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Background The best way of comparing healthcare treatments is through a randomised trial. In a randomised trial, we compare something (a treatment or intervention) to something else, often another treatment. Who gets what is decided at random, meaning everyone has an equal chance of getting any of the treatments. This means any differences found can be put down to the treatment received rather than other things, such as where people live, or health conditions they might have. The People’s Trial aimed to help the public better understand randomised trials by inviting them to design and carry out a trial. The question chosen by the public for The People’s Trial was: ‘Does reading a book in bed make a difference to sleep, in comparison to not reading a book in bed?’ This paper describes that trial, called ‘The Reading Trial’. Methods The Reading Trial was an online, randomised trial. Members of the public were invited to take part through social media campaigns. People were asked to either read a book in bed before going to sleep (intervention group) or not read a book in bed before going to sleep (control group). We asked everyone to do this for 7 days, after which they measured their sleep quality. Results During December 2019, a total of 991 people took part in The Reading Trial, half (496 (50%)) in the intervention group and half (495 (50%)) in the control group. Not everyone finished the trial: 127 (25.6%) people in the intervention group and 90 (18.18%) people in the control group. Of those providing data, 156/369 (42%) people in the intervention group felt their sleep improved, compared to 112/405 (28%) of those in the control group, a difference of 14%. When we consider how certain we are of this finding, we estimate that, in The Reading Trial, sleep improved for between 8 and 22% more people in the intervention group compared to the control group. Conclusions Reading a book in bed before going to sleep improved sleep quality, compared to not reading a book in bed. Trial registration ClinicalTrials.gov NCT04185818. Registered on 4 December 2019.

Background:Shortages of personal protective equipment during the coronavirus disease 2019 (COVID-19) pandemic have led to the extended use or reuse of single-use respirators and surgical masks by frontline healthcare workers. The evidence base underpinning such practices warrants examination.Objectives:To synthesize current guidance and systematic review evidence on extended use, reuse, or reprocessing of single-use surgical masks or filtering face-piece respirators.Data sources:We used the World Health Organization, the European Centre for Disease Prevention and Control, the US Centers for Disease Control and Prevention, and Public Health England websites to identify guidance. We used Medline, PubMed, Epistemonikos, Cochrane Database, and preprint servers for systematic reviews.Methods:Two reviewers conducted screening and data extraction. The quality of included systematic reviews was appraised using AMSTAR-2. Findings were narratively synthesized.Results:In total, 6 guidance documents were identified. Levels of detail and consistency across documents varied. They included 4 high-quality systematic reviews: 3 focused on reprocessing (decontamination) of N95 respirators and 1 focused on reprocessing of surgical masks. Vaporized hydrogen peroxide and ultraviolet germicidal irradiation were highlighted as the most promising reprocessing methods, but evidence on the relative efficacy and safety of different methods was limited. We found no well-established methods for reprocessing respirators at scale.Conclusions:Evidence on the impact of extended use and reuse of surgical masks and respirators is limited, and gaps and inconsistencies exist in current guidance. Where extended use or reuse is being practiced, healthcare organizations should ensure that policies and systems are in place to ensure these practices are carried out safely and in line with available guidance.

Introduction We Can Quit” (WCQ) is community-based stop-smoking program delivered by trained community facilitators, based on the socio-ecological framework and developed using a Community-based Participatory Research approach, targeting women living in socioeconomically disadvantaged (SED) areas of Ireland. Aims and Methods The We Can Quit2 (WCQ2) pilot trial assessed the feasibility of WCQ. A pragmatic cluster randomized controlled trial with a process evaluation WCQ2, was conducted in four matched pairs of SED districts (8–10 000 women per district). Districts were independently randomized to WCQ (group support + nicotine replacement therapy), or to individual support delivered by health professionals. Participants were adult women smokers interested in quitting, who were living or working in trial districts. Recruitment of districts and 194 women in four waves (49 women per wave); retention at 12 weeks and 6 months; fidelity to intervention delivery and acceptability of trial-related processes were assessed. Validated smoking abstinence at 12-week and 6-month post-intervention was recorded, missing data assumed as continued smoking. Results Eight districts were recruited. 125/188 (66.5%) eligible women consented. The 49 women target was reached in wave4. Retention at 12 weeks was (Intervention [I]: 55.4%; Control [C]: 51.7%), at 6 months (I: 47.7%; C: 46.7%). Smoking abstinence at 12 weeks was (I: 23.1%, [95% CI: 14.5 to 34.7]; C: 13%, [95% CI: 6.9 to 24.1]). 83.8% of session activities were delivered. Trial-related processes were acceptable to facilitators. Low literacy was highlighted as a barrier for participants’ acceptability. Conclusions WCQ was feasible to deliver by trained facilitators and indicated a positive direction in abstinence rates. Low literacy will need to be addressed in a future trial design. Implications This pilot trial showed that a stop-smoking intervention tailored to a group of women smokers living in SED areas which was delivered by trained local women within their local communities was feasible. Furthermore, although not formally compared, more WCQ women were abstinent from smoking at the end of treatment. The results are relevant to enhance the design of a fully powered effectiveness trial, and provide important evidence on the barriers to deliver a tailored smoking cessation service to SED women smokers in Ireland.

Background Ensuring that a trial is designed so that its participants reflect those who might benefit from the results, or be spared harms, is key to the potential benefits of the trial reaching all they should. This paper describes the process, facilitated by Trial Forge, that was used between July 2019 and October 2020 to develop the INCLUDE Ethnicity Framework, part of the wider INCLUDE initiative from the National Institute for Health Research to improve inclusion of under-served groups in clinical research studies. Methods Development of the Framework was done in seven phases: (1) outline, (2) initial draft, (3) stakeholder meeting, (4) modify draft, (5) Stakeholder feedback, (6) applying the Framework and (7) packaging. Phases 2 and 3 were face-to-face meetings. Consultation with stakeholders was iterative, especially phases 4 to 6. Movement to the next phase was done once all or most stakeholders were comfortable with the results of the current phase. When there was a version of the Framework that could be considered final, the Framework was applied to six trials to create a set of examples (phase 6). Finally, the Framework, guidance and examples were packaged ready for dissemination (phase 7). Results A total of 40 people from stakeholder groups including patient and public partners, clinicians, funders, academics working with various ethnic groups, trial managers and methodologists contributed to the seven phases of development. The Framework comprises two parts. The first part is a list of four key questions: Who should my trial apply to? Are the groups identified likely to respond in different ways? Will my study intervention make it harder for some groups to engage? Will the way I have designed the study make it harder for some groups to engage? The second part is a set of worksheets to help trial teams address these questions. The Framework can be used for any stage of trial, for a healthcare intervention in any disease area. The Framework was launched on 1st October 2020 and is available open access at the Trial Forge website: https://www.trialforge.org/trial-forge-centre/include/. Conclusion Thinking about the number of people in our trials is not enough: we need to start thinking more carefully about who our participants are.

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.

BACKGROUND: A considerable challenge for maternity care providers is recognising clinical deterioration early in pregnant women. Professional bodies recommend the use of clinical assessment protocols or evaluation tools, commonly referred to as physiological track‐and‐trigger systems (TTS) or early warning systems (EWS), as a means of helping maternity care providers recognise actual or potential clinical deterioration early. TTS/EWS are clinician‐administered (midwife, obstetrician), bedside physiological assessment protocols, charts or tools designed to record routinely assessed clinical parameters; that is, blood pressure, temperature, heart rate, urine output and mental/neurological alertness. In general, these systems involve the application of scores or alert indicators to the observed physiological parameters based on their prespecified limits of normality. The overall system score or alert limit is then used to assist the maternity care provider identify a need to escalate care. This, in turn, may allow for earlier intervention(s) to alter the course of the emerging critical illness and ultimately reduce or avoid mortality and morbidity sequelae. OBJECTIVES: To evaluate the clinical‐ and cost‐effectiveness of maternal physiological TTS/EWS on pregnancy, labour and birth, postpartum (up to 42 days) and neonatal outcomes. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register (28 May 2021), ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (7 June 2021), OpenGrey, the ProQuest Dissertations and Theses database (7 June 2021), and reference lists of retrieved studies. SELECTION CRITERIA: We included randomised and quasi‐randomised controlled trials (RCTs), including cluster‐RCTs, comparing physiological TTS/EWS with no system or another system. Participants were women who were pregnant or had given birth within the previous 42 days, at high risk and low risk for pregnancy, labour and birth, and postpartum complications. DATA COLLECTION AND ANALYSIS: Two review authors (VS and MN) independently assessed all identified papers for inclusion and performed risk of bias assessments. Any discrepancies were resolved through discussion and consensus. Data extraction was also conducted independently by two review authors (VS and MN) and checked for accuracy. We used the summary odds ratio (OR) with 95% confidence intervals (CIs) to present the results for dichotomous data and the mean difference (MD) with 95% CI to present the results for continuous data. MAIN RESULTS: We included two studies, a parallel RCT involving 700 women and a stepped‐wedge cluster trial involving 536,233 women. Both studies were published in 2019, and both were conducted in low‐resource settings. The interventions were the 'Saving Mothers Score' (SMS) and the CRADLE Vital Sign Alert (VSA) device, and both interventions were compared with standard care. Both studies had low or unclear risk of bias on all seven risk of bias criteria. Evidence certainty, assessed using GRADE, ranged from very low to moderate certainty, mainly due to other bias as well as inconsistency and imprecision. For women randomised to TTS/EWS compared to standard care there is probably little to no difference in maternal death (OR 0.80, 95% CI 0.30 to 2.11; 1 study, 536,233 participants; moderate‐certainty evidence). Use of TTS/EWS compared to standard care may reduce total haemorrhage (OR 0.36, 95% CI 0.19 to 0.69; 1 study, 700 participants; low‐certainty evidence). For women randomised to TTS/EWS compared to standard care there may be little to no difference in sepsis (OR 0.21, 95% CI 0.02 to 1.80; 1 study, 700 participants; low‐certainty evidence), eclampsia (OR 1.50, 95% CI 0.74 to 3.03; 2 studies, 536,933 participants; low‐certainty evidence) and HELLP (OR 0.21, 95% CI 0.01 to 4.40; 1 study, 700 participants; very low‐certainty evidence), and probably little to no difference in maternal admission to the intensive care unit (ICU) (OR 0.78, 95% CI 0.53 to 1.15; 2 studies, 536,933 participants; moderate‐certainty evidence). Use of TTS/EWS compared to standard care may reduce a woman's length of hospital stay (MD ‐1.21, 95% CI ‐1.78 to ‐0.64; 1 study, 700 participants; low‐certainty evidence) but may result in little to no difference in neonatal death (OR 1.06, 95% CI 0.62 to 1.84; 1 study, 700 participants; low‐certainty evidence). Cost‐effectiveness measures were not measured in either of the two studies. AUTHORS' CONCLUSIONS: Use of TTS/EWS in maternity care may be helpful in reducing some maternal outcomes such as haemorrhage and maternal length of hospital stay, possibly through early identification of clinical deterioration and escalation of care. The evidence suggests that the use of TTS/EWS compared to standard care probably results in little to no difference in maternal death and may result in little to no difference in neonatal death. Both of the included studies were conducted in low‐resource settings where the use of TTS/EWS might potentially confer a different effect to TTS/EWS use in high‐resource settings. Further high‐quality trials in high‐ and middle‐resource settings, as well as in discrete populations of high‐ and low‐risk women, are required.

Objective The objective of this study was to examine the effectiveness of education and training interventions on recruitment to randomized and non-randomized trials. Study Design and Setting A systematic review of the effectiveness of education and training interventions for recruiters to trials. The review included randomized and non-randomized controlled trials of any type of education and training intervention for recruiters to trials, within any health care field. The primary outcome was recruitment rates, and secondary outcomes were quality of informed consent, recruiter self-confidence, understanding/knowledge of trial information, numbers of potential trial participants approached, satisfaction with training, and retention rates. Results Of the 19 records reviewed at full-text level, six met the inclusion criteria for our review. Owing to heterogeneity of outcomes and methods between the included studies, meta-analysis was not possible for the primary outcome. Of the three studies that reported recruitment rates, one favored the education and training intervention for increased recruitment; the remaining two found no differences between the groups. Of the reported secondary outcomes, quality of informed consent was improved, but no differences between groups in understanding/knowledge of trial information were found. Conclusion There is limited evidence of effectiveness on the impact of education and training interventions on trial recruitment. Further work on developing a substantial evidence base around the effectiveness of education and training interventions for recruiters to trials is required.

Aims/hypothesis Gestational diabetes mellitus (GDM) is linked with a higher lifetime risk for the development of impaired fasting glucose, impaired glucose tolerance, type 2 diabetes, the metabolic syndrome, cardiovascular disease, postpartum depression and tumours. Despite this, there is no consistency in the long-term follow-up of women with a previous diagnosis of GDM. Further, the outcomes selected and reported in the research involving this population are heterogeneous and lack standardisation. This amplifies the risk of reporting bias and diminishes the likelihood of significant comparisons between studies. The aim of this study is to develop a core outcome set (COS) for RCTs and other studies evaluating the long-term follow-up at 1 year and beyond of women with previous GDM treated with insulin and/oral glucose-lowering agents. Methods The study consisted of three work packages: (1) a systematic review of the outcomes reported in previous RCTs of the follow-up at 1 year and beyond of women with GDM treated with insulin and/or oral glucose-lowering agents; (2) a three-round online Delphi survey with key stakeholders to prioritise these outcomes; and (3) a consensus meeting where the final COS was decided. Results Of 3344 abstracts identified and evaluated, 62 papers were retrieved and 25/62 papers were included in this review. A total of 121 outcomes were identified and included in the Delphi survey. Delphi round 1 was emailed to 835 participants and 288 (34.5%) responded. In round 2, 190 of 288 (65.9%) participants responded and in round 3, 165 of 190 (86.8%) participants responded. In total, nine outcomes were selected and agreed for inclusion in the final COS: assessment of glycaemic status; diagnosis of type 2 diabetes since the index pregnancy; number of pregnancies since the index pregnancy; number of pregnancies with a diagnosis of GDM since the index pregnancy; diagnosis of prediabetes since the index pregnancy; BMI; post-pregnancy weight retention; resting blood pressure; and breastfeeding. Conclusions/interpretation This study identified a COS that will help bring consistency and uniformity to outcome selection and reporting in clinical trials and other studies involving the follow-up at 1 year and beyond of women diagnosed with GDM treated with insulin and/or oral glucose-lowering agents during pregnancy. Electronic supplementary material The online version of this article (10.1007/s00125-019-4935-9) contains peer-reviewed but unedited supplementary material, which is available to authorised users.

Background Measuring care processes is an important component of any effort to improve care quality, however knowing the appropriate metrics to measure is a challenge both in Ireland and other countries. Quality of midwifery care depends on the expert knowledge of the midwife and her/his contribution to women and their babies’ safety in the healthcare environment. Therefore midwives need to be able to clearly articulate and measure what it is that they do, the dimensions of their professional practice frequently referred to as midwifery care processes. The objective of this paper is to report on the development and prioritisation of a national suite of Quality Care Metrics (QCM), and their associated indicators, for midwifery care processes in Ireland. Methods The study involved four discrete, yet complimentary, phases; i) a systematic literature review to identify midwifery care process metrics and their associated measurement indicators; ii) a two-round, online Delphi survey of midwives to develop consensus on the set of midwifery care process metrics to be measured; iii) a two-round online Delphi survey of midwives to develop consensus on the indicators that will be used to measure prioritised metrics; and iv) a face-to-face consensus meeting with midwives to review the findings and achieve consensus on the final suite of metrics and indicators. Results Following the consensus meeting, 18 metrics and 93 indicators were prioritised for inclusion in the suite of QCM Midwifery Metrics. These metrics span the pregnancy, birth and postpartum periods. Conclusion The development of this suite of process metrics and indicators for midwifery care provides an opportunity for measuring the safety and quality of midwifery care in Ireland and for adapting internationally. This initial work should be followed by a rigorous evaluation of the impact of the new suite of metrics on midwifery care processes. Electronic supplementary material The online version of this article (10.1186/s12884-019-2346-z) contains supplementary material, which is available to authorized users.

