scholarly journals Development of the Near Vision Presbyopia Task-based Questionnaire for use in evaluating the impact of presbyopia

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Elaheh Shirneshan ◽  
Cheryl D. Coon ◽  
Nathan Johnson ◽  
Jonathan Stokes ◽  
Ted Wells ◽  
...  
Keyword(s):  
Reading Ability ◽  
Alternative Assessment ◽  
Patient Reported Outcome ◽  
Good Test ◽  
Specific Patient ◽  
Near Vision ◽  
Regulatory Guidance ◽  
Patient Reported ◽  
The Impact ◽  
Domain Scores

Abstract Background Presbyopia is a progressive condition that reduces the eye’s ability to focus on near objects with increasing age. After a systematic literature review identified no existing presbyopia-specific patient-reported outcome (PRO) instruments meeting regulatory guidance, a new PRO instrument, the Near Vision Presbyopia Task-based Questionnaire (NVPTQ), was developed. Results To explore the patient experience with presbyopia, concept elicitation interviews were conducted with 20 presbyopic participants. The most frequently reported impacts were difficulty with reading menus/books/newspapers/magazines, reading on a cell phone/caller ID, and reading small print. Based on these results, a task-based PRO instrument (the NVPTQ) was developed instructing participants to complete four near-vision, paper-based reading tasks (book, newspaper, nutrition label, menu) under standardized settings, and subsequently assess their vision-related reading ability and associated satisfaction. The draft NVPTQ was cognitively debriefed with a sample of 20 presbyopes, which demonstrated that most participants interpreted the items as intended and endorsed the relevance of the concepts being assessed. After the qualitative research, the draft instrument was psychometrically tested using data from a Phase 2 study. Based on item-level analyses, all items in the NVPTQ demonstrated expected response option patterns and lacked substantial floor or ceiling effects. The reliability, validity, and responsiveness of the NVPTQ Performance and Satisfaction domain scores were assessed. All domains scores had large Cronbach’s coefficient α values and good test–retest statistics, indicating that the scores are internally consistent and produce stable values over time. The pattern of correlations with a concurrent measure of visual functioning (National Eye Institute Visual Function Questionnaire 25) demonstrated that the NVPTQ domain scores were related to an alternative assessment of near-vision activities. The NVPTQ domain scores were able to distinguish between groups that were known to differ on the clinical outcome of uncorrected near visual acuity, supporting the construct validity of these scores. The NVPTQ domain scores showed evidence of responsiveness to change by being able to distinguish between groups defined as improved and not improved based on patient-reported and clinical outcomes. Conclusions This research has resulted in a content-valid and psychometrically sound instrument designed to evaluate vision-related reading ability and satisfaction with vision-related reading ability. Trial registration: ClinicalTrials.gov NCT02780115. Registered 23 May 2016, https://www.clinicaltrials.gov/ct2/show/NCT02780115?term=NCT02780115&draw=2&rank=1.

scholarly journals Development of a patient-reported outcome measure for neck pain in military aircrew: qualitative interviews to inform design and content

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e039488
Author(s):  
Anna Dowling ◽  
Ellen Slungaard ◽  
Nicola R Heneghan
Keyword(s):  
Neck Pain ◽  
Outcome Measure ◽  
Physical Symptoms ◽  
Patient Reported Outcome ◽  
Direct Access ◽  
Specific Patient ◽  
Concept Elicitation ◽  
Patient Reported Outcome Measure ◽  
Patient Reported ◽  
The Impact

IntroductionThe prevalence of flight-related neck pain is 70% in UK fast jet pilots; much higher than the general population. The Aircrew Conditioning Programme and direct access physiotherapy exist to minimise the impact on military capability, but a population specific patient-reported outcome measure (PROM) is required to investigate the effectiveness of these. We aimed to explore the experiences of flight-related neck pain to inform the content validity and development of a population specific PROM.MethodsQualitative semistructured interviews combining phenomenological and grounded theory methods, reported using Consolidated criteria for Reporting Qualitative research guidelines. A purposive sample of 10 fast jet pilots with neck pain was recruited. Concept elicitation interviews were audio recorded, transcribed verbatim along with field notes. Data analysis involved subject and methodological expertise used a concept elicitation approach.ResultsParticipants included 10 male fast jet pilots, age 34.7 years. Identified themes included: (1) physical symptoms associated with flying activities; (2) occupational effects revealed modifications of flying, or ‘suboptimal’ performance owing to neck pain; (3) psychological effects revealed feelings or worry and (4) social and activity effects showed impact on out of work time.ConclusionPopulation-specific occupational, psychological and social factors should be considered alongside physical symptoms when managing neck pain in military aircrew. Findings support the development of a PROM specifically designed for military aircrew with neck pain.

