Core outcome sets will improve the quality of obstetrics research

Abstract Background Bariatric surgery may lead to symptomatic postprandial hypoglycaemia as a major side effect without established therapy so far. We aimed to develop an evidence-based study design of a clinical trial that tests treatment options and can provide useful patient-relevant evidence. Methods We searched systematically for guidance of core outcome sets to determine the most relevant types of outcomes and duration of such a trial. Our search comprised literature databases, a database of core outcome sets and self-help organizations. We then developed a simple online questionnaire based on interviews with German-speaking patients with postprandial hypoglycaemia after bariatric surgery. We recruited participants by reaching out to all German speaking endocrinologists in Switzerland and large Swiss bariatric centres. We asked for preferences regarding outcome types and acceptable duration of being included in a corresponding clinical trial. Results The literature search did not identify evidence-based guidance for informing our study design. Experience of clinical and research routine as well as patient interviews helped in identifying potential outcomes and the design of an online questionnaire. Therein, a total of 29 persons started the questionnaire and 22 answered questions related to the primary outcome. Of these, 17 (77.3%) deemed quality of life more relevant as primary outcome than the rate of hypoglycaemic episodes. A trial length of four weeks or longer was regarded as acceptable for 19 of 21 respondents to this question (91.4%) and of six months or longer for 12 respondents (56%). Conclusions In situations with no other guidance, a simple questionnaire may help to inform trial design decisions. This study identifies a patient preference for “quality of life” as a primary outcome and supports the evidence-based conception of a patient-centred clinical trial in postbariatric hypoglycaemia.

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Surgery-first orthognathic approach: A “scoping review” for mapping outcomes and plausible recommendations to develop core outcome sets

APOS Trends in Orthodontics ◽

10.25259/apos-77-2019 ◽

2019 ◽

Vol 9 ◽

pp. 77-88 ◽

Cited By ~ 1

Author(s):

Narayan H. Gandedkar ◽

María Mélita Chacón Dávila ◽

Chai Kiat Chng ◽

Eric J. W. Liou ◽

Ali Darendeliler

Keyword(s):

Scoping Review ◽

Selection Criteria ◽

Well Being ◽

Core Outcome ◽

Health Resource ◽

Health Resource Utilization ◽

Core Outcome Sets ◽

Surgery First ◽

Meta Analyses

Aims and Objectives The aim of this scoping review was to identify the type of outcomes measured in surgery- first orthognathic approach (SFOA). The objectives were to classify the outcomes into predetermined domains and explore the degree of representation of each domain. Furthermore, to identify which domains are over- or under-represented and determine whether the findings of this scoping review could be employed to provide a template for core outcome sets (COS). Five outcomes were identified, and all the research pertinent to SFOA were assigned to these outcomes. Materials and Methods Electronic databases and additional records were searched from January 2009 to March 2019 to source the data, and 525 records were identified. Results The initial database and additional search resulted in 525 records, of which 54 potentially relevant articles were retrieved in full. 35 studies met the selection criteria following screening and were included in the scoping review with the results of the search depicted in the preferred reporting items for systematic reviews and meta-analyses. Domains such as morphological features or changes in maxillofacial skeleton and occlusion (n = 25, 71.42%) and psychosocial well-being including quality of life outcome (n = 8, 22.85%) were well represented while functional status (n = 1, 2.85%), health resource utilization (n = 0), and adverse effects (n = 1, 2.85 %) were under-represented. Conclusions Limited research on SFOA precludes development of COS. However, future SFOA clinical trials should consider underrepresented outcome domains to address the SFOA treatment modality comprehensively.

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Outcome selection for tissue-agnostic drug trials for immune-mediated inflammatory diseases: a systematic review of core outcome sets and regulatory guidance

Trials ◽

10.1186/s13063-022-06000-w ◽

2022 ◽

Vol 23 (1) ◽

Author(s):

Olalekan Lee Aiyegbusi ◽

Lavinia Ferrante di Ruffano ◽

Ameeta Retzer ◽

Philip N. Newsome ◽

Christopher D. Buckley ◽

...

