Systematic Evaluation of Patient-Reported Outcome Protocol Content and Reporting in Cancer Trials

Abstract Background Patient-reported outcomes (PROs) are captured within cancer trials to help future patients and their clinicians make more informed treatment decisions. However, variability in standards of PRO trial design and reporting threaten the validity of these endpoints for application in clinical practice. Methods We systematically investigated a cohort of randomized controlled cancer trials that included a primary or secondary PRO. For each trial, an evaluation of protocol and reporting quality was undertaken using standard checklists. General patterns of reporting where also explored. Results Protocols (101 sourced, 44.3%) included a mean (SD) of 10 (4) of 33 (range = 2–19) PRO protocol checklist items. Recommended items frequently omitted included the rationale and objectives underpinning PRO collection and approaches to minimize/address missing PRO data. Of 160 trials with published results, 61 (38.1%, 95% confidence interval = 30.6% to 45.7%) failed to include their PRO findings in any publication (mean 6.43-year follow-up); these trials included 49 568 participants. Although two-thirds of included trials published PRO findings, reporting standards were often inadequate according to international guidelines (mean [SD] inclusion of 3 [3] of 14 [range = 0–11]) CONSORT PRO Extension checklist items). More than one-half of trials publishing PRO results in a secondary publication (12 of 22, 54.5%) took 4 or more years to do so following trial closure, with eight (36.4%) taking 5–8 years and one trial publishing after 14 years. Conclusions PRO protocol content is frequently inadequate, and nonreporting of PRO findings is widespread, meaning patient-important information may not be available to benefit patients, clinicians, and regulators. Even where PRO data are published, there is often considerable delay and reporting quality is suboptimal. This study presents key recommendations to enhance the likelihood of successful delivery of PROs in the future.

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Strain Elastography and Tendon Response to an Exercise Program in Patients With Supraspinatus Tendinopathy: An Exploratory Study

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967120965185 ◽

2020 ◽

Vol 8 (12) ◽

pp. 232596712096518

Author(s):

Karen Brage ◽

Birgit Juul-Kristensen ◽

John Hjarbaek ◽

Eleanor Boyle ◽

Per Kjaer ◽

...

Keyword(s):

Patient Reported Outcomes ◽

Structural Changes ◽

Supraspinatus Tendon ◽

Patient Reported Outcome ◽

Minimal Detectable Change ◽

Detectable Change ◽

Tendon Stiffness ◽

Patient Reported ◽

Tendon Thickness

Background: Shoulder pain is common, with a lifetime prevalence of up to 67%. Evidence is conflicting in relation to imaging findings and pain in the shoulder. Sonoelastography can be used to estimate tissue stiffness and may be a clinically relevant technique for diagnosing and monitoring tendon healing. Purpose: To evaluate changes in supraspinatus tendon stiffness using strain elastography (SEL) and associations with changes in patient-reported outcomes, supraspinatus tendon thickness, and grade of tendinopathy after 12 weeks of unilateral shoulder exercises in patients with supraspinatus tendinopathy. Study Design: Controlled laboratory study. Methods: A total of 23 patients with unilateral clinical supraspinatus tendinopathy performed 12 weeks of “standard care” exercises. At baseline and follow-up, supraspinatus tendon stiffness was measured bilaterally using SEL and compared with tendinopathy grading on magnetic resonance imaging scans and tendon thickness measured using conventional ultrasound. Patient-reported outcome measures included physical function and symptoms from the Disabilities of the Arm, Shoulder and Hand questionnaire and pain rating (visual analog scale). Results: No significant changes in SEL within or between groups (asymptomatic vs symptomatic tendon) were seen. All patient-reported outcomes showed significant improvement from baseline to follow-up, but with no change in tendinopathy grading and tendon thickness. No significant differences in the proportion of patients changing above the minimal detectable change in SEL and PROM were seen, except for discomfort while sleeping. Conclusion: Despite no significant within-group or between-group changes in SEL, significant improvements were found in patient-reported outcomes. An acceptable agreement between patients changing above the minimal detectable change in SEL and patient-reported outcome measure was seen. Further studies should explore the use of SEL to detect changes after tendon repair and long-term training potentially in subgroups of different tendinopathy phases. Clinical Relevance: In the short term, structural changes in supraspinatus tendons could not be visualized using SEL, indicating that a longer time span should be expected in order to observe structural changes, which should be considered before return to sports. Subgrouping based on stage of tendinopathy may also be important in order to evaluate changes over time with SEL among patients with supraspinatus tendinopathy. Registration: NCT03425357 ( ClinicalTrials.gov identifier).

