Cancer‐Associated ThrOmboSIs – Patient‐Reported OutcoMes With RivarOxaban (COSIMO) – Baseline characteristics and clinical outcomes

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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Association of Patient-reported Outcomes With Clinical Outcomes After Distal Humerus Fracture Treatment

JAAOS Global Research and Reviews ◽

10.5435/jaaosglobal-d-19-00122 ◽

2020 ◽

Vol 4 (2) ◽

pp. e19.00122

Author(s):

Abhiram R. Bhashyam ◽

Yassine Ochen ◽

Quirine M.J. van der Vliet ◽

Luke P.H. Leenen ◽

Falco Hietbrink ◽

...

Keyword(s):

Clinical Outcomes ◽

Patient Reported Outcomes ◽

Distal Humerus ◽

Humerus Fracture ◽

Fracture Treatment ◽

Distal Humerus Fracture ◽

Patient Reported

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The HOPE Pilot Study: Harnessing Patient-Reported Outcomes and Biometric Data to Enhance Cancer Care

JCO Clinical Cancer Informatics ◽

10.1200/cci.17.00149 ◽

2018 ◽

pp. 1-12 ◽

Cited By ~ 14

Author(s):

Alexi A. Wright ◽

Nikita Raman ◽

Patrick Staples ◽

Stephanie Schonholz ◽

Angel Cronin ◽

...

Keyword(s):

Physical Activity ◽

Health Status ◽

Clinical Outcomes ◽

Mobile Health ◽

Symptom Management ◽

Patient Reported Outcomes ◽

Perceived Effectiveness ◽

Activity Data ◽

Patient Reported ◽

Wearable Accelerometers

Purpose Integrating patient-reported outcomes (PROs) into clinical practice is an increasingly promising strategy for improving patients’ symptoms, communication, and clinical outcomes. The objective of the current study was to assess the feasibility, acceptability, and perceived effectiveness of a mobile health intervention that was designed to collect PROs and activity data as a measure of health status. Patients and Methods This work was a pilot intervention with 10 patients with gynecologic cancers who received palliative chemotherapy. The HOPE (Helping Our Patients Excel) study used wearable accelerometers to assess physical activity and the Beiwe research platform to collect PROs, stratify patient responses by risk, provide tailored symptom management, and notify patients and clinicians of high-risk symptoms. Feasibility and acceptability were assessed through enrollment and adherence rates, and perceived effectiveness was evaluated by patients and oncologists at study completion. Results The approach-to-consent rate was 100%, and participants were 90% and 70% adherent to the wearable accelerometers and smartphone surveys, respectively. Participants’ mean daily step count was 3,973 (standard deviation [SD], 2,305 steps) and increased from week 1 (mean, 3,520 steps; SD, 1,937 steps) to week 3 (mean, 4,136 steps; SD, 1,578 steps). Active monitoring of participants’ heart rates, daily steps, and PROs throughout the study identified anomalies in participants’ behavior patterns that suggested poor health for two patients (20%). Patients and clinicians indicated that the intervention improved physical activity, communication, and symptom management. Conclusion A mobile health intervention that collects PROs and activity data as a measure of health status is feasible, acceptable, and was perceived to be effective in improving symptom management in patients with advanced gynecologic cancers. A larger, multisite, randomized clinical trial to assess the efficacy of the HOPE intervention on patients’ symptoms, health-related quality of life, clinical outcomes, and health care use is warranted.

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Two Year Clinical Outcomes of the Subchondroplasty® Procedure for Treatment of Symptomatic Bone Marrow Lesions of the Knee

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967119s00291 ◽

2019 ◽

Vol 7 (7_suppl5) ◽

pp. 2325967119S0029

Author(s):

Christopher Hajnik ◽

Sam Akhavan ◽

Douglas J. Wyland ◽

Steven B. Cohen ◽

Laith M. Jazrawi ◽

...

