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1.
Fertil Steril ; 119(5): 804-812, 2023 05.
Artigo em Inglês | MEDLINE | ID: mdl-36736812

RESUMO

OBJECTIVE: To address methodological deficiencies in published randomized controlled trials and systematic reviews, this study has developed a core outcome set to guide future research in ectopic pregnancy (EP). DESIGN: To identify potential outcomes, we performed a comprehensive literature review and interviews with individuals with lived experience in EP. Potential core outcomes were then entered into a 3-round Delphi survey. A total of 154 participants from 6 continents, comprising health care professionals, researchers, and individuals with lived experience in EP, completed all 3 rounds of the Delphi survey. Outcomes were prioritized at 3 consensus development meetings, and recommendations were developed on how to report these outcomes where possible. SETTING: Not applicable. PATIENT(S): Health care professionals, researchers, and individuals with lived experience in EP. INTERVENTION(S): Not applicable. MAIN OUTCOME MEASURE(S): Consensus for inclusion in core outcome set. RESULT(S): Six outcomes reached full consensus, including treatment success, resolution time, the number of additional interventions, adverse events, mortality and severe morbidity, and treatment satisfaction. CONCLUSION(S): The core outcome set with 6 outcomes for EP will help standardize reporting of clinical trials, facilitate implementation of findings into clinical practice, and enhance patient-centered care.


Assuntos
Gravidez Ectópica , Projetos de Pesquisa , Gravidez , Feminino , Humanos , Consenso , Técnica Delphi , Resultado do Tratamento , Gravidez Ectópica/diagnóstico , Gravidez Ectópica/epidemiologia , Gravidez Ectópica/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto
2.
BJOG ; 130(6): 560-576, 2023 05.
Artigo em Inglês | MEDLINE | ID: mdl-36655361

RESUMO

BACKGROUND: A core outcome set could address inconsistent outcome reporting and improve evidence for stillbirth care research, which have been identified as an important research priority. OBJECTIVES: To identify outcomes and outcome measurement instruments reported by studies evaluating interventions after the diagnosis of a stillbirth. SEARCH STRATEGY: Amed, BNI, CINAHL, ClinicalTrials.gov, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Embase, MEDLINE, PsycINFO, and WHO ICTRP from 1998 to August 2021. SELECTION CRITERIA: Randomised and non-randomised comparative or non-comparative studies reporting a stillbirth care intervention. DATA COLLECTION AND ANALYSIS: Interventions, outcomes reported, definitions and outcome measurement tools were extracted. MAIN RESULTS: Forty randomised and 200 non-randomised studies were included. Fifty-eight different interventions were reported, labour and birth care (52 studies), hospital bereavement care (28 studies), clinical investigations (116 studies), care in a multiple pregnancy (2 studies), psychosocial support (28 studies) and care in a subsequent pregnancy (14 studies). A total of 391 unique outcomes were reported and organised into 14 outcome domains: labour and birth; postpartum; delivery of care; investigations; multiple pregnancy; mental health; emotional functioning; grief and bereavement; social functioning; relationship; whole person; subsequent pregnancy; subsequent children and siblings and economic. A total of 242 outcome measurement instruments were used, with 0-22 tools per outcome. CONCLUSIONS: Heterogeneity in outcome reporting, outcome definition and measurement tools in care after stillbirth exists. Considerable research gaps on specific intervention types in stillbirth care were identified. A core outcome set is needed to standardise outcome collection and reporting for stillbirth care research.


