The value of patient-reported outcomes to predict for symptom burden and health-related quality of life after chemoradiation for cervical cancer: A prospective study.

PURPOSE: Cervical cancer patients undergoing chemoradiation have high symptom burden. We performed an analysis of prospectively collected patient-reported outcomes(PROs) to determine characteristics predictive of poor treatment experience. METHODS: Between 2021-2023, we prospectively collected PROs from cervical cancer patients undergoing definitive chemoradiation. EORTC-QLQ-C30 and EORTC-QLQ-CX24 were completed at baseline(BL) and at the end of treatment(EOT). Poor treatment experience was defined as EOT poor health-related quality of life (HRQOL), low physical function, or significant overall symptom burden. Predictive factors analyzed included demographic, clinical, disease-specific factors, and baseline financial toxicity, depression, social function, and emotional function. ROC analysis provided appropriate predictive cut-off values. Univariable(UVA) and multivariable(MVA) linear regression analyses were performed. RESULTS: Fourty-nine patients completed BL and EOT questionnaires. Median age was 43 (range, 18-85). Most patients (59%) had stage III disease. Baseline financial toxicity ≥66.7, depression ≥66.7, social function ≤50 and emotional function ≤58 on the EORTC linear transformed scale of 0-100 were significant predictors for poor treatment experience (p≤0.04) based on ROC analysis. On MVA poor BL social function was associated with reduced EOT HRQOL (ß-9.3,_95%CI_-16.1_to_-2.6,_p<0.008), decreased physical function (ß-24.4,_95%CI_-36.3_to_-12.6,_p<0.001), and high symptom burden_(ß26.9,_95%CI_17.5_to_36.3,_p<0.001). Earlier disease stage predicted for decreased symptom burden_(ß-6.7,_95%CI_-13.1_to_-0.3,_p=0.039). BL financial toxicity was a significant predictor on UVA (p=0.001-0.044) and showed a significant interaction term on MVA (p=0.024-0.041) for all three domains of poor treatment experience. Demographic and treatment-related factors were not predictive. CONCLUSION: Cervical cancer patients with poor baseline social function or high financial toxicity were at-risk for increased symptom burden and poor HRQOL. Screening for these factors provides an opportunity for early intervention to improve treatment experience.

Patient-reported outcome measures in surgical patients with upper gastrointestinal cancers: A qualitative interview study.

BACKGROUND AND OBJECTIVES: Patients with pancreatic and gastroesophageal (PGE) cancers experience high symptom burden, but patient experience throughout multimodality treatment remains unclear. We aimed to delineate the experience and symptom burden of patients throughout their perioperative course. METHODS: Qualitative interviews were performed with 17 surgical patients with PGE cancer. Interview transcripts were analyzed and symptoms were ranked by frequency. An expert panel assessed the relevance of these symptom inventory items. RESULTS: Of the 17 patients included, 35% (n = 6) underwent gastrectomy, 30% (n = 5) underwent esophagectomy, and 35% (n = 6) underwent pancreatectomy; 76% (n = 13) received neoadjuvant systemic chemotherapy and/or chemoradiation. Overall, 32 symptoms were reported, and 19 were reported by over 20% of patients. An expert panel rated nine symptoms to be relevant or very relevant to PGE surgical patients. These symptoms (difficulty swallowing, heartburn/reflux, diarrhea, constipation, flushing/sweating, stomach feeling full, malaise, dizziness, or feeling cold) were added to the core MD Anderson Symptom Inventory (MDASI) if they were commonly reported or reached a threshold relevancy score. CONCLUSIONS: In this qualitative study, we developed a provisional symptom inventory for patients undergoing surgery for PGE cancer. This symptom inventory module of the MDASI for PGE surgical patients will be psychometrically tested for validity and reliability.

Patient-reported outcomes after oncologic hepatic resection predict the risk of delayed readiness to return to intended oncologic therapy (RIOT).

