Midwife-led continuity models versus other models of care for childbearing women.

BACKGROUND: Midwives are primary providers of care for childbearing women around the world. However, there is a lack of synthesised information to establish whether there are differences in morbidity and mortality, effectiveness and psychosocial outcomes between midwife-led continuity models and other models of care. OBJECTIVES: To compare midwife-led continuity models of care with other models of care for childbearing women and their infants. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 May 2015) and reference lists of retrieved studies. SELECTION CRITERIA: All published and unpublished trials in which pregnant women are randomly allocated to midwife-led continuity models of care or other models of care during pregnancy and birth. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. MAIN RESULTS: We included 15 trials involving 17,674 women. We assessed the quality of the trial evidence for all primary outcomes (i.e., regional analgesia (epidural/spinal), caesarean birth, instrumental vaginal birth (forceps/vacuum), spontaneous vaginal birth, intact perineum, preterm birth (less than 37 weeks) and overall fetal loss and neonatal death (fetal loss was assessed by gestation using 24 weeks as the cut-off for viability in many countries) using the GRADE methodology: All primary outcomes were graded as of high quality.For the primary outcomes, women who had midwife-led continuity models of care were less likely to experience regional analgesia (average risk ratio (RR) 0.85, 95% confidence interval (CI) 0.78 to 0.92; participants = 17,674; studies = 14; high quality), instrumental vaginal birth (average RR 0.90, 95% CI 0.83 to 0.97; participants = 17,501; studies = 13; high quality), preterm birth less than 37 weeks (average RR 0.76, 95% CI 0.64 to 0.91; participants = 13,238; studies = 8; high quality) and less overall fetal/neonatal death (average RR 0.84, 95% CI 0.71 to 0.99; participants = 17,561; studies = 13; high quality evidence). Women who had midwife-led continuity models of care were more likely to experience spontaneous vaginal birth (average RR 1.05, 95% CI 1.03 to 1.07; participants = 16,687; studies = 12; high quality). There were no differences between groups for caesarean births or intact perineum.For the secondary outcomes, women who had midwife-led continuity models of care were less likely to experience amniotomy (average RR 0.80, 95% CI 0.66 to 0.98; participants = 3253; studies = 4), episiotomy (average RR 0.84, 95% CI 0.77 to 0.92; participants = 17,674; studies = 14) and fetal loss/neonatal death before 24 weeks (average RR 0.81, 95% CI 0.67 to 0.98; participants = 15,645; studies = 11). Women who had midwife-led continuity models of care were more likely to experience no intrapartum analgesia/anaesthesia (average RR 1.21, 95% CI 1.06 to 1.37; participants = 10,499; studies = 7), have a longer mean length of labour (hours) (mean difference (MD) 0.50, 95% CI 0.27 to 0.74; participants = 3328; studies = 3) and more likely to be attended at birth by a known midwife (average RR 7.04, 95% CI 4.48 to 11.08; participants = 6917; studies = 7). There were no differences between groups for fetal loss or neonatal death more than or equal to 24 weeks, induction of labour, antenatal hospitalisation, antepartum haemorrhage, augmentation/artificial oxytocin during labour, opiate analgesia, perineal laceration requiring suturing, postpartum haemorrhage, breastfeeding initiation, low birthweight infant, five-minute Apgar score less than or equal to seven, neonatal convulsions, admission of infant to special care or neonatal intensive care unit(s) or in mean length of neonatal hospital stay (days).Due to a lack of consistency in measuring women's satisfaction and assessing the cost of various maternity models, these outcomes were reported narratively. The majority of included studies reported a higher rate of maternal satisfaction in midwife-led continuity models of care. Similarly, there was a trend towards a cost-saving effect for midwife-led continuity care compared to other care models. AUTHORS' CONCLUSIONS: This review suggests that women who received midwife-led continuity models of care were less likely to experience intervention and more likely to be satisfied with their care with at least comparable adverse outcomes for women or their infants than women who received other models of care.Further research is needed to explore findings of fewer preterm births and fewer fetal deaths less than 24 weeks, and overall fetal loss/neonatal death associated with midwife-led continuity models of care