Assuntos
Sistemas de Apoio Psicossocial , Natimorto , Criança , Feminino , Humanos , Gravidez , Avaliação de Resultados em Cuidados de Saúde , Parto
4.
Hum Reprod Open ; 2022(2): hoac010, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35386119

RESUMO

STUDY QUESTION: What are the primary outcomes and outcome measures used in randomized controlled trials (RCTs) evaluating potential treatments for male infertility in the last 10 years? SUMMARY ANSWER: Outcome reporting across male infertility trials is heterogeneous with numerous definitions and measures used to define similar outcomes. WHAT IS KNOWN ALREADY: No core outcome set for male infertility trials has been developed. Male infertility trials are unique in that they have potentially three participants, a man, a female partner and their offspring and this will likely lead to significant variation in outcome reporting in randomized trials. STUDY DESIGN SIZE DURATION: A systematic review of RCTs mapping outcomes and outcome measures evaluating potential treatments for men with infertility registered in the Cochrane Register of Controlled Trials (CENTRAL) between January 2010 and July 2021. PARTICIPANTS/MATERIALS SETTING METHODS: Abstract screening and study selection was undertaken in duplicate using a review protocol that was developed prior to commencing the review. No risk of bias assessment was undertaken as this review aims to report on outcome reporting only. MAIN RESULTS AND THE ROLE OF CHANCE: One hundred and seventy-five RCTs were identified, and given the large number of studies we limited our review to the 100 largest trials. Seventy-nine different treatments were reported across the 100 largest RCTs including vitamin and dietary supplements (18 trials), surgical treatments (18 trials) and sperm selection techniques (22 trials). When considering the largest 100 trials (range: 80-2772 participants), 36 primary and 89 secondary outcomes were reported. Forty-seven trials reported a primary outcome and 36 trials clearly defined their primary outcome. Pregnancy outcomes were inconsistently reported and included pregnancy rate (51 trials), pregnancy loss including miscarriage, ectopic pregnancy, stillbirth (9 trials) and live birth (13 trials). Trials consistently reporting the same outcome frequently used different definitions. For example, semen quality was reported by 75 trials and was defined in 7 different ways, including; the World Health Organization (WHO) 2010 criteria (32 trials), WHO 1999 criteria (18 trials), WHO 1992 criteria (3 trials), WHO 1999 and 1992 criteria (1 trial) and the Kruger strict morphology criteria (1 trial). LIMITATIONS REASONS FOR CAUTION: We only evaluated the 100 largest trials published in the last 10 years and did not report outcomes on the remaining 75. An outcome was included as a primary outcome only if clearly stated in the manuscript and we did not contact authors to clarify this. As our review mapped outcomes and outcome measures, we did not undertake an integrity assessment of the trials included in our review. WIDER IMPLICATIONS OF THE FINDINGS: Most randomized trials evaluating treatments for male infertility report different outcomes. Only half of the RCTs reported pregnancy rate and even fewer reported live birth; furthermore, the definitions of these outcomes varies across trials. Developing, disseminating and implementing a minimum data set, known as a core outcome set, for male infertility research could help to improve outcome selection, collection and reporting. STUDY FUNDING/COMPETING INTERESTS: A.P.-chairman of external scientific advisory committee of Cryos International Denmark ApS, member of the scientific advisory board for Cytoswim LDT and ExSeed Health. Guest lecture at the 'Insights for Fertility Conference', funded by MERK SERONO Limited. M.v.W.-holds a ZON-MW research grant. No external funding was obtained for this study.

