RESUMO
BACKGROUND: Suboptimal or slow recruitment affects 30-50% of trials. Education and training of trial recruiters has been identified as one strategy for potentially boosting recruitment to randomised controlled trials (hereafter referred to as trials). The Training tRial recruiters, An educational INtervention (TRAIN) project was established to develop and assess the acceptability of an education and training intervention for recruiters to neonatal trials. In this paper, we report the development and acceptability of TRAIN. METHODS: TRAIN involved three sequential phases, with each phase contributing information to the subsequent phase(s). These phases were 1) evidence synthesis (systematic review of the effectiveness of training interventions and a content analysis of the format, content, and delivery of identified interventions), 2) intervention development using a Partnership (co-design/co-creation) approach, and 3) intervention acceptability assessments with recruiters to neonatal trials. RESULTS: TRAIN, accompanied by a comprehensive intervention manual, has been designed for online or in-person delivery. TRAIN can be offered to recruiters before trial recruitment begins or as refresher sessions during a trial. The intervention consists of five core learning outcomes which are addressed across three core training units. These units are the trial protocol (Unit 1, 50 min, trial-specific), understanding randomisation (Unit 2, 5 min, trial-generic) and approaching and engaging with parents (Unit 3, 70 min, trial-generic). Eleven recruiters to neonatal trials registered to attend the acceptability assessment training workshops, although only four took part. All four positively valued the training Units and resources for increasing recruiter preparedness, knowledge, and confidence. More flexibility in how the training is facilitated, however, was noted (e.g., training divided across two workshops of shorter duration). Units 2 and 3 were considered beneficial to incorporate into Good Clinical Practice Training or as part of induction training for new staff joining neonatal units. CONCLUSION: TRAIN offers a comprehensive co-produced training and education intervention for recruiters to neonatal trials. TRAIN was deemed acceptable, with minor modification, to neonatal trial recruiters. The small number of recruiters taking part in the acceptability assessment is a limitation. Scale-up of TRAIN with formal piloting and testing for effectiveness in a large cluster randomised trial is required.
Assuntos
Seleção de Pacientes , Projetos de Pesquisa , Humanos , Recém-Nascido , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: Pregestational diabetes mellitus (PGDM) is associated with adverse pregnancy outcomes. Studies assessing interventions to improve maternal and infant outcomes have increased exponentially over recent years. Several outcomes in this field of maternal diabetes are rare, making it difficult to synthesise evidence. OBJECTIVES: To collect outcomes reported in studies assessing treatment interventions in pregnant women with PGDM. SEARCH STRATEGY: CENTRAL, Web of Science, Medline, CINAHL, Embase and ClinicalTrials.gov from their inception until 27 January 2020. SELECTION CRITERIA: Any randomised controlled trial assessing treatment interventions in pregnant women with PGDM reported in English. DATA COLLECTION AND ANALYSIS: Two independent reviewers assessed the suitability of articles and retrieved the data. Outcomes extracted from the literature were broadly categorised into maternal, fetal/infant or other outcomes by the study advisory group. MAIN RESULTS: Sixty-seven of the 1475 studies identified fulfilled the inclusion criteria. The median number of outcomes reported per study was 15 (range 1-46). The majority of studies were from North America and Europe. Insulin and metformin were the most commonly investigated pharmacological interventions. Glucose monitoring was the most assessed technological intervention. In all, 131 unique outcomes were extracted: maternal (n = 69), fetal/infant (n = 61) and other (n = 1). CONCLUSIONS: Outcome reporting in treatment interventions trials of pregnant women with PGDM is varied, making it difficult to synthesise evidence, especially for rare outcomes. Systems are needed to standardise outcome reporting in future clinical trials and so facilitate evidence synthesis in this area of maternal diabetes. REGISTRATION: The systematic review was registered prospectively with the International Prospective Register of Systematic Reviews (PROSPERO) database (Registration number CRD42020173549). TWEETABLE ABSTRACT: Outcome reporting is heterogeneous in intervention trials of pregnant women with diabetes existing before pregnancy.
