COMET Studies

Selecting Core Outcomes for Randomised Effectiveness trials in Type 2 diabetes (SCORE-IT): A patient and healthcare professional consensus on a core outcome set for type 2 diabetes

Mon, 13 Jan 2020 15:05:13 GMT

Objectives Heterogeneity in outcomes measured across trials of glucose-lowering interventions for people with type 2 diabetes impacts on the ability to compare findings and may mean that the results have little importance to healthcare professionals and the patients that they care for. The SCORE-IT study (Selecting Core Outcomes for Randomised Effectiveness trials In Type 2 diabetes) has addressed this issue by establishing consensus on the most important outcomes for non-surgical interventions for hyperglycemia in type 2 diabetes. Research design and methods A comprehensive list of outcomes was developed from registered clinical trials, online patient resources, qualitative literature and long-term studies in the field. This list was then scored in a two-round online Delphi survey completed by healthcare professionals, people with type 2 diabetes, researchers in the field and healthcare policymakers. The results of this online Delphi were discussed and ratified at a face-to-face consensus meeting. Results 173 people completed both rounds of the online survey (116 people with type 2 diabetes, 37 healthcare professionals, 14 researchers and 6 policymakers), 20 of these attended the consensus meeting (13 people with type 2 diabetes and 7 healthcare professionals). Consensus was reached on 18 core outcomes across five domains, which include outcomes related to diabetes care, quality of life and long-term diabetes-related complications. Conclusions Implementation of the core outcome set in future trials will ensure that outcomes of importance to all stakeholders are measured and reported, enhancing the relevance of trial findings and facilitating the comparison of results across trials. © © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.

Primary Outcome Measures in Pediatric Septic Shock Trials: A Systematic Review

Mon, 13 Jan 2020 14:55:41 GMT

OBJECTIVE: To evaluate all published pediatric randomized controlled trials of patients with septic shock from any cause to examine the outcome measures used, the strengths and limitations of these measurements and whether the trial outcomes met feasibility criteria. DATA SOURCES: We used a previously published database of pediatric critical care randomized controlled trials (PICUtrials.net) derived from searches of MEDLINE, EMBASE, LILACS, and CENTRAL. STUDY SELECTION: We included randomized controlled trials of interventions to children admitted to a PICU with septic or dengue hemorrhagic shock which were published in English. DATA EXTRACTION: Study characteristics and outcomes were retrieved by two independent reviewers with disagreement being resolved by a third reviewer. We defined feasibility as 1) recruitment of at least 90% of the targeted sample size and agreement of the observed outcome rate in the control group with the rate used for the sample size calculation to within 10% or 2) finding of a statistically significant difference in an interim or final analysis. DATA SYNTHESIS: Nineteen of 321 identified articles were selected for review. Fourteen of 19 studies (74%) provided an a priori definition of their primary outcome measure in their "Methods section." Mortality rate was the most commonly reported primary outcome (8/14; 57%), followed by duration of shock (4/14; 29%) followed by organ failure (1/14; 7%). Only three of 19 included trials met feasibility criteria. CONCLUSIONS: Our review found that use of mortality alone as a primary outcome in pediatric septic shock trials was associated with significant limitations and that long-term patient-centered outcomes were not used in this setting. Composite outcomes incorporating mortality and long-term outcomes should be explored for use in future pediatric septic shock trials.

Quality of core outcome sets in maternal and newborn health – a systematic review protocol

Mon, 13 Jan 2020 14:41:10 GMT

Significant variation exists in outcomes reported in clinical trials related to maternal and neonatal care. Variation in outcome definitions and measurement limits accurate conclusions regarding safety, and clinical effectiveness of maternity-related treatments, interventions, and care procedures. Previous work in the area of Womens Health conducted by Duffy and colleagues in 2017 identified 49 core outcome set registry records and four completed COS, three maternity specific. Lack of a formal quality assessment tool inhibited the ability to draw conclusions regarding whether appropriate methods had been used to develop the COS. Outcome generation represents the first step in the standardisation of outcomes. Once a COS is agreed, it is then important to determine how the outcomes included in the set should be defined and measured. Without harmonisation of how to measurement outcomes, ongoing variation may continue. Currently little is known regarding concordance of outcomes, definitions or measurement between similar maternity and newborn COS. This review build on previous work to identify all maternity and neonatal core outcome sets. It is anticipated that many of the ongoing projects identified by Duffy will now be complete. Further, the recent publication of minimum standards for COS development offers the opportunity to formally assess COS. Review aims: (1) To evaluate the quality of maternity and neonatal core outcome sets, and (2) Develop a baseline for maternity and neonatal care COS standard of development Research questions: (1) Do maternity and neonatal COS meet minimum standards for development? (2) What is the extent of concordance in regard to maternal and neonatal outcomes recommended between COS?

