Clinical outcomes in hemophilia: Towards development of a core set of standardized outcome measures for research

Objective: To determine the current applications of 3-dimensional (3D) printing in the care of patients with cleft lip and palate. We also reviewed 3D printing limitations, financial analysis, and future implications. Design: Retrospective systematic review. Methods: Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines were used by 3 independent reviewers. Articles were identified from Cochrane library, Ovid Medline, and Embase. Search terms included 3D printing, 3 dimensional printing, additive manufacturing, rapid prototyping, cleft lip, and cleft palate. Exclusion criteria included articles not in English, animal studies, reviews without original data, oral presentations, abstracts, opinion pieces, and articles without relevance to 3D printing or cleft lip and palate. Main Outcome Measures: Primary outcome measure was the purpose of 3D printing in the care of patients with cleft lip and palate. Secondary outcome measures were cost analysis and clinical outcomes. Results: Eight-four articles were identified, and 39 met inclusion/exclusion criteria. Eleven studies used 3D printing models for nasoalveolar molding. Patient-specific implants were developed via 3D printing in 6 articles. Surgical planning was conducted via 3D printing in 8 studies. Eight articles utilized 3D printing for anatomic models/educational purposes. 3-Dimensional printed models were used for surgical simulation/training in 6 articles. Bioprinting was utilized in 4 studies. Secondary outcome of cost was addressed in 8 articles. Conclusion: 3-Dimensional printing for the care of patients with cleft lip and palate has several applications. Potential advantages of utilizing this technology are demonstrated; however, literature is largely descriptive in nature with few clinical outcome measures. Future direction should be aimed at standardized reporting to include clinical outcomes, cost, material, printing method, and results.

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

Children ◽

10.3390/children8070587 ◽

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.

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Suprapectoral vs. Intra Articular Biceps Tenodesis: A Comparison of Clinical Outcomes

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967118s00108 ◽

2018 ◽

Vol 6 (7_suppl4) ◽

pp. 2325967118S0010

Author(s):

Brian M. Godshaw ◽

Nicholas Kolodychuk ◽

Benjamin Bryan Browning ◽

Gerard Williams ◽

Rachel Burdette ◽

...

Keyword(s):

Clinical Outcomes ◽

Outcome Measures ◽

Glenohumeral Joint ◽

Short Form ◽

Biceps Tendon ◽

Biceps Tenodesis ◽

Measured Time ◽

Long Head ◽

Distally Based

Objectives: The long head of the biceps tendon is a frequent pain generator within the shoulder. It is subjected to trauma and wear within the glenohumeral joint and within the intertubercular groove. Tenodesis of this tendon is a common treatment option for patients experiencing biceps tendon related pain. There are several different techniques to perform this procedure. Proximal intra-articular tenodesis can be performed but leaves the tendon within the intertubercular groove. Alternatively, suprapectoral tenodesis can be performed removing the tendon from the bicipital groove and sheath while avoiding conversion to an open procedure. Further, suprapectoral tenodesis limits complications associated with an open distally based incision. Several studies have compared these techniques to tenotomy or open-subpectoral tenodesis. This is the first study to directly compare patient outcomes between intra-articular and suprapectoral bicep tenodeses. Methods: Retrospective review of patients undergoing intra-articular or suprapectoral arthroscopic biceps tenodesis from 2010 - 2015. Clinical outcomes were measured at set intervals post-operatively (3 months, 6 months, and 12 months) and compared to pre-operative scores. Outcome measures included short form-12, both physical (PSF) and mental (MSF) component scores, and the American Shoulder and Elbow Surgeons score (ASES). Results: A total of 96 patients were available for this study, 43 had intra-articular tenodesis and 56 had suprapectoral tenodesis. There was no difference in functional outcomes between intra and extra articular biceps tenodesis at 1-year post-operative. The intra-articular group had a quicker improvement in scores with the greatest increase at 3 months post-operatively, specifically in PSF group (p=0.016): however, this difference leveled off at 1-year follow up (p=0.238). The intra-articular group had greater absolute scores at all measured time points, but not significantly. Both groups showed improvement in all outcome measures and there was found to be no difference in changes for ASES, PSF, or MSF (p=0.262, p=0.489, and p=0.907 respectively). Conclusion: This study demonstrates that both intra-articular and surpapectoral techniques are acceptable options for biceps tenodesis. Despite leaving the biceps tendon within the glenohumeral joint and intertubercular groove, the intra-articular technique offers similar improvement in outcome measures to the suprapectoral technique.

