scholarly journals Patient-Reported Outcome-Based Symptom Management Versus Usual Care After Lung Cancer Surgery: A Multicenter Randomized Controlled Trial

2022 ◽  
Author(s):  
Wei Dai ◽  
Wenhong Feng ◽  
Yuanqiang Zhang ◽  
Xin Shelley Wang ◽  
Yangjun Liu ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Usual Care ◽  
Symptom Management ◽  
Intervention Group ◽  
Lung Cancer Surgery ◽  
Patient Reported Outcome ◽  
Cancer Surgery ◽  
Interquartile Range ◽  
Control Group ◽  
Patient Reported

PURPOSE We aimed to evaluate the efficacy and feasibility of patient-reported outcome (PRO)-based symptom management in the early period after lung cancer surgery. METHODS Before surgery, patients with clinically diagnosed lung cancer were randomly assigned 1:1 to receive postoperative PRO-based symptom management or usual care. All patients reported symptoms on MD Anderson Symptom Inventory-Lung Cancer presurgery, daily postsurgery, and twice a week after discharge for up to 4 weeks via an electronic PRO system. In the intervention group, treating surgeons responded to overthreshold electronic alerts driven by any of the five target symptom scores (score ≥ 4 on a 0-10 scale for pain, fatigue, disturbed sleep, shortness of breath, and coughing). The control group patients received usual care and no alerts were generated. The primary outcome was the number of symptom threshold events (any target symptom with a score of ≥ 4) at discharge. Per-protocol analyses were conducted. RESULTS Of the 166 participants, 83 were randomly allocated to each group. At discharge, the intervention group reported fewer symptom threshold events than the control group (median [interquartile range], 0 [0-2] v 2 [0-3]; P = .007). At 4 weeks postdischarge, this difference was maintained between the intervention and control groups (median [interquartile range], 0 [0-0] v 0 [0-1]; P = .018). The intervention group had a lower complication rate than the control group (21.5% v 40.6%; P = .019). Surgeons spent a median of 3 minutes managing an alert. CONCLUSION PRO-based symptom management after lung cancer surgery showed lower symptom burden and fewer complications than usual care for up to 4 weeks postdischarge.

scholarly journals Using patient-reported outcomes to manage postoperative symptoms in patients with lung cancer: protocol for a multicentre, randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e030041
Author(s):  
Wei Dai ◽  
Yuanqiang Zhang ◽  
Wenhong Feng ◽  
Xiaoqing Liao ◽  
Yunfei Mu ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Symptom Management ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Intervention Group ◽  
Postoperative Recovery ◽  
Control Group ◽  
Oncological Treatment ◽  
Study Results ◽  
Patient Reported

IntroductionSurgery is one of the primary treatments for lung cancer. The postoperative symptom burden experienced by patients with lung cancer is substantial, seriously delaying their recovery from surgery and impairing their quality of life. Patient-reported outcome (PRO)-based symptom management is increasingly regarded as an optimal model for patient-centred care. Currently, clinical trial-based evidence involving early-phase (immediately after surgery for up to 1 month) symptom management of lung cancer is lacking. We propose a randomised trial to evaluate the effect of a PRO-based symptom-monitoring programme with overthreshold alerts and responses for postoperative recovery in patients with lung cancer.Methods and analysisThe study will recruit 160 patients with lung cancer from six hospitals. The patients will be randomly allocated to the intervention group or control group in a ratio of 1:1. Patients in the intervention group will receive PRO-based symptom management from the specialists when their reported target symptom (pain, coughing, fatigue, disturbed sleep and shortness of breath) scores reach the preset threshold (score ≥4). Patients in the control group will not generate alerts and will follow the standard procedures for symptom management. All patients will receive symptom assessments via the MD Anderson Symptom Inventory—lung cancer module on the day before surgery, daily after surgery and twice a week after discharge until 4 weeks or the start of postoperative oncological treatment. The primary outcome—mean symptom threshold events—will be compared between the intervention and control group via independent sample Student’s t-test.Ethics and disseminationThe study was approved by the Ethics Committee of Sichuan Cancer Hospital on 22 November 2018 (No. SCCHEC-02-2018-045). This manuscript is based on V.2.0, 9 May 2019 of the protocol. The study results will be disseminated in publications in peer-reviewed journals and presentations at academic conferences.Trials registration numberChiCTR1900020846.

scholarly journals Developing and validating utility parameters to establish patient-reported outcome-based perioperative symptom management in patients with lung cancer: a multicentre, prospective, observational cohort study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e030726
Author(s):  
Wei Dai ◽  
Shaohua Xie ◽  
Rui Zhang ◽  
Xing Wei ◽  
Chuanmei Wu ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Symptom Management ◽  
Lung Cancer Surgery ◽  
Symptom Assessment ◽  
Patient Reported Outcome ◽  
Medical Intervention ◽  
Optimal Time ◽  
Symptom Scale ◽  
Time Points ◽  
Patient Reported