scholarly journals A systematic review of patient-reported outcome measures in paediatric otolaryngology

2017 ◽  
Vol 132 (1) ◽  
pp. 2-7 ◽  
Author(s):  
J Powell ◽  
S Powell ◽  
A Robson
Keyword(s):  
Outcome Measures ◽  
English Language ◽  
Health Assessment ◽  
Paediatric Population ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Specific Patient ◽  
Patient Reported ◽  
The Impact

AbstractBackground:Recently, there has been increased emphasis on the development and application of patient-reported outcome measures. This drive to assess the impact of illness or interventions, from the patient's perspective, has resulted in a greater number of available questionnaires. The importance of selecting an appropriate patient-reported outcome measure is specifically emphasised in the paediatric population. The literature on patient-reported outcome measures used in paediatric otolaryngology was reviewed.Methods:A comprehensive literature search was conducted using the databases Medline, Embase, Cumulative Index to Nursing and Allied Health Literature, and PsycInfo, using the terms: ‘health assessment questionnaire’, ‘structured questionnaire’, ‘questionnaire’, ‘patient reported outcome measures’, ‘PROM’, ‘quality of life’ or ‘survey’, and ‘children’ or ‘otolaryngology’. The search was limited to English-language articles published between 1996 and 2016.Results:The search yielded 656 articles, of which 63 were considered relevant. This included general paediatric patient-reported outcome measures applied to otolaryngology, and paediatric otolaryngology disease-specific patient-reported outcome measures.Conclusion:A large collection of patient-reported outcome measures are described in the paediatric otolaryngology literature. Greater standardisation of the patient-reported outcome measures used in paediatric otolaryngology would assist in pooling of data and increase the validation of tools used.

scholarly journals Development and validation of Gaucher disease type 1 (GD1)-specific patient-reported outcome measures (PROMs) for clinical monitoring and for clinical trials

2022 ◽  
Vol 17 (1) ◽  
Author(s):  
Deborah Elstein ◽  
Nadia Belmatoug ◽  
Patrick Deegan ◽  
Özlem Göker-Alpan ◽  
Derralynn A. Hughes ◽  
...  
Keyword(s):  
Gaucher Disease ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Psychometric Validation ◽  
Specific Patient ◽  
Patient Reported ◽  
Test Retest Reliability ◽  
Development And Validation ◽  
The Impact

Abstract Background Disease-specific patient-reported outcome measures (PROMs) are fundamental to understanding the impact on, and expectations of, patients with genetic disorders, and can facilitate constructive and educated conversations about treatments and outcomes. However, generic PROMs may fail to capture disease-specific concerns. Here we report the development and validation of a Gaucher disease (GD)-specific PROM for patients with type 1 Gaucher disease (GD1) a lysosomal storage disorder characterized by hepatosplenomegaly, thrombocytopenia, anemia, bruising, bone disease, and fatigue. Results and discussion The questionnaire was initially developed with input from 85 patients or parents of patients with GD1 or GD3 in Israel. Owing to few participating patients with GD3, content validity was assessed for patients with GD1 only. Content validity of the revised questionnaire was assessed in 33 patients in the US, France, and Israel according to US Food and Drug Administration standards, with input from a panel of six GD experts and one patient advocate representative. Concept elicitation interviews explored patient experience of symptoms and treatments, and a cognitive debriefing exercise explored patients’ understanding and relevance of instructions, items, response scales, and recall period. Two versions of the questionnaire were subsequently developed: a 24-item version for routine monitoring in clinical practice (rmGD1-PROM), and a 17-item version for use in clinical trials (ctGD1-PROM). Psychometric validation of the ctGD1-PROM was assessed in 46 adult patients with GD1 and re-administered two weeks later to examine test–retest reliability. Findings from the psychometric validation study revealed excellent internal consistency and strong evidence of convergent validity of the ctGD1-PROM based on correlations with the 36-item Short Form Health Survey. Most items were found to show moderate, good, or excellent test–retest reliability. Conclusions Development of the ctGD1-PROM represents an important step forward for researchers measuring the impact of GD and its respective treatment.

scholarly journals An Analysis of Change in Patient-Reported Outcome Measures Following First Metatarsophalangeal Joint Arthrodesis: Do Baseline Scores or Comorbidities Make a Difference?