Assuntos
Resultado da Gravidez , Gravidez em Diabéticas/tratamento farmacológico , Cuidado Pré-Natal/métodos , Automonitorização da Glicemia , Feminino , Humanos , Hipoglicemiantes/uso terapêutico , Metformina/uso terapêutico , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do TratamentoRESUMO
OBJECTIVE: To develop a core outcome set (COS) for randomised controlled trials (RCTs) evaluating the effectiveness of interventions for the treatment of pregnant women with pregestational diabetes mellitus (PGDM). DESIGN: A consensus developmental study. SETTING: International. POPULATION: Two hundred and five stakeholders completed the first round. METHODS: The study consisted of three components. (1) A systematic review of the literature to produce a list of outcomes reported in RCTs assessing the effectiveness of interventions for the treatment of pregnant women with PGDM. (2) A three-round, online eDelphi survey to prioritise these outcomes by international stakeholders (including healthcare professionals, researchers and women with PGDM). (3) A consensus meeting where stakeholders from each group decided on the final COS. MAIN OUTCOME MEASURES: All outcomes were extracted from the literature. RESULTS: We extracted 131 unique outcomes from 67 records meeting the full inclusion criteria. Of the 205 stakeholders who completed the first round, 174/205 (85%) and 165/174 (95%) completed rounds 2 and 3, respectively. Participants at the subsequent consensus meeting chose 19 outcomes for inclusion into the COS: trimester-specific haemoglobin A1c, maternal weight gain during pregnancy, severe maternal hypoglycaemia, diabetic ketoacidosis, miscarriage, pregnancy-induced hypertension, pre-eclampsia, maternal death, birthweight, large for gestational age, small for gestational age, gestational age at birth, preterm birth, mode of birth, shoulder dystocia, neonatal hypoglycaemia, congenital malformations, stillbirth and neonatal death. CONCLUSIONS: This COS will enable better comparison between RCTs to produce robust evidence synthesis, improve trial reporting and optimise research efficiency in studies assessing treatment of pregnant women with PGDM. TWEETABLE ABSTRACT: 165 key stakeholders have developed #Treatment #CoreOutcomes in pregnant women with #diabetes existing before pregnancy.
Assuntos
Diabetes Gestacional/terapia , Avaliação de Resultados em Cuidados de Saúde/normas , Cuidado Pré-Natal/normas , Consenso , Técnica Delphi , Feminino , Humanos , Cooperação Internacional , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto , Participação dos Interessados , Resultado do TratamentoRESUMO
OBJECTIVE: To perform a health economic analysis of an intervention designed to increase rates of vaginal birth after caesarean, compared with usual care. DESIGN: Economic analysis alongside the cluster-randomised OptiBIRTH trial (Optimising childbirth by increasing vaginal birth after caesarean section (VBAC) through enhanced women-centred care). SETTING: Fifteen maternity units in three European countries - Germany (five), Ireland (five), and Italy (five) - with relatively low VBAC rates. POPULATION: Pregnant women with a history of one previous lower-segment caesarean section; sites were randomised (3:2) to intervention or control. METHODS: A cost-utility analysis from both societal and health-services perspectives, using a decision tree. MAIN OUTCOME MEASURES: Costs and resource use per woman and infant were compared between the control and intervention group by country, from pregnancy recognition until 3 months postpartum. Based on the caesarean section rates, and maternal and neonatal morbidities and mortality, the incremental cost-utility ratios were calculated per country. RESULTS: The mean difference in costs per quality-adjusted life years (QALYs) gained from a societal perspective between the intervention and the control group, using a probabilistic sensitivity analysis, was: 263 (95% CI 258-268) and 0.008 QALYs (95% CI 0.008-0.009 QALYs) for Germany, 456 (95% CI 448-464) and 0.052 QALYs (95% CI 0.051-0.053 QALYs) for Ireland, and 1174 (95% CI 1170-1178) and 0.006 QALYs (95% CI 0.005-0.007 QALYs) for Italy. The incremental cost-utility ratios were 33,741/QALY for Germany, 8785/QALY for Ireland, and 214,318/QALY for Italy, with a 51% probability of being cost-effective for Germany, 92% for Ireland, and 15% for Italy. CONCLUSION: The OptiBIRTH intervention was likely to be cost-effective in Ireland and Germany. TWEETABLE ABSTRACT: The OptiBIRTH intervention (to increase VBAC rates) is likely to be cost-effective in Germany and Ireland.
Assuntos
Análise Custo-Benefício , Serviços de Saúde Materno-Infantil/economia , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto/economia , Nascimento Vaginal Após Cesárea/economia , Adulto , Análise por Conglomerados , Feminino , Alemanha , Humanos , Irlanda , Itália , Gravidez , Anos de Vida Ajustados por Qualidade de VidaRESUMO
OBJECTIVE: To assess the effect of admission cardiotocography (ACTG) versus intermittent auscultation (IA) of the fetal heart (FH) in low-risk pregnancy during assessment for possible labour on caesarean section rates. DESIGN: A parallel multicentre randomised trial. SETTING: Three maternity units in the Republic of Ireland. POPULATION: Healthy, low-risk pregnant women, at term and ≥ 18 years old, who provided written informed consent. METHODS: Women were randomised to receive IA of the FH or 20 minutes ACTG on admission for possible labour onset, using remote telephone randomisation. Both groups received IA during labour, with conversion to continuous CTG as clinically indicated. MAIN OUTCOME MEASURES: Caesarean section (primary outcome), obstetric interventions (e.g. continuous CTG during labour, fetal blood sampling, augmentation of labour) and neonatal morbidity (e.g. metabolic acidosis, admission to the neonatal intensive care unit, neonatal death). RESULTS: Based on 3034 women (1513 and 1521 randomised to IA and ACTG, respectively), there was no statistical difference between the groups in caesarean section [130 (8.6%) and 105 (6.9%) for IA and ACTG groups, respectively; relative risk (RR) 1.24; 95% CI 0.97-1.58], or in any other outcome except for use of continuous CTG during labour, which was lower in the IA group (RR 0.90, 95% CI 0.86-0.93). CONCLUSION: Our study demonstrates no differences in obstetric or neonatal outcomes between IA and ACTG for women with possible labour onset, other than an increased risk for continuous CTG in women receiving ACTG. TWEETABLE ABSTRACT: No differences in outcomes between intermittent auscultation and admission cardiotocography for women with possible labour onset.
