Chapter 3: Choosing the Important Outcomes for a Systematic Review of a Medical Test

In this chapter of the Evidence-based Practice Centers Methods Guide for Medical Tests, we describe how the decision to use a medical test generates a broad range of outcomes and that each of these outcomes should be considered for inclusion in a systematic review. Awareness of these varied outcomes affects how a decision maker balances the benefits and risks of the test; therefore, a systematic review should present the evidence on these diverse outcomes. The key outcome categories include clinical management outcomes and direct health effects; emotional, social, cognitive, and behavioral responses to testing; legal and ethical outcomes, and costs. We describe the challenges of incorporating these outcomes in a systematic review, suggest a framework for generating potential outcomes for inclusion, and describe the role of stakeholders in choosing the outcomes for study. Finally, we give examples of systematic reviews that either included a range of outcomes or that might have done so. The following are the key messages in this chapter: Consider both the outcomes that are relevant to the process of testing and those that are relevant to the results of the test.Consider inclusion of outcomes in all five domains: clinical management effects, direct test effects; emotional, social, cognitive and behavioral effects; legal and ethical effects, and costs.Consider to which group the outcomes of testing are most relevant.Given resource limitations, prioritize which outcomes to include. This decision depends on the needs of the stakeholder(s), who should be assisted in prioritizing the outcomes for inclusion

Association of Vasopressin Plus Catecholamine Vasopressors vs Catecholamines Alone With Atrial Fibrillation in Patients With Distributive Shock

Importance Vasopressin is an alternative to catecholamine vasopressors for patients with distributive shock—a condition due to excessive vasodilation, most frequently from severe infection. Blood pressure support with a noncatecholamine vasopressor may reduce stimulation of adrenergic receptors and decrease myocardial oxygen demand. Atrial fibrillation is common with catecholamines and is associated with adverse events, including mortality and increased length of stay (LOS). Objectives To determine whether treatment with vasopressin + catecholamine vasopressors compared with catecholamine vasopressors alone was associated with reductions in the risk of adverse events. Data Sources MEDLINE, EMBASE, and CENTRAL were searched from inception to February 2018. Experts were asked and meta-registries searched to identify ongoing trials. Study Selection Pairs of reviewers identified randomized clinical trials comparing vasopressin in combination with catecholamine vasopressors to catecholamines alone for patients with distributive shock. Data Extraction and Synthesis Two reviewers abstracted data independently. A random-effects model was used to combine data. Main Outcomes and Measures The primary outcome was atrial fibrillation. Other outcomes included mortality, requirement for renal replacement therapy (RRT), myocardial injury, ventricular arrhythmia, stroke, and LOS in the intensive care unit and hospital. Measures of association are reported as risk ratios (RRs) for clinical outcomes and mean differences for LOS. Results Twenty-three randomized clinical trials were identified (3088 patients; mean age, 61.1 years [14.2]; women, 45.3%). High-quality evidence supported a lower risk of atrial fibrillation associated with vasopressin treatment (RR, 0.77 [95% CI, 0.67 to 0.88]; risk difference [RD], −0.06 [95% CI, −0.13 to 0.01]). For mortality, the overall RR estimate was 0.89 (95% CI, 0.82 to 0.97; RD, −0.04 [95% CI, −0.07 to 0.00]); however, when limited to trials at low risk of bias, the RR estimate was 0.96 (95% CI, 0.84 to 1.11). The overall RR estimate for RRT was 0.74 (95% CI, 0.51 to 1.08; RD, −0.07 [95% CI, −0.12 to −0.01]). However, in an analysis limited to trials at low risk of bias, RR was 0.70 (95% CI, 0.53 to 0.92, P for interaction = .77). There were no significant differences in the pooled risks for other outcomes. Conclusions and Relevance In this systematic review and meta-analysis, the addition of vasopressin to catecholamine vasopressors compared with catecholamines alone was associated with a lower risk of atrial fibrillation. Findings for secondary outcomes varied

Prevalence of Risk Factors for Adverse Pregnancy Outcomes During Pregnancy and the Preconception Period—United States, 2002–2004