2020 ◽  
Vol 5 (4) ◽  
pp. 2473011420S0025
Author(s):  
Linzy Houchen-Wolloff ◽  
Maitravaarun Burgula ◽  
Nikhil Nanavati ◽  
Alistair J. Best ◽  
Patricia Allen ChB ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Metatarsophalangeal Joint ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
First Metatarsophalangeal Joint ◽  
Radiographic Findings ◽  
Patient Reported ◽  
End Stage ◽  
The Impact ◽  
Domain Scores

Category: Midfoot/Forefoot Introduction/Purpose: First metatarsal phalangeal joint (MTPJ) arthrodesis is a well established procedure in the treatment of end-stage arthritis. Patient reported outcome measures (PROMs) are an important part of the modern healthcare system. The aim of surgery is to improve pain, function and health related quality of life (HRQoL). The Manchester-Oxford Foot Questionnaire (region-specific) and the Euro-QOL 5 dimension (generic) are both PROMs, known to be sensitive to change following foot/ ankle surgery at 6-months post-procedure (Maher & Kilmartin, J of Foot & Ankle Res, 5: 17, 2012). However we don’t know if baseline scores and the presence of comorbidities influence the change in these PROMs. This is important to understand so that we can identify which patients to offer MTPJ arthrodesis surgery to. Methods: Aims 1. To identify the change in two patient-reported outcome measures (PROMs) following MTPJ arthrodesis: The Manchester-Oxford Foot Questionnaire (MOxFQ) and the Euro-QOL 5 dimension tool. Do baseline scores make a difference to the change? 2. To describe the impact of co-morbidities on the change in both PROMs. Data was collected prospectively from patients who had undergone a first MTPJ arthrodesis. Patients with complete pre- and post-PROMs data were included in the analysis. PROMs data was collected on average 5.2 months post-operatively. Surgery notes were crosschecked with radiographic findings. A comparative analysis was done between pre and post-operative data using SPSS (version 20). The MOxFQ generates a total score, as well as 3 sub-domain scores for pain, walking/ standing and social interaction. The EQ5D generates a total score and a health today score (visual analogue scale: VAS from 0-100). Results: 90 patients were identified, 52 had complete data. Mean (SD) age 56.9(17.8) years, 78% female. Comorbidities: diabetes 2%, hypertension 21%, rheumatoid arthritis (RA) 43%, current smokers 10%, average (SD) weekly units of alcohol 5.2 (9.1). Most cases were unilateral (94%) and fixed with two screws (87%). 37% had other foot procedures carried out concurrently.Table 1 shows the change in MoxFQ total, domain scores and the EQ5D total score, health today (VAS). The correlation between baseline EQ5D total and the change for this outcome was r=0.6 (p<0.001). The correlation between baseline MOxFQ total and the change for this outcome was r=0.5 (p<0.001). The only comorbidity to have an influence on PROMs was RA- the presence of RA significantly reduced change in EQ5D total (p<0.05). Conclusion: Following MTPJ arthrodesis, statistically and clinically significant changes were observed in EQ5D total score, MOxFQ total scores (and all sub-domains). The EQ5D VAS did not change. Baseline scores in both PROMs were correlated with the change scores following surgery- suggesting that we may be able to identify a baseline score which could predict the outcome in PROMs and target who we offer surgery to as a consequence. Comorbidities had little influence on the change in both PROMs following surgery, other than the presence of RA dampening the change in EQ5D total score. Again this is useful to inform pre- operative discussions. [Table: see text]

Correlation of the I-HaND Scale with Other Musculoskeletal Patient-Reported Outcome Measurement Scores

2021 ◽  
Author(s):  
Joost T.P. Kortlever ◽  
S. Ryan Pierson ◽  
David Ring ◽  
Lee M. Reichel ◽  
Gregg A. Vagner
Keyword(s):  
Pain Intensity ◽  
Upper Extremity ◽  
Short Form ◽  
Multivariable Analysis ◽  
Patient Reported Outcome ◽  
Specific Patient ◽  
Symptoms Of Depression ◽  
Patient Reported ◽  
The Impact ◽  
Hand Scale