BACKGROUND: Optimal surgical recovery is critical to readiness to return to intended oncologic therapy (RIOT). The current study defined the value of patient-reported outcomes (PROs) in predicting the risk for delayed RIOT after oncologic hepatic resection. METHODS: In a prospective longitudinal study, perioperative symptoms were assessed using a valid PRO assessment tool, the MD Anderson Symptom Inventory module for hepatectomy perioperative care (MDASI-PeriOp-Hep), for 4 weeks after surgery. The timed up and go test (TUGT) was administered before surgery, by discharge day, and at the first postoperative follow-up visit. Multivariate logistic regression analysis assessed the predictive value of PROs for delayed RIOT. RESULTS: We enrolled 210 patients and analyzed 148 patients who received adjuvant chemotherapy and contributed more than 3 PRO assessments postoperatively. About 36 percent of the patients had delayed RIOT (>5 weeks, range 1-14 weeks). MDASI scores for drowsiness, fatigue, dry mouth, and interference with general activity, walking, and work on day 7 after discharge and MDASI scores for incisional tightness, fatigue, dry mouth, shortness of breath, and interference with work on day 14 after discharge were associated with delayed RIOT (all P < 0.05). Walking and general activity items on the MDASI-Interference subscale on day 7 after discharge were highly correlated with prolonged TUGT scores at discharge (P < 0.01). CONCLUSION: We defined clinically meaningful PROs on MDASI-PeriOp-Hep after hepatic resection that predicted increased risk of delayed RIOT. These findings highlight the importance PROs for monitoring symptoms and functioning 1-2 weeks after discharge to be implementing into perioperative care.

Electronic Patient-Reported Outcome-Based Symptom Management Versus Usual Care After Lung Cancer Surgery: Long-Term Results of a Multicenter, Randomized, Controlled Trial.

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.We previously reported superior symptom control of electronic patient-reported outcome (ePRO)-based symptom management after lung cancer surgery for up to 1 month postdischarge. Here, we present the long-term results (1-12 months) of this multicenter, randomized trial, where patients were assigned 1:1 to receive postoperative ePRO-based symptom management or usual care daily postsurgery, twice weekly postdischarge until 1 month, and at 3, 6, 9, and 12 months postdischarge. Long-term patient-reported outcomes were assessed with MD Anderson Symptom Inventory-Lung Cancer module. Per-protocol analyses were performed with 55 patients in the ePRO group and 57 in the usual care group. At 12 months postdischarge, the ePRO group reported significantly fewer symptom threshold events (any of the five target symptom scored ≥4; median [IQR], 0 [0-0] v 0 [0-1]; P = .040) than the usual care group. From 1 to 12 months postdischarge, the ePRO group consistently reported significantly lower composite scores for physical interference (estimate, -0.86 [95% CI, -1.32 to -0.39]) and affective interference (estimate, -0.70 [95% CI, -1.14 to -0.26]). Early intensive ePRO-based symptom management after lung cancer surgery reduced symptom burden and improved functional status for up to 1 year postdischarge, supporting its integration into standard care.

The impact of scrambler therapy on pain and quality of life for chemotherapy-induced peripheral neuropathy: A pilot study.

BACKGROUND: Chemotherapy-induced peripheral neuropathy (CIPN) is a debilitating disturbance among patients who received chemotherapy, with no effective treatment available. Scrambler therapy (ST) is a noninvasive treatment capable of improving multiple quality-of-life symptoms beyond pain. We aimed to evaluate the efficacy of ST for pain and nonpain symptoms related to CIPN. METHODS: Ten patients with moderate to severe CIPN symptoms for >3 months were enrolled in a single-arm trial of ST for 10 daily sessions. CIPN-related symptoms were measured throughout the treatment period and up to 6 months thereafter. RESULTS: The worst pain was reduced by 6 months (p = 0.0039). QST demonstrated the greatest improvement in pressure of 60 g (p = 0.308, Cohen's d = 0.42) and cold temperature threshold of 2.5°C (p = 0.9375, Cohen's d = 0.51) in the gastrocnemius area. Symptoms of numbness, tingling, trouble walking, and disturbed sleep had significant improvements at 6 months. Pain medication use decreased by 70% at the end of treatment and by 42% at 6 months. Patient satisfaction was high (82%) and no adverse events with ST treatment were reported. CONCLUSIONS: The results of this pilot trial support the use of ST by demonstrating improvement in multiple domains of quality of life for CIPN patients during an extended follow-up of 6 months. However, further large-scale studies are needed to confirm our findings.

The Symptom Experience of Patients with Advanced Melanoma Undergoing Immune Checkpoint Inhibitor (ICI) Therapy.

