Reported Outcomes and Outcome Measures in Proximal Interphalangeal Joint Arthroplasty: A Systematic Review

2021 ◽  
pp. 229255032110428
Author(s):  
Kathryn Uhlman ◽  
Hassaan Abdel Khalik ◽  
Jessica Murphy ◽  
Marta Karpinski ◽  
Achilles Thoma
Keyword(s):  
Outcome Measures ◽  
Core Outcome Set ◽  
Case Series ◽  
Proximal Interphalangeal Joint ◽  
Interphalangeal Joint ◽  
Pool Data ◽  
Outcome Set ◽  
Patient Reported ◽  
Unique Outcome ◽  
Substantial Heterogeneity

Purpose: There is a lack of scientific consensus on the best arthroplasty implant option for proximal interphalangeal joint (PIPJ) arthritis, due to diversity in outcome reporting and measurement methods. The development of a standardized core outcome set (COS) and standard outcome measures could mitigate this issue. This study catalogs the reported outcomes and outcome measures found in PIPJ arthroplasty studies, which can be used in the first step of developing a COS. Methods: A database search of MEDLINE, EMBASE, and Web of Science (January 1, 2010, to March 10, 2021) was performed to retrieve studies that reported outcomes of the 3 most common primary PIPJ arthroplasty implants: silicone, pyrocarbon, and metal-polyethylene. The primary objectives of this study include reported outcomes and outcome measures. Secondary objectives include clinimetric properties of outcome measures, study design, and implant types. Results: Fifty articles met inclusion criteria. Of the included studies, 41 (82%) were case series, 8 (16%) were cohort studies, and 1 (2%) was a randomized control trial. Thirty-three unique outcomes were identified. Fifteen (46%) outcomes were clinician-reported and 26 (79%) were patient-reported. Eighteen unique outcome measures were identified. Of the outcome measures, 15 (83%) were patient-reported, 1 (6%) was clinician-reported, and 2 (11%) were reported by both patients and clinicians. Conclusions: Substantial heterogeneity was found in reported outcomes and outcome measures across studies evaluating PIPJ arthroplasty, impeding knowledge translation. The development of a COS for PIPJ arthroplasty is necessary to help compare and pool data across studies, and advance scientific knowledge.

scholarly journals Prospective, Multicenter, Clinical and Radiographic Evaluation of a Biointegrative, Fiber-Reinforced Implant for Proximal Interphalangeal Joint Arthrodesis

2020 ◽  
Vol 5 (4) ◽  
pp. 247301142096631
Author(s):  
Luke D. Cicchinelli ◽  
Jurij Štalc ◽  
Martinus Richter ◽  
Stuart Miller
Keyword(s):  
Adverse Events ◽  
Prospective Trial ◽  
Case Series ◽  
Proximal Interphalangeal Joint ◽  
Interphalangeal Joint ◽  
Radiographic Evaluation ◽  
Fiber Reinforced ◽  
Level Of Evidence ◽  
Surgery Patient ◽  
Patient Reported

Background: A novel biointegrative implant was developed for proximal interphalangeal joint (PIPJ) arthrodesis to treat hammertoe deformity. Composed of continuous reinforcing mineral fibers bound by bioabsorbable polymer matrix, the implant demonstrated quiescent, gradual degradation with complete elimination at 104 weeks in animal models. This prospective trial assessed the implant’s safety, clinical performance, and fusion rate of PIPJ arthrodesis for hammertoe correction. Methods: Twenty-five patients (mean age 63.9±7.5 years) who required PIPJ arthrodesis were enrolled at 3 centers. Outcomes included radiographic joint fusion, adverse events, pain visual analog scale (VAS) score, Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) score, and patient satisfaction. Patients were evaluated 2, 4, 6, 12, and 26 weeks postoperatively. Results: Twenty-two patients (88%) achieved radiographic fusion at 26 weeks. All joints (100%) were considered clinically stable, with no complications or serious adverse events. Pain VAS improved from 5.3±2.5 preoperatively to 0.5±1.4 at 26 weeks postoperatively. FAAM-ADL total scores and level of functioning improved by mean 19.5±19.0 points and 24.4±15.7 percentage points, respectively, from preoperation to 26 weeks postoperation. Improvements in pain VAS and FAAM scores surpassed established minimal clinically important differences. All patients were very satisfied (84%) or satisfied (16%) with the surgery. Patient-reported postoperative results greatly exceeded (72%), exceeded (20%), or matched (8%) expectations. Conclusion: This prospective, multicenter, first-in-human clinical trial of a novel biointegrative fiber-reinforced implant in PIPJ arthrodesis of hammertoe deformity demonstrated a favorable rate of radiographic fusion at 12 and 26 weeks, with no complications and good patient-reported clinical outcomes. Level of Evidence: Level IV, prospective case series.

