Use of PROM during follow-up of patients with ovarian cancer: the PROMova study protocol

2020 ◽  
Vol 30 (9) ◽  
pp. 1444-1449
Author(s):  
Anette Stolberg Kargo ◽  
Angela Coulter ◽  
Kristina Lindemann ◽  
Pernille Tine Jensen ◽  
Niels Henrik Hjøllund ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Outcome Measures ◽  
Standard Care ◽  
Patient Reported Outcome Measures ◽  
Primary Treatment ◽  
Patient Reported Outcome ◽  
Patient Reported ◽  
Follow Up Care ◽  
Eortc Qlq

BackgroundThere is a paucity of high-level evidence on the optimal follow-up of patients with ovarian cancer after primary treatment. A debate is ongoing on the extent to which follow-up should consider patient preferences and patient-reported outcome measures. Incorporation of patient-reported outcome measures supports the dialog between patient and clinician and may be instrumental in symptom monitoring and detection of underlying issues, especially when used actively during the clinical consultation.Primary Objective and EndpointThe PROMova study aims to assess whether proactive use of patient-reported outcome measures during follow-up care increases patient involvement as perceived by the patient compared with standard care. Another objective is to measure satisfaction with the care provided.Study HypothesisIt is hypothesized that proactive use of patient-reported outcome measures during the clinical encounter will improve patients’ experience of involvement in follow-up care.Trial DesignPROMova is a multi-center, observational cohort study collecting data from eight departments in Denmark. Five departments use the patient-reported outcome measures proactively during the consultation and three provide standard care. Participants are followed up with patient-reported outcome measures for up to 3 years. The patient-reported outcome measures package comprises EORTC QLQ-C30, EORTC QLQ-OV28, a questionnaire screening tool for recurrence, CollaboRATE, and selected questions from the Patient Experience Questionnaire.Major Inclusion/Exclusion CriteriaPatients older than 18 years diagnosed with ovarian, fallopian tube, or primary peritoneal cancer are eligible when entering the follow-up program after primary treatment. Participants must be able to speak and read Danish.Sample Size223 patients with ovarian cancer.Estimated Dates for Completing Accrual and Presenting ResultsThe protocol closed for enrollment in 2019. Publication of final results is expected in spring 2022.Trial RegistrationPROMova was registered with ClinicalTrials.gov November 2016 Identifier: NCT02916875.

Patient-Reported Outcome Measures in Colorectal Surgery: Construction of Core Measures Using Open-Source Research Method

2021 ◽  
pp. 155335062199887
Author(s):  
Alaa El-Hussuna ◽  
Ines Rubio-Perez ◽  
Monica Millan ◽  
Gianluca Pellino ◽  
Ionut Negoi ◽  
...  
Keyword(s):  
Colorectal Surgery ◽  
Outcome Measures ◽  
Short Form ◽  
Wide Spectrum ◽  
Core Outcome Set ◽  
Well Being ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Patient Reported ◽  
Eortc Qlq

Purpose. The primary aim of the study was to review the existing literature about patient-reported outcome measures (PROMs) in colorectal cancer and IBD. The secondary aim was to present a road map to develop a core outcome set via opinion gathering using social media. Method. This study is the first step of a three-step project aimed at constructing simple, applicable PROMs in colorectal surgery. This article was written in a collaborative manner with authors invited both through Twitter via the #OpenSourceResearch hashtag. The 5 most used PROMs were presented and discussed as slides/images on Twitter. Inputs from a wide spectrum of participants including researchers, surgeons, physicians, nurses, patients, and patients’ organizations were collected and analyzed. The final draft was emailed to all contributors and 6 patients’ representatives for proofreading and approval. Results. Five PROM sets were identified and discussed: EORTC QLQ-CR29, IBDQ short health questionnaire, EORTC QLQ-C30, ED-Q5-5L, and Short Form-36. There were 315 tweets posted by 50 tweeters with 1458 retweets. Awareness about PROMs was generally limited. The general psycho-physical well-being score (GPP) was suggested and discussed, and then a survey was conducted in which more than 2/3 of voters agreed that GPP covers the most important aspects in PROMs. Conclusion. Despite the limitations of this exploratory study, it offered a new method to conduct clinical research with opportunity to engage patients. The general psycho-physical well-being score suggested as simple, applicable PROMs to be eventually combined procedure-specific, disease-specific, or symptom-specific PROMs if needed.

