scholarly journals Study protocol for the validation of a new patient-reported outcome measure (PROM) of listening effort in cochlear implantation: the Listening Effort Questionnaire-Cochlear Implant (LEQ-CI)

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e028881 ◽  
Author(s):  
Sarah E Hughes ◽  
Frances Rapport ◽  
Alan Watkins ◽  
Isabelle Boisvert ◽  
Catherine M McMahon ◽  
...  

IntroductionListening effort may be defined as the cognitive resources needed to understand an auditory message. A sustained requirement for listening effort is known to have a negative impact on individuals’ sense of social connectedness, well-being and quality of life. A number of hearing-specific patient-reported outcome measures (PROMs) exist currently; however, none adequately assess listening effort as it is experienced in the listening situations of everyday life. The Listening Effort Questionnaire-Cochlear Implant (LEQ-CI) is a new, hearing-specific PROM designed to assess perceived listening effort as experienced by adult CI patients. It is the aim of this study to conduct the first psychometric evaluation of the LEQ-CI’s measurement properties.Methods and analysisThis study is a phased, prospective, multi-site validation study in a UK population of adults with severe-profound sensorineural hearing loss who meet local candidacy criteria for CI. In phase 1, 250 CI patients from four National Health Service CI centres will self-complete a paper version of the LEQ-CI. Factor analysis will establish unidimensionality and Rasch analysis will evaluate item fit, differential item functioning, response scale ordering, targeting of persons and items, and reliability. Classical test theory methods will assess acceptability/data completeness, scaling assumptions, targeting and internal consistency reliability. Phase 1 results will inform refinements to the LEQ-CI. In phase 2, a new sample of adult CI patients (n=100) will self-complete the refined LEQ-CI, the Speech, Spatial and Qualities of Hearing Scale, the Nijmegen Cochlear Implant Questionnaire and the Fatigue Assessment Scale to assess construct validity.Ethics and disseminationThis study was approved by the Abertawe Bro Morgannwg University Health Board/Swansea University Joint Study Review Committee and the Newcastle and North Tyneside 2 Research Ethics Committee, Ref: 18/NE/0320. Dissemination will be in high-quality journals, conference presentations and SEH’s doctoral dissertation.

2020 ◽  
pp. 1-11
Author(s):  
James L. Farnsworth ◽  
Todd Evans ◽  
Helen Binkley ◽  
Minsoo Kang

Context: Previous research suggests that several knee-specific patient-reported outcome measures have poor measurement properties. The patient-reported outcomes knee assessment tool (PROKAT) was created to improve assessment of knee-specific function. Examination of the measurement properties of this new measure is critical to determine its clinical value. Objective: Examine the measurement properties of the PROKAT. Design: Cross-sectional study. Setting: Clinical athletic training setting. Patients or Other Participants: The pilot study included 32 student-athletes (mean age = 20.78 [1.01], males = 56.30%). The full study included 203 student-athletes (mean age = 21.46 [4.64], males = 54.70%) from 3 separate institutions. The participants were recruited for both the pilot and full study using face-to-face and electronic (eg, email and social media sites) communications. Intervention(s): Evaluation of the measurement properties of the PROKAT occurred using the Rasch partial-credit model. Main Outcome Measures: Infit and outfit statistics, item step difficulties, person ability parameters, category function, item and test information functions, and Cronbach alpha. An independent samples t test was used to evaluate the differences in injured and noninjured athletes’ scores. Results: The Rasch partial-credit model analysis of pilot test items and qualitative participant feedback were used to modify the initial PROKAT. Evaluation of the revised PROKAT (32 items) indicated 27 items had acceptable model–data fit. The injured athletes scored significantly worse than the noninjured athletes (t188 = 12.89; P < .01). The ceiling effects for the PROKAT were minimal (3.9%). Conclusions: A major advantage of this study was the use of the Rasch measurement and the targeted population. Compared with alternative knee-specific patient-reported outcome measures (eg, Knee Injury Osteoarthritis Outcome Score, International Knee Documentation Committee Subjective Knee Form), the PROKAT has low ceiling effects in athletic populations. In addition, evidence suggests the measure may be capable of distinguishing between injured and noninjured athletes.


2020 ◽  
pp. 1-8
Author(s):  
James L. Farnsworth II ◽  
Todd Evans ◽  
Helen Binkley ◽  
Minsoo Kang