Palliative care interventions in advanced dementia

BACKGROUND: Dementia is a chronic, progressive and ultimately fatal neurodegenerative disease. Advanced dementia is characterised by profound cognitive impairment, inability to communicate verbally and complete functional dependence. Usual care of people with advanced dementia is not underpinned universally by a palliative approach. Palliative care has focused traditionally on care of people with cancer, but for more than a decade, there have been calls worldwide to extend palliative care services to include all people with life-limiting illnesses in need of specialist care, including people with dementia. This review is an updated version of a review first published in 2016. OBJECTIVES: To assess the effect of palliative care interventions in advanced dementia. SEARCH METHODS: We searched ALOIS, the Cochrane Dementia and Cognitive Improvement Group's Specialised Register on 7 October 2020. ALOIS contains records of clinical trials identified from monthly searches of several major healthcare databases, trial registries and grey literature sources. We ran additional searches across MEDLINE (OvidSP), Embase (OvidSP), four other databases and two trial registries on 7 October 2020 to ensure that the searches were as comprehensive and as up-to-date as possible. SELECTION CRITERIA: We searched for randomised (RCTs) and non-randomised controlled trials (nRCTs), controlled before-and-after studies and interrupted time series studies evaluating the impact of palliative care interventions for adults with advanced dementia of any type. Participants could be people with advanced dementia, their family members, clinicians or paid care staff. We included clinical interventions and non-clinical interventions. Comparators were usual care or another palliative care intervention. We did not exclude studies based on outcomes measured. DATA COLLECTION AND ANALYSIS: At least two review authors (SW, EM, PC) independently assessed all potential studies identified in the search against the review inclusion criteria. Two authors independently extracted data from eligible studies. Where appropriate, we estimated pooled treatment effects in a fixed-effect meta-analysis. We assessed the risk of bias of included studies using the Cochrane Risk of Bias tool and the overall certainty of the evidence for each outcome using GRADE. MAIN RESULTS: Nine studies (2122 participants) met the review inclusion criteria. Two studies were individually-randomised RCTs, six were cluster-randomised RCTs and one was a controlled before-and-after study. We conducted two separate comparisons: organisation and delivery of care interventions versus usual care (six studies, 1162 participants) and advance care planning interventions versus usual care (three studies, 960 participants). Two studies were carried out in acute hospitals and seven in nursing homes or long-term care facilities. For both comparisons, we found the included studies to be sufficiently similar to conduct meta-analyses. Changes to the organisation and delivery of care for people with advanced dementia may increase comfort in dying (MD 1.49, 95% CI 0.34 to 2.64; 5 studies, 335 participants; very low certainty evidence). However, the evidence is very uncertain and unlikely to be clinically significant. These changes may also increase the likelihood of having a palliative care plan in place (RR 5.84, 95% CI 1.37 to 25.02; 1 study, 99 participants; I2 = 0%; very low certainty evidence), but again the evidence is very uncertain. Such interventions probably have little effect on the use of non-palliative interventions (RR 1.11, 95% CI 0.71 to 1.72; 2 studies, 292 participants; I2 = 0%; moderate certainty evidence). They may also have little or no effect on documentation of advance directives (RR 1.46, 95% CI 0.50 to 4.25; 2 studies, 112 participants; I2 = 52%; very low certainty evidence), or whether discussions take place about advance care planning (RR 1.08, 95% CI 1.00 to 1.18; 1 study, 193 participants; I2 = 0%; very low certainty evidence) and goals of care (RR 2.36, 95% CI 1.00 to 5.54; 1 study, 13 participants; I2 = 0%; low certainty evidence). No included studies assessed adverse effects. Advance care planning interventions for people with advanced dementia probably increase the documentation of advance directives (RR 1.23, 95% CI 1.07 to 1.41; 2 studies, 384; moderate certainty evidence) and the number of discussions about goals of care (RR 1.33, 95% CI 1.11 to 1.59; 2 studies, 384 participants; moderate certainty evidence). They may also slightly increase concordance with goals of care (RR 1.39, 95% CI 1.08 to 1.79; 1 study, 63 participants; low certainty evidence). On the other hand, they may have little or no effect on perceived symptom management (MD -1.80, 95% CI -6.49 to 2.89; 1 study, 67 participants; very low certainty evidence) or whether advance care planning discussions occur (RR 1.04, 95% CI 0.87 to 1.24; 1 study, 67 participants; low certainty evidence). AUTHORS' CONCLUSIONS: The evidence on palliative care interventions in advanced dementia is limited in quantity and certainty. When compared to usual care, changes to the organisation and delivery of care for people with advanced dementia may lead to improvements in comfort in dying, but the evidence for this was of very low certainty. Advance care planning interventions, compared to usual care, probably increase the documentation of advance directives and the occurrence of discussions about goals of care, and may also increase concordance with goals of care. We did not detect other effects. The uncertainty in the evidence across all outcomes in both comparisons is mainly driven by imprecision of effect estimates and risk of bias in the included studies

