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.

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.

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.

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.

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.

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.

Establishment of Minimal Clinically Important Improvement for Patient-Reported Symptoms to Define Recovery After Video-Assisted Thoracoscopic Surgery.

PURPOSE: The aim of this study was to define a threshold of minimal clinically important improvement (MCII) for interpreting patient condition following video-assisted thoracoscopic surgery (VATS). METHODS: Patients undergoing VATS were recruited for this multicenter, prospective, observational cohort study. Symptoms were measured using the MD Anderson Symptom Inventory-Lung Cancer Module perioperatively. To define MCIIs, we first identified index symptoms, defined as the most severe symptoms showing the largest reduction from day 1 post-surgery to discharge. MCIIs for each index symptom were then obtained via an anchor-based approach. Symptom recovery was defined as an MCII after post-surgery day 1. Cox regression models were used to identify risk factors for unrecovered index symptoms. RESULTS: Using 366 patients, we identified pain and fatigue as index symptoms after VATS. MCII was defined as a 30% reduction in pain or fatigue. At discharge, 22.6% of patients had not recovered from pain and 22.4% had not recovered from fatigue. Cox models found that risk factors for unrecovered pain were Charlson Comorbidity Index score ≥1 (hazard ratio [HR] 1.36, 95% confidence interval [CI] 1.04-1.77; p = 0.02) and preoperative neoadjuvant therapy (HR 2.78, 95% CI 1.13-6.83; p = 0.02). Malignancy was a risk factor for unrecovered fatigue (HR 1.47, 95% CI 1.02-2.13; p = 0.04). CONCLUSION: Pain and fatigue can be used as index measures for symptom recovery in patients following VATS. A 30% MCII represented meaningful recovery after VATS and could identify patients who may need extensive care after discharge.

Cancer-Related Fatigue Outcome Measures in Integrative Oncology: Evidence for Practice and Research Recommendations.

Cancer-related fatigue (CRF) is one of the most common symptoms across the cancer continuum and is often underreported and undertreated. Defined as a distressing, persistent, subjective sense of tiredness or exhaustion related to cancer or its treatment, CRF includes physical, emotional, cognitive, and spiritual dimensions. Patient-reported outcome (PRO) measures are the most widely used tool to screen for and assess fatigue and the associated negative impacts on quality of life. However, selecting subjective CRF measures can be complex. This has resulted in the availability of and inconsistent use of numerous PROs, limiting the ability to cross-compare outcomes clinically and within research. To address this, the PROs that are most widely reported in the literature are recommended to support the standardization of a core set of validated measures. The National Comprehensive Cancer Network single-item tool for clinical significance is recommended for quick use in clinical environments; the Brief Fatigue Inventory allows for fast, easy, helpful cutoffs on severity threshold for triage, and measures both severity and interference with daily functioning; while the MD Anderson Symptom Inventory allows for multisymptomatic assessment. In addition, a fundamental consideration for any PRO use is the administrative burden on the patient and clinician. In this review, we aim to summarize current, validated PROs specific to CRF to aid clinicians and researchers in patient care and in study design and implementation. We conclude with suggestions for future directions in CRF research that can increase the possibility for long-term impact on future guidelines of fatigue management.

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.

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.

Assessment of physical function by subjective and objective methods in patients undergoing open gynecologic surgery.

OBJECTIVE: To evaluate the utility of patient-reported outcomes (PROs) to measure physical functioning in perioperative care for patients with gynecological (GYN) tumors. METHODS: 180 patients with GYN tumors undergoing open surgery participated in this longitudinal study. The physical functioning was measured by a subjective PRO tool, the Interference subscales of the MD Anderson Symptom Inventory (MDASI-I); as well as by an objective tool, the Timed Up & Go test (TUGT), perioperatively. Longer time (>20 s) needed to complete the TUGT was defined as "Prolonged". Patients completed EuroQoL-5D as well. The association between the scores of MDASI-I items and TUGT was assessed via the Spearman correlation coefficient. The known-group validity was assessed using the t-test and Cohen's D effect size. RESULTS: Compliance rates at preoperative, discharge and postoperative time points of MDASI-I were 98%, 95%, 96%; while TUGT completion rates were 92%, 75%, and 80%, respectively. Patients who had refused TUGT at discharge reported a significantly worse "MDASI-general activity" score compared to patients who completed TUGT (mean score of 7.00 vs. 5.38, P = 0.020). Patient-reported "Walking" on MDASI-I significantly differentiated patients with prolonged vs. those with frail/normal TUGT at discharge (mean score of 4.89 vs. 2.79, Cohen's d effect size = 0.82, P < 0.001). MDASI-I demonstrated excellent known-group validity per performance status and for the EuroQoL-5D subscales. CONCLUSION: Patient-reported physical functioning impairment after GYN surgery correspond with observed worse scores of the objective functioning measure test (TUGT). MDASI-I assessment represents a feasible and valid tool to evaluate functional status and warrants further implementation in the perioperative setting.

Patient-Reported Outcomes of Pain and Related Symptoms in Integrative Oncology Practice and Clinical Research: Evidence and Recommendations.

