Medication utilization patterns in patients with post-COVID syndrome (PCS): Implications for polypharmacy and drug-drug interactions.

BACKGROUND: Post-COVID syndrome (PCS) causes lasting symptoms like fatigue and cognitive issues. PCS treatment is nonspecific, focusing on symptom management, potentially increasing the risk of polypharmacy. OBJECTIVES: To describe medication use patterns among patients with Post-COVID Syndrome (PCS) and estimate the prevalence of polypharmacy, potential drug-drug interactions, and anticholinergic/sedative burden. METHODS: A cross-sectional analysis of baseline data from the Quebec Action for Post-COVID cohort, consisting of individuals self-identifying with persistent COVID-19 symptoms beyond 12 weeks. Medications were categorized using Anatomical Therapeutic Classification (ATC) codes. Polypharmacy was defined as using 5 or more concurrent medications. The Anticholinergic and Sedative Burden Catalog assessed anticholinergic and sedative loads. The Lexi-Interact checker identified potential drug-drug interactions, which were categorized into 3 severity tiers. RESULTS: Out of 414 respondents, 154 (average age 47.7 years) were prescribed medications related to persistent COVID-19 symptoms. Drugs targeting the nervous system were predominant at 54.5%. The median number of medications was 2, while 11.7% reported polypharmacy. Over half of the participants prescribed medications used at least 1 anticholinergic or sedative medication, and 25% had the potential risk for clinically significant drug-drug interactions, primarily needing therapy monitoring. CONCLUSIONS: Our study reveals prescription patterns for PCS, underscoring the targeted management of nervous system symptoms. The risks associated with polypharmacy, potential drug-drug interactions, and anticholinergic/sedative burden stress the importance of judicious prescribing. While limitations like recall bias and a regional cohort are present, the findings underscore the imperative need for vigilant PCS symptom management.

Unsupervised item response theory models for assessing sample heterogeneity in patient-reported outcomes measures.

PURPOSE: Unsupervised item-response theory (IRT) models such as polytomous IRT based on recursive partitioning (IRTrees) and mixture IRT (MixIRT) models can be used to assess differential item functioning (DIF) in patient-reported outcome measures (PROMs) when the covariates associated with DIF are unknown a priori. This study examines the consistency of results for IRTrees and MixIRT models. METHODS: Data were from 4478 individuals in the Alberta Provincial Project on Outcome Assessment in Coronary Heart Disease registry who received cardiac angiography in Alberta, Canada, and completed the Hospital Anxiety and Depression Scale (HADS) depression subscale items. The partial credit model (PCM) based on recursive partitioning (PCTree) and mixture PCM (MixPCM) were used to identify covariates associated with differential response patterns to HADS depression subscale items. Model covariates included demographic and clinical characteristics. RESULTS: The median (interquartile range) age was 64.5(15.7) years, and 3522(78.5%) patients were male. The PCTree identified 4 terminal nodes (subgroups) defined by smoking status, age, and body mass index. A 3-class PCM fits the data well. The MixPCM latent classes were defined by age, disease indication, smoking status, comorbid diabetes, congestive heart failure, and chronic obstructive pulmonary disease. CONCLUSION: PCTree and MixPCM were not consistent in detecting covariates associated with differential interpretations of PROM items. Future research will use computer simulations to assess these models' Type I error and statistical power for identifying covariates associated with DIF.

The Patient Generated Index (PGI) as an early-warning system for predicting brain health challenges: a prospective cohort study for people living with Human Immunodeficiency Virus (HIV).

PURPOSE: In research people are often asked to fill out questionnaires about their health and functioning and some of the questions refer to serious health concerns. Typically, these concerns are not identified until the statistician analyses the data. An alternative is to use an individualized measure, the Patient Generated Index (PGI) where people are asked to self-nominate areas of concern which can then be dealt with in real-time. This study estimates the extent to which self-nominated areas of concern related to mood, anxiety and cognition predict the presence or occurrence of brain health outcomes such as depression, anxiety, psychological distress, or cognitive impairment among people aging with HIV at study entry and for successive assessments over 27 months. METHODS: The data comes from participants enrolled in the Positive Brain Health Now (+ BHN) cohort (n = 856). We analyzed the self-nominated areas that participants wrote on the PGI and classified them into seven sentiment groups according to the type of sentiment expressed: emotional, interpersonal, anxiety, depressogenic, somatic, cognitive and positive sentiments. Tokenization was used to convert qualitative data into quantifiable tokens. A longitudinal design was used to link these sentiment groups to the presence or emergence of brain health outcomes as assessed using standardized measures of these constructs: the Hospital Anxiety and Depression Scale (HADS), the Mental Health Index (MHI) of the RAND-36, the Communicating Cognitive Concerns Questionnaire (C3Q) and the Brief Cognitive Ability Measure (B-CAM). Logistic regressions were used to estimate the goodness of fit of each model using the c-statistic. RESULTS: Emotional sentiments predicted all of the brain health outcomes at all visits with adjusted odds ratios (OR) ranging from 1.61 to 2.00 and c-statistics > 0.73 (good to excellent prediction). Nominating an anxiety sentiment was specific to predicting anxiety and psychological distress (OR 1.65 & 1.52); nominating a cognitive concern was specific to predicting self-reported cognitive ability (OR 4.78). Positive sentiments were predictive of good cognitive function (OR 0.36) and protective of depressive symptoms (OR 0.55). CONCLUSIONS: This study indicates the value of using this semi-qualitative approach as an early-warning system in predicting brain health outcomes.