OBJECTIVES: The advent of immune checkpoint inhibitor (ICI) therapy has vastly improved outcomes for patients with advanced melanoma. However, the symptom burden and intensity with their impact on quality-of-life (HRQoL) and functionality are heterogeneous and unpredictable. We used descriptive exploratory content analysis from interviews to capture the patient experience after they had completed quantitative data collection of their symptom burden and interference with the use of two patient-reported outcome (PRO) instruments. DATA SOURCES: Participants from a single center with advanced melanoma (n = 19) who are undergoing ICI therapy completed the Modified MD Anderson Symptom Inventory and Functional Assessment of Cancer Therapy-Melanoma and recorded semistructured interviews. Interpretive description informed the inductive and iterative analysis approach. CONCLUSION: Participants had a heterogenous experience of ICI and melanoma-related symptoms: distress (84%), fatigue (68%), rash or skin changes (53%), pain (30%), diarrhea (30%), itching (26%), and shortness of breath (21%), with varying interference within HRQoL domains, mood (47%), relations with other people (26%), and activity (21%). Some noted a lack of physical interference (79%). Uncertainty was a pervasive theme in the interviews (68%) despite the majority having positive thoughts about ICI therapy (58%) and expectations of the success of therapy (53%). The physical and emotional burden of a melanoma diagnosis, undergoing therapy, and the uncertainty of the outcomes are pervasive for patients. IMPLICATIONS FOR NURSING PRACTICE: Communication surrounding the diagnosis, prognosis, treatment options, and outcomes need to be clear and acknowledge there are unknowns. Nurses may benefit from using a validated PRO instrument to help document and understand the patient's symptom experience while undergoing ICI therapy.

Are Published Cancer Care Trial Protocols With Traditional Chinese Medicine Interventions Concordant With SPIRIT-TCM Extension 2018? A Scoping Review on Published Trial Protocols Between 2019 and 2022.

BACKGROUND: The SPIRIT-TCM Extension 2018 was created to guide the design and reporting of Traditional Chinese Medicine (TCM) clinical trial protocols. This study aims to investigate the extent of concordance with this guideline in the relevant field of cancer care research. METHODS: A scoping review of TCM cancer trial protocols published in English and Chinese since January 2019 was conducted. Five major academic databases (MEDLINE, EMBASE, CINAHL, CENTRAL, and China National Knowledge Infrastructure) were searched. Concordance with the SPIRIT-TCM Extension 2018 was assessed by descriptive analysis. RESULTS: Fifty-three TCM cancer care trial protocols were identified, comprising 23 acupuncture, 26 Chinese herbal medicine (CHM), and 4 Tai Chi/Qigong (TCQ) interventions. The majority of the checklist items had a low rate of concordance, especially in the reporting of quality control and safety, dosage, TCM diagnostic patterns, possible interactions between Western Medicine and TCM interventions, and TCM-related outcome assessments. CONCLUSIONS: Although the SPIRIT-TCM Extension 2018 guideline was established through extensive Delphi consultation, there are low rates of concordance between published TCM cancer care clinical trial protocols with the guideline. Further research is necessary to understand the low rate of concordance and how scientific rigors of reporting can be improved in TCM cancer care research.

National survey on the availability of oncology palliative care services at tertiary general and cancer hospitals in China.

BACKGROUND: This nationwide survey studied the level of palliative care (PC) access for Chinese patients with cancer among cancer care providers either in tertiary general hospitals or cancer hospitals in China. METHODS: Using a probability-proportionate-to-size method, we identified local tertiary general hospitals with oncology departments to match cancer hospitals at the same geographic area. A PC program leader or a designee at each hospital reported available PC services, including staffing, inpatient and outpatient services, education, and research, with most questions adapted from a previous national survey on PC. The primary outcome was availability of a PC service. RESULTS: Most responders reported that some type of PC service (possibly called "comprehensive cancer care," "pain and symptom management," or "supportive care") was available at their institution (84.3% of tertiary general hospitals, 82.8% of cancer hospitals). However, cancer hospitals were significantly more likely than tertiary general hospitals to have a PC department or specialist (34.1% vs. 15.5%, p < 0.001). The most popular services were pain consultation (> 92%), symptom management (> 77%), comprehensive care plans (~ 60%), obtaining advanced directives and do-not-resuscitate orders (~ 45%), referrals to hospice (> 32%), and psychiatric assessment (> 25%). Cancer hospitals were also more likely than tertiary general hospitals to report having inpatient beds for PC (46.3% vs. 30.5%; p = 0.010), outpatient PC clinics (28.0% vs. 16.8%; p = 0.029), educational programs (18.2% vs. 9.0%, p = 0.014), and research programs (17.2% vs. 9.3%, p < 0.001). CONCLUSIONS: Cancer hospitals are more likely to offer PC than are tertiary general hospitals in China. Our findings highlight opportunities to further increase the PC capacity in Chinese hospitals.

