scholarly journals Systematic Review of Outcome Measures Used in Observational Studies of Adults with Eosinophilic Esophagitis

2021 ◽  
pp. 1-25
Author(s):  
Alain M. Schoepfer ◽  
Camilla Schürmann ◽  
Sven Trelle ◽  
Marcel Zwahlen ◽  
Christopher Ma ◽  
...  
Keyword(s):  
Systematic Review ◽  
Outcome Measures ◽  
Eosinophilic Esophagitis ◽  
Observational Studies ◽  
Patient Reported Outcomes ◽  
Case Series ◽  
Open Label ◽  
Topical Corticosteroids ◽  
Therapeutic Trials ◽  
Patient Reported

<b><i>Background:</i></b> Over the last 20 years, diverse outcome measures have been used to evaluate the effectiveness of therapies for eosinophilic esophagitis (EoE). This systematic review aims to identify the readouts used in observational studies of topical corticosteroids, diet, and dilation in adult EoE patients. <b><i>Methods:</i></b> We searched MEDLINE and Embase for prospective and retrospective studies (cohorts/case series, randomized open-label, and case-control) evaluating the use of diets, dilation, and topical corticosteroids in adults with EoE. Two authors independently assessed the articles and extracted information about histologic, endoscopic, and patient-reported outcomes and tools used to assess treatment effects. <b><i>Results:</i></b> We included 69 studies that met inclusion criteria. EoE-associated endoscopic findings (assessed either as absence/presence or using Endoscopic Reference Score) were evaluated in 24/35, 11/17, and 9/17 studies of topical corticosteroids, diet, and dilation, respectively. Esophageal eosinophil density was recorded in 32/35, 17/17, and 11/17 studies of topical corticosteroids, diet, and dilation, respectively. Patient-reported outcomes were not uniformly used (only in 14, 8, and 3 studies of topical corticosteroids, diet, and dilation, respectively), and most tools were not validated for use in adults with EoE. <b><i>Conclusions:</i></b> Despite the lack of an agreed set of core outcomes that should be recorded and reported in studies in adult EoE patients, endoscopic EoE-associated findings and esophageal eosinophil density are commonly used to assess disease activity in observational studies. Standardization of outcomes and data supporting the use of outcomes are needed to facilitate interpretation of evidence, its synthesis, and comparisons of interventions in meta-analyses of therapeutic trials in adults with EoE.

scholarly journals Oxygen saturation improved with nitrate-based nutritional formula in patients with COVID-19

2021 ◽  
Vol 49 (4) ◽  
pp. 030006052110123
Author(s):  
Sergej M. Ostojic ◽  
Aleksandra Milovancev ◽  
Patrik Drid ◽  
Alexandros Nikolaidis
Keyword(s):  
Oxygen Saturation ◽  
Patient Reported Outcomes ◽  
Case Series ◽  
Potassium Nitrate ◽  
Open Label ◽  
Patient Reported ◽  
Baseline Values ◽  
Study Participants ◽  
To Receive ◽  
Test Result

In this open-label case series trial, we evaluated the effects of a nitrate-based nutritional formula on oxygen saturation (SpO2) and patient-reported outcomes in individuals with coronavirus disease 2019 (COVID-19). Five adult patients (three men and two women, age 39.6 ± 6.9 years) with a positive COVID-19 test result, breathing difficulties, and SpO2 ≤95%, who were free from other pulmonary and cardiovascular conditions, were recruited for this study. Participants were assigned to receive a multi-component nutritional formula (containing 1200 mg of potassium nitrate, 200 mg of magnesium, 50 mg of zinc, and 1000 mg of citric acid) every 4 hours during the 48-hour monitoring period. In all participants, SpO2 improved immediately after administration of the nutritional formula, from 1 to 7 percentage points (mean increase 3.6 ± 2.7 points; 95% confidence interval 0.3 to 7.0). SpO2 remained above baseline values throughout the monitoring interval, with values persisting over threshold values (>92%) for all patients and at each time point during the 48 hours. No patients reported any side effects of the intervention. These promising and rather unexpected results call for immediate, well-sampled, mechanistic randomized controlled trials to validate our findings.

scholarly journals Generic Patient-Reported Outcomes and Outcome Measures: A Systematic Review Study Protocol

2021 ◽  
Author(s):  
Yuki Seidler ◽  
Erika Mosor ◽  
Margaret R Andrews ◽  
Carolina Watson ◽  
Nick Bott ◽  
...  
Keyword(s):  
Systematic Review ◽  
Outcome Measures ◽  
Systematic Reviews ◽  
Patient Reported Outcomes ◽  
Outcome Measurement ◽  
Meta Analysis ◽  
Patient Reported Outcome ◽  
Cochrane Library ◽  
Screening Process ◽  
Patient Reported