Objectives: To assess the prevalence of risk factors for adverse pregnancy outcome during the preconception stage and during pregnancy, and to assess differences between women in preconception and pregnancy. Methods: Data from the 2002 and 2004 Behavioral Risk Factor Surveillance System, United States, were used to estimate the prevalence of selected risk factors among women 18–44 in the preconception period (women who wanted a baby in the next 12 months, and were not using contraception, not sterile and not already pregnant) with women who reported that they were pregnant at the time of interview. Results: Major health risks were reported by substantial proportions of women in the preconceptional period and were also reported by many pregnant women, although pregnant women tended to report lower levels of risk than preconception women. For example, 54.5% of preconception women reported one or more of 3 risk factors (frequent drinking, current smoking, and absence of an HIV test), compared with 32.0% of pregnant women (p < .05). The difference in the prevalence of these three risk factors between preconception and pregnancy was significant for women with health insurance (52.5% in preconception vs. 29.4% in pregnancy, p < .05), but not for women without insurance (63.4% vs. 52.7%, p > .05). Conclusions: Women appear to be responding to messages regarding behaviors that directly affect pregnancy such as smoking, alcohol consumption and taking folic acid, but many remain unaware of the benefits of available interventions to prevent HIV transmission and birth defects. Although it appears that some women reduce their risk for adverse pregnancy outcomes after learning of their pregnancy, the data suggest that a substantial proportion of women do not. Furthermore, if such change occurs it is often too late to affect outcomes, such as birth defects resulting from alcohol consumption during the periconception period. Preconception interventions are recommended to achieve a more significant reduction in risk and further improvement in perinatal outcomes

Evidence summaries: the evolution of a rapid review approach

<p>Abstract</p> <p>Background</p> <p>Rapid reviews have emerged as a streamlined approach to synthesizing evidence - typically for informing emergent decisions faced by decision makers in health care settings. Although there is growing use of rapid review 'methods', and proliferation of rapid review products, there is a dearth of published literature on rapid review methodology. This paper outlines our experience with rapidly producing, publishing and disseminating evidence summaries in the context of our Knowledge to Action (KTA) research program.</p> <p>Methods</p> <p>The KTA research program is a two-year project designed to develop and assess the impact of a regional knowledge infrastructure that supports evidence-informed decision making by regional managers and stakeholders. As part of this program, we have developed evidence summaries - our form of rapid review - which have come to be a flagship component of this project. Our eight-step approach for producing evidence summaries has been developed iteratively, based on evidence (where available), experience and knowledge user feedback. The aim of our evidence summary approach is to deliver quality evidence that is both timely and user-friendly.</p> <p>Results</p> <p>From November 2009 to March 2011 we have produced 11 evidence summaries on a diverse range of questions identified by our knowledge users. Topic areas have included questions of clinical effectiveness to questions on health systems and/or health services. Knowledge users have reported evidence summaries to be of high value in informing their decisions and initiatives. We continue to experiment with incorporating more of the established methods of systematic reviews, while maintaining our capacity to deliver a final product in a timely manner.</p> <p>Conclusions</p> <p>The evolution of the KTA rapid review evidence summaries has been a positive one. We have developed an approach that appears to be addressing a need by knowledge users for timely, user-friendly, and trustworthy evidence and have transparently reported these methods here for the wider rapid review and scientific community.</p

Chapter 1: Introduction to the Methods Guide for Medical Test Reviews

Evaluation of medical tests presents challenges distinct from those involved in the evaluation of therapies; in particular, the very great importance of context and the dearth of comprehensive RCTs aimed at comparing the clinical outcomes of different tests and test strategies. Available guidance provides some suggestions: 1) Use of the PICOTS typology for clarifying the context relevant to the review, and 2) use of an organizing framework for classifying the types of medical test evaluation studies and their relationship to potential key questions. However, there is a diversity of recommendations for reviewers of medical tests and a proliferation of concepts, terms, and methods. As a contribution to the field, this Methods Guide for Medical Test Reviews seeks to provide practical guidance for achieving the goals of clarity, consistency, tractability, and usefulness

Grand Challenges: Improving HIV Treatment Outcomes by Integrating Interventions for Co-Morbid Mental Illness.