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Acceptability of no-test medical abortion provided via telemedicine: analysis of patient-reported outcomes

BMJ Sexual & Reproductive Health ◽

10.1136/bmjsrh-2020-200954 ◽

2021 ◽

pp. bmjsrh-2020-200954

Author(s):

Chelsey Porter Erlank ◽

Jonathan Lord ◽

Kathryn Church

Keyword(s):

Patient Reported Outcomes ◽

Medical Abortion ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Post Procedure ◽

High Satisfaction ◽

First Choice ◽

Patient Reported ◽

At Home

IntroductionThe English government approved both stages of early medical abortion (EMA), using mifepristone and misoprostol under 10 weeks’ gestation, for at-home use on 30 March 2020. MSI Reproductive Choices UK (MSUK), one of the largest providers of abortion services in England, launched a no-test telemedicine EMA pathway on 6 April 2020. The objectives of this study were to report key patient-reported outcome measures and to assess whether our sample was representative of the whole population receiving no-test telemedicine EMA.MethodsA sample of all MSUK’s telemedicine EMA patients between April and August 2020 were invited to opt in to a follow-up call to answer clinical and satisfaction questions. A total of 1243 (13.7% of all telemedicine EMAs) were successfully followed-up, on average within 5 days post-procedure.ResultsPatients reported high confidence in telemedicine EMA and high satisfaction with the convenience, privacy and ease of managing their abortion at home. The sample responding were broadly equivalent to the whole population receiving telemedicine. No patient reported that they were unable to consult privately. The majority (1035, 83%) of patients reported preferring the telemedicine pathway, with 824 (66%) indicating that they would choose telemedicine again if COVID-19 were no longer an issue.ConclusionsTelemedicine EMA is a valued, private, convenient and more accessible option that is highly acceptable for patients seeking an abortion, especially those for whom in-clinic visits are logistically or emotionally challenging. Evidence that this pathway would be a first choice again in future for most patients supports the case to make telemedicine EMA permanent.

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Midterm Outcomes Following Hip Labral Augmentation

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967121s00241 ◽

2021 ◽

Vol 9 (7_suppl4) ◽

pp. 2325967121S0024

Author(s):

Joseph Ruzbarsky ◽

Justin Arner ◽

Karen Briggs ◽

Marc Philippon ◽

Rui Soares

Keyword(s):

Patient Satisfaction ◽

Treatment Option ◽

Patient Reported Outcomes ◽

Patient Reported Outcome ◽

Harris Hip Score ◽

Iliotibial Band ◽

Patient Reported ◽

Modified Harris Hip Score ◽

Suction Seal

Objectives: Arthroscopic hip labral preservation techniques have evolved over the last decade. Arthroscopic hip labral augmentation with iliotibial band (ITB) autograft placed into a labral defect with viable circumferential fibers is a novel treatment option to restore the hip suction seal and improve functionality. The purpose of this study is to determine midterm (3-5 year follow up) outcomes of arthroscopic hip labral augmentation procedure. Methods: Patients who underwent arthroscopic hip labral augmentation from August 2011 to March 2017 were prospectively evaluated. Pre- and post-operative patient reported outcome scores were compared and included SF12 PCS, SF12 MCS, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Modified Harris Hip Score (mHHS), Hip Outcome Score (HOS) (Activities of Daily Living (ADL) and Sport). Post-operative Tegner Activity Scale and patient satisfaction (1 – 10) were also evaluated. Results: One hundred and six patients underwent arthroscopic hip labral augmentation with minimum 3-year follow-up. Mean follow-up was 5-year follow-up (range, 3 to 9.2 years). All patient reported outcomes improved after labral augmentation (SF12 PCS 39±8 vs. 50±10, p>0.01; mHHS 59±15 vs. 79±21, p<0.01; WOMAC 31±16 vs. 16±17, p<0.01; HOS ADL 64±17 vs. 84±21, p<0.01; HOS Sport 41±22 vs. 71±29, p<0.01). Median post-operative Tegner score was 4. Median post-operative patient satisfaction was 9 out of 10 (range, 1-10). In terms of survivorship, 12 patients (11%) required revision surgery and 6 (5.7%) converted to total hip arthroplasty (THA). Conclusions: Arthroscopic hip labral augmentation is a successful treatment option for patients that have viable circumferential fibers present at the time of arthroscopy. This technique continues to show improved patient reported outcomes and is another hip labral preservation technique that may help reestablish the intra-articular fluid suction seal.