Residual respiratory disability after successful treatment of pulmonary tuberculosis: a systematic review and meta-analysis.

Background: Pulmonary tuberculosis (PTB) can result in long-term health consequences, even after successful treatment. We conducted a systematic review and meta-analysis to estimate the occurrence of respiratory impairment, other disability states, and respiratory complications following successful PTB treatment. Methods: We identified studies from January 1, 1960, to December 6, 2022, describing populations of all ages that successfully completed treatment for active PTB and had been assessed for at least one of the following outcomes: occurrence of respiratory impairment, other disability states, or respiratory complications following PTB treatment. Studies were excluded if they reported on participants with self-reported TB, extra-pulmonary TB, inactive TB, latent TB, or if participants had been selected on the basis of having more advanced disease. Study characteristics and outcome-related data were abstracted. Meta-analysis was performed using a random effects model. We adapted the Newcastle Ottawa Scale to evaluate the methodological quality of the included studies. Heterogeneity was assessed using the I2 statistic and prediction intervals. Publication bias was assessed using Doi plots and LFK indices. This study is registered with PROSPERO (CRD42021276327). Findings: 61 studies with 41,014 participants with PTB were included. In 42 studies reporting post-treatment lung function measurements, 59.1% (I2 = 98.3%) of participants with PTB had abnormal spirometry compared to 5.4% (I2 = 97.4%) of controls. Specifically, 17.8% (I2 = 96.6%) had obstruction, 21.3% (I2 = 95.4%) restriction, and 12.7% (I2 = 93.2%) a mixed pattern. Among 13 studies with 3179 participants with PTB, 72.6% (I2 = 92.8%) of participants with PTB had a Medical Research Council dyspnoea score of 1-2 and 24.7% (I2 = 92.2%) a score of 3-5. Mean 6-min walk distance in 13 studies was 440.5 m (I2 = 99.0%) in all participants (78.9% predicted, I2 = 98.9%) and 403.0 m (I2 = 95.1%) among MDR-TB participants in 3 studies (70.5% predicted, I2 = 97.6%). Four studies reported data on incidence of lung cancer, with an incidence rate ratio of 4.0 (95% CI 2.1-7.6) and incidence rate difference of 2.7 per 1000 person-years (95% CI 1.2-4.2) when compared to controls. Quality assessment indicated overall low-quality evidence in this field, heterogeneity was high for pooled estimates of nearly all outcomes of interest, and publication bias was considered likely for almost all outcomes. Interpretation: The occurrence of post-PTB respiratory impairment, other disability states, and respiratory complications is high, adding to the potential benefits of disease prevention, and highlighting the need for optimised management after successful treatment. Funding: Canadian Institutes of Health Research Foundation Grant.

"Alone, there is nobody": A qualitative study of the lived experience of loneliness in older men living with HIV.

Loneliness has been shown to be a predictor of poor health and early mortality in the general population. Older men living with human immunodeficiency virus (HIV) are at heightened risk of experiencing loneliness. Here, we aim to describe the lived experience of loneliness in older men living with HIV and identify targets for intervention. We used grounded theory with a theoretical framework of narrative phenomenology to focus data collection and analysis on significant experiences related to loneliness. Based on individual narrative interviews with 10 older men living with HIV, experiences of loneliness related to "multiple losses," "being invisible" and "hiding out" as emergent themes. Participants also described living with loneliness by "finding meaning," "creating social experiences," "pursuing interests and things to 'live for'" and attending events in which "everyone is welcome." The discussion situates experiences of loneliness within the accumulation of losses and stigmas over time and how the participants strategies for living with loneliness could inform interventions to reduce loneliness in older men living with HIV at individual and societal levels.

Development of a Frailty Ladder Using Rasch Analysis: If the Shoe Fits.

