Development of a Patient-Reported Outcome Measures to Detect Perioperative Symptom Burden Following Major Abdominal Surgery for Cancer
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ABSTRACT:
DISEASE(S): Malignant Neoplasm Of Other And Unspecified Parts Of Biliary Tract,Malignant Neoplasm Of Oesophagus,Malignant Neoplasm Of Rectum,Malignant Neoplasm Of Small Intestine,Malignant Neoplasm Of Rectosigmoid Junction,Malignant Neoplasm Of Stomach,Malignant Neoplasm Of Anus And Anal Canal,Malignant Neoplasm Of Pancreas,Malignant Neoplasm Of Gallbladder,Malignant Neoplasm Of Liver And Intrahepatic Bile Ducts,Malignant Neoplasm Of Colon
PROVIDER: 2437895 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:BackgroundInformation to the patient about the long-term prognosis of symptom burden and functioning is an integrated part of clinical practice, but relies mostly on the clinician's personal experience. Relevant prognostic models based on patient-reported outcome (PRO) data with repeated measurements are rarely available.ObjectiveThe aim was to describe a generic method for individual long-term prognosis of symptom burden and functioning that implied few statistical presumptions, to evaluate an implementation for prognosis of depressive symptoms in stroke patients and to provide open access to a Web-based prototype of this implementation for individual use.MethodsThe method used to describe individual prognosis of a PRO outcome was based on the selection of a specific subcohort of patients who have the same score as the patient in question at the same time (eg, after diagnosis or treatment start), plus or minus one unit of minimal clinically important difference. This subcohort's experienced courses were then used to provide quantitative measures of prognosis over time. A cohort of 1404 stroke patients provided data for a simulation study and a prototype for individual use. Members of the cohort answered questionnaires every 6 months for 3.5 years. Depressive symptoms were assessed by the Hospital Anxiety and Depression Scale (HADS) and a single item from the SF-12 (MH4) health survey. Four approaches were compared in a simulation study in which the prognosis for each member of the cohort was individually assessed.ResultsThe mean standard deviations were 40% to 70% higher in simulated scores. Mean errors were close to zero, and mean absolute errors were between 0.46 and 0.66 SD in the four approaches. An approach in which missing HADS scores were estimated from the single-item SF-12 MH4 performed marginally better than methods restricted to questionnaires with a genuine HADS score, which indicates that data collected with shorter questionnaires (eg, in clinical practice) may be used together with longer versions with the full scale, given that the design includes at least two simultaneous measurements of the full scale and the surrogate measure.ConclusionsThis is the first description and implementation of a nonparametric method for individual PRO-based prognosis. Given that relevant PRO data have been collected longitudinally, the method may be applied to other patient groups and to any outcome related to symptom burden and functioning. This initial implementation has been deliberately made simple, and further elaborations as well as the usability and clinical validity of the method will be scrutinized in clinical practice. An implementation of the prototype is available online at www.prognosis.dk.
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Project description:ObjectivesTreatment burden is the workload of healthcare for people with long-term conditions (LTC) and its impact on well-being. A method of measurement is required to identify those experiencing high burden and to measure intervention efficacy. Our aim was to identify, examine and appraise validated patient-reported measures (PRMs) of treatment burden in stroke. Here, stroke serves as an exemplar LTC of older adults.DesignA systematic review of published studies that describe the development and validation of PRMs measuring treatment burden in stroke survivors.Data sourcesWe searched MEDLINE, Embase, CINAHL and PsycINFO electronic databases.Eligibility criteriaStudies published between January 2000 and 12 April 2019 inclusive, in English language. No restrictions were set based on clinical setting or geographical location.Data extraction and synthesisScreening, data extraction and quality appraisal were conducted by two independent reviewers. Content of the PRMs was compared with a published taxonomy of treatment burden. Quality appraisal was conducted using International Society for Quality of Life Research standards.ResultsFrom 3993 articles, 6 relevant PRMs were identified: 3 were stroke specific: The Satisfaction with Stroke Care questionnaire; The Stroke Patient-Reported Outcome Measure and The Barriers to Physical Activity after Stroke scale. Three were generic but validated in stroke: The WHO Quality of Life-100; The Patient's Questionnaire on Participation in Discharge Planning and The Chao Perception of Continuity scale. None comprehensively measured treatment burden. Examples of omitted burdens included developing coping strategies, managing finances and returning to driving. The most notable issue regarding quality appraisal was that three PRMs lacked any underpinning qualitative research relevant to the sample.ConclusionThere is a need to develop a comprehensive PRM of treatment burden for use in stroke, with potential for use in other older populations.