IntroductionPatient-reported outcome-based symptom monitoring and alerting have been attractive for patient care after a tumour-removal surgery. However, the implementation parameters of this patient-centred symptom management system in perioperative patients with lung cancer are still lacking. We aim to develop a perioperative symptom scale (PSS) for monitoring, to determine the optimal time points for symptom assessment and to define the alert thresholds for medical intervention.Methods and analysisThis study will prospectively recruit 300 patients undergoing lung cancer surgery in six hospitals. The MD Anderson Symptom Inventory–Lung Cancer Module (MDASI-LC) is used to collect longitudinal symptom data preoperatively, daily postoperatively during in-hospital stay and weekly after discharge until 4 weeks or the start of postoperative oncological therapy. Symptoms that change significantly over time will be generated as the PSS. We will determine the optimal time points for follow-up using the generalised linear mixed-effects models. The MDASI-LC interference-measured functional status will be used as the anchor for the alert thresholds.Ethics and disseminationEthics Committee of Sichuan Cancer Hospital approved this study on 16 October 2017 (No. SCCHEC-02-2017-042). The manuscript is based on the latest protocol of Version 3.0, 15 September 2019. The results of this study will be presented at medical conferences and published in peer-reviewed journals.Trials registration numberNCT03341377.

Discrepancy in perception of symptoms among patients and medical staff after lung cancer surgery

2021 ◽  
Author(s):  
Xing Wei ◽  
Hongfan Yu ◽  
Wei Dai ◽  
Wei Xu ◽  
Qingsong Yu ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Medical Staff ◽  
Qualitative Interviews ◽  
Lung Cancer Surgery ◽  
Cancer Surgery ◽  
Disturbed Sleep ◽  
Open Questions ◽  
Patient Reported ◽  
Postoperative Symptoms ◽  
Cancer Experience

Abstract Context: Patients undergoing surgery for lung cancer experience a variety of symptoms such as pain and coughing, which interfere patients’ daily function after surgery. However, there may be some differences between the perception of symptoms by medical staff and the actual situation of patients. Objectives This study aimed to investigate patient’s experiences after lung cancer surgery and analyze whether the perception of postoperative symptoms by the medical staff differed from that reported by patients. Methods Semi-structured qualitative interviews concerning in-hospital experiences were conducted from June 2018 to October 2019 in 39 patients undergoing lung cancer surgery at the Sichuan Cancer Hospital. Moreover, 22 thoracic medical staff were instructed to answer open questions about their perception of symptoms related to the lung cancer surgery. Types and frequencies of symptoms from patients and medical staff were compared. Results Thirty-nine patients were interviewed, and 22 medical staff from the Department of Thoracic Surgery were investigated. The most frequent patient-reported symptoms were pain (967 times, 39 patients, 100%), coughing (904 times, 37 patients, 94.87%), shortness of breath (491 times, 35 patients, 89.74%), disturbed sleep (412 times, 34 patients, 87.18%), and interference with walking (347 times, 36 patients, 92.31%). Of the above symptoms, four were perceived by medical staff, whereas interference with walking was replaced by fatigue. Conclusion Although the medical staff and patients had a certain consensus on main symptoms, differences in perception still exist. Medical staff need to pay more attention to postoperative interference with walking.

Robot-assisted training after proximal humeral fracture: A randomised controlled multicentre intervention trial

2020 ◽  
pp. 026921552096165
Author(s):  
Inga Kröger ◽  
Corinna Nerz ◽  
Lars Schwickert ◽  
Sabine Schölch ◽  
Janina Anna Müßig ◽  
...  
Keyword(s):  
Prospective Trial ◽  
Intervention Group ◽  
Humeral Fracture ◽  
Patient Reported Outcome ◽  
Control Group ◽  
Robot Assisted ◽  
Patient Reported ◽  
Usual Therapy ◽  
Randomised Controlled