Background: The current measurement approach to frailty is to create an index of frailty status, rather than measure it. The purpose of this study is to test the extent to which a set of items identified within the frailty concept fit a hierarchical linear model (e.g., Rasch model) and form a true measure reflective of the frailty construct. Methods: A sample was assembled from three sources: community organization for at-risk seniors (n=141); colorectal surgery group assessed post-surgery (n=47); and hip fracture assessed post-rehabilitation (n=46). The 234 individuals (age 57 to 97) contributed 348 measurements. The frailty construct was defined according to the named domains within commonly used frailty indices, and items drawn to reflect the frailty came from self-report measures. Performance tests were tested for the extent to which they fit the Rasch model. Results: Of the 68 items, 29 fit the Rasch model: 19 self-report items on physical function and 10 performance tests, including one for cognition; patient reports of pain, fatigue, mood, and health did not fit; nor did body mass index (BMI) nor any item representing participation. Conclusion: Items that are typically identified as reflecting the frailty concept fit the Rasch model. The Frailty Ladder would be an efficient and statistically robust way of combining results of different tests into one outcome measure. It would also be a way of identifying which outcomes to target in a personalized intervention. The rungs of the ladder, the hierarchy, could be used to guide treatment goals.

The prototype of a preference-based index of weight-related quality of life: demonstrating the possibilities.

PURPOSE: Evidence for comparative and cost-effectiveness of weight-loss interventions is lacking as there are no obesity-specific measures fit for this purpose. This study aimed to estimate the extent to which a prototype of a brief, multi-dimensional obesity-specific Preference-Based Index of Weight-Related Quality of Life (PBI-WRQL) could fill this gap. METHODS: Longitudinal data from a Canadian bariatric cohort was used. Forty-eight items from the IWQoL-Lite, EQ-5D-3L, and SF-12V2 were mapped onto the WHO ICF domains, and one item was chosen for the dimension based on fit to the Rasch model. Individuals' health ratings (0-100) were regressed on each dimension, and the regression coefficients for the response options were used as weights to generate a total score. Generalized estimation equations were used to compare measure parameters across groups and levels of converging constructs. RESULTS: Pre-surgery data were available on 201 people (Women: 82%; BMI: 48.8 ± 6.7 kg/m2; age: 43 ± 9.0 years) and on 125 (62%) at 6 months post-bariatric surgery. Seven dimensions with three response options formed the PB-WRQL prototype: Mobility/Physical Function, Pain, Depression, Participation, Energy, Peripheral Edema, and Dyspnea. The prototype showed substantial change (mean + 40) with bariatric surgery, higher than the EQ-5D (mean + 11.5). The prototype showed the strongest relationship with BMI at baseline (t = - 3.68) and was the most sensitive to change in BMI (t = - 3.42). CONCLUSION: This study demonstrates that a brief, 7-dimension index weighted by health impact performed as well as the 31-item IWQoL-Lite and better than the EQ-5D-3L. These findings demonstrate the potential value of the brief PB-WRQL prototype index and support its further development using preference weights to reflect the current generation's needs and concerns.

Factors partitioning physical frailty in people aging with HIV: A classification and regression tree approach.

OBJECTIVE: To estimate the extent to which comorbidity and lifestyle factors were associated with physical frailty in middle-aged and older Canadians living with HIV. DESIGN: Cross-sectional analysis of 856 participants from the Canadian Positive Brain Health Now cohort. METHODS: The frailty indicator phenotype was adapted from Fried's criteria using self-report items. Univariate logistic regression and classification and regression tree (CaRT) models were used to identify the most relevant independent contributors to frailty. RESULTS: In all, 100 men (14.0%) and 26 women (19.7%) were identified as frail (≥ 3/5 criteria) for an overall prevalence of 15.2%. Nine comorbidities showed an influential association with frailty. The most influential comorbidities were hypothyroidism [odds ratio (OR) = 2.55, 95% confidence interval (CI): 1.29-5.03] and arthritis (OR = 2.54, 95% CI: 1.58-4.09). Additionally, tobacco (OR = 1.79, 95% CI: 1.05-3.04) showed an association. Any level of alcohol consumption showed a protective effect for frailty. The CaRT model showed nine pathways that led to frailty. Arthritis was the most discriminatory variable followed by alcohol, hypothyroidism, tobacco, cancer, cannabis, liver disease, kidney disease, osteoporosis, lung disease and peripheral vascular disease. The prevalence of physical frailty for people with arthritis was 27.4%; with additional cancer or tobacco and alcohol the prevalence rates were 47.1% and 46.1%, respectively. The protective effect of alcohol consumption evident in the univariate model appeared again in the CaRT model, but this effect varied. Cognitive frailty (19.5% overall) and emotional frailty (37.9% overall) were higher than the prevalence of physical frailty. CONCLUSIONS: Specific comorbidities and tobacco use were implicated in frailty, suggesting that it is comorbidities causing frailty. However, some frailty still appears to be HIV-related. The higher prevalence of cognitive and emotional frailty highlights the fact that physical frailty should not be the only focus in HIV.

Understanding the Meaning of Recovery to Patients Undergoing Abdominal Surgery.

