scholarly journals Mind the methods of determining minimal important differences: three critical issues to consider

2020 ◽  
pp. ebmental-2020-300164
Author(s):  
Tahira Devji ◽  
Alonso Carrasco-Labra ◽  
Gordon Guyatt
Keyword(s):  
Systematic Review ◽  
Design Methodology ◽  
Clinical Guideline ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Patient Reported ◽  
Critical Issues ◽  
Key Issues ◽  
Key Aspects ◽  
Minimal Important Differences

ObjectiveClinical trialists, meta-analysts and clinical guideline developers are increasingly using minimal important differences (MIDs) to enhance the interpretability of patient-reported outcome measures (PROMs). Here, we elucidate three critical issues of which MID users should be aware. Improved understanding of MID concepts and awareness of common pitfalls in methodology and reporting will better inform the application of MIDs in clinical research and decision-making.MethodsWe conducted a systematic review to inform the development of an inventory of anchor-based MID estimates for PROMs. We searched four electronic databases to identify primary studies empirically calculating an anchor-based MID estimate for any PROM in adolescent or adult populations across all clinical areas. Our findings are based on information from 338 studies reporting 3389 MIDs for 358 PROMs published between 1989 and 2015.ResultsWe identified three key issues in the MID literature that demand attention. (1) The profusion of terms representing the MID concept adds unnecessary complexity to users’ task in identifying relevant MIDs, requiring meticulous inspection of methodology to ensure estimates offered truly reflect the MID. (2) A multitude of diverse methods for MID estimation that will yield different estimates exist, and whether there are superior options remains unresolved. (3) There are serious issues of incomplete presentation and reporting of key aspects of the design, methodology and results of studies providing anchor-based MIDs, which threatens the optimal use of these estimates for interpretation of intervention effects on PROMs.ConclusionsAlthough the MID represents a powerful tool for enhancing the interpretability of PROMs, realising its full value will require improved understanding and reporting of its measurement fundamentals.

scholarly journals Minimal important differences for improvement in shoulder condition patient-reported outcomes: a systematic review to inform aBMJRapid Recommendation

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e028777 ◽  
Author(s):  
Qiukui Hao ◽  
Tahira Devji ◽  
Dena Zeraatkar ◽  
Yuting Wang ◽  
Anila Qasim ◽  
...  
Keyword(s):  
Systematic Review ◽  
Shoulder Pain ◽  
Outcome Measures ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Decompression Surgery ◽  
Subacromial Decompression ◽  
Review Team ◽  
Patient Reported ◽  
Minimal Important Differences

ObjectivesTo identify credible anchor-based minimal important differences (MIDs) for patient-reported outcome measures (PROMs) relevant to aBMJRapid Recommendations addressing subacromial decompression surgery for shoulder pain.DesignSystematic review.Outcome measuresEstimates of anchor-based MIDs, and their credibility, for PROMs judged by the parallelBMJRapid Recommendations panel as important for informing their recommendation (pain, function and health-related quality of life (HRQoL)).Data sourcesMEDLINE, EMBASE and PsycINFO up to August 2018.Study selection and review methodsWe included original studies of any intervention for shoulder conditions reporting estimates of anchor-based MIDs for relevant PROMs. Two reviewers independently evaluated potentially eligible studies according to predefined selection criteria. Six reviewers, working in pairs, independently extracted data from eligible studies using a predesigned, standardised, pilot-tested extraction form and independently assessed the credibility of included studies using an MID credibility tool.ResultsWe identified 22 studies involving 5562 patients that reported 74 empirically estimated anchor-based MIDs for 10 candidate instruments to assess shoulder pain, function and HRQoL. We identified MIDs of high credibility for pain and function outcomes and of low credibility for HRQoL. We offered median estimates for the systematic review team who applied these MIDs in Grading of Recommendations Assessment, Development and Evaluation (GRADE) evidence summaries and in their interpretations of results in the linked systematic review addressing the effectiveness of surgery for shoulder pain.ConclusionsOur review provides anchor-based MID estimates, as well as a rating of their credibility, for PROMs for patients with shoulder conditions. The MID estimates inform the interpretation for a linked systematic review and guideline addressing subacromial decompression surgery for shoulder pain, and could also prove useful for authors addressing other interventions for shoulder problems.PROSPERO registration numberCRD42018106531.