Keyword(s):

Systematic Review ◽

Inflammatory Diseases ◽

Core Outcome ◽

Core Outcome Sets ◽

Regulatory Guidance ◽

Immune Mediated ◽

Outcome Selection ◽

Similarities And Differences ◽

Selection For

Abstract Background Tissue-agnostic drug development provides a paradigm shift in precision medicine and requires innovative trial designs. However, outcome selection for such trials can prove challenging. The objectives of this review were to: Identify and map core outcome sets (COS), across 11 immune-mediated inflammatory diseases (IMIDs) in order to facilitate the selection of relevant outcomes across the conditions for innovative trials of tissue-agnostic drug therapies. Compare outcomes or endpoints recommended by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) to identify and highlight similarities and differences. Methods The Core Outcome Measures in Effectiveness Trials (COMET), International Consortium for Health Outcomes Measurement (ICHOM), FDA and EMA databases were searched from inception to 28th December 2019. Two reviewers independently screened titles and abstracts of retrieved entries and conducted the subsequent full text screening. Hand searching of the reference lists and citation searching of the selected publications was conducted. The methodological quality of the included peer-reviewed articles was independently assessed by the reviewers based on the items of the COS–Standards for Development recommendations (COS–STAD) checklist. Core outcomes from the included publications were extracted and mapped across studies and conditions. Regulatory guidance from FDA and EMA, where available for clinical trials for the IMIDs, were obtained from their databases and recommendations on outcomes to measure directly compared. Results Forty-four COS publications were included in the final analysis. Outcomes such as disease activity, pain, fatigue, quality of life, physical function, work limitation/productivity, steroid use and biomarkers were recommended across majority of the conditions. There were significant similarities and differences in FDA and EMA recommendations. The only instance where either regulatory body directly referenced a COS was for jSLE—both referenced the Paediatric Rheumatology International Trials Organization (PRINTO) COS. Conclusions The findings from this systematic review provide valuable information to inform outcome selection in tissue-agnostic trials for IMIDs. There is a need for increased collaboration between regulators and COS developers and inclusion of regulators as key stakeholders in COS development to enhance the quality of COS. Trial registration Not registered.

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Quality assessment of outcome reporting, publication characteristics and overall methodological quality in trials on synthetic mesh procedures for the treatment of pelvic organ prolapse for development of core outcome sets

International Urogynecology Journal ◽

10.1007/s00192-021-04749-3 ◽

2021 ◽

Author(s):

Thais Regina de Mattos Lourenço ◽

◽

Vasilis Pergialiotis ◽

Constantin M. Durnea ◽

Abdullatif Elfituri ◽

...

Keyword(s):

Methodological Quality ◽

Reporting Quality ◽

Pelvic Organ ◽

Synthetic Mesh ◽

Core Outcome ◽

Core Outcome Sets ◽

Outcome Reporting ◽

Randomized Controlled ◽

The Mean

Abstract Introduction and hypothesis Variations in outcome measures and reporting of outcomes in trials on surgery for pelvic organ prolapse (POP) using synthetic mesh have been evaluated and reported. However, the quality of outcome reporting, methodology of trials and their publication parameters are important considerations in the process of development of Core Outcome Sets. We aimed to evaluate these characteristics in randomized controlled trials on surgery for POP using mesh. Methods Secondary analysis of randomized controlled trials on surgical treatments using synthetic mesh for POP previously included in a systematic review developing an inventory of reported outcomes and outcome measures. The methodological quality was investigated with the modified Jadad criteria. Outcome reporting quality was evaluated with the MOMENT criteria. Publication parameters included publishing journal, impact factor and year of publication. Results Of the 71 previously reviewed studies published from 2000 to 2017, the mean JADAD score was 3.59 and the mean MOMENT score was 4.63. Quality of outcomes (MOMENT) was related to methodological quality (JADAD) (rho = 0.662; p = 0.000) and to year of publication (rho = 0.262; p = 0.028). Conclusions Methodological quality and outcome reporting quality appear correlated. However, publication characteristics do not have strong associations with the methodological quality of the studies. Evaluation of the quality of outcomes, methodology and publication characteristics are all an indispensable part of a staged process for the development of Core Outcome and Outcome Measure Sets.