Trans-pacific multicenter collaborative study of minimally invasive proximal versus total gastrectomy for proximal gastric and gastroesophageal junction cancers.

BACKGROUND: The current standard operation for proximal gastric and gastroesophageal junction (P/GEJ) cancers with limited esophageal extension is total gastrectomy (TG). TG is associated with impaired appetite and weight loss due to the loss of gastric functions such as production of ghrelin and with anemia due to intrinsic factor loss and vitamin B12 malabsorption. Theoretically, proximal gastrectomy (PG) can mitigate these problems by preserving gastric function. However, PG with direct esophagogastric reconstruction is associated with severe postoperative reflux, delayed gastric emptying, and poor quality of life (QoL). Minimally invasive PG (MIPG) with antireflux techniques has been increasingly performed by experts but is technically demanding owing to its complexity. Moreover, the actual advantages of MIPG over minimally invasive TG (MITG) with regards to postoperative QoL are unknown. Our overall objective of this study is to determine the short-term QoL benefits of MIPG. Our central hypotheses are that MIPG is safe and that patients have improved appetite after MIPG with effective antireflux techniques, which leads to an overall QoL improvement when compared with MITG. METHODS: Enrollment of a total of 60 patients in this prospective survey-collection study is expected. Procedures (MITG versus MIPG, antireflux techniques for MIPG [double-tract reconstruction versus the double-flap technique]) will be chosen based on surgeon and/or patient preference. Randomization is not considered feasible because patients often have strong preferences regarding MITG and MIPG. The primary outcome is appetite level (reported on a 0-10 scale) at 3 months after surgery. With an expected 30 patients per cohort (MITG versus MIPG), this study will have 80% power to detect a one-point difference in appetite level. Patient-reported outcomes will be longitudinally collected (including questions about appetite and reflux), and specific QoL items, body weight, body mass index and ghrelin, albumin, and hemoglobin levels will be compared. DISCUSSION: Surgeons from the US, Japan, and South Korea formed this collaboration with the agreement that the surgical approach to P/GEJ cancers is an internationally important but controversial topic that requires immediate action. At the completion of the proposed research, our expected outcome is the establishment of the benefit and safety of MIPG. TRIAL REGISTRATION: This trial was registered with Clinical Trials Reporting Program Registration under the registration number NCI-2022-00267 on January 11, 2022, as well as with ClinicalTrials.gov under the registration number NCT05205343 on January 11, 2022.

Compound Kushen Injection Reduces Severe Toxicity and Symptom Burden Associated With Curative Radiotherapy in Patients With Lung Cancer.

BACKGROUND: Radiotherapy (RT) causes adverse events for which there are no effective treatments. This study investigated the clinical benefits of compound Kushen injection (CKI) in managing radiation injury in patients with lung cancer. METHODS: A multicenter, open-label, randomized clinical trial randomly assigned patients with lung cancer to receive either CKI (20 mL/d for at least 4 weeks) integrated with curative RT (RT + CKI group; n=130) or RT alone (control group; n=130). The primary outcome was the incidence of grade ≥2 radiation-induced lung injury (RILI) in the lungs, esophagus, or heart. Secondary outcomes included patient-reported symptoms, quality of life, objective response rate (ORR), and toxic effects. RESULTS: During the 16-week trial, the RT + CKI group had a significantly lower incidence of grade ≥2 RT-related injury than the control group (12.3% [n=16] vs 23.1% [n=30]; P=.02). Compared with the control group, the RT + CKI group experienced a significant decrease in moderate-to-severe symptoms of fatigue, cough, and pain (P<.001 for the treatment and time interaction term); significantly less physical symptom interference (P=.01); and significantly better quality of life by the end of the trial (P<.05). No statistically significant difference in ORR was found. Adverse reactions associated with CKI were rare. CONCLUSIONS: This study demonstrated low toxicity of CKI and its effectiveness in patients with lung cancer in reducing the incidence of grade ≥2 RILI and symptom burden, improving patients' quality of life.

