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Gastroenterology Apr 2021The Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) initiative of the International Organization for the Study of Inflammatory Bowel Diseases...
STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD.
BACKGROUND
The Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) initiative of the International Organization for the Study of Inflammatory Bowel Diseases (IOIBD) has proposed treatment targets in 2015 for adult patients with inflammatory bowel disease (IBD). We aimed to update the original STRIDE statements for incorporating treatment targets in both adult and pediatric IBD.
METHODS
Based on a systematic review of the literature and iterative surveys of 89 IOIBD members, recommendations were drafted and modified in 2 surveys and 2 voting rounds. Consensus was reached if ≥75% of participants scored the recommendation as 7 to 10 on a 10-point rating scale.
RESULTS
In the systematic review, 11,278 manuscripts were screened, of which 435 were included. The first IOIBD survey identified the following targets as most important: clinical response and remission, endoscopic healing, and normalization of C-reactive protein/erythrocyte sedimentation rate and calprotectin. Fifteen recommendations were identified, of which 13 were endorsed. STRIDE-II confirmed STRIDE-I long-term targets of clinical remission and endoscopic healing and added absence of disability, restoration of quality of life, and normal growth in children. Symptomatic relief and normalization of serum and fecal markers have been determined as short-term targets. Transmural healing in Crohn's disease and histological healing in ulcerative colitis are not formal targets but should be assessed as measures of the remission depth.
CONCLUSIONS
STRIDE-II encompasses evidence- and consensus-based recommendations for treat-to-target strategies in adults and children with IBD. This frameworkshould be adapted to individual patients and local resources to improve outcomes.
Topics: Adolescent; Adolescent Development; Adult; Age Factors; Biomarkers; Child; Child Development; Colitis, Ulcerative; Consensus; Crohn Disease; Delphi Technique; Endpoint Determination; Humans; Quality of Life; Remission Induction; Research Design; Treatment Outcome; Wound Healing
PubMed: 33359090
DOI: 10.1053/j.gastro.2020.12.031 -
Zeitschrift Fur Evidenz, Fortbildung... Aug 2022Delphi techniques are conducted across different subfields in the health sciences. The reporting practices of studies using Delphi techniques vary, and current reporting... (Review)
Review
BACKGROUND
Delphi techniques are conducted across different subfields in the health sciences. The reporting practices of studies using Delphi techniques vary, and current reporting guidelines for Delphi techniques focus on individual subfields of the health sciences or on different aspects of research and are therefore of limited applicability. The aim of this article was to identify similarities, differences, and possible shortcomings of existing Delphi reporting guidelines and to draft an initial proposal for a comprehensively applicable reporting guideline.
METHODS
A systematic literature search for reporting guidelines on Delphi studies was performed in existing data resources based on databases in the health sciences (Scopus, MEDLINE, CINAHL, Epistemonikos) including publications from 2016 to 2021. In June 2021, we conducted an additional search in PubMed and included further studies by contacting experts of the scientific Delphi expert network (DeWiss). Title and abstract screening of articles was performed, followed by a full-text screening of the articles included. We qualitatively and quantitatively evaluated, compared and contrasted the reporting guidelines identified using content analysis and discussed the results among the members of the Delphi expert network.
RESULTS
We retrieved ten health science articles with reporting guidelines for Delphi studies. In analyzing them, we identified nine main categories (Justification, Expert panel, Questionnaire, Survey design, Process regulation, Analyses, Results, Discussion, Methods reflection & Ethics). The current reporting guidelines vary significantly, with only the aspect of consensus appearing in all of them. Frequency distributions show that most of the subcategories are only addressed in individual articles (e.g., meeting of participants, proceeding with the survey method, transfer of the results, validation, prevention of bias) and that epistemological foundations of the Delphi technique are rarely mentioned or reflected on. We drafted an initial proposal for Delphi reporting guidelines for the health science sector.
DISCUSSION
A well-justified position concerning epistemological foundations of Delphi studies is necessary to make the quality of the process assessable and, along with the reporting of the process, to classify and compare study results. This will increase the acceptance of both the method in the health science sector and the results in medical practice. A Delphi reporting guideline must, above all, take into account the diversity of variants, subfield-related objectives and application areas, and their modifications of the Delphi technique in order to be comprehensively applicable in the health sciences.