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Patient involvement to inform the design of a clinical trial in postbariatric hypoglycaemia

10.21203/rs.3.rs-55915/v2 ◽

2021 ◽

Author(s):

Matthias Hepprich ◽

Marc Y Donath ◽

Lars G Hemkens

Keyword(s):

Quality Of Life ◽

Bariatric Surgery ◽

Clinical Trial ◽

Primary Outcome ◽

Evidence Based ◽

Core Outcome ◽

Online Questionnaire ◽

Core Outcome Sets ◽

German Speaking

Abstract Background: Bariatric surgery may lead to symptomatic postprandial hypoglycaemia as a major side effect without established therapy so far. We aimed to develop an evidence-based study design of a clinical trial that tests treatment options and can provide useful patient-relevant evidence.Methods: We searched systematically for guidance of core outcome sets to determine the most relevant types of outcomes and duration of such a trial. Our search comprised literature databases, a database of core outcome sets and self-help organizations. We then developed a simple online questionnaire based on interviews with German-speaking patients with postprandial hypoglycaemia after bariatric surgery. We recruited participants by reaching out to all German speaking endocrinologists in Switzerland and large Swiss bariatric centres. We asked for preferences regarding outcome types and acceptable duration of being included in a corresponding clinical trial.Results: The literature search did not identify evidence-based guidance for informing our study design. Experience of clinical and research routine as well as patient interviews helped in identifying potential outcomes and the design of an online questionnaire. Therein, a total of 29 persons started the questionnaire and 22 answered questions related to the primary outcome. Of these, 17 (77.3%) deemed quality of life more relevant as primary outcome than the rate of hypoglycaemic episodes. A trial length of four weeks or longer was regarded as acceptable for 19 of 21 respondents to this question (91.4 %) and of six months or longer for 12 respondents (56 %). Conclusions: In situations with no other guidance, a simple questionnaire may help to inform trial design decisions. This study identifies a patient preference for “quality of life” as a primary outcome and supports the evidence-based conception of a patient-centred clinical trial in postbariatric hypoglycaemia.

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Patient Involvement to Inform the Design of a Clinical Trial in Postbariatric Hypoglycemia

10.21203/rs.3.rs-55915/v1 ◽

2020 ◽

Author(s):

Matthias Hepprich ◽

Marc Y Donath ◽

Lars G Hemkens

Keyword(s):

Quality Of Life ◽

Bariatric Surgery ◽

Clinical Trial ◽

Primary Outcome ◽

Evidence Based ◽

Core Outcome ◽

Online Questionnaire ◽

Core Outcome Sets ◽

German Speaking

Abstract Background: Bariatric surgery may lead to symptomatic postprandial hypoglycemia as a major side effect without established therapy so far. We aimed to develop an evidence-based study design of a clinical trial that tests treatment options and can provide useful patient-relevant evidence.Methods: We searched systematically for guidance of core outcome sets to determine the most relevant types of outcomes and duration of such a trial. Our search comprised literature databases, a database of core outcome sets and self-help organizations. We then developed a simple online questionnaire based on interviews with German-speaking patients with postprandial hypoglycemia after bariatric surgery. We recruited participants by reaching out to all German speaking endocrinologists in Switzerland and large Swiss bariatric centers. We asked for preferences regarding outcome types and acceptable duration of being included in a corresponding clinical trial.Results: The systematic search did not identify evidence-based guidance for informing our study design. Experience of clinical and research routine as well as patient interviews helped in identifying potential outcomes and the design of an online questionnaire. Therein, a total of 29 persons started the questionnaire and 22 answered questions related to the primary outcome. Of these, 17 (77.3%) deemed quality of life more relevant as primary outcome than the rate of hypoglycemic episodes. A trial length of four weeks or longer was regarded as acceptable for 19 of 21 respondents to this question (91.4 %) and of six months or longer for 12 respondents (56 %). Conclusions: In situations with no other guidance, a simple questionnaire may help to inform trial design decisions. This study identifies a patient preference for “quality of life” as a primary outcome and supports the evidence-based conception of a patient-centered clinical trial in postbariatric hypoglycemia.