5.
BMJ Open ; 12(2): e056629, 2022 Feb 09.
Artigo em Inglês | MEDLINE | ID: mdl-35140161

RESUMO

INTRODUCTION: Stillbirth is associated with significant physical, psychosocial and economic consequences for parents, families, wider society and the healthcare system. There is emerging momentum to design and evaluate interventions for care after stillbirth and in subsequent pregnancies. However, there is insufficient evidence to inform clinical practice compounded by inconsistent outcome reporting in research studies. To address this paucity of evidence, we plan to develop a core outcome set for stillbirth care research, through an international consensus process with key stakeholders including parents, healthcare professionals and researchers. METHODS AND ANALYSIS: The development of this core outcome set will be divided into five distinct phases: (1) Identifying potential outcomes from a mixed-methods systematic review and analysis of interviews with parents who have experienced stillbirth; (2) Creating a comprehensive outcome long-list and piloting of a Delphi questionnaire using think-aloud interviews; (3) Choosing the most important outcomes by conducting an international two-round Delphi survey including high-income, middle-income and low-income countries; (4) Deciding the core outcome set by consensus meetings with key stakeholders and (5) Dissemination and promotion of the core outcome set. A parent and public involvement panel and international steering committee has been convened to coproduce every stage of the development of this core outcome set. ETHICS AND DISSEMINATION: Ethical approval for the qualitative interviews has been approved by Berkshire Ethics Committee REC Reference 12/SC/0495. Ethical approval for the think-aloud interviews, Delphi survey and consensus meetings has been awarded from the University of Bristol Faculty of Health Sciences Research Ethics Committee (Reference number: 116535). The dissemination strategy is being developed with the parent and public involvement panel and steering committee. Results will be published in peer-reviewed specialty journals, shared at national and international conferences and promoted through parent organisations and charities. PROSPERO REGISTRATION NUMBER: CRD42018087748.


Assuntos
Projetos de Pesquisa , Natimorto , Consenso , Técnica Delphi , Feminino , Humanos , Avaliação de Resultados em Cuidados de Saúde/métodos , Gravidez , Inquéritos e Questionários , Revisões Sistemáticas como Assunto
7.
Trials ; 22(1): 813, 2021 Nov 17.
Artigo em Inglês | MEDLINE | ID: mdl-34789295

RESUMO

BACKGROUND: Randomised controlled trials (RCTs) evaluating ectopic pregnancy have reported many different outcomes, which are themselves often defined and measured in distinct ways. This level of variation results in an inability to compare results of individual RCTs. The development of a core outcome set to ensure outcomes important to key stakeholders are collected consistently will guide future research in ectopic pregnancy. STUDY AIM: To develop and implement a core outcome set to guide future research in ectopic pregnancy. METHODS AND ANALYSIS: We have established an international steering group of key stakeholders, including healthcare professionals, researchers, and individuals with lived experience of ectopic pregnancy. We will identify potential outcomes from ectopic pregnancy from a comprehensive literature review of published randomised controlled trials. We will then utilise a modified Delphi method to prioritise outcomes. Subsequently, key stakeholders will be invited to score potential core outcomes on a nine-point Likert scale, ranging from 1 (not important) to 9 (critical). Repeated reflection and rescoring should promote whole and individual stakeholder group convergence towards consensus 'core' outcomes. We will also establish standardised definitions and recommend high-quality measurements for individual core outcomes. TRIAL REGISTRATION: COMET 1492 . Registered in November 2019.


Assuntos
Gravidez Ectópica , Projetos de Pesquisa , Consenso , Técnica Delphi , Feminino , Humanos , Avaliação de Resultados em Cuidados de Saúde , Gravidez , Gravidez Ectópica/diagnóstico , Gravidez Ectópica/terapia , Resultado do Tratamento
8.
Contraception ; 104(5): 484-491, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-34273335

RESUMO

OBJECTIVE: To develop a minimum data set, known as a core outcome set, for future abortion randomized controlled trials. STUDY DESIGN: We extracted outcomes from quantitative and qualitative systematic reviews of abortion studies to assess using a modified Delphi method. Via email, we invited researchers, clinicians, patients, and healthcare organization representatives with expertise in abortion to rate the importance of the outcomes on a 9-point Likert scale. After 2 rounds, we used descriptive analyses to determine which outcomes met the predefined consensus criteria. We finalized the core outcome set during a series of consensus development meetings. RESULTS: We entered 42 outcomes, organized in 15 domains, into the Delphi survey. Two-hundred eighteen of 251 invitees (87%) provided responses (203 complete responses) for round 1 and 118 of 218 (42%) completed round2. Sixteen experts participated in the development meetings. The final outcome set includes 15 outcomes: 10 outcomes apply to all abortion trials (successful abortion, ongoing pregnancy, death, hemorrhage, uterine infection, hospitalization, surgical intervention, pain, gastrointestinal symptoms, and patients' experience of abortion); 2 outcomes apply to only surgical abortion trials (uterine perforation and cervical injury), one applies only to medical abortion trials (uterine rupture); and 2 apply to trials evaluating abortions with anesthesia (over-sedation/respiratory depression and local anesthetic systemic toxicity). CONCLUSION: Using robust consensus science methods we have developed a core outcome set for future abortion research. IMPLICATIONS: Standardized outcomes in abortion research could decrease heterogeneity among trials and improve the quality of systematic reviews and clinical guidelines. Researchers should select, collect, and report these core outcomes in future abortion trials. Journal editors should advocate for core outcome set reporting.