Assuntos
Cardiotocografia , Auscultação Cardíaca , Frequência Cardíaca Fetal , Início do Trabalho de Parto/fisiologia , Adulto , Cesárea/estatística & dados numéricos , Feminino , Humanos , Gravidez , Resultado da Gravidez , Estudos RetrospectivosRESUMO
OBJECTIVE: To develop core outcome sets (COS) for studies evaluating interventions for (1) prevention and (2) treatment of postpartum haemorrhage (PPH), and recommendations on how to report the COS. DESIGN: A two-round Delphi survey and face-to-face meeting. POPULATION: Healthcare professionals and women's representatives. METHODS: Outcomes were identified from systematic reviews of PPH studies and stakeholder consultation. Participants scored each outcome in the Delphi on a Likert scale between 1 (not important) and 9 (critically important). Results were discussed at the face-to-face meeting to agree the final COS. Consensus at the meeting was defined as ≥ 70% of participants scoring the outcome as critically important (7-9). Lectures, discussion and voting were used to agree how to report COS outcomes. MAIN OUTCOME MEASURES: Outcomes from systematic reviews and consultations. RESULTS: Both Delphi rounds were completed by 152/205 (74%) participants for prevention and 143/197 (73%) for treatment. For prevention of PPH, nine core outcomes were selected: blood loss, shock, maternal death, use of additional uterotonics, blood transfusion, transfer for higher level of care, women's sense of wellbeing, acceptability and satisfaction with the intervention, breastfeeding, and adverse effects. For treatment of PPH, 12 core outcomes were selected: blood loss, shock, coagulopathy, hysterectomy, organ dysfunction, maternal death, blood transfusion, use of additional haemostatic intervention, transfer for higher level of care, women's sense of wellbeing, acceptability and satisfaction with the intervention, breastfeeding, and adverse effects. Recommendations were developed on how to report these outcomes where possible. CONCLUSIONS: These COS will help standardise outcome reporting in PPH trials. TWEETABLE ABSTRACT: Core outcome sets for PPH: nine core outcomes for PPH prevention and 12 core outcomes for PPH treatment.
Assuntos
Avaliação de Resultados em Cuidados de Saúde , Hemorragia Pós-Parto/terapia , Consenso , Técnica Delphi , Feminino , Humanos , Cooperação Internacional , Satisfação do Paciente , Hemorragia Pós-Parto/prevenção & controle , GravidezRESUMO
OBJECTIVE: Although fetal growth restriction (FGR) is well known to be associated with adverse outcomes for the mother and offspring, effective interventions for the management of FGR are yet to be established. Trials reporting interventions for the prevention and treatment of FGR may be limited by heterogeneity in the underlying pathophysiology. The aim of this study was to conduct a systematic review of outcomes reported in randomized controlled trials (RCTs) assessing interventions for the prevention or treatment of FGR, in order to identify and categorize the variation in outcome reporting. METHODS: MEDLINE, EMBASE and The Cochrane Library were searched from inception until August 2018 for RCTs investigating therapies for the prevention and treatment of FGR. Studies were assessed systematically and data on outcomes that were reported in the included studies were extracted and categorized. The methodological quality of the included studies was assessed using the Jadad score. RESULTS: The search identified 2609 citations, of which 153 were selected for full-text review and 72 studies (68 trials) were included in the final analysis. There were 44 trials relating to the prevention of FGR and 24 trials investigating interventions for the treatment of FGR. The mean Jadad score of all studies was 3.07, and only nine of them received a score of 5. We identified 238 outcomes across the included studies. The most commonly reported were birth weight (88.2%), gestational age at birth (72.1%) and small-for-gestational age (67.6%). Few studies reported on any measure of neonatal morbidity (27.9%), while adverse effects of the interventions were reported in only 17.6% of trials. CONCLUSIONS: There is significant variation in outcome reporting across RCTs of therapies for the prevention and treatment of FGR. The clinical applicability of future research would be enhanced by the development of a core outcome set for use in future trials. Copyright © 2018 ISUOG. Published by John Wiley & Sons Ltd.
