Relevant domains, core outcome sets and measurements for implant dentistry clinical trials: The Implant Dentistry Core Outcome Set and Measurement (ID-COSM) international consensus report.

AIM: Lack of consistently reported outcomes limits progress in evidence-based implant dentistry and quality of care. The objective of this initiative was to develop a core outcome set (COS) and measurements for implant dentistry clinical trials (ID-COSM). MATERIALS AND METHODS: This Core Outcome Measures in Effectiveness Trials (COMET)-registered international initiative comprised six steps over 24 months: (i) systematic reviews of outcomes reported in the last 10 years; (ii) international patient focus groups; (iii) a Delphi project with a broad range of stakeholders (care providers, clinical researchers, methodologists, patients and industry representatives); (iv) expert group discussions organizing the outcomes in domains using a theoretical framework and identifying the COSs; (v) identification of valid measurement systems to capture the different domains and (vi) final consensus and formal approval involving experts and patients. The methods were modified from the best practice approach following the Outcome Measures in Rheumatoid Arthritis Clinical Trial and COMET manuals. RESULTS: The systematic reviews and patient focus groups identified 754 (665 + 89, respectively) relevant outcome measures. After elimination of redundancies and duplicates, 111 were formally assessed in the Delphi project. By applying pre-specified filters, the Delphi process identified 22 essential outcomes. These were reduced to 13 after aggregating alternative assessments of the same features. The expert committee organized them into four core outcome areas: (i) pathophysiology, (ii) implant/prosthesis lifespan, (iii) life impact and (iv) access to care. In each area, core outcomes were identified to capture both the benefits and harms of therapy. Mandatory outcome domains included assessment of surgical morbidity and complications, peri-implant tissue health status, intervention-related adverse events, complication-free survival and overall patient satisfaction and comfort. Outcomes deemed mandatory in specific circumstances comprised function (mastication, speech, aesthetics and denture retention), quality of life, effort for treatment and maintenance and cost effectiveness. Specialized COSs were identified for bone and soft-tissue augmentation procedures. The validity of measurement instruments ranged from international consensus (peri-implant tissue health status) to early identification of important outcomes (patient-reported outcomes identified by the focus groups). CONCLUSIONS: The ID-COSM initiative reached a consensus on a core set of mandatory outcomes for clinical trials in implant dentistry and/or soft tissue/bone augmentation. Adoption in future protocols and reporting on the respective domain areas by currently ongoing trials will contribute to improving evidence-informed implant dentistry and quality of care.

Multi-stakeholder contribution to the identification of a core outcome set and measurements in implant dentistry (ID-COSM initiative) using the Delphi methodology.

AIM: To obtain input from multiple stakeholders and generate agreement on essential outcomes in implant dentistry using the Delphi methodology and incorporate them into an international consensus defining a core outcome set. MATERIALS AND METHODS: Candidate outcomes in implant dentistry were generated from scientific evidence through five commissioned systematic reviews and from people with lived experience in dental implants (PWLE) through four international focus groups. A steering committee identified stakeholders among representatives from dental professionals, industry-related experts and PWLE. Participants underwent a three-round Delphi survey using a multi-stakeholder approach; they assessed candidate outcomes and additional outcomes identified in the first Delphi round. The process followed the COMET methodology. RESULTS: From the 665 potential outcomes identified in the systematic reviews and 89 in the PWLE focus group, the steering committee selected 100 and organized them into 13 categories, to be included in the first-round questionnaire as candidate outcomes. A total of 99 dental experts, 7 dental-industry-related experts and 17 PWLE participated in the first round, and 11 additional outcomes were added to the second round. There was no attrition between the first and second rounds, where 61 (54.9%) outcomes exceeded the pre-established threshold of agreement. PWLE and experts participated in the third round that applied "a priori" standard filters to distil a list of candidate essential outcomes. CONCLUSION: This Delphi study utilized a standardized, transparent and inclusive methodology and preliminarily validated 13 essential outcomes organized into four core areas. These results informed the final stage of the ID-COSM consensus.

Multi-stakeholder contribution to the identification of a core outcome set and measurements in implant dentistry (ID-COSM initiative) using the Delphi methodology.