Assuntos
Aborto Induzido , Consenso , Técnica Delphi , Feminino , Humanos , Gravidez , Projetos de Pesquisa , Inquéritos e Questionários , Revisões Sistemáticas como Assunto , Resultado do Tratamento
9.
Aust N Z J Obstet Gynaecol ; 61(5): 658-666, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34060072

RESUMO

AIMS: To develop a core outcome set for trials investigating interventions to prevent stillbirth. MATERIALS & METHODS: Outcomes identified from a systematic literature review and semi-structured interviews with parents in Australia and the UK were entered into a two-round online Delphi survey and focus group/consensus meetings. RESULTS: A core outcome set containing 11 outcomes in two categories. Five outcomes were related to the mother; fetal loss, onset of and mode of delivery, maternal mortality or near miss, psychological and social impact on the women, women's knowledge. Six outcomes were related to the baby; timing of stillbirth, neonatal mortality, gestational age at delivery, birthweight, congenital anomaly, NICU/SCBU or other higher-level neonatal care length of stay. CONCLUSIONS: Implementation and dissemination of this core outcome set in future trials will contribute towards coordinated outcome reporting and advancing usefulness of research to guide clinical practice.


Assuntos
Cuidado Pré-Natal , Natimorto , Consenso , Feminino , Humanos , Recém-Nascido , Mortalidade Materna , Avaliação de Resultados em Cuidados de Saúde , Gravidez , Projetos de Pesquisa
11.
Pregnancy Hypertens ; 21: 208-217, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32674052

RESUMO

OBJECTIVES: To develop consensus definitions for the core outcome set for pre-eclampsia. STUDY DESIGN: Potential definitions for individual core outcomes were identified across four formal definition development initiatives, nine national and international guidelines, 12 Cochrane systematic reviews, and 79 randomised trials. Eighty-six definitions were entered into the consensus development meeting. Ten healthcare professionals and three researchers, including six participants who had experience of conducting research in low- and middle-income countries, participated in the consensus development process. The final core outcome set was approved by an international steering group. RESULTS: Consensus definitions were developed for all core outcomes. When considering stroke, pulmonary oedema, acute kidney injury, raised liver enzymes, low platelets, birth weight, and neonatal seizures, consensus definitions were developed specifically for low- and middle-income countries because of the limited availability of diagnostic interventions including computerised tomography, chest x-ray, laboratory tests, equipment, and electroencephalogram monitoring. CONCLUSIONS: Consensus on measurements for the pre-eclampsia core outcome set will help to ensure consistency across future randomised trials and systematic reviews. Such standardization should make research evidence more accessible and facilitate the translation of research into clinical practice. Video abstract can be available at: www.dropbox.com/s/ftrgvrfu0u9glqd/6.%20Standardising%20definitions%20in%20teh%20pre-eclampsia%20core%20outcome%20set%3A%20a%20consensus%20development%20study.mp4?dl=0.