CONCLUSION
The results of our methodological review do not provide a final reporting guideline. The newly developed proposal is intended to encourage discussion and agreement in further analyses.
Topics: Consensus; Delphi Technique; Germany; Humans; Research Design; Research Report
PubMed: 35718726
DOI: 10.1016/j.zefq.2022.04.025 -
European Journal of Surgical Oncology :... Dec 2020Enhanced recovery after surgery (ERAS) pathways have been shown to considerably reduce complications, length of stay and costs after most of surgical procedures by...
Guidelines for Perioperative Care in Cytoreductive Surgery (CRS) with or without hyperthermic IntraPEritoneal chemotherapy (HIPEC): Enhanced recovery after surgery (ERAS®) Society Recommendations - Part I: Preoperative and intraoperative management.
BACKGROUND
Enhanced recovery after surgery (ERAS) pathways have been shown to considerably reduce complications, length of stay and costs after most of surgical procedures by standardised application of best evidence-based perioperative care. The aim was to elaborate dedicated recommendations for cytoreductive surgery (CRS) ± hyperthermic intraperitoneal chemotherapy (HIPEC) in a two-part series of guidelines based on expert consensus. The present part I of the guidelines highlights preoperative and intraoperative management.
METHODS
The core group assembled a multidisciplinary panel of 24 experts involved in peritoneal surface malignancy surgery representing the fields of general surgery (n = 12), gynaecological surgery (n = 6), and anaesthesia (n = 6). Experts systematically reviewed and summarized the available evidence on 72 identified perioperative care items, following the GRADE (grading of recommendations, assessment, development, evaluation) system. Final consensus (defined as ≥50%, or ≥70% of weak/strong recommendations combined) was reached by a standardised 2-round Delphi process, regarding the strength of recommendations.
RESULTS
Response rates were 100% for both Delphi rounds. Quality of evidence was evaluated high, moderate low and very low, for 15 (21%), 26 (36%), 29 (40%) and 2 items, respectively. Consensus was reached for 71/72(98.6%) items. Strong recommendations were defined for 37 items, No consensus could be reached regarding the preemptive use of fresh frozen plasma.
CONCLUSION
The present ERAS recommendations for CRS±HIPEC are based on a standardised expert consensus process providing clinicians with valuable guidance. There is an urgent need to produce high quality studies for CRS±HIPEC and to prospectively evaluate recommendations in clinical practice.
Topics: Cytoreduction Surgical Procedures; Delphi Technique; Enhanced Recovery After Surgery; Humans; Hyperthermic Intraperitoneal Chemotherapy; Intraoperative Care; Perioperative Care; Peritoneal Neoplasms; Preoperative Care
PubMed: 32873454
DOI: 10.1016/j.ejso.2020.07.041 -
Journal of Clinical Oncology : Official... Jun 2020To develop recommendations concerning the management of male breast cancer.
PURPOSE
To develop recommendations concerning the management of male breast cancer.
METHODS
ASCO convened an Expert Panel to develop recommendations based on a systematic review and a formal consensus process.
RESULTS
Twenty-six descriptive reports or observational studies met eligibility criteria and formed the evidentiary basis for the recommendations.
RECOMMENDATIONS
Many of the management approaches used for men with breast cancer are like those used for women. Men with hormone receptor-positive breast cancer who are candidates for adjuvant endocrine therapy should be offered tamoxifen for an initial duration of five years; those with a contraindication to tamoxifen may be offered a gonadotropin-releasing hormone agonist/antagonist plus aromatase inhibitor. Men who have completed five years of tamoxifen, have tolerated therapy, and still have a high risk of recurrence may be offered an additional five years of therapy. Men with early-stage disease should not be treated with bone-modifying agents to prevent recurrence, but could still receive these agents to prevent or treat osteoporosis. Men with advanced or metastatic disease should be offered endocrine therapy as first-line therapy, except in cases of visceral crisis or rapidly progressive disease. Targeted systemic therapy may be used to treat advanced or metastatic cancer using the same indications and combinations offered to women. Ipsilateral annual mammogram should be offered to men with a history of breast cancer treated with lumpectomy regardless of genetic predisposition; contralateral annual mammogram may be offered to men with a history of breast cancer and a genetic predisposing mutation. Breast magnetic resonance imaging is not recommended routinely. Genetic counseling and germline genetic testing of cancer predisposition genes should be offered to all men with breast cancer.