Objective: To examine whether robotic-assisted training as a supplement to usual therapy is safe, acceptable and improves function and patient reported outcome after proximal humeral fractures (PHF). Design: Multicentre, assessor-blinded, randomised controlled prospective trial. Setting: Three different rehabilitation hospitals in Germany. Subjects: In total 928 PHF patients between 35 and 70 years were screened. Forty-eight participants were included in the study (intervention group n = 23; control group n = 25). Intervention: The control group received usual occupational and physiotherapy over three weeks, and the intervention group received additional 12 robot-assisted training sessions at the ARMEO®-Spring. Main measures: Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH), the Wolf Motor Function Test-Orthopaedic, active range of motion and grip strength were determined before and after intervention period. The DASH was additionally obtained postal 6 and 13 months following surgery. Results: The mean age of participants was 55 ± 10 years and was similar in both groups ( p > 0.05). The change in DASH as the primary endpoint in the intervention group after intervention was −15 (CI = 8–22), at follow-up six month −7 (CI = −2 to 16) at follow up 13 month −9 (CI = 1–16); in control group −14 (CI = 11–18), at follow-up six month −13 (CI = 7–19) at follow up 13 month −6 (CI = −3 to 14). No difference in the change was found between groups ( p > 0.05). None of the follow-up time points demonstrated an additional benefit of the robotic therapy. Conclusion: The additional robot-assisted therapy was safe, acceptable but showed no improvement in functional shoulder outcome compared to usual therapy only.

scholarly journals Improving patient engagement, adherence, and satisfaction in lung cancer surgery with implementation of a mobile device platform for patient reported outcomes

2020 ◽  
Vol 12 (11) ◽  
pp. 6883-6891
Author(s):  
Peter J. Kneuertz ◽  
Niveditha Jagadesh ◽  
Alicia Perkins ◽  
Morgan Fitzgerald ◽  
Susan D. Moffatt-Bruce ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Mobile Device ◽  
Patient Engagement ◽  
Patient Reported Outcomes ◽  
Lung Cancer Surgery ◽  
Cancer Surgery ◽  
Patient Reported

Treatment with and without stabilizing lumbar spinal orthosis after one- or two-level spondylodesis: A randomized controlled trial

2020 ◽  
Vol 28 (5) ◽  
pp. 541-549
Author(s):  
Yorck Rommelspacher ◽  
Hannah Bode ◽  
Jana Ziob ◽  
Charlotte Struwe ◽  
Adnan Kasapovic ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Control Group ◽  
Patient Reported ◽  
Subjective Pain ◽  
Postoperative Mobility ◽  
Lumbar Spinal ◽  
Spinal Orthosis

BACKGROUND AND OBJECTIVE: Musculature affected during spondylodesis surgery may benefit and recover faster if supported by spine orthosis postoperatively. METHODS: This prospective study included 50 consecutive patients undergoing one- or two-level spondylodesis. The intervention group received a lumbar spine orthosis (n= 23), while the control group remained without orthosis (n= 27). Patients were assessed for pain (Visual Analogue Scale, VAS), Oswestry Disability index (ODI) as well as the use of analgesics. RESULTS: Patients wearing an orthosis postoperatively reported a higher degree of subjective stability. However, both intervention as well as control group did not show any significant differences for each of the follow-up points regarding VAS, ODI or the use of analgesics. CONCLUSION: Wearing an orthosis has neither impact on subjective pain, the need for analgesics nor for postoperative functionality. However, patients reported that they profited from wearing the orthosis by feeling more stable, thereby nicely improving their postoperative mobility. Thus, novel patient reported outcome measures have to be developed to assess these features in future studies.

scholarly journals Peer mentorship to improve self-management of hip and knee osteoarthritis: a randomised feasibility trial

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e045389
Author(s):  
Anna M Anderson ◽  
Elizabeth C Lavender ◽  
Esther Dusabe-Richards ◽  
Teumzghi F Mebrahtu ◽  
Linda McGowan ◽  
...  
Keyword(s):  
Usual Care ◽  
Sample Size ◽  
Intervention Group ◽  
Feasibility Trial ◽  
Self Management ◽  
Control Group ◽  
Peer Mentor ◽  
Peer Mentorship ◽  
Knee Oa ◽  
Patient Reported

ObjectiveTo determine the feasibility of conducting a randomised controlled trial (RCT) of a peer mentorship intervention to improve self-management of osteoarthritis (OA).DesignSix-month parallel group non-blinded randomised feasibility trial.SettingOne secondary care and one primary care UK National Health Service Trust.ParticipantsFifty adults aged ≥55 years old with hip and/or knee OA.InterventionsParticipants were allocated 1:1 to the intervention or control group using an online randomisation service. Intervention group participants received usual care (information resources) and up to eight community-based self-management support sessions delivered by a peer mentor (trained volunteer with hip and/or knee OA). Control group participants received usual care only.Outcome measuresKey feasibility outcomes were participant and peer mentor recruitment and attrition, intervention completion and the sample size required for a definitive RCT. Based on these feasibility outcomes, four success criteria for proceeding to a definitive RCT were prespecified. Patient-reported outcomes were collected via questionnaires at baseline, 8 weeks and 6 months.ResultsNinety-six individuals were screened, 65 were eligible and 50 were randomised (25 per group). Of the 24 participants who commenced the intervention, 20 completed it. Four participants did not complete the 6-month questionnaire. Twenty-one individuals were eligible for the peer mentor role, 15 were trained and 5 withdrew prior to being matched with a participant. No intervention-related harms occurred. Allowing for 20% attrition, the sample size required for a definitive RCT was calculated as 170 participants. The intervention group showed improvements in self-management compared with the control group.ConclusionsThe feasibility outcomes achieved the prespecified criteria for proceeding to an RCT. The exploratory analyses suggest peer mentorship may improve OA self-management. An RCT of the OA peer mentorship intervention is therefore warranted with minor modifications to the intervention and trial procedures.Trial registration numberISRCTN:50675542.