Donepezil Effects on Mood in Patients with Schizophrenia and Schizoaffective Disorder

Donepezil, 5 mg/d for 6 wk then 10 mg/d for 6 wk, and placebo daily for 12 wk in a double-blind cross-over paradigm, was added to the therapeutic regimen of 13 patients with schizophrenia or schizoaffective disorders, clinically stable on atypical antipsychotic medications. Patients had varying degrees of depressive symptoms, ranging from no depression to clinically significant depression. There was no worsening or induction of depression in individual patients or the group as a whole. In addition there was a statistically significant antidepressant effect in the group as a whole during the donepezil condition and a clinically significant antidepressant effect in the patients with clinically significant depressive symptoms, although there were not enough depressed patients in the group to conclude that donepezil may have antidepressant effects. Thus, in this study, donepezil did not induce or worsen depressive symptoms in schizophrenic and schizoaffective disorder patients

Protocol for the development of a salutogenic intrapartum core outcome set (SIPCOS)

Background: Maternity intrapartum care research and clinical care more often focus on outcomes that minimise or prevent adverse health rather than on what constitutes positive health and wellbeing (salutogenesis). This was highlighted recently in a systematic review of reviews of intrapartum reported outcomes where only 8% of 1648 individual outcomes, from 102 systematic reviews, were agreed as being salutogenically-focused. Added to this is variation in the outcomes measured in individual studies rendering it very difficult for researchers to synthesise, fully, the evidence from studies on a particular topic. One of the suggested ways to address this is to develop and apply an agreed standardised set of outcomes, known as a ‘core outcome set’ (COS). In this paper we present a protocol for the development of a salutogenic intrapartum COS (SIPCOS) for use in maternity care research and a SIPCOS for measuring in daily intrapartum clinical care. Methods: The study proposes three phases in developing the final SIPCOSs. Phase one, which is complete, involved the conduct of a systematic review of reviews to identify a preliminary list of salutogenically-focused outcomes that had previously been reported in systematic reviews of intrapartum interventions. Sixteen unique salutogenically-focused outcome categories were identified. Phase two will involve prioritising these outcomes, from the perspective of key stakeholders (users of maternity services, clinicians and researchers) by asking them to rate the importance of each outcome for inclusion in the SIPCOSs. A final consensus meeting (phase three) will be held, bringing international stakeholders together to review the preliminary SIPCOSs resulting from the survey and to agree and finalise the final SIPCOSs for use in future maternity care research and daily clinical care. Discussion: The expectation in developing the SIPCOSs is that they will be collected and reported in all future studies evaluating intrapartum interventions and measured/recorded in future intrapartum clinical care, as routine, alongside other outcomes also deemed important in the context of the study or clinical scenario. Using the SIPCOSs in this way, will promote and encourage standardised measurements of positive health outcomes in maternity care, into the future