Developing a core outcome set for distal tibia and ankle fractures (COSTA)

Mon, 13 Jan 2020 14:21:16 GMT

Accurate assessment of important outcomes provides essential evidence for judging the value and effectiveness of care. However, in distal tibia and ankle fractures, there is limited outcome reporting guidance. Heterogeneity in reporting and limited consideration of important patient outcomes undermines data synthesis and impedes the developing evidence base. The aim of this project is to develop a core outcome set for distal tibia and ankle fractures (COSTA). The study will be supported by an interdisciplinary research team, wider international advisory group and a patient research partner group. Methods will include: 1. Systematic reviews of outcome reporting 2. Reviews of qualitative literature 3. Semi-structured interviews with patients 4. Focus groups with patients and professionals to generate outcome statements. This will support the identification formulation of a list of potential outcome domains. The domains will then be prioritised through an international e-Delphi process with multiple stakeholders.

Developing a Core outcome set of Traditional Chinese Medicine on Traumatic Optic Neuropathy

Mon, 13 Jan 2020 14:10:22 GMT

Traumatic optic neuropathy (TON) is an injury to the optic nerve or anterior optic system caused by injuries, often resulting in permanent visual field impairment or blindness. In clinical practice, traditional Chinese medicine plays a important role in the treatment of TON. A certain number of randomized controlled studies have been done in the treatment of TON by traditional Chinese medicine. However, the outcome indicators of TON by traditional Chinese medicine vary greatly and are not standardized, which is not conducive to meta-analysis and cannot prove the effectiveness of traditional Chinese medicine. At the same time, there may be problems with selective outcome reporting. It is very important to establish the core index set for the clinical trial of traumatic optic neuropathy of traditional Chinese medicine.

Developing a Core outcome set of Traditional Chinese Medicine on Chronic Heart Failure

Wed, 08 Jan 2020 15:24:41 GMT

Chronic heart failure (CHF) is a serious and advanced stage of various cardiovascular diseases and portends poor prognosis. The prevalence of CHF is rising with the aging population and changes in lifestyle habits. China has an incidence rate of approximately 0.9% in HF, with 500,000 new HF patients being diagnosed every year and the mortality of CHF in five years is as high as 60% - 80%. Traditional Chinese Medicine (TCM) is commonly used for treating CHF in China, improving clinical symptoms and health status on the premise of long-term survival. However, the heterogeneous reporting of outcomes in these clinical trials lack consistency and transparency, making it difficult to compare the effectiveness of various trials during meta-analysis synthesis. Furthermore, there exist a risk of selective outcome reporting bias in these clinical trials. Developing a COS can help to overcome poor methodological quality present in clinical trials especially in the field of TCM.This research aims to establish COS for clinical trials of CHF in TCM. Following the development of a COS, the next step is to select OMIs for outcomes included in a COS. Traditional Chinese Medicine (TCM) is commonly used for treating CHF in China and has achieved improvement of clinical symptoms and health status on the premise of long-term survival. Hence, the aim of this study is to develop OMIs for a COS of TCM on chronic heart failure (CHF).

Developing a core outcome set for proximal humerus fractures (COSH)

Wed, 08 Jan 2020 15:13:22 GMT

Accurate assessment of important outcomes provides essential evidence for judging the value and effectiveness of care. However, in proximal humerus fractures, there is limited outcome reporting guidance. Heterogeneity in reporting and limited consideration of important patient outcomes undermines data synthesis and impedes the developing evidence base. The aim of this project is to develop a core outcome set for proximal humerus fractures. The study will be supported by an interdisciplinary research team, wider international advisory group and a patient research partner group. Systematic reviews of outcome reporting coupled with reviews of qualitative literature, combined with semi-structured interviews with patients will support the identification formulation of a list of potential outcome domains. The domains will then be prioritised through an international e-Delphi process with multiple stakeholders.

