scholarly journals Quality of life and experiences of sarcoma trajectories (the QUEST study): protocol for an international observational cohort study on diagnostic pathways of sarcoma patients

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e039309
Author(s):  
Vicky Soomers ◽  
Ingrid ME Desar ◽  
Lonneke V van de Poll-Franse ◽  
Olga Husson ◽  
Winette TA van der Graaf
Keyword(s):  
Quality Of Life ◽  
Cohort Study ◽  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
The Netherlands ◽  
Patient Reported Outcomes ◽  
Tumour Size ◽  
Patient Reported ◽  
Total Interval

IntroductionSarcomas are rare tumours with considerable heterogeneity. Early and accurate diagnosis is important to optimise patient outcomes in terms of local disease control, overall survival (OS) and health-related quality of life (HRQoL). Time to diagnosis is variable in bone as well as soft tissue sarcoma. Possible factors for a long time from first symptom to diagnosis (the total interval) include patient, tumour and healthcare characteristics, but until now the most relevant risk factors and its association with outcomes remain unknown. Our study aims to (1) quantify total interval, the time interval from first symptom until (histological) diagnosis; (2) identify factors associated with interval length and (3) determine the association between total interval and HRQoL, stage and tumour size at diagnosis, progression-free survival (PFS) and OS.Methods and analysisWe will conduct a longitudinal, prospective, international, multicentre cohort study among patients aged ≥18 years with newly diagnosed bone or soft tissue sarcoma at eight centres (three in UK, five in The Netherlands). Patients will be asked to complete questionnaires at five points in time; one at diagnosis and at follow-up points of 3, 6, 12 and 24 months. Questionnaire data is collected within the Patient Reported Outcomes Following Initial treatment and Long term Evaluation of Survivorship (PROFILES) registry: an international data management system for collection of patient-reported outcomes. Clinical data will be extracted from patient records. The primary endpoint is HRQoL at diagnosis, measured with the EORTC QLQ-C30. Secondary endpoints are stage and tumour size at diagnosis, PFS, OS, additional patient-reported outcomes, such as quality-adjusted life years and psychological distress.Ethics and disseminationEthical approval was given by the Health Research Authority and Research Ethics Committee for the United Kingdom (18/WA/0096) and medical ethical committee of Radboudumc for The Netherlands (2017-3881). Results will be presented in peer-reviewed journals and presented at meetings.Trial registration numberNCT03441906.

scholarly journals Quality of life and added value of a tailored palliative care intervention in patients with soft tissue sarcoma undergoing treatment with trabectedin: a multicentre, cluster-randomised trial within the German Interdisciplinary Sarcoma Group (GISG)

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e035546
Author(s):  
Leopold Hentschel ◽  
Stephan Richter ◽  
Hans-Georg Kopp ◽  
Bernd Kasper ◽  
Annegret Kunitz ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Functional Assessment ◽  
Patient Reported Outcomes ◽  
Statistical Significance ◽  
Case Vignette ◽  
Cluster Randomised ◽  
Patient Reported

ObjectivesThe choice of drug treatment in advanced soft tissue sarcoma (STS) continues to be a challenge regarding efficacy, quality of life (QoL) and toxicity. Unlike other cancer types, where integrating patient-reported outcomes (PRO) has proven to be beneficial for QoL, there is no such evidence in patients with STS as of now. The YonLife trial aimed to explore the effect of a tailored multistep intervention on QoL, symptoms and survival in patients with advanced STS undergoing treatment with trabectedin as well as identifying predictors of QoL.DesignYonLife is a cluster-randomised, open-label, proof-of-concept study. The intervention incorporates electronic PRO assessment, a case vignette and expert-consented treatment recommendations.ParticipantsSix hospitals were randomised to the control arm (CA) or interventional arm (IA). Seventy-nine patients were included of whom 40 were analysed as per-protocol analysis set.Primary and secondary outcome measuresThe primary end point was the change of Functional Assessment for Cancer Therapy (FACT-G) total score after 9 weeks. Secondary outcomes included QoL (FACT-G subscales), anorexia and cachexia (Functional Assessment of Anorexia/Cachexia Therapy (FAACT)), symptoms (MD Anderson Symptom Inventory (MDASI)), anxiety and depression (HADS), pain intensity and interference (Brief Pain Inventory (BPI)) and survival assessment.ResultsAfter 9 weeks of treatment, QoL declined less in the IA (ΔFACT-G total score: −2.4, 95% CI: −9.2 to 4.5) as compared with CA (ΔFACT-G total score: −3.9; 95% CI:−11.3 to 3.5; p=0.765). In almost all FACT-G subscales, average declines were lower in IA, but without reaching statistical significance. Smaller adverse trends between arms were observed for MDASI, FAACT, HADS and BPI scales. These trends failed to reach statistical significance. Overall mean survival was longer in IA (648 days) than in CA (389 days, p=0.110). QoL was predicted by symptom severity, symptom interference, depression and anxiety.ConclusionOur data suggest a potentially favourable effect of an electronic patient-reported outcomes based intervention on QoL that needs to be reappraised in confirmatory studies.Trial registration numberClinicalTrials.gov Identifier (NCT02204111).