Factors that impact on recruitment to randomised trials in health care: a qualitative evidence synthesis

BACKGROUND: Randomised trials (also referred to as 'randomised controlled trials' or 'trials') are the optimal way to minimise bias in evaluating the effects of competing treatments, therapies and innovations in health care. It is important to achieve the required sample size for a trial, otherwise trialists may not be able to draw conclusive results leading to research waste and raising ethical questions about trial participation. The reasons why potential participants may accept or decline participation are multifaceted. Yet, the evidence of effectiveness of interventions to improve recruitment to trials is not substantial and fails to recognise these individual decision-making processes. It is important to synthesise the experiences and perceptions of those invited to participate in randomised trials to better inform recruitment strategies. OBJECTIVES: To explore potential trial participants' views and experiences of the recruitment process for participation. The specific objectives are to describe potential participants' perceptions and experiences of accepting or declining to participate in trials, to explore barriers and facilitators to trial participation, and to explore to what extent barriers and facilitators identified are addressed by strategies to improve recruitment evaluated in previous reviews of the effects of interventions including a Cochrane Methodology Review. SEARCH METHODS: We searched the Cochrane Library, Medline, Embase, CINAHL, Epistemonikos, LILACS, PsycINFO, ORRCA, and grey literature sources. We ran the most recent set of searches for which the results were incorporated into the review in July 2017. SELECTION CRITERIA: We included qualitative and mixed-methods studies (with an identifiable qualitative component) that explored potential trial participants' experiences and perceptions of being invited to participate in a trial. We excluded studies that focused only on recruiters' perspectives, and trials solely involving children under 18 years, or adults who were assessed as having impaired mental capacity. DATA COLLECTION AND ANALYSIS: Five review authors independently assessed the titles, abstracts and full texts identified by the search. We used the CART (completeness, accuracy, relevance, timeliness) criteria to exclude studies that had limited focus on the phenomenon of interest. We used QSR NVivo to extract and manage the data. We assessed methodological limitations using the Critical Skills Appraisal Programme (CASP) tool. We used thematic synthesis to analyse and synthesise the evidence. This provided analytical themes and a conceptual model. We used the GRADE-CERQual (Confidence in the Evidence from Reviews of Qualitative research) approach to assess our confidence in each finding. Our findings were integrated with two previous intervention effectiveness reviews by juxtaposing the quantitative and qualitative findings in a matrix. MAIN RESULTS: We included 29 studies (published in 30 papers) in our synthesis. Twenty-two key findings were produced under three broad themes (with six subthemes) to capture the experience of being invited to participate in a trial and making the decision whether to participate. Most of these findings had moderate to high confidence. We identified factors from the trial itself that influenced participation. These included how trial information was communicated, and elements of the trial such as the time commitment that might be considered burdensome. The second theme related to personal factors such as how other people can influence the individual's decision; and how a personal understanding of potential harms and benefits could impact on the decision. Finally, the potential benefits of participation were found to be key to the decision to participate, namely personal benefits such as access to new treatments, but also the chance to make a difference and help others. The conceptual model we developed presents the decision-making process as a gauge and the factors that influence whether the person will, or will not, take part. AUTHORS' CONCLUSIONS: This qualitative evidence synthesis has provided comprehensive insight into the complexity of factors that influence a person's decision whether to participate in a trial. We developed key questions that trialists can ask when developing their recruitment strategy. In addition, our conceptual model emphasises the need for participant-centred approaches to recruitment. We demonstrated moderate to high level confidence in our findings, which in some way can be attributed to the large volume of highly relevant studies in this field. We recommend that these insights be used to direct or influence or underpin future recruitment strategies that are developed in a participant-driven way that ultimately improves trial conduct and reduces research waste