Abstract Background Experiments can determine if nerve-specific patient-reported outcome measures (PROMs) can outperform regional or condition-specific PROMs. We compared a nerve-specific PROM of the upper extremity, the Impact of Hand Nerve Disorders (I-HaND) scale, to other validated measures quantifying activity intolerance and sought to assess interquestionnaire correlations and factors independently associated with activity intolerance and pain intensity. Methods One hundred and thirty patients with any upper extremity nerve-related condition completed measures of demographics, psychological limitations, quality of life, activity intolerance, and pain intensity. To quantify activity intolerance, we used the I-HaND, Patient-Reported Outcomes Measurement Information System Physical Function Upper Extremity, and Disabilities of the Arm, Shoulder and Hand short form. Results Strong interquestionnaire correlations were found between the activity intolerance measures (r between 0.70 and 0.91). Multivariable analysis revealed that greater activity intolerance and greater pain intensity correlated most with greater symptoms of depression on all scales, with symptoms of depression accounting for 53 to 84% of the variability in the PROMs. Conclusion There is no clear advantage of the nerve-specific I-HaND over shorter, regional PROMs, perhaps because they are all so closely tied to mental health. Unless an advantage relating to responsiveness to treatment is demonstrated, we support using a brief arm-specific PROM for all upper extremity conditions. Level of Evidence Level II; Prognostic.

scholarly journals Fundamental Outcome Measurement: Selecting Patient Reported Outcome Instruments and Interpreting the Data they Produce

2021 ◽  
Vol 12 (2) ◽  
pp. 17
Author(s):  
Stephen P McKenna ◽  
Alice Heaney ◽  
Paul C Langley
Keyword(s):  
Outcome Measurement ◽  
Therapy Response ◽  
Simulation Models ◽  
Patient Reported Outcome ◽  
Specific Patient ◽  
Patient Reported ◽  
The Many ◽  
Reported Data ◽  
The Impact ◽  
Pro Instruments

Over the past 40 years literally thousands of generic and disease specific patient reported outcome (PRO) instruments have been developed. While most were developed for a specific study and were never used again, there is still the question of how manufacturers and others should select a PRO instrument for a study. These studies may be clinical pivotal trials or observational tracking studies to support therapy response. Formulary committees also need to be able to interpret PRO data to make decisions about whether to accept claims for therapy response. It is possible to argue that the many different approaches to outcome measurement have resulted from the lack of agreed methodologies. However, a more likely explanation is that the authors have failed to apply the axioms of fundamental measurement when creating their measures. The result is a plethora of ordinal PRO instruments that inform little about the impact of interventions. Clinical trials rarely report PRO data. Where they do, analyses are generally restricted to (for example) changes in the experimental group’s scores. Comparisons between the treatment and placebo groups or between active groups are infrequently reported, most likely due to the failure of the instrument to show differences or changes in outcome. This is unfortunate as it means no assessment is made of the value that patients gain from the intervention. This commentary is intended to make researchers and formulary committees aware of the issues that need to be addressed when selecting PRO instruments for a study or evaluating publications and claims for therapy response. The latter is crucial as reported data influence the selection of medicines and healthcare products. In the latter case a particular concern is with PRO claims embedded in simulation models.

Optimizing electronic capture of patient-reported outcome measures in oncology clinical trials: lessons learned from a qualitative study

2020 ◽  
Vol 9 (17) ◽  
pp. 1195-1204
Author(s):  
Florence D Mowlem ◽  
Brad Sanderson ◽  
Jill V Platko ◽  
Bill Byrom
Keyword(s):  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Lessons Learned ◽  
Structured Interviews ◽  
Patient Reported ◽  
Oncology Clinical Trials ◽  
Anticancer Treatment ◽  
Fit For Purpose ◽  
The Impact ◽  
Electronic Implementation

Aim: To understand the impact of anticancer treatment on oncology patients’ ability to use electronic solutions for completing patient-reported outcomes (ePRO). Materials & methods: Semi-structured interviews were conducted with seven individuals who had experienced a cancer diagnosis and treatment. Results: Participants reported that the following would impact the ability to interact with an ePRO solution: peripheral neuropathy of the hands (4/7), fatigue and/or concentration and memory issues (6/7), where they are in a treatment cycle (5/7). Approaches to improve usability included: larger, well-spaced buttons to deal with finger numbness, the ability to pause a survey and complete at a later point and presenting the recall period with every question to reduce reliance on memory. Conclusion: Symptoms associated with cancers and anticancer treatments can impact the use of technologies. The recommendations for optimizing the electronic implementation of patient-reported outcome instruments in this population provides the potential to improve data quality in oncology trials and places patient needs at the forefront to ensure ‘fit-for-purpose’ solutions.