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A Core Set of Outcome Measures for Adults With Neurologic Conditions Undergoing Rehabilitation

Journal of Neurologic Physical Therapy ◽

10.1097/npt.0000000000000229 ◽

2018 ◽

Vol 42 (3) ◽

pp. 174-220 ◽

Cited By ~ 40

Author(s):

Jennifer L. Moore ◽

Kirsten Potter ◽

Kathleen Blankshain ◽

Sandra L. Kaplan ◽

Linda C. OʼDwyer ◽

...

Keyword(s):

Outcome Measures ◽

Core Set

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Examination of GG-Mobility Items and Select Core Set Outcome Measures on Predicting Discharge Destination and Length of Stay From an Inpatient Rehab Facility in Stroke: A Pilot Study

Archives of Physical Medicine and Rehabilitation ◽

10.1016/j.apmr.2021.07.568 ◽

2021 ◽

Vol 102 (10) ◽

pp. e37

Author(s):

Matthew Annessi ◽

Chris Young ◽

Katherine Gibson

Keyword(s):

Pilot Study ◽

Length Of Stay ◽

Outcome Measures ◽

Discharge Destination ◽

Core Set

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Update on Outcome Measure Development in Large-vessel Vasculitis: Report from OMERACT 2018

The Journal of Rheumatology ◽

10.3899/jrheum.181072 ◽

2019 ◽

Vol 46 (9) ◽

pp. 1198-1201 ◽

Cited By ~ 2

Author(s):

Sibel Z. Aydin ◽

Joanna C. Robson ◽

Antoine G. Sreih ◽

Catherine Hill ◽

Fatma Alibaz-Oner ◽

...

Keyword(s):

Outcome Measures ◽

Patient Reported Outcome ◽

Large Vessel Vasculitis ◽

Large Vessel ◽

Disease States ◽

Core Set ◽

Patient Reported ◽

Delphi Exercise ◽

Patient Acceptable Symptom State ◽

Selection Of

Objective.The Outcome Measures in Rheumatology (OMERACT) Vasculitis Working Group seeks to develop validated outcome measures for use in trials for large-vessel vasculitis (LVV).Methods.An international Delphi exercise conducted among investigators identified items considered important to measure active disease. In parallel, qualitative research with patients was conducted, including interviews and focus groups.Results.Next steps prioritized by the group for LVV include (1) defining disease states (remission, flare, and patient-acceptable symptom state) and (2) selection of patient-reported outcome tools.Conclusion.The ultimate goal is to develop an OMERACT-endorsed core set of outcome measures for use in clinical trials of LVV.

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Six out of ten patients with sinus tarsi syndrome returned to pre-injury type of sport after subtalar arthroscopy

Knee Surgery Sports Traumatology Arthroscopy ◽

10.1007/s00167-020-06385-8 ◽

2020 ◽

Author(s):

Kenny Lauf ◽

Jari Dahmen ◽

J. Nienke Altink ◽

Sjoerd A. S. Stufkens ◽

Gino M. M. J. Kerkhoffs

Keyword(s):