scholarly journals Outcomes in randomised controlled trials of multifocal lenses in cataract surgery: the case for development of a core outcome set

2020 ◽  
Vol 104 (10) ◽  
pp. 1345-1349
Author(s):  
Jennifer R Evans ◽  
Samantha R de Silva ◽  
Mohammed Ziaei ◽  
Varo Kirthi ◽  
Martin D Leyland
Keyword(s):  
Cataract Surgery ◽  
Outcome Measures ◽  
Randomised Controlled Trials ◽  
Core Outcome Set ◽  
Intraocular Lenses ◽  
Controlled Trials ◽  
Core Outcome ◽  
Outcome Set ◽  
Patient Reported ◽  
Randomised Controlled

Background/aimsTo describe and summarise the outcomes reported in randomised controlled trials of multifocal versus monofocal intraocular lenses in cataract surgery.MethodsWe identified all randomised controlled trials of multifocal versus monofocal lenses in a Cochrane review (last search date June 2016). We extracted and summarised data on all outcomes reported using the framework of domain, measurement, metric and method of aggregation.ResultsAll studies collected data on distance and near visual acuity but there was considerable variation in the measures used and whether these outcomes were unaided or best corrected. Most studies reported final value measurements, rather than change from baseline. Approximately half of the studies reported data as a continuous measure only, one-third reported both continuous and categorical measures and a minority reported categorical measures only. There was little consensus as to cut-points. Although a majority of studies included one or more patient-reported outcome measures, none of the studies reported patient involvement in the choice of outcomes.ConclusionThe collection and analysis of data on outcome measures in studies of multifocal intraocular lenses in cataract surgery are complicated. As a result, there is considerable heterogeneity in collection and reporting in the medical literature. This makes it difficult to synthesise such data to provide robust estimates of effect and is a potential source of research waste. Investigators in this field must produce a core outcome set that is informed by patients’ views and we propose an initial set of outcomes on which these could be based.

A Midterm Review of Lesser Toe Arthrodesis With an Intramedullary Implant

2017 ◽  
Vol 10 (5) ◽  
pp. 458-464 ◽  
Author(s):  
James Lee Harmer ◽  
Anthony Wilkinson ◽  
Anthony John Maher
Keyword(s):  
Case Series ◽  
Proximal Interphalangeal Joint ◽  
Interphalangeal Joint ◽  
Complex Nature ◽  
Patient Reported ◽  
Related Quality ◽  
Intramedullary Implant ◽  
Health Related ◽  
Surgical Options ◽  
Alternative Fixation

Lesser toe deformities are one of the most common conditions encountered by podiatric surgeons. When conservative treatments fail surgical correction is indicated. Many surgical options have been described to address the complex nature of these deformities but no perfect solution has been reported to date. However, with the continued advancement of internal fixation technology, interphalangeal joint (IPJ) arthrodesis with an intramedullary implant may be a good option. This retrospective study presents patient reported outcomes and complications at 6 months and 3 years following lesser toe proximal interphalangeal joint (PIPJ) arthrodesis with a polyketone intrameduallary implant (Toe Grip, Orthosolutions, UK). Between September 2011 and November 2012, a total of 38 patients attended for second toe PIPJ arthrodesis by means of the Toe Grip device. At 6 months postoperation, 94.7% of patients and at 3 years postoperation, 92.8% of patients felt that their original complaint was better or much better. Health-related quality of life scores continued to improve overtime as measured by the Manchester Oxford Foot Questionnaire. Complications were generally observational and asymptomatic. The most common complications were floating toes (17.8%), mallet deformities (14.2%), metatarsalgia (17.8%), and transverse plane deformity of the toe (10.7%). This study demonstrates excellent patient-eported outcomes with minimal symptomatic complications making the “Toe Grip” implant a safe and effective alternative fixation device for IPJ arthrodesis when dealing with painful digital deformities. Levels of Evidence: Therapeutic, Level IV: Case series