Topics: Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms, Male; Chemotherapy, Adjuvant; Consensus; Delphi Technique; Evidence-Based Medicine; Genetic Counseling; Genetic Testing; Humans; Magnetic Resonance Imaging; Male; Mammography; Mastectomy; Medical Oncology; Predictive Value of Tests; Treatment Outcome
PubMed: 32058842
DOI: 10.1200/JCO.19.03120 -
The Lancet. Psychiatry Jan 2021A major barrier to improving care effectiveness for mental health is a lack of consensus on outcomes measurement. The International Consortium for Health Outcomes...
A major barrier to improving care effectiveness for mental health is a lack of consensus on outcomes measurement. The International Consortium for Health Outcomes Measurement (ICHOM) has already developed a consensus-based standard set of outcomes for anxiety and depression in adults (including the Patient Health Questionnaire-9, the Generalised Anxiety Disorder 7-item Scale, and the WHO Disability Schedule). This Position Paper reports on recommendations specifically for anxiety, depression, obsessive-compulsive disorder, and post-traumatic stress disorder in children and young people aged between 6 and 24 years. An international ICHOM working group of 27 clinical, research, and lived experience experts formed a consensus through teleconferences, an exercise using an adapted Delphi technique (a method for reaching group consensus), and iterative anonymous voting, supported by sequential research inputs. A systematic scoping review identified 70 possible outcomes and 107 relevant measurement instruments. Measures were appraised for their feasibility in routine practice (ie, brevity, free availability, validation in children and young people, and language translation) and psychometric performance (ie, validity, reliability, and sensitivity to change). The final standard set recommends tracking symptoms, suicidal thoughts and behaviour, and functioning as a minimum through seven primarily patient-reported outcome measures: the Revised Children's Anxiety and Depression Scale, the Obsessive Compulsive Inventory for Children, the Children's Revised Impact of Events Scale, the Columbia Suicide Severity Rating Scale, the KIDSCREEN-10, the Children's Global Assessment Scale, and the Child Anxiety Life Interference Scale. The set's recommendations were validated through a feedback survey involving 487 participants across 45 countries. The set should be used alongside the anxiety and depression standard set for adults with clinicians selecting age-appropriate measures.
Topics: Adolescent; Anxiety; Child; Consensus; Depression; Humans; Internationality; Obsessive-Compulsive Disorder; Psychometrics; Sickness Impact Profile; Stress Disorders, Post-Traumatic; Treatment Outcome; Young Adult
PubMed: 33341172
DOI: 10.1016/S2215-0366(20)30356-4 -
The British Journal of Surgery May 2021Lynch syndrome is the most common genetic predisposition for hereditary cancer but remains underdiagnosed. Large prospective observational studies have recently...
BACKGROUND
Lynch syndrome is the most common genetic predisposition for hereditary cancer but remains underdiagnosed. Large prospective observational studies have recently increased understanding of the effectiveness of colonoscopic surveillance and the heterogeneity of cancer risk between genotypes. The need for gene- and gender-specific guidelines has been acknowledged.
METHODS
The European Hereditary Tumour Group (EHTG) and European Society of Coloproctology (ESCP) developed a multidisciplinary working group consisting of surgeons, clinical and molecular geneticists, pathologists, epidemiologists, gastroenterologists, and patient representation to conduct a graded evidence review. The previous Mallorca guideline format was used to revise the clinical guidance. Consensus for the guidance statements was acquired by three Delphi voting rounds.
RESULTS
Recommendations for clinical and molecular identification of Lynch syndrome, surgical and endoscopic management of Lynch syndrome-associated colorectal cancer, and preventive measures for cancer were produced. The emphasis was on surgical and gastroenterological aspects of the cancer spectrum. Manchester consensus guidelines for gynaecological management were endorsed. Executive and layperson summaries were provided.