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.

Background The translation of research into clinical practice is a key component of evidence-informed decision making. We implemented a multi-component dissemination and implementation strategy for healthcare professionals (HCPs) called Evidence Rounds. We report the findings of focus groups and interviews with HCPs to explore their perceptions of Evidence Rounds and help inform the implementation of future similar initiatives. This is the second paper in a two-part series. Methods We employed total population, purposive sampling by targeting all of the health care professionals who attended or presented at group sessions exploring the evidence on clinical questions or topics chosen and presented by the HCPs. We conducted and audio-recorded in-person focus groups and one-to-one interviews, which were then transcribed verbatim. Two authors independently coded transcripts. NVivo software was used to collate the primary data and codes. We analysed data guided by the five steps involved in framework analysis; 1) familiarization 2) identifying a thematic framework 3) indexing 4) charting 5) mapping and interpretation. Results Thirteen HCPs participated, of which 6 were medical doctors an d 7 were nursing or midwifery staff. We identified the following key domains; organisational readiness for change, barriers and facilitators to attendance, barriers and facilitators to presenting, communication and dissemination of information, and sustainability. During focus groups and interviews HCPs reported that Evidence Rounds had a positive impact on their continuing education and clinical practice. They also provided insights into how future initiatives could be optimised to support and enable them to narrow the gap between research evidence and practice. Conclusions Individual, departmental and organisational level contextual factors can play a major role in implementation within complex health services. HCPs highlighted how in combination with clinical guideline development, implementation of evidence could be increased. Further research after a longer period of implementation could investigate how initiatives might be optimised to promote the uptake of evidence, improve implementation and expedite behaviour change. Electronic supplementary material The online version of this article (10.1186/s12909-019-1488-z) contains supplementary material, which is available to authorized users.

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.

Background: Interleukin 6 (IL-6) blocking agents have been used for treating severe coronavirus disease 2019 (COVID-19). Their immunosuppressive effect might be valuable in patients with COVID-19 characterised by substantial immune system dysfunction by controlling inflammation and promoting disease tolerance. Objectives: To assess the effect of IL-6 blocking agents compared to standard care alone or with placebo on efficacy and safety outcomes in COVID-19. We will update this assessment regularly. Search methods: We searched the World Health Organization (WHO) International Clinical Trials Registry Platform (up to 11 February 2021) and the L-OVE platform, and Cochrane COVID-19 Study Register to identify trials up to 26 February 2021. Selection criteria: We included randomised controlled trials (RCTs) evaluating IL-6 blocking agents compared with standard care alone or with placebo for people with COVID-19, regardless of disease severity. Data collection and analysis: We followed standard Cochrane methodology. The protocol was amended to reduce the number of outcomes considered. Two review authors independently collected data and assessed the risk of bias with the Cochrane Risk of Bias 2 tool. We rated the certainty of evidence with the GRADE approach for the critical outcomes such as clinical improvement (defined as hospital discharge or improvement on the scale used by trialists to evaluate clinical progression or recovery) (day (D) 28 / ≥ D60); WHO Clinical Progression Score of level 7 or above (i.e. the proportion of participants with mechanical ventilation +/- additional organ support OR death) (D28 / ≥ D60); all-cause mortality (D28 / ≥ D60); incidence of any adverse events; and incidence of serious adverse events. Main results: We identified 10 RCTs with available data including one platform trial comparing tocilizumab and sarilumab with standard of care. These trials evaluated tocilizumab (nine RCTs including two platform trials; seven were reported as peer-reviewed articles, two as preprints; 6428 randomised participants); and two sarilumab (one platform trial reported as peer reviewed article, one reported as preprint, 880 randomised participants). All trials included were multicentre trials. They were conducted in Brazil, China, France, Italy, UK, USA, and four were multi-country trials. The mean age range of participants ranged from 56 to 65 years; 4572 (66.3%) of trial participants were male. Disease severity ranged from mild to critical disease. The reported proportion of participants on oxygen at baseline but not intubated varied from 56% to 100% where reported. Five trials reported the inclusion of intubated patients at baseline. We identified a further 20 registered RCTs of tocilizumab compared to placebo/standard care (five completed without available results, five terminated without available results, eight ongoing, two not recruiting); 11 RCTs of sarilumab (two completed without results, three terminated without available results, six ongoing); six RCTs of clazakisumab (five ongoing, one not recruiting); two RCTs of olokizumab (one completed, one not recruiting); one of siltuximab (ongoing) and one RCT of levilimab (completed without available results). Of note, three were cancelled (2 tocilizumab, 1 clazakisumab). One multiple-arm RCT evaluated both tocilizumab and sarilumab compared to standard of care, one three-arm RCT evaluated tocilizumab and siltuximab compared to standard of care and consequently they appear in each respective comparison. Tocilizumab versus standard care alone or with placebo. a. Effectiveness of tocilizumab for patients with COVID-19. Tocilizumab probably results in little or no increase in the outcome of clinical improvement at D28 (RR 1.06, 95% CI 1.00 to 1.13; I2 = 40.9%; 7 RCTs, 5585 participants; absolute effect: 31 more with clinical improvement per 1000 (from 0 fewer to 67 more); moderate-certainty evidence). However, we cannot exclude that some subgroups of patients could benefit from the treatment. We did not obtain data for longer-term follow-up (≥ D60). The effect of tocilizumab on the proportion of participants with a WHO Clinical Progression Score of level of 7 or above is uncertain at D28 (RR 0.99, 95% CI 0.56 to 1.74; I2 = 64.4%; 3 RCTs, 712 participants; low-certainty evidence). We did not obtain data for longer-term follow-up (≥ D60). Tocilizumab reduces all-cause mortality at D28 compared to standard care alone or placebo (RR 0.89, 95% CI 0.82 to 0.97; I2 = 0.0%; 8 RCTs, 6363 participants; absolute effect: 32 fewer deaths per 1000 (from 52 fewer to 9 fewer); high-certainty evidence). The evidence suggests uncertainty around the effect on mortality at ≥ D60 (RR 0.86, 95% CI 0.53 to 1.40; I2 = 0.0%; 2 RCTs, 519 participants; low-certainty evidence). b. Safety of tocilizumab for patients with COVID-19. The evidence is very uncertain about the effect of tocilizumab on adverse events (RR 1.23, 95% CI 0.87 to 1.72; I2 = 86.4%; 7 RCTs, 1534 participants; very low-certainty evidence). Nevertheless, tocilizumab probably results in slightly fewer serious adverse events than standard care alone or placebo (RR 0.89, 95% CI 0.75 to 1.06; I2 = 0.0%; 8 RCTs, 2312 participants; moderate-certainty evidence). Sarilumab versus standard care alone or with placebo. The evidence is uncertain about the effect of sarilumab on all-cause mortality at D28 (RR 0.77, 95% CI 0.43 to 1.36; 2 RCTs, 880 participants; low certainty), on all-cause mortality at ≥ D60 (RR 1.00, 95% CI 0.50 to 2.0; 1 RCT, 420 participants; low certainty), and serious adverse events (RR 1.17, 95% CI 0.77 to 1.77; 2 RCTs, 880 participants; low certainty). It is unlikely that sarilumab results in an important increase of adverse events (RR 1.05, 95% CI 0.88 to 1.25; 1 RCT, 420 participants; moderate certainty). However, an increase cannot be excluded. No data were available for other critical outcomes. Authors' conclusions: On average, tocilizumab reduces all-cause mortality at D28 compared to standard care alone or placebo and probably results in slightly fewer serious adverse events than standard care alone or placebo. Nevertheless, tocilizumab probably results in little or no increase in the outcome clinical improvement (defined as hospital discharge or improvement measured by trialist-defined scales) at D28. The impact of tocilizumab on other outcomes is uncertain or very uncertain. With the data available, we were not able to explore heterogeneity. Individual patient data meta-analyses are needed to be able to identify which patients are more likely to benefit from this treatment. Evidence for an effect of sarilumab is uncertain and evidence for other anti-IL6 agents is unavailable. Thirty-nine RCTs of IL-6 blocking agents with no results are currently registered, of which nine are completed and seven trials were terminated with no results available. The findings of this review will be updated as new data are made available on the COVID-NMA platform (covid-nma.com).

Background The Delphi method is used in a wide variety of settings as a method of building consensus on important issues. Traditionally, the Delphi method uses multiple rounds of a survey to allow for feedback of other participants’ survey responses in between rounds. By informing participants about how others answer a question or prioritise specific topics, it allows for diverse opinions to inform the consensus process. For this reason, the Delphi method is popular as a consensus building approach in developing core outcome sets (COS), i.e. the minimum agreed set of standardised outcomes that should be measured and reported in studies on a specific health condition. In a COS setting, participants prioritise the importance of outcomes for inclusion in a COS. This usually involves participating in multiple rounds of a survey that can span several weeks or months. Challenges with participant retention have been highlighted in previous COS. We will compare a three-round with a Real-Time Delphi approach on prioritised outcomes. This trial is embedded within the COHESION study which is developing a COS for interventions treating neonatal encephalopathy. Methods One hundred and eighty stakeholders (parents/caregivers of infants diagnosed and treated with neonatal encephalopathy, healthcare providers and researchers) will be randomised using stratified randomisation to take part in either the Multi-Round or Real-Time Delphi. Stakeholders will rate the importance of the same set of outcomes in both arms. We will compare the prioritised outcomes at the end of both surveys as well as other parameters such as feedback, initial condition and iteration effects. Discussion This trial will provide evidence to inform decisions on the use of Multi-Round compared to Real-Time Delphi survey methods. Trial registration NCT04471103. Registered on 14 July 2020.

