In cooperation with the Core Outcome Measures in Effectiveness Trials (COMET) initiative, the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) initiative aimed ...to develop a guideline on how to select outcome measurement instruments for outcomes (i.e., constructs or domains) included in a "Core Outcome Set" (COS). A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease or trial population.
Informed by a literature review to identify potentially relevant tasks on outcome measurement instrument selection, a Delphi study was performed among a panel of international experts, representing diverse stakeholders. In three consecutive rounds, panelists were asked to rate the importance of different tasks in the selection of outcome measurement instruments, to justify their choices, and to add other relevant tasks. Consensus was defined as being achieved when 70 % or more of the panelists agreed and when fewer than 15 % of the panelists disagreed.
Of the 481 invited experts, 120 agreed to participate of whom 95 (79 %) completed the first Delphi questionnaire. We reached consensus on four main steps in the selection of outcome measurement instruments for COS: Step 1, conceptual considerations; Step 2, finding existing outcome measurement instruments, by means of a systematic review and/or a literature search; Step 3, quality assessment of outcome measurement instruments, by means of the evaluation of the measurement properties and feasibility aspects of outcome measurement instruments; and Step 4, generic recommendations on the selection of outcome measurement instruments for outcomes included in a COS (consensus ranged from 70 to 99 %).
This study resulted in a consensus-based guideline on the methods for selecting outcome measurement instruments for outcomes included in a COS. This guideline can be used by COS developers in defining how to measure core outcomes.
Newborn admission temperature is a strong predictor of outcomes across all gestations. Hypothermia immediately after birth remains a worldwide issue and, if prolonged, is associated with harm. ...Keeping preterm infants warm is difficult even when recommended routine thermal care guidelines are followed in the delivery room.
To assess the efficacy and safety of interventions designed for prevention of hypothermia in preterm and/or low birth weight infants applied within 10 minutes after birth in the delivery room, compared with routine thermal care or any other single/combination of intervention(s) also designed for prevention of hypothermia in preterm and/or low birth weight infants applied within 10 minutes after birth in the delivery room.
We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 5), MEDLINE via PubMed (1966 to 30 June 2016), Embase (1980 to 30 June 2016), and CINAHL (1982 to 30 June 2016). We also searched clinical trials databases, conference proceedings, and reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.
Trials using randomised or quasi-randomised allocations to test interventions designed to prevent hypothermia (apart from 'routine' thermal care) applied within 10 minutes after birth in the delivery room for infants at < 37 weeks' gestation and/or birth weight ≤ 2500 grams.
We used Cochrane Neonatal methods when performing data collection and analysis.
Twenty-five studies across 15 comparison groups met the inclusion criteria, categorised as: barriers to heat loss (18 studies); external heat sources (three studies); and combinations of interventions (four studies).Barriers to heat loss Plastic wrap or bag versus routine carePlastic wraps improved core body temperature on admission to the neonatal intensive care unit (NICU) or up to two hours after birth (mean difference (MD) 0.58°C, 95% confidence interval (CI) 0.50 to 0.66; 13 studies; 1633 infants), and fewer infants had hypothermia on admission to the NICU or up to two hours after birth (typical risk ratio (RR) 0.67, 95% CI 0.62 to 0.72; typical risk reduction (RD) -0.25, 95% CI -0.29 to -0.20; number needed to treat for an additional beneficial outcome (NNTB) 4, 95% CI 4 to 5; 10 studies; 1417 infants). Risk of hyperthermia on admission to the NICU or up to two hours after birth was increased in infants in the wrapped group (typical RR 3.91, 95% CI 2.05 to 7.44; typical RD 0.04, 95% CI 0.02 to 0.06; number needed to treat for an additional harmful outcome (NNTH) 25, 95% CI 17 to 50; 12 studies; 1523 infants), but overall, fewer infants receiving plastic wrap were outside the normothermic range (typical RR 0.75, 95% CI 0.69 to 0.81; typical RD -0.20, 95% CI -0.26 to -0.15; NNTH 5, 95% CI 4 to 7; five studies; 1048 infants).Evidence was insufficient to suggest that plastic wraps or bags significantly reduce risk of death during hospital stay or other major morbidities, with the exception of reducing risk of pulmonary haemorrhage.Evidence of practices regarding permutations on this general approach is still emerging and has been based on the findings of only one or two small studies.External heat sourcesEvidence is emerging on the efficacy of external heat sources, including skin-to-skin care (SSC) versus routine care (one study; 31 infants) and thermal mattress versus routine care (two studies; 126 infants).SSC was shown to be effective in reducing risk of hypothermia when compared with conventional incubator care for infants with birth weight ≥ 1200 and ≤ 2199 grams (RR 0.09, 95% CI 0.01 to 0.64; RD -0.56, 95% CI -0.84 to -0.27; NNTB 2, 95% CI 1 to 4). Thermal (transwarmer) mattress significantly kept infants ≤ 1500 grams warmer (MD 0.65°C, 95% CI 0.36 to 0.94) and reduced the incidence of hypothermia on admission to the NICU, with no