scholarly journals Optimising symptom management in children with cancer using a novel mobile phone application: protocol for a controlled hybrid effectiveness implementation trial (RESPONSE)

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Natalie Bradford ◽  
Paula Condon ◽  
Erin Pitt ◽  
Zephanie Tyack ◽  
Kimberly Alexander
Keyword(s):  
Symptom Management ◽  
Controlled Trial ◽  
Intervention Group ◽  
Symptom Burden ◽  
Control Group ◽  
Children With Cancer ◽  
Randomised Study ◽  
Response System ◽  
Implementation Outcomes ◽  
Patient Reported

Abstract Background Intense and aggressive treatment regimens for most children’s cancer have achieved vast improvements in survival but are also responsible for both a high number and burden of symptoms. The use of Patient Reported Outcome Measures (PROMs) demonstrates a range of benefits for improved symptom management in adults with cancer. There are, however, multiple barriers to integrating PROMs into routine care in children and adolescents with cancer. This study aims to evaluate: (1) the effectiveness of electronic PROMs to generate stratified alerts, symptom management recommendations and graphical summaries (the RESPONSE system) to improve health outcomes and (2) the implementation of the RESPONSE system by assessing feasibility, acceptability, satisfaction, and sustainability. Methods A pragmatic hybrid II effectiveness-implementation controlled trial, using mixed methods, will be undertaken, advancing both knowledge of the effectiveness of the intervention and implementation factors. One-hundred and sixty children with cancer receiving active treatment will be recruited 1:1 to a non-randomised study involving two groups with an equal number of participants in each group. The intervention group (n = 80) will be prospectively recruited to receive the RESPONSE system intervention over eight weeks, versus the historical matched control group (n = 80) who will complete the ePROMs without access to the RESPONSE system. The primary outcome of the effectiveness trial is change between groups in total symptom burden. Secondary outcomes include child health-related quality-of-life and implementation outcomes. Trial data will be analysed using linear mixed-effects models. Formative implementation evaluation is informed by CFIR and ERIC frameworks and implementation outcomes will be mapped to the RE-AIM framework and include interviews, field notes, as well as administrative data to evaluate feasibility, acceptability, satisfaction and sustainability. Trial registration number ACTRN12621001084875. Retrospectively Registered 16 August 2021.

scholarly journals PERIOPERATIVE DEXMEDETOMIDINE REDUCES DELIRIUM IN ELDERLY PATIENTS AFTER LUNG CANCER SURGERY

2018 ◽  
Author(s):  
Ting Huyan ◽  
Xuejiao Hu ◽  
Hourong Peng ◽  
Zheng Zhu ◽  
Qi Li ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Elderly Patients ◽  
Pulmonary Resection ◽  
Rating Scale ◽  
Lung Cancer Surgery ◽  
Cancer Surgery ◽  
Control Group ◽  
High Morbidity ◽  
Care Providers ◽  
Lung Cancer Patients

Background: Delirium, which is one of the most disturbing postoperative complications in elderly patients, shows high morbidity in patients undergoing lung cancer surgery. Dexmedetomidine (DEX) is considered a potential prophylactic agent for preventing patients’ delirium after lung cancer surgery.Subjects and methods: Medical records of lung cancer patients over 65 years old with radical pulmonary resection at Henan Provincial People’s Hospital from January 2015 to December 2017, China, were evaluated. Patients, care-providers, and investigators were all blinded to group assignment. DEX was administered in the preoperative and intraoperative periods. The incidence of delirium was calculated based on the Intensive Care Delirium Screening Checklist (ICDSC). Scores of ≥4 and 1-3 points represent the diagnoses of delirium and a pre-delirious state, respectively.Results: During postoperative day 1(POD 1) to POD 7, delirium occurs in both groups. During postoperative POD 1 to POD 7, the incidence of delirium is lower in the DEX group than that in the control group. Furthermore, there are more mild delirium patients but fewer moderate and severe delirium patients in the DEX group compared with the control group. Finally, patients in the DEX group have a shorter duration of delirium, lower numeric pain rating scale during movement and better sleep quality.Conclusion: Preoperative and intraoperative application of DEX can reduce the incidence and intensity of delirium after pulmonary resection in elderly patients with lung cancer.

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