A proximal interphalangeal joint custom-made orthosis in trigger finger: Functional outcome

Hand Therapy ◽  
2021 ◽  
pp. 175899832110187
Author(s):  
Kawee Pataradool ◽  
Chayanin Lertmahandpueti
Keyword(s):  
Outcome Measures ◽  
Proximal Interphalangeal Joint ◽  
Interphalangeal Joint ◽  
Mean Difference ◽  
Trigger Finger ◽  
Symptom Improvement ◽  
Dash Score ◽  
Full Time ◽  
Custom Made ◽  
Quick Dash

Introduction Trigger finger is a common and functionally limiting disorder. Finger immobilization using an orthotic device is one of the conservative treatment options for treating this condition. The most common orthosis previously described for trigger finger is metacarpophalangeal joint immobilization. There are limited studies describing the effectiveness of proximal interphalangeal joint orthosis for treatment of trigger finger. Methods This study was a single group pretest-posttest design. Adult patients with single digit idiopathic trigger finger were recruited and asked to wear a full-time orthoses for 6 weeks. The pre- and post-outcome measures included Quick-DASH score, the Stages of Stenosing Tenosynovitis (SST), the Visual Analogue Scale (VAS) for pain, the number of triggering events in ten active fists, and participant satisfaction with symptom improvement. Orthotic devices were made with thermoplastic material fabricated with adjustable Velcro tape at dorsal side. All participants were given written handouts on this disease, orthotic care and gliding exercises. Paired t-tests were used to determine changes in outcome measures before and after wearing the orthosis. Results There were 30 participants included in this study. Evaluation after the use of PIP joint orthosis at 6 weeks revealed that there were statistically significant improvements in Quick-DASH score from enrolment (mean difference −29.0 (95%CI −34.5 to −23.4); p < 0.001), SST (mean difference −1.4 (95%CI −1.8 to −1.0); p < 0.001) and VAS (mean difference −3.4 (95%CI −4.3 to −2.5); p < 0.001). There were no serious adverse events and patient satisfaction with the treatment was high. Conclusions Despite our small study size, the use of proximal interphalangeal joint orthosis for 6 weeks resulted in statistically significant improvements in function, pain and triggering, and also high rates of acceptance in patients with isolated idiopathic trigger finger.

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 Protocol for the development of a core outcome set for lateral elbow tendinopathy (COS-LET)

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Marcus Bateman ◽  
Jonathan P. Evans ◽  
Viana Vuvan ◽  
Val Jones ◽  
Adam C. Watts ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Health Care Professionals ◽  
Delphi Study ◽  
Evidence Synthesis ◽  
Core Outcome Set ◽  
Outcome Evaluation ◽  
Core Outcome ◽  
Outcome Set ◽  
Lateral Elbow ◽  
Lateral Elbow Tendinopathy

Abstract Background Lateral elbow tendinopathy (LET) is a common condition that can cause significant disability and associated socioeconomic cost. Although it has been widely researched, outcome measures are highly variable which restricts evidence synthesis across studies. In 2019, a working group of international experts, health care professionals and patients, in the field of tendinopathy (International Scientific Tendinopathy Symposium Consensus (ICON) Group), published the results of a consensus exercise defining the nine core domains that should be measured in tendinopathy research. The aim of this study is to develop a core outcome set (COS) for LET mapping to these core domains. The primary output will provide a template for future outcome evaluation of LET. In this protocol, we detail the methodological approach to the COS-LET development. Methods This study will employ a three-phase approach. (1) A systematic review of studies investigating LET will produce a comprehensive list of all instruments currently employed to quantify the treatment effect or outcome. (2) Instruments will be matched to the list of nine core tendinopathy outcome domains by a Steering Committee of clinicians and researchers with a specialist interest in LET resulting in a set of candidate instruments. (3) An international three-stage Delphi study will be conducted involving experienced clinicians, researchers and patients. Within this Delphi study, candidate instruments will be selected based upon screening using the Outcome Measures in Rheumatology (OMERACT) truth, feasibility and discrimination filters with a threshold of 70% agreement set for consensus. Conclusions There is currently no COS for the measurement or monitoring of LET in trials or clinical practice. The output from this project will be a minimum COS recommended for use in all future English language studies related to LET. The findings will be published in a high-quality journal and disseminated widely using professional networks, social media and via presentation at international conferences. Trial registration Registered with the Core Outcome Measures in Effectiveness Trials (COMET) database, November 2019. https://www.comet-initiative.org/Studies/Details/1497.