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Project description:BackgroundChronic graft-versus-host disease (GVHD) is a potentially life-threatening complication of allogeneic hematopoietic stem cell transplantation (HSCT) treatment for hematologic malignancies. There are limited patient-reported data concerning symptom burden and effects on activities of daily living (ADL).MethodsThe cross-sectional Living With Chronic GVHD Patient Survey was administered online in the United States (May-August 2020) to participants aged ≥18 years who underwent allogeneic HSCT, were diagnosed with chronic GVHD by a healthcare provider, and self-reported active chronic GVHD (within past 5 years). Information on patient demographics, disease characteristics, symptom burden, and ability to perform ADL was collected. Symptom burden was assessed using the validated Lee Symptom Scale (range from 0-100 with higher scores indicating greater burden). All data were summarized using descriptive statistics; no formal statistical comparisons were conducted.ResultsOut of 580 participants who entered the survey screener, 165 participants (28.4%) across 33 states fulfilled all study eligibility criteria, completed the entire survey, and were included (age: mean [SD], 53.7 (13.8) years; median [range], 57.0 [18-78] years; female, n = 105 [63.6%]; White, n = 137 [83.0%]). Respondents described their chronic GVHD severity primarily as moderate (n = 54 [32.7%]) or severe (n = 102 [61.8%]) at the time when symptoms were at their worst. One-third of respondents (33.9%) indicated that their chronic GVHD symptoms were at their worst for ≥1 year in duration. Mean (SD; range) Lee Symptom Scale score was 44.8 (19.4; 2-100); 44% of respondents considered "dry eye" the most burdensome symptom. Almost half of respondents (n = 73 [44.2%]) rated their overall quality of life (QoL) as poor. Participants reported a detrimental impact of symptoms on ADL, including basic activities (eg, eating, personal hygiene, dressing).ConclusionsSurvey respondents self-reported high chronic GVHD symptom burden and felt that their symptoms severely interfered with physical function and ADL. Effective strategies to mitigate chronic GVHD symptoms are needed to improve QoL among HSCT survivors.
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Project description:Interventions: e-Prom (electronic patient reported outcome measures) comprising of a short questionnaire administered via an electronic platform prior to clinic appointments (during treatment and follow-up) and monthly or as desired by the patient between follow-up appointments. The tools provide information only and thus are not classed as medical devices.
It is anticipated that the e-PROM will take 10 minutes to complete, The questionnaires are sent by link via email/SMS and will be self-administered, the links are monitored by research nurse. The overall duration of e-PROM use will be up to 2 years from date of consent. Adherence to intervention is monitored at time of clinical visit, if patient has not completed pre-visit e-Prom the research nurse will assist them to log onto study iPad and complete questionnaire prior to seeing clinician.
Primary outcome(s): Physical and functional well-being is a composite primary outcome and is measured by the Physical Wellbeing and Functional subscales of the Functional Assessment of Cancer Treatment - General (FACT-G) scale[At completion of patient treatment and the completion of the patient’s FACT-G questionnaire at 6 months post consent date.];The rate of unplanned hospital presentations/admissions will be treated as a composite outcome. This information will be obtained from hospital records and linkage to Queensland Health Admitted Patients Data Collection (QHAPDC), Emergency Data and Medical Benefits Scheme (MBS) data.[At completion of all patient recruitment and all clinical follow-up and access to data linkage
Clinical follow up will occur at baseline (post recruitment) at 12 months and 24 months from date of consent (primary endpoint).]
Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy
| 2471505 | ecrin-mdr-crc