scholarly journals Comparison of Patient-Reported Outcomes at 1 Year After Injury Between Limb Salvage and Amputation: A Prospective Cohort Study

2021 ◽  
Author(s):  
Taketo Kurozumi ◽  
Takahiro Inui ◽  
Yuhei Nakayama ◽  
Akifumi Honda ◽  
Kentaro Matsui ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Cohort Study ◽  
Limb Salvage ◽  
Lower Limb ◽  
Prospective Cohort ◽  
Patient Reported Outcomes ◽  
Early Recovery ◽  
Patient Reported

Abstract Background: Owing to advances in knowledge and technology, salvaging the limbs of patients with severe trauma and injuries is possible. However, severe limb injuries occasionally necessitate amputation because it allows patients to regain their social lives earlier than limb salvaging. Moreover, previous related investigations are retrospective cohort studies or meta-analyses of retrospective studies, and prospective cohort studies of patient-reported outcomes are extremely rare. This single-center, prospective cohort study aimed to compare the patient-reported outcomes at 1 year after injury between limb salvage and amputation and to elucidate whether amputation contributes to early recovery of functionality and quality of life.Methods: We included 47 limbs of 45 patients with severe open fractures of the lower limb and categorized them into limb salvage and amputation groups. They were registered in the Database of Orthopedic Trauma by the Japanese Society for Fracture Repair at our center; data on patient-reported outcomes at 1 year after injury were obtained from this database. The mean patient age was 49.6 years. Patients’ limbs were evaluated using the lower extremity functional scale (LEFS) and Short-Form 8 (SF-8). Early recovery was evaluated using functionality and quality-of-life questionnaires. Nonparametric statistical analyses were conducted.Results: Of the 47 limbs, 34 limbs of 34 patients were salvaged and 13 limbs of 11 patients were amputated. Significant differences were noted between the limb salvage and amputation groups in terms of the LEFS scores (mean: 49.5 vs 33.1, P=0.025) and scores for the mental health component (mean: 48.7 vs 38.7, P=0.003), role–physical component (mean: 42.2 vs 33.3, P=0.026), and mental component summary (mean: 48.2 vs 41.3, P=0.042) of the SF-8. The limb salvage group had better scores than the amputation group. Conclusions: In this study, limb salvage results in better functional and mental health outcomes at 1 year after severe lower limb injury than after amputation. As reconstruction technology has advanced and limb salvaging has become possible, the focus of studies should now be based on the perspective of “how the patient feels”; hence, we believe that the results of this study, which is based on patient-reported outcomes, are meaningful.

scholarly journals Exploring the personal burden of shoulder pain among younger people in Australia: protocol for a multicentre cohort study

BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e021859
Author(s):  
Ilana N Ackerman ◽  
Richard S Page ◽  
Kathy Fotis ◽  
Peter Schoch ◽  
Nigel Broughton ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cohort Study ◽  
Psychological Distress ◽  
Shoulder Pain ◽  
Patient Reported Outcomes ◽  
Healthcare Expenditure ◽  
Well Being ◽  
Musculoskeletal Conditions ◽  
Patient Reported

IntroductionPersistent musculoskeletal conditions can impact profoundly on younger people’s quality of life, psychological distress and capacity to work, as shown by previous research involving younger people with osteoarthritis. The personal impacts, in particular, work and parenting impacts, of other musculoskeletal conditions (such as persistent shoulder pain) on younger patient groups remain poorly understood. Furthermore, the personal financial burden associated with managing musculoskeletal conditions is rarely documented. This study aims to investigate well-being, work participation and productivity, shoulder-related parenting disability and out-of-pocket healthcare expenditure among younger people with shoulder pain and evaluate changes over 12 months.Methods and analysisOne hundred and fifty people aged 20–55 years with shoulder pain of more than 6 weeks’ duration (excluding those with recent history of fracture or dislocation) will be recruited for this cohort study. Participants will be recruited from three major public hospitals in Victoria, Australia, following screening of orthopaedic outpatient clinics lists and referrals. Participants will be asked to complete a baseline questionnaire and 2-week healthcare costs diary, with follow-up data collected at 12 months. Patient-reported outcomes will be collected, including health-related quality of life (HRQoL), shoulder pain and function, psychological distress, shoulder-related parenting disability and work productivity. Information on sociodemographics, employment, health services utilisation and shoulder-related healthcare expenditure will also be collected. Descriptive analysis of baseline data will provide a comprehensive snapshot of the personal burden of shoulder pain. Baseline HRQoL and psychological distress data will be compared with Australian population norms to provide context around well-being. Associations between sociodemographic factors and patient-reported outcomes will be evaluated using univariate and multivariate analyses. Changes in patient-reported outcomes from baseline to 12 months will be analysed using paired t-tests.Ethics and disseminationEthics approval has been obtained. The study findings will be submitted to peer-reviewed journals and presented at relevant scientific meetings.

scholarly journals Outcomes of Tissue Reconstruction in Distal Lower Leg Fractures: a Retrospective Cohort Study