Pain is a primary concern among patients with cancer and cancer survivors. Integrative interventions such as acupuncture, massage, and music therapy are effective nonpharmacologic approaches for cancer pain with low cost and minimal adverse events. Patient-reported outcomes (PROs) that have been validated in many clinical and research settings can be used to evaluate pain intensity, associated symptom burden, and quality of life. Clearly defined, reliable PROs can improve patient satisfaction and symptom control. As integrative oncology continues to evolve and expand, cancer-related pain PROs must be standardized to accurately guide clinicians and researchers. Well-validated pain PROs, such as the Brief Pain Inventory, are among the most commonly used for pain intensity assessment. Multiple symptom assessment tools such as the MD Anderson Symptom Inventory, the Memorial Symptom Assessment Scale, the Edmonton Symptom Assessment System, and the Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events measurement system can also capture pain-associated symptom burden. Electronic PROs provide flexibility in collecting and analyzing PRO data. Clinical trials using carefully selected PROs and rigorous statistical analysis plans are fundamental to conducting high-quality integrative oncology research and promoting utilization of effective integrative interventions to improve patient outcomes. In this review, we aim to summarize current, validated PROs specific to cancer-related pain to aid integrative oncology clinicians and researchers in patient care and in study design and implementation.

Minocycline for symptom reduction in patients with multiple myeloma during maintenance therapy: a phase II placebo-controlled randomized trial.

BACKGROUND: Patients with multiple myeloma (MM) experience substantial cancer/treatment-related symptom burden during maintenance therapy. This is a phase II randomized, double-blinded, placebo-controlled clinical trial to examine the effect of minocycline for symptom reduction by its potential anti-inflammatory effect. METHODS: Eligible MM patients for maintenance therapy were randomized to receive minocycline (100 mg twice daily) or placebo. The MD Anderson Symptom Inventory for MM (MDASI-MM) was used to assess multiple symptoms weekly during the trial. Clinician-rated toxicities and blood samples were prospectively collected. The effect size, area under the curve (AUC), and t tests were used to determine the symptom burden between treatment groups and identify the 5 most-severe MDASI-MM symptoms. The longitudinal analysis compared the changes in symptom severity and associated inflammatory markers between groups over time. RESULTS: Sixty-nine evaluable MM patients (33 from the intervention group and 36 from the placebo group) were included. No grade 3+ adverse events related to study medication were noted. The AUCs for the 5 worst MDASI-MM symptoms (fatigue, pain, disturbed sleep numbness/tingling, and drowsiness) were not significantly different between two arms. Regardless of group assignment, pain reduction was positively associated with decreased serum levels of soluble tumor necrosis factor-α receptors 1 and 2 during therapy (all P < 0.05). CONCLUSIONS: This pPhase II randomized study observed no statistically significant positive signal impact from minocycline on symptom reduction or inflammatory markers during maintenance therapy for MM, although using minocycline was feasible and had a low toxicity profile.

Symptom burden and its functional impact in patients with "symptomatic" relapsed or refractory multiple myeloma.

PURPOSE: Relapsed or refractory multiple myeloma (RRMM) is labeled "symptomatic" based on laboratory values, but not relevant to quantitative measure of patient's perspectives. This study aimed to describe symptom burden, health status, and quality of life in RRMM patients. METHODS: The cross-sectional study included 184 MM patients (141 RRMM cases and 43 MM patients on follow-up without diagnosis/treatment of RRMM disease as controls), while 64 RRMM patients also provided longitudinal patient-reported outcomes (PROs) data. Symptomatic status was based on clinical measures of disease activity. PROs included the MD Anderson Symptom Inventory multiple myeloma module (MDASI-MM), single-item quality of life (SIQOL), and EuroQol-5D (EQ-5D). Wilcoxon rank test and effect size were used for comparisons. Regression models were used to describe symptom trajectory and to identify predictors of high symptom burden during 3 months of RRMM therapy. RESULTS: Most patients were clinically identified as symptomatic (93%). RRMM patients tended to report more severe symptoms, with significantly lower QOL scores and more severe fatigue, poor appetite, and lower enjoyment of life compared with controls (all p < 0.05). In RRMM patients, lower hemoglobin and higher B-2 microglobulin levels significantly correlated with higher burdens of fatigue, pain, and muscle weakness and also with lower QOL and EQ-5D scores (all p < 0.05). During RRMM therapy, being female, with any comorbidity, ≥ 65 years old, and ≥ 5 years MM history, contributed to high symptoms burden and poor QOL status (each p < 0.05). CONCLUSIONS: MDASI-MM modules were sensitive to detect the RRMM-related symptoms burden, which correlated with objective clinical measures. RRMM patients reported a more compromised QOL.

Longitudinal patient-reported outcomes and restrictive opioid prescribing after minimally invasive gynecologic surgery.