Context: Documentation of patient outcomes following injury is critical to ensure that patients are receiving the best care. Several patient-reported outcome measures (PROMs) have been developed to assess knee-related function following injury; however, there is limited data investigating the measurement properties of these instruments using Rasch model analyses. Objective: To evaluate the measurement properties of several PROMs through application of the Rasch measurement model. Design: Cross-sectional study. Setting: Clinical setting. Patients or Other Participants: A convenience sample of 160 adults (mean age = 28.08 [10.95] y; male = 38.10%) were recruited for this study. Data collected were combined with existing pilot data from an earlier study containing de-identified Knee Injury and Osteoarthritis Outcome Score (KOOS) data from 79 adults with knee injuries resulting in a total sample size of 239 adults. Intervention(s): Psychometric evaluation of the KOOS, International Knee Documentation Committee subjective knee form, and the Marx Activity Rating Scale using the Rasch partial credit model. Main Outcome Measures: Infit and outfit statistics, item step difficulties, person ability parameters, category function, and item and test information functions. Results: Large ceiling effects were present in the KOOS and International Knee Documentation Committee subjective knee form. Of the 65 items examined in this study, 35 items showed poor measurement properties. Item step difficulty for the remaining 30 items ranged from −5.45 (least difficult) to 0.57 logits (most difficult). The 5-category response options did not function well. Measurement precision decreased significantly as ability score increased beyond 0.30 logits. Conclusions: Despite their use in clinical practice, several items showed poor measurement properties. Future studies are needed to develop and evaluate novel items that are suitable for measuring knee-related function in high-functioning populations to ensure continuity of PROMs as individuals recover from injuries.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Martin Heine ◽  
Lidwine B. Mokkink ◽  
Chanel van Zyl ◽  
Wayne Derman ◽  
Susan Hanekom

Abstract Introduction Sub-Saharan Africa is a subcontinent with a proud cultural richness and diversity, yet inexplicably also a region with severe health care challenges and inequity. To challenge this health equity gap and reduce the burden of disease, the patient’s voice in monitoring and evaluation of health and health care interventions is paramount. The aim of this two-phased review is to map the availability of patient-reported outcome measures (PROMs) in a selection of non-English, African Languages, and systematically evaluate the measurement properties of the PROMs that were identified. Methods This systematic review will be conducted in two phases. In phase 1, we will scope the literature for patient-reported outcome measures (PROMs), either developed from scratch or through translation and validation in a sub-Saharan African country and a selection of non-English, African languages (n = 31; spoken in > 10 million people and/or a national language). The availability of PROMs will be mapped against the previously reported burden of disease in the respective countries included. Subsequently, in phase 2, we systematically evaluate the measurement properties of these PROMs using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology for systematic reviews on PROMs. To ensure rigour, secondary searches will be developed to specifically locate articles that report on the measurement properties of the PROMs identified during phase 1. The evidence will be graded using the modified GRADE approach. Discussion This review will provide a comprehensive overview and quality appraisal of PROMs developed in non-English, African languages. Consequently, this review when concluded may be an important first step in promoting access to these PROMs for use in clinical practice and research, as well as facilitate identification and prioritization of key knowledge gaps.


Rheumatology ◽  
2018 ◽  
Vol 57 (suppl_8) ◽  
Author(s):  
Laura E Lunt ◽  
Stephanie Shoop-Worrall ◽  
Nicola Smith ◽  
Sharon Douglas ◽  
Gavin Cleary ◽  
...  

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e039488
Author(s):  
Anna Dowling ◽  
Ellen Slungaard ◽  
Nicola R Heneghan

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.


2021 ◽  
pp. 155335062199887
Author(s):  
Alaa El-Hussuna ◽  
Ines Rubio-Perez ◽  
Monica Millan ◽  
Gianluca Pellino ◽  
Ionut Negoi ◽  
...  

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.


Author(s):  
Michaela Gabes ◽  
Helge Knüttel ◽  
Gesina Kann ◽  
Christina Tischer ◽  
Christian J. Apfelbacher

Abstract Purpose To critically appraise, compare and summarize the quality of all existing PROMs that have been validated in hyperhidrosis to at least some extend by applying the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology. Thereby, we aim to give a recommendation for the use of PROMs in future clinical trials in hyperhidrosis. Methods We considered studies evaluating, describing or comparing measurement properties of PROMs as eligible. A systematic literature search in three big databases (MEDLINE, EMBASE and Web of Science) was performed. We assessed the methodological quality of each included study using the COSMIN Risk of Bias checklist. Furthermore, we applied predefined quality criteria for good measurement properties and finally, graded the quality of the evidence. Results Twenty-four articles reporting on 13 patient-reported outcome measures were included. Three instruments can be further recommended for use. They showed evidence for sufficient content validity and moderate- to high-quality evidence for sufficient internal consistency. The methodological assessment showed existing evidence gaps for eight other PROMs, which therefore require further validation studies to make an adequate decision on their recommendation. The Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) and the short-form health survey with 36 items (SF-36) were the only questionnaires not recommended for use in patients with hyperhidrosis due to moderate- to high-quality evidence for insufficient measurement properties. Conclusion Three PROMs, the Hyperhidrosis Quality of Life Index (HidroQoL), the Hyperhidrosis Questionnaire (HQ) and the Sweating Cognitions Inventory (SCI), can be recommended for use in future clinical trials in hyperhidrosis. Results obtained with these three instruments can be seen as trustworthy. Nevertheless, further validation of all three PROMs is desirable. Systematic review registration PROSPERO CRD42020170247


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