scholarly journals Implementation of patient-reported outcome measures and patient-reported experience measures in melanoma clinical quality registries: a systematic review

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e040751
Author(s):  
Zachary Blood ◽  
Anh Tran ◽  
Lauren Caleo ◽  
Robyn Saw ◽  
Mbathio Dieng ◽  
...  
Keyword(s):  
Systematic Review ◽  
Cost Effectiveness ◽  
Outcome Measures ◽  
Cutaneous Melanoma ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Secondary Outcome ◽  
Clinical Quality ◽  
Patient Reported ◽  
Eortc Qlq

ObjectivesTo identify patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) in clinical quality registries, for people with cutaneous melanoma, to inform a new Australian Melanoma Clinical Outcomes Registry; and describe opportunities and challenges of routine PROM/PREM collection, especially in primary care.DesignSystematic review.Primary and secondary outcome measuresWhich PROMs and PREMs are used in clinical quality registries for people with cutaneous melanoma, how they are collected, frequency of collection, participant recruitment methods and funding models for each registry.Results1134 studies were identified from MEDLINE, PreMEDLINE, Embase, PsychInfo, Cochrane Database of Abstracts of Reviews of Effects databases and TUFTS Cost-Effectiveness Analysis Registry, alongside grey literature, from database inception to 5th February 2020. Following screening, 14 studies were included, identifying four relevant registries: Dutch Melanoma Registry, Adelphi Real-World Disease-Specific Programme (Melanoma), Patient-Reported Outcomes Following Initial treatment and Long-term Evaluation of Survivorship Registry, and Cancer Experience Registry. These used seven PROMs: EuroQol-5 Dimensions, Functional Assessment of Cancer-General (FACT-G) and FACT-Melanoma (FACT-M), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Cancer 30 (EORTC QLQ-C30), Fatigue Assessment Scale Hospital Anxiety and Depression Scale, Patient-Reported Outcome Measures Information System-29 and one PREM; EORTC QLQ-Information Module 26. PROMs/PREMs in registries were reported to improve transparency of care; facilitate clinical auditing for quality assessment; enable cost-effectiveness analyses and create large-scale research platforms. Challenges included resource burden for data entry and potential collection bias toward younger, more affluent respondents. Feedback from patients with melanoma highlighted the relevance of PROMs/PREMs in assessing patient outcomes and patient experiences.ConclusionsClinical registries indicate PROMs/PREMs for melanoma care can be incorporated and address important gaps, however cost and collection bias may limit generalisability.PROSPERO registration numberCRD42018086737.

scholarly journals The Olympia anatomic polished cemented stem is associated with a high survivorship, excellent hip-specific functional outcome, and high satisfaction levels: follow-up of 239 consecutive patients beyond 15 years

2021 ◽  
Author(s):  
Gareth S. Turnbull ◽  
Claire Marshall ◽  
Jamie A. Nicholson ◽  
Deborah J. MacDonald ◽  
Nicholas D. Clement ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Femoral Stem ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
High Satisfaction ◽  
Age At Surgery ◽  
Patient Reported ◽  
Cemented Stem ◽  
Oxford Hip Score

Abstract Introduction The Olympia femoral stem is a stainless steel, anatomically shaped, polished and three-dimensionally tapered implant designed for use in cemented total hip arthroplasty (THA). The primary aim of this study was to determine the long-term survivorship, radiographic outcome, and patient-reported outcome measures (PROMs) of the Olympia stem. Patients and methods Between May 2003 and December 2005, 239 patients (264 THAs) underwent a THA with an Olympia stem in our institution. Patient-reported outcome measures were assessed using the Oxford Hip Score (OHS), EuroQol-5 dimensions (EQ-5D) score, and patient satisfaction at mean 10 years following THA. Patient records and radiographs were then reviewed at a mean of 16.5 years (SD 0.7, 15.3–17.8) following THA to identify occurrence of complications or revision surgery for any cause following surgery. Radiographs were assessed for lucent lines and lysis according to Gruen’s zones Results Mean patient age at surgery was 68.0 years (SD 10.9, 31–93 years). There were 156 women (65%, 176 THAs). Osteoarthritis was the indication for THA in 204 patients (85%). All cause stem survivorship at 10 years was 99.2% (95% confidence interval [CI], 97.9%–100%) and at 15 years was 97.5% (94.6%–100%). The 15-year stem survival for aseptic loosening was 100%. Analysis of all-cause THA failure demonstrated a survivorship of 98.5% (96.3%–100%) at 10 years and 95.9% (92.4%–99.4%) at 15 years. There were 9 THAs with non-progressive lucent lines in a single Gruen zone and 3 had lines in two zones, and no patient demonstrated signs for lysis. At a mean of 10-year (SD 0.8, 8.7–11.3) follow-up, mean OHS was 39 (SD 10.3, range 7–48) and 94% of patients reported being very satisfied or satisfied with their THA. Conclusions The Olympia stem demonstrated excellent 10-year PROMs and very high rates of stem survivorship at final follow-up beyond 15 years.