significant difference in hyperthermia risk.Combinations of interventionsTwo studies (77 infants) compared thermal mattresses versus plastic wraps or bags for infants at ≤ 28 weeks' gestation. Investigators reported no significant differences in core body temperature nor in the incidence of hypothermia, hyperthermia, or core body temperature outside the normothermic range on admission to the NICU.Two additional studies (119 infants) compared plastic bags and thermal mattresses versus plastic bags alone for infants at < 31 weeks' gestation. Meta-analysis of these two studies showed improvement in core body temperature on admission to the NICU or up to two hours after birth, but an increase in hyperthermia. Data show no significant difference in the risk of having a core body temperature outside the normothermic range on admission to the NICU nor in the risk of other reported morbidities.
Evidence of moderate quality shows that use of plastic wraps or bags compared with routine care led to higher temperatures on admission to NICUs with less hypothermia, particularly for extremely preterm infants. Thermal mattresses and SSC also reduced hypothermia risk when compared with routine care, but findings are based on two or fewer small studies. Caution must be taken to avoid iatrogenic hyperthermia, particularly when multiple interventions are used simultaneously. Limited evidence suggests benefit and no evidence of harm for most short-term morbidity outcomes known to be associated with hypothermia, including major brain injury, bronchopulmonary dysplasia, retinopathy of prematurity, necrotising enterocolitis, and nosocomial infection. Many observational studies have shown increased mortality among preterm hypothermic infants compared with those who maintain normothermia, yet evidence is insufficient to suggest that these interventions reduce risk of in-hospital mortality across all comparison groups. Hypothermia may be a marker for illness and poorer outcomes by association rather than by causality. Limitations of this review include small numbers of identified studies; small sample sizes; and variations in methods and definitions used for hypothermia, hyperthermia, normothermia, routine care, and morbidity, along with lack of power to detect effects on morbidity and mortality across most comparison groups. Future studies should: be adequately powered to detect rarer outcomes; apply standardised morbidity definitions; focus on longer-term outcomes, particularly neurodevelopmental outcomes.
Abstract Registry-based randomized controlled trials are defined as pragmatic trials that use registries as a platform for case records, data collection, randomization, and follow-up. Recently, the ...application of registry-based randomized controlled trials has attracted increasing attention in health research to address comparative effectiveness research questions in real-world settings, mainly due to their low cost, enhanced generalizability of findings, rapid consecutive enrollment, and the potential completeness of follow-up for the reference population, when compared with conventional randomized effectiveness trials. However several challenges of registry-based randomized controlled trials have to be taken into consideration, including registry data quality, ethical issues, and methodological challenges. In this article, we summarize the advantages, challenges, and areas for future research related to registry-based randomized controlled trials.
During the last decade critical new information has been published pertaining to folic acid supplementation in the prevention of neural tube defects (NTDs) and other folic acid–sensitive congenital ...malformations. These new data have important implications for women, their families, and health care professionals. We performed a review looking for the optimal dosage of folic acid that should be given to women of reproductive age who are planning or not avoiding conception to propose updated guidelines and thus help health care providers and patients. In addition to fortification of dietary staples with folic acid, women of reproductive age should supplement before conception with 0.4‐1.0 mg of folic acid daily as part of their multivitamins. In the United States all enriched rice is also fortified with folic acid at 0.7 mg per pound of raw rice. However, this is not the case in many countries, and it has been estimated that only 1% of industrially milled rice is fortified with folic acid. In countries where rice is the main staple (eg, China), this does not allow effective folate fortification. Whereas the incidence of NTDs is around 1/1000 in the United States, it is 3‐ to 5‐fold higher in Northern China and 3‐fold higher in India. A recent population‐based US study estimated that the reduction in NTD rates by folic acid is more modest than previously predicted. The potential of NTD prevention by folic acid is underutilized due to low adherence with folic acid supplementation, and calls for revising the policy of supplementation have been raised. We identified groups of women of reproductive age who may benefit from higher daily doses of folic acid, and this should be considered in current practice. These include women who have had previous pregnancies with NTDs, those who did not plan their pregnancy and hence did not supplement, and women with low intake or impaired adherence to daily folic acid supplementation. In addition, women with known genetic variations in the folate metabolic cycle, those exposed to medications with antifolate effects, smokers, diabetics, and the obese may benefit from higher doses of folic acid daily during the first trimester.