Diabetic foot ulceration (DFU) can be defined as a full-thickness wound below the ankle and is a major complication of diabetes mellitus. Despite best practice, many wounds fail to heal, and when they do, the risk of recurrence of DFU remains high. Beliefs about personal control, or influence, on ulceration are associated with better engagement with self-care in DFU. Psychological interventions aim to reduce levels of psychological distress and empower people to engage in self-care, and there is some evidence to suggest that they can impact positively on the rate of wound healing.To evaluate the effects of psychological interventions on healing and recurrence of DFU.In September 2019, we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE (including In-ProcessOther Non-Indexed Citations), Ovid Embase, Ovid PsycINFO and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and reviewed reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.We included randomised controlled trials (RCTs) and quasi-RCTs that evaluated psychological interventions compared with standard care, education or another psychological intervention. Our primary outcomes were the proportion of wounds completely healed; time to complete wound healing; time to recurrence and number of recurrences.Four review authors independently screened titles and abstracts of the studies identified by the search strategy for eligibility. Three authors independently screened all potentially relevant studies using the inclusion criteria and carried out data extraction, assessment of risk of bias and GRADE assessment of the certainty of the evidence.We identified seven trials that met the inclusion criteria with a total of 290 participants: six RCTs and one quasi-RCT. The studies were conducted in Australia, the USA, the UK, Indonesia, Norway and South Africa. Three trials used a counselling-style intervention and one assessed an intervention designed to enhance an understanding of well-being. One RCT used a biofeedback relaxation training intervention and one used a psychosocial intervention based on cognitive behavioural therapy. A quasi-RCT assessed motivation and tailored the intervention accordingly. Due to the heterogeneity of the trials identified, pooling of data was judged inappropriate, and we therefore present a narrative synthesis. Comparisons were (1) psychological intervention compared with standard care and (2) psychological intervention compared with another psychological intervention. We are uncertain whether there is a difference between psychological intervention and standard care for people with diabetic foot ulceration in the proportion of wounds completely healed (two trials, data not pooled, first trial RR 6.25, 95% CI 0.35 to 112.5; 16 participants, second trial RR 0.59, 95% CI 0.26 to 1.39; 60 participants), in foot ulcer recurrence after one year (two trials, data not pooled, first trial RR 0.67, 95% CI 0.32 to 1.41; 41 participants, second trial RR 0.63, 95% CI 0.05 to 7.90; 13 participants) or in health-related quality of life (one trial, MD 5.52, 95% CI -5.80 to 16.84; 56 participants). This is based on very low-certainty evidence which we downgraded for very serious study limitations, risk of bias and imprecision. We are uncertain whether there is a difference in the proportion of wounds completely healed in people with diabetic foot ulceration depending on whether they receive a psychological intervention compared with another psychological intervention (one trial, RR 2.33, 95% CI 0.92 to 5.93; 16 participants). This is based on very low-certainty evidence from one study which we downgraded for very serious study limitations, risk of bias and imprecision. Time to complete wound healing was reported in two studies but not in a way that was suitable for inclusion in this review. One trial reported self-efficacy and two trials reported quality of life, but only one reported quality of life in a manner that enabled us to extract data for this review. No studies explored the other primary outcome (time to recurrence) or secondary outcomes (amputations (major or distal) or cost).We are unable to determine whether psychological interventions are of any benefit to people with an active diabetic foot ulcer or a history of diabetic foot ulcers to achieve complete wound healing or prevent recurrence. This is because there are few trials of psychological interventions in this area. Of the trials we included, few measured all of our outcomes of interest and, where they did so, we judged the evidence, using GRADE criteria, to be of very low certainty.Das diabetische Fußsyndrom (DFS) kann als eine vollflächige Wunde unterhalb des Knöchels definiert werden und ist eine Hauptkomplikation der Diabetes mellitus. Auch bei bestmöglicher Behandlung heilen viele Wunden nicht, und wenn sie es tun, bleibt das Risiko des Wiederauftretens eines DFS hoch. Das Vertrauen in die persönliche Kontrolle, oder Einflussmöglichkeit, auf die Ulzeration ist mit einem höheren Einsatz bei der Selbstversorgung des DFS verbunden. Psychologische Interventionen zielen darauf ab, den Grad der psychischen Belastung zu reduzieren und die Betroffenen darin zu bestärken, sich selbst zu versorgen. Es gibt Evidenz dafür, dass sich diese Interventionen positiv auf die Wundheilungsrate auswirken können.Ziel des Reviews war die Ermittlung der Wirkungen psychologischer Interventionen auf die Heilung und das Wiederauftreten des DFS.Wir durchsuchten im September 2019 das Cochrane Wounds Specialised Register, das Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE (einschließlich In‐ProcessOther Non‐Indexed Citations), Ovid Embase und EBSCO CINAHL Plus. Außerdem durchsuchten wir klinische Studienregister nach laufenden und unveröffentlichten Studien und prüften die Referenzlisten relevanter eingeschlossener Studien sowie von Reviews, Metaanalysen und HTA‐Berichten (health technology assessments, HTA), um weitere Studien zu identifizieren. Es gab keine Einschränkungen hinsichtlich der Sprache, des Datums der Veröffentlichung oder des Durchführungsortes der Studien.Wir schlossen randomisierte kontrollierte Studien (RCTs) und Quasi‐RCTs ein, die psychologische Interventionen im Vergleich zur Standardversorgung, Schulungsmaßnahmen oder einer anderen psychologischen Intervention untersuchten. Unsere primären Endpunkte waren der Anteil der vollständig abgeheilten Wunden, die Zeit bis zur vollständigen Wundheilung, die Zeit bis zum Wiederauftreten und die Häufigkeit des Wiederauftretens. DATENSAMMLUNG UND ‐ANALYSE: Vier Review‐Autoren überprüften unabhängig voneinander die Titel und Abstracts der durch die Suchstrategie identifizierten Studien auf ihre Eignung für den Einschluss in den Review. Drei Autoren überprüften unabhängig voneinander alle potenziell relevanten Studien anhand der Einschlusskriterien und führten die Datenextraktion, die Bewertung des Risikos für Bias und die GRADE‐Bewertung der Vertrauenswürdigkeit der Evidenz durch.Wir fanden sieben Studien, die die Einschlusskriterien erfüllten, mit insgesamt 290 Teilnehmenden: sechs RCTs und einen Quasi‐RCT. Die Studien wurden in Australien, den USA, Großbritannien, Indonesien, Norwegen und Südafrika durchgeführt. Drei Studien verwendeten eine Beratung als Intervention und eine Studie bewertete eine Intervention, die darauf abzielte, das Verständnis von Wohlbefinden zu verbessern. Eine RCT untersuchte ein Entspannungstraining mit Biofeedback und eine RCT eine psychosoziale Intervention, die auf kognitiver Verhaltenstherapie basiert. In einer Quasi‐RCT wurde die Motivation bewertet und wurde die Intervention entsprechend angepasst. Aufgrund der Heterogenität der identifizierten Studien wurde eine statistische (rechnerische) Zusammenfassung der Daten als ungeeignet erachtet, weshalb wir eine narrative (beschreibende) Synthese präsentieren. Die Vergleiche waren (1) eine psychologische Intervention im Vergleich zur Standardversorgung und (2) eine psychologische Intervention im Vergleich zu einer anderen psychologischen Intervention. Wir sind unsicher, ob es einen Unterschied zwischen einer psychologischen Intervention und der Standardbehandlung für Menschen mit diabetischen Fußulzerationen gibt, bezogen auf den Anteil der vollständig geheilten Wunden (zwei Studien, Daten nicht statistisch (rechnerisch) zusammengefasst, erste Studie RR 6,25, 95% KI 0,35 bis 112,5; 16 Teilnehmende, zweite Studie RR 0,59, 95% KI 0.26 bis 1,39; 60 Teilnehmende), das Wiederauftreten von Fußgeschwüren nach einem Jahr (zwei Studien, Daten nicht statistisch (rechnerisch) zusammengefasst, erste Studie RR 0,67, 95% KI 0,32 bis 1,41; 41 Teilnehmende, zweite Studie RR 0,63, 95% KI 0,05 bis 7,90; 13 Teilnehmende) oder die gesundheitsbezogenen Lebensqualität (eine Studie, MD 5,52, 95% KI.‐5,80 bis 16,84; 56 Teilnehmende). Diese Bewertung basiert auf Evidenz von sehr niedriger Vertrauenswürdigkeit, die wir aufgrund von sehr schwerwiegenden methodischen Einschränkungen der Studien, dem Risiko für Bias und der unzureichenden Genauigkeit der Ergebnisse herabgestuft haben. Wir sind uns nicht sicher, ob es einen Unterschied im Anteil der vollständig geheilten Wunden bei Menschen mit diabetischen Fußgeschwüren gibt, je nachdem, ob sie eine psychologische Intervention vergleichen mit einer anderen psychologische Intervention erhalten (eine Studie, RR 2,33, 95% KI 0,92 bis 5,93; 16 Teilnehmende). Diese Bewertung basiert auf Evidenz von sehr niedriger Vertrauenswürdigkeit, die wir aufgrund von sehr schwerwiegenden methodischen Einschränkungen der Studien, dem Risiko für Bias und der unzureichenden Genauigkeit der Ergebnisse herabgestuft haben. Die Zeit bis zur vollständigen Wundheilung wurde in zwei Studien berichtet, jedoch nicht in einer Weise, die dazu geeignet war, die Ergebnisse in diesen Review aufzunehmen. Eine Studie berichtete über die Selbstwirksamkeit und zwei Studien berichteten über die Lebensqualität, aber nur eine Studie berichtete über die Lebensqualität in einer Weise, die es uns ermöglichte, Daten für diesen Review zu entnehmen. Keine Studie untersuchte den anderen primären Endpunkt (Zeit bis zum Wiederauftreten) oder sekundäre Endpunkte (Amputationen (größere oder distale) oder Kosten.Wir konnten nicht ermitteln, ob psychologische Interventionen für Menschen mit einem aktiven diabetischen Fußgeschwür oder einem diabetischen Fußgeschwür in der Vorgeschichte von Nutzen sind, um eine vollständige Wundheilung zu erreichen oder ein Wiederauftreten zu verhindern. Dies liegt daran, dass es nur wenige Studien zu psychologischen Interventionen in diesem Bereich gibt. Von den eingeschlossenen Studien erhoben nur wenige alle interessierenden Endpunkte. In den Studien, in denen dies der Fall war, stuften wir die Vertrauenswürdigkeit der Evidenz anhand der GRADE‐Kriterien als sehr niedrig ein.บทนำ: แผลที่เท้าจากเบาหวาน (Diabetic foot ulceration: DFU) คือ แผลที่มีความลึก full‐thickness ที่เกิดขึ้นตั้งแต่ข้อเท้าลงไป ซึ่งเป็นภาวะแทรกซ้อนที่สำคัญของโรคเบาหวาน ที่แม้จะมีแนวทางการรักษาที่ดีที่สุด แต่แผลของผู้ป่วยหลายคนก็ไม่สามารถรักษาให้หายขาดได้ และเมื่อหายแล้วความเสี่ยงของการกลับเป็นซ้ำของ DFU ก็ยังคงสูงอยู่ ซึ่งความเชื่อของผู้ป่วยเกี่ยวกับความสามารถในการดูแลแผลของตัวเองสัมพันธ์กับการมีส่วนร่วมที่ดีในการดูแล DFU การบำบัดทางจิตมีเป้าหมายเพื่อลดระดับความเครียดทางจิตใจ และส่งเสริมให้ผู้ป่วยมีส่วนร่วมในการดูแลตนเอง และมีหลักฐานบางอย่างที่ชี้ให้เห็นว่าวิธีนี้ส่งผลในเชิงบวกต่ออัตราการหายของแผลได้ วัตถุประสงค์: เพื่อประเมินประสิทธิผลของการบำบัดทางจิตใจต่อการหายและการกลับเป็นซ้ำของ DFU วิธีการสืบค้น: ในเดือนกันยายน 2019 ผู้วิจัยได้สืบค้นใน the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In‐ProcessOther Non‐Indexed Citations); Ovid Embase,Ovid PsycINFO และ EBSCO CINAHL Plus นอกจากนี้ยังได้สืบค้นการศึกษาทางคลินิกที่ลงทะเบียนและกำลังดำเนินการอยู่, การศึกษาที่ไม่ได้ตีพิมพ์ และรายการเอกสารอ้างอิงจากการศึกษาที่เกี่ยวข้อง เช่นเดียวกับบทความทบทวนวรรณกรรม, การวิเคราะห์อภิเมตต้า และรายงานเกี่ยวกับเทคโนโลยีสุขภาพเพื่อค้นหาการศึกษาเพิ่มเติม โดยไม่มีข้อจำกัดทั้งในด้านภาษา วันที่ตีพิมพ์ หรือสถานที่ที่ทำวิจัย เกณฑ์การคัดเลือก: ผู้วิจัยรวบรวมการทดลองแบบ randomised controlled trials (RCT) และ quasi‐RCTs ที่ประเมินการบำบัดทางจิตเปรียบเทียบกับการดูแลมาตรฐาน หรือเทียบกับการให้ความรู้หรือการบำบัดทางจิตวิธีอื่นๆ โดยผลลัพธ์หลัก คือ สัดส่วนของบาดแผลที่หายสนิท, ระยะเวลารักษาจนกว่าแผลจะหายสนิท, ระยะเวลาจนกว่าจะเกิดแผลซ้ำ และจำนวนครั้งที่เกิดแผลซ้ำ การรวบรวมและวิเคราะห์ข้อมูล: ผู้วิจัย 4 คนได้คัดกรองชื่อเรื่องและบทคัดย่อของการศึกษาที่ถูกค้นพบด้วย search strategy โดยเป็นอิสระต่อกัน ผู้วิจัย 3 คนคัดกรองการศึกษาที่อาจเกี่ยวข้องทั้งหมดอย่างเป็นอิสระตามเกณฑ์การคัดเลือก และดำเนินการดึงข้อมูล, ประเมินความเสี่ยงของการมีอคติ และประเมิน GRADE ของความเชื่อมั่นของหลักฐาน ผลการวิจัย: ผู้วิจัยค้นพบการทดลอง 7 ฉบับ (RCT 6 ฉบับและ quasi‐RCT 1 ฉบับ) ที่ตรงตามเกณฑ์การคัดเลือก โดยมีผู้เข้าร่วมทั้งหมด 290 คน การศึกษาเหล่านี้ดำเนินการในออสเตรเลีย, สหรัฐอเมริกา, นอร์เวย์, อินโดนีเซีย, แอฟริกาใต้และสหราชอาณาจักร การศึกษา 3 ฉบับใช้การบำบัดในรูปแบบการให้คำปรึกษา และการศึกษาอีก 1 ฉบับประเมินการบำบัดที่เพิ่มความเข้าใจในสุขภาวะของตนเอง มี RCT 1 ฉบับ ที่ใช้การฝึกแบบ biofeedback relaxation training และอีก 1 ฉบับใช้การบำบัดทางความคิดและพฤติกรรม (cognitive behavioural therapy) และมี quasi‐RCT 1 ฉบับ ที่ประเมินแรงจูงใจและปรับแต่งวิธีการบำบัดให้เหมาะสมกับแต่ละคน เนื่องจากความแตกต่างของรูปแบบการทดลอง การรวมกันของข้อมูลจึงถูกตัดสินว่าไม่เหมาะสมดังนั้นผู้วิจัยจึงนำเสนอการสังเคราะห์แบบบรรยายแทน มีการเปรียบเทียบได้แก่ (1) การบำบัดทางจิตใจเปรียบเทียบกับการดูแลตามมาตรฐานและ (2) การบำบัดทางจิตใจวิธีต่างๆ เปรียบเทียบกัน ผู้วิจัยไม่แน่ใจว่ามีความแตกต่างระหว่างการบำบัดทางจิตใจและการดูแลมาตรฐานสำหรับผู้ที่มี DFU ในแง่ของสัดส่วนของบาดแผลที่หายสนิท (มี 2 การศึกษาที่ไม่ได้เอาผลลัพธ์รวมกัน, การศึกษาแรก RR 6.25, 95% CI 0.35 ถึง 112.5; ผู้เข้าร่วม 16 คน, การศึกษาที่สอง RR 0.59, 95% CI 0.26 ถึง 1.39; ผู้เข้าร่วม 60 คน), ในแง่ของการกลับเป็นซ้ำของแผลที่เท้าหลังจากหนึ่งปี (มี 2 การศึกษาที่ไม่ได้เอาผลลัพธ์รวมกัน, การศึกษาแรก RR 0.67, 95% CI 0.32 ถึง 1.41; ผู้เข้าร่วม 41 คน, การศึกษาที่สอง RR 0.63, 95% CI 0.05 ถึง 7.90; ผู้เข้าร่วม 13 คน) หรือในคุณภาพชีวิตที่เกี่ยวข้องกับสุขภาพ (การศึกษา 1 ฉบับ, MD 5.52, 95% CI ‐5.80 ถึง 16.84; ผู้เข้าร่วม 56 คน) ผลลัพธ์นี้มาจากหลักฐานที่มีความเชื่อมั่นต่ำมาก ซึ่งผู้วิจัยได้ตัดสินจากข้อจำกัดในการศึกษาที่ร้ายแรงมาก, ความเสี่ยงของการมีอคติ และความไม่แม่นยำ ผู้วิจัยไม่แน่ใจว่าการบำบัดทางจิตด้วยวิธีที่แตกต่างกันจะส่งผลใดๆ หรือไม่ต่อสัดส่วนของบาดแผลที่หายสนิทในผู้ที่มี DFU (การศึกษา 1 ฉบับ, RR 2.33, 95% CI 0.92 ถึง 5.93; ผู้เข้าร่วม 16 คน ) ผลลัพธ์นี้มาจากหลักฐานที่มีความเชื่อมั่นต่ำมาก ซึ่งผู้วิจัยได้ตัดสินจากข้อจำกัดในการศึกษาที่ร้ายแรงมาก, ความเสี่ยงของการมีอคติ และความไม่แม่นยำ ระยะเวลารักษาจนกว่าแผลจะหายสนิทมีรายงานในการศึกษา 2 ฉบับ แต่ไม่ใช่วิธีการวัดผลที่เหมาะสมที่จะนำมารวมไว้ในการทบทวนนี้ มีการศึกษา 1 ฉบับ รายงานการรับรู้ความสามารถของตนเอง และมีการศึกษาอีก 2 ฉบับ รายงานเรื่องคุณภาพชีวิต แต่มีเพียงการศึกษาเดียวเท่านั้นที่รายงานคุณภาพชีวิตในลักษณะที่ทำให้ผู้วิจัยดึงข้อมูลมาตรวจสอบได้ และไม่มีการศึกษาใดที่สำรวจผลลัพธ์หลักอื่นๆ (ระยะเวลาจนกว่าจะเกิดแผลซ้ำ) หรือผลลัพธ์รอง (การตัดแขนขาหรือค่าใช้จ่าย) ข้อสรุปของผู้วิจัย: ผู้วิจัยไม่สามารถระบุได้ว่าการบำบัดทางจิตใจจะเป็นประโยชน์ต่อผู้ที่เป็นแผลที่เท้าจากเบาหวานหรือเคยมีแผลที่เท้าจากเบาหวาน เพื่อให้การรักษาบาดแผลสมบูรณ์หรือป้องกันการกลับเป็นซ้ำ เนื่องจากมีจำนวนการศึกษาเกี่ยวกับการบำบัดทางจิตน้อยมากในประเด็นนี้ จากการศึกษาที่รวบรวมมา มีผลลัพธ์หลักเพียงไม่กี่ตัวที่มีรายงาน และเมื่อมีข้อมูลก็จะมาจากการศึกษาที่มีความเชื่อมั่นต่ำมากตามเกณฑ์ของ GRADE.پیشینه: زخم پای دیابتی (diabetic foot ulcers; DFU) را می‌توان به عنوان یک زخم با درگیری ضخامت کامل پوست زیر مچ پا تعریف کرد و عارضه اصلی دیابت ملیتوس به شمار می‌آید. با وجود بهترین روش‌های درمانی، بسیاری از زخم‌ها بهبود نمی‌یابند، و در صورت بهبود، خطر عود DFU همچنان بالا است. درک هر فرد بیمار در ارتباط با کنترل شخصی، یا تاثیر بر زخم، مرتبط با تعامل بهتر با مراقبت از خود در DFU است. هدف از مداخلات روان‌شناختی کاهش سطح دیسترس روان‌شناختی و توانمند‐سازی افراد برای انجام مراقبت از خود است، و برخی شواهد نشان می‌دهد که آن‌ها می‌توانند بر نرخ بهبودی زخم تاثیر مثبت داشته باشند. اهداف: ارزیابی تاثیرات مداخلات روان‌شناختی در بهبود و عود DFU. روش‌های جست‌وجو: در سپتامبر 2019، پایگاه ثبت تخصصی گروه زخم‌ها در کاکرین؛ پایگاه ثبت مرکزی کارآزمایی‌های کنترل شده کاکرین (CENTRAL)؛ Ovid MEDLINE (شامل In‐ProcessOther Non‐Indexed Citations)؛ Ovid Embase؛ Ovid PsycINFO و EBSCO CINAHL Plus را جست‌وجو کردیم. همچنین پایگاه‌های ثبت کارآزمایی‌های بالینی را برای یافتن مطالعات در‌ حال انجام و منتشر ‌نشده جست‌وجو کرده و فهرست‌ منابع مطالعات وارد شده مرتبط، همچنین مرورها، متاآنالیزها (meta‐analyses) و گزارش‌های فناوری سلامت را برای شناسایی مطالعات بیشتر بررسی کردیم. هیچ نوع محدودیتی از نظر زبان انتشار، تاریخ انتشار یا محیط اجرای مطالعه اعمال نشدند. معیارهای انتخاب: کارآزمایی‌های تصادفی‌سازی و کنترل شده (randomised controlled trials; RCTs) و شبه‐RCTهایی را وارد کردیم که مداخلات روان‌شناختی را در مقایسه با مراقبت‌های استاندارد، آموزش یا مداخلات روان‌شناختی دیگر ارزیابی کردند. پیامدهای اولیه ما نسبتی از زخم‌های کاملا بهبود یافته؛ زمان لازم تا ترمیم کامل زخم؛ زمان لازم تا عود زخم و تعداد موارد عودها، بودند. گردآوری و تجزیه‌وتحلیل داده‌ها: چهار نویسنده مرور به‌طور مستقل از هم عناوین و خلاصه‌مقالات مربوط به مطالعات شناسایی شده را بر اساس استراتژی جست‌وجو، از نظر واجد شرایط بودن ارزیابی کردند. سه نویسنده با استفاده از معیارهای ورود، تمام مطالعات بالقوه مرتبط را مستقلا غربالگری کرده و استخراج داده‌ها، ارزیابی خطر سوگیری (bias) و ارزیابی قطعیت شواهد را با کمک رویکرد درجه‌‏بندی توصیه‏، ارزیابی، توسعه و ارزشیابی (GRADE) انجام دادند. نتایج اصلی: هفت کارآزمایی را با حضور 290 شرکت‌کننده شناسایی کردیم که معیارهای ورود را داشتند: شش RCT و یک شبه‐RCT. این مطالعات در استرالیا، ایالات متحده آمریکا، انگلیس، اندونزی، نروژ و آفریقای جنوبی انجام شدند. سه کارآزمایی از یک مداخله به سبک مشاوره استفاده کرده و یک مورد مداخله‌ای را ارزیابی کرد که برای درک بهتر از بهزیستی (well‐being) طراحی شده بود. یک RCT از مداخله آموزش آرام‌سازی بیوفیدبک (biofeedback) و دیگری از مداخله روان‌شناختی مبتنی بر درمان شناختی رفتاری استفاده کرد. یک شبه‐RCT انگیزه را ارزیابی کرده و متناسب با آن مداخله را انجام داد. با توجه به ناهمگونی در کارآزمایی‌های شناسایی شده، گردآوری داده‌ها نامناسب بودند، بنابراین یک سنتز روایت‌گونه (narrative) را ارائه می‌دهیم. مقایسه‌ها عبارت بودند از (1) مداخله روان‌شناختی در مقایسه با مراقبت استاندارد و (2) مداخله روان‌شناختی در مقایسه با مداخله روان‌شناختی دیگر. ما مطمئن نیستیم که تفاوتی بین مداخله روان‌شناختی و مراقبت استاندارد برای افراد مبتلا به زخم پای دیابتی در نسبتی از زخم‌های کاملا بهبود یافته (دو کارآزمایی، داده‌ها تجمیع نشدند، اولین کارآزمایی؛ RR: 6.25؛ 95% CI؛ 0.35 تا 112.5؛ 16 شرکت‌کننده، کارآزمایی دوم؛ RR: 0.59؛ 95% CI؛ 0.26 تا 1.39؛ 60 شرکت‌کننده)، در عود زخم پا پس از یک سال (دو کارآزمایی، داده‌ها تجمیع نشدند، کارآزمایی اول؛ RR: 0.67؛ 95% CI؛ 0.32 تا 1.41؛ 41 شرکت‌کننده، کارآزمایی دوم؛ RR: 0.63؛ 95% CI؛ 0.05 تا 7.90؛ 13 شرکت‌کننده) یا در کیفیت زندگی مرتبط با سلامت (یک کارآزمایی، MD: 5.52؛ 95% CI؛ 5.80‐ تا 16.84؛ 56 شرکت‌کننده) وجود دارد یا خیر. این یافته بر اساس شواهدی با قطعیت بسیار پائین است، که سطح کیفیت آن را به دلیل محدودیت‌های بسیار جدی در مطالعه، خطر سوگیری، و عدم دقت کاهش دادیم. ما مطمئن نیستیم که در نسبتی از زخم‌های کاملا بهبود یافته در افراد مبتلا به زخم پای دیابتی بسته به اینکه یک مداخله روان‌شناختی را در مقایسه با یک مداخله روان‌شناختی دیگر دریافت می‌کنند، تفاوتی وجود دارد یا خیر (یک کارآزمایی، RR: 2.33؛ 95% CI؛ 0.92 تا 5.93؛ 16 شرکت‌کننده). این بر اساس شواهدی با قطعیت بسیار پائین از یک مطالعه است، که سطح کیفیت آن را به دلیل محدودیت‌های بسیار جدی مطالعه، وجود خطر سوگیری، و عدم دقت کاهش دادیم. زمان لازم تا بهبود کامل زخم در دو مطالعه گزارش شد، اما نه به روشی که برای گنجاندن در این مرور مناسب باشد. یک کارآزمایی، خود‐کارآمدی و دو کارآزمایی کیفیت زندگی را گزارش کردند، اما فقط یک مورد کیفیت زندگی را به روشی گزارش کرد که به ما امکان استخراج داده را برای این مرور می‌داد. هیچ مطالعه‌ای پیامد اولیه دیگر (زمان لازم تا عود) یا پیامدهای ثانویه (قطع عضو (ماژور یا دیستال) یا هزینه) را بررسی نکرد. نتیجه‌گیری‌های نویسندگان: ما نتوانستیم تعیین کنیم که مداخلات روان‌شناختی برای افراد مبتلا به زخم پای دیابتی فعال یا سابقه زخم پای دیابتی فوایدی برای دستیابی به ترمیم کامل زخم یا پیشگیری از عود آن دارد یا خیر. این امر به این دلیل است که کارآزمایی‌های مداخلات روان‌شناختی اندکی در این زمینه انجام شدند. از کارآزمایی‌هایی که وارد کردیم، تعداد کمی همه پیامدهای مورد نظر ما را اندازه‌گیری کردند و، در مواردی که این کار انجام شد، قطعیت شواهد را با استفاده از معیارهای درجه‌‏بندی توصیه‏، ارزیابی، توسعه و ارزشیابی (GRADE) در سطح بسیار پائین قضاوت کردیم.L'ulcère du pied diabétique (UPD) peut être définie comme une plaie de pleine épaisseur sous la cheville et constitue une complication majeure du diabète sucré. Malgré les meilleures pratiques, de nombreuses blessures ne cicatrisent pas, et lorsqu'elles le font, le risque de récidive d’UPD reste élevé. Les croyances relatives à la capacité personnelle, ou à l'influence, de gérer les ulcères sont associées à un meilleur engagement dans l'autogestion de la santé concernant les UPD. Les interventions psychologiques visent à réduire les niveaux de détresse psychologique et à donner aux gens les moyens de prendre soin d'eux‐mêmes, et certaines données probantes indiquent qu'elles pourraient avoir un impact positif sur le taux de guérison des blessures.Évaluer les effets des interventions psychologiques sur la guérison et la récidive des UPD. STRATÉGIE DE RECHERCHE DOCUMENTAIRE: En septembre 2019, nous avons effectué des recherches dans le Registre spécialisé du groupe Cochrane sur les plaies et contusions ; le registre Cochrane des essais contrôlés (CENTRAL), Ovid MEDLINE (y compris les références en cours de traitement et autres références non indexées), Ovid Embase, Ovid PsycINFO et EBSCO CINAHL Plus. Nous avons également effectué des recherches dans les registres d'essais cliniques pour trouver des études en cours et non publiées, et avons examiné les références bibliographiques des études incluses pertinentes ainsi que des revues, des méta‐analyses et des rapports sur les technologies de la santé afin de trouver des études supplémentaires. Aucune restriction n’a été appliquée concernant la langue, la date de publication ou le cadre de l'étude. CRITÈRES DE SÉLECTION: Nous avons inclus des essais contrôlés randomisés (ECR) et des quasi‐ECR évaluant les interventions psychologiques par rapport aux soins standard, à l'éducation ou à une autre intervention psychologique. Nos critères de jugement principaux étaient la proportion de blessures complètement guéries, le temps nécessaire à la guérison complète des blessures, la durée avant récidive et le nombre de récidives. RECUEIL ET ANALYSE DES DONNÉES: Quatre auteurs de la revue ont indépendamment examiné les titres et les résumés des études identifiées par la stratégie de recherche pour leur éligibilité. Trois auteurs ont indépendamment examiné toutes les études potentiellement pertinentes en utilisant les critères d'inclusion et procédé à l'extraction des données, à l'évaluation du risque de biais et à l'évaluation du niveau de confiance des données probantes avec la méthode GRADE. RÉSULTATS PRINCIPAUX: Nous avons identifié sept essais répondant aux critères d'inclusion avec un total de 290 participants: six ECR et un quasi‐ERC. Les études ont été menées en Australie, aux États‐Unis, au Royaume‐Uni, en Indonésie, en Norvège et en Afrique du Sud. Trois essais ont utilisé une intervention de counseling et un autre a évalué une intervention destinée à améliorer la compréhension du bien‐être. Un ECR a utilisé une intervention d'entraînement à la relaxation par rétroaction biologique et un autre une intervention psychosociale basée sur la thérapie cognitivo‐comportementale. Un quasi‐RCT a évalué la motivation et adapté l'intervention en conséquence. En raison de l'hétérogénéité des essais identifiés, la combinaison statistique n'était pas appropriée, et nous présentons donc une synthèse narrative. Les comparaisons ont porté sur (1) l'intervention psychologique par rapport aux soins standard et (2) l'intervention psychologique par rapport à une autre intervention psychologique. Nous ne savons pas s'il existe une différence entre l'intervention psychologique et les soins standard pour les personnes souffrant d'ulcères du pied diabétique en ce qui concerne la proportion de plaies complètement guéries (deux essais, données non combinées, premier essai RR 6,25, IC à 95 % 0,35 à 112,5 ; 16 participants, deuxième essai RR 0,59, IC à 95 % 0.26 à 1,39 ; 60 participants), la récidive des ulcères du pied après un an (deux essais, données non combinées, premier essai RR 0,67, IC à 95 % 0,32 à 1,41 ; 41 participants, deuxième essai RR 0,63, IC à 95 % 0,05 à 7,90 ; 13 participants) ou la qualité de vie liée à la santé (un essai, DM 5,52, IC à 95 % ‐5,80 à 16,84 ; 56 participants). Cela est basé sur des données probantes d’un niveau de confiance très faible que nous avons abaissées en raison de limitations de l'étude, du risque de biais et d'imprécision très importants. Nous ne savons pas s'il existe une différence dans la proportion de plaies complètement guéries chez les personnes souffrant d'ulcères du pied diabétique selon qu'elles bénéficient d'une intervention psychologique ou d’une autre intervention psychologique (un essai, RR 2,33, IC à 95 % 0,92 à 5,93 ; 16 participants). Cela est basé sur des données probantes d’un niveau de confiance très faible provenant d'une étude que nous avons abaissées en raison de limitations de l'étude, du risque de biais et d'imprécision très importants. La durée nécessaire à la cicatrisation complète des plaies a été rapportée dans deux études, mais d'une manière qui ne convenait pas pour être incluse dans cette revue. Un essai a rapporté l'auto‐efficacité et deux essais ont rapporté la qualité de vie, mais un seul a rapporté la qualité de vie d'une manière qui nous a permis d'extraire des données pour cette revue. Les études n'ont pas exploré l'autre critère de jugement principal (durée avant récidive) ou les critères de jugement secondaires (amputations (majeures ou distales) ou le coût).Nous ne sommes pas en mesure de déterminer si les interventions psychologiques apportent un quelconque bénéfice aux personnes souffrant d'ulcères du pied diabétique actif ou ayant des antécédents des ulcères du pied diabétique concernant la guérison complète des plaies ou la prévention de la récidive. Cela s'explique par le fait qu'il y a peu d'essais d'interventions psychologiques dans ce domaine. Parmi les essais que nous avons inclus, rares sont ceux ayant mesuré tous nos critères de jugement d'intérêt et, lorsqu'ils l'ont fait, nous avons jugé les données probantes comme étant d’un niveau de confiance très faible, en utilisant les critères GRADE.La úlcera del pie diabético (UPD) se puede definir como una herida de espesor total por debajo del tobillo y es una de las principales complicaciones de la diabetes mellitus. A pesar de las mejores prácticas, muchas heridas no cicatrizan, y cuando lo hacen, el riesgo de recurrencia de la UPD aún es alto. Las creencias sobre el control personal, o su influencia sobre la ulceración, se asocian con un mejor compromiso con el autocuidado en la UPD. Las intervenciones psicológicas tienen como objetivo reducir los niveles de angustia psicológica y capacitar a las personas para que se ocupen del autocuidado, y hay alguna evidencia que indica que puede tener una repercusión positiva sobre la tasa de cicatrización de las heridas.Evaluar los efectos de las intervenciones psicológicas sobre la cicatrización y la recurrencia de la UPD. MÉTODOS DE BÚSQUEDA: En septiembre de 2019 se hicieron búsquedas en el registro especializado del Grupo Cochrane de Heridas (Cochrane Wounds), en el Registro Cochrane central de ensayos controlados (CENTRAL); Ovid MEDLINE (incluido In‐ProcessOther Non‐Indexed Citations); Ovid Embase y EBSCO CINAHL Plus. También se buscaron estudios en curso y no publicados en los registros de ensayos clínicos, y se examinaron las listas de referencias de los estudios incluidos pertinentes, así como las revisiones, los metanálisis e informes de tecnología sanitaria para identificar estudios adicionales. No hubo restricciones en cuanto al idioma, la fecha de publicación ni el contexto de los estudios. CRITERIOS DE SELECCIÓN: Se incluyeron ensayos controlados aleatorizados (ECA) y ensayos controlados cuasialeatorizados que evaluaron las intervenciones psicológicas en comparación con la atención estándar, la educación u otra intervención psicológica. Los desenlaces principales fueron la proporción de heridas completamente cicatrizadas; el tiempo hasta la cicatrización completa de la herida; el tiempo hasta la recurrencia y el número de recurrencias. OBTENCIÓN Y ANÁLISIS DE LOS DATOS: Dos autores de la revisión de forma independiente evaluaron la elegibilidad de los títulos y resúmenes de los estudios identificados mediante la estrategia de búsqueda. Tres autores revisaron de forma independiente todos los estudios potencialmente relevantes y utilizaron los criterios de inclusión y realizaron la extracción de los datos, la evaluación del riesgo de sesgo y la evaluación GRADE de la certeza de la evidencia.Se identificaron siete ensayos que cumplieron con los criterios de inclusión con un total de 290 participantes: seis ECA y un ensayo controlado cuasialeatorizado. Los estudios se realizaron en Australia, EE.UU., Indonesia, Noruega, el Reino Unido y Sudáfrica. Tres ensayos utilizaron una intervención de estilo de asesoramiento y uno evaluó una intervención diseñada para mejorar la comprensión del bienestar. Un ECA utilizó una intervención de entrenamiento de relajación con biorretroalimentación y otro utilizó una intervención psicosocial basada en la terapia cognitivo‐conductual. Un ensayo controlado cuasialeatorizado evaluó la motivación y adaptó la intervención en consecuencia. Debido a la heterogeneidad de los ensayos identificados, se consideró inapropiado agrupar los datos, por lo que se presenta una síntesis narrativa. Las comparaciones fueron (1) intervención psicológica comparada con atención estándar y (2) intervención psicológica comparada con otra intervención psicológica. No se sabe si hay una diferencia entre la intervención psicológica y la atención estándar en las personas con úlceras del pie diabético en cuanto a la proporción de heridas completamente cicatrizadas (dos ensayos, datos no agrupados, primer ensayo RR 6,25; IC del 95%: 0,35 a 112,5; 16 participantes, segundo ensayo RR 0,59; IC del 95%: 0,26 a 1,39; 60 participantes), la recurrencia de la úlcera del pie después de un año (dos ensayos, datos no agrupados, primer ensayo RR 0,67; IC del 95%: 0,32 a 1,41; 41 participantes, segundo ensayo RR 0,63; IC del 95%: 0,05 a 7,90; 13 participantes) o la calidad de vida relacionada con la salud (un ensayo, DM 5,52; IC del 95%: ‐5,80 a 16,84; 56 participantes). Lo anterior se basa en evidencia de certeza muy baja, que se disminuyó debido a las limitaciones muy graves de los estudios, el riesgo de sesgo y la imprecisión. No se sabe si existe una diferencia en la proporción de heridas completamente cicatrizadas en personas con úlcera del pie diabético según si reciben una intervención psicológica en comparación con otra (un ensayo, RR 2,33; IC del 95%: 0,92 a 5,93; 16 participantes). Este resultado se basó en evidencia de certeza muy baja de un estudio, que se disminuyó debido a limitaciones muy graves del estudio, el riesgo de sesgo y la imprecisión. El tiempo para completar la cicatrización de la herida se informó en dos estudios, pero no de manera adecuada para su inclusión en esta revisión. Un ensayo informó sobre la autoeficacia y dos ensayos informaron sobre la calidad de vida, pero solo uno informó sobre la calidad de vida de una manera que permitió extraer datos para esta revisión. Ningún estudio exploró el otro desenlace principal (tiempo hasta la recurrencia) o los desenlaces secundarios (amputaciones [mayores o distales] o coste).No es posible determinar si las intervenciones psicológicas tienen algún efecto beneficioso en las personas con una úlcera de pie diabético activa o con antecedentes de úlceras del pie diabético para lograr la cicatrización completa de la herida o prevenir la recurrencia. Esto se debe a que hay pocos ensayos de intervenciones psicológicas en esta área. De los ensayos que se incluyeron, pocos midieron todos los desenlaces de interés y, cuando lo hicieron, se consideró que la evidencia, según los criterios de GRADE, fue de certeza muy baja.