CONCLUSION
The recommendations from the EHTG and ESCP for identification of patients with Lynch syndrome, colorectal surveillance, surgical management of colorectal cancer, lifestyle and chemoprevention in Lynch syndrome that reached a consensus (at least 80 per cent) are presented.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Chemoprevention; Colonoscopy; Colorectal Neoplasms, Hereditary Nonpolyposis; Delphi Technique; Digestive System Surgical Procedures; Early Detection of Cancer; Female; Genetic Carrier Screening; Genetic Testing; Genital Neoplasms, Female; Humans; Life Style; Prophylactic Surgical Procedures
PubMed: 34043773
DOI: 10.1002/bjs.11902 -
Chest Aug 2023Respiratory failure is a significant concern in neuromuscular diseases (NMDs). This CHEST guideline examines the literature on the respiratory management of patients...
BACKGROUND
Respiratory failure is a significant concern in neuromuscular diseases (NMDs). This CHEST guideline examines the literature on the respiratory management of patients with NMD to provide evidence-based recommendations.
STUDY DESIGN AND METHODS
An expert panel conducted a systematic review addressing the respiratory management of NMD and applied the Grading of Recommendations, Assessment, Development, and Evaluations approach for assessing the certainty of the evidence and formulating and grading recommendations. A modified Delphi technique was used to reach a consensus on the recommendations.
RESULTS
Based on 128 studies, the panel generated 15 graded recommendations, one good practice statement, and one consensus-based statement.
INTERPRETATION
Evidence of best practices for respiratory management in NMD is limited and is based primarily on observational data in amyotrophic lateral sclerosis. The panel found that pulmonary function testing every 6 months may be beneficial and may be used to initiate noninvasive ventilation (NIV) when clinically indicated. An individualized approach to NIV settings may benefit patients with chronic respiratory failure and sleep-disordered breathing related to NMD. When resources allow, polysomnography or overnight oximetry can help to guide the initiation of NIV. The panel provided guidelines for mouthpiece ventilation, transition to home mechanical ventilation, salivary secretion management, and airway clearance therapies. The guideline panel emphasizes that NMD pathologic characteristics represent a diverse group of disorders with differing rates of decline in lung function. The clinician's role is to add evaluation at the bedside to shared decision-making with patients and families, including respect for patient preferences and treatment goals, considerations of quality of life, and appropriate use of available resources in decision-making.
Topics: Humans; Quality of Life; Respiration, Artificial; Noninvasive Ventilation; Respiratory Insufficiency; Physicians
PubMed: 36921894
DOI: 10.1016/j.chest.2023.03.011 -
Fertility and Sterility Jan 2021Can the priorities for future research in infertility be identified?
STUDY QUESTION
Can the priorities for future research in infertility be identified?
SUMMARY ANSWER
The top 10 research priorities for the four areas of male infertility, female and unexplained infertility, medically assisted reproduction, and ethics, access, and organization of care for people with fertility problems were identified.
WHAT IS KNOWN ALREADY
Many fundamental questions regarding the prevention, management, and consequences of infertility remain unanswered. This is a barrier to improving the care received by those people with fertility problems.
STUDY DESIGN, SIZE, DURATION
Potential research questions were collated from an initial international survey, a systematic review of clinical practice guidelines, and Cochrane systematic reviews. A rationalized list of confirmed research uncertainties was prioritized in an interim international survey. Prioritized research uncertainties were discussed during a consensus development meeting. Using a formal consensus development method, the modified nominal group technique, diverse stakeholders identified the top 10 research priorities for each of the categories male infertility, female and unexplained infertility, medically assisted reproduction, and ethics, access, and organization of care.
PARTICIPANTS/MATERIALS, SETTING, METHODS
Healthcare professionals, people with fertility problems, and others (healthcare funders, healthcare providers, healthcare regulators, research funding bodies and researchers) were brought together in an open and transparent process using formal consensus methods advocated by the James Lind Alliance.