Keyword(s):

Bone Marrow ◽

Clinical Outcomes ◽

Conversion Rate ◽

Bone Substitute ◽

Patient Reported Outcomes ◽

Bone Substitute Material ◽

Bone Marrow Lesions ◽

Patient Reported ◽

Substitute Material ◽

One Year

Objectives: Bone Marrow Lesions (BML) are a common finding on knee MRI. In the knee, BML have a strong correlation to patient-reported pain, function, joint deterioration and rapid progression to TKR. Histologic analyses of BML have demonstrated findings consistent with fracture and bony remodeling of the trabeculae. The Subchondroplasty (SCP®) Procedure aims to treat the bone defects present in the BML by percutaneously filling them with a bone substitute material, designed to flow through intact bone, harden at body temperature and then heal through natural bone turnover. Previous retrospective, single-center case series have demonstrated improvements in patient-reported outcomes. The purpose of this prospective, multi-center study is to evaluate the 2-year clinical and radiographic outcomes of patients with BML of the knee treated with the Subchondroplasty Procedure. Methods: Seventy patients were treated between 2012 and 2017 for BML of the tibial plateau and/or femoral condyle. Self-drilling cannulas were inserted into the BML using arthroscopic and fluoroscopic guidance, then injected with AccuFill® Bone Substitute Material. All patients also underwent arthroscopy to aid in targeting the underlying bony lesion and address intra-articular pathology. MRIs and radiographs were obtained pre-operatively, at 6, 12 and 24 months, with additional radiographs collected at 6 weeks and 3 months. Patient-reported outcomes, including VAS pain, IKDC and KOOS were collected pre-operatively, 2 and 6 weeks, and 3, 6, 12 and 24 months post-operatively. Results: Seventy patients (36 males and 34 females), average age 57 were consented and enrolled in the study. Preoperative K-L grade included 1.4% Grade 0, 2.9% Grade 1, 27.1% Grade 2, 55.7% Grade 3 and 7.1% Grade 4. Fifty eight tibial plateaus and 41 femoral condyles were treated (29 bipolar lesions treated). VAS Pain scores improved from a mean of 6.2/10 pre-op to 2.9/10 at 1 year. IKDC scores improved from mean 33.9 pre-op to 61.3 at 1 year. KOOS scores improved from baseline to 1 year (Fig. 1) with mean KOOS Pain from 45.8 to 73.9, ADL 52.9 to 79.2, Symptoms 49.7 to 71.9, Sports 21.2 to 49.9 and Quality of Life 18.1 to 52.3. All patient-reported outcomes showed statistically significant improvement at one year. Two year outcomes collected to date appear to follow the same trend. The last study subject is due to return in January 2019 at which point the final 2 year analysis will be completed. Six patients (8.6%) converted to arthroplasty (1 UKA and 5 TKA) at one year. To date, the 24 month conversion rate is 16.1% out of 62 subjects. The final conversion rate for 24 months will be calculated after the final subject returns. Radiographs and MRIs demonstrated good incorporation of the AccuFill material through 12 months with evidence of early remodeling and a lack of OA progression in the majority of subjects. Twenty-four month MRIs demonstrate continued remodeling of the AccuFill material. Conclusion: This study presents statistically and clinically-meaningful evidence of improvements in clinical outcomes following Subchondroplasty procedure for BML of the knee. The low conversion rate suggests this less-invasive procedure may delay the need for knee arthroplasty. MR imaging demonstrates good incorporation of the BSM and evidence of remodeling and reduction in material volume over time. [Figure: see text][Table: see text]

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Assessment of Clinical Outcomes Following Erythropoietic Intervention at a Hemoglobin Concentration above 10 g/dL: A Comprehensive Review of Recent Literature.

Blood ◽

10.1182/blood.v104.11.3714.3714 ◽

2004 ◽

Vol 104 (11) ◽

pp. 3714-3714

Author(s):

Gary Lyman ◽

Gregory Rossi ◽

John Glaspy

Keyword(s):