Utility of Patient-Reported Symptom and Functional Outcomes to Indicate Recovery after First 90 Days of Radical Cystectomy: A Longitudinal Study.

This is a longitudinal prospective study that tracked multiple symptom burden and functioning status for bladder cancer (BLC) patients for 3 months post-radical cystectomy at The University of Texas MD Anderson Cancer Center, using a validated disease-specific patient-reported outcome measure (PROM) tool, the MD Anderson Symptom Inventory (the MDASI-PeriOp-BLC). The feasibility of collecting an objective measure for physical functioning, using "Timed Up & Go test" (TUGT) and PRO scores at baseline, discharge and end of study, was tested. Patients (n = 52) received care under an ERAS pathway. The more severe scores of fatigue, sleep disturbance, distress, drowsiness, frequent urination and urinary urgency at baseline predicted poor functional recovery postoperatively (OR = 1.661, 1.039-2.655, p = 0.034); other more severe symptoms at discharge (pain, fatigue, sleep disturbance, lack of appetite, drowsiness, bloating/abdominal tightness) predicted poor functional recovery (OR = 1.697, 1.114-2.584, p = 0.014) postoperatively. Compliance rates at preoperative, discharge and end of study were 100%, 79% and 77%, while TUGT completion rates were 88%, 54% and 13%, respectively. This prospective study found that more severe symptom burden at baseline and discharge is associated with poor functional recovery post-radical cystectomy for BLC. The collection of PROs is more feasible than using performance measures (TUGT) of function following radical cystectomy.

Recommendations on the use of item libraries for patient-reported outcome measurement in oncology trials: findings from an international, multidisciplinary working group.

The use of item libraries for patient-reported outcome (PRO) measurement in oncology allows for the customisation of PRO assessment to measure key health-related quality of life concepts of relevance to the target population and intervention. However, no high-level recommendations exist to guide users on the design and implementation of these customised PRO measures (item lists) across different PRO measurement systems. To address this issue, a working group was set up, including international stakeholders (academic, independent, industry, health technology assessment, regulatory, and patient advocacy), with the goal of creating recommendations for the use of item libraries in oncology trials. A scoping review was carried out to identify relevant publications and highlight any gaps. Stakeholders commented on the available guidance for each research question, proposed recommendations on how to address gaps in the literature, and came to an agreement using discussion-based methods. Nine primary research questions were identified that formed the scope and structure of the recommendations on how to select items and implement item lists created from item libraries. These recommendations address methods to drive item selection, plan the structure and analysis of item lists, and facilitate their use in conjunction with other measures. The findings resulted in high-level, instrument-agnostic recommendations on the use of item-library-derived item lists in oncology trials.

Development and validation of a patient-reported outcome measure to assess symptom burden after chimeric antigen receptor T-cell therapy.

This cross-sectional study aimed to develop and validate a patient-reported outcomes (PROs) assessment tool to assess symptom burden and daily functioning in patients after chimeric antigen receptor (CAR) T-cell therapy, the MD Anderson Symptom Inventory (MDASI-CAR). The items were generated based on literature review, content elicitation interviews with patients, and clinician's review. The patients completed the MDASI core and module, single-item quality-of-life (QoL) measure and Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29). The psychometric validation analysis was based on the acceptability after item reduction process. The final 10 MDASI-CAR module items included tremors, fever/chills, headache, balance, dizziness, attention, difficulty speaking, coughing, sexual dysfunction, and diarrhoea with high internal consistency (Cronbach's alpha: MDASI Core, 0.865; MDASI Interference, 0.915; CAR-T module, 0.746). The MDASI-CAR has excellent known-group validity that was demonstrated by differentiate patients based on patient's performance status (Cohen's d for MDASI core = -1.008, interference = -0.771, module = -0.835). Criterion validity was demonstrated by the significant correlations between the MDASI-CAR composite score, the single QoL item and the relevant domains on PROMIS-29 (all p < 0.05). This study established the MDASI-CAR module as a reliable and valid PRO tool for monitoring symptom burden after CAR T-cell therapy in patients with haematological malignancies. The findings need to be validated with a longitudinal design.