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The Association of AUSCAN and PRWHE Patient-reported Outcome Measures With Radiographic Progression of Early Thumb Carpometacarpal Arthritis at 36-Month Follow-up Is Limited to Subtle Changes in the Pain Subscale

Hand ◽

10.1177/1558944720928489 ◽

2020 ◽

pp. 155894472092848

Author(s):

Joseph A. Gil ◽

Justin Kleiner ◽

Thomas J. McQuillan ◽

Deborah Kenney ◽

Amy L. Ladd ◽

...

Keyword(s):

Regression Analysis ◽

Patient Reported Outcomes ◽

Radiographic Progression ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Multivariable Logistic Regression Analysis ◽

Pain Subscale ◽

Patient Reported ◽

Thumb Carpometacarpal

Background There is a paucity of literature that examines how patient-reported outcomes correspond to early radiographic progression of thumb carpometacarpal (CMC) osteoarthritis (OA). This study examines how Australian/Canadian Osteoarthritis Hand Index (AUSCAN) and Patient-Rated Hand and Wrist Evaluation (PRWHE) scores change over 36 months in subjects with early CMC OA. Methods Ninety-one subjects with symptomatic early thumb CMC OA were enrolled. Differences in AUSCAN and PRWHE scores were measured between subjects at baseline and at 18-month follow-up, and between the subjects at baseline and at 36-month follow-up. Radiographic progression was defined as an increase in modified Eaton Stage. Differences in AUSCAN and PRWHE scores were compared between these 2 groups in order to determine if radiographic progression was associated with a greater change in AUSCAN and PRWHE at 18- and 36-month follow-up. Results At 18- and 36-month follow-up visits, there were no significant differences in AUSCAN or PRWHE compared to baseline. Multivariable logistic regression analysis did not reveal any significant differences between subjects with radiographic progression to subjects without radiographic progression at 18-month follow-up. At 36-month follow-up, this analysis did demonstrate that subjects with evidence of radiographic progression had a significant increase in the PRWHE pain subscale. Conclusion AUSCAN and PRWHE scores were not found to significantly progress at 18-month and 36-month follow-up. However, when comparing the subset of subjects with and without radiographic OA, subjects with early CMC OA who had 1 stage of radiographic progression were found to have a significantly higher intensity of pain on the PRWHE pain subscale at 36-month follow-up.

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Intermediate-term Patient-Reported Outcomes and Radiographic Evaluation Following Intramedullary- vs Extramedullary-Referenced Total Ankle Replacement

Foot & Ankle International ◽

10.1177/1071100720980024 ◽

2021 ◽

pp. 107110072098002

Author(s):

Craig C. Akoh ◽

Rishin Kadakia ◽

Amanda Fletcher ◽

Young Uk Park ◽

Hyongnyun Kim ◽

...