Importance: Postoperative recovery is difficult to define or measure. Research addressing interventions aimed to improve recovery after abdominal surgery often focuses on measures such as duration of hospital stay and complication rates. Although these clinical parameters are relevant, understanding patients' perspectives regarding postoperative recovery is fundamental to guiding patient-centered care. Objective: To elucidate the meaning of recovery from the perspective of patients undergoing abdominal surgery. Design, Setting, and Participants: This international qualitative study involved semistructured interviews with patients recovering from abdominal surgery from October 2016 to November 2018 in tertiary hospitals in 4 countries (Canada, Italy, Brazil, and Japan). A purposive maximal variation sampling method was used to ensure the recruitment of patients with varying demographic, clinical, and surgical characteristics. Data on race were not collected. Each interview lasted between 1 and 2 hours. Interviews were recorded and then transcribed verbatim. Transcripts were then analyzed using an inductive thematic analysis approach. Data analysis was conducted from July 2019 to September 2019. Main Outcomes and Measures: The qualitative analysis revealed themes reflecting the meaning of recovery from the perspective of patients undergoing abdominal surgery. Results: Thirty patients recovering from abdominal surgery were interviewed (15 [50%] female; mean [SD] age, 57 [18] years; 10 [33%] underwent major surgery; 16 [53%] underwent laparoscopic surgery). The interviews revealed that for patients undergoing abdominal surgery, the meaning of recovery embodied 5 overarching themes: (1) returning to habits and routines, (2) resolution of symptoms, (3) overcoming mental strains, (4) regaining independence, and (5) enjoying life. Themes associating the meaning of recovery to traditional parameters, such as earlier hospital discharge or absence of complications, were not identified in the interviews. Conclusions and Relevance: This qualitative study suggests that the meaning of recovery from the perspective of patients undergoing abdominal surgery goes beyond traditional clinical parameters. The elements of recovery identified in this study should be taken into account in patient-surgeon discussions about recovery and when developing patient-centered strategies to improve postoperative outcomes.

Impact of Facilitation of Early Mobilization on Postoperative Pulmonary Outcomes After Colorectal Surgery: A Randomized Controlled Trial.

OBJECTIVE: To estimate the extent to which staff-directed facilitation of early mobilization impacts recovery of pulmonary function and 30-day postoperative pulmonary complications (PPCs) after colorectal surgery. SUMMARY BACKGROUND DATA: Early mobilization after surgery is believed to improve pulmonary function and prevent PPCs; however, adherence is low. The value of allocating resources (eg, staff time) to increase early mobilization is unknown. METHODS: This study involved the analysis of a priori secondary outcomes of a pragmatic, observer-blind, randomized trial. Consecutive patients undergoing colorectal surgery were randomized 1:1 to usual care (preoperative education) or facilitated mobilization (staff dedicated to assist transfers and walking during hospital stay). Forced vital capacity, forced expiratory volume in 1 second (FEV1), and peak cough flow were measured preoperatively and at 1, 2, 3 days and 4 weeks after surgery. PPCs were defined according to the European Perioperative Clinical Outcome Taskforce. RESULTS: Ninety-nine patients (57% male, 80% laparoscopic, median age 63, and predicted FEV1 97%) were included in the intention-to-treat analysis (usual care 49, facilitated mobilization 50). There was no between-group difference in recovery of forced vital capacity [adjusted difference in slopes 0.002 L/d (95% CI -0.01 to 0.01)], FEV1 [-0.002 L/d (-0.01 to 0.01)] or peak cough flow [-0.002 L/min/d (-0.02 to 0.02)]. Thirty-day PPCs were also not different between groups [adjusted odds ratio 0.67 (0.23-1.99)]. CONCLUSIONS: In this randomized controlled trial, staff-directed facilitation of early mobilization did not improve postoperative pulmonary function or reduce PPCs within an enhanced recovery pathway for colorectal surgery. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02131844.

Association Between Patient Activation and Health Care Utilization After Thoracic and Abdominal Surgery.