Background: Patient-reported outcomes (PROs) are an essential part of health outcome measurement and vital to patient-centricity and valued-based care. Several international consortia have developed core outcome sets and many of them include PROs. PROs are measured by patient-reported outcome measures (PROMs). PROs and PROMs can be generic or specific to certain diseases or conditions. While the characteristics of generic PROs and PROMs are well recognised as widely relevant and applicable across different domains, diseases and conditions, there is a lack of knowledge on the types of PROs measured by generic PROMs. We also do not know in which disease areas generic PROs and PROMs are commonly used. To date, there has been no systematic review solely focusing on generic PROMs, what they measure and their areas of application. Objectives: This systematic review will identify core PROs measured by generic PROMs used in adult populations and the areas in which they are applied. Methods: We will conduct a systematic review of reviews. The screening process and the reporting will comply with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) 2020 Statement. We will use four databases, Medline [PubMed], CINHAL [Ebsco], Cochrane [Cochrane Library], and PsycINFO [Ovid], and reports from international consortia. Inclusion criteria are systematic reviews, meta-analysis or patient-reported outcome sets developed by international consortia reporting on generic PROMs in adult populations. Articles primarily focusing on patient-reported experience measures (PREMs), children or adolescents, or those not written in English will be excluded. Risk of bias will be assessed by checking if the included articles comply with established guidelines for systematic reviews such as the PRISMA statement. We will extract generic PROMs and PROs measured by these PROMs, and the areas applied from the selected articles and reports. Extracted data and information will be quantitatively and qualitatively synthesised without statistical interference. The quality of the synthesised evidences will be assessed by clarifying the strengths, limitations and possible biases in our review.

scholarly journals Outcome measures in coeliac disease trials: the Tampere recommendations

Gut ◽  
2018 ◽  
Vol 67 (8) ◽  
pp. 1410-1424 ◽  
Author(s):  
Jonas F Ludvigsson ◽  
Carolina Ciacci ◽  
Peter HR Green ◽  
Katri Kaukinen ◽  
Ilma R Korponay-Szabo ◽  
...  
Keyword(s):  
Clinical Outcome ◽  
Coeliac Disease ◽  
Outcome Measures ◽  
Patient Reported Outcomes ◽  
Treatment Strategies ◽  
Therapeutic Trials ◽  
Immunogenic Peptides ◽  
Patient Reported ◽  
Patient Representatives

ObjectiveA gluten-free diet is the only treatment option of coeliac disease, but recently an increasing number of trials have begun to explore alternative treatment strategies. We aimed to review the literature on coeliac disease therapeutic trials and issue recommendations for outcome measures.DesignBased on a literature review of 10 062 references, we (17 researchers and 2 patient representatives from 10 countries) reviewed the use and suitability of both clinical and non-clinical outcome measures. We then made expert-based recommendations for use of these outcomes in coeliac disease trials and identified areas where research is needed.ResultsWe comment on the use of histology, serology, clinical outcome assessment (including patient-reported outcomes), quality of life and immunological tools including gluten immunogenic peptides for trials in coeliac disease.ConclusionCareful evaluation and reporting of outcome measures will increase transparency and comparability of coeliac disease therapeutic trials, and will benefit patients, healthcare and the pharmaceutical industry.

The popularity of outcome measures used in shoulder arthroplasty literature

2020 ◽  
pp. 175857322093586
Author(s):  
Fady Y Hijji ◽  
Thomas G Cheslik ◽  
Andrew D Schneider ◽  
Blake M Schach ◽  
Indresh Venkatarayappa
Keyword(s):  
Systematic Review ◽  
Outcome Measures ◽  
Shoulder Arthroplasty ◽  
Patient Reported Outcomes ◽  
Reverse Shoulder Arthroplasty ◽  
Specific Measure ◽  
Level Of Evidence ◽  
Shoulder Hemiarthroplasty ◽  
Patient Reported ◽  
Disease Specific

Introduction Patient-reported outcomes (PROs) are frequently utilized within orthopaedics to determine the extent of patient disease and the efficacy of surgical treatments. Shoulder arthroplasty is a common treatment option for a range of pathologies; however, substantial variety exists regarding the instruments used within the published literature, limiting their quality and generalizability. The purpose of the present systematic review is to evaluate the overall number and frequency of outcome measures used in all clinical studies evaluating outcomes following shoulder arthroplasty. Methods This systematic review was performed following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Relevant studies that assessed patient reported outcomes following total shoulder arthroplasty, reverse shoulder arthroplasty, and shoulder hemiarthroplasty were obtained from PubMed, MEDLINE, and EMBASE databases. For each manuscript, the journal, authors, region of origin, level of evidence, and subject/pathology were recorded. The frequency of each reported outcome measure and category. Associations between study characteristics and measure categories were tested using Poisson regression with robust error variance. Results A total of 682 articles were included in the analysis, reporting 42 different PROs. The most popular tools were the Constant-Murley score (49.7%), the American Shoulder and Elbow Surgeons Evaluation Form (37.7%), and the Visual Analog Scale (34.3%). A generic outcome tool was used in 287 studies (42.1%), while 645 (94.6%) utilized a shoulder-specific measure and 49 (7.2%) used a disease-specific measure. The use of generic (p<0.001) and disease specific (p<0.001) measures were associated with higher level of evidence. Conclusion Studies assessing patient outcomes following shoulder arthroplasty employ a large range of PRO measuring tools, many of which are non-validated. Furthermore, only a small percentage of studies utilize a combination of tools from different categories despite current recommendations. Consensus on validated and clinically-meaningful tools from multiple categories is necessary to increase the generalizability and applicability of published studies in shoulder arthroplasty literature. Level of Evidence 1

scholarly journals Endoscopic posterior nasal neurectomy for intractable rhinitis: a systematic review of the literature Running Title: Endoscopic PNN: a systematic review