Assuntos
Confiabilidade dos Dados , Retardo do Crescimento Fetal/prevenção & controle , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Projetos de Pesquisa/normas , Feminino , Humanos , GravidezRESUMO
OBJECTIVE: To develop a set of core outcomes to be minimally reported in trials on induction of labour. DESIGN: Two-round Delphi survey and consensus meeting. POPULATION: Four stakeholder groups: midwives, obstetricians, neonatologists, and women's representatives. METHODS: Protocol registered with COMET (Registration Number: 695). Stakeholders rated reported outcomes for importance (1-limited to 9-critical). The median rating of each outcome was calculated. The consensus criteria to include outcomes were as follows: ≥70% participants rated outcomes as critical and <15% rated outcomes as limited importance. Outcomes that did not achieve consensus were taken to round two and, if there was still no consensus, to the final consensus meeting. MAIN OUTCOME MEASURES: Outcomes in trials of induction of labour. RESULTS: Of the 159 invited participants, 54% (86/159) completed the first round, and 83% completed the second round (71/86). The core outcome set included 28 core outcomes in four domains: Short-term maternal outcomes (n = 18)-cardiorespiratory arrest, damage to internal organs, death, haemorrhage, hysterectomy, infection, intensive care admission, length of hospital stay, mode of delivery, need for more than one induction agent, oxytocin augmentation, postnatal depression, pulmonary embolus, satisfaction with care, stroke, time from induction to delivery, uterine hyperstimulation, uterine scar dehiscence/rupture; short-term offspring outcomes (n = 8)-admission to the neonatal unit, birth trauma, death, hypoxic ischaemic encephalopathy/need for therapeutic hypothermia, meconium aspiration syndrome, need for respiratory support, infection, and seizures; long-term maternal outcomes (n = 1)-operative pelvic floor repair; long-term offspring outcomes (n = 1)-disability including neurodevelopmental delay. CONCLUSION: Trials on induction of labour should include this core outcome set to standardise reporting. TWEETABLE ABSTRACT: International multistakeholder Delphi study identifies a core outcome set for trials on induction of labour.
Assuntos
Ensaios Clínicos como Assunto , Determinação de Ponto Final , Trabalho de Parto Induzido , Avaliação de Resultados em Cuidados de Saúde/métodos , Consenso , Técnica Delphi , Feminino , Humanos , Gravidez , Projetos de Pesquisa/normas , Participação dos InteressadosRESUMO
OBJECTIVE: Venous leg ulcers (VLUs) affect up to 4% of the population aged over 65 years. Outcomes of randomised controlled trials (RCTs) in VLUs are important to guide clinical and resource decision making. Our objective was to identify what endpoints and wound bed outcomes were assessed in RCTs in VLUs; how these were assessed and what reference was made to validity and reliability of methods used. METHOD: A systematic review of all full text RCTs, published in English, from 1998-2013. RESULTS: Our criteria were met by 102 studies. There were 78 different endpoints recorded, the majority (n=34) related to healing and were evaluated at 12 different times points. Size was the most frequently reported outcome measure (n=99), with photographs, tissue type, exudate, odour and pain also recorded. There was poor reporting of methods used to assess outcomes. Visual analogue scales predominated as a method of assessment, but 95% of studies made no reference to the validity or reliability of assessment methods. CONCLUSION: Future research in VLUs requires standards for measuring outcomes with acceptable inter-rater reliability and validated measures of patient-reported outcomes.
Assuntos
Úlcera Varicosa/terapia , Cicatrização , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Ensaios Clínicos Controlados Aleatórios como Assunto , Reprodutibilidade dos Testes , Projetos de Pesquisa/normas , Resultado do TratamentoRESUMO
BACKGROUND: Evidence to support decisions on trial processes is minimal. One way to generate this evidence is to use a Study Within A Trial (SWAT) to test trial processes or explore methodological uncertainties. SWAT evidence relies on replication to ensure sufficient power and broad applicability of findings. Prompt reporting is therefore essential; however, SWAT publications are often the first to be abandoned in the face of other time pressures. Reporting guidance for embedded methodology trials does exist but is not widely used. We sought therefore to build on these guidelines to develop a straightforward, concise reporting standard, which remains adherent to the CONSORT guideline. METHODS: An iterative process was used to develop the guideline. This included initial meetings with key stakeholders, development of an initial guideline, pilot testing of draft guidelines, further iteration and pilot testing, and finalisation of the guideline. RESULTS: We developed a reporting guideline applicable to randomised SWATs, including replications of previous evaluations. The guideline follows the Consolidated Standards for Reporting Trials (CONSORT) statement and provides example text to ensure ease and clarity of reporting across all domains. CONCLUSIONS: The SWAT reporting guideline will aid authors, reviewers, and journal editors to produce and review clear, structured reports of randomised SWATs, whilst also adhering to the CONSORT guideline. TRIAL REGISTRATION: EQUATOR Network - Guidelines Under Development ( https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials/#SWAT ). Registered on 25 March 2021.