No-Boundary Thinking in Bioinformatics

The following sections are included:Bioinformatics is a Mature DisciplineThe Golden Era of Bioinformatics Has BegunNo-Boundary Thinking in BioinformaticsReference

Is there evidence for accelerated polyethylene wear in uncemented compared to cemented acetabular components? A systematic review of the literature

Joint arthroplasty registries show an increased rate of aseptic loosening in uncemented acetabular components as compared to cemented acetabular components. Since loosening is associated with particulate wear debris, we postulated that uncemented acetabular components demonstrate a higher polyethylene wear rate than cemented acetabular components in total hip arthroplasty. We performed a systematic review of the peer-reviewed literature, comparing the wear rate in uncemented and cemented acetabular components in total hip arthroplasty. Studies were identified using MEDLINE (PubMed), EMBASE and the Cochrane Central Register of Controlled Trials. Study quality was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. The search resulted in 425 papers. After excluding duplicates and selection based on title and abstracts, nine studies were found eligible for further analysis: two randomised controlled trials, and seven observational studies. One randomised controlled trial found a higher polyethylene wear rate in uncemented acetabular components, while the other found no differences. Three out of seven observational studies showed a higher polyethylene wear in uncemented acetabular component fixation; the other four studies did not show any differences in wear rates. The available evidence suggests that a higher annual wear rate may be encountered in uncemented acetabular components as compared to cemented components

Standardising outcomes for clinical trials and systematic reviews

Fifteen years ago, what was to become OMERACT met for the first time in The Netherlands to discuss ways in which the multitude of outcomes in assessments of the effects of treatments for rheumatoid arthritis might be standardised. In Trials, Tugwell et al have described the need for, and success of, this initiative [1] and Cooney and colleagues have set out their plans for a corresponding initiative for ulcerative colitis [2]. Why do we need such initiatives? What\u27s the problem? And are these and other initiatives the solution

Core Outcome Set for GROwth restriction: deVeloping Endpoints (COSGROVE).

BACKGROUND: Foetal growth restriction (FGR) refers to a foetus that does not reach its genetically predetermined growth potential. It is well recognised that growth-restricted foetuses are at increased risk of stillbirth, foetal compromise, early neonatal death and neonatal morbidity. Later in life, they are prone to health problems, including increased risk of cardiovascular diseases and neurodevelopmental disorders. Interventions for preventing and treating FGR have been studied in many trials, but evidence is often difficult to synthesise and compare because of differences in the selection and definition of outcomes. To enable future trials to measure similar, meaningful outcomes, we are developing two core outcome sets (COS) - one for prevention and the other for treatment of FGR. METHODS: We will review the literature to identify previously reported outcomes. An international panel of relevant stakeholders who have experience of FGR (parent or carer of a baby that was growth restricted, health professional involved in the care of mothers and babies affected by FGR, a person with expertise in FGR research) will rate the importance of each of those outcomes in a series of three sequential online rounds of a Delphi study. Participants will be able to add items to the proposed list in round 1. A final face-to-face consensus meeting will be held with representatives of each stakeholder group at which a final list of outcomes for inclusion in the COS will be agreed. DISCUSSION: The development of COSs in FGR will ensure the collection and reporting of a minimum dataset agreed by stakeholder consensus and will reduce inconsistencies in the reporting of outcomes across relevant trials. Such standardisation in the reporting of outcomes will improve synthesis of evidence and generalisability of knowledge in the future by reducing heterogeneity in outcomes between trials and thus improve the results of systematic reviews and meta-analyses. Ultimately, we hope that the COSs will lead to an improvement in the quality of evidence-based clinical practice, enhance patient care, and improve the quality and consistency of research. TRIAL REGISTRATION: Not applicable. This study is registered in the Core Outcome Measures for Effectiveness (COMET) database