Keyword(s):

Patient Reported Outcomes ◽

Patient Reported Outcome ◽

Total Ankle Replacement ◽

Radiographic Evaluation ◽

Consecutive Series ◽

Ankle Replacement ◽

Implant Survivorship ◽

Patient Reported ◽

Outcome Scores

Background: The purpose of this study was to report on the radiographic outcomes, clinical outcomes, and implant survivorship following extramedullary-referenced (EMr) vs intramedullary-referenced (IMr) total ankle replacement (TAR). Methods: From May 2007 to February 2018, a consecutive series of patients with end-stage tibiotalar osteoarthritis undergoing TAR was enrolled in this study. Analyses were performed comparing IMr vs EMr components for patient-reported outcomes data, pre- and postoperative radiographic ankle alignment, concomitant procedures, and complications. Kaplan-Meier survivorship analyses served to determine implant reoperation and revision surgery. A total of 340 TARs were included with 105 IMr TAR and 235 EMr TAR. The mean follow-up was 5.3 years (±2.5, range 2-12). Results: The absolute value for preoperative coronal alignment was significantly greater for IMr compared to EMr TAR (13.0 vs 6.4 degrees; P < .0001), but both groups achieved near neutral alignment postoperatively (1.4 vs 1.5 degrees; P = .6655). The odds of having a concomitant procedure was 2.7 times higher in patients with an IMr TAR (OR 2.7, CI 1.7-4.4; P < .0001). There were similar improvements in patient-reported outcome scores at 1 year and final follow-up (all P > .05). The 5-year implant survivorship was 98.6% for IMr vs 97.5% for EMr at final follow-up. Conclusion: The IMr and EMr TAR components had comparable postoperative alignment, patient-reported outcome scores, and complications. The 5-year implant survivorship was similar between the IMr and EMr groups. Level of Evidence: Level III, retrospective comparative study.

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Do pre-operative radiologic assessment predict postoperative outcomes in patients with insertional Achilles tendinopathy?: a retrospective database study

Archives of Orthopaedic and Trauma Surgery ◽

10.1007/s00402-021-03897-x ◽

2021 ◽

Author(s):

Sebastian Felix Baumbach ◽

Hubert Hörterer ◽

Sonja Oppelt ◽

Ulrike Szeimies ◽

Hans Polzer ◽

...

Keyword(s):

Surgical Treatment ◽

Patient Reported Outcomes ◽

General Health Questionnaire ◽

Correlation Study ◽

Patient Reported Outcome ◽

Achilles Tendinopathy ◽

Insertional Tendinopathy ◽

Patient Reported ◽

Open Debridement

Abstract Introduction Diagnosis and treatment of insertional tendinopathy of the Achilles tendon (IAT) remains a challenge. The aim of this study was to assess the influence of pre-operative radiological pathologies on the patient-reported outcomes following open debridement of all pathologies for IAT. Materials and methods In this IRB-approved retrospective correlation and comparative study, patients with pre-operative imaging were identified from the authors’ retrospective IAT database comprising of 118 patients. All were treated by a standardized surgical treatment strategy utilizing a midline, transachillary approach and debridement of all pathologies. A total of fifteen radiologic parameters were measured on radiographs (RX) and MRI. The patient-reported outcomes were assessed using the Victorian Institute of Sport Assessment-Achilles questionnaire (VISA-A-G) and the general health questionnaire SF-12 at a minimum follow-up of 12 months. The data are presented as mean ± SD (95% CI). Results 88 patients (74.6%) with an average age of 50 ± 12 (47–52) years were included. Radiographs were available in 68 patients and MRI in 53. The mean follow-up was 3.8 ± 1.9 (3.4–4.3) years. The overall VISA-A-G was 81 ± 22 (77–86), the SF-12 PCS 54 ± 7 (52–55), and the SF-12 MCS 52 ± 9 (50–54) points. None of the assessed radiological parameters had a significant influence on the patient-reported outcome following surgical treatment for IAT. Conclusion In this retrospective correlation study, no significant association was found between preoperative radiographic and MRI radiologic parameters for IAT and postoperative patient-reported outcomes (VISA-A-G and SF-12).

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Proton Pump Inhibitor Use Affects Pseudarthrosis Rates and Influences Patient-Reported Outcomes

Global Spine Journal ◽

10.1177/2192568219853222 ◽

2019 ◽

Vol 10 (1) ◽

pp. 55-62 ◽

Cited By ~ 1

Author(s):

John J. Mangan ◽

Srikanth N. Divi ◽

James C. McKenzie ◽

Justin D. Stull ◽

William Conaway ◽

...