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2), the strain of coronavirus that causes coronavirus disease 2019 (COVID‐19) can cause serious illness in some people resulting in admission to intensive care units (ICU) and frequently, ventilatory support for acute respiratory failure. Evaluating ICU care, and what is effective in improving outcomes for these patients is critical. Care bundles, a small set of evidence‐based interventions, delivered together consistently, may improve patient outcomes. To identify the extent of the available evidence on the use of care bundles in patients with COVID‐19 in the ICU, the World Health Organization (WHO) commissioned a scoping review to inform WHO guideline discussions. This review does not assess the effectiveness of the findings, assess risk of bias, or assess the certainty of the evidence (GRADE). As this review was commissioned to inform guideline discussions, it was done rapidly over a three‐week period from 26 October to 18 November 2020. OBJECTIVES: To identify and describe the available evidence on the use of care bundles in the ICU for patients with COVID‐19 or related conditions (acute respiratory distress syndrome (ARDS) viral pneumonia or pneumonitis), or both. In carrying out the review the focus was on characterising the evidence base and not evaluating the effectiveness or safety of the care bundles or their component parts. SEARCH METHODS: We searched MEDLINE, Embase, the Cochrane Library (CENTRAL and the Cochrane COVID‐19 Study Register) and the WHO International Clinical Trials Registry Platform on 26 October 2020. SELECTION CRITERIA: Studies of all designs that reported on patients who are critically ill with COVID‐19, ARDS, viral pneumonia or pneumonitis, in the ICU setting, where a care bundle was implemented in providing care, were eligible for inclusion. One review author (VS) screened all records on title and abstract. A second review author (DR) checked 20% of excluded and included records; agreement was 99.4% and 100% respectively on exclude/include decisions. Two review authors (VS and DR) independently screened all records at full‐text level. VS and DR resolved any disagreements through discussion and consensus, or referral to a third review author (AN) as required. DATA COLLECTION AND ANALYSIS: One review author (VS) extracted the data and a second review author (DR) checked 20% of this for accuracy. As the review was not designed to synthesise effectiveness data, assess risk of bias, or characterise the certainty of the evidence (GRADE), we mapped the extracted data and presented them in tabular format based on the patient condition; that is patients with confirmed or suspected COVID‐19, patients with ARDS, patients with any influenza or viral pneumonia, patients with severe respiratory failure, and patients with mixed conditions. We have also provided a narrative summary of the findings from the included studies. MAIN RESULTS: We included 21 studies and identified three ongoing studies. The studies were of variable designs and included a systematic review of standardised approaches to caring for critically ill patients in ICU, including but not exclusive to care bundles (1 study), a randomised trial (1 study), prospective and retrospective cohort studies (4 studies), before and after studies (7 studies), observational quality improvement reports (4 studies), case series/case reports (3 studies) and audit (1 study). The studies were conducted in eight countries, most commonly China (5 studies) and the USA (4 studies), were published between 1999 and 2020, and involved over 2000 participants in total. Studies categorised participant conditions patients with confirmed or suspected COVID‐19 (7 studies), patients with ARDS (7 studies), patients with another influenza or viral pneumonia (5 studies), patients with severe respiratory failure (1 study), and patients with mixed conditions (1 study). The care bundles described in the studies involved multiple diverse practices. Guidance on ventilator settings (10 studies), restrictive fluid management (8 studies), sedation (7 studies) and prone positioning (7 studies) were identified most frequently, while only one study mentioned chest X‐ray. None of the included studies reported the prespecified outcomes ICU‐acquired weakness (muscle wasting, weight loss) and users' experience adapting care bundles. Of the remaining prespecified outcomes, 14 studies reported death in ICU, nine reported days of ventilation (or ventilator‐free days), nine reported length of stay in ICU in days, five reported death in hospital, three reported length of stay in hospital in days, and three reported adherence to the bundle. AUTHORS' CONCLUSIONS: This scoping review has identified 21 studies on care bundle use in critically ill patients in ICU with COVID‐19, ARDS, viral influenza or pneumonia and severe respiratory failure. The data for patients with COVID‐19 specifically are limited, derived mainly from observational quality improvement or clinical experiential accounts. Research is required, urgently, to further assess care bundle use and optimal components of these bundles in this patient cohort. The care bundles described were also varied, with guidance on ventilator settings described in 10 care bundles, while chest X‐ray was part mentioned in one care bundle in one study only. None of the studies identified in this scoping review measured users' experience of adapting care bundles. Optimising care bundle implementation requires that the components of the care bundle are collectively and consistently applied. Data on challenges, barriers and facilitators to implementation are needed. A formal synthesis of the outcome data presented in this review and a critical appraisal of the evidence is required by a subsequent effectiveness review. This subsequent review should further explore effect estimates across the included studies.