scholarly journals Patient-Reported Outcome Measures and Clinical Outcomes in Children with Foregut Anomalies

Children ◽  
2021 ◽  
Vol 8 (7) ◽  
pp. 587
Author(s):  
Isabel I. Sreeram ◽  
Chantal A. ten Kate ◽  
Joost van Rosmalen ◽  
Johannes M. Schnater ◽  
Saskia J. Gischler ◽  
...  
Keyword(s):  
Linear Regression ◽  
Clinical Outcomes ◽  
Outcome Measures ◽  
Clinical Decision Making ◽  
Linear Regression Analysis ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Added Value ◽  
Patient Reported

Increasing numbers of children and adults with chronic disease status highlight the need for a value-based healthcare system. Patient-reported outcome measures (PROMs) are essential to value-based healthcare, yet it remains unclear how they relate to clinical outcomes such as health and daily functioning. We aimed to assess the added value of self-reported PROMs for health status (HS) and quality of life (QoL) in the long-term follow-up of children with foregut anomalies. We evaluated data of PROMs for HS and/or QoL among eight-year-olds born with congenital diaphragmatic hernia (CDH), esophageal atresia (EA), or congenital lung malformations (CLM), collected within the infrastructure of a multidisciplinary, longitudinal follow-up program. Clinical outcomes were categorized into different outcome domains, and their relationships with self-reported HS and QoL were assessed through multivariable linear regression analyses. A total of 220 children completed HS and/or QoL self-reports. In children with CDH and EA, lower cognition was significantly associated with lower self-reported HS. Due to the low number of cases, multivariable linear regression analysis was not possible in children with CLM. HS, QoL, and clinical outcomes represent different aspects of a child’s wellbeing and should be measured simultaneously to facilitate a more holistic approach to clinical decision making.

scholarly journals Surgical Treatments of Talar Osteochondral Lesion: A Long-term Follow-up of Return to Sport and Patient-Reported Outcome Measures

2019 ◽  
Vol 4 (4) ◽  
pp. 2473011419S0037
Author(s):  
Andrew Schwartz ◽  
Shuo Niu ◽  
Faris Mirza ◽  
Ashley Thomas ◽  
Sameh Labib
Keyword(s):  
Outcome Measures ◽  
Osteochondral Lesion ◽  
Return To Sport ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Surgical Interventions ◽  
Patient Reported ◽  
Long Term Follow Up ◽  
And Function