Assuntos
Pré-Eclâmpsia/terapia , Complicações na Gravidez/etiologia , Resultado da Gravidez , Resultado do Tratamento , Adulto , Consenso , Técnica Delphi , Feminino , Humanos , Gravidez , Padrões de Referência
12.
Fertil Steril ; 113(6): 1100-1106, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32482245

RESUMO

In reproductive medicine, the needs and desires of infertility patients drive future research, with the most important outcome being live birth of a baby. Large, multicenter, randomized clinical trials are considered the best research tool to evaluate the effectiveness of medical interventions, but they can often take a long time to find definitive answers. Advances in individual participant data (IPD) and network meta-analysis have enabled research questions to be answered more quickly, but better planning could streamline this process further. To harmonize research findings that are taking place globally in this way, it is crucial that the same outcomes are collected in clinical trials conducted in reproductive medicine. Furthermore, the conduct of clinical trials often requires collaboration on an international scale; however, individual countries have their own processes for research prioritization and delivery. We describe the perspective of high- and low-resourced settings and industry as well as the mechanisms of prioritization and coordination that are in place in different settings. In addition, we discuss the importance of the patient perspective, which can help shape the research question, clinical trial design, and the logistical operations of trial delivery. The need for increased global collaboration and coalitions within and between stakeholders is evident for the research community to accelerate advances and maximize benefits in reproductive medicine.


Assuntos
Infertilidade/terapia , Cooperação Internacional , Medicina Reprodutiva , Comportamento Cooperativo , Confiabilidade dos Dados , Determinação de Ponto Final , Medicina Baseada em Evidências , Feminino , Fertilidade , Humanos , Infertilidade/diagnóstico , Infertilidade/fisiopatologia , Nascido Vivo , Masculino , Estudos Multicêntricos como Assunto , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Participação dos Interessados , Resultado do Tratamento
14.
Eur J Obstet Gynecol Reprod Biol ; 250: 224-230, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32473505

RESUMO

OBJECTIVE: We aim to evaluate the accuracy, quality, and readability of online patient information concerning fibroids. STUDY DESIGN: We searched the most popular Internet search engine: Google.com. We developed a search strategy in consultation with patients with fibroids, to identify relevant websites. Two independent authors screened the search results. Websites were evaluated using validated instruments across three domains, including assessments of: [1] quality (DISCERN instrument; range 0-85); [2] readability (Flesch-Kincaid instrument; range 0-100); and [3] accuracy. Accuracy was assessed using evidence-based statements. We summarised this data narratively including the use of figures and tables. RESULTS: We identified 750 websites, of which 48 were included. Over a third of websites did not attribute authorship and almost half the included websites did not report the sources of information or academic references. No website provided written patient information in line with recommendations from the American Medical Association. A minority (18%) of websites were assessed as high quality. Twelve webpages provided only accurate statements. Available information was, in general, skewed towards the surgical management of fibroids. No website scored highly across all three domains. CONCLUSION: In the unlikely event that a website reports high quality and accurate health information, it is typically challenging for a lay audience to comprehend. Healthcare professionals and the wider community, should inform women with fibroids of the risk of outdated, inaccurate, or even dangerous information online. The implementation of an Information Standard certification will incentivise providers of online information to establish and adhere to codes of conduct. VIDEO ABSTRACT.


Assuntos
Informação de Saúde ao Consumidor , Leiomioma , Autoria , Compreensão , Feminino , Humanos , Internet , Ferramenta de Busca
15.
Obstet Gynecol ; 135(2): 444-451, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31923056