AIM: To obtain input from multiple stakeholders and generate agreement on essential outcomes in implant dentistry using the Delphi methodology and incorporate them into an international consensus defining a core outcome set. MATERIALS AND METHODS: Candidate outcomes in implant dentistry were generated from scientific evidence through five commissioned systematic reviews and from people with lived experience in dental implants (PWLE) through four international focus groups. A steering committee identified stakeholders among representatives from dental professionals, industry-related experts and PWLE. Participants underwent a three-round Delphi survey using a multi-stakeholder approach; they assessed candidate outcomes and additional outcomes identified in the first Delphi round. The process followed the COMET methodology. RESULTS: From the 665 potential outcomes identified in the systematic reviews and 89 in the PWLE focus group, the steering committee selected 100 and organized them into 13 categories, to be included in the first-round questionnaire as candidate outcomes. A total of 99 dental experts, 7 dental-industry-related experts and 17 PWLE participated in the first round, and 11 additional outcomes were added to the second round. There was no attrition between the first and second rounds, where 61 (54.9%) outcomes exceeded the pre-established threshold of agreement. PWLE and experts participated in the third round that applied "a priori" standard filters to distil a list of candidate essential outcomes. CONCLUSION: This Delphi study utilized a standardized, transparent and inclusive methodology and preliminarily validated 13 essential outcomes organized into four core areas. These results informed the final stage of the ID-COSM consensus.

Relevant domains, core outcome sets and measurements for implant dentistry clinical trials: The Implant Dentistry Core Outcome Set and Measurement (ID-COSM) international consensus report.

AIM: Lack of consistently reported outcomes limits progress in evidence-based implant dentistry and quality of care. The objective of this initiative was to develop a core outcome set (COS) and measurements for implant dentistry clinical trials (ID-COSM). MATERIALS AND METHODS: This Core Outcome Measures in Effectiveness Trials (COMET)-registered international initiative comprised six steps over 24 months: (i) systematic reviews of outcomes reported in the last 10 years; (ii) international patient focus groups; (iii) a Delphi project with a broad range of stakeholders (care providers, clinical researchers, methodologists, patients and industry representatives); (iv) expert group discussions organizing the outcomes in domains using a theoretical framework and identifying the COSs; (v) identification of valid measurement systems to capture the different domains and (vi) final consensus and formal approval involving experts and patients. The methods were modified from the best practice approach following the Outcome Measures in Rheumatoid Arthritis Clinical Trial and COMET manuals. RESULTS: The systematic reviews and patient focus groups identified 754 (665 + 89, respectively) relevant outcome measures. After elimination of redundancies and duplicates, 111 were formally assessed in the Delphi project. By applying pre-specified filters, the Delphi process identified 22 essential outcomes. These were reduced to 13 after aggregating alternative assessments of the same features. The expert committee organized them into four core outcome areas: (i) pathophysiology, (ii) implant/prosthesis lifespan, (iii) life impact and (iv) access to care. In each area, core outcomes were identified to capture both the benefits and harms of therapy. Mandatory outcome domains included assessment of surgical morbidity and complications, peri-implant tissue health status, intervention-related adverse events, complication-free survival and overall patient satisfaction and comfort. Outcomes deemed mandatory in specific circumstances comprised function (mastication, speech, aesthetics and denture retention), quality of life, effort for treatment and maintenance and cost effectiveness. Specialized COSs were identified for bone and soft-tissue augmentation procedures. The validity of measurement instruments ranged from international consensus (peri-implant tissue health status) to early identification of important outcomes (patient-reported outcomes identified by the focus groups). CONCLUSIONS: The ID-COSM initiative reached a consensus on a core set of mandatory outcomes for clinical trials in implant dentistry and/or soft tissue/bone augmentation. Adoption in future protocols and reporting on the respective domain areas by currently ongoing trials will contribute to improving evidence-informed implant dentistry and quality of care.

Outcome reporting in randomized trials in gout: A systematic scoping review from the OMERACT gout working group assessing the uptake of the core outcome set.

OBJECTIVE: The selection and reporting of core outcome measures in clinical trials is essential for patients, researchers, and healthcare providers for clinical research to have an impact on healthcare. In this systematic scoping review, we aimed to quantify the extent to which gout clinical trials are collecting and reporting data in accordance with the core outcome domains from Outcome Measures in Rheumatology (OMERACT) published in 2009 applicable for both acute and chronic trials and evaluate the reporting according to the core domains before and after the 2009 OMERACT endorsement. METHODS: We searched multiple databases PubMed, EMBASE, the Cochrane Library including the Cochrane Central Register of Controlled Trials (CENTRAL), and Cochrane Database of Systematic Reviews (CDSR) and www. CLINICALTRIALS: gov for randomized controlled trials (RCTs) allocating people with gout versus an active pharmacological gout treatment or a control comparator (no date limitation). We extracted the data in accordance with the core outcome sets, focusing individually on core outcome domains and the core outcome measurements for acute and chronic trials, respectively. In this study 'Acute trials' reflect studies that describe interventions for short term management of gout flares, and 'chronic trials' describe interventions for long-term urate lowering therapy in the management of gout. RESULTS: From 8,522 records identified in the database search, 134 full text papers were reviewed, and 71 trials were included, of which 36 were acute and 35 were chronic. Only 3 of 36 (8%) acute trials reported all five core domains and none of the 35 included chronic trials reported all 7 core domains. In the acute trials, twenty-seven unique measurement instruments across the 5 core domains were identified. For chronic trials there were 31 unique measurement instruments used across the 7 core domains. Serum urate was reported in 100% of the chronic trials and gout flares in 80%. However, other core domains were reported in <30% of chronic trials. In particular the patient-important domains such as HR-QOL, patient global assessment and activity limitations were rarely reported. A broad variety of different measurement instruments were used to assess each endorsed core domain, a minority of trials used the OMERACT endorsed instruments. For acute trials, the number reporting on all core domains was consistently low and no change was detected before and after the endorsement of the core domains in 2009. None of the included chronic trials reported on all 7 endorsed core domains at any time. CONCLUSION: In this study we found a low adherence with the intended endorsed (i.e., core) outcome domains for acute and chronic gout studies which represents a poor uptake of the global OMERACT efforts for the minimum of what should be measured in clinical trials. In addition, there is a significant variation in how the OMERACT endorsed outcome domains have been measured. This systematic review demonstrates the need for continuous encouragement among gout researchers to adhere to OMERACT core domains as well as further guidance on outcome measurements reporting. REGISTRATION: Prospero: CRD42019151316.