Background The COVID-19 pandemic has created a sense of urgency in the research community in their bid to contribute to the evidence required for healthcare policy decisions. With such urgency, researchers experience methodological challenges to maintain the rigour and transparency of their work. With this in mind, we offer reflections on our recent experience of undertaking a rapid Cochrane qualitative evidence synthesis (QES). Methods This process paper, using a reflexive approach, describes a rapid QES prepared during, and in response to, the COVID-19 pandemic. Findings This paper reports the methodological decisions we made and the process we undertook. We place our decisions in the context of guidance offered in relation to rapid reviews and previously conducted QESs. We highlight some of the challenges we encountered in finding the balance between the time needed for thoughtfulness and comprehensiveness whilst providing a rapid response to an urgent request for evidence. Conclusion The need for more guidance on rapid QES remains, but such guidance needs to be based on actual worked examples and case studies. This paper and the reflections offered may provide a useful framework for others to use and further develop.

On the 11th of March 2020, the World Health Organisation (WHO) declared a global pandemic due to the SARS-CoV-2 virus, which causes coronavirus disease 2019 (COVID-19). This was one month after Dr. Tedros Adhanom Ghebreyesus, Director-General of the WHO declared that we are also fighting an ‘infodemic’. The WHO has described an infodemic as an “over-abundance of information – some accurate and some not – that makes it hard for people to find trustworthy sources and reliable guidance when they need it”. iHealthFacts.ie is an Irish resource where the public can quickly and easily check the credibility and reliability of health claims circulating on social media. Unreliable claims can lead to poorly informed health choices. iHealthFacts is an initiative that supports the public to think critically about health claims and make well-informed choices. Here, we describe the role iHealthFacts plays in providing reliable information to the public and offer reflections from those involved in launching this initiative during a pandemic.

Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows:. To provide a living mapping of registered randomized trials, and to assess and rank where appropriate the relative effects of interventions for the prevention and treatment of COVID-19. Our approach has been described in Boutron 2020 and Nguyen 2020. As part of the methodological process of living systematic reviews, we will continuously (i.e. every working day) collect and critically appraise results from all eligible RCTs addressing specific clinical outcomes related to COVID-19. We will synthesize the available study results using pairwise meta-analyses and when possible and appropriate, network meta-analyses (NMAs). The interventions and the research questions considered will evolve over time and will be guided by end-users’ needs. We will report our updated evidence synthesis every week, and will make all results available on a website: www.covid-nma.com. In addition, we will update this Cochrane Review at least once every six months, or as soon as the certainty of evidence (assessed with the GRADE methodology) changes. We will wait until the accumulating evidence changes one or more of the following aspects of the review, before incorporating it and re-publishing the Cochrane Review:. the findings of one or more critical outcomes; the credibility (e.g. GRADE rating) of one or more critical outcomes; new settings, population, interventions, comparisons or outcomes studied; or new serious adverse events. We will develop a steering committee of epidemiologists, methodologists, statisticians and clinicians with content expertise. This committee will meet regularly and discuss the conduct of the project, difficulties encountered and possible changes in the protocol according to new knowledge becoming available for the disease. Changes to the protocol could include, for example, changes in the search strategy, eligibility criteria (e.g. study design), research questions for the pairwise meta-analyses, or outcomes. The steering committee will systematically discuss and achieve consensus on the changes to the protocol. The process will also evolve over time according to new knowledge available regarding COVID-19.

Background Virtual reality (VR) computer technology creates a simulated environment, perceived as comparable to the real world, with which users can actively interact. The effectiveness of VR distraction on acute pain intensity in children is uncertain. Objectives To assess the effectiveness and adverse effects of virtual reality (VR) distraction interventions for children (0 to 18 years) with acute pain in any healthcare setting. Search methods We searched CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO and four trial registries to October 2019. We also searched reference lists of eligible studies, handsearched relevant journals and contacted study authors. Selection criteria Randomised controlled trials (RCTs), including cross-over and cluster-RCTs, comparing VR distraction to no distraction, non-VR distraction or other VR distraction. Data collection and analysis We used standard Cochrane methodological processes. Two reviewers assessed risk of bias and extracted data independently. The primary outcome was acute pain intensity (during procedure, and up to one hour post-procedure). Secondary outcomes were adverse effects, child satisfaction with VR, pain-related distress, parent anxiety, rescue analgesia and cost. We used GRADE and created 'Summary of findings' tables. Main results We included 17 RCTs (1008 participants aged four to 18 years) undergoing various procedures in healthcare settings. We did not pool data because the heterogeneity in population (i.e. diverse ages and developmental stages of children and their different perceptions and reactions to pain) and variations in procedural conditions (e.g. phlebotomy, burn wound dressings, physical therapy sessions), and consequent level of pain experienced, made statistical pooling of data impossible. We narratively describe results. We judged most studies to be at unclear risk of selection bias, high risk of performance and detection bias, and high risk of bias for small sample sizes. Across all comparisons and outcomes, we downgraded the certainty of evidence to low or very low due to serious study limitations and serious or very serious indirectness. We also downgraded some of the evidence for very serious imprecision. 1: VR distraction versus no distraction Acute pain intensity: during procedure Self-report: one study (42 participants) found no beneficial effect of non-immersive VR (very low-certainty evidence). Observer-report: no data. Behavioural measurements (observer-report): two studies, 62 participants; low-certainty evidence. One study (n = 42) found no beneficial effect of non-immersive VR. One study (n = 20) found a beneficial effect favouring immersive VR. Acute pain intensity: post-procedure Self-report: 10 studies, 461 participants; very low-certainty evidence. Four studies (n = 95) found no beneficial effect of immersive and semi-immersive or non-immersive VR. Five studies (n = 357) found a beneficial effect favouring immersive VR. Another study (n = 9) reported less pain in the VR group. Observer-report: two studies (216 participants; low-certainty evidence) found a beneficial effect of immersive VR, as reported by primary caregiver/parents or nurses. One study (n = 80) found a beneficial effect of immersive VR, as reported by researchers. Behavioural measurements (observer-report): one study (42 participants) found no beneficial effect of non-immersive VR (very low-certainty evidence). Adverse effects: five studies, 154 participants; very low-certainty evidence. Three studies (n = 53) reported no adverse effects. Two studies (n = 101) reported mild adverse effects (e.g. nausea) in the VR group. 2: VR distraction versus other non-VR distraction Acute pain intensity: during procedure Self-report, observer-report and behavioural measurements (observer-report): two studies, 106 participants: Self-report: one study (n = 65) found a beneficial effect favouring immersive VR and one (n = 41) found no evidence of a difference in mean pain change scores (very low-certainty evidence). Observer-report: one study (n = 65) found a beneficial effect favouring immersive VR and one (n = 41) found no evidence of a difference in mean pain change scores (low-certainty evidence). Behavioural measurements (observer-report): one study (n = 65) found a beneficial effect favouring immersive VR and one (n = 41) reported a difference in mean pain change scores with fewer pain behaviours in VR group (low-certainty evidence). Acute pain intensity: post-procedure Self-report: eight studies, 575 participants; very low-certainty evidence. Two studies (n = 146) found a beneficial effect favouring immersive VR. Two studies (n = 252) reported a between-group difference favouring immersive VR. One study (n = 59) found no beneficial effect of immersive VR versus television and Child Life non-VR distraction. One study (n = 18) found no beneficial effect of semi-immersive VR. Two studies (n = 100) reported no between-group difference. Observer-report: three studies, 187 participants; low-certainty evidence. One study (n = 81) found a beneficial effect favouring immersive VR for parent, nurse and researcher reports. One study (n = 65) found a beneficial effect favouring immersive VR for caregiver reports. Another study (n = 41) reported no evidence of a difference in mean pain change scores. Behavioural measurements (observer-report): two studies, 106 participants; low-certainty evidence. One study (n = 65) found a beneficial effect favouring immersive VR. Another study (n = 41) reported no evidence of a difference in mean pain change scores. Adverse effects: six studies, 429 participants; very low-certainty evidence. Three studies (n = 229) found no evidence of a difference between groups. Two studies (n = 141) reported no adverse effects in VR group. One study (n = 59) reported no beneficial effect in reducing estimated cyber-sickness before and after VR immersion. 3: VR distraction versus other VR distraction We did not identify any studies for this comparison. Authors' conclusions We found low-certainty and very low-certainty evidence of the effectiveness of VR distraction compared to no distraction or other non-VR distraction in reducing acute pain intensity in children in any healthcare setting. This level of uncertainty makes it difficult to interpret the benefits or lack of benefits of VR distraction for acute pain in children. Most of the review primary outcomes were assessed by only two or three small studies. We found limited data for adverse effects and other secondary outcomes. Future well-designed, large, high-quality trials may have an important impact on our confidence in the results.

Background: Standardisation of outcomes measured and reported in trials of infant-feeding interventions to prevent childhood obesity is essential to evaluate and synthesise intervention effects. The aim of this study is to develop an infant-feeding core outcome set for use in randomised trials of infant-feeding interventions, with children ≤1 year old, to prevent childhood obesity. Methods: Core outcome set development followed four stages: (1) systematic review of outcomes reported in the extant literature; (2) meeting with national and international stakeholders to discuss and clarify identified outcomes; (3) e-Delphi study with national and international stakeholders to prioritise outcomes; (4) meeting with national and international stakeholders to reach consensus on outcomes. Stakeholders in stages 2–4 were paediatricians, general practitioners, nurses, midwives, non-clinician researchers, parents, dieticians, nutritionists, and childcare providers. Results: Twenty-six outcomes were identified for inclusion in the core outcome set. These were grouped in nine outcome domains: ‘breastfeeding and formula feeding’, ‘introduction of solids’, ‘parent feeding practices and styles’, ‘parent knowledge and beliefs’, ‘practical feeding’, ‘food environment’, ‘dietary intake’, ‘perceptions of infant behaviour and preferences’, and ‘child weight’. Conclusions: The core outcome set identified in this study is the minimum that should be measured and reported in trials of infant-feeding interventions to prevent childhood obesity. This standardisation of outcomes will enable more comprehensive examination and synthesis of the effects of infant-feeding interventions to prevent childhood obesity.

International audience; These authors propose an “evidence ecosystem” for COVID-19–related studies that minimizes multiple low-quality reviews and helps connect evidence generation, synthesis, and decision making.