Category: Ankle, Arthroscopy, Sports, Trauma Introduction/Purpose: Talar osteochondral lesion (TOCL) is a common problem in the young athletic population, mostly related to trauma. TOCL surgical treatment algorithm remains controversial, though results are improving as we gain experience. The results of TOCL surgical treatment on function and return to sport are promising, but quantified return to sport metrics remain largely unknown. Methods: A total of 156 consecutive patients following TOCL chondroplasty (10/1/2000-5/31/2018) by a single practice were retrospectively reviewed and included in this study. There were 54.5% female with a mean age 38.2 years, and mean follow-up 40.2 months following the index surgery. Patients were divided into four groups according to the type of chondroplasty performed: Antegrade arthroscopic drilling and/or microfracture (antegrade, 83 patients), retrograde arthroscopic drilling (retrograde, 35 patients), osteochondral autograft transfer (OATS, 26 patients), and allograft cartilage implantation (allograft, 12 patients). VAS scores for pain and function at the final clinic visit were collected. Patient-reported outcome measures including the short form-12 (SF-12), The Foot and Ankle Disability Index Sports Module (FADI-sports), Tegner score, Marx scale, Naal’s Sports inventory are also actively being collected. Results: Nearly 75% of patients are satisfied with surgical intervention of TOCLs. Allograft transplant was the least satisfying (71.4%), while OATS was the most satisfying (90%). Each surgical intervention yielded significantly decreased pain and increased function postoperatively (all p<0.001). Currently, 57 patients (36%) provided patient-reported outcome measures, with an average follow up of 79.8 months (Table 1). All surgical interventions trended toward decreased Tegner score, though only antegrade drilling showed a significant decrease (p<0.001). Based on Naal’s sports inventory, 85.7% of surgically treated patients reported participating in sport activities, on average 3 times/week and 50.6 minutes/session. Conclusion: Traditionally, TOCLs presented a difficult problem that is marred by unsatisfactory surgical outcomes in typically active patients. As our surgical understanding has evolved, we’ve continued to improve on outcomes. Our patients demonstrated a 74.5% satisfaction rate, a statistically significant improvement in pain and function, and a high rate of return to sport with little difference between surgical interventions at a long-term follow-up.

scholarly journals Feasibility of Collecting Multiple Patient-Reported Outcome Measures Alongside the Dutch Arthroplasty Register

2019 ◽  
Vol 7 (4) ◽  
pp. 484-492
Author(s):  
Claire Tilbury ◽  
Claudia S Leichtenberg ◽  
Bart L Kaptein ◽  
Lennard A Koster ◽  
Suzan H M Verdegaal ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Short Form ◽  
Response Rates ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Participation Rates ◽  
Arthroplasty Register ◽  
Patient Reported ◽  
Lost To Follow Up

Background: Compliance rates with patient-reported outcome measures (PROMs) collected alongside arthroplasty registries vary in the literature. We described the feasibility of a routinely collected set PROMs alongside the Dutch Arthroplasty Register. Methods: The longitudinal Leiden Orthopaedics Outcomes of OsteoArthritis Study is a multicenter (7 hospitals), observational study including patients undergoing total hip or total knee arthroplasty (THA or TKA). A set of PROMs: Short Form-12, EuroQol 5 Dimensions, Hip/Knee injury and Osteoarthritis Outcome Score, Oxford Hip/Knee Score was collected preoperatively and at 6, 12, 24 months, and every 2 years thereafter. Participation rates and response rates were recorded. Results: Between June 2012 and December 2014, 1796 THA and 1636 TKA patients were invited, of whom 1043 THA (58%; mean age 68 years [standard deviation, SD: 10]) and 970 TKA patients (59%; mean age 71 years [SD 9.5]) participated in the study. At 6 months, 35 THA/38 TKA patients were lost to follow-up. Response rates were 90% for THA (898/1000) and 89% for TKA (827/932) participants. At 1 and 2 years, 8 and 18 THA and 17 and 11 TKA patients were lost to follow-up, respectively. The response rates among those eligible were 87% (866/992) and 84% (812/972) for THA and 84% (771/917) and 83% (756/906) for TKA patients, respectively. The 2-year questionnaire was completed by 78.5% of the included THA patients and by 77.9% of the included TKA patients. Conclusions: About 60% of patients undergoing THA or TKA complete PROMs preoperatively, with more than 80% returning follow-up PROMs. To increase the participation rates, more efforts concerning the initial recruitment of patients are needed.

Patient-reported outcome measures after surgery for an acetabular fracture

2018 ◽  
Vol 100-B (5) ◽  
pp. 640-645 ◽  
Author(s):  
B. Frietman ◽  
J. Biert ◽  
M. J. R. Edwards
Keyword(s):  
Outcome Measures ◽  
Hip Joint ◽  
Acetabular Fracture ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Ct Scans ◽  
Sf 36 ◽  
Patient Reported ◽  
Post Traumatic