Assuntos
Guias como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , HumanosRESUMO
OBJECTIVE: To derive nationally representative incidence rates of postpartum haemorrhage (PPH), and to investigate trends associated with method of delivery, blood transfusion and morbidly adherent placenta (accreta, percreta and increta). DESIGN: Population-based retrospective cohort study. SETTING: Republic of Ireland. POPULATION: Childbirth hospitalisations during the period 1999-2009. METHODS: International Classification of Diseases (ICD)-9-CM and ICD-10-AM diagnostic codes from hospital discharge records were used to identify cases of PPH. Significant temporal trends in PPH incidence were determined using Cochrane-Armitage tests for trend. Log-binomial regression was conducted to assess annual changes in the risk of PPH diagnosis, with adjustment for potential confounding factors. MAIN OUTCOME MEASURES: PPH, uterine atony, blood transfusion and morbidly adherent placenta. RESULTS: A total of 649,019 childbirth hospitalisations were recorded; 2.6% (n = 16,909) included a diagnosis of PPH. The overall PPH rate increased from 1.5% in 1999 to 4.1% in 2009; atonic PPH rose from 1.0% in 1999 to 3.4% in 2009. Significant increasing trends in atonic PPH rates were observed across vaginal, instrumental, and emergency and elective caesarean deliveries (P < 0.001). The rate of atonic PPH co-diagnosed with blood transfusion also significantly increased (P < 0.001). Relative to 1999, the risk of atonic PPH in 2009 was three-fold increased (adjusted RR 3.03; 95% CI 2.76-3.34). Women diagnosed with a morbidly adherent placenta had a markedly higher risk of total PPH (unadjusted RR 13.14; 95% CI 11.43-15.11). CONCLUSIONS: Increasing rates of atonic PPH highlight the pressing need for research and for clinical audit focusing on aetiological factors, preventative measures and quality of care, to guide current clinical practice.
Assuntos
Placenta Acreta/epidemiologia , Hemorragia Pós-Parto/epidemiologia , Adolescente , Adulto , Transfusão de Sangue/estatística & dados numéricos , Estudos de Coortes , Parto Obstétrico/estatística & dados numéricos , Feminino , Humanos , Incidência , Irlanda/epidemiologia , Pessoa de Meia-Idade , Análise Multivariada , Hemorragia Pós-Parto/etiologia , Hemorragia Pós-Parto/terapia , Gravidez , Análise de Regressão , Estudos Retrospectivos , Risco , Inércia Uterina/epidemiologia , Adulto JovemRESUMO
BACKGROUND: Pregnancies affected by gestational diabetes mellitus (GDM) are associated with an increased risk of adverse maternal and foetal outcomes. Current treatments for GDM involve initial medical nutritional therapy (MNT) and exercise and pharmacotherapy in those with persistent hyperglycaemia. Insulin is considered first-line pharmacotherapy but is associated with hypoglycaemia, excessive gestational weight gain (GWG) and an increased caesarean delivery rate. Metformin is safe in selected groups of women with GDM but is not first-line therapy in many guidelines due to a lack of long-term data on efficacy. The EMERGE trial will evaluate the effectiveness of early initiation of metformin in GDM. METHODS: EMERGE is a phase III, superiority, parallel, 1:1 randomised, double-blind, placebo-controlled trial comparing the effectiveness of metformin versus placebo initiated by 28 weeks (+6 days) plus usual care. Women aged 18-50 years will be recruited. Women with established diabetes, multiple pregnancies, known major congenital malformation or small for gestational age (<10th centile), intolerance or contraindication to the use of metformin, shock or sepsis, current gestational hypertension or pre-eclampsia, significant gastrointestinal problems, congestive heart failure, severe mental illness or galactose intolerance are excluded. INTERVENTION: Immediate introduction of metformin or placebo in addition to MNT and usual care. Metformin is initiated at 500mg/day and titrated to a maximum dose of 2500mg over 10 days. Women are followed up at 4 and 12 weeks post-partum to assess maternal and neonatal outcomes. The composite primary outcome measure is initiation of insulin or fasting blood glucose ≥ 5.1 mmol/L at gestational weeks 32 or 38. The secondary outcomes are the time to insulin initiation and insulin dose required; maternal morbidity at delivery; mode and time of delivery; postpartum glucose status; insulin resistance; postpartum body mass index (BMI); gestational weight gain; infant birth weight; neonatal height and head circumference at delivery; neonatal morbidities (neonatal care unit admission, respiratory distress, jaundice, congenital anomalies, Apgar score); neonatal hypoglycaemia; cost-effectiveness; treatment acceptability and quality of life determined by the EQ5D-5L scale. DISCUSSION: The EMERGE trial will determine the effectiveness and safety of early and routine use of metformin in GDM. TRIAL REGISTRATION: EudraCT Number 2016-001644-19l; NCT NCT02980276 . Registered on 6 June 2017.