Relative Risk ◽

Clinical Outcomes ◽

Patient Reported Outcomes ◽

Eligibility Criterion ◽

Epoetin Alfa ◽

Treatment Control ◽

Intervention Point ◽

Patient Reported ◽

American Society ◽

Hb Concentration

Abstract Current practice guidelines for the management of chemotherapy-induced anemia (CIA) recommend initiating erythropoietic intervention at hemoglobin (Hb) ≤ 10 g/dL (American Society of Hematology [ASH]/American Society of Clinical Oncology [ASCO]), or at Hb ≤ 11 g/dL (National Comprehensive Cancer Network [NCCN]). This comprehensive literature review summarizes published findings of randomized controlled trials (RCTs) that evaluated the effects of initiating erythropoietic treatment at Hb > 10 g/dL on transfusion incidence, Hb concentration, and/or patient-reported outcomes, relative to control. A search of the Medline database and conference proceedings (ASH and ASCO) from 1999 to 15 June 2004 was conducted to identify RCTs that evaluated the ability of erythropoietic agents to prevent the onset or worsening of CIA. Mantel-Haenszel weighted summary estimates of the relative risk were calculated to evaluate outcomes in patients treated with epoetin alfa compared to control patients. Using predefined selection criteria, 4 full-length papers (summarized in the table) and 5 abstracts (Chang ASCO 2003; Savonije ASCO 2004; Straus ASH 2003; Crawford ASCO 2003; Rearden ASCO 2004) were identified and reviewed. Epoetin alfa effectively decreased transfusion incidence and the percentage of patients with Hb decline to < 10 g/dL vs no treatment in 4 RCTs reported from 1997 onward (table). The estimated summary relative risk (95% CI) for transfusion and Hb < 10 g/dL are 0.39 (0.26–0.57; P < 0.0001) and 0.48 (0.25–0.89), respectively. These results were consistent with early results reported in 2 additional RCTs (Chang ASCO 2003; Savonije ASCO 2004), which were of similar design. The preliminary results of 3 additional RCTs that directly compared outcomes following early (Hb > 10 g/dL) and late (Hb ≤ 10 g/dL) erythropoietic intervention were presented at recent ASH and ASCO conferences (Straus ASH 2003; Crawford ASCO 2003; Rearden ASCO 2004). All 3 studies provided evidence of lower incidence of transfusion, higher Hb levels over time, and/or better patient-reported outcomes among patients treated early compared with those treated late. The results of the studies examined demonstrate the clinical benefits of initiating erythropoietic treatment at a Hb concentration > 10 g/dL, with respect to reducing transfusion requirements and improving Hb levels, in patients with cancer undergoing chemotherapy. Although the findings are preliminary and have yet to appear in peer-reviewed journals, the comparative RCTs of early vs late intervention point to a trend in which patients who received erythropoietic treatment early experienced better clinical outcomes overall than patients treated late. Bamias 2003 Thatcher 1999 ten Bokkel Huinink 1998 Del Mastro 1997 E=epoetin alfa; C=no treatment control; reported p < 0.05 (*), 0.01 (**), 0.001 (***) vs control. ªHb ≤10 g/dL in Del Mastro study Hb Eligibility Criterion (g/dL) ≤13 ≥10.5 < 13 ≥ 12 Baseline Hb (g/dL) 11.5 (E) 13.7 (E) 12.0 (E) 13.0 (E) 11.5 (C) 13.4 (C) 11.8 (C) 13.1 (C) Transfusion Incidence (%) 15* (E) 45* (E) 4**(E) 0 (E) 33 (C) 59 (C) 39 (C) 6 (C) % Patients with Hb < 10 g/dLª 17*** (E) 48* (E) 18* (E) 0*** (E) 46 (C) 66 (C) 50 (C) 52 (C) Dosing Regimen 10,000 U TIW 150 U/kg TIW 150 U/kg TIW 150 U/kg TIW No treatment (control) No treatment (control) No treatment (control) No treatment (control)

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Validation and equivalency of electronic clinical outcomes assessment systems

International Journal of Clinical Trials ◽

10.18203/2349-3259.ijct20204485 ◽

2020 ◽

Vol 7 (4) ◽

pp. 271

Author(s):

Sarah T. Gary ◽

Antonio V. Otero ◽

Kenneth G. Faulkner ◽

Nadeeka R. Dias

Keyword(s):