In evidence synthesis practice, dealing with studies with no cases in both arms has been a tough problem, for which there is no consensus in the research community. In this study, we propose a method ...to measure the potential impact of studies with no cases for meta-analysis results which we define as harms index (Hi) and benefits index (Bi) as an alternative solution for deciding how to deal with such studies.
Hi and Bi are defined by the minimal number of cases added to the treatment arm (Hi) or control arm (Bi) of studies with no cases in a meta-analysis that lead to a change of the direction of the estimates or its statistical significance. Both exact and approximating methods are available to calculate Hi and Bi. We developed the "hibi" module in Stata so that researchers can easily implement the method. A real-world investigation of meta-analyses from Cochrane reviews was employed to evaluate the proposed method.
Based on Hi and Bi, our results suggested that 21.53% (Hi) to 26.55% (Bi) of Cochrane meta-analyses may be potentially impacted by studies with no cases, for which studies with no cases could not be excluded from the synthesis. The approximating method shows excellent specificity (100%) for both Hi and Bi, moderate sensitivity (68.25%) for Bi, and high sensitivity (80.61%) for Hi compared to the exact method.
The proposed method is practical and useful for systematic reviewers to measure whether studies with no cases impact the results of meta-analyses and may act as an alternative solution for review authors to decide whether to include studies with no events for the synthesis or not.
With the objective of increasing the magnitude of treatment effects in behavioral health, there is steadily growing interest in tailoring assessments and interventions to better match individual ...needs. This aligns with the central idea that behavior can be adequately understood by considering the unique characteristics of the individual and context. Thus, data collected at an individual level provides critical evidence that can be used to inform health care decisions, improve treatment, or refine theories. Yet, the majority of research in behavioral health is based on group-level analyses. Recent developments in the field of single-case experimental design (SCED) has provided new opportunities to utilize individual data. The present article provides a state-of-the art overview regarding key aspects of SCED, including a historical background to why and how SCED emerged, declined, and recently reemerged as well as methodological aspects such as design issues, challenges related to reliability and validity of repeated observations, innovations in visual and statistical analyses of individual data, strategies to deal with missing values, methodology to examine effect size, and approaches to summarize data from a large number of SCEDs using multilevel models and meta-analyses of replication data. Finally, the article discusses key concerns and actions needed to move the field forward.
Abstract Objectives To summarize the methods of design, analysis, and meta-analysis used in N-of-1 trials. Study Design and Setting Electronic search for English language articles published from 1950 ...to 2013. N-of-1 trials were selected if they followed an ABAB design and if they assessed a health intervention for a medical condition. Elements of design, analysis, and meta-analysis were extracted. Results We included 100 reports representing 1,995 participants. N-of-1 trials have been conducted in over 50 health conditions. Most reports incorporated the use of elements that maintain methodological rigor, including randomization, blinding, and formal outcome assessment; however, many failed to address trial registration, funding source, and adverse events. Most reports statistically analyzed individual N-of-1 trials; however, only a small proportion of included series meta-analyzed their results. Conclusions N-of-1 trials have the ability to assess treatment response in individual participants and can be used for a variety of health interventions for a wide range of medical conditions in both clinical and research settings. Considerable heterogeneity exists in the methods used in N-of-1 trials.