2020 ◽  
Author(s):  
Emrah Aydogan ◽  
Stefan Langer ◽  
Christoph Josten ◽  
Johannes Maria Karl Fakler ◽  
Ralf Henkelmann
Keyword(s):  
Quality Of Life ◽  
Cohort Study ◽  
Soft Tissue ◽  
Lower Leg ◽  
Soft Tissue Reconstruction ◽  
Patient Reported ◽  
Tissue Reconstruction ◽  
Closed Fractures ◽  
The Mean

Abstract Background:Open and closed fractures can be associated with posttraumatic or postoperative soft tissue defects caused by initial trauma, operative procedures or infections. This study evaluated the outcomes of postoperative qualities ofpatients with open or closed lower leg fractures,related softtissue defects, and subsequent flap coverage.Methods:We performed a retrospective single-center cohort study in a level 1 trauma center. We analyzed thepatients treated fromJanuary 2012 through December 2017 and recorded demographics, treatment, and outcome data.The outcome data were measured via patient-reported Foot and Ankle Outcomes Scores (FAOS) and EQ-5D-5L scores.Results: We included 22 patients with complicated fractures (11 open and 11 closed) and subsequent softtissue defects and flap coverages. The mean follow-up time was 41.2 months. Twenty-onepatients developed infections, and necrosis at the site of surgery manifested in all closed fractures. Therefore, all patients needed soft tissue reconstructions. Preoperatively, 16patients underwent arterial examinations via angiography and sixunderwent ultrasound examinations of the venous system. Ten patients had complications involving the flaps due to ischemia and consequent necrosis. The mean EQ-5D index was 0.62 ± 0.27, EQ-5DVAS score was 57.7 ± 20.2. The mean FAOS was 60.7 ± 22.2; in particular,quality of life was 32.3± 28.8. The rate of returning to work in our patient groupwas 37.5% after one year.Conclusions:Distal tibial fracturesoften require revisions and soft tissue reconstruction. The evaluated patient population had poor outcomes in terms of function, quality of life and return to work. Our results imply that the severity of associated soft tissue damage with many revision operations and flap complications lead to a poorer outcome with respect to patients without flap ischemia.

scholarly journals Comparison of Patient-reported Outcomes at 1 Year after Injury between Limb Salvage and Amputation: A Prospective Cohort Study

2021 ◽  
Author(s):  
Taketo Kurozumi ◽  
Takahiro Inui ◽  
Yuhei Nakayama ◽  
Akifumi Honda ◽  
Kentaro Matsui ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Cohort Study ◽  
Limb Salvage ◽  
Lower Limb ◽  
Prospective Cohort ◽  
Patient Reported Outcomes ◽  
Early Recovery ◽  
Patient Reported

Abstract Background: Owing to advances in knowledge and technology, salvaging the limbs of patients with severe trauma and injuries is possible. However, severe limb injuries occasionally necessitate amputation because it allows patients to regain their social lives earlier than limb salvaging. Moreover, previous related investigations are retrospective cohort studies or meta-analyses of retrospective studies, and prospective cohort studies of patient-reported outcomes are extremely rare. This single-center, prospective cohort study aimed to compare the patient-reported outcomes at 1 year after injury between limb salvage and amputation and to elucidate whether amputation contributes to early recovery of functionality and quality of life.Methods: We included 47 limbs of 45 patients with severe open fractures of the lower limb and categorized them into limb salvage and amputation groups. They were registered in the Database of Orthopedic Trauma by the Japanese Society for Fracture Repair at our center; data on patient-reported outcomes at 1 year after injury were obtained from this database. The mean patient age was 49.6 years. Patients’ limbs were evaluated using the lower extremity functional scale (LEFS) and Short-Form 8 (SF-8). Early recovery was evaluated using functionality and quality-of-life questionnaires. Nonparametric statistical analyses were conducted.Results: Of the 47 limbs, 34 limbs of 34 patients were salvaged and 13 limbs of 11 patients were amputated. Significant differences were noted between the limb salvage and amputation groups in terms of the LEFS scores (mean: 49.5 vs 33.1, P=0.025) and scores for the mental health component (mean: 48.7 vs 38.7, P=0.003), role–physical component (mean: 42.2 vs 33.3, P=0.026), and mental component summary (mean: 48.2 vs 41.3, P=0.042) of the SF-8. The limb salvage group had better scores than the amputation group. Conclusions: In this study, limb salvage results in better functional and mental health outcomes at 1 year after severe lower limb injury than after amputation. As reconstruction technology has advanced and limb salvaging has become possible, the focus of studies should now be based on the perspective of “how the patient feels”; hence, we believe that the results of this study, which is based on patient-reported outcomes, are meaningful.

P048 QUALITY OF LIFE AND OTHER PATIENT REPORTED OUTCOMES IN PATIENTS WITH POUCHITIS

2020 ◽  
Vol 158 (3) ◽  
pp. S107
Author(s):  
Edward Barnes ◽  
Millie Long ◽  
Laura Raffals ◽  
Xian Zhang ◽  
Anuj Vyas ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Patient Reported Outcomes ◽  
Patient Reported
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