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

Author(s):  
Yuki Seidler ◽  
Erika Mosor ◽  
Margaret R Andrews ◽  
Carolina Watson ◽  
Nick Bott ◽  
...  

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.

2019 ◽  
Author(s):  
Irushi Ratnayake ◽  
Susannah Ahern ◽  
Rasa Ruseckaite

BACKGROUND Patients with cystic fibrosis (CF) can struggle with burdensome symptoms and treatment regimens that negatively affect every aspect of their life. As physiological parameters can fail to capture these complications, the assessment of health-related quality of life (HRQOL) has gained prominence. HRQOL can be measured using standardized patient questionnaires called patient-reported outcome measures (PROMs). The Australian Cystic Fibrosis Data Registry (ACFDR) collects clinical data on adult and pediatric patients with CF. The incorporation of PROMs into the ACFDR would enable monitoring of HRQOL trends, benchmarking of HRQOL outcomes, and support of HRQOL research in CF. OBJECTIVE Prior to incorporation of a PROM in the ACFDR, this systematic review was planned to evaluate whether any suitable PROMs are currently being used for CF. METHODS This systematic review will be conducted in compliance with the PRISMA-P (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols) guidelines. MEDLINE, EMBASE, Scopus, CINAHL (Cumulative Index of Nursing and Allied Health Literature), PsycINFO, and Cochrane Library databases were searched for articles published between January 2009 and February 2019 on the use of PROMs to measure HRQOL in adult and pediatric patients with CF. Study designs such as observational studies, reviews and validation studies were included. Studies describing randomized controlled trials, dissertations, books, guideline statements, and abstracts were excluded. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) risk of bias checklist was used to assess the methodological quality of included studies. A descriptive synthesis of the results will be undertaken in line with the outcomes of this study. RESULTS As of July 2019, the search has been conducted and 4530 records were screened. After two phases of screening, 97 studies were included in the final review and subjected to data extraction. Reviewers are currently in the process of critical appraisal. CONCLUSIONS This review will identify any PROM(s) that may be used to measure HRQOL in the ACFDR. CLINICALTRIAL PROSPERO International Prospective Register of Systematic Reviews CRD42019126931; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=126931


10.2196/15467 ◽  
2020 ◽  
Vol 9 (5) ◽  
pp. e15467
Author(s):  
Irushi Ratnayake ◽  
Susannah Ahern ◽  
Rasa Ruseckaite

Background Patients with cystic fibrosis (CF) can struggle with burdensome symptoms and treatment regimens that negatively affect every aspect of their life. As physiological parameters can fail to capture these complications, the assessment of health-related quality of life (HRQOL) has gained prominence. HRQOL can be measured using standardized patient questionnaires called patient-reported outcome measures (PROMs). The Australian Cystic Fibrosis Data Registry (ACFDR) collects clinical data on adult and pediatric patients with CF. The incorporation of PROMs into the ACFDR would enable monitoring of HRQOL trends, benchmarking of HRQOL outcomes, and support of HRQOL research in CF. Objective Prior to incorporation of a PROM in the ACFDR, this systematic review was planned to evaluate whether any suitable PROMs are currently being used for CF. Methods This systematic review will be conducted in compliance with the PRISMA-P (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols) guidelines. MEDLINE, EMBASE, Scopus, CINAHL (Cumulative Index of Nursing and Allied Health Literature), PsycINFO, and Cochrane Library databases were searched for articles published between January 2009 and February 2019 on the use of PROMs to measure HRQOL in adult and pediatric patients with CF. Study designs such as observational studies, reviews and validation studies were included. Studies describing randomized controlled trials, dissertations, books, guideline statements, and abstracts were excluded. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) risk of bias checklist was used to assess the methodological quality of included studies. A descriptive synthesis of the results will be undertaken in line with the outcomes of this study. Results As of July 2019, the search has been conducted and 4530 records were screened. After two phases of screening, 97 studies were included in the final review and subjected to data extraction. Reviewers are currently in the process of critical appraisal. Conclusions This review will identify any PROM(s) that may be used to measure HRQOL in the ACFDR. Trial Registration PROSPERO International Prospective Register of Systematic Reviews CRD42019126931; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=126931


2020 ◽  
Author(s):  
Yu Heng Kwan ◽  
Si Dun Weng ◽  
Dionne Hui Fang Loh ◽  
Jie Kie Phang ◽  
Livia Jia Yi Oo ◽  
...  