Abstract Objective To conduct a systematic review of the efficacy and safety of exogenous melatonin in managing secondary sleep disorders and sleep disorders accompanying sleep restriction, such as ...jet lag and shiftwork disorder. Data sources 13 electronic databases and reference lists of relevant reviews and included studies; Associated Professional Sleep Society abstracts (1999 to 2003). Study selection The efficacy review included randomised controlled trials; the safety review included randomised and non-randomised controlled trials. Quality assessment Randomised controlled trials were assessed by using the Jadad Scale and criteria by Schulz et al, and non-randomised controlled trials by the Downs and Black checklist. Data extraction and synthesis One reviewer extracted data and another reviewer verified the data extracted. The inverse variance method was used to weight studies and the random effects model was used to analyse data. Main results Six randomised controlled trials with 97 participants showed no evidence that melatonin had an effect on sleep onset latency in people with secondary sleep disorders (weighted mean difference −13.2 (95% confidence interval −27.3 to 0.9) min). Nine randomised controlled trials with 427 participants showed no evidence that melatonin had an effect on sleep onset latency in people who had sleep disorders accompanying sleep restriction (−1.0 (−2.3 to 0.3) min). 17 randomised controlled trials with 651 participants showed no evidence of adverse effects of melatonin with short term use (three months or less). Conclusions There is no evidence that melatonin is effective in treating secondary sleep disorders or sleep disorders accompanying sleep restriction, such as jet lag and shiftwork disorder. There is evidence that melatonin is safe with short term use.
Fatigue is one of many unintended consequences of shift work in the nursing profession. Natural health products (NHPs) for fatigue are becoming an increasingly popular topic of clinical study; one ...such NHP is Rhodiola rosea. A well-designed, rigorously conducted randomized controlled trial is required before therapeutic claims for this product can be made.
To compare the efficacy of R. rosea with placebo for reducing fatigue in nursing students on shift work.
A parallel-group randomized, double-blinded, placebo-controlled trial of 18-55 year old students from the Faculty of Nursing from the University of Alberta, participating in clinical rotations between January 2011 and September 2011.
Participants were randomized to take 364 mg of either R. rosea or identical placebo at the start of their wakeful period and up to one additional capsule within the following four hours on a daily basis over a 42-day period.
The primary outcome was reduction in fatigue over the 42-day trial period measured using the Vitality-subscale of the RAND-36, cross-validated by the visual analogue scale for fatigue (VAS-F). Secondary outcomes included health-related quality of life, individualized outcomes assessment, and adverse events.
A total of 48 participants were randomized to R. rosea (n = 24) or placebo (n = 24). The mean change in scores on the Vitality-subscale was significantly different between the study groups at day 42 in favor of placebo (-17.3 (95% CI -30.6, -3.9), p = 0.011), The mean change in scores on the VAS-F was also significantly difference between study groups at day 42 in favour of placebo (1.9 (95% CI 0.4, 3.5), p = 0.015). Total number of adverse events did not differ between R. rosea and placebo groups.
This study indicates that among nursing students on shift work, a 42-day course of R. Rosea compared with placebo worsened fatigue; however, the results should be interpreted with caution.
Clinicaltrials.gov NCT01278992.
Shared decision-making (SDM) can advance patient satisfaction, understanding, goal fulfilment, and patient-reported outcomes. We lack clarity on whether this physician-focused literature applies to ...community rehabilitation, and on the integration of SDM policies in healthcare settings. We aimed to understand patient and provider perceptions of shared decision-making (SDM) in community rehabilitation, particularly the barriers and facilitators to SDM.
We used a focused ethnography involving 14 community rehabilitation sites across Alberta, including rural, regional-urban and metropolitan-urban sites. We conducted semi-structured interviews that asked participants about their positive and negative communication experiences (n = 23 patients; n = 26 providers).
We found SDM experiences fluctuated between extremes: Getting Patient Buy-In and Aligning Expectations. The former is provider-driven, prescriptive and less flexible; the latter is collaborative, inquisitive and empowering. In Aligning Expectations, patients and providers express humility and openness, communicate in the language of ask and listen, and view education as empowering. Patients and providers described barriers and facilitators to SDM in community rehabilitation. Facilitators included geography influencing context and connections; consistent, patient-specific messaging; patient lifestyle, capacity and perceived outlook; provider confidence, experience and perceived independence; provider training; and perceptions of more time (and control over time) for appointments. SDM barriers included lack of privacy; waitlists and financial barriers to access; provider approach; how choices are framed; and, patient's perceived assertiveness, lack of capacity, and level of deference.
We have found both excellent experiences and areas for improvement for applying SDM in community rehabilitation. We proffer recommendations to advance high-quality SDM in community rehabilitation based on promoting facilitators and overcoming barriers. This research will support the spread, scale and evaluation of a new Model of Care in rehabilitation by the provincial health system, which aimed to promote patient-centred care.
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