Background Post-term pregnancy is associated with an increased risk of maternal complications, respiratory distress and trauma to the neonate. Amniotic membrane sweeping has been recommended as a simple procedure to promote the spontaneous onset of labour. However, despite its widespread use, there is an absence of evidence on (a) its effectiveness and (b) its optimal timing and frequency. The primary aim of the MILO Study is to inform the optimal design of a future definitive randomised trial to evaluate the effectiveness (including optimal timing and frequency) of membrane sweeping to prevent post-term pregnancy. We will also assess the acceptability and feasibility of the proposed trial interventions to clinicians and women (through focus group interviews). Methods/design Multicentre, pragmatic, parallel-group, pilot randomised controlled trial with an embedded factorial design. Pregnant women with a live, singleton foetus ≥ 38 weeks gestation; cephalic presentation; longitudinal lie; intact membranes; English speaking and ≥ 18 years of age will be randomised in a 2:1 ratio to membrane sweep versus no membrane sweep. Women allocated randomly to a sweep will then be randomised further (factorial component) to early (from 39 weeks) versus late (from 40 weeks) sweep commencement and a single versus weekly sweep. The proposed feasibility study consists of four work packages, i.e. (1) a multicentre, pilot randomised trial; (2) a health economic analysis; (3) a qualitative study; and (4) a study within the host trial (a SWAT). Outcomes to be collected include recruitment and retention rates, compliance with protocol, randomisation and allocation processes, attrition rates and cost-effectiveness. Focus groups will be held with women and clinicians to explore the acceptability and feasibility of the proposed intervention, study procedures and perceived barriers and enablers to recruitment. Discussion The primary aim of the MILO Study is to inform the optimal design of a future definitive randomised trial to evaluate the effectiveness (including optimal timing and frequency) of membrane sweeping to prevent post-term pregnancy. Results will inform whether and how the design of the definitive trial as originally envisaged should be delivered or adapted. Trial registration ClinicalTrials.gov NCT04307199. Registered on 12 March 2020

Background Bipolar disorder is one of the most common serious mental illnesses, affecting approximately 60 million people worldwide. Characterised by extreme alterations in mood, cognition, and behaviour, bipolar disorder can have a significant negative impact on the functioning and quality of life of the affected individual. Compared with the general population, the prevalence of comorbid obesity is significantly higher in bipolar disorder. Approximately 68% of treatment seeking bipolar patients are overweight or obese. Clinicians are aware that obesity has the potential to contribute to other physical health conditions in people with bipolar disorder, including diabetes, hypertension, metabolic syndrome, cardiovascular disease, and coronary heart disease. Cardiovascular disease is the leading cause of premature death in bipolar disorder, happening a decade or more earlier than in the general population. Contributing factors include illness-related factors (mood-related factors, i.e. mania or depression), treatment-related factors (weight implications and other side effects of medications), and lifestyle factors (physical inactivity, poor diet, smoking, substance abuse). Approaches to the management of obesity in individuals with bipolar disorder are diverse and include non-pharmacological interventions (i.e. dietary, exercise, behavioural, or multi-component), pharmacological interventions (i.e. weight loss drugs or medication switching), and bariatric surgery. Objectives To assess the effectiveness of interventions for the management of obesity in people with bipolar disorder. Search methods We searched the Cochrane Common Mental Disorders Controlled Trials Register (CCMDCTR) and the Cochrane Central Register for Controlled Trials (CENTRAL) to February 2019. We ran additional searches via Ovid databases including MEDLINE, Embase, and PsycInfo to May 2020. We searched the World Health Organization (WHO) trials portal (International Clinical Trials Registry Platform (ICTRP)) and ClinicalTrials.gov. We also checked the reference lists of all papers brought to full-text stage and all relevant systematic reviews. Selection criteria Randomised controlled trials (RCTs), randomised at the level of the individual or cluster, and cross-over designs of interventions for management of obesity, in which at least 80% of study participants had a clinical diagnosis of bipolar disorder and comorbid obesity (body mass index (BMI) ≥ 30 kg/m²), were eligible for inclusion. No exclusions were based on type of bipolar disorder, stage of illness, age, or gender. We included non-pharmacological interventions comprising dietary, exercise, behavioural, and multi-component interventions; pharmacological interventions consisting of weight loss medications and medication switching interventions; and surgical interventions such as gastric bypass, gastric bands, biliopancreatic diversion, and vertical banded gastroplasty. Comparators included the following approaches: dietary intervention versus inactive comparator; exercise intervention versus inactive comparator; behavioural intervention versus inactive comparator; multi-component lifestyle intervention versus inactive comparator; medication switching intervention versus inactive comparator; weight loss medication intervention versus inactive comparator; and surgical intervention versus inactive comparator. Primary outcomes of interest were changes in body mass, patient-reported adverse events, and quality of life. Data collection and analysis Four review authors were involved in the process of selecting studies. Two review authors independently screened the titles and abstracts of studies identified in the search. Studies brought to the full-text stage were then screened by another two review authors working independently. However, none of the full-text studies met the inclusion criteria. Had we included studies, we would have assessed their methodological quality by using the criteria recommended in the Cochrane Handbook for Systematic Reviews of Interventions. We intended to combine dichotomous data using risk ratios (RRs), and continuous data using mean differences (MDs). For each outcome, we intended to calculate overall effect size with 95% confidence intervals (CIs). Main results None of the studies that were screened met the inclusion criteria. Authors' conclusions None of the studies that were assessed met the inclusion criteria of this review. Therefore we were unable to determine the effectiveness of interventions for the management of obesity in individuals with bipolar disorder. Given the extent and impact of the problem and the absence of evidence, this review highlights the need for research in this area. We suggest the need for RCTs that will focus only on populations with bipolar disorder and comorbid obesity. We identified several ongoing studies that may be included in the update of this review.

Core Outcome Sets (COS) contain an agreed minimum set of outcomes to be measured and reported in all studies in a specific area, with the objective of standardizing outcome reporting. COS may minimize research waste by identifying outcomes important to key stakeholders, allowing for improved evidence synthesis, and facilitating translation of research findings to clinical practice. Over the past 5 years, there has been significant progress in developing COS relevant to studies of diabetes in pregnancy. This review summarizes work in this area, reviews the role of patient and public involvement in COS development, and suggests areas for future research.

Background Despite efforts to improve the accuracy and transparency of the design, conduct, and reporting of randomised controlled trials (RCTs), deficiencies remain. Such deficiencies contribute to significant, avoidable waste of health research investment and impede reproducibility. This study aimed to synthesise and critically analyse changes over time in the conduct and reporting of internationally published evidence on patient and/or population health-oriented RCTs conducted in one country. Methods This observational study drew on systematic review methods. We searched six databases for published RCTs (database inception to December 2018) where ≥ 80% of participants were recruited in the Republic of Ireland. RCTs of interventions targeted at patients, providers and/or policy makers intended to improve health, healthcare or health research were included. For each study, screening, data extraction and methodological quality appraisal were conducted by one member of the author team. Results From 17,560 titles and abstracts, 752 unique RCTs were published in 745 papers between 1968 and 2018, with a steady year-on-year increase since 1968. The number of participants was in the range of 2–8628. The majority were parallel design (86%) and classified as treatment evaluation. Of the 418 RCTs published since the introduction of mandatory clinical trial registration by the International Committee of Medical Journal Editors in 2005, 32% (n = 134) provided a trial registration number. This increased to 47% when taking studies published between 2013 and 2018 (n = 232). Since the 1996 publication of the CONSORT statement, 16% of included RCTs made specific reference to a standardised reporting guideline and this increased to 31% for more recent studies published between 2013 and 2018. Overall, 7% (n = 53) of studies referred to a published study protocol, increasing to 20% for studies published between 2013 and 2018. Conclusion Evidence from this single-country study of RCTs published in the international literature suggests that both the number overall, the number registered and the number referencing reporting guidelines have increased steadily over time. Despite widespread endorsement of reporting standards, reporting of RCTs remains suboptimal in domains such as compliance with the CONSORT statement and prospective trial registration. Researchers, funders and journal editors, nationally and internationally, should continue to focus on improving reporting and examining avoidable waste of health research investment.

BackgroundThe COVID-19 pandemic has led to unprecedented demand for personal protective equipment. Shortages of surgical masks and filtering facepiece respirators has led to the extended use or re-use of single-use respirators and surgical masks by frontline healthcare workers. The evidence base underpinning such practices has been questioned.ObjectivesTo summarise guidance and synthesise systematic review evidence on extended use, re-use or reprocessing of single-use surgical masks or filtering facepiece respirators.MethodsA targeted search of the World Health Organization, European Centre for Disease Prevention and Control, the US Centers for Disease Control and Prevention, and Public Health England websites was conducted to identify guidance. Four databases (Medline, Pubmed, Epistemonikos, Cochrane Database of Systematic Reviews) and three preprint repositories (Litcovid, MedRxiv and Open Science Framework) were searched for relevant systematic reviews. Record screening and data extraction was conducted by two reviewers. Quality of included systematic reviews was appraised using the AMSTAR-2 checklist. Findings were integrated and narratively synthesised to highlight the extent to which key claims in guidance documents were supported by research evidence.ResultsSix guidance documents were identified. All note that extended use or re-use of single-use surgical masks and respirators (with or without reprocessing) should be considered only in situations of critical shortage. Extended use was generally favoured over re-use because of reduced risk of contact transmission. Four high-quality systematic reviews were included: three focused on reprocessing (decontamination) of N95 respirators and one focused on reprocessing of surgical masks. There was limited evidence on the impact of extended use on masks and respirators. Vaporised hydrogen peroxide and ultraviolet germicidal irradiation were highlighted as the most promising reprocessing methods, but evidence on the relative efficacy and safety of different methods was limited. We found no well-established methods for reprocessing respirators at scale.ConclusionsThere is limited evidence on the impact of extended use and re-use of surgical masks and respirators. Where extended use or re-use is being practiced, healthcare organisations should ensure that policies and systems are in place to ensure these practices are carried out safely and in line with available guidance.

Background The current COVID-19 pandemic has been identified as a possible trigger for increases in loneliness and social isolation among older people due to the restrictions on movement that many countries have put in place. Loneliness and social isolation are consistently identified as risk factors for poor mental and physical health in older people. Video calls may help older people stay connected during the current crisis by widening the participant's social circle or by increasing the frequency of contact with existing acquaintances. Objectives The primary objective of this rapid review is to assess the effectiveness of video calls for reducing social isolation and loneliness in older adults. The review also sought to address the effectiveness of video calls on reducing symptoms of depression and improving quality of life. Search methods We searched CENTRAL, MEDLINE, PsycINFO and CINAHL from 1 January 2004 to 7 April 2020. We also searched the references of relevant systematic reviews. Selection criteria Randomised controlled trials (RCTs) and quasi-RCTs (including cluster designs) were eligible for inclusion. We excluded all other study designs. The samples in included studies needed to have a mean age of at least 65 years. We included studies that included participants whether or not they were experiencing symptoms of loneliness or social isolation at baseline. Any intervention in which a core component involved the use of the internet to facilitate video calls or video conferencing through computers, smartphones or tablets with the intention of reducing loneliness or social isolation, or both, in older adults was eligible for inclusion. We included studies in the review if they reported self-report measures of loneliness, social isolation, symptoms of depression or quality of life. Two review authors screened 25% of abstracts; a third review author resolved conflicts. A single review author screened the remaining abstracts. The second review author screened all excluded abstracts and we resolved conflicts by consensus or by involving a third review author. We followed the same process for full-text articles. Data collection and analysis One review author extracted data, which another review author checked. The primary outcomes were loneliness and social isolation and the secondary outcomes were symptoms of depression and quality of life. One review author rated the certainty of evidence for the primary outcomes according to the GRADE approach and another review author checked the ratings. We conducted fixed-effect meta-analyses for the primary outcome, loneliness, and the secondary outcome, symptoms of depression. Main results We identified three cluster quasi-randomised trials, which together included 201 participants. The included studies compared video call interventions to usual care in nursing homes. None of these studies were conducted during the COVID-19 pandemic. Each study measured loneliness using the UCLA Loneliness Scale. Total scores range from 20 (least lonely) to 80 (most lonely). The evidence was very uncertain and suggests that video calls may result in little to no difference in scores on the UCLA Loneliness Scale compared to usual care at three months (mean difference (MD) -0.44, 95% confidence interval (CI) -3.28 to 2.41; 3 studies; 201 participants), at six months (MD -0.34, 95% CI -3.41 to 2.72; 2 studies; 152 participants) and at 12 months (MD -2.40, 95% CI -7.20 to 2.40; 1 study; 90 participants). We downgraded the certainty of this evidence by three levels for study limitations, imprecision and indirectness. None of the included studies reported social isolation as an outcome. Each study measured symptoms of depression using the Geriatric Depression Scale. Total scores range from 0 (better) to 30 (worse). The evidence was very uncertain and suggests that video calls may result in little to no difference in scores on the Geriatric Depression Scale compared to usual care at three months' follow-up (MD 0.41, 95% CI -0.90 to 1.72; 3 studies; 201 participants) or six months' follow-up (MD -0.83, 95% CI -2.43 to 0.76; 2 studies, 152 participants). The evidence suggests that video calls may have a small effect on symptoms of depression at one-year follow-up, though this finding is imprecise (MD -2.04, 95% CI -3.98 to -0.10; 1 study; 90 participants). We downgraded the certainty of this evidence by three levels for study limitations, imprecision and indirectness. Only one study, with 62 participants, reported quality of life. The study measured quality of life using a Taiwanese adaptation of the Short-Form 36-question health survey (SF-36), which consists of eight subscales that measure different aspects of quality of life: physical function; physical role; emotional role; social function; pain: vitality; mental health; and physical health. Each subscale is scored from 0 (poor health) to 100 (good health). The evidence is very uncertain and suggests that there may be little to no difference between people allocated to usual care and those allocated to video calls in three-month scores in physical function (MD 2.88, 95% CI -5.01 to 10.77), physical role (MD -7.66, 95% CI -24.08 to 8.76), emotional role (MD -7.18, 95% CI -16.23 to 1.87), social function (MD 2.77, 95% CI -8.87 to 14.41), pain scores (MD -3.25, 95% CI -15.11 to 8.61), vitality scores (MD -3.60, 95% CI -9.01 to 1.81), mental health (MD 9.19, 95% CI 0.36 to 18.02) and physical health (MD 5.16, 95% CI -2.48 to 12.80). We downgraded the certainty of this evidence by three levels for study limitations, imprecision and indirectness. Authors' conclusions Based on this review there is currently very uncertain evidence on the effectiveness of video call interventions to reduce loneliness in older adults. The review did not include any studies that reported evidence of the effectiveness of video call interventions to address social isolation in older adults. The evidence regarding the effectiveness of video calls for outcomes of symptoms of depression was very uncertain. Future research in this area needs to use more rigorous methods and more diverse and representative participants. Specifically, future studies should target older adults, who are demonstrably lonely or socially isolated, or both, across a range of settings to determine whether video call interventions are effective in a population in which these outcomes are in need of improvement.

peer-reviewed Background: Systematic reviews of randomised trials guide policy and healthcare decisions. Yet, we observed that some reviews judge randomised trials as high or unclear risk of bias (ROB) for sequence generation, potentially introducing bias. However, to date, the extent of this issue has not been well examined. We evaluated the consistency in the ROB assessment for sequence generation of randomised trials in Cochrane and non-Cochrane reviews, and explored the reviewers’ judgement of the quality of evidence for the related outcomes. Methods: Cochrane intervention reviews (01/01/2017–31/03/2017) were retrieved from the Cochrane Database of Systematic Reviews. We also searched for systematic reviews in ten general medical journals with highest impact factors (01/01/2016–31/03/2017). We examined the proportion of reviews that rated the sequence generation domain as high, low or unclear risk of selection bias. For reviews that had rated any randomised trials as high or unclear risk of bias, we examined the proportion that had assessed the quality of evidence. Results: Overall, 100 systematic reviews were included in our analysis. We evaluated 64 Cochrane reviews which comprised of 984 randomised trials; 0.8% (n = 8) and 52.2% (n = 514) were rated as high and unclear ROB for sequence generation respectively. We further evaluated 36 non-Cochrane reviews which comprised of 1376 trials; 5.8% (n = 80) and 39.6% (n = 545) were rated as high and unclear ROB respectively. Ninety percent (n = 10) of non- Cochrane reviews which rated randomised trials as high ROB for sequence generation did not report an underlying reason. All Cochrane reviews assessed the quality of evidence (GRADE). For the non-Cochrane reviews, only just over half had assessed the quality of evidence. Conclusion: Systematic reviews of interventions frequently rate randomised trials as high or unclear ROB for sequence generation. In general, Cochrane reviews were more transparent than non-Cochrane reviews in ROB and quality of evidence assessment. The scientific community should more strongly promote consistent ROB assessment for sequence generation to minimise selection bias and support transparent quality of evidence assessment. Consistency ensures that appropriate conclusions are drawn from the data.