Assuntos
Diabetes Gestacional , Ganho de Peso na Gestação , Hipoglicemia , Metformina , Glicemia , Ensaios Clínicos Fase III como Assunto , Diabetes Gestacional/diagnóstico , Diabetes Gestacional/tratamento farmacológico , Feminino , Galactose , Humanos , Hipoglicemia/induzido quimicamente , Recém-Nascido , Insulina/efeitos adversos , Metformina/efeitos adversos , Gravidez , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Aumento de PesoRESUMO
AIMS: Patient-reported outcomes (PROs) are reports of the patient's health status that come directly from the patient without interpretation by the clinician or anyone else. They are increasingly used in randomised controlled trials (RCTs). In this systematic review we identified RCTs conducted in women with diabetes in pregnancy which included PROs in their primary or secondary outcomes. We then evaluated the quality of PRO reporting against an internationally accepted reporting framework (Consolidated Standards of Reporting Trials (CONSORT-PRO) guidelines). METHODS: We searched online databases for studies published 2013-2021 using a combination of keywords. Two authors reviewed all abstracts independently. Data on study characteristics and the quality of PRO reporting were extracted from relevant studies. We conducted a multiple regression analysis to identify factors associated with high quality reporting. RESULTS: We identified 7122 citations. Thirty-five articles were included for review. Only 17% of RCTs included a PRO as a primary or secondary outcome. Out of a maximum score of 100 the median score was 46, indicating sub-optimal reporting. A multiple regression analysis did not reveal any factors associated with high quality reporting. CONCLUSIONS: Researchers should be mindful of the importance of PRO inclusion and reporting and include reliable PROs in trials.
Assuntos
Diabetes Mellitus , Medidas de Resultados Relatados pelo Paciente , Diabetes Mellitus/terapia , Feminino , Nível de Saúde , Humanos , GravidezRESUMO
BACKGROUND: Cardiotocography (CTG) is a screening test used to detect fetal hypoxia in labour. It has a high false positive rate resulting in many potentially unnecessary caesarean sections. Fetal blood sampling (FBS) is a second-line test of the acid-base status of the fetus. It is used to provide either reassurance that it is safe for labour to continue or objective evidence of compromise so that delivery can be expedited. Digital fetal scalp stimulation (dFSS) to elicit a fetal heart rate acceleration is an alternative less invasive second-line test of fetal wellbeing. This study aims to provide robust evidence on the role of these two second-line tests in assessing fetal wellbeing and potentially preventing operative delivery. METHODS: A multi-centre parallel group randomised controlled trial (RCT) is planned in four maternity centres in Ireland. The study aims to recruit 2500 nulliparous women with a term (≥37+0 weeks) singleton pregnancy who require a second-line test of fetal wellbeing in labour due to an abnormal CTG. Women will be allocated randomly to dFSS or FBS on a 1:1 ratio. The primary outcome is caesarean section. With 1250 women in each arm, the study will have 90% power to detect a difference of 5-6%, at a two-sided alpha significance level of 5%, assuming a caesarean section rate of at least 20% in the dFSS group. DISCUSSION: If the proposed study shows evidence that dFSS is a safe, reliable and effective alternative to FBS, this would have ground-breaking implications for labour management worldwide. It could potentially lead to a reduction in invasive procedures and emergency caesarean sections. TRIAL REGISTRATION: ClinicalTrials.gov NCT05306756. Registered on 31 March 2022. The trial commenced enrolment on 10 May 2022. Ethical committee approval has been granted by the Research Ethics Committee (REC) of each hospital: Dublin/CWIUH REC: 12.06.2019; Cork/UCC REC: 29.11.2019; Galway/NUIG REC: 06.09.2019; Limerick/UL REC: 30.09.2019.
Assuntos
Trabalho de Parto , Couro Cabeludo , Cardiotocografia/métodos , Feminino , Sangue Fetal , Frequência Cardíaca Fetal/fisiologia , Humanos , GravidezRESUMO
OBJECTIVE: To determine whether the addition of placental growth factor (PlGF) measurement to current clinical assessment of women with suspected pre-eclampsia before 37 weeks' gestation would reduce maternal morbidity without increasing neonatal morbidity. DESIGN: Stepped wedge cluster randomised control trial from 29 June 2017 to 26 April 2019. SETTING: National multisite trial in seven maternity hospitals throughout the island of Ireland PARTICIPANTS: Women with a singleton pregnancy between 20+0 to 36+6 weeks' gestation, with signs or symptoms suggestive of evolving pre-eclampsia. Of the 5718 women screened, 2583 were eligible and 2313 elected to participate. INTERVENTION: Participants were assigned randomly to either usual care or to usual care plus the addition of point-of-care PlGF testing based on the randomisation status of their maternity hospital at the time point of enrolment. MAIN OUTCOMES MEASURES: Co-primary outcomes of composite maternal morbidity and composite neonatal morbidity. Analysis was on an individual participant level using mixed-effects Poisson regression adjusted for time effects (with robust standard errors) by intention-to-treat. RESULTS: Of the 4000 anticipated recruitment target, 2313 eligible participants (57%) were enrolled, of whom 2219 (96%) were included in the primary analysis. Of these, 1202 (54%) participants were assigned to the usual care group, and 1017 (46%) were assigned the intervention of additional point-of-care PlGF testing. The results demonstrate that the integration of point-of-care PlGF testing resulted in no evidence of a difference in maternal morbidity-457/1202 (38%) of women in the control group versus 330/1017 (32%) of women in the intervention group (adjusted risk ratio (RR) 1.01 (95% CI 0.76 to 1.36), P=0.92)-or in neonatal morbidity-527/1202 (43%) of neonates in the control group versus 484/1017 (47%) in the intervention group (adjusted RR 1.03 (0.89 to 1.21), P=0.67). CONCLUSIONS: This was a pragmatic evaluation of an interventional diagnostic test, conducted nationally across multiple sites. These results do not support the incorporation of PlGF testing into routine clinical investigations for women presenting with suspected preterm pre-eclampsia, but nor do they exclude its potential benefit. TRIAL REGISTRATION: ClinicalTrials.gov NCT02881073.