Symptom Trajectories Informing Patient Care After Lung Cancer Surgery: A Longitudinal Patient-Reported Outcome Study.

BACKGROUND: Application of patient-reported outcomes (PROs) in surgical oncology has been limited because of patient heterogeneity. We analyzed symptom trajectories and their associations with recovery outcomes after lung cancer surgery, aiming to profile the heterogeneity of patients' experiences and to identify patients needing extensive care. METHODS: Symptoms were assessed with the MDASI-LC before surgery, daily after surgery in hospital and weekly within 1 month after discharge. Patients were clustered based on symptoms from post-operative day 1 (POD1) to POD5, using the latent-class-trajectory-model. Functional recovery was compared across the trajectories. Logistic regression was used to explore risk factors for trajectories of more severe symptoms. RESULTS: Based on the five most severe post-surgery symptoms (pain, fatigue, coughing, shortness of breath, and disturbed sleep), we identified three distinct symptom trajectories among 424 patients [mild, N = 225 (53.07%); severe-to-mild, N = 86 (20.28%); severe, N = 104 (24.53%)]. At discharge, more 'severe' patients (73.96%) did not achieve a functional recovery compared with those in mild (32.54%, P < 0.0001) or severe-to-mild (56.96%, P = 0.0274) groups. Factors of significant symptom increase on POD1 were younger-than-55 (OR = 1.94 [95% CI 1.30-2.93], P = 0.001), undergoing open or multi-port video-assisted thoracoscopic surgery (OR = 1.59 [95% CI 1.05-2.41], P = 0.03), and using two chest tubes (OR = 1.72 [95% CI 1.12-2.65], P = 0.01). For patients experiencing dramatic symptom increase on POD1, older age (OR = 2.51 [95% CI 1.40-4.59], P = 0.002) was associated with 'severe' trajectory. CONCLUSIONS: This study demonstrated that PRO measures were capable of profiling heterogeneous symptom trajectories after lung cancer surgery. Those in-hospital trajectories were able to differentiate patients' responses to treatments and signal the needs for extensive post-discharge care.

Patient-reported symptoms at discharge and risk of complications after gynecologic surgery.

OBJECTIVE: Current gaps in knowledge limit clinicians from fully implementing patient-reported outcomes in routine post-operative care. METHODS: This prospective study assessed symptoms via the gynecologic module of the MD Anderson Symptom Inventory (MDASI-PeriOp-GYN) in patients who underwent open laparotomy. RESULTS: At discharge, patient-reported moderate to severe (≥4 on a 0-10 scale) abdominal bloating or abdominal cramping, combined with length of stay of ≥4 days, were found to be associated with a higher risk of 30-day post-operative grade II-IV complications by the Clavien-Dindo system (all p values <0.01). Also, length of stay of ≥4 days and moderate to severe urinary urgency at discharge were found to be associated with the need for re-admission (all p values <0.01). CONCLUSION: This study defined the clinically meaningful symptoms that related to the risk of developing important complications after discharge from major open gynecological surgery.These findings support the integration of assessment of patient-reported outcomes into patient-centered post-operative care.

Opioid-sparing anesthesia and patient-reported outcomes after open gynecologic surgery: a historical cohort study.