Background This review is one of a series of rapid reviews that Cochrane contributors have prepared to inform the 2020 COVID‐19 pandemic. When new respiratory infectious diseases become widespread, such as during the COVID‐19 pandemic, healthcare workers’ adherence to infection prevention and control (IPC) guidelines becomes even more important. Strategies in these guidelines include the use of personal protective equipment (PPE) such as masks, face shields, gloves and gowns; the separation of patients with respiratory infections from others; and stricter cleaning routines. These strategies can be difficult and time‐consuming to adhere to in practice. Authorities and healthcare facilities therefore need to consider how best to support healthcare workers to implement them. Objectives To identify barriers and facilitators to healthcare workers’ adherence to IPC guidelines for respiratory infectious diseases. Search methods We searched OVID MEDLINE on 26 March 2020. As we searched only one database due to time constraints, we also undertook a rigorous and comprehensive scoping exercise and search of the reference lists of key papers. We did not apply any date limit or language limits. Selection criteria We included qualitative and mixed‐methods studies (with an identifiable qualitative component) that focused on the experiences and perceptions of healthcare workers towards factors that impact on their ability to adhere to IPC guidelines for respiratory infectious diseases. We included studies of any type of healthcare worker with responsibility for patient care. We included studies that focused on IPC guidelines (local, national or international) for respiratory infectious diseases in any healthcare setting. These selection criteria were framed by an understanding of the needs of health workers during the COVID‐19 pandemic. Data collection and analysis Four review authors independently assessed the titles, abstracts and full texts identified by the search. We used a prespecified sampling frame to sample from the eligible studies, aiming to capture diverse respiratory infectious disease types, geographical spread and data‐rich studies. We extracted data using a data extraction form designed for this synthesis. We assessed methodological limitations using an adapted version of the Critical Skills Appraisal Programme (CASP) tool. We used a ‘best fit framework approach’ to analyse and synthesise the evidence. This provided upfront analytical categories, with scope for further thematic analysis. We used the GRADE‐CERQual (Confidence in the Evidence from Reviews of Qualitative research) approach to assess our confidence in each finding. We examined each review finding to identify factors that may influence intervention implementation and developed implications for practice. Main results We found 36 relevant studies and sampled 20 of these studies for our analysis. Ten of these studies were from Asia, four from Africa, four from Central and North America and two from Australia. The studies explored the views and experiences of nurses, doctors and other healthcare workers when dealing with severe acute respiratory syndrome (SARS), H1N1, MERS (Middle East respiratory syndrome), tuberculosis (TB), or seasonal influenza. Most of these healthcare workers worked in hospitals; others worked in primary and community care settings. The review points to several barriers and facilitators that influenced healthcare workers’ ability to adhere to IPC guidelines. The following factors are based on findings assessed as of moderate to high confidence. Healthcare workers felt unsure as to how to adhere to local guidelines when they were lengthy and ambiguous or did not reflect national or international guidelines. They could feel overwhelmed because local guidelines were constantly changing. They also described how IPC strategies led to increased workloads and fatigue, for instance because they had to use PPE and take on additional cleaning. Healthcare workers described how their responses to IPC guidelines were influenced by the level of support they felt that they received from their management team. Clear communication about IPC guidelines was seen as vital. But healthcare workers pointed to a lack of training about the infection itself and about how to use PPE. They also thought it was a problem when training was not mandatory. Sufficient space to isolate patients was also seen as vital. A lack of isolation rooms, anterooms and shower facilities was identified as a problem. Other important practical measures described by healthcare workers included minimising overcrowding, fast‐tracking infected patients, restricting visitors, and providing easy access to handwashing facilities. A lack of PPE, and provision of equipment that was of poor quality, was a serious concern for healthcare workers and managers. They also pointed to the need to adjust the volume of supplies as infection outbreaks continued. Healthcare workers believed that they followed IPC guidance more closely when they saw its value. Some healthcare workers felt motivated to follow the guidance because of fear of infecting themselves or their families, or because they felt responsible for their patients. Some healthcare workers found it difficult to use masks and other equipment when it made patients feel isolated, frightened or stigmatised. Healthcare workers also found masks and other equipment uncomfortable to use. The workplace culture could also influence whether healthcare workers followed IPC guidelines or not. Across many of the findings, healthcare workers pointed to the importance of including all staff, including cleaning staff, porters, kitchen staff and other support staff when implementing IPC guidelines. Authors' conclusions Healthcare workers point to several factors that influence their ability and willingness to follow IPC guidelines when managing respiratory infectious diseases. These include factors tied to the guideline itself and how it is communicated, support from managers, workplace culture, training, physical space, access to and trust in personal protective equipment, and a desire to deliver good patient care. The review also highlights the importance of including all facility staff, including support staff, when implementing IPC guidelines.

Recurrent miscarriage (RM) was recently re-defined by the European Society of Human Reproduction and Embryology (ESHRE) as the loss of two or more consecutive pregnancies. Before this, and indeed still in some countries, RM was defined as three or more consecutive pregnancy losses. While the incidence of RM depends on the definition employed and population studied, it is generally accepted to affect 1-6% of women of reproductive age. Clinical practice guidelines (CPGs) for RM have been published by some professional organisations. While there are CPGs on miscarriage in Ireland, there are none concerning RM specifically. The aim of this systematic review is to identify, appraise and describe published CPGs for the management, investigation and/or follow-up of RM within high-income countries. Electronic databases (MEDLINE (Ovid®; 1946), Embase® (Elsevier; 1980), CINAHL Complete (EBSCOhost; 1994), Web of Science™ (Thomson Reuters), Scopus (Elsevier; 2004), and Open Grey (INIST-CNRS; 2011)), selected guideline repositories, and the websites of professional societies will be searched to identify CPGs, published within the last 20 years, for potential inclusion. Two reviewers will review abstracts and full texts independently against the eligibility criteria. Characteristics and recommendations of included CPGs will be extracted by one reviewer and double-checked by another. Two reviewers will use the Appraisal of Guidelines for Research and Evaluation version 2 (AGREE II) instrument independently to assess the quality of the included CPGs. Narrative synthesis will be conducted to appraise and compare CPGs and their recommendations or guidance therein. The identification, appraisal and description of published CPGs in other high-income countries will be a valuable first step in informing efforts to promote the optimisation and standardisation of RM care.

Background Despite evidence supporting the safety of vaginal birth after caesarean section (VBAC), rates are low in many countries. Methods OptiBIRTH investigated the effects of a woman-centred intervention designed to increase VBAC rates through an unblinded cluster randomised trial in 15 maternity units with VBAC rates Results The OptiBIRTH intervention was feasible and safe across hospital settings in three countries. There was no statistically significant difference in the change in the proportion of women having a VBAC between intervention sites (25.6% in 2012 to 25.1% in 2016) and control sites (18.3 to 22.3%) (odds ratio adjusted for differences between intervention and control groups (2012) and for homogeneity in VBAC rates at sites in the countries: 0.87, 95% CI: 0.67, 1.14, p = 0.32 based on 5674 women (2012) and 5284 (2016) with outcome data. Among recruited women with birth data, 4/1147 perinatal deaths > 24 weeks gestation occurred in the intervention group (0.34%) and 4/782 in the control group (0.51%), and two uterine ruptures (one per group), a rate of 1:1000. Conclusions Changing clinical practice takes time. As elective repeat CS is the most common reason for CS in multiparous women, interventions that are feasible and safe and that have been shown to lead to decreasing repeat CS, should be promoted. Continued research to refine the best way of promoting VBAC is essential. This may best be done using an implementation science approach that can modify evidence-based interventions in response to changing clinical circumstances. Trial registration The OptiBIRTH trial was registered on 3/4/2013. Trial registration number ISRCTN10612254.

BACKGROUND: Induction of labour involves stimulating uterine contractions artificially to promote the onset of labour. There are several pharmacological, surgical and mechanical methods used to induce labour. Membrane sweeping is a mechanical technique whereby a clinician inserts one or two fingers into the cervix and using a continuous circular sweeping motion detaches the inferior pole of the membranes from the lower uterine segment. This produces hormones that encourage effacement and dilatation potentially promoting labour. This review is an update to a review first published in 2005. OBJECTIVES: To assess the effects and safety of membrane sweeping for induction of labour in women at or near term (≥ 36 weeks' gestation). SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth’s Trials Register (25 February 2019), ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (25 February 2019), and reference lists of retrieved studies. SELECTION CRITERIA: Randomised and quasi‐randomised controlled trials comparing membrane sweeping used for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed on a predefined list of labour induction methods. Cluster‐randomised trials were eligible, but none were identified. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion, risk of bias and extracted data. Data were checked for accuracy. Disagreements were resolved by discussion, or by including a third review author. The certainty of the evidence was assessed using the GRADE approach. MAIN RESULTS: We included 44 studies (20 new to this update), reporting data for 6940 women and their infants. We used random‐effects throughout. Overall, the risk of bias was assessed as low or unclear risk in most domains across studies. Evidence certainty, assessed using GRADE, was found to be generally low, mainly due to study design, inconsistency and imprecision. Six studies (n = 1284) compared membrane sweeping with more than one intervention and were thus included in more than one comparison. No trials reported on the outcomes uterine hyperstimulation with/without fetal heart rate (FHR) change, uterine rupture or neonatal encephalopathy. Forty studies (6548 participants) compared membrane sweeping with no treatment/sham Women randomised to membrane sweeping may be more likely to experience: · spontaneous onset of labour (average risk ratio (aRR) 1.21, 95% confidence interval (CI) 1.08 to 1.34, 17 studies, 3170 participants, low‐certainty evidence). but less likely to experience: · induction (aRR 0.73, 95% CI 0.56 to 0.94, 16 studies, 3224 participants, low‐certainty evidence); There may be little to no difference between groups for: · caesareans (aRR 0.94, 95% CI 0.85 to 1.04, 32 studies, 5499 participants, moderate‐certainty evidence); · spontaneous vaginal birth (aRR 1.03, 95% CI 0.99 to 1.07, 26 studies, 4538 participants, moderate‐certainty evidence); · maternal death or serious morbidity (aRR 0.83, 95% CI 0.57 to 1.20, 17 studies, 2749 participants, low‐certainty evidence); · neonatal perinatal death or serious morbidity (aRR 0.83, 95% CI 0.59 to 1.17, 18 studies, 3696 participants, low‐certainty evidence). Four studies reported data for 480 women comparing membrane sweeping with vaginal/intracervical prostaglandins There may be little to no difference between groups for the outcomes: · spontaneous onset of labour (aRR, 1.24, 95% CI 0.98 to 1.57, 3 studies, 339 participants, low‐certainty evidence); · induction (aRR 0.90, 95% CI 0.56 to 1.45, 2 studies, 157 participants, low‐certainty evidence); · caesarean (aRR 0.69, 95% CI 0.44 to 1.09, 3 studies, 339 participants, low‐certainty evidence); · spontaneous vaginal birth (aRR 1.12, 95% CI 0.95 to 1.32, 2 studies, 252 participants, low‐certainty evidence); · maternal death or serious morbidity (aRR 0.93, 95% CI 0.27 to 3.21, 1 study, 87 participants, low‐certainty evidence); · neonatal perinatal death or serious morbidity (aRR 0.40, 95% CI 0.12 to 1.33, 2 studies, 269 participants, low‐certainty evidence). One study, reported data for 104 women, comparing membrane sweeping with intravenous oxytocin +/‐ amniotomy There may be little to no difference between groups for: · spontaneous onset of labour (aRR 1.32, 95% CI 88 to 1.96, 1 study, 69 participants, low‐certainty evidence); · induction (aRR 0.51, 95% CI 0.05 to 5.42, 1 study, 69 participants, low‐certainty evidence); · caesarean (aRR 0.69, 95% CI 0.12 to 3.85, 1 study, 69 participants, low‐certainty evidence); · maternal death or serious morbidity was reported on, but there were no events. Two studies providing data for 160 women compared membrane sweeping with vaginal/oral misoprostol There may be little to no difference between groups for: · caesareans (RR 0.82, 95% CI 0.31 to 2.17, 1 study, 96 participants, low‐certainty evidence). One study providing data for 355 women which compared once weekly membrane sweep with twice‐weekly membrane sweep and a sham procedure There may be little to no difference between groups for: · induction (RR 1.19, 95% CI 0.76 to 1.85, 1 study, 234 participants, low‐certainty); · caesareans (RR 0.93, 95% CI 0.60 to 1.46, 1 study, 234 participants, low‐certainty evidence); · spontaneous vaginal birth (RR 1.00, 95% CI 0.86 to 1.17, 1 study, 234 participants, moderate‐certainty evidence); · maternal death or serious maternal morbidity (RR 0.78, 95% CI 0.30 to 2.02, 1 study, 234 participants, low‐certainty evidence); · neonatal death or serious neonatal perinatal morbidity (RR 2.00, 95% CI 0.18 to 21.76, 1 study, 234 participants, low‐certainty evidence); We found no studies that compared membrane sweeping with amniotomy only or mechanical methods. Three studies, providing data for 675 women, reported that women indicated favourably on their experience of membrane sweeping with one study reporting that 88% (n = 312) of women questioned in the postnatal period would choose membrane sweeping in the next pregnancy. Two studies reporting data for 290 women reported that membrane sweeping is more cost‐effective than using prostaglandins, although more research should be undertaken in this area. AUTHORS' CONCLUSIONS: Membrane sweeping may be effective in achieving a spontaneous onset of labour, but the evidence for this was of low certainty. When compared to expectant management, it potentially reduces the incidence of formal induction of labour. Questions remain as to whether there is an optimal number of membrane sweeps and timings and gestation of these to facilitate induction of labour.

Background Striae gravidarum are a common occurrence in pregnancy and many women use a topical product to prevent their development or lessen their appearance if they do develop. There is a lack of evidence on the effectiveness of many of the products used by women. This study arose from challenges in recruitment to a pilot randomised trial (ISRCTN trial registration number:76992326) designed to evaluate the feasibility of a definitive trial to compare a moisturising oil to no treatment in the prevention and reduction in severity of striae gravidarum. The study reported here explored the factors influencing recruitment to that pilot trial. Methods A qualitative descriptive study was undertaken involving primigravid women attending an Irish maternity hospital. Data were collected by semi-structured telephone interviews over a four-week period and analysed using the framework method of analysis. Fifteen interview transcripts were included in the analysis. Results Four main themes consisting of twelve categories were identified from the interview data. The themes focused on women’s prevention of stretch marks and their choice of anti-stretch mark product, who and what influenced that choice and influences on trial participation. In relation to influences on trial participation, the possibility of being randomised to the non- intervention or control group was a deterrent for many women. Conclusions The prevention of stretch marks is important to pregnant women, as is their choice of product to prevent them. Offering women the opportunity to be part of a trial that would be of low burden and would test a well-known product may optimise recruitment. However, reluctance to be randomised because of the possibility of being allocated to the non-intervention control group suggests that further work is needed in this field on how best to communicate uncertainty to potential participants.