Assuntos
Mortalidade Materna/tendências , Fator de Crescimento Placentário/metabolismo , Testes Imediatos/normas , Pré-Eclâmpsia/diagnóstico , Adulto , Biomarcadores/sangue , Estudos de Casos e Controles , Análise por Conglomerados , Feminino , Idade Gestacional , Humanos , Lactente , Mortalidade Infantil/tendências , Recém-Nascido , Irlanda , Avaliação de Resultados em Cuidados de Saúde , Fator de Crescimento Placentário/sangue , Testes Imediatos/estatística & dados numéricos , Pré-Eclâmpsia/sangue , Pré-Eclâmpsia/etnologia , GravidezRESUMO
BACKGROUND: Fatigue is a common symptom in cancer patients that can persist beyond the curative treatment phase. This systematic review evaluated the effectiveness of psychological interventions for cancer-related fatigue in post-treatment cancer survivors. METHODS: We searched relevant online databases and sources of grey literature. Randomised controlled trials (RCTs) evaluating psychological interventions in adult cancer patients after the completion of treatment, with fatigue as an outcome measure, were included. Two review authors extracted data independently from the selected studies and assessed the methodological quality using the Cochrane Collaboration Risk of Bias Tool. RESULTS: Thirty-three psychological interventions were identified. The sample size of the included studies varied between 28 and 409, with 4525 participants overall. Twenty-three of the included studies reported a significant effect of the interventions on reducing fatigue in cancer survivors. Most interventions focused on psychoeducation, mindfulness, cognitive or behaviour therapy-oriented strategies. However, studies differed widely in terms of measurement tools used to assess fatigue, mode, duration and frequency of the intervention delivery. CONCLUSIONS: This review showed some tentative support for psychological interventions for fatigue after cancer treatment. However, as the RCTs were heterogeneous in nature and the number of high-quality studies was limited, definitive conclusions are not yet possible. With the growing need for stage-specific research in cancer, this review sought to inform current practice and to summarise the existing evidence base of randomised controlled trials in the area. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration number: CRD42014015219.
Assuntos
Sobreviventes de Câncer/psicologia , Terapia Cognitivo-Comportamental , Fadiga/terapia , Atenção Plena , Ensaios Clínicos Controlados Aleatórios como Assunto , Humanos , Qualidade de VidaRESUMO
BACKGROUND: A biophysical profile (BPP) includes ultrasound monitoring of fetal movements, fetal tone and fetal breathing, ultrasound assessment of liquor volume with or without assessment of the fetal heart rate. The BPP is performed in an effort to identify babies that may be at risk of poor pregnancy outcome, so that additional assessments of wellbeing may be performed, or labour may be induced or a caesarean section performed to expedite birth. OBJECTIVES: To assess the effects of the BPP when compared with conventional monitoring (CTG only or MBPP) on pregnancy outcome in high-risk pregnancies. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (October 2007), CENTRAL (The Cochrane Library 2006, Issue 4), MEDLINE (1966 to November 2006), EMBASE (1974 to November 2006) and CINAHL (1980 to November 2006). SELECTION CRITERIA: Randomised and quasi-randomised controlled trials involving a comparison of fetal BPP with other forms of antepartum fetal assessment in women with high-risk pregnancies. DATA COLLECTION AND ANALYSIS: Two authors independently assessed eligibility, quality and extracted data. MAIN RESULTS: We included five trials, involving 2974 women. Most trials were not of high quality. Although the overall incidence of adverse outcomes was low, available evidence from randomised controlled trials does not support the use of BPP as a test of fetal wellbeing in high-risk pregnancies. We found no significant differences between the groups in perinatal deaths (relative risk (RR) 1.33, 95% confidence interval (CI) 0.60 to 2.98) or in Apgar score less than seven at five minutes (RR 1.27, 95% CI 0.85 to 1.92). Combined data from the two high-quality trials suggest an increased risk of caesarean section in the BPP group RR 1.60, 95% CI 1.05 to 2.44, n = 280, interaction test P = 0.03. However, the number of participating women was relatively small (n = 280). Therefore, additional evidence is required in order to be definitive regarding the efficacy of this test in high-risk pregnancies. Furthermore, the impact of the BPP on other interventions, length of hospitalisation, serious short-term and long-term neonatal morbidity and parental satisfaction requires further evaluation. AUTHORS' CONCLUSIONS: At present, there is insufficient evidence from randomised trials to support the use of BPP as a test of fetal wellbeing in high-risk pregnancies.