Keyword(s):

Logistic Regression ◽

Patient Outcomes ◽

Proton Pump ◽

Retrospective Cohort ◽

Patient Reported Outcomes ◽

Patient Reported Outcome ◽

Significant Difference ◽

Patient Reported ◽

Group A

Study Design: Retrospective cohort review Objectives: Cervical pseudarthrosis is a frequent cause of need for revision anterior cervical discectomy and fusion (ACDF) and may lead to worse patient-reported outcomes. The effect of proton pump inhibitors on cervical fusion rates are unknown. The purpose of this study was to determine if patients taking PPIs have higher rates of nonunion after ACDF. Methods: A retrospective cohort review was performed to compare patients who were taking PPIs preoperatively with those not taking PPIs prior to ACDF. Patients younger than 18 years of age, those with less than 1-year follow-up, and those undergoing surgery for trauma, tumor, infection, or revision were excluded. The rates of clinically diagnosed pseudarthrosis and radiographic pseudarthrosis were compared between PPI groups. Patient outcomes, pseudarthrosis rates, and revision rates were compared between PPI groups using either multiple linear or logistic regression analysis, controlling for demographic and operative variables. Results: Out of 264 patients, 58 patients were in the PPI group and 206 were in the non-PPI group. A total of 23 (8.71%) patients were clinically diagnosed with pseudarthrosis with a significant difference between PPI and non-PPI groups ( P = .009). Using multiple linear regression, PPI use was not found to significantly affect any patient-reported outcome measure. However, based on logistic regression, PPI use was found to increase the odds of clinically diagnosed pseudarthrosis (odds ratio 3.552, P = .014). Additionally, clinically diagnosed pseudarthrosis negatively influenced improvement in PCS-12 scores ( P = .022). Conclusions: PPI use was found to be a significant predictor of clinically diagnosed pseudarthrosis following ACDF surgery. Furthermore, clinically diagnosed pseudarthrosis negatively influenced improvement in PCS-12 scores.

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Six Sessions of Anterior-to-Posterior Ankle Joint Mobilizations Improve Patient-Reported Outcomes in Patients With Chronic Ankle Instability: A Critically Appraised Topic

Journal of Sport Rehabilitation ◽

10.1123/jsr.2016-0237 ◽

2019 ◽

Vol 28 (4) ◽

pp. 381-384

Author(s):

Erik A. Wikstrom ◽

Sajad Bagherian ◽

Nicole B. Cordero ◽

Kyeongtak Song

Keyword(s):

Ankle Joint ◽

Patient Reported Outcomes ◽

Ankle Instability ◽

Patient Reported Outcome ◽

Chronic Ankle Instability ◽

Bottom Line ◽

Joint Mobilization ◽

Patient Reported ◽

Improve Patient

Clinical Scenario: Chronic ankle instability (CAI) is a complex musculoskeletal condition that results in sensorimotor and mechanical alterations. Manual therapies, such as ankle joint mobilizations, are known to improve clinician-oriented outcomes like dorsiflexion range of motion, but their impact on patient-reported outcomes remains less clear. Focused Clinical Question: Do anterior-to-posterior ankle joint mobilizations improve patient-reported outcomes in patients with chronic ankle instability? Summary of Key Findings: Three studies (2 randomized controlled trials and 1 prospective cohort) quantified the effect of at least 2 weeks of anterior-to-posterior ankle joint mobilizations on improving patient-reported outcomes immediately after the intervention and at a follow-up assessment. All 3 studies demonstrated significant improvements in at least 1 patient-reported outcome immediately after the intervention and at the follow-up assessment. Clinical Bottom Line: At least 2 weeks of ankle joint mobilization improves patient-reported outcomes in patients with chronic ankle instability, and these benefits are retained for at least a week following the termination of the intervention. Strength of Recommendation: Strength of recommendation is grade A due to consistent good-quality patient-oriented evidence.