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Entwicklung und Anwendung der Lebensqualitätserfassung in der Dermatologie

Karger Kompass Dermatologie ◽

10.1159/000505472 ◽

2020 ◽

Vol 8 (1) ◽

pp. 6-10 ◽

Cited By ~ 1

Author(s):

Pavel V. Chernyshov

Keyword(s):

Quality Of Life ◽

Klinische Studien ◽

Dermatology Life Quality Index ◽

Quality Index ◽

Life Quality ◽

Core Outcome ◽

Core Outcome Sets ◽

Life Quality Index

Die Entwicklung des Dermatology Life Quality Index (DLQI) Fragebogens erleichterte die Durchführung zahlreicher Studien zu den Auswirkungen von Hautkrankheiten auf die Lebensqualität (quality of life, QoL) der Patienten. Viele nationale und internationale Leitlinien empfehlen die Erfassung der Lebensqualität in der Dermatologie und einige enthalten detaillierte Empfehlungen zu den Behandlungszielen und Änderungen von Behandlungsansätzen entsprechend den DLQI-Score-Gruppen und dem geringsten klinisch relevanten Unterschied. Die Methoden zur Entwicklung und Validierung von QoL-Instrumenten werden kontinuierlich strenger. Initiativen zur Auswahl von Core Outcome Sets für Hautkrankheiten sind auf klinische Studien ausgerichtet, können aber auch für Kliniker hilfreich sein. Die Verwendung von QoL-Daten in der klinischen Praxis ist mit verschiedenen Vorteilen verbunden, doch liegen derzeit nur sehr begrenzte Erfahrungen damit vor. Die Erfassung der Lebensqualität in der Dermatologie entwickelt sich rasant und verlagert sich allmählich von der Theorie in die Praxis.

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Core outcome set for three ophthalmic conditions: a healthcare professional and patient consensus on core outcome sets for amblyopia, ocular motility and strabismus (COSAMS Study)

BMJ Open ◽

10.1136/bmjopen-2020-042403 ◽

2021 ◽

Vol 11 (5) ◽

pp. e042403

Author(s):

Samiya Al-Jabri ◽

Fiona J Rowe ◽

Jamie J Kirkham

Keyword(s):

Healthcare Professionals ◽

Core Outcome Set ◽

Routine Clinical Practice ◽

Ocular Motility ◽

Core Outcome ◽

Core Outcome Sets ◽

The Core ◽

Outcome Set ◽

Core Outcomes

ObjectivesAmblyopia, strabismus and ocular motility disorders are common conditions with significant impact on visual function, appearance and quality of life. We aimed to establish a core set of outcomes for each of the three conditions for use in clinical trials and routine clinical practice.DesignA comprehensive databank of outcomes was developed from a systematic review of the literature and a series of focus groups with healthcare professionals, researchers, patients and carers. The databank of outcomes was scored in a two-round Delphi Survey completed by two stakeholder groups: healthcare professionals/researchers and patients/carers. Results of the online Delphi were discussed at a face-to-face consensus meeting where the core outcome sets were finalised.SettingUK-wide consultation.ParticipantsResearchers, clinicians, patients and carers.Outcome measuresCore outcome sets.ResultsFor amblyopia, strabismus and ocular motility, 40/42/33 participants contributed to both rounds of the Delphi; six/nine/seven members attended consensus meetings, respectively. Consensus was reached on ten core outcomes for both amblyopia and ocular motility and nine for strabismus. All three conditions shared the core outcomes: adverse events, cost, vision-related quality of life and ocular alignment. The strabismus and ocular motility disorder core sets included, in addition, measuring the deviation, binocular vision, ocular movement, patient satisfaction and symptoms. The amblyopia set, distinct from the sets for the other two conditions, included best corrected distance and near visual acuity, spherical and cylindrical refraction, compliance and treatment-related and functionality/long-term impacts.ConclusionsThe study used robust consensus methods to develop a core outcome set for three ophthalmic conditions. Implementation of these core outcome sets in clinical trials and routine clinical practice will ensure that the outcomes being measured and reported are relevant to all stakeholders. This will enhance the relevance of study findings and enable comparison of results from different studies.

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