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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.

ABSTRACT: INTRODUCTION:Patient-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 ANALYSIS:This 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 DISSEMINATION:Ethics 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 NUMBER:NCT03341377.

SUBMITTER: Dai W

PROVIDER: S-EPMC6830688 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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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.

Dai Wei W Xie Shaohua S Zhang Rui R Wei Xing X Wu Chuanmei C Zhang Yuanqiang Y Feng Wenhong W Liao Xiaoqing X Mu Yunfei Y Zhou Heling H Cheng Xuemei X Jiang Yanhua Y He Jintao J Li Qiang Q Yang Xiaojun X Shi Qiuling Q

BMJ open 20191028 10

<h4>Introduction</h4>Patient-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.<h4>M ...[more]

PMID: 31662377

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Project description:BackgroundIt is well established that racism is a fundamental contributor to poor health and inequities. There is consistent evidence of high exposure to discrimination among Aboriginal and Torres Strait Islander (Indigenous Australian) peoples, but impacts have not been fully quantified, in part due to limited measurement tools. We aim to validate instruments developed to measure interpersonal discrimination.MethodsInstruments were discussed at five focus groups and with experts, and field tested in developing Mayi Kuwayu: The National Study of Aboriginal and Torres Strait Islander Wellbeing. Data from 7501 baseline survey participants were analysed. Acceptability was assessed according to extent of missingness, construct validity using exploratory and confirmatory factor analysis, and reliability using Cronbach's alpha. Associations between each instrument and outcomes conceptually understood to be closely (community-level racism) or less closely (family wellbeing) related were quantified to test convergent and discriminant validity.ResultsAn 8-item instrument captures experiences of discrimination in everyday life and a 4-item instrument experiences in healthcare, each followed by a global attribution item. Item missingness was 2.2-3.7%. Half (55.4%) of participants reported experiencing any everyday discrimination, with 65.7% attributing the discrimination to Indigeneity; healthcare discrimination figures were 34.1% and 51.1%. Items were consistent with two distinct instruments, differentiating respondents with varying experiences of discrimination. Scales demonstrated very good reliability and convergent and divergent validity.ConclusionThese brief instruments demonstrate face validity and robust psychometric properties in measuring Aboriginal and Torres Strait Islander adults' experiences of interpersonal discrimination in everyday life and in healthcare. They can be used to quantify population-level experiences of discrimination, and associated wellbeing consequences, and monitor change.

Project description:BackgroundRelapse in schizophrenia may be preceded by early warning signs of biological, sensory, and clinical status. Early detection of warning signs may facilitate intervention and prevent relapses.ObjectiveThis study aims to investigate the feasibility of using wearable devices and self-reported technologies to identify symptom exacerbation correlates and relapse in patients with schizophrenia.MethodsIn this observational study, patients with schizophrenia were provided with remote sensing devices to continuously monitor activity (Garmin vivofit) and sleep (Philips Actiwatch), and smartphones were used to record patient-reported outcomes. Clinical assessments of symptoms (Positive and Negative Syndrome Scale and Brief Psychiatric Rating Scale) were performed biweekly, and other clinical scales on symptoms (Clinical Global Impression-Schizophrenia, Calgary Depression Scale), psychosocial functioning, physical activity (Yale Physical Activity Survey), and sleep (Pittsburgh Sleep Quality Index) were assessed every 4 weeks. Patients were observed for 4 months, and correlations between clinical assessments and aggregated device metrics data were assessed using a mixed-effect model. An elastic net model was used to predict the clinical symptoms based on the device features.ResultsOf the 40 patients enrolled, 1 patient relapsed after being stable with evaluable postbaseline data. Weekly patient-reported outcomes were moderately correlated with psychiatric symptoms (Brief Psychiatric Rating Scale total score, r=0.29; Calgary Depression Scale total score, r=0.37; and Positive and Negative Syndrome Scale total score, r=0.3). In the elastic net model, sleep and activity features derived from Philips Actigraph and Garmin vivofit were predictive of the sitting index of the Yale Physical Activity Survey and sleep duration component of the Pittsburgh Sleep Quality Index. On the basis of the combined patient data, a high percentage of data coverage and compliance (>80%) was observed for each device.ConclusionsThis study demonstrated that wearable devices and smartphones could be effectively deployed and potentially used to monitor patients with schizophrenia. Furthermore, metrics-based prediction models can assist in detecting earlier signs of symptom changes. The operational learnings from this study may provide insights to conduct future studies.Trial registrationClinicalTrials.gov NCT02224430; https://www.clinicaltrials.gov/ct2/show/NCT02224430.

Project description:BackgroundResearch has shown that routinely assessed, patient-reported outcome measures (PROMs) have positive effects in patients with advanced oncologic diseases. However, the transferability of these results to specialist palliative care is uncertain because patients are more impaired and staff doubt the feasibility and benefits. The aim of this study is to evaluate the feasibility of patient self-assessment of PROMs, their use by staff and the benefits in palliative care wards.MethodA multicentre observational study was conducted in the context of the implementation of the Integrated Patient Outcome Scale (IPOS) in three specialist palliative care wards at university hospitals in Germany. All admitted patients who screened positive regarding their ability to complete questionnaires were asked to participate and complete the IPOS on paper weekly, with assistance if necessary. Feasibility of questionnaire completion (e.g. proportion of patients able to complete them), use (e.g. involvement of different professional groups) and benefit (e.g. unexpected information in IPOS as rated by treating physicians) were assessed. Staff members' opinion was obtained in a written, anonymous evaluation survey, patients' opinion in a short written evaluation.ResultsA total of 557 patients were screened for eligibility, 235 were assessed as able to complete the IPOS (42.2%) and 137 participated in the study (24.6%). A majority needed support in completing the IPOS; 40 staff members and 73 patients completed the evaluation. Unexpected information was marked by physicians in 95 of the 137 patient questionnaires (69.3%). The staff differed in their opinions on the question of whether this also improved treatment. A majority of 32 staff members (80.0%) were in favour of continuing the use of IPOS (4 against continuation, 4 no answer); 43 (58.9%) patients rated their overall experience of IPOS use as 'positive', 29 (39.7%) as 'neutral' and 1 (1.4%) as 'negative'.ConclusionsWhile most staff wished to continue using IPOS, it was a challenge to integrate the effort to support the completion of IPOS into daily practice. Digital implementation was not successful, despite various attempts. To explore the effects on care and patient outcomes, multicentre cluster-randomised trials could be employed.Trial registrationGerman Clinical Trials Register DRKS-ID: DRKS00016681 (24/04/2019).

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Dataset Information

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.

Publications

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.

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