In the fourth article of a five-part series providing a global perspective on integrating mental health, Sylvia Kaaya and colleagues discuss the importance of integrating mental health interventions into HIV prevention and treatment platforms. Please see later in the article for the Editors' Summary

Screening and brief interventions for hazardous and harmful alcohol use in primary care: a cluster randomised controlled trial protocol

A large number of randomised controlled trials in health settings have consistently reported positive effects of brief intervention in terms of reductions in alcohol use. However,although alcohol misuse is common amongst offenders, there is limited evidence of alcohol brief interventions in the criminal justice field. This factorial pragmatic cluster randomised controlledtrial with Offender Managers (OMs) as the unit of randomisation will evaluate the effectiveness and cost-effectiveness of different models of screening to identify hazardous and harmful drinkers in probation and different intensities of brief intervention to reduce excessive drinking in probation clients. Ninety-six OMs from 9 probation areas across 3 English regions (the NorthEast Region (n = 4) and London and the South East Regions (n = 5)) will be recruited. OMs will berandomly allocated to one of three intervention conditions: a client information leaflet control condition (n = 32 OMs); 5-minute simple structured advice (n = 32 OMs) and 20-minute brieflifestyle counselling delivered by an Alcohol Health Worker (n = 32 OMs). Randomisation will be stratified by probation area. To test the relative effectiveness of different screening methods all OMs will be randomised to either the Modified Single Item Screening Questionnaire (M-SASQ) orthe Fast Alcohol Screening Test (FAST). There will be a minimum of 480 clients recruited into the trial. There will be an intention to treat analysis of study outcomes at 6 and 12 months postintervention. Analysis will include client measures (screening result, weekly alcohol consumption,alcohol-related problems, re-offending, public service use and quality of life) and implementation measures from OMs (the extent of screening and brief intervention beyond the minimum recruitment threshold will provide data on acceptability and feasibility of different models of brief intervention). We will also examine the practitioner and organisational factors associated with successful implementation.The trial will evaluate the impact of screening and brief alcohol intervention in routine probation work and therefore its findings will be highly relevant to probation teams and thus the criminal justice system in the UK

Length of stay and associated costs of obesity related hospital admissions in Ireland

BACKGROUND: Obesity is the cause of other chronic diseases, psychological problems, obesity shortens the lifespan and puts strain on health systems. The risk associated with childhood obesity in particular, which will accelerate the development of adult morbidity and mortality, has been identified as an emerging public health problem. METHODS: To estimate the length of stay and associated hospital costs for obesity related illnesses a cost of illness study was set up. All discharges from all acute hospitals in the Republic of Ireland from 1997 to 2004 with a principal or secondary diagnostic code for obesity for all children from 6 to 18 years of age and for adults were collected.A discharge frequency was calculated by dividing obesity related discharges by the total number of diagnoses (principal and secondary) for each year. The hospital costs related to obesity was calculated based on the total number of days care. RESULTS: The discharge frequency of obesity related conditions increased from 1.14 in 1997 to 1.49 in 2004 for adults and from 0.81 to 1.37 for children. The relative length of stay (number of days in care for obesity related conditions per 1000 days of hospital care given) increased from 1.47 in 1997 to 4.16 in 2004 for children and from 3.68 in 1997 to 6.74 in 2004 for adults.Based on the 2001 figures for cost per inpatient bed day, the annual hospital cost was calculated to be 4.4 Euromillion in 1997, increasing to 13.3 Euromillion in 2004. At a 20% variable hospital cost the cost ranges from 0.9 Euromillion in 1997 to 2.7 Euromillion in 2004; a 200% increase. CONCLUSION: The annual increase in the proportion of hospital discharges related to obesity is alarming. This increase is related to a significant increase in economic costs. This paper emphasises the need for action at an early stage of life. Health promotion and primary prevention of obesity should be high on the political agenda

Effectiveness of skills-based training using the Drink-less package to increase family practitioner confidence in intervening for alcohol use disorders

BACKGROUND: Misuse of alcohol is second only to tobacco as a leading cause of preventable