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Patient-Reported Outcome Following Ulnotriquetral Ligament Split Tear Repair

The Journal of Hand Surgery (Asian-Pacific Volume) ◽

10.1142/s0218810417500484 ◽

2017 ◽

Vol 22 (04) ◽

pp. 445-451 ◽

Cited By ~ 1

Author(s):

Camelia Qian Ying Tang ◽

Sean Wei Hong Lai ◽

Geraldine Leow ◽

Shian Chao Tay

Keyword(s):

Grip Strength ◽

Patient Reported Outcomes ◽

Clinical Presentation ◽

Surgical Repair ◽

Patient Reported Outcome ◽

Range Of Movement ◽

Post Surgery ◽

Patient Reported ◽

The Mean

Background: While the clinical presentation and mechanism of injury of ulnotriquetral (UT) ligament split tear had been well described, there has been no other studies that has reported on the outcome of a UT ligament repair. This study aims to look at the patient-reported outcomes following UT ligament split tear repair. Methods: 18 wrists (13 right and 5 left) in 17 patients (12 males and 5 females, mean age 25.0 ± 8.4 years, range 16–50 years) who had UT ligament split tear and undergone surgical repair between November 2007 and December 2013 were retrospectively analysed. Patient-reported outcome of resolution of pain, and objective measurements such as improvement in grip strength and range of movement of the wrist were recorded. Patients were followed up until the pain was completely resolved or the last documented consultation. The mean follow-up duration was 16.2 months. Results: 94% reported improvements post-surgery, of which 63% reported complete resolution of pain. 6% reported no improvement in pain post-operatively. No patient reported worsening of pain after the surgery. There was significant improvement in grip strength from a mean of 23.5 kg to 27.1 kg. There was no significant change in range of motion of the wrist. Conclusions: The majority of patients reported resolution or improvement of pain after surgical repair. In addition, there was statistically significant improvement in grip strength recorded.

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Arthroscopic Anterior Cruciate Ligament Reconstruction: A Meta-Analysis Comparing Semitendinosus Alone and Semitendinosus with Gracilis Tendon Autografts

The Journal of Knee Surgery ◽

10.1055/s-0038-1669950 ◽

2018 ◽

Vol 32 (08) ◽

pp. 796-803

Author(s):

Brian Zhaojie Chin ◽

Ian Jun Yan Wee ◽

Nicholas Li-Xun Syn ◽

Lingaraj Krishna

Keyword(s):

Acl Reconstruction ◽

Patient Reported Outcomes ◽

Cruciate Ligament ◽

Meta Analysis ◽

Peak Torque ◽

Patient Reported Outcome ◽

Patient Reported ◽

Anterior Laxity ◽

Anterior Cruciate

AbstractThe objective of this study was to provide a comprehensive systematic review and meta-analysis to compare patient-reported outcomes and functional knee parameters of anterior cruciate ligament (ACL) reconstruction surgery with semitendinosus (ST) and ST-gracilis (G) grafts. This study was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and Meta-Analysis of Observational Studies in Epidemiology (MOOSE) guidelines. All studies in PubMed and Embase that reported functional knee parameters and patient-reported outcomes after ACL reconstruction with ST and ST-G grafts independently were included in the review. Selected end points for random effects, pairwise meta-analysis included side-to-side deficit (%) in isokinetic peak torque, peak torque ratio (%), side-to-side difference (mm) in anterior laxity, and patient-reported outcome scores at minimum 2-year follow-up. A total of 15 primary references comprising 1,109 participants were identified. The ST group had decreased side-to-side deficit in isokinetic peak torque when compared with the ST-G group for flexion at 60 degrees/s (p = 0.02) and 180 degrees/s (p = 0.01) at 2-year follow-up. There were no significant differences in side-to-side difference in anterior laxity (p = 0.81), hamstring/quadriceps peak torque ratios at 60 degrees/s (p = 0.83) and 180 degrees/s (p = 0.36), and patient-reported outcomes in the International Knee Documentation Committee score (p = 0.06) and Lysholm score (p = 0.67). The addition of the gracilis tendon to the hamstring autograft in ACL reconstruction results in increased side-to-side deficits in isokinetic peak flexion torque. However, patient-reported outcome scores and knee laxity measurements are comparable with those of ST grafts.

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