, p0.001) and quadriceps strength (p = 0.001) by the eighth physical therapy session. The patients who received OxyContin also were discharged from the rehabilitation hospital at an average of 2.3 days earlier than the patients in the placebo group (p = 0.013).Preemptive use of controlled-release oxycodone during rehabilitation following total knee arthroplasty leads to improved pain control, more rapid functional recovery, and a reduced need for inpatient rehabilitative services.

Cancer rehabilitation is a rapidly emerging and evolving medical field in both Europe and the United States, in large part because of increases in the number of cancer survivors. Although few argue with the need to restore function and quality of life to patients affected by cancer and its treatments, differences exist between European countries with regard to the funding, accessibility, and even the definition of cancer rehabilitation services. In the United States, there is tremendous variability in the provision of rehabilitation services resulting from a variety of factors, including a lack of highly trained cancer rehabilitation physicians and therapists as well as a lack of comprehensive cancer rehabilitation programs, even at the majority of top cancer centers. Although studies evaluating the effectiveness of rehabilitation programs in the cancer setting, particularly exercise, have influenced clinical decision-making in both Europe and the United States for some time, this emerging evidence base also is now starting to influence guideline and policy making. Coordinated research efforts are essential to establish a robust framework to support future investigation and establish shared initiatives. Determining the best way forward for cancer survivors will require investment in large-scale prospective cohort studies that sufficiently describe their rehabilitation needs through the continuum of the survivorship experience.

The objective of this study was to describe the progression of arm lymphedema (ALE) after the initial presentation among patients receiving breast conservation therapy for early stage breast cancer and to identify potential risk factors contributing to ALE progression. The study sample was the 266 stage I or II breast cancer patients with documented ALE who underwent breast conservation therapy that included lumpectomy, axillary staging followed by radiation therapy. ALE were graded according to a difference of 0.5-2 cm (mild), 2.1-3 cm (moderate), and3 cm (severe) in the circumference between the upper extremities for the treated and untreated sides. ALE at presentation was scored as mild, moderate, and severe in 109 (41%), 125 (47%), and 32 (12%) patients, respectively. One third of patients with ALE progressed to a more severe grade of lymphedema at 5 years of follow-up. Age older than 65 years at the time of breast cancer treatment was associated with higher risk of ALE progression when compared 65 year age or younger (p = 0.04). The patients who had regional lymph node irradiation including posterior axillary boost were at higher risk of lymphedema progression than the patients treated with whole breast irradiation only (p = 0.001). Progression of ALE is a common occurrence. The current study provides support for the utility of routine arm measurements after breast cancer treatment to facilitate timely diagnosis and treatment of ALE.

The purpose of this study was to determine the feasibility of an acupuncture clinical trial to prevent radiation therapy (RT)-induced fatigue. We conducted a cross-sectional survey study and a single-arm acupuncture clinical trial among patients undergoing RT. Patients with a Karnofsky score of less than 60, severe anemia, or substantial psychological diagnoses were excluded. Patients received up to 12 treatments of acupuncture over the entire course of their RT. The Lee Fatigue Scale (LFS) was administered at baseline, in the middle of RT, and at the end of RT, along with the Patient Global Impression of Change (PGIC). Among the 48 of 53 (91% response rate) survey participants, 20 (42%) reported that they would participate if the study were available, 13 (27%) would not participate, and 15 (31%) were unsure. Among the 16 trial participants, average fatigue and energy domains of the LFS remained stable during and after RT, without any expected statistical decline owing to RT. Based on the PGIC at the end of RT, 2 subjects (13%) reported their fatigue as worse, 8 (50%) as stable, and 6 (37%) as better. Acupuncture has the potential to prevent RT-related fatigue, which will need to be confirmed by conducting a randomized controlled trial.

Despite growing interest in advanced cancer patients' quality of life, little attention has been directed toward preservation or recovery of their function. Although there is a dearth of supportive literature, extensive experience with other advanced disease populations suggests that standard, widely available rehabilitation strategies can enhance function in cancer. Logistic challenges to the provision of adequate rehabilitation to advanced cancer patients is discussed in this article, based on the author's experience and discussions in the literature. Common sources of functional impairment are reviewed with elucidation of rehabilitation approaches likely to benefit affected patients. Appropriate physical and occupational therapy techniques, as well as appropriate orthotics, assistive devices, and environmental modifications, are outlined for each of these impairments. In the author's view, rehabilitation should be considered for all advanced cancer patients experiencing functional decline. Pathways and referral patterns need to be established so that timely and appropriate functional restoration may occur.

Methadone is currently best known for its use as the maintenance drug in opioid addiction. The main concern when using methadone for the treatment of pain is its long and unpredictable half-life, which is associated with the risk of delayed toxicity. This may result in side effects such as sedation and respiratory depression if careful titration and close observation of individual patient responses are not performed. For this reason, methadone is often viewed as a second line opioid, after other opioids with a more predictable dose-response have been tried. We report six patients with long-term exposure to methadone as a treatment for heroin dependency, who were also treated with methadone for cancer pain. The first five patients were at least partially refractory to the analgesic effects of opioids other than methadone. All six patients achieved analgesia without sedation or respiratory depression from aggressive upward methadone titration. Methadone analgesia can be considered early in the course of treatment of patients with chronic exposure to methadone who develop new or worsening pain requiring opioid therapy.