Aims The aim of this study was to record the incidence of post-traumatic osteoarthritis (OA), the need for total hip arthroplasty (THA), and patient-reported outcome measures (PROMS) after surgery for a fracture of the acetabulum, in our centre. Patients and Methods All patients who underwent surgery for an acetabular fracture between 2004 and 2014 were included. Patients completed the 36-Item Short Form Health Survey (SF-36) and the modified Harris Hip Score (mHHS) questionnaires. A retrospective chart and radiographic review was performed on all patients. CT scans were used to assess the classification of the fracture and the quality of reduction. Results A total of 220 patients were included, of which 55 (25%) developed post-traumatic OA and 33 (15%) underwent THA. A total of 164 patients completed both questionnaires. At a mean follow-up of six years (2 to 10), the mean SF-36 score for patients with a preserved hip joint was higher on role limitations due to physical health problems than for those with OA or those who underwent THA. In the dimension of bodily pain, patients with OA had a significantly better score than those who underwent THA. Patients with a preserved hip joint had a significantly better score on the function scale of the mHHS and a better total score than those with OA or who underwent THA. Conclusion Of the patients who were treated surgically for an acetabular fracture (with a mean follow-up of six years), 15% underwent THA at a mean of 2.75 years postoperatively. Patients with a THA had a worse functional outcome than those who retain their native hip joint. We recommend using PROMS and CT scans when reviewing these patients. Cite this article: Bone Joint J 2018;100-B:640–5.

PROMIS Versus Legacy Patient-Reported Outcome Measures in Patients Undergoing Surgical Treatment for Symptomatic Acetabular Dysplasia

2020 ◽  
Vol 48 (2) ◽  
pp. 385-394 ◽  
Author(s):  
Deborah J. Li ◽  
John C. Clohisy ◽  
Maria T. Schwabe ◽  
Elizabeth L. Yanik ◽  
Cecilia Pascual-Garrido
Keyword(s):  
Outcome Measures ◽  
Acetabular Dysplasia ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Patient Reported ◽  
Ceiling Effects ◽  
The Mean ◽  
Symptomatic Acetabular Dysplasia ◽  
Good Agreement

Background: No previous study has investigated how the Patient-Reported Outcomes Measurement Information System (PROMIS) performs compared with legacy patient-reported outcome measures in patients with symptomatic acetabular dysplasia treated with periacetabular osteotomy (PAO). Purpose: To (1) measure the strength of correlation between the PROMIS and legacy outcome measures and (2) assess floor and ceiling effects of the PROMIS and legacy outcome measures in patients treated with PAO for symptomatic acetabular dysplasia. Study Design: Cohort study (Diagnosis); Level of evidence, 2. Methods: This study included 220 patients who underwent PAO for the treatment of symptomatic acetabular dysplasia. Outcome measures included the Hip disability and Osteoarthritis Outcome Score (HOOS) pain, HOOS activities of daily living (ADL), modified Harris Hip Score (mHHS), PROMIS pain, and PROMIS physical function subsets, with scores collected preoperatively and/or postoperatively at a minimum 12-month follow-up. The change in mean scores from preoperatively to postoperatively was calculated only in a subgroup of 57 patients with scores at both time points. Distributions of the PROMIS and legacy scores were compared to evaluate floor and ceiling effects, and Pearson correlation coefficients were calculated to evaluate agreement. Results: The mean age at the time of surgery was 27.7 years, and 83.6% were female. The mean follow-up time was 1.5 years. Preoperatively, neither the PROMIS nor the legacy measures showed significant floor or ceiling effects. Postoperatively, all legacy measures showed significant ceiling effects, with 15% of patients with a maximum HOOS pain score of 100, 29% with a HOOS ADL score of 100, and 21% with an mHHS score of 100. The PROMIS and legacy instruments showed good agreement preoperatively and postoperatively. The PROMIS pain had a moderate to strong negative correlation with the HOOS pain ( r = −0.66; P < .0001) and mHHS ( r = −0.60; P < .0001) preoperatively and the HOOS pain ( r = −0.64; P < .0001) and mHHS ( r = −0.64; P < .0001) postoperatively. The PROMIS physical function had a moderate positive correlation with the HOOS ADL ( r = 0.51; P < .0001) and mHHS ( r = 0.49; P < .0001) preoperatively and a stronger correlation postoperatively with the HOOS ADL ( r = 0.56; P < .0001) and mHHS ( r = 0.56; P < .0001). Conclusion: We found good agreement between PROMIS and legacy scores preoperatively and postoperatively. PROMIS scores were largely normally distributed, demonstrating an expanded ability to capture variability in patients with improved outcomes after treatment.

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