2021 ◽  
Author(s):  
Mun Leng Lee ◽  
Patrick Chakravarty ◽  
David Ellul
Keyword(s):  
Systematic Review ◽  
Outcome Measures ◽  
Human Subjects ◽  
Case Series ◽  
Symptom Burden ◽  
Case Control Studies ◽  
Patient Reported ◽  
Maximal Medical Therapy ◽  
Non Allergic Rhinitis ◽  
Randomised Controlled

Objectives: Rhinitis affects up to 40% of the population worldwide and can significantly reduce quality of life. Some patients remain symptomatic despite maximal medical therapy. In refractory cases, posterior nasal neurectomy (PNN - the division of the intranasal nerve branches containing postganglionic parasympathetic fibres) is postulated to reduce symptom burden. The objectives of this paper were to review the literature to establish whether the procedure is effective and safe in the management of allergic and non-allergic rhinitis. Design: A systematic review of Pubmed, EMBASE and MEDLINE was undertaken. Studies were excluded if not available in English or undertaken in non-human subjects. Participants: Seventeen articles satisfied the inclusion criteria studying in total 2029 patients. Sample size ranged from 8-1056. Main Outcome Measures: Patient-reported objective and subjective outcomes and post-operative complications were reviewed Results: There were two randomised controlled trials, two case control studies, and the remaining thirteen were case series using both objective and subjective outcome measures. All but one study found improved patient reported outcomes following PNN. Complications were reported in 10 studies - haemorrhage was the most common complication and was observed in 28 patients (1.6% of subjects). Conclusions: Endoscopic posterior nasal neurectomy is safe and appears to be effective in the treatment of intractable rhinitis but the level of the available evidence was generally poor. Larger, well designed studies are needed to clarify its role in the management of difficult-to-treat rhinitis.

Patient-reported outcomes and outcome measures in childbirth perineal trauma research: a systematic review

2021 ◽  
Author(s):  
Stergios K. Doumouchtsis ◽  
Jemina Loganathan ◽  
John Fahmy ◽  
Gabriele Falconi ◽  
Maria Rada ◽  
...  
Keyword(s):  
Systematic Review ◽  
Outcome Measures ◽  
Patient Reported Outcomes ◽  
Perineal Trauma ◽  
Trauma Research ◽  
Patient Reported

scholarly journals Patient-Reported Outcomes Following Lumbar Decompression Surgery: A Review of 2699 Cases

2020 ◽  
pp. 219256821989654 ◽  
Author(s):  
Geraint Sunderland ◽  
Mitchell Foster ◽  
Sujay Dheerendra ◽  
Robin Pillay
Keyword(s):  
Lumbar Spine ◽  
Outcome Measures ◽  
Patient Reported Outcomes ◽  
Case Series ◽  
Leg Pain ◽  
Lumbar Spine Surgery ◽  
Decompression Surgery ◽  
Lumbar Decompression ◽  
Patient Reported

Study Design: Retrospective case series. Objective: Despite numerous advances in the technology and techniques available to spinal surgeons, lumbar decompression remains the mainstay of degenerative lumbar spine surgery. It has proven efficacy in trials, but only limited evidence of advantage over conservative management in large scale systematic reviews. We collated data from a large surgically managed cohort to evaluate the patient-reported outcomes. Methods: We performed a retrospective analysis of a prospectively populated database. Patient demographics, surgical details, and patient outcomes (Spine Tango core outcome measures index [COMI]–Low Back) were collected for 2699 lumbar decompression surgeries. Results: Lumbar decompression was shown to be successful at improving leg pain (mean improvement in visual analogue scale [VAS] at 3 months = 4) and to a lesser extent, back pain (mean improvement in VAS at 3 months = 2.61). Mean improvement in COMI score was 3.15 for all-comers. Minimal clinically important improvement (MCID) in COMI score (−2 points) was achieved in 73% of patients by 2-year follow-up. Primary surgery was more effective than redo surgery: odds ratio 0.547 (95% CI 0.408-0.733, P < .001). The benefits across all outcomes were maintained for the 2-year follow-up period. Patients can be classified according to their outcome as “early responders”; achieving MCID by 3 months (61% primary vs 41% redo), “late responders”; achieving MCID by 2 years (15% vs 20%) or nonresponders (24% vs 39%). Conclusions: Lumbar decompression is effective in improving quality of life in appropriately selected patients. Patient-reported outcome measures collected routinely and collated within a registry are a powerful tool for assessing the efficacy of lumbar spine interventions and allow accurate counseling of patients perioperatively.

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