Importance: Increased patient activation (PA) (ie, knowledge, skills, motivation, confidence to participate in care) may result in improved outcomes, especially in surgical settings. Objective: To estimate the extent to which PA is associated with 30-day postdischarge unplanned health care utilization after major thoracic or abdominal surgery. Design, Setting, and Participants: This cohort study was performed at 2 centers of a tertiary care hospital network between October 2017 and January 2019. Adult patients undergoing thoracic or abdominal surgery were included. Of 880 patients assessed for eligibility, 692 were deemed eligible, of whom 34 declined to participate, 1 withdrew consent, and 4 were excluded after consent. Exposures: Patient activation was measured immediately after surgery during the initial admission using the Patient Activation Measure (score range, 0-100). Patients were dichotomized into low and high PA groups using previously described thresholds (Patient Activation Measure score, ≤55.1). Main Outcomes and Measures: The primary outcome was unplanned 30-day postdischarge health care utilization (composite including emergency department and outpatient clinic visits and/or hospital readmission). Secondary outcomes were length of stay, 30-day emergency department visits, 30-day readmissions, and postoperative complications. Results: A total of 653 patients admitted for thoracic, general, colorectal, and gynecologic surgery were included in the study (mean [SD] age, 58 [15] years; 369 women [56%]; 366 [56%] had minimally invasive surgery; 52 [8%] had emergency surgery), of which 152 (23%) had a low level of PA. Baseline characteristics were similar between patients with low- and high-level PA. Low PA was associated with unplanned health care utilization (odds ratio [OR], 3.15; 95% CI, 2.05-4.86; P < .001), emergency department visits (OR, 1.64; 95% CI, 1.02-2.64; P = .04), complications (OR, 1.63; 95% CI, 1.11-2.41; P = .01), and length of stay (adjusted mean difference, 1.19 days; 95% CI, 0.06-2.33; P = .04). Low PA was not associated with a higher risk of readmission (adjusted OR, 1.04; 95% CI, 0.56-1.93; P = .90). Conclusions and Relevance: In this study, low level of PA was associated with postdischarge unplanned health care use, hospital stay, and complications after major surgery. Identification of patients with low activation may allow the implementation of interventions to improve health care knowledge and support self-management postdischarge.

Pediatric Kidney Transplantation in Perú: A Single-Center Initial Experience.

BACKGROUND: Pediatric kidney transplantation (PKTx) is the preferred therapy for children with end-stage renal disease (ESRD) worldwide. Regrettably, in Perú, access to PKTx is extremely difficult due to recipient/donor socio-economic status, health care structure and especially, scarcity of organs. Our center (the only pediatric institute in the country) has recently started a PKTx program with good midterm results. The aim of this study was to present our outcomes. METHODS: Retrospective analysis of prospectively collected data between December 2017 and August 2019. Fourteen PKTx (< 18 years old) were achieved. As per our protocol: pre-implantation/protocol biopsies, antibody assessment (T/B cell flow cytometric plus HLA testing applying polymerase chain reaction-based technology), triple immunosuppression (tacrolimus, mycophenolate mofetil, steroids) and induction therapy was performed in every case. RESULTS: The recipient's mean age at the time of PKTx was 14.14 ± 2.62, 8/14 (57.14%) were male, 50% developed ESRD due to undetermined etiology, 11/14 (78.57%) received a deceased donor allograft, and 9/14 (64.28%) required induction with thymoglobulin. Postoperative complications included: delayed graft function (1/14, 7.14%), 1 (7.14%) developed gross hematuria associated with allograft disfunction post-protocol allograft biopsy that was managed conservatively and 1 recipient (7.14%) developed grade II oligoastrocytoma, at 10 months post PKTx. CONCLUSIONS: PKTx is the best therapeutic option for children with ESRD. Our group demonstrated that even in countries with limited resources like Perú, good midterm results can be achieved. Emphasis should be given to improve access to transplantation especially in the setting of pediatric recipients.

Development of a conceptual framework of recovery after abdominal surgery.

BACKGROUND: There is a lack of patient-reported outcome measures (PROMs) with robust measurement properties to assess postoperative recovery and support patient-centered care after abdominal surgery. The aim of this study was to establish a conceptual framework of recovery after abdominal surgery to support the development of a conceptually relevant and psychometrically sound PROM. METHODS: Patients from four different countries (Canada, Italy, Brazil, and Japan) participated in qualitative interviews focusing on their lived experiences of recovery after abdominal surgery. Interviews were guided by a previously developed hypothesized conceptual framework established based on a literature review and expert consensus. Interviews were analyzed according to a modified grounded theory approach and transcripts were coded according to the International Classification of Functioning, Disability and Health (ICF). Codes for which thematic saturation was reached were classified into domains of health that are relevant to the process of recovery after abdominal surgery. These domains were organized into a structured diagram. RESULTS: 30 Patients with diverse demographics and surgical characteristics were interviewed (50% female, age 57 ± 18 years, 66% major or major extended surgery). 39 Unique domains of recovery emerged from the interviews, 17 falling under the ICF category of "Body Functions" and 22 under "Activities and Participation". These domains constitute the conceptual framework of recovery after abdominal surgery. CONCLUSIONS: This study provides comprehensive insight into patients' perspectives of the recovery process after abdominal surgery. This conceptual framework will support content validity and provide the pivotal basis for the development of a novel PROM to inform quality improvement initiatives and patient-centered research in abdominal surgery.

Preoperative Risk Index Among Patients Undergoing Thyroid or Parathyroid Surgery.