PURPOSE: Dexmedetomidine and ketamine may be administered intraoperatively as continuous infusions to provide opioid-sparing anesthesia. Recent evidence has yielded controversial results regarding the impact of opioid-free anesthesia on postoperative complications, and there is a gap in knowledge regarding patient-reported outcomes (PROs). This study aimed to determine the impact of opioid-sparing anesthesia and opioid-based anesthesia on PROs among gynecologic patients within an enhanced recovery after surgery (ERAS) program. METHODS: We formed a single-center historical cohort from patients enrolled in another study who underwent open gynecologic surgery on an ERAS program from November 2014 to December 2020 (n = 2,095). We identified two cohorts based on the type of balanced anesthesia administered: 1) opioid-sparing anesthesia defined as the continuous infusion of dexmedetomidine and ketamine (adjuvants) during surgery or 2) opioid-based anesthesia (no adjuvants). We measured the quality of postoperative recovery using the MD Anderson Symptom Inventory (MDASI), a 29-item validated tool that was administered preoperatively, daily while admitted, and weekly after discharge until week 6. The primary outcome was interference with walking. We matched both cohorts and used a multilevel linear mixed-effect model to evaluate the effect of opioid-sparing anesthesia on the primary outcome. RESULTS: In total, 498 patients were eligible (159 in the opioid-sparing anesthesia cohort and 339 in the opioid-based anesthesia cohort), of whom 149 matched pairs were included in the final analysis. Longitudinal assessment showed no significant or clinically important difference in interference with walking (P = 0.99), general activity (P = 0.99), or other PROs between cohorts. Median [interquartile range (IQR)] intraoperative opioid administration (expressed as morphine milligram equivalents [MME]) among matched patients in the opioid-sparing anesthesia cohort was 30 [25-55] mg vs 58 [8-70] mg in the opioid-based anesthesia cohort (P < 0.01). Patients in the opioid-sparing anesthesia cohort had a lower opioid consumption in the postanesthesia care unit than those in the opioid-based anesthesia cohort (MME, 3 [0-10] mg vs 5 [0-15] mg; P < 0.01), but there was no significant difference between cohorts in total postoperative opioid consumption (MME, 23 [0-94] mg vs 35 [13-95] mg P = 0.053). CONCLUSIONS: In this single-center historical cohort study, opioid-sparing anesthesia had no significant or clinically important effects on interference with walking or other PROs in patients undergoing gynecologic surgery compared with opioid-based anesthesia. Opioid-sparing anesthesia was associated with less short-term opioid consumption than opioid-based anesthesia.

RéSUMé: OBJECTIF: La dexmédétomidine et la kétamine peuvent être administrées en peropératoire sous forme de perfusions continues pour fournir une anesthésie avec épargne opioïde. Des données probantes récentes ont présenté des résultats controversés concernant l'impact d'une anesthésie sans opioïdes sur les complications postopératoires, et il existe une lacune dans les connaissances concernant les issues rapportées par les patients (IRP). Cette étude visait à déterminer l'impact d'une anesthésie avec épargne opioïde et d'une anesthésie à base d'opioïdes sur les IRP chez les patientes de chirurgie gynécologique dans le cadre d'un programme de Récupération rapide après la chirurgie (ERAS ­ Enhanced Recovery After Surgery). MéTHODE: Nous avons formé une cohorte historique monocentrique composée de patientes inscrites à une autre étude qui ont bénéficié d'une chirurgie gynécologique avec laparotomie dans le cadre d'un programme d'ERAS entre novembre 2014 et décembre 2020 (n = 2095). Nous avons identifié deux cohortes en fonction du type d'anesthésie équilibrée administrée : 1) anesthésie avec épargne opioïde, définie comme une perfusion continue de dexmédétomidine et de kétamine (adjuvants) pendant la chirurgie, ou 2) anesthésie à base d'opioïdes (sans adjuvants). Nous avons mesuré la qualité de la récupération postopératoire à l'aide de l'inventaire des symptômes MDASI, un outil validé comportant 29 éléments qui a été administré avant l'opération, quotidiennement pendant l'admission et chaque semaine après le congé jusqu'à la semaine 6. Le critère d'évaluation principal était l'interférence avec la marche. Nous avons apparié les deux cohortes et utilisé un modèle linéaire à effets mixtes à plusieurs niveaux pour évaluer l'effet de l'anesthésie avec épargne opioïde sur le critère d'évaluation principal. RéSULTATS: Au total, 498 patientes étaient éligibles (159 dans la cohorte d'anesthésie avec épargne opioïde et 339 dans la cohorte d'anesthésie à base d'opioïdes), dont 149 paires appariées ont été incluses dans l'analyse finale. L'évaluation longitudinale n'a révélé aucune différence significative ou cliniquement importante dans l'interférence avec la marche (P = 0,99), l'activité générale (P = 0,99), ou d'autres IRP entre les deux cohortes. L'administration médiane d'opioïdes peropératoires [écart interquartile (ÉIQ)] (exprimée en équivalents de morphine en milligrammes [EMM]) chez les patientes appariées de la cohorte d'anesthésie avec épargne opioïde était de 30 [25-55] mg vs 58 [8­70] mg dans la cohorte d'anesthésie à base d'opioïdes (P < 0,01). Les patientes de la cohorte d'anesthésie avec épargne opioïde avaient une consommation d'opioïdes plus faible en salle de réveil que celles de la cohorte d'anesthésie à base d'opioïdes (EMM, 3 [0-10] mg vs 5 [0­15] mg; P < 0,01), mais il n'y avait pas de différence significative entre les cohortes dans la consommation totale d'opioïdes postopératoires (EMM, 23 [0-94] mg vs 35 [13­95] mg; P = 0,053). CONCLUSION: Dans cette étude de cohorte historique monocentrique, l'anesthésie avec épargne opioïde n'a eu aucun effet significatif ou cliniquement important sur l'interférence avec la marche ou d'autres IRP chez les patientes bénéficiant d'une chirurgie gynécologique par rapport à l'anesthésie à base d'opioïdes. L'anesthésie avec épargne opioïde était associée à une consommation d'opioïdes moindre à court terme que l'anesthésie à base d'opioïdes.