BACKGROUND Medication adherence is essential for improving the health outcomes of patients. Various patient-reported outcome measures (PROMs) have been developed to measure medication adherence in patients. However, no study has summarized the psychometric properties of these PROMs to guide selection for use in clinical practice or research. OBJECTIVE This study aims to evaluate the quality of the PROMs used to measure medication adherence. METHODS This study was guided by the PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analysis) guidelines. Relevant articles were retrieved from the EMBASE, PubMed, Cochrane Library, Web of Science, and CINAHL (Cumulative Index to Nursing and Allied Health Literature) databases. The PROMs were then evaluated based on the COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) guidelines. RESULTS A total of 121 unique medication adherence PROMs from 214 studies were identified. <i>Hypotheses testing for construct validity</i> and <i>internal consistency</i> were the most frequently assessed measurement properties. PROMs with at least a <i>moderate</i> level of evidence for ≥5 measurement properties include the Adherence Starts with Knowledge 20, Compliance Questionnaire-Rheumatology, General Medication Adherence Scale, Hill-Bone Scale, Immunosuppressant Therapy Barrier Scale, Medication Adherence Reasons Scale (MAR-Scale) revised, 5-item Medication Adherence Rating Scale (MARS-5), 9-item MARS (MARS-9), 4-item Morisky Medication Adherence Scale (MMAS-4), 8-item MMAS (MMAS-8), Self-efficacy for Appropriate Medication Adherence Scale, Satisfaction with Iron Chelation Therapy, Test of Adherence to Inhalers, and questionnaire by Voils. The MAR-Scale revised, MMAS-4, and MMAS-8 have been administered electronically. CONCLUSIONS This study identified 121 PROMs for medication adherence and provided synthesized evidence for the measurement properties of these PROMs. The findings from this study may assist clinicians and researchers in selecting suitable PROMs to assess medication adherence.


2020 ◽  
Author(s):  
Abanoub Riad ◽  
Jitka Klugarova ◽  
Veronika Chuchmova ◽  
Simona Slezakova ◽  
Andrea Pokorna ◽  
...  

Abstract Background: Subclinical changes in response to different types of toothbrushes represent a challenging knowledge gap in the context of self-administered oral hygiene regimes; therefore, this systematic review will be the first to evaluate the oral microbiome response to powered versus manual toothbrushes.Methods: We will conduct a systematic review using the Cochrane Handbook’s guidelines and will adhere to a standardized reporting format: Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). A comprehensive search strategy will be conducted in the following databases for published studies: Ovid MEDLINE(R), EMBASE, Cochrane Library, Web of Science, Scopus, ProQuest Central, ProQuest Dissertations Theses Global, Bibliographia Medica Cechoslovaca, and Dentistry Oral Sciences Source. Following a two-level screening process, data including the full reference, objectives, target population, description of the intervention and control intervention, outcome measures, design, length of the post-intervention follow-up period, and the study results will be extracted, synthesized, and reported. Risk of bias and quality of the studies will also be assessed.Discussion: No primary data collection will be undertaken; therefore, no formal ethical assessment is required. The results of this systematic review and meta-analysis will be published in a peer-reviewed journal.Registration: The protocol has been registered with the PROSPERO International Prospective Register of Systematic Reviews (CRD42020153557) since April 28th, 2020.


2020 ◽  
Author(s):  
Yu Heng Kwan ◽  
Livia Jia Yi Oo ◽  
Dionne Hui Fang Loh ◽  
Jie Kie Phang ◽  
Si Dun Weng ◽  
...  

BACKGROUND Medication adherence is important in managing the progression of chronic diseases. A promising approach to reduce cognitive burden when measuring medication adherence lies in the use of computer‐adaptive tests (CATs) or in the development of shorter patient-reported outcome measures (PROMs). However, the lack of an item bank currently hampers this progress. OBJECTIVE We aim to develop an item bank to measure general medication adherence. METHODS Using the preferred reporting items for systematic review and meta-analysis (PRISMA), articles published before October 2019 were retrieved from PubMed, Embase, CINAHL, the Cochrane Library, and Web of Science. Items from existing PROMs were classified and selected (“binned” and “winnowed”) according to standards published by the Patient-Reported Outcomes Measurement Information System (PROMIS) Cooperative Group. RESULTS A total of 126 unique PROMs were identified from 213 studies in 48 countries. Items from the literature review (47 PROMs with 579 items for which permission has been obtained) underwent binning and winnowing. This resulted in 421 candidate items (77 extent of adherence and 344 reasons for adherence). CONCLUSIONS We developed an item bank for measuring general medication adherence using items from validated PROMs. This will allow researchers to create new PROMs from selected items and provide the foundation to develop CATs.