Importance: Frailty represents a multidimensional syndrome that is increasingly being used to stratify risk in surgical patients. Current frailty risk models are limited among those undergoing thyroid or parathyroid surgery. Objective: To develop and compare preoperative risk indices to determine factors associated with short-term major postoperative adverse events in patients undergoing thyroid or parathyroid surgery. Design, Setting, and Participants: This cohort study evaluated 154 895 patients in the American College of Surgeons National Surgical Quality Improvement Program who underwent thyroid or parathyroid surgery from January 1, 2007, to December 31, 2016. Exposures: Preoperative frailty-related and surgical factors from a derivation cohort were evaluated using simple and multiple logistic regression. Variables potentially associated with postoperative adverse events were subsequently combined into a personalized preoperative Cervical Endocrine Surgery Risk Index (CESRI) and compared with existing risk models using the validation cohort. Main Outcomes and Measures: Composite variable of any major postoperative adverse event, including death, within 30 days of surgery. Results: Of the 154 895 operations reviewed, 3318 patients (2.1%; 2296 women and 1022 men; mean [SD] age, 56.1 [15.6] years) experienced a major postoperative adverse event, with 163 deaths (0.1%). Older age (age, ≥80 years: odds ratio [OR], 2.35; 95% CI, 1.74-3.13), inpatient status (OR, 3.55; 95% CI, 3.08-4.11), male sex (OR, 1.49; 95% CI, 1.29-1.71), current tobacco smoking (OR, 1.25; 95% CI, 1.05-1.48), dyspnea (OR, 1.58; 95% CI, 1.29-1.91), recent weight loss (OR, 1.88; 95% CI, 1.23-2.78), functional dependence (OR, 2.77; 95% CI, 2.05-3.69), obesity (OR, 1.33; 95% CI, 1.10-1.60), anemia (OR, 2.14; 95% CI, 1.82-2.52), leukocytosis (OR, 1.73; 95% CI, 1.38-2.14), hypoalbuminemia (OR, 1.87; 95% CI, 1.56-2.23), use of anticoagulation (OR, 2.16; 95% CI, 1.64-2.81), and length of surgery (>4 hours: OR, 2.92; 95% CI, 2.37-3.59) were independently associated with major adverse events or death on multiple regression analysis (C statistic, 0.77; 95% CI, 0.76-0.78). The area under the curve of the CESRI to determine major adverse events, including death, using the validation cohort was 0.63 (95% CI, 0.61-0.64), with a sensitivity of 0.66 (95% CI, 0.64-0.68) and specificity of 0.66 (95% CI, 0.65-0.66). The CESRI outperformed other risk models for determining adverse events (CESRI vs 5-Factor Modified Frailty Index: delta C index, 0.11; 95% CI, 0.09-0.13; CESRI vs American Society of Anesthesiologists Physical Status Classification System: delta C index, 0.05; 95% CI, 0.03-0.07; CESRI vs American College of Surgeons Risk Calculator: delta C index, 0.02; 95% CI, 0.01-0.03; and CESRI vs Head and Neck Surgery Risk Index: delta C index, 0.04; 95% CI, 0.03-0.06). Conclusions and Relevance: This study suggests that the CESRI is able to determine major postoperative adverse events in patients undergoing thyroid or parathyroid surgery.

Evaluation of a Preoperative Adverse Event Risk Index for Patients Undergoing Head and Neck Cancer Surgery.

Importance: Patients 65 years or older are the most frequent users of operative resources and are also the most vulnerable to postoperative adverse events (AEs). Frailty indices are increasingly being used for preoperative risk stratification within head and neck cancer surgery, but most models lack a multifactorial basis and cannot be directly applied to clinical practice. A practical risk index is needed for clinicians to gauge risk factors preoperatively. Objective: To develop a preoperative risk index of short-term major postoperative AEs for patients undergoing head and neck cancer surgery. Design: Cohort analysis of patients from multiple medical centers undergoing inpatient ablative or reconstructive head and neck cancer surgery and registered in the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) from 2006 to 2016. Exposures: Inpatient ablative or reconstructive head and neck cancer surgery. Main Outcomes and Measures: Sociodemographic, frailty-related, and surgical factors in the derivation cohort were evaluated using simple and multiple logistic regression. Risk factors were subsequently integrated into a preoperative head and neck surgery risk index (HNSRI) and compared with existing models using the validation cohort. A composite variable of major postoperative AEs was used, including death within 30 days of surgery. Results: A total of 43 968 operations were found using the ACS NSQIP database. Of these, 12 569 cases were excluded as non-head and neck cancer or emergency surgery. Of the included 31 399 operations reviewed, the mean (SD) patient age was 56.9 (15.4) years, and 16 994 of the patients were women (54.1%). A total of 4556 (14.5%) patients had a major postoperative AE, and 209 (0.7%) died. Older age, male sex, smoking, anticoagulation, recent weight loss, functional dependence, free-tissue transfer, tracheotomy, duration of surgery, wound classification, anemia, leukocytosis, and hypoalbuminemia were independently associated with major AEs or death on multiple regression analysis (C statistic, 0.83). The area under the curve of the HNSRI to predict major AEs including death using the validation cohort (n = 15 699) was 0.84 (95% CI, 0.83-0.85) with a sensitivity of 80.1% (95% CI, 79.4%-80.8%) and specificity, 72.3% (95% CI, 70.3%-74.2%). The HNSRI outperformed existing risk models for prediction of AEs: delta C index of the HNSRI to the modified frailty index 11, 0.23 (95% CI, 0.22-0.25); the American Society of Anesthesiologists classification, 0.14 (95% CI, 0.13-0.16); and the ACS risk calculator, 0.02 (95% CI, 0.01-0.03). Conclusions and Relevance: The proposed HNSRI demonstrated a high sensitivity and specificity for major postoperative AEs and death in the studied population. This risk index can be used to counsel patients awaiting head and neck cancer surgery.