Consensus development of priority outcome domains for community mental health cares by multiple stakeholders: Protocol for an online Delphi study in Japan.

BACKGROUND: Treatment goals for mental illness have expanded from hospital discharge and improved functioning to employment, living alone, and personal realization. These changes in treatment goals have also influenced mental health research. Recent studies have addressed the development of core outcome sets focusing on clinical aspects of mental illness such as depression and anxiety. However, a well-developed framework of essential outcomes for people with mental illness (service users) who live in the community is lacking. In addition, recent worldwide trends suggest more patient and public involvement and the importance of considering multiple stakeholders' views in the area of mental health research. Purpose of this study is to explore consensus on high-priority outcome domains among multiple stakeholders in community mental healthcare fields in Japan. METHODS: A three-step approach to developing an outcome list will be used. First, we developed a long list of outcomes for community mental health through a literature review, focus group interviews with key stakeholders, and online questionnaire surveys of service users and caregivers. Second, the long list was checked and revised in a pilot study. Third, the long list will be shortened to the outcome list through the Delphi methodology with participation from multiple stakeholders. DISCUSSION: Identifying important common outcome domains through collaboration with multiple stakeholders appears to contribute to the development of evidence for community mental health research in Japan. In addition, the study process itself may help promote patient and public involvement in education, practice, and research in the field of community mental health.

Toward a Core Outcome Set for Head, Neck, and Respiratory Disease in Mucopolysaccharidosis Type II: Systematic Literature Review and Assessment of Heterogeneity in Outcome Reporting

Abstract The mucopolysaccharidoses (MPS) are a relatively uncommon group of inherited metabolic disorders, with significant negative implications for life span and aspects of quality of life. Their rarity means that producing evidence to guide best practice has often entailed assimilating findings from multiple studies. Core outcome sets (COS) are being increasingly used across medicine as a potential solution to the problems arising from heterogeneous reporting of outcomes in effectiveness studies. A COS is a recommended minimum set of outcomes that should be measured for a given condition in an effectiveness study, with the ultimate aim of increasing the value of clinical information by enabling meaningful comparison and combination of data from various sources. A systematic review identified 41 outcomes measured in published studies and ongoing and completed clinical trials, with individual outcomes being measured using a variety of measurement instruments/tools. This work represents the important initial steps in the development of COS for head, neck, and respiratory disorders in MPS type II, raising awareness of the extent of heterogeneity in outcome reporting and determining the scope of outcomes and corresponding instruments currently used. The next step will be to use the generated "longlist" of outcomes to develop an electronic Delphi prioritization exercise with the intention of reaching a consensus regarding the most important outcomes to measure in effectiveness studies for head, neck, and respiratory disease in MPS type II.

Authors' lack of awareness and use of core outcome set on postoperative pain in children is hindering comparative effectiveness research.

AIM: To analyze awareness about and acceptability of core outcome set (COS) for pediatric pain recommended by the PedIMMPACT. METHODS: We invited authors of systematic reviews and randomized controlled trials about interventions for postoperative pain in children to participate in a survey. RESULTS: Only a third of surveyed authors of systematic reviews and randomized controlled trials about postoperative pain in children had heard about the PedIMMPACT COS for acute pediatric pain. Problems indicated as preventing them from using the COS were lack of awareness, difficulties with implementation, and lack of resources. CONCLUSION: Further discussions about the adequacy of COS for acute pediatric pain, as well as interventions to increase the uptake of COS may be warranted.