MAIN RESULTS AND THE ROLE OF CHANCE
The initial survey was completed by 388 participants from 40 countries, and 423 potential research questions were submitted. Fourteen clinical practice guidelines and 162 Cochrane systematic reviews identified a further 236 potential research questions. A rationalized list of 231 confirmed research uncertainties were entered into an interim prioritization survey completed by 317 respondents from 43 countries. The top 10 research priorities for each of the four categories male infertility, female and unexplained infertility (including age-related infertility, ovarian cysts, uterine cavity abnormalities, and tubal factor infertility), medically assisted reproduction (including ovarian stimulation, IUI, and IVF), and ethics, access, and organization of care, were identified during a consensus development meeting involving 41 participants from 11 countries. These research priorities were diverse and seek answers to questions regarding prevention, treatment, and the longer-term impact of infertility. They highlight the importance of pursuing research which has often been overlooked, including addressing the emotional and psychological impact of infertility, improving access to fertility treatment, particularly in lower resource settings, and securing appropriate regulation. Addressing these priorities will require diverse research methodologies, including laboratory-based science, qualitative and quantitative research, and population science.
LIMITATIONS, REASONS FOR CAUTION
We used consensus development methods, which have inherent limitations, including the representativeness of the participant sample, methodological decisions informed by professional judgement, and arbitrary consensus definitions.
WIDER IMPLICATIONS OF THE FINDINGS
We anticipate that identified research priorities, developed to specifically highlight the most pressing clinical needs as perceived by healthcare professionals, people with fertility problems, and others, will help research funding organizations and researchers to develop their future research agenda.
STUDY FUNDING/ COMPETING INTEREST(S)
The study was funded by the Auckland Medical Research Foundation, Catalyst Fund, Royal Society of New Zealand, and Maurice and Phyllis Paykel Trust. Geoffrey Adamson reports research sponsorship from Abbott, personal fees from Abbott and LabCorp, a financial interest in Advanced Reproductive Care, committee membership of the FIGO Committee on Reproductive Medicine, International Committee for Monitoring Assisted Reproductive Technologies, International Federation of Fertility Societies, and World Endometriosis Research Foundation, and research sponsorship of the International Committee for Monitoring Assisted Reproductive Technologies from Abbott and Ferring. Siladitya Bhattacharya reports being the Editor-in-Chief of Human Reproduction Open and editor for the Cochrane Gynaecology and Fertility Group. Hans Evers reports being the Editor Emeritus of Human Reproduction. Andrew Horne reports research sponsorship from the Chief Scientist's Office, Ferring, Medical Research Council, National Institute for Health Research, and Wellbeing of Women and consultancy fees from Abbvie, Ferring, Nordic Pharma, and Roche Diagnostics. M. Louise Hull reports grants from Merck, grants from Myovant, grants from Bayer, outside the submitted work and ownership in Embrace Fertility, a private fertility company. Neil Johnson reports research sponsorship from Abb-Vie and Myovant Sciences and consultancy fees from Guerbet, Myovant Sciences, Roche Diagnostics, and Vifor Pharma. José Knijnenburg reports research sponsorship from Ferring and Theramex. Richard Legro reports consultancy fees from Abbvie, Bayer, Ferring, Fractyl, Insud Pharma and Kindex and research sponsorship from Guerbet and Hass Avocado Board. Ben Mol reports consultancy fees from Guerbet, iGenomix, Merck, Merck KGaA and ObsEva. Ernest Ng reports research sponsorship from Merck. Craig Niederberger reports being the Co Editor-in-Chief of Fertility and Sterility and Section Editor of the Journal of Urology, research sponsorship from Ferring, and retains a financial interest in NexHand. Jane Stewart reports being employed by a National Health Service fertility clinic, consultancy fees from Merck for educational events, sponsorship to attend a fertility conference from Ferring, and being a clinical subeditor of Human Fertility. Annika Strandell reports consultancy fees from Guerbet. Jack Wilkinson reports being a statistical editor for the Cochrane Gynaecology and Fertility Group. Andy Vail reports that he is a Statistical Editor of the Cochrane Gynaecology & Fertility Review Group and of the journal Reproduction. His employing institution has received payment from HFEA for his advice on review of research evidence to inform their 'traffic light' system for infertility treatment 'add-ons'. Lan Vuong reports consultancy and conference fees from Ferring, Merck and Merck Sharp and Dohme. The remaining authors declare no competing interests in relation to the present work. All authors have completed the disclosure form.