Background The Health Research Board-Trials Methodology Research Network (HRB-TMRN) celebrates International Clinical Trials Day with the help of the younger members of our community through the Network’s ‘Schools Teaching Awareness of Randomised Trials (START)’ initiative. START seeks to increase public awareness of randomised trials in Ireland. Launched in 2016, it asks children (8–12 years old) to conduct and report their very own fun randomised trial. The study reported in this paper sought to explore children and teachers perceptions and experiences of the START initiative. Methods We conducted eight, one-to one interviews with teachers and eight focus groups with 61 children who took part in the 2018 START initiative. Interviews and focus groups were recorded and transcribed and the data analysed using template analysis. Results The findings of this study highlight the benefits of participating in START and the areas of the initiative that required further attention. Teachers and children recalled the benefits of experiential learning associated with START and learning by doing encouraged a fun way of engaging with trial processes. By recalling all aspects of planning, conducting and reporting their trial, the children in this study demonstrated their awareness of the trial processes. The teachers suggested that START provides a valuable framework to contribute to key aspects of the primary school curriculum in Ireland. The experiences of these participants also provided recommendation for improving the programme for future START participants. Conclusions Increasing public awareness and understanding of randomised trials can help increase public engagement in trials. By educating children about the importance of trials and supporting them to ‘learn by doing’ by carrying out their own trial, the START initiative can contribute substantially to children’s awareness and understanding of trial processes. Given that children are the public, the patients and the researchers of the future, initiatives such as START deserve attention.

no modification between a continuous monitoring and an intermittent monitoring of the patient's condition and of the neonatal and obstetric issues in low-risk pregnancy.

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

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 .

Chronic obstructive pulmonary disease is a common, preventable and treatable disease. Exercise training programmes (ETPs) improve symptoms, health-related quality of life (HRQoL) and exercise capacity, but the optimal setting is unknown. In this review, we compared the effects of ETPs in different settings on HRQoL and exercise capacity. We searched (5 July 2016) the Cochrane Airways Group Specialised Register, ClinicalTrials.gov and World Health Organization trials portal. We selected studies, extracted data and assessed risk of bias with two independent reviewers. We calculated mean differences (MD) with 95% CI. We assessed the quality of evidence using Grades of Recommendation, Assessment, Development and Evaluation. Ten trials (934 participants) were included. Hospital (outpatient) and home-based ETPs (seven trials) were equally effective at improving HRQoL on the Chronic Respiratory Questionnaire (CRQ) (dyspnoea: MD -0.09, 95% CI: -0.28 to 0.10; fatigue: MD -0.00, 95% CI: -0.18 to 0.17; emotional: MD 0.10, 95% CI: -0.24 to 0.45; and mastery: MD -0.02, 95% CI: -0.28 to 0.25; moderate quality) and on the St George's Respiratory Questionnaire (SGRQ) (MD -0.82, 95% CI: -7.47 to 5.83, low quality). Hospital (outpatient) and community-based ETPs (three trials) were equally effective at improving HRQoL (CRQ dyspnoea: MD 0.29, 95% CI: -0.05 to 0.62, moderate quality; fatigue: MD -0.02, 95% CI: -1.09 to 1.05, low quality; emotional: MD 0.10, 95% CI: -0.40 to 0.59, moderate quality; and mastery: MD -0.08, 95% CI: -0.45 to 0.28, moderate quality). There was no difference in exercise capacity. There was low to moderate evidence that outpatient and home-based ETPs are equally effective. See related Editorial.

Background Childhood obesity is a significant public health challenge that affects approximately one in five children worldwide. Infant feeding practices are implicated in the aetiology of childhood obesity. Infant feeding interventions for childhood obesity are increasingly popular but outcome reporting is inconsistent across trials. Lack of standardisation limits examination of intervention effects and mechanisms of change. The aim of the current project is to develop a core set of infant feeding outcomes for children ≤ 1 year old, to be evaluated in childhood obesity intervention trials. Methods This project will use similar methodology to previous core outcome development research. An infant feeding core outcome set (COS) will be developed in four stages: (1) a systematic review of the literature, (2) discussion and clarification of outcomes in a meeting involving multiple stakeholder perspectives, (3) prioritisation of outcomes using the Delphi technique with an expert panel of stakeholders, and (4) achieving consensus on the COS using the nominal group technique (NGT) consensus meeting. An online Delphi survey will be conducted following the NGT meeting to prioritise outcomes identified in the systematic review. An NGT meeting will be conducted with groups of health professionals, non-clinician researchers, and parents of infants ≤ 1 year old, to achieve final consensus on the infant feeding COS. Discussion This study aims to develop a core outcome set of infant feeding outcomes for randomised infant feeding studies to prevent childhood obesity. This research will improve examination and syntheses of the outcomes of such studies to prevent and reduce childhood obesity. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-2180-4) contains supplementary material, which is available to authorized users.

Aims/hypothesis The aim of this study was to develop a core outcome set (COS) for trials and other studies evaluating the effectiveness of prepregnancy care for women with pregestational (pre-existing) diabetes mellitus. Methods A systematic literature review was completed to identify all outcomes reported in prior studies in this area. Key stakeholders then prioritised these outcomes using a Delphi study. The list of outcomes included in the final COS were finalised at a face-to-face consensus meeting. Results In total, 17 outcomes were selected and agreed on for inclusion in the final COS. These outcomes were grouped under three domains: measures of pregnancy preparation (n = 9), neonatal outcomes (n = 6) and maternal outcomes (n = 2). Conclusions/interpretation This study identified a COS essential for studies evaluating prepregnancy care for women with pregestational diabetes. It is advocated that all trials and other non-randomised studies and audits in this area use this COS with the aim of improving transparency and the ability to compare and combine future studies with greater ease. Electronic supplementary material The online version of this article (doi:10.1007/s00125-017-4277-4) contains peer-reviewed but unedited supplementary material, which is available to authorised users.

The work described here was discussed at and after a meeting held in Aberdeen on 23 March 2017, which was funded by the Medical Research Council (MRC) Network of Hubs for Trials Methodology Research (Grant Reference: MR/L004933/1– B2) and the Health Research Board – Trials Methodology Research Network (Ireland). The evidence base available to trialists to support trial process decisions—e.g. how best to recruit and retain participants, how to collect data or how to share the results with participants—is thin. One way to fill gaps in evidence is to run Studies Within A Trial, or SWATs. These are self-contained research studies embedded within a host trial that aim to evaluate or explore alternative ways of delivering or organising a particular trial process. SWATs are increasingly being supported by funders and considered by trialists, especially in the UK and Ireland. At some point, increasing SWAT evidence will lead funders and trialists to ask: given the current body of evidence for a SWAT, do we need a further evaluation in another host trial? A framework for answering such a question is needed to avoid SWATs themselves contributing to research waste. This paper presents criteria on when enough evidence is available for SWATs that use randomised allocation to compare different interventions. Publisher PDF

Background Dementia is a worldwide concern. Its global prevalence is increasing. At present, there is no medication licensed to prevent or delay the onset of dementia. Inflammation has been suggested as a key factor in dementia pathogenesis. Therefore, medications with anti-inflammatory properties could be beneficial for dementia prevention. Objectives To evaluate the effectiveness and adverse effects of aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs) for the primary or secondary prevention of dementia. Search methods We searched ALOIS, the specialised register of the Cochrane Dementia and Cognitive Improvement Group up to 9 January 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) and six other databases to ensure that the searches were as comprehensive and up-to-date as possible. We also reviewed citations of reference lists of included studies. Selection criteria We searched for randomised controlled trials (RCTs) and controlled clinical trials (CCTs) comparing aspirin or other NSAIDs with placebo for the primary or secondary prevention of dementia. We included trials with cognitively healthy participants (primary prevention) or participants with mild cognitive impairment (MCI) or cognitive complaints (secondary prevention). Data collection and analysis We used standard methodological procedures according to the Cochrane Handbook for Systematic Reviews of Interventions. We rated the strength of evidence for each outcome using the GRADE approach. Main results We included four RCTs with 23,187 participants. Because of the diversity of these trials, we did not combine data to give summary estimates, but presented a narrative description of the evidence. We identified one trial (19,114 participants) comparing low-dose aspirin (100 mg once daily) to placebo. Participants were aged 70 years or older with no history of dementia, cardiovascular disease or physical disability. Interim analysis indicated no significant treatment effect and the trial was terminated slightly early after a median of 4.7 years' follow-up. There was no evidence of a difference in incidence of dementia between aspirin and placebo groups (risk ratio (RR) 0.98, 95% CI 0.83 to 1.15; high-certainty evidence). Participants allocated aspirin had higher rates of major bleeding (RR 1.37, 95% CI 1.17 to 1.60, high-certainty evidence) and slightly higher mortality (RR 1.14, 95% CI 1.01 to 1.28; high-certainty evidence). There was no evidence of a difference in activities of daily living between groups (RR 0.84, 95% CI 0.70 to 1.02; high-certainty evidence). We identified three trials comparing non-aspirin NSAIDs to placebo. All three trials were terminated early due to adverse events associated with NSAIDs reported in other trials. One trial (2528 participants) investigated the cyclo-oxygenase-2 (COX-2) inhibitor celecoxib (200 mg twice daily) and the non-selective NSAID naproxen (220 mg twice daily) for preventing dementia in cognitively healthy older adults with a family history of Alzheimer's disease (AD). Median follow-up was 734 days. Combining both NSAID treatment arms, there was no evidence of a difference in the incidence of AD between participants allocated NSAIDs and those allocated placebo (RR 1.91, 95% CI 0.89 to 4.10; moderate-certainty evidence). There was also no evidence of a difference in rates of myocardial infarction (RR 1.21, 95% CI 0.61 to 2.40), stroke (RR 1.82, 95% CI 0.76 to 4.37) or mortality (RR 1.37, 95% CI 0.78 to 2.43) between treatment groups (all moderate-certainty evidence). One trial (88 participants) assessed the effectiveness of celecoxib (200 mg or 400 mg daily) in delaying cognitive decline in participants aged 40 to 81 years with mild age-related memory loss but normal memory performance scores. Mean duration of follow-up was 17.6 months in the celecoxib group and 18.1 months in the placebo group. There was no evidence of a difference between groups in test scores in any of six cognitive domains. Participants allocated celecoxib experienced more gastrointestinal adverse events than those allocated placebo (RR 2.66, 95% CI 1.05 to 6.75; low-certainty evidence). One trial (1457 participants) assessed the effectiveness of the COX-2 inhibitor rofecoxib (25 mg once daily) in delaying or preventing a diagnosis of AD in participants with MCI. Median duration of study participation was 115 weeks in the rofecoxib group and 130 weeks in the placebo group. There was a higher incidence of AD in the rofecoxib than the placebo group (RR 1.32, 95% CI 1.01 to 1.72; moderate-certainty evidence). There was no evidence of a difference between groups in cardiovascular adverse events (RR 1.07, 95% CI 0.68 to 1.66; moderate-certainty evidence) or mortality (RR 1.62, 95% CI 0.85 to 3.05; moderate-certainty evidence). Participants allocated rofecoxib had more upper gastrointestinal adverse events (RR 3.53, 95% CI 1.17 to 10.68; moderate-certainty evidence). Reported annual mean difference scores showed no evidence of a difference between groups in activities of daily living (year 1: no data available; year 2: 0.0, 95% CI -0.1 to 0.2; year 3: 0.1, 95% CI -0.1 to 0.3; year 4: 0.1, 95% CI -0.1 to 0.4; moderate-certainty evidence). Authors' conclusions There is no evidence to support the use of low-dose aspirin or other NSAIDs of any class (celecoxib, rofecoxib or naproxen) for the prevention of dementia, but there was evidence of harm. Although there were limitations in the available evidence, it seems unlikely that there is any need for further trials of low-dose aspirin for dementia prevention. If future studies of NSAIDs for dementia prevention are planned, they will need to be cognisant of the safety concerns arising from the existing studies.

Background The use of survey instruments to measure women’s experiences of their maternity care is regarded internationally as an indicator of the quality of care received. To ensure the credibility of the data arising from these instruments, the methodological quality of development must be high. This paper reports the protocol for a systematic review of self-report instruments used to measure women’s experiences of their maternity care. Methods Citation databases CINAHL, Ovid MEDLINE and EMBASE will be searched from 2002 to 2018 using keywords including women, experience, maternity care, questionnaires, surveys, and self-report. Citations will be screened by two reviewers, in two rounds, for inclusion as per predetermined inclusion and exclusion criteria. Data extraction forms will be populated with data, extracted from each study, to evaluate the methodological quality of each survey instrument and the criteria for good measurement properties using quality criteria. Data will also be extracted to categorise the items included in each survey instrument. A combination of a structured narrative synthesis and quantitate summaries in tabular format will allow for recommendations to be made on the use, adaptation and development of future survey instruments. Discussion The value of survey instruments that evaluate women’s experiences of their maternity care, as a marker of quality care, has been recognised internationally with many countries employing the use of such instruments to inform policy and practice. The development of these instruments must be methodologically sound and the instrument itself fit for the purpose and context in which it is used. This protocol describes the methods that will be used to complete a systematic review that will serve as a guide for choosing the most appropriate existing instruments to use or adapt so that they are fit for purpose, in addition to informing the development of new instruments. Systematic review registration PROSPERO CRD42018105325

Background The aim of clinical practice guidelines (CPGs) is to improve patient care; however inconsistencies between recommended practice and what actually happens in clinical practice continues. Venous Leg Ulcers (VLUs) have a significant negative impact on patients’ quality of life and it is acknowledged that managing people with venous leg ulcers is protracted and costly. The aim of this review is to identify the most effective strategies to implement clinical practice guidelines for the management of VLUs by health care professionals in the hospital, outpatient, home and community setting. Methods A systematic review guided by methods from the Cochrane Effective Practice and Organisation of Care (EPOC) group was undertaken to identify implementation strategies for VLU clinical practice guidelines. Eligible studies were identified via systematic electronic searches of Medline, Embase, CINHAL and the Cochrane Library. Results We identified 142 potential studies of which one randomised controlled trial met the inclusion criteria. Following an analysis of the included study, it is not possible to recommend one implementation strategy over another when implementing practice guidelines for people with VLUs. Conclusion We identified a limited evidence base for the effectiveness of implementation strategies for VLU CPGs. No one implementation strategy is better than another to facilitate VLU CPG implementation by health care professionals in hospital, outpatient, home or community settings.

Background Tobacco use is the leading cause of preventable death in Ireland with almost 6000 smokers dying each year from smoking-related diseases. The ‘We Can Quit2’ (WCQ2) study is a pilot pragmatic two-arm, parallel-group, cluster randomised trial that aims to explore the feasibility and acceptability of trial processes including recruitment and to estimate parameters to inform sample size estimates needed for an effectiveness trial. This future trial will assess the effectiveness of a community-based smoking cessation intervention for women living in disadvantaged areas on short- and medium-term cessation rates. Methods/design Four matched pairs of districts (eight clusters) selected by area level of deprivation, geographical proximity, and eligibility for free medical services will be randomised to receive either WCQ (behavioural support + access to Nicotine Replacement Therapy (NRT)) delivered over 12 weeks by trained Community Facilitators (CFs) or to a form of usual care, a one-to-one smoking cessation service delivered by Smoking Cessation Officers from Ireland’s national health service, the Health Service Executive (HSE). Within each cluster, 24–25 women will be recruited (97 per arm; 194 in total) in 4 phases with consent obtained prior to cluster randomisation. The outcome measures will assess feasibility and acceptability of trial processes, including randomisation. Outcome data for a future definitive intervention (biochemically validated smoking abstinence) will be collected at end of programme (12 weeks) and at 6 months. WCQ2 has an embedded process evaluation using both qualitative and quantitative methods. This will be conducted (semi-structured client and CF interviews, intervention delivery checklist, and diary) to explore acceptability of trial processes, intervention fidelity, trial context, and implementation. Trial processes will be assessed against domains of the PRECIS-2 wheel to inform a future definitive trial design. Discussion Data from this pilot trial will inform the design and sample size for a full cluster randomised trial to determine the effectiveness of an intervention tailored to disadvantaged women in improving smoking cessation rates. It will provide transferable learning on the systems and implementation strategies needed to support effective design of future pragmatic community-based trials which address health promotion interventions for women in disadvantaged communities. Trial registration Concurrent to publication. Controlled trials ISRCTN74721694.