Construct Validity and Responsiveness of the Abdominal Surgery Impact Scale in the Context of Recovery After Colorectal Surgery.

BACKGROUND: The Abdominal Surgery Impact Scale is a patient-reported outcome measure that evaluates quality of life after abdominal surgery. Evidence supporting its measurement properties is limited. OBJECTIVE: This study aimed to contribute evidence for the construct validity and responsiveness of the Abdominal Surgery Impact Scale as a measure of recovery after colorectal surgery in the context of an enhanced recovery pathway. DESIGN: This is an observational validation study designed according to the Consensus-based Standards for the Selection of Health Measurement Instruments checklist. SETTING: This study was conducted at a university-affiliated tertiary hospital. PATIENTS: Included were 100 consecutive patients undergoing colorectal surgery (mean age, 65; 57% male). INTERVENTION: There were no interventions. MAIN OUTCOME MEASURES: Construct validity was assessed at 2 days and 2 and 4 weeks after surgery by testing the hypotheses that Abdominal Surgery Impact Scale scores were higher 1) in patients without vs with postoperative complications, 2) with higher preoperative physical status vs lower, 3) without vs with postoperative stoma, 4) in men vs women, 5) with shorter time to readiness for discharge (≤4 days) vs longer, and 6) with shorter length of stay (≤4 days) vs longer. To test responsiveness, we hypothesized that scores would be higher 1) preoperatively vs 2 days postoperatively, 2) at 2 weeks vs 2 days postoperatively, and 3) at 4 weeks vs 2 weeks postoperatively. RESULTS: The data supported 3 of the 6 hypotheses (hypotheses 1, 5, and 6) tested for construct validity at all time points. Two of the 3 hypotheses tested for responsiveness (hypotheses 1 and 2) were supported. LIMITATIONS: This study was limited by the risk of selection bias due to the use of secondary data from a randomized controlled trial. CONCLUSIONS: The Abdominal Surgery Impact Scale was responsive to the expected trajectory of recovery up to 2 weeks after surgery, but did not discriminate between all groups expected to have different recovery trajectories. There remains a need for the development of recovery-specific, patient-reported outcome measures with adequate measurement properties. See Video Abstract at http://links.lww.com/DCR/A814.

Divergence from osteoporosis screening guidelines in older breast cancer patients treated with anti-estrogen therapy: A population-based cohort study.

PURPOSE: Older Breast Cancer (BC) survivors are an increased risk of osteoporosis due to natural aging and long-term cancer treatment-related toxicity. It is well known that anti-estrogen therapy (AET), especially aromatase inhibitors (AI), is associated with rapid bone loss and thus increases the risk of osteoporosis. This study characterizes patterns and predictors of receiving guideline-recommended bone densitometry (BD) screening at AET initiation. METHODS: A retrospective cohort study (1998-2012) of all women ≥65 years of age initiating AET was designed using claims data from Quebec's universal health care. Associations with BD screening were estimated using a generalized estimating equations regression model, adjusting for clustering of patients within physicians. RESULTS: Among 16,480 women initiating AET, 36.1% received a baseline BD. Among AI users, the rate was 58.4%. In the multivariate analysis, age, lower socioeconomic status, tamoxifen use, lack of periodic health exam and having a general practitioner as the AET prescriber were associated with lower odds of BD screening. In terms of quality of care-related variables, lack of guideline-appropriate radiotherapy (OR: 0.69 (95% CI, 0.57-0.83), or chemotherapy consideration (0.82 (95% CI, 0.71-0.94)) and non-adherence to AET (0.76 (95% CI, 0.68-0.84)) were associated with lower odds of receiving BD screening. Women diagnosed with BC after 2003 had significantly better odds of being screened. CONCLUSION: Despite an increase in rates since 2003, BD screening remains suboptimal, especially for women at higher risk of osteoporosis. Coordination of health care and service-delivery monitoring can potentially optimize long-term management of treatment-related toxicity in older BC survivors.