scholarly journals Effect of routinely assessing and addressing depression and diabetes distress using patient-reported outcome measures in improving outcomes among adults with type 2 diabetes: a systematic review protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e044888
Author(s):  
Rita McMorrow ◽  
Barbara Hunter ◽  
Christel Hendrieckx ◽  
Dominika Kwasnicka ◽  
Leanne Cussen ◽  
...  
Keyword(s):  
Systematic Review ◽  
Type 2 Diabetes ◽  
Outcome Measures ◽  
Study Design ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Diabetes Distress ◽  
Controlled Trials ◽  
Patient Reported

IntroductionType 2 diabetes is a global health priority. People with diabetes are more likely to experience mental health problems relative to people without diabetes. Diabetes guidelines recommend assessment of depression and diabetes distress during diabetes care. This systematic review will examine the effect of routinely assessing and addressing depression and diabetes distress using patient-reported outcome measures in improving outcomes among adults with type 2 diabetes.Methods and analysisMEDLINE, Embase, CINAHL Complete, PsycInfo, The Cochrane Library and Cochrane Central Register of Controlled Trials will be searched using a prespecified strategy using a prespecified Population, Intervention, Comparator, Outcomes, Setting and study design strategy. The date range of the search of all databases will be from inception to 3 August 2020. Randomised controlled trials, interrupted time-series studies, prospective and retrospective cohort studies, case–control studies and analytical cross-sectional studies published in peer-reviewed journals in the English language will be included. Two review authors will independently screen abstracts and full texts with disagreements resolved by a third reviewer, if required, using Covidence software. Two reviewers will undertake risk of bias assessment using checklists appropriate to study design. Data will be extracted using prespecified template. A narrative synthesis will be conducted, with a meta-analysis, if appropriate.Ethics and disseminationEthics approval is not required for this review of published studies. Presentation of results will follow the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidance. Findings will be disseminated via peer-reviewed publication and conference presentations.PROSPERO registration numberCRD42020200246.

scholarly journals Implementation of patient-reported outcome measures and patient-reported experience measures in melanoma clinical quality registries: a systematic review

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e040751
Author(s):  
Zachary Blood ◽  
Anh Tran ◽  
Lauren Caleo ◽  
Robyn Saw ◽  
Mbathio Dieng ◽  
...  
Keyword(s):  
Systematic Review ◽  
Cost Effectiveness ◽  
Outcome Measures ◽  
Cutaneous Melanoma ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Secondary Outcome ◽  
Clinical Quality ◽  
Patient Reported ◽  
Eortc Qlq