RESUMO

OBJECTIVE: To assess the effectiveness of patient decision aids to facilitate shared decision making in obstetrics and gynecology. DATA SOURCES: We searched ClinicalTrials.gov, MEDLINE, CENTRAL, Cochrane Gynaecology and Fertility specialized register, CINAHL, and EMBASE from 1946 to July 2019. METHODS OF STUDY SELECTION: We selected randomized controlled trials comparing patient decision aids with usual clinical practice or a control intervention. TABULATION, INTEGRATION, AND RESULTS: Thirty-five randomized controlled trials, which reported data from 9,790 women, were included. Patient decision aids were evaluated within a wide range of clinical scenarios relevant to obstetrics and gynecology, including contraception, vaginal birth after cesarean delivery, and pelvic organ prolapse. Study characteristics and quality were recorded for each study. The meta-analysis was based on random-effects methods for pooled data. A standardized mean difference of 0.2 is considered small, 0.5 moderate, and 0.8 large. When compared with usual clinical practice, the use of patient decision aids reduced decisional conflict (standardized mean difference -0.23; 95% CI -0.36, to -0.11; 19 trials; 4,624 women) and improved patient knowledge (standardized mean difference 0.58; 95% CI 0.44 to 0.71; 17 trials; 4,375 women). There was no difference in patient anxiety (standardized mean difference -0.04; 95% CI -0.14 to 0.06; 12 trials; 2,714 women) or satisfaction (standardized mean difference 0.17; 95% CI 0.09 to 0.24; 6 trials; 2,718 women). CONCLUSION: Patient decision aids are effective in facilitating shared decision making and can be helpful in clinical practice to support patient centered care informed by the best evidence. SYSTEMATIC REVIEW REGISTRATION: PROSPERO International Register of Systematic Reviews, www.crd.york.ac.uk/prospero/89953, CRD42018089953.


Assuntos
Tomada de Decisão Compartilhada , Técnicas de Apoio para a Decisão , Participação do Paciente , Feminino , Ginecologia/métodos , Humanos , Obstetrícia/métodos , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto
16.
Arch Dis Child Fetal Neonatal Ed ; 105(1): 69-75, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31085676

RESUMO

OBJECTIVE: Inconsistent outcome selection and reporting in clinical trials are important sources of research waste; it is not known how common this problem is in neonatal trials. Our objective was to determine whether large clinical trials involving infants receiving neonatal care report a consistent set of outcomes, how composite outcomes are used and whether parents or former patients were involved in outcome selection. DESIGN: A literature search of CENTRAL, CINAHL, EMBASE and MEDLINE was conducted; randomised trials published between 1 July 2012 and 1 July 2017 and involving at least 100 infants in each arm were included. Outcomes and outcome measures were extracted and categorised by physiological system; reported former patient and parent involvement in outcome selection was extracted. RESULTS: Seventy-six trials involving 43 126 infants were identified; 216 different outcomes with 889 different outcome measures were reported. Outcome reporting covered all physiological systems but was variable between individual trials: only 67/76 (88%) of trials reported survival and 639 outcome measures were only reported in a single trial. Thirty-three composite outcomes were used in 41 trials. No trials reported former patient or parent involvement in outcome selection. CONCLUSIONS: Inconsistent outcome reporting and a lack of parent and former patient involvement in outcome selection in neonatal clinical trials limits the ability of such trials to answer clinically meaningful questions. Developing and implementing a core outcome set for future neonatal trials, with input from all stakeholders, should address these issues.


Assuntos
Doenças do Recém-Nascido , Avaliação de Processos e Resultados em Cuidados de Saúde , Ensaios Clínicos Controlados Aleatórios como Assunto , Humanos , Recém-Nascido
17.
Arch Dis Child Fetal Neonatal Ed ; 105(4): 425-431, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31732683