2021 ◽  
Vol 8 (1) ◽  
Author(s):  
Lucas Beckers ◽  
Thiago Vivacqua ◽  
Andrew D. Firth ◽  
Alan M. J. Getgood

Abstract Purpose The purpose of this investigation was to systematically review the contemporary literature to determine if a lateral augmentation (LA) added to an Anterior Cruciate Ligament Reconstruction (ACLR) provides better clinical and patient reported outcomes compared to an isolated ACLR. Methods A systematic review and meta-analysis was performed according to the Preferred Reporting Items for Systematic reviews and Meta-analyses (PRISMA) criteria. Two authors independently conducted an electronic search using MEDLINE® and Embase® on February 6th, 2021 for level I-III randomized controlled trials (RCT) and prospective cohort studies without randomization, published after 2012 and with a minimum of two year follow-up. Publications were included when they reported on the objective knee stability examination, patient reported outcome scores, return to sports or graft rupture rate of any type of primary, isolated ACLR compared to ACLR combined with any type of LA. Results A total of 11 studies that reported on a combined total of 1892 unique patients were eligible for data extraction, including five RCTs and six prospective cohort studies. In 6 studies, an Anterolateral Ligament reconstruction (ALLR) was the LA of choice, while the 5 other publications used different types of Lateral Extra-articular Tenodesis (LET). A significant reduction in graft ruptures was found in patients treated with ACLR + LA (3%) compared to isolated ACLR (12%). Rotational laxity was significantly higher in isolated ACLR (14%) compared to ACLR + LA (6%). Addition of a LA reduced anterior translation when assessed via instrumented laxity testing. No significant difference was found in the patient reported outcome scores (IKDC and Tegner) between both patient groups, except for the Lysholm Score which was significant in favour of the ACLR + LA group. Conclusion Combination of a primary ACLR with a LA can significantly reduce the risk of graft rupture and provide better rotatory stability, without jeopardizing patient reported outcomes. Level of evidence Level III, Systematic Review of Level I, II and III studies.


10.2196/19179 ◽  
2020 ◽  
Vol 22 (10) ◽  
pp. e19179
Author(s):  
Yu Heng Kwan ◽  
Si Dun Weng ◽  
Dionne Hui Fang Loh ◽  
Jie Kie Phang ◽  
Livia Jia Yi Oo ◽  
...  

Background Medication adherence is essential for improving the health outcomes of patients. Various patient-reported outcome measures (PROMs) have been developed to measure medication adherence in patients. However, no study has summarized the psychometric properties of these PROMs to guide selection for use in clinical practice or research. Objective This study aims to evaluate the quality of the PROMs used to measure medication adherence. Methods This study was guided by the PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analysis) guidelines. Relevant articles were retrieved from the EMBASE, PubMed, Cochrane Library, Web of Science, and CINAHL (Cumulative Index to Nursing and Allied Health Literature) databases. The PROMs were then evaluated based on the COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) guidelines. Results A total of 121 unique medication adherence PROMs from 214 studies were identified. Hypotheses testing for construct validity and internal consistency were the most frequently assessed measurement properties. PROMs with at least a moderate level of evidence for ≥5 measurement properties include the Adherence Starts with Knowledge 20, Compliance Questionnaire-Rheumatology, General Medication Adherence Scale, Hill-Bone Scale, Immunosuppressant Therapy Barrier Scale, Medication Adherence Reasons Scale (MAR-Scale) revised, 5-item Medication Adherence Rating Scale (MARS-5), 9-item MARS (MARS-9), 4-item Morisky Medication Adherence Scale (MMAS-4), 8-item MMAS (MMAS-8), Self-efficacy for Appropriate Medication Adherence Scale, Satisfaction with Iron Chelation Therapy, Test of Adherence to Inhalers, and questionnaire by Voils. The MAR-Scale revised, MMAS-4, and MMAS-8 have been administered electronically. Conclusions This study identified 121 PROMs for medication adherence and provided synthesized evidence for the measurement properties of these PROMs. The findings from this study may assist clinicians and researchers in selecting suitable PROMs to assess medication adherence.


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