Long-term core outcomes in cauda equina syndrome

2021 ◽  
Vol 103-B (9) ◽  
pp. 1464-1471
Author(s):  
Thomas Patrick Barker ◽  
Nick Steele ◽  
Girish Swamy ◽  
Andrew Cook ◽  
Am Rai ◽  
...  
Keyword(s):  
Back Pain ◽  
Sexual Dysfunction ◽  
Autonomic Dysfunction ◽  
Core Outcome Set ◽  
Cauda Equina ◽  
Core Outcome ◽  
Lower Back ◽  
Outcome Set

Aims Cauda equina syndrome (CES) can be associated with chronic severe lower back pain and long-term autonomic dysfunction. This study assesses the recently defined core outcome set for CES in a cohort of patients using validated questionnaires. Methods Between January 2005 and December 2019, 82 patients underwent surgical decompression for acute CES secondary to massive lumbar disc prolapse at our hospital. After review of their records, patients were included if they presented with the clinical and radiological features of CES, then classified as CES incomplete (CESI) or with painless urinary retention (CESR) in accordance with guidelines published by the British Association of Spinal Surgeons. Patients provided written consent and completed a series of questionnaires. Results In total, 61 of 82 patients returned a completed survey. Their mean age at presentation was 43 years (20 to 77; SD 12.7), and the mean duration of follow-up 58.2 months (11 to 182; SD 45.3). Autonomic dysfunction was frequent: 33% of patients reported bladder dysfunction, and 10% required a urinary catheter. There was a 38% and 53% incidence of bowel and sexual dysfunction, respectively: 47% of patients reported genital numbness. A total of 67% reported significant back pain: 44% required further investigation and 10% further intervention for the management of lower back pain. Quality of life was lower than expected when corrected for age and sex. Half the patients reported moderate or worse depression, and 40% of patients of working age could no longer work due to problems attributable to CES. Urinary and faecal incontinence, catheter use, sexual dysfunction, and genital numbness were significantly more common in patients with CESR. Conclusion This study reports the long-term outcome of patients with CES and is the first to use validated patient-reported outcome measures to assess the CES Core Outcome Set. Persistent severe back pain and on-going autonomic dysfunction were frequently reported at a mean follow-up of five years. Cite this article: Bone Joint J 2021;103-B(9):1464–1471.

scholarly journals Towards core outcome set (COS) development: a follow-up descriptive survey of outcomes in Cochrane reviews

2015 ◽  
Vol 4 (1) ◽  
Author(s):  
Francesca Wuytack ◽  
Valerie Smith ◽  
Mike Clarke ◽  
Paula Williamson ◽  
Elizabeth Gargon
Keyword(s):  
Core Outcome Set ◽  
Core Outcome ◽  
Cochrane Reviews ◽  
Outcome Set ◽  
Descriptive Survey

scholarly journals Protocol for the development of a core outcome set for cauda equina syndrome: systematic literature review, qualitative interviews, Delphi survey and consensus meeting

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e024002 ◽  
Author(s):  
Nisaharan Srikandarajah ◽  
Adam J Noble ◽  
Martin Wilby ◽  
Simon Clark ◽  
Paula R Williamson ◽  
...  
Keyword(s):  
Literature Review ◽  
Systematic Literature Review ◽  
Cauda Equina Syndrome ◽  
Qualitative Interviews ◽  
Core Outcome Set ◽  
Cauda Equina ◽  
Consensus Meeting ◽  
Core Outcome ◽  
The Core ◽  
Outcome Set

IntroductionCauda equina syndrome (CES) is a serious neurological condition most commonly due to compression of the lumbosacral nerve roots, which can result in significant disability. The evidence for acute intervention in CES is mainly from retrospective studies. There is heterogeneity in the outcomes chosen for analysis in these studies, which makes it difficult to synthesise the data across studies. This study will develop a core outcome set for use in future studies of CES, engaging with key stakeholders and using transparent methodology. This will help ensure that relevant outcomes are used in future and will facilitate attempts to summarise data across studies in systematic reviews.Methods and analysisA systematic literature review will document all the outcomes for CES after surgery mentioned in the literature. The qualitative interviews with patients with CES will be semistructured, audio recorded, transcribed and thematically analysed with the use of NVivo V.10 to identify outcomes and determine the themes described. The outcomes from the literature review and patient interviews will be combined and prioritised to determine what the most important outcomes are in CES research studies to patients and healthcare professionals. The prioritisation will be done through a two-round iterative Delphi survey and a consensus meeting. This process will decide the core outcome set for patients with CES.Ethics and disseminationREC and HRA approval was obtained on the 6/12/16 for the qualitative interviews from South Central—Hampshire A REC. REC reference 16/SC/0587. REC and HRA approval was obtained on 26/3/18 for the Delphi process and consensus meeting from North West—Greater Manchester Central REC. REC reference was 18/NW/0022. The final core outcome set will be published and freely available.Trial registration numberThis study is registered with the Core Outcome Measures in Effectiveness Trials database as study 824.

scholarly journals 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

2019 ◽  
Vol 7 (1) ◽  
pp. e000700 ◽  
Author(s):  
Nicola L Harman ◽  
John P H Wilding ◽  
Dave Curry ◽  
James Harris ◽  
Jennifer Logue ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Healthcare Professionals ◽  
Core Outcome Set ◽  
Consensus Meeting ◽  
Core Outcome ◽  
Outcome Set ◽  
Core Outcomes ◽  
Effectiveness Trials

ObjectivesHeterogeneity 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 methodsA 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.Results173 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.ConclusionsImplementation 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.

scholarly journals Development of a Core Outcome Set for Fetal MyelomenIngoCele (COSMiC): study protocol

2020 ◽  
Author(s):  
Samar Altoukhi ◽  
Clare L Whitehead ◽  
Greg Ryan ◽  
Jan Deprest ◽  
Luc Joyeux ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Systematic Reviews ◽  
Core Outcome Set ◽  
Fetal Surgery ◽  
Second Phase ◽  
Core Outcome ◽  
Outcome Reporting ◽  
Ventriculoperitoneal Shunting ◽  
Outcome Set

Abstract Background: Open spina bifida (OSB) is one of the most common congenital central nervous system defects and leads to long-term physical and cognitive disabilities. Open fetal surgery for OSB improves neurological outcomes and reduces the need for ventriculoperitoneal shunting, compared to postnatal surgery, at the expense of increased prematurity. It however confers significant morbidity to the mother in the index pregnancy and potential risks to future pregnancies. Fetoscopic surgery may prevent maternal morbidity yet the question remains whether the procedure is neuroprotective and reduces prematurity. Comparison of outcomes between different treatment options is challenging due to inconsistent outcome reporting. We aim to develop and disseminate a core outcome set (COS) for fetal OSB, to ensure that outcomes relevant to all stakeholders are collected and reported in a standardised fashion in future studies. Methods: The COS will be developed using a validated Delphi methodology. A systematic literature review will be performed to identify previously reported outcomes focused on prenatally diagnosed OSB. Outcomes assessed will include maternal (primary and subsequent pregnancies), fetal, neonatal and childhood to adolescence. In a second phase, semi-structured interviews with stakeholders will be performed to ensure representation of additional relevant outcomes that may not have been reported in the literature. We will include patients and parents, as well as health professionals involved in the care of these pregnancies and children (fetal medicine specialists, fetal surgeons, neonatologists/paediatricians, and allied health). Subsequently, an international group of key stakeholders will rate the importance of the identified outcomes using three sequential, online, rounds of a modified Delphi Survey. Final agreement on outcomes to be included in the COS, their definition and measurement will be achieved through a final face-to-face consensus meeting with all stakeholder groups represented. Dissemination of the final COS will be ensured through different media and relevant societies. Discussion: Development and implementation of a COS for fetal OSB will ensure consistent outcome reporting in future clinical trials, systematic reviews, and clinical practice guidelines. This will lead to higher quality research, better evidence-based clinical practice and ultimately improved maternal, fetal and long term childhood outcomes. Trial registration: Core Outcome Measures in Effectiveness Trials (COMET): 1187. International Prospective Register of Systematic Reviews (PROSPERO): CRD42018104880.

scholarly journals Development of a Core Outcome Set for Fetal MyelomenIngoCele (COSMiC): study protocol

2020 ◽  
Author(s):  
Samar Altoukhi ◽  
Clare L Whitehead ◽  
Greg Ryan ◽  
Jan Deprest ◽  
Luc Joyeux ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Systematic Reviews ◽  
Maternal Morbidity ◽  
Core Outcome Set ◽  
Significant Risk ◽  
Second Phase ◽  
Core Outcome ◽  
Outcome Reporting ◽  
Outcome Set

Abstract Background: Open spina bifida (OSB) is one of the most common congenital central nervous system defects and leads to long-term physical and cognitive disabilities. Open fetal surgery for OSB improves neurological outcomes and reduces the need for ventriculoperitoneal shunting, compared to postnatal surgery, but is associated with a significant risk of prematurity and maternal morbidity. Fetoscopic surgery comes with less maternal morbidity yet the question remains whether the procedure is neuroprotective and reduces prematurity. Comparison of outcomes between different treatment options is challenging due to inconsistent outcome reporting. We aim to develop and disseminate a core outcome set (COS) for fetal OSB, to ensure that outcomes relevant to all stakeholders are collected and reported in a standardised fashion in future studies. Methods: The COS will be developed using a validated Delphi methodology. A systematic literature review will be performed to identify outcomes previously reported for prenatally diagnosed OSB. We will assess will maternal (primary and subsequent pregnancies), fetal, neonatal and childhood outcomes until adolescence. In a second phase, we will conduct semi-structured interviews with stakeholders, to ensure representation of additional relevant outcomes that may not have been reported in the literature. We will include patients and parents, as well as health professionals involved in the care of these pregnancies and children (fetal medicine specialists, fetal surgeons, neonatologists/paediatricians, and allied health). Subsequently, an international group of key stakeholders will rate the importance of the identified outcomes using three sequential online rounds of a modified Delphi Survey. Final agreement on outcomes to be included in the COS, their definition and measurement will be achieved through a face-to-face consensus meeting with all stakeholder groups. Dissemination of the final COS will be ensured through different media and relevant societies. Discussion: Development and implementation of a COS for fetal OSB will ensure consistent outcome reporting in future clinical trials, systematic reviews, and clinical practice guidelines. This will lead to higher quality research, better evidence-based clinical practice and ultimately improved maternal, fetal and long term childhood outcomes.Trial registration: Core Outcome Measures in Effectiveness Trials (COMET): 1187. International Prospective Register of Systematic Reviews (PROSPERO): CRD42018104880.

scholarly journals Development of a core outcome set for trials investigating the long-term management of bronchiectasis

2018 ◽  
Vol 16 ◽  
pp. 147997231880416 ◽  
Author(s):  
Maureen Spargo ◽  
Cristín Ryan ◽  
Damian Downey ◽  
Carmel Hughes
Keyword(s):  
Core Outcome Set ◽  
Delphi Panel ◽  
Core Outcome ◽  
Outcome Set ◽  
Overview Of Systematic Reviews ◽  
Outcome Selection ◽  
Accurate Comparison ◽  
Initial List ◽  
Selection Of

Heterogeneity in outcomes measured in trials limits accurate comparison of bronchiectasis studies. A core outcome set (COS) is an agreed, standardized set of outcomes that should be measured in trials for specific clinical areas. A COS for bronchiectasis could encourage consistency in future studies. An overview of systematic reviews and qualitative study on outcome selection in bronchiectasis informed an initial list of outcomes. A Delphi panel ( n = 86) rated the importance of each outcome from 1 to 9 in 3 sequential questionnaires, as a means to achieve consensus: 1–3 = ‘of limited importance’; 4–6 = ‘important, but not critical’; and 7–9 = ‘critical’. Outcomes rated ‘critical’ by ≥70% of the panel were added to the COS. Eighty-two participants responded to the first questionnaire. Attrition between each questionnaire was 5%. After 3 rounds of questioning, 18 outcomes exceeded the threshold for consensus and were included in the COS. This study has achieved consensus on 18 outcomes that should be measured in trials of interventions for bronchiectasis. Selection of the highest ranked outcomes may represent a pragmatic means for comparison. Further research is required to condense the number of outcomes selected and to determine its relevance to interventions.

scholarly journals A core outcome set for clinical trials on non-specific low back pain: study protocol for the development of a core domain set

Trials ◽  
2014 ◽  
Vol 15 (1) ◽  
Author(s):  
Alessandro Chiarotto ◽  
Caroline B Terwee ◽  
Richard A Deyo ◽  
Maarten Boers ◽  
Chung-Wei Christine Lin ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Low Back Pain ◽  
Back Pain ◽  
Study Protocol ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Low Back ◽  
Core Domain ◽  
Outcome Set ◽  
Core Domain Set

scholarly journals Cauda Equina Syndrome Core Outcome Set (CESCOS): An international patient and healthcare professional consensus for research studies

PLoS ONE ◽  
2020 ◽  
Vol 15 (1) ◽  
pp. e0225907
Author(s):  
Nisaharan Srikandarajah ◽  
Adam Noble ◽  
Simon Clark ◽  
Martin Wilby ◽  
Brian J. C. Freeman ◽  
...  
Keyword(s):  
Healthcare Professional ◽  
Cauda Equina Syndrome ◽  
Core Outcome Set ◽  
Cauda Equina ◽  
Core Outcome ◽  
Outcome Set ◽  
Research Studies

scholarly journals Patient priorities in relation to surgery for gastric cancer: qualitative interviews with gastric cancer surgery patients to inform the development of a core outcome set

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e034782
Author(s):  
Bilal Alkhaffaf ◽  
Jane M Blazeby ◽  
Iain A Bruce ◽  
Rebecca L Morris
Keyword(s):  
Gastric Cancer ◽  
Cancer Survival ◽  
Qualitative Interviews ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Curative Intent ◽  
Surgical Trials ◽  
Cancer Support ◽  
Outcome Set

ObjectiveThe reporting of outcomes in surgical trials for gastric cancer is inconsistent. The GASTROS study (GAstric CancerSurgeryTRialsReportedOutcomeStandardisation) aims to address this by developing a core outcome set (COS) for use in all future trials within this field. A COS should reflect the views of all stakeholders, including patients. We undertook a series of interviews to identify outcomes important to patients which would be considered for inclusion in a COS.SettingAll interviews took place within the UK. Interviews were carried out face-to-face at hospitals and cancer support centres or via the telephone.ParticipantsTwenty participants at varying stages of recovery following surgery for gastric cancer with curative intent.DesignQualitative design using semistructured interviews, supported by an interview guide which was iteratively modified; thematic analysis was used to explore patient priorities.ResultsSix themes enveloping 38 outcomes were identified; surviving and controlling cancer, technical aspects of surgery, adverse events from surgery, recovering from surgery, long-term problems following surgery and long-term life impact of surgery. The ‘most important’ patient priority was to be ‘cured of cancer’.ConclusionSurgical trials for gastric cancer should consider broader priorities of patients when choosing which outcomes to report. This study highlighted the importance of longer-term outcomes such as cancer survival. Outcomes identified in this study will be used to inform an international Delphi survey to develop a COS in this field.

scholarly journals Development of a Core outcome set for fetal Myelomeningocele (COSMiC): study protocol

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Samar Altoukhi ◽  
Clare L. Whitehead ◽  
Greg Ryan ◽  
Jan Deprest ◽  
Luc Joyeux ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Systematic Reviews ◽  
Maternal Morbidity ◽  
Core Outcome Set ◽  
Second Phase ◽  
Core Outcome ◽  
Outcome Reporting ◽  
Link Type ◽  
Outcome Set

Abstract Background Open spina bifida (OSB) is one of the most common congenital central nervous system defects and leads to long-term physical and cognitive disabilities. Open fetal surgery for OSB improves neurological outcomes and reduces the need for ventriculoperitoneal shunting, compared to postnatal surgery, but is associated with a significant risk of prematurity and maternal morbidity. Fetoscopic surgery comes with less maternal morbidity, yet the question remains whether the procedure is neuroprotective and reduces prematurity. Comparison of outcomes between different treatment options is challenging due to inconsistent outcome reporting. We aim to develop and disseminate a core outcome set (COS) for fetal OSB, to ensure that outcomes relevant to all stakeholders are collected and reported in a standardised fashion in future studies. Methods The COS will be developed using a validated Delphi methodology. A systematic literature review will be performed to identify outcomes previously reported for prenatally diagnosed OSB. We will assess maternal (primary and subsequent pregnancies), fetal, neonatal and childhood outcomes until adolescence. In a second phase, we will conduct semi-structured interviews with stakeholders, to ensure representation of additional relevant outcomes that may not have been reported in the literature. We will include patients and parents, as well as health professionals involved in the care of these pregnancies and children (fetal medicine specialists, fetal surgeons, neonatologists/paediatricians and allied health). Subsequently, an international group of key stakeholders will rate the importance of the identified outcomes using three sequential online rounds of a modified Delphi Survey. Final agreement on outcomes to be included in the COS, their definition and measurement will be achieved through a face-to-face consensus meeting with all stakeholder groups. Dissemination of the final COS will be ensured through different media and relevant societies. Discussion Development and implementation of a COS for fetal OSB will ensure consistent outcome reporting in future clinical trials, systematic reviews and clinical practice guidelines. This will lead to higher quality research, better evidence-based clinical practice and ultimately improved maternal, fetal and long-term childhood outcomes. Trial registration International Prospective Register of Systematic Reviews (PROSPERO) CRD42018104880. Registered on December 5, 2018. Core Outcome Measures in Effectiveness Trials (COMET): 1187

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