OBJECTIVE: To determine post-discharge patient-reported symptoms before and after implementation of restrictive opioid prescribing among women undergoing minimally invasive gynecologic surgery. METHODS: We compared clinical outcomes and symptom burden among a cohort of 389 women undergoing minimally invasive gynecologic surgery at a single institution before and after implementation of a restrictive opioid prescribing quality improvement initiative in July 2018. Post-discharge symptom burdens were collected up to 42 days after discharge using the MD Anderson Symptom Inventory and analyzed using linear mixed effects models. RESULTS: The majority of women included in this study were white non-smokers and the median age was 55 (range 23-83). Most women underwent hysterectomy (64%), had surgery for malignancy (71%), and were discharged from the hospital on the day of surgery (65%). Women in the restrictive opioid prescribing group had a median reduction in morphine equivalent dose prescribed at discharge of 83%, corresponding to a median reduction in 25 tablets of 5 mg oxycodone per person. There was no difference between opioid prescribing groups in either the rate of refill requests (P=1) or hospital re-admission (P=1) up to 30 days after discharge. After adjustment for co-variates, there was no statistically significant difference in post-discharge symptom burden including patient-reported pain (P=0.08), sleep (P=0.30), walking interference (P=0.64), activity interference (P=0.12), or affective interference (P=0.67). There was a trend toward less reported constiptation in the restrictive opioid prescribing group that did not reach statistical significance (P=0.05). CONCLUSION: We found that restrictive post-operative opioid prescribing was not associated with differences in longitudinal symptom burden among women undergoing minimally invasive gynecologic surgery. These results provide the most comprehensive picture to date of post-operative symptom recovery under different opioid prescribing approaches, lending additional support for existing recommendations to reduce opioid prescribing following gynecologic surgery.

Impact of a tiered discharge opioid algorithm on prescriptions and patient-reported outcomes after open gynecologic surgery.

OBJECTIVE: To compare discharge opioid refills, prescribed morphine equivalent dose and quantity, and longitudinal patient-reported outcomes before and after implementation of a tiered opioid prescribing algorithm among women undergoing open gynecologic surgery within an enhanced recovery after surgery program. METHODS: We compared opioid prescriptions, clinical outcomes, and patient-reported outcomes among 273 women. Post-discharge symptom burden was collected up to 42 days after discharge using the validated 27-item MD Anderson Symptom Inventory and analyzed using linear mixed effects models and Kaplan-Meier curves for symptom recovery. RESULTS: Among 113 pre-implementation and 160 post-implementation patients there was no difference in opioid refills (9.7% vs 11.3%, p=0.84). The post-implementation cohort had a significant reduction in median morphine equivalent dose (112.5 mg vs 225 mg, p<0.01), with no difference in median hospital length of stay (3 days vs 3 days, p=1.0) or 30-day readmission rate (9.4% vs 7.1%, p=0.66). There was no difference in patient-reported pain between the pre- and post-implementation cohorts on the day of discharge (severity 4.93 vs 5.14, p=0.53) or in any patient-reported symptoms, interference measures, or composite scores by post-discharge day 7. The median recovery time for most symptoms was 7 days, except for pain (14 days), fatigue (18 days), and physical interference (21 days), with no differences between cohorts. CONCLUSIONS: After implementation of a tiered opioid prescribing algorithm, the quantity and dose of discharge opioids prescribed decreased with no change in post-operative refills and without negatively impacting patient-reported symptom burden or interference, which can be used to educate and reassure patients and providers.

Persistent Somatic Symptom Burden and Sleep Disturbance in Patients with COVID-19 During Hospitalization and After Discharge: A Prospective Cohort Study.

BACKGROUND The present study was designed to reveal the trajectory of self-reported somatic symptom burden and sleep quality over time in patients with COVID-19 and to identify prognostic factors for greater somatic symptom burden and sleep disturbance. MATERIAL AND METHODS Seventy-four patients with COVID-19 were prospectively followed for longitudinal assessment of somatic symptom burden and sleep quality. We used the 8-item Somatic Symptom Scale (SSS-8) and the modified Medical Research Council (mMRC) scale for somatic symptom burden and the Pittsburgh Sleep Quality Index for sleep quality investigation. Univariate and multivariate analyses were performed to identify independent factors associated with somatic symptom burden and sleep quality. RESULTS Although the degree of physical discomfort and sleep quality issues tended to decline during self-quarantine, patients still experienced these problems to a certain degree. Univariate and multivariate analyses showed that SSS-8 scores at admission (relative risk [RR] 1.234, 95% CI 1.075-1.417, P=0.003) and mMRC scores at discharge (RR 2.420, 95% CI 1.251-4.682, P=0.009) were 2 independent prognostic indicators of somatic symptom burden. In addition, muscle pain as a chief complaint (RR 4.682, 95% CI 1.247-17.580, P<0.022) and history of use of hypnotic drugs (RR 0.148, 95% CI 0.029-0.749, P<0.019) were 2 independent indicators of patient sleep quality during hospitalization. CONCLUSIONS To the best of our knowledge, the present study was the first dynamic assessment of the somatic symptom burden and sleep quality in patients with COVID-19 during hospitalization and quarantine after discharge. Patients with high somatic symptom burden at admission, especially muscle pain as the chief complaint, are prone to having a higher physical burden and more sleep disturbance at discharge.