RESUMO

BACKGROUND: Neonatal research evaluates many different outcomes using multiple measures. This can prevent synthesis of trial results in meta-analyses, and selected outcomes may not be relevant to former patients, parents and health professionals. OBJECTIVE: To define a core outcome set (COS) for research involving infants receiving neonatal care in a high-income setting. DESIGN: Outcomes reported in neonatal trials and qualitative studies were systematically reviewed. Stakeholders were recruited for a three-round international Delphi survey. A consensus meeting was held to confirm the final COS, based on the survey results. PARTICIPANTS: Four hundred and fourteen former patients, parents, healthcare professionals and researchers took part in the eDelphi survey; 173 completed all three rounds. Sixteen stakeholders participated in the consensus meeting. RESULTS: The literature reviews identified 104 outcomes; these were included in round 1. Participants proposed 10 additional outcomes; 114 outcomes were scored in rounds 2 and 3. Round 1 scores showed different stakeholder groups prioritised contrasting outcomes. Twelve outcomes were included in the final COS: survival, sepsis, necrotising enterocolitis, brain injury on imaging, general gross motor ability, general cognitive ability, quality of life, adverse events, visual impairment/blindness, hearing impairment/deafness, retinopathy of prematurity and chronic lung disease/bronchopulmonary dysplasia. CONCLUSIONS AND RELEVANCE: A COS for clinical trials and other research studies involving infants receiving neonatal care in a high-income setting has been identified. This COS for neonatology will help standardise outcome selection in clinical trials and ensure these are relevant to those most affected by neonatal care.


Assuntos
Pesquisa Biomédica , Neonatologia , Avaliação de Resultados em Cuidados de Saúde , Humanos , Lactente
18.
Trials ; 20(1): 35, 2019 Jan 09.
Artigo em Inglês | MEDLINE | ID: mdl-30626413

RESUMO

BACKGROUND: Selective fetal growth restriction in monochorionic twin pregnancies is associated with an increased risk of perinatal mortality and morbidity and represents a clinical dilemma. Interventions include expectant management with early preterm delivery if there are signs of fetal compromise, selective termination of the compromised twin, fetoscopic laser coagulation of the communicating placental vessels or termination of the whole pregnancy. Previous studies evaluating interventions have reported many different outcomes and outcome measures. Such variation makes comparing, contrasting, and combining results challenging, limiting ongoing research on this uncommon condition to inform clinical practice. We aim to produce, disseminate, and implement a core outcome set for selective fetal growth restriction research in monochorionic twin pregnancies. METHODS: An international steering group, including professionals, researchers, and lay experts, has been established to oversee the development of this core outcome set. The methods have been guided by the Core Outcome Measures in Effectiveness Trials Initiative Handbook. Potential core outcomes will be developed by undertaking a systematic review of studies evaluating interventions for selective fetal growth restriction in monochorionic twin pregnancies. Potential core outcomes will be entered into a three-round Delphi survey and key stakeholders including clinical professionals, researchers, and lay experts will be invited to participate. Repeated reflection and rescoring of individual outcomes should encourage group and individual stakeholder convergence towards consensus outcomes which will be entered into a modified Nominal Group Technique to finalize the core outcome set. Once core outcomes have been agreed, we will establish standardized definitions and recommend high-quality measurement instruments for each outcome. DISCUSSION: The development, dissemination, and implementation of a core outcome set for selective fetal growth restriction should ensure that future research protocols select, collect, and report outcomes and outcome measures in a standardized manner. Data synthesis will be possible on a broad level and rigorous implementation should advance the quality of research studies and their effective use in order to guide clinical practice, improve patient care, maternal, short-term perinatal outcomes, and long-term neurodevelopmental outcomes. TRIAL REGISTRATION: Core Outcome Measures in Effectiveness Trials (COMET) registration number: 998. International Prospective Register of Systematic Reviews (PROSPERO) registration number: CRD42018092697 . 18th April 2018.


Assuntos
Doenças em Gêmeos/terapia , Retardo do Crescimento Fetal/terapia , Gravidez de Gêmeos , Projetos de Pesquisa , Gêmeos Monozigóticos , Consenso , Conferências de Consenso como Assunto , Técnica Delphi , Doenças em Gêmeos/diagnóstico , Doenças em Gêmeos/fisiopatologia , Determinação de Ponto Final , Feminino , Retardo do Crescimento Fetal/diagnóstico , Retardo do Crescimento Fetal/fisiopatologia , Humanos , Gravidez , Participação dos Interessados , Revisões Sistemáticas como Assunto , Resultado do Tratamento
19.
Am J Obstet Gynecol ; 220(1): 71.e1-71.e4, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30273584