Clinical Outcomes ◽

Patient Reported Outcomes ◽

Bring Your Own Device ◽

Equivalence Testing ◽

Patient Reported ◽

The Us ◽

Different Types ◽

Fit For Purpose ◽

Clinical Outcomes Assessment ◽

Recent Patient

<p>The US food and drug administration (FDA) has long called for clinical outcomes assessments (COA), such as patient-reported outcomes (PRO), to be ‘fit-for-purpose’ meaning the COA has been validated to support the context of use. The FDA’s recent patient-focused drug development guidance series has renewed the importance of ensuring that COA is ‘fit-for-purpose’ and valid. In addition, the FDA has recommended that COA be collected electronically and that the electronic (eCOA) system and devices also be validated. Advancing technology requires eCOA systems and devices to evolve; eCOA devices may change over time. As bring your own device (BYOD) models gain popularity and acceptance, devices may also be mixed within trials. Changes in eCOA devices or mixing devices may require equivalence testing to prove validity across platforms. The aim of this article is to provide an overview of the different types of validation at both the assessment level and the eCOA system (device) level to help clinical trial sponsors determine the appropriate level of validation or equivalence testing required for COA used in their clinical trials. </p>

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161 EUROSTAD Prospective Observational Study: Baseline Characteristics, Atopic Dermatitis Severity, and Patient-Reported Outcomes

Journal of Investigative Dermatology ◽

10.1016/j.jid.2019.07.165 ◽

2019 ◽

Vol 139 (9) ◽

pp. S241

Author(s):

M. de Bruin-Weller ◽

A.E. Pink ◽

A. Patrizi ◽

A.M. Giménez-Arnau ◽

T. Agner ◽

...

Keyword(s):

Atopic Dermatitis ◽

Observational Study ◽

Patient Reported Outcomes ◽

Prospective Observational Study ◽

Atopic Dermatitis Severity ◽

Patient Reported ◽

Baseline Characteristics

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Contribution of First Tarsometatarsal Joint Fusion to Deformity Correction in the Treatment of Adult Acquired Flatfoot Deformity

Foot & Ankle Orthopaedics ◽

10.1177/2473011420s00184 ◽

2020 ◽

Vol 5 (4) ◽

pp. 2473011420S0018

Author(s):

Jonathan Day ◽

Matthew S. Conti ◽

Nicholas Williams ◽

Scott J. Ellis ◽

Jonathan T. Deland ◽

...

Keyword(s):

Clinical Outcomes ◽

Patient Reported Outcomes ◽

Interobserver Reliability ◽

Deformity Correction ◽

Measurement Information ◽

Radiographic Parameters ◽

Metatarsal Angle ◽

Patient Reported ◽

Adult Acquired Flatfoot Deformity

Category: Midfoot/Forefoot; Other Introduction/Purpose: Severe adult-acquired flatfoot deformity (AAFD) is often associated with painful medial column collapse at the naviculocuneiform (NC) joint. The purpose of this study was to examine the role of first tarsometatarsal (1st TMT) fusion combined with subtalar fusion in correcting deformity at this joint. Methods: We retrospectively analyzed 40 patients (41 feet) who underwent 1st TMT and subtalar (ST) fusion as part of a flatfoot reconstructive procedure. We assessed six radiographic parameters both preoperatively and at a minimum of 6 months postoperatively, including talonavicular (TN) coverage angle, lateral talo-first metatarsal angle, lateral talocalcaneal angle, calcaneal pitch, hindfoot moment arm, and a newly defined navicular-cuneiform incongruency angle (NCIA). Patient-Reported Outcomes Measurement Information System (PROMIS) clinical outcomes were assessed preoperatively and at a minimum 1 year follow-up. Results: The NCIA demonstrated excellent interobserver reliability, with no significant change between pre- and postoperative measurements. All other radiographic parameters, except calcaneal pitch, demonstrated statistically significant improvement postoperatively (p <0.01). Overall, patients had statistically significant improvement in all PROMIS domains (p <0.01), except for depression. Worsening NC deformity was not associated with worse patient-reported outcomes. Conclusion: Our data suggests that when addressing collapse of the medial arch in patients with AAFD, fusion of the 1st TMT joint in combination with other procedures leads to acceptable radiographic and clinical outcomes. There was no change in deformity at the NC joint at short-term follow-up, and patients achieved significant improvement in multiple PROMIS domains. Based on our findings, deformity through the NC joint does not significantly impact clinical outcomes. In addition, the NCIA was established as a reliable radiographic parameter that can be used to assess NC deformity in the presence of talonavicular and/or 1st TMT fusion. [Table: see text]

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