Measuring In-Hospital Recovery After Colorectal Surgery Within a Well-Established Enhanced Recovery Pathway: A Comparison Between Hospital Length of Stay and Time to Readiness for Discharge.

BACKGROUND: Hospital length of stay is often used as a measure of in-hospital recovery but may be confounded by organizational factors. Time to readiness for discharge may provide a superior index of recovery. OBJECTIVE: The purpose of this study was to contribute evidence for the construct validity of time to readiness for discharge and length of stay as measures of in-hospital recovery after colorectal surgery in the context of a well-established enhanced recovery pathway. DESIGN: This was an observational validation study designed according to the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) checklist. SETTINGS: The study was conducted at a university-affiliated tertiary hospital. PATIENTS: A total of 100 consecutive patients undergoing elective colorectal resection (mean age = 65 y; 57% men; 81% laparoscopic) who participated in a randomized controlled trial were included. MAIN OUTCOME MEASURES: We tested a priori hypotheses that length of stay and time-to-readiness for discharge are longer in patients undergoing open surgery, with lower physical status, with severe comorbidities, with postoperative complications, undergoing rectal surgery, who are older (≥75 y), who have a new stoma, and who have inflammatory bowel disease. RESULTS: Median time-to-readiness for discharge and length of stay were both 3 days. For both measures, 6 of 8 construct validity hypotheses were supported (hypotheses 1 and 4-8). LIMITATIONS: The use of secondary data from a randomized controlled trial (risk of selection bias) was a limitation. Results may not be generalizable to institutions where patient care is not equally structured. CONCLUSIONS: This study contributes evidence to the construct validity of time-to-readiness for discharge and length of stay as measures of in-hospital recovery within enhanced recovery pathways. Our findings suggest that length of stay can be a less resource-intensive and equally construct-valid index of in-hospital recovery compared with time-to-readiness for discharge. Enhanced recovery pathways may decrease process-of-care variances that impact length of stay, allowing more timely discharge once discharge criteria are achieved. See Video Abstract at http://links.lww.com/DCR/A564.

Development of a patient-reported outcome measure of recovery after abdominal surgery: a hypothesized conceptual framework.

BACKGROUND: We initiated a research program to develop a novel patient-reported outcome measure (PROM) to assess postoperative recovery from the perspective of abdominal surgery patients. In light of FDA recommendations, the first stage of our program aimed to, based on previous literature and expert input, develop a hypothesized conceptual framework portraying the health domains that are potentially relevant to the process of recovery after abdominal surgery. METHODS: This study was conducted in three phases: (1) systematic review to identify PROMs with measurement properties appraised in the context of recovery after abdominal surgery, (2) content analysis to categorize the health domains covered by the PROMs according to the ICF, and (3) two-round Delphi study to gain expert input regarding which of these health domains are relevant to the process of recovery. Participants were experts in perioperative care identified through two major surgical societies (35 invited). RESULTS: The systematic review identified 19 PROMs covering 66 ICF domains. 23 experts (66%) participated in the Delphi process. After Round 2, experts agreed that 22 health domains (8 body functions, 14 activities and participation) are potentially relevant to the process of recovery after abdominal surgery. These domains were organized into a diagram, representing our hypothesized conceptual framework. CONCLUSIONS: This hypothesized conceptual framework is an important first step in our research program and will be further refined based on in-depth qualitative interviews with patients. The sound methodological approach used to derive this framework may be valuable for studies aimed to develop PROMs according to FDA standards.

Impact of reconceptualization response shift on rating of quality of life over time among people with advanced cancer.

BACKGROUND: People with cancer may experience change in what constitutes quality of life (QOL) over time as a result of the cancer progression (true change) or adaptation to the experience, considered as a response shift phenomenon. As individualized measures are ideally suited to explore response shift, this study aimed to estimate the extent to which reconceptualization response shift occurred over time in a cancer population and the impact of this response shift on estimates of change on QOL measures. METHODS: Ninety-seven people with advanced cancer completed the study measures including the Patient-Generated Index (PGI) at diagnosis (T0) and 1 year later (T1). The response shift indicator was the change in the number of areas nominated (range - 4 to + 3). Multivariate linear regression was used to estimate the effect of changing areas on change in the PGI score, single indicators of global QOL, and the EQ-5Dindex adjusted for age and sex. RESULTS: Approximately 72% of people in this sample either added or dropped areas over time. People who dropped more than two areas had higher PGI scores at T1 than T0 while people who added areas showed low PGI score. CONCLUSION: The results are consistent with the PGI framework as areas nominated tend to focus on negative aspects of QOL.