scholarly journals O3 Validation of a novel juvenile idiopathic arthritis specific patient-reported outcome and experience measures

Rheumatology ◽  
2018 ◽  
Vol 57 (suppl_8) ◽  
Author(s):  
Laura E Lunt ◽  
Stephanie Shoop-Worrall ◽  
Nicola Smith ◽  
Sharon Douglas ◽  
Gavin Cleary ◽  
...  
Keyword(s):  
Juvenile Idiopathic Arthritis ◽  
Patient Reported Outcome ◽  
Specific Patient ◽  
Patient Reported

Correlation between nasal mucosal temperature change and the perception of nasal patency: a literature review

2021 ◽  
Vol 135 (2) ◽  
pp. 104-109
Author(s):  
R Tjahjono ◽  
N Singh
Keyword(s):  
Temperature Change ◽  
Outcome Measure ◽  
Patient Reported Outcome ◽  
Subjective Perception ◽  
Nasal Patency ◽  
Patient Reported Outcome Measure ◽  
Physical Measurements ◽  
Pubmed Database ◽  
Patient Reported ◽  
The Impact

AbstractBackgroundThe mechanism of nasal airflow sensation is poorly understood. This study aimed to examine the role of nasal mucosal temperature change in the subjective perception of nasal patency and the methods by which it can be quantified.MethodMedline and PubMed database searches were performed to retrieve literature relevant to the topic.ResultsThe primary mechanism producing the sensation of nasal patency is thought to be the activation of transient receptor potential melastatin family member 8 (‘TRPM8’), a thermoreceptor that is activated by nasal mucosal cooling. Computational fluid dynamics studies have demonstrated that increased airflow and heat flux are correlated with better patient-reported outcome measure scores. Similarly, physical measurements of the nasal cavity using temperature probes have shown a correlation between lower nasal mucosal temperatures and better patient-reported outcome measure scores.ConclusionNasal mucosal temperature change may be correlated with the perception of improved nasal patency. Future research should quantify the impact of mucosal cooling on the perception of nasal airway obstruction.

Nonunion Rates After Anterior Cervical Discectomy and Fusion: Comparison of Polyetheretherketone vs Structural Allograft Implants

Neurosurgery ◽  
2021 ◽  
Author(s):  
Won Hyung A Ryu ◽  
Dominick Richards ◽  
Mena G Kerolus ◽  
Adewale A Bakare ◽  
Ryan Khanna ◽  
...  
Keyword(s):  
Smoking Status ◽  
Posterior Instrumentation ◽  
Patient Reported Outcome ◽  
Anterior Cervical Discectomy ◽  
Successful Outcome ◽  
Cervical Discectomy ◽  
Structural Allograft ◽  
Modifiable Factors ◽  
Patient Reported ◽  
The Impact

Abstract BACKGROUND Although advances in implant materials, such as polyetheretherketone (PEEK), have been developed aimed to improve outcome after anterior cervical discectomy and fusion (ACDF), it is essential to confirm whether these changes translate into clinically important sustained benefits. OBJECTIVE To compare the radiographic and clinical outcomes of patients undergoing up to 3-level ACDF with PEEK vs structural allograft implants. METHODS In this cohort study, radiographic and symptomatic nonunion rates were compared in consecutive patients who underwent 1 to 3 level ACDF with allograft or PEEK implant. Prospectively collected clinical data and patient-reported outcome (PRO) scores were compared between the allograft and PEEK groups. Regression analysis was performed to determine the predictors of nonunion. RESULTS In total, 194 of 404 patients met the inclusion criteria (79% allograft vs 21% PEEK). Preoperative demographic variables were comparable between the 2 groups except for age. The rate of radiographic nonunion was higher with PEEK implants (39% vs 27%, P = .0035). However, a higher proportion of nonunion in the allograft cohort required posterior instrumentation (14% vs 3%, P = .039). Patients with multilevel procedures and PEEK implants had up to 5.8 times the risk of radiographic nonunion, whereas younger patients, active smokers, and multilevel procedures were at higher risk of symptomatic nonunion. CONCLUSION Along with implant material, factors such as younger age, active smoking status, and the number of operated levels were independent predictors of fusion failure. Given the impact of nonunion on PRO, perioperative optimization of modifiable factors and surgical planning are essential to ensure a successful outcome.

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