ObjectivesTo identify patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) in clinical quality registries, for people with cutaneous melanoma, to inform a new Australian Melanoma Clinical Outcomes Registry; and describe opportunities and challenges of routine PROM/PREM collection, especially in primary care.DesignSystematic review.Primary and secondary outcome measuresWhich PROMs and PREMs are used in clinical quality registries for people with cutaneous melanoma, how they are collected, frequency of collection, participant recruitment methods and funding models for each registry.Results1134 studies were identified from MEDLINE, PreMEDLINE, Embase, PsychInfo, Cochrane Database of Abstracts of Reviews of Effects databases and TUFTS Cost-Effectiveness Analysis Registry, alongside grey literature, from database inception to 5th February 2020. Following screening, 14 studies were included, identifying four relevant registries: Dutch Melanoma Registry, Adelphi Real-World Disease-Specific Programme (Melanoma), Patient-Reported Outcomes Following Initial treatment and Long-term Evaluation of Survivorship Registry, and Cancer Experience Registry. These used seven PROMs: EuroQol-5 Dimensions, Functional Assessment of Cancer-General (FACT-G) and FACT-Melanoma (FACT-M), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Cancer 30 (EORTC QLQ-C30), Fatigue Assessment Scale Hospital Anxiety and Depression Scale, Patient-Reported Outcome Measures Information System-29 and one PREM; EORTC QLQ-Information Module 26. PROMs/PREMs in registries were reported to improve transparency of care; facilitate clinical auditing for quality assessment; enable cost-effectiveness analyses and create large-scale research platforms. Challenges included resource burden for data entry and potential collection bias toward younger, more affluent respondents. Feedback from patients with melanoma highlighted the relevance of PROMs/PREMs in assessing patient outcomes and patient experiences.ConclusionsClinical registries indicate PROMs/PREMs for melanoma care can be incorporated and address important gaps, however cost and collection bias may limit generalisability.PROSPERO registration numberCRD42018086737.

scholarly journals Measurement properties of patient-reported outcome measures (PROMs) in hyperhidrosis: a systematic review

2021 ◽  
Author(s):  
Michaela Gabes ◽  
Helge Knüttel ◽  
Gesina Kann ◽  
Christina Tischer ◽  
Christian J. Apfelbacher
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Measurement Properties ◽  
High Quality ◽  
High Quality Evidence ◽  
Patient Reported ◽  
Quality Evidence

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

scholarly journals A systematic review of the measurement properties of patient reported outcome measures used for adults with an ankle fracture

2019 ◽  
Vol 3 (1) ◽  
Author(s):  
Rebecca McKeown ◽  
David R. Ellard ◽  
Abdul-Rasheed Rabiu ◽  
Eleni Karasouli ◽  
Rebecca S. Kearney
Keyword(s):  
Systematic Review ◽  
Construct Validity ◽  
Outcome Measures ◽  
Ankle Fracture ◽  
Methodological Quality ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Measurement Properties ◽  
Health Measurement ◽  
Patient Reported

Abstract Background Ankle fractures are painful and debilitating injuries that pose a significant burden to society and healthcare systems. Patient reported outcome measures (PROMs) are commonly used outcome measures in clinical trials of interventions for ankle fracture but there is little evidence on their validity and reliability. This systematic review aims to identify and appraise evidence for the measurement properties of ankle specific PROMs used in adults with an ankle fracture using Consensus Based Standards for the Selection of Health Measurement Instrument (COSMIN) methodology. Methods We searched MEDLINE, Embase and CINAHL online databases for evidence of measurement properties of ankle specific PROMs. Articles were included if they assessed or described the development of the PROM in adults with ankle fracture. Articles were ineligible if they used the PROM to assess the measurement properties of another instrument. Abstracts without full articles and conference proceedings were ineligible, as were articles that adapted the PROM under evaluation without any formal justification of the changes as part of a cross-cultural validation or translation process. Two reviewers completed the screening. To assess methodological quality we used COSMIN risk of bias checklist and summarised evidence using COSMIN quality criteria and a modified Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Two reviewers assessed the methodological quality and extracted the data for a sample of articles. Results The searches returned a total of 377 articles. From these, six articles were included after application of eligibility criteria. These articles evaluated three PROMs: A-FORM, OMAS and AAOS. The A-FORM had evidence of a robust development process within the patient population, however lacks post-formulation testing. The OMAS showed sufficient levels of reliability, internal consistency and construct validity. The AAOS showed low quality evidence of sufficient construct validity. Conclusions There is insufficient evidence to support the recommendation of a particular PROM for use in adult ankle fracture research based on COSMIN methodology. Further validation of these outcome measures is required in order to ensure PROMs used in this area are sufficiently valid and reliable to assess treatment effects. This would enable high quality, evidenced-based management of adults with ankle fracture.

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