Constructing core outcome indicators set of on Facial palsy

Wed, 08 Jan 2020 14:56:24 GMT

Facial palsy(FP) is a clinical common facial nerve disease. Although the etiologies are different, however, once onset, it will cause expression muscle dysfunction due to local facial nerve injury. In case of injuring to sensory nerve fibers, it will lead to auditory dysfunction, gustation dysfunction and salivary secretion dysfunction. There are different treatments for different stages of disease progression. In the currently, therapeutic strategies may include pharmaceutical agents, physical therapy (PT), acupunctures and a various of surgical treatments. Due to the inconsistent clinical assessment criteria for FP, there are multifarious criterion for disease remission. Therefore, a series of accurate and effective assessment method(s) is needed, and it is necessary to establish a core outcome set (COS) for clinical trials of FP.

Developing a Core outcome set of Traditional Chinese Medicine on Lung Cancer

Wed, 08 Jan 2020 13:38:45 GMT

Lung cancer is one of the most common malignant tumors, with the incidence rate ranked top two among all other tumors, and on the rise annually. Surgical treatment has been deemed to be a reliable mean in curing and obtaining long term efficacy in early stage lung cancer, but the results are not satisfactory. The recurrence and metastasis rate of lung cancer are high. Radiotherapy and chemotherapy, though effective for some patients, have strong side effects and most of them only have palliative effect. Traditional Chinese medicine for lung cancer can be used in improving therapeutic efficacy, reducing toxicity, improving immunity of the body ,as well as improving quality of life and prolonging survival time. Relevant clinical trials increase year by year. However, the heterogeneous reporting of outcomes in these trials has hindered synthesizing clinical results in meta-analyses, which reduce the value of clinical trials. Meanwhile, it may exist risk of selective outcome reporting bias in clinical trials. Hence, developing core outcome set(COS)for clinical trials in the field of Traditional Chinese Medicine(TCM)is necessary and urgent. This research aims to establish COS for clinical trials of lung cancer in TCM.

A Systematic Review of Core Outcomes for Hypospadias Surgery

Wed, 08 Jan 2020 13:23:07 GMT

Although the outcome of hypospadias surgery requires careful scrutiny, there is little consensus on what clinical outcome parameters should be considered essential as part of routine clinical practice. To understand the extent of variation in reported outcome measures, Pubmed was searched to identify outcomes in boys with hypospadias published in the English language from 2008 to 2017. Eligibility criteria were met in 268 publications. Outcomes were inconsistently reported and only 9 (13%) were reported in more than 25% of papers. Outcome studies describing younger boys were overrepresented. Urethrocutaneous fistula was reported in about 90% of publications that included boys aged <16 years. Among younger boys meatal stenosis, dehiscence, and urethral strictures were next most frequent. In the older age groups, an increasing frequency of cosmesis, meatal shape/location, and genital skin changes was described. Outcomes reflecting sexual health, erection, and relationship status including paternity were reported in those aged >16 years. The current study identifies the range of parameters that are measured to assess outcome after hypospadias surgery. The results can be used to promote the development of an age-specific core outcome set that can be applied as a standardized assessment tool in future routine clinical settings.

A systematic review of reported outcomes and outcome measures in randomized trials evaluating surgical interventions for posterior vaginal prolapse to aid development of a core outcome set

Wed, 08 Jan 2020 13:08:03 GMT

BACKGROUND: Recent systematic reviews have demonstrated wide variations on outcome measure selection and outcome reporting in trials on surgical treatments for anterior, apical and mesh prolapse surgery. A systematic review of reported outcomes and outcome measures in posterior compartment vaginal prolapse interventions is highly warranted in the process of developing core outcome sets. OBJECTIVE: To evaluate outcome and outcome measures reporting in posterior prolapse surgical trials. SEARCH STRATEGY: We searched MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL). SELECTION CRITERIA: Randomized trials evaluating the efficacy and safety of different surgical interventions for posterior compartment vaginal prolapse. DATA COLLECTION AND ANALYSIS: Two researchers independently assessed studies for inclusion, evaluated methodological quality, and extracted relevant data. Methodological quality, outcome reporting quality and publication characteristics were evaluated. MAIN RESULTS: Twenty-seven interventional and four follow-up trials were included. Seventeen studies enrolled patients with posterior compartment surgery as the sole procedure and 14 with multicompartment procedures. Eighty-three reported outcomes and 45 outcome measures were identified. The most frequently reported outcomes were blood loss (20 studies, 74%), pain (18 studies, 66%) and infection (16 studies, 59%). CONCLUSIONS: Wide variations in reported outcomes and outcome measures were found. Until a core outcome set is established, we propose an interim core outcome set that could include the three most commonly reported outcomes of the following domains: hospitalization; intraoperative, postoperative urinary, gastrointestinal, vaginal and sexual outcomes; clinical effectiveness.

A core outcome set for problem-based learning

Wed, 08 Jan 2020 12:47:33 GMT

Objective: To develop a core outcome set (COS) for problem-based learning (PBL) in health care professions, which should assist in standardizing outcome selection, collection and reporting in future research studies. Methods: Drawing on the guidance and approaches of the Core Outcome Measures in Effectiveness Trials (COMET), this study uses a four-phase mixed-methods design: (1) Focus groups and interviews with key stakeholder groups (teachers and students) and a review of the literature will be undertaken to build a long list of outcomes; (2) Three rounds of Delphi surveys will be used with key stakeholder groups. Statements for the Delphi surveys and participation processes will be developed and informed through substantial member involvement with teachers and students in health care professions; (3) A consensus meeting will be convened with key participant groups to discuss the key findings and finalize the COS. Discussion: We hope that the COSs will lead to an improvement in the quality and consistency of research.

Establishing core outcome sets for gastrointestinal recovery in studies of postoperative ileus and small bowel obstruction

Mon, 06 Jan 2020 14:34:55 GMT

Gastrointestinal recovery describes the restoration of normal bowel function in patients receiving treatment for bowel disease. This may be prolonged in two settings. The first is postoperative ileus, characterised by reduced or uncoordinated intestinal transit. This occurs in 10-20% of patients undergoing major gastrointestinal surgery, depending on the criteria used for assessment. The second is small bowel obstruction, characterised by intestinal blockage. This is responsible for half of all emergency laparotomies in the United Kingdom and over 300,000 hospital admissions per year in North America. Whilst both represent different aetiologies, the features of gastrointestinal recovery are similar. Delayed gastrointestinal recovery is distressing for patients. It leads to painful abdominal distension, vomiting, delayed elimination, and prolonged hospital stay. It may also implicate the need for nasogastric decompression. The Association of Coloproctology in Great Britain & Ireland recently identified gastrointestinal recovery as a key research priority during a patient-clinician consensus process. Researchers are limited, however, by methodological challenges related to the definition of normal gastrointestinal function and the selection of clinical outcomes. Recently, two systematic reviews of previous literature identified 73 and 50 outcomes used to measure gastrointestinal recovery in settings of ileus and small bowel obstruction, respectively. This wide variation in reporting limits comparability between studies and is problematic for evaluating new treatments and translating these into practice. As there is considerable overlap in the features of gastrointestinal recovery between both conditions, co-development of two outcome sets with the scope to combine or segment condition-specific domains will be pursued. This represents an efficient and pragmatic approach.

Choosing important health outcomes for comparative effectiveness research: 5th annual update to a systematic review of core outcome sets for research

Thu, 19 Dec 2019 17:33:52 GMT

BACKGROUND: A systematic review of core outcome sets (COS) for research is updated annually to populate an online database. It is a resource intensive review to do annually but automation techniques have potential to aid the process. The production of guidance and standards in COS development means that there is now an expectation that COS are being developed and reported to a higher standard. This is the fifth update to the systematic review and will explore these issues. METHODS: Searches were carried out to identify studies published or indexed in 2018. Automated screening methods were used to rank the citations in order of relevance. The cut-off for screening was set to the top 25% in ranked priority order, following development and validation of the algorithm. Studies were eligible for inclusion if they reported the development of a COS, regardless of any restrictions by age, health condition or setting. COS were assessed against each of the Core Outcome Set-STAndards for Development (COS-STAD). RESULTS: Thirty studies describing the development of 44 COS were included in this update. Six COS (20%) were deemed to have met all 12 criteria representing the 11 minimum standards for COS development (range = 4 to 12 criteria, median = 10 criteria). All 30 COS studies met all four minimum standards for scope. Twenty-one (70%) COS met all three minimum standards for stakeholders. Twenty-three studies (77%) included patients with the condition or their representatives. The number of countries involved in the development of COS ranged from 1 to 39 (median = 10). Six studies (20%) met all four minimum standards [five criteria] for the consensus process. CONCLUSION: Automated ranking was successfully used to assist the screening process and reduce the workload of this systematic review update. With the provision of guidelines, COS are better reported and being developed to a higher standard.

A core outcome set for clinical trials of Frozen Shoulder

Mon, 16 Dec 2019 12:25:58 GMT

Frozen shoulder (FS) is one of the most common, yet challenging clinical disorder presenting to the Department of orthopedics and physical therapy, It is a disease characterized by a significant decrease of active and passive range of motion (ROM) of the glenohumeral joint along with pain. , seriously affecting quality of life in FS patients. At present, clinical treatment methods are diverse,Treatment modalities for FS include medication, local steroid injection, physiotherapy, hydrodistension, manipulation under anesthesia, arthroscopic capsular release, and open capsular release. However, due to the inconsistent clinical evaluation criteria for FS, lack of practicality, the remission rates of different therapies vary greatly, and the best treatment plan cannot be selected. Therefore, a series of accurate and effective assessment method(s) is needed, and it is necessary to establish a core outcome set (COS) for clinical trials of FS.

A core outcome set of traditional Chinese medicine for improving postoperative recovery in patients with breast cancer

Mon, 16 Dec 2019 12:17:28 GMT

Breast cancer is one of the most commonly diagnosed malignancies and the second most common cause of cancer-related mortality. Currently, surgery is still the main treatment strategy for breast cancer. However, patients often experience some complications after surgery. More and more traditional Chinese medicines (TCMs) have been used for postoperative rehabilitation of breast cancer patients, and have shown good prospects. However, the outcomes of clinical trials are clearly inconsistent and there is no standardized outcome set. Therefore, it is necessary to develop a core outcome set for clinical trials of TCM for improving postoperative recovery in patients with breast cancer.

Developing a Core Outcome Set for Traditional Chinese Medicine on Treatment of Hypertensive Cerebral Hemorrhage

Mon, 16 Dec 2019 12:11:06 GMT

Stroke is one of the leading causes of morbidity and mortality in both developed and developing countries, and has been the top leading cause of death in China. Traditional Chinese medicine (TCM) has a unique therapeutic effect in the treatment of hypertensive cerebral hemorrhage. However, the standardization of clinical trials limits the development of TCM on treatment of hypertensive cerebral hemorrhage, such as no accepted outcomes or indices applied for assessments, or no consensus among the varied outcomes or indices, or high risks of the selective reported bias or lots of missing data, etc. It is necessary to establish a Core Outcome Set for hypertensive cerebral hemorrhage in clinical trials of TCM.

Developing a Core Outcome Set for Traditional Chinese Medicine on Treatment of vascular cognitive dysfunction

Wed, 11 Dec 2019 12:47:30 GMT

Vascular cognitive dysfunction is one of the common complications of cerebrovascular disease, which seriously affects the rehabilitation and quality of life of patients. Cerebrovascular diseases include hemorrhagic and ischemic cerebrovascular diseases. Traditional Chinese medicine has a unique effect in the treatment of vascular cognitive dysfunction. Howevere, the standardization of clinical trials limits the development of TCM on treatment of vascular cognitive dysfunction , such as no accepted exports or indexes applied for assessments, or no concerns about the varied exports or indexes, or high risks of the selective reported bias or lots of missing data, etc. it is necessary to establish a Core outcome set for vascular cognitive dysfunction in clinical trials of TCM.

Developing a Core Outcome Set for Traditional Chinese Medicine on Treatment of tension headache

Wed, 11 Dec 2019 12:36:21 GMT

Tension headache is a common and frequently occurring clinical disease. Traditional Chinese medicine (TCM) has a unique therapeutic effect in the treatment of tension headache. However, the standardization of clinical trials limits the development of TCM on treatment of tension headache, such as no accepted outcomes or indices applied for assessments, or no consensus among the varied outcomes or indices, or high risks of the selective reported bias or lots of missing data, etc. It is necessary to establish a Core Outcome Set for for tension headache in clinical trials of TCM.

Developing a Core Outcome Set for Traditional Chinese Medicine on Treatment of cerebral infarction

Tue, 10 Dec 2019 12:29:10 GMT

Stroke is one of the leading causes of morbidity and mortality in both developed and developing countries, and has been the top leading cause of death in China. Traditional Chinese medicine (TCM) has a unique therapeutic effect in the treatment of cerebral infarction. However, the standardization of clinical trials limits the development of TCM on treatment of cerebral infarction, such as no accepted outcomes or indices applied for assessments, or no consensus among the varied outcomes or indices, or high risks of the selective reported bias or lots of missing data, etc. It is necessary to establish a Core Outcome Set for for cerebral infarction in clinical trials of TCM.