RESUMO

Clinical research should ultimately improve patient care. To enable this, randomized controlled trials must select, collect, and report outcomes that are both relevant to clinical practice and genuinely reflect the perspectives of key stakeholders including health care professionals, researchers, and patients. Unfortunately, many randomized controlled trials fall short of this requirement. Complex issues, including a failure to take into account the perspectives of key stakeholders when selecting outcomes, variations in outcome definitions and measurement instruments, and outcome reporting bias make research evidence difficult to interpret, undermining the translation of research into clinical practice. Problems with poor outcome selection, measurement, and reporting can be addressed by developing, disseminating, and implementing core outcome sets. A core outcome set represents a minimum data set of outcomes developed using robust consensus science methods engaging diverse stakeholders including health care professionals, researchers, and patients. Core outcomes should be routinely utilized by researchers, collected in a standardized manner, and reported consistently in the final publication. They are currently being developed across our specialty including infertility, endometriosis, and preeclampsia. Recognizing poorly selected, collected, and reported outcomes as serious hindrances to progress in our specialty, more than 80 journals including the Journal, have come together to support the Core Outcomes in Women's and Newborn Health (CROWN) initiative. The consortium supports researchers to develop, disseminate, and implement core outcome sets. Implementing core outcome sets could make a profound contribution to addressing poorly selected, collected, and reported outcomes. Implementation should ensure future randomized controlled trials hold the necessary reach and relevance to inform clinical practice, enhance patient care, and improve patient outcomes.


Assuntos
Pesquisa Biomédica/normas , Ginecologia/normas , Disseminação de Informação , Obstetrícia/normas , Avaliação de Resultados em Cuidados de Saúde , Pesquisa Biomédica/tendências , Coleta de Dados , Feminino , Ginecologia/tendências , Humanos , Avaliação das Necessidades , Obstetrícia/tendências , Medidas de Resultados Relatados pelo Paciente , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Estados Unidos
20.
Int Urogynecol J ; 30(5): 713-723, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30159721

RESUMO

OBJECTIVE: There is no systematic evaluation of online health information pertaining to obstetric anal sphincter injury. Therefore, we evaluated the accuracy, credibility, reliability, and readability of online information concerning obstetric anal sphincter injury. MATERIALS AND METHODS: Multiple search engines were searched. The first 30 webpages were identified for each keyword and considered eligible if they provided information regarding obstetric anal sphincter injury. Eligible webpages were assessed by two independent researchers for accuracy (prioritised criteria based upon the RCOG Third and Fourth Degree Tear guideline); credibility; reliability; and readability. RESULTS: Fifty-eight webpages were included. Seventeen webpages (30%) had obtained Health On the Net certification, or Information Standard approval and performed better than those without such approvals (p = 0.039). The best overall performing website was http://www.pat.nhs.uk (score of 146.7). A single webpage (1%) fulfilled the entire criteria for accuracy with a score of 18: www.tamesidehospital.nhs.uk . Twenty-nine webpages (50%) were assessed as credible (scores ≥7). A single webpage achieved a maximum credibility score of 10: www.meht.nhs.uk . Over a third (21 out of 58) were rated as poor or very poor. The highest scoring webpage was http://www.royalsurrey.nhs.uk (score 62). No webpage met the recommended Flesch Reading Ease Score above 70. The intra-class coefficient between researchers was 0.98 (95% CI 0.96-0.99) and 0.94 (95% CI 0.89-0.96) for accuracy and reliability assessments. CONCLUSION: Online information concerning obstetric anal sphincter injury often uses language that is inappropriate for a lay audience and lacks sufficient accuracy, credibility, and reliability.


Assuntos
Canal Anal/lesões , Informação de Saúde ao Consumidor/normas , Internet , Lacerações , Compreensão , Feminino , Humanos , Complicações do Trabalho de Parto/fisiopatologia , Gravidez
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