scholarly journals Patient-Reported Outcomes in Inflammatory Bowel Disease: A Measurement of Effect in Research and Clinical Care

2021 ◽  
Vol 12 (2) ◽  
pp. 225-237
Author(s):  
Jane Fletcher ◽  
Sheldon C. Cooper ◽  
Amelia Swift
Keyword(s):  
Inflammatory Bowel Disease ◽  
Systematic Reviews ◽  
Bowel Disease ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Health Measurement ◽  
Outcome Set ◽  
Patient Reported ◽  
Inflammatory Bowel ◽  
Selection Of

The measurement of outcomes is key in evaluating healthcare or research interventions in inflammatory bowel disease (IBD). In patient-centred care, patient-reported outcome measures (PROMs) are central to this evaluation. In this review, we provide an overview of validated, adult disease-specific PROMs developed for use in IBD. Our aim is to assist clinicians and researchers in selection of PROMs to measure outcomes in their patient cohort. The Consensus-based Standards for the Selection of Health Measurement Instruments database of systematic reviews was the primary resource used to identify PROMs used in IBD. Search terms were ‘Crohn’s disease’, ‘ulcerative colitis’, and ‘IBD’. Seven systematic reviews were identified from this search. In addition, the publication by the IBD Core Outcome Set Working Group was used to identify further PROMs. Three systematic reviews were excluded as they did not meet the inclusion criteria. From the five included systematic reviews, we identified 21 PROMs and their shortened versions. In conclusion, it does not appear that any one PROM is entirely suitable for both research and clinical practice. Overall, the IBDQ-32 is most widely used in research but has the limitation of cost, whereas the IBD-Control has been recommended in the clinical core outcome set.

scholarly journals Development of a working core outcome set for cutaneous lupus erythematosus: a practical approach to an urgent unmet need

2021 ◽  
Vol 8 (1) ◽  
pp. e000529
Author(s):  
Lisa N Guo ◽  
Lourdes M Perez-Chada ◽  
Robert Borucki ◽  
Vinod E Nambudiri ◽  
Victoria P Werth ◽  
...  
Keyword(s):  
Disease Activity ◽  
Outcome Measures ◽  
Lupus Erythematosus ◽  
Global Assessment ◽  
Core Outcome Set ◽  
Cutaneous Lupus Erythematosus ◽  
Core Outcome ◽  
Outcome Set ◽  
Starting Point ◽  
Cutaneous Lupus

ObjectiveThe lack of standardised outcomes and outcome measures for cutaneous lupus erythematosus (CLE) represents a substantial barrier to clinical trial design, comparative analysis and approval of novel investigative treatments. We aimed to develop a working core outcome set (COS) for CLE randomised controlled trials and longitudinal observational studies.MethodsWe conducted a multistage literature review of CLE and SLE studies to generate candidate domains and outcome measures. Domains were narrowed to a working core domain set. Outcome measures for core domains were identified and examined.ResultsProposed core domains include skin-specific disease activity and damage, investigator global assessment (IGA) of disease activity, symptoms (encompassing itch, pain and photosensitivity), health-related quality of life (HRQoL) and patient global assessment (PtGA) of disease activity. Recommended physician-reported outcome measures include the Cutaneous Lupus Erythematous Disease Area and Severity Index (CLASI) and Cutaneous Lupus Activity IGA (CLA-IGA). For the domains of symptoms, HRQoL and PtGA of disease activity, we were unable to recommend one clearly superior instrument.ConclusionThis work represents a starting point for further refinement pending formal consensus activities and more rigorous evaluations of outcome measure quality. In the interim, the proposed working COS can serve as a much-needed guide for upcoming CLE clinical trials.

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