Assuntos
Desenvolvimento Fetal , Monitorização Fetal/métodos , Gravidez de Alto Risco , Ultrassonografia Pré-Natal , Feminino , Humanos , Gravidez , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
This study describes the use of intrapartum electronic fetal monitoring in Ireland. Electronic fetal monitoring (EFM) has become routine in the assessment of fetal wellbeing during labour. Current evidence indicates that the routine use of EFM leads to an increased caesarean section and operative vaginal delivery rate and a reduction in the rate of neonatal seizures. Practices and service provision related to the use and interpretation of and educational provision for electronic fetal monitoring have not been investigated in Ireland. A national survey of all (n = 22) maternity units in Ireland was undertaken using a self-reported questionnaire amended, with permission, from that used in the 8th CESDI report. The questionnaire sought information on unit birth rate in 2002, number of cardiotocograph (CTG) monitors available in delivery units, use of the admission CTG, use of continuous EFM for women with various risk factors for pregnancy and/or labour, availability of fetal blood sampling facilities, use of umbilical cord blood sampling and availability of guidelines on the use of EFM. All units responded to the survey giving a national picture of the use of EFM during labour. All units had cardiotocograph (CTG) monitors available in the delivery area (median 6, range 3-14). An admission CTG was performed on all women by 96% (n=21) of units. Thirty six per cent of units (n=8) used continuous EFM routinely during labour in women who did not have risk factors for labour. Fetal blood sampling (FBS) was used in 36% (n=8) of units in cases of suspicious CTG tracings. Umbilical cord blood gases were sampled routinely following emergency caesarean section in 46% (n= 10) of units while 64% (n= 14) did so if the baby's condition was poor at birth. A departmental guideline on the use of EFM was available in 73% (n= 16) units. The findings of this survey indicate wide variations in the use of intrapartum EFM in Ireland. The use of continuous EFM for specific high-risk indications was variable and EFM was used by a third of units for women who did not have risk factors for labour. The admission CTG was used by 21 of the 22 units despite evidence of no benefit. The absence of FBS in the majority of units surveyed and the low rate of umbilical cord blood sampling is of concern.
Assuntos
Cardiotocografia/estatística & dados numéricos , Sofrimento Fetal/diagnóstico , Adulto , Gasometria , Feminino , Frequência Cardíaca Fetal , Humanos , Irlanda , Trabalho de Parto , Gravidez , Resultado da Gravidez , Gravidez de Alto Risco , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Cardiotocography (sometimes known as electronic fetal monitoring), records changes in the fetal heart rate and their temporal relationship to uterine contractions. The aim is to identify babies who may be short of oxygen (hypoxic), so additional assessments of fetal well-being may be used, or the baby delivered by caesarean section or instrumental vaginal birth. OBJECTIVES: To evaluate the effectiveness of continuous cardiotocography during labour. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group Trials Register (March 2006), CENTRAL (The Cochrane Library 2005, Issue 4), MEDLINE (1966 to December 2005), EMBASE (1974 to December 2005), Dissertation Abstracts (1980 to December 2005) and the National Research Register (December 2005). SELECTION CRITERIA: Randomised and quasi-randomised controlled trials involving a comparison of continuous cardiotocography (with and without fetal blood sampling) with (a) no fetal monitoring, (b) intermittent auscultation (c) intermittent cardiotocography. DATA COLLECTION AND ANALYSIS: Two authors independently assessed eligibility, quality and extracted data. MAIN RESULTS: Twelve trials were included (over 37,000 women); only two were high quality. Compared to intermittent auscultation, continuous cardiotocography showed no significant difference in overall perinatal death rate (relative risk (RR) 0.85, 95% confidence interval (CI) 0.59 to 1.23, n = 33,513, 11 trials), but was associated with a halving of neonatal seizures (RR 0.50, 95% CI 0.31 to 0.80, n = 32,386, nine trials) although no significant difference was detected in cerebral palsy (RR 1.74, 95% CI 0.97 to 3.11, n = 13,252, two trials). There was a significant increase in caesarean sections associated with continuous cardiotocography (RR 1.66, 95% CI 1.30 to 2.13, n =18,761, 10 trials). Women were also more likely to have an instrumental vaginal birth (RR 1.16, 95% CI 1.01 to 1.32, n = 18,151, nine trials). Data for subgroups of low-risk, high-risk, preterm pregnancies and high quality trials were consistent with overall results. Access to fetal blood sampling did not appear to influence the difference in neonatal seizures nor any other prespecified outcome. AUTHORS' CONCLUSIONS: Continuous cardiotocography during labour is associated with a reduction in neonatal seizures, but no significant differences in cerebral palsy, infant mortality or other standard measures of neonatal well-being. However, continuous cardiotocography was associated with an increase in caesarean sections and instrumental vaginal births. The real challenge is how best to convey this uncertainty to women to enable them to make an informed choice without compromising the normality of labour.