Validation and Application of MD Anderson Symptom Inventory Module for Patients with Bladder Cancer in the Perioperative Setting.

Objectives: We developed and validated a disease-specific tool for perioperative patient-reported outcomes assessment for bladder cancer (BLC) patients undergoing radical cystectomy, The MD Anderson Symptom Inventory (the MDASI-PeriOp-BLC). Methods: Patients who underwent radical cystectomy were recruited. We used qualitative interviews and experts' input to generate disease/treatment-specific items of the MDASI-PeriOp-BLC module; conducted item reduction; examined the psychometric properties of the resultant items for reliability, validity, and clinical interpretability; and conducted cognitive debriefing interviews to assess the tool's performance. Results: A total of 150 BLC patients contributed to psychometric validation. We identified and defined eight BLC-specific module items (blood in urine, leaking urine, frequent urination, urinary urgency, burning with urination, constipation, changes in sexual function, and stomal problems). We included those 8 items in addition to 13 MDASI core symptoms and 6 interference items to form the MDASI-PeriOp-BLC module. Cronbach alphas were 0.89 and 0.90 for the 21 severity items and the 6 interference items, respectively. Test−retest reliability (intra-class correlation) was 0.92 for the 21 severity items. The MDASI-PeriOp-BLC module significantly differentiated the patients by performance status (p < 0.0001). Conclusions: The MDASI-PeriOp-BLC is a valid, reliable, and concise tool for monitoring symptom burden during perioperative care in BLC patients undergoing radical cystectomy.

Identifying patients who suffered from post-discharge cough after lung cancer surgery.

PURPOSE: To establish a discharge cutoff point (CP) on a simple patient-reported cough score to identify patients requiring post-discharge cough intervention. METHODS: Data were extracted from a prospective cohort study of patients undergoing lung cancer surgery. Symptoms were assessed using the MD Anderson Symptom Inventory-Lung Cancer Module. Group-based trajectory modeling was used to identify patient subgroups defined by post-discharge cough trajectories. Generalized linear model and bootstrap resampling with 2000 samples were used to determine the optimal cutoff points of discharge cough scores and their robustness. Analysis of variance, chi-square test, and mixed-effects model were used to validate the optimal cutoff points. RESULTS: The cough trajectories of post-discharge followed three patterns (high, middle, low); higher cough was associated with poor recovery of the enjoyment of life within 4 weeks after discharge (P < 0.001). The CP (3, 6) of discharge cough demonstrated as the optimal CP (F = 21.72). When discharged, 45.66% (179/392) of patients suffered a none/mild cough (0-2 points), 41.82% (164/392) suffered a moderate cough (3-5 points), and 12.5% (49/392) suffered a severe cough (6-10 points). Among these patients, there was a significant difference in the proportion of returning to work at 1 month after discharge (non-mild: 77.70%; moderate: 60.74%; severe: 48.57%; p < 0.001). CONCLUSIONS: Moderate-to-severe cough is relatively common in patients undergoing lung cancer surgery, and the higher the cough trajectory, the worse the recovery to normal life. Therefore, these patients with a cough score ≥ 3 or ≥ 6 at discharge may require additional medical intervention and extensive care.