Clinical Outcomes ◽

Median Time ◽

Outcome Measures ◽

Return To Sport ◽

Injury Type ◽

Sinus Tarsi ◽

Sinus Tarsi Syndrome ◽

Improved Performance

Abstract Purpose The purpose of this study was to determine multiple return to sport rates, long-term clinical outcomes and safety for subtalar arthroscopy for sinus tarsi syndrome. Methods Subtalar arthroscopies performed for sinus tarsi syndrome between 2013 and 2018 were analyzed. Twenty-two patients were assessed (median age: 28 (IQR 20–40), median follow-up 60 months (IQR 42–76). All patients were active in sports prior to the injury. The primary outcome was the return to pre-injury type of sport rate. Secondary outcomes were time and rate of return to any type of sports, return to performance and to improved performance. Clinical outcomes consisted of Numerous Rating Scale of pain, Foot and Ankle Outcome Score, 36-item Short Form Survey and complications and re-operations. Results Fifty-five percent of the patients returned to their preoperative type of sport at a median time of 23 weeks post-operatively (IQR 9.0–49), 95% of the patients returned to any type and level sport at a median time of 12 weeks post-operatively (IQR 4.0–39), 18% returned to their preoperative performance level at a median time of 25 weeks post-operatively (IQR 8.0–46) and 5% returned to improved performance postoperatively at 28 weeks postoperatively (one patient). Median NRS in rest was 1.0 (IQR 0.0–4.0), 2.0 during walking (IQR 0.0–5.3) during walking, 3.0 during running (IQR 1.0–8.0) and 2.0 during stair-climbing (IQR 0.0–4.5). The summarized FAOS score was 62 (IQR 50–90). The median SF-36 PCSS and the MCSS were 46 (IQR 41–54) and 55 (IQR 49–58), respectively. No complications and one re-do subtalar arthroscopy were reported. Conclusion Six out of ten patients with sinus tarsi syndrome returned to their pre-injury type of sport after being treated with a subtalar arthroscopy. Subtalar arthroscopy yields effective outcomes at long-term follow-up concerning patient-reported outcome measures in athletic population, with favorable return to sport level, return to sport time, clinical outcomes and safety outcome measures. Level of evidence IV.

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Prospective, observational study to evaluate the relation between patient-reported outcomes and component rotation in total knee replacement: protocol for the CRACK study

BMJ Open ◽

10.1136/bmjopen-2019-031166 ◽

2019 ◽

Vol 9 (11) ◽

pp. e031166

Author(s):

Hans-Peter van Jonbergen ◽

Ellie Landman ◽

Maarten Horst ◽

Robin Westerbeek ◽

Ydo Kleinlugtenbelt

Keyword(s):

Total Knee Replacement ◽

Clinical Outcomes ◽

Outcome Measures ◽

Knee Replacement ◽

Tibial Component ◽

Patient Reported Outcomes ◽

Persistent Pain ◽

Component Rotation ◽

Patient Reported ◽

Total Knee

IntroductionTotal knee replacement (TKR) for osteoarthritis results in a satisfactory outcome in the majority of patients, although up to one in five patients may be dissatisfied with the outcome. Persistent pain is a main contributor to patient dissatisfaction, and femoral and tibial component malrotation have been identified as a potential cause for both persistent pain and patellofemoral problems. Based on the assumption that component malrotation is the causative factor for persistent pain, early revision for patients with symptomatic malrotated components has been advocated in the literature. However, convincing evidence that component malrotation indeed results in less than optimal outcomes is lacking. This study aims to assess the relation between knee prosthesis component rotation and patient-reported outcomes in a large group of patients and to determine the range of femoral, tibial and combined rotation that results in the best clinical outcomes.Methods and analysisIn this single-centre, prospective observational cohort study, a total of 500 patients will undergo TKR. All patients will have a 3D-CT assessment of femoral and tibial component rotation within 8 weeks after surgery. Outcome measures will include the Oxford Knee Score, the Knee Injury and Osteoarthritis Outcome Score, EQ-5D, visual analogue scale for pain, the American Knee Society Score and the knee joint range of motion. We will assess the relation between femoral, tibial and combined component rotation and patient-reported outcome measures at 8 weeks and 1 year of follow-up, and we will determine the range of femoral, tibial and combined rotation that results in the best clinical outcomes.Ethics and disseminationEthical approval for this study has been granted by the Isala Hospital ethics committee. The results will be published in a peer-reviewed journal and presented at relevant meetings.Trial registration numberNL7635.

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Associations between Pre-Admission Risk Scores and Two-Year Clinical Outcomes in Ischemic Stroke or Transient Ischemic Attack Patients with Non-Valvular Atrial Fibrillation

Cerebrovascular Diseases ◽

10.1159/000487896 ◽

2018 ◽

Vol 45 (3-4) ◽

pp. 170-179 ◽

Cited By ~ 1

Author(s):

Keisuke Tokunaga ◽

Hiroshi Yamagami ◽

Masatoshi Koga ◽

Kenichi Todo ◽

Kazumi Kimura ◽

...

Keyword(s):

Atrial Fibrillation ◽

Ischemic Stroke ◽

Clinical Outcomes ◽

Scale Score ◽

Outcome Measures ◽

Transient Ischemic Attack ◽

Risk Scores ◽

Modified Rankin Scale ◽

Hemorrhagic Events ◽

Ischemic Attack

Background: We aimed to clarify associations between pre-admission risk scores (CHADS2, CHA2DS2-VASc, and HAS-BLED) and 2-year clinical outcomes in ischemic stroke or transient ischemic attack (TIA) patients with non-valvular atrial fibrillation (NVAF) using a prospective, multicenter, observational registry. Methods: From 18 Japanese stroke centers, ischemic stroke or TIA patients with NVAF hospitalized within 7 days after onset were enrolled. Outcome measures were defined as death/disability (modified Rankin Scale score ≥3) at 2 years, 2-year mortality, and ischemic or hemorrhagic events within 2 years. Results: A total of 1,192 patients with NVAF (527 women; mean age, 78 ± 10 years), including 1,141 ischemic stroke and 51 TIA, were analyzed. Rates of death/disability, mortality, and ischemic or hemorrhagic events increased significantly with increasing pre-admission CHADS2 (p for trend <0.001 for death/disability and mortality, p for trend = 0.024 for events), CHA2DS2-VASc (p for trend <0.001 for all), and HAS-BLED (p for trend = 0.004 for death/disability, p for trend <0.001 for mortality, p for trend = 0.024 for events) scores. Pre-admission CHADS2 (OR per 1 point, 1.52; 95% CI 1.35–1.71; p <0.001 for death/disability; hazard ratio (HR) per 1 point, 1.23; 95% CI 1.12–1.35; p <0.001 for mortality; HR per 1 point, 1.14; 95% CI 1.02–1.26; p = 0.016 for events), CHA2DS2-VASc (1.55, 1.41–1.72, p < 0.001; 1.21, 1.12–1.30, p < 0.001; 1.17, 1.07–1.27, p < 0.001; respectively), and HAS-BLED (1.33, 1.17–1.52, p < 0.001; 1.23, 1.10–1.38, p < 0.001; 1.18, 1.05–1.34, p = 0.008; respectively) scores were independently associated with all outcome measures. Conclusions: In ischemic stroke or TIA patients with NVAF, all pre-admission risk scores were independently associated with death/disability at 2 years and 2-year mortality, as well as ischemic or hemorrhagic events within 2 years.

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Clinical outcomes

10.1093/med/9780198734444.003.0012 ◽

2016 ◽

Author(s):

Astrid van Tubergen ◽

Robert Landewé

Keyword(s):

Clinical Practice ◽

Medical Care ◽

Clinical Outcomes ◽

International Society ◽

Axial Spondyloarthritis ◽

Response Criteria ◽

The Core ◽

Core Set ◽

Core Sets ◽

Chronic Course

In general, axial spondyloarthritis (axSpA) follows a chronic course, requiring regular medical care and monitoring. The outcome of axSpA may vary substantially due to heterogenic presentation. For both research and clinical practice, it is important to have relevant, reliable, validated instruments for measuring outcome, to evaluate patients in a standardized way and capture all disease aspects. The Assessment in SpondyloArthritis international Society has developed core sets and instruments to measure these domains, and recommends only the most important domains being measured with best available methods. This chapter provides an overview of the most important outcomes in axSpA and most commonly used instruments to measure these. Additional measures frequently used but not (yet) included in the core set are addressed, and several sets of response criteria applied in axSpA research described. This chapter also provides guidance in which setting (research versus practice) and with which frequency these measures can be used.

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