TRIAL REGISTRATION NUMBER
Not applicable.
Topics: Consensus; Delphi Technique; Female; Fertility Clinics; Humans; Infertility; International Cooperation; Male; Practice Guidelines as Topic; Pregnancy; Reproductive Medicine; Research
PubMed: 33272617
DOI: 10.1016/j.fertnstert.2020.11.014 -
Pediatrics Sep 2020is a common cause of community and health care-associated bacteremia, with authors of recent studies estimating the incidence of bacteremia (SAB) in high-income...
is a common cause of community and health care-associated bacteremia, with authors of recent studies estimating the incidence of bacteremia (SAB) in high-income countries between 8 and 26 per 100 000 children per year. Despite this, <300 children worldwide have ever been randomly assigned into clinical trials to assess the efficacy of treatment of SAB. A panel of infectious diseases physicians with clinical and research interests in pediatric SAB identified 7 key clinical questions. The available literature is systematically appraised, summarizing SAB management in children in relation to these priority clinical questions. The management of neonates, children, and adolescents with SAB is predominantly based on clinical experience and trial data extrapolated from adult studies, with limited high-quality evidence available to guide management. The optimal, comprehensive management strategies for SAB in children will remain unknown until the questions outlined are answered through prospective observational cohorts and inclusion of children with SAB in clinical trials.
Topics: Adolescent; Age Factors; Algorithms; Anti-Bacterial Agents; Bacteremia; Case-Control Studies; Catheter-Related Infections; Cephalosporins; Child; Child, Preschool; Delphi Technique; Drug Administration Schedule; Echocardiography; Endocarditis, Bacterial; Glycopeptides; Humans; Incidence; Infant; Infant, Newborn; Injections, Intravenous; Methicillin-Resistant Staphylococcus aureus; Observational Studies as Topic; Penicillins; Randomized Controlled Trials as Topic; Referral and Consultation; Staphylococcal Infections; Staphylococcus aureus; Vancomycin; beta-Lactams
PubMed: 32759380
DOI: 10.1542/peds.2020-0134 -
Chest Apr 2020Transbronchial cryobiopsy (TBC) is increasingly recognized as a potential alternative to surgical lung biopsy (SLB) for the diagnosis of interstitial lung disease (ILD)....
BACKGROUND
Transbronchial cryobiopsy (TBC) is increasingly recognized as a potential alternative to surgical lung biopsy (SLB) for the diagnosis of interstitial lung disease (ILD). The goal of this analysis was to examine the literature on TBC as it relates to diagnostic utility and safety to provide evidence-based and expert guidance to clinicians.
METHODS
Approved panelists developed key questions regarding the diagnostic utility and safety of TBC for the evaluation of ILD using the PICO (Population, Intervention, Comparator, Outcome) format. MEDLINE (via PubMed) and the Cochrane Library were systematically searched for relevant literature, which was supplemented by manual searches. References were screened for inclusion, and vetted evaluation tools were used to assess the quality of included studies, to extract data, and to grade the level of evidence supporting each recommendation or statement. Graded recommendations and ungraded consensus-based statements were drafted and voted on using a modified Delphi technique to achieve consensus.
RESULTS
The systematic review and critical analysis of the literature based on four PICO questions resulted in six statements: two evidence-based graded recommendations and four ungraded consensus-based statements.
CONCLUSIONS
Evidence of the utility and safety of TBC for the diagnosis of ILD is limited but suggests TBC is safer than SLB, and its contribution to the diagnosis obtained via multidisciplinary discussion is comparable to that of SLB, although the histological diagnostic yield appears higher with SLB (approximately 80% for TBC vs 95% for SLB). Additional research is needed to enhance knowledge regarding utility and safety of TBC, its role in the diagnostic algorithm of ILD, and the impact of technical aspects of the procedure on diagnostic yield and safety.
Topics: Biopsy; Bronchoscopy; Cryosurgery; Humans; Lung Diseases, Interstitial; Procedures and Techniques Utilization; Safety Management
PubMed: 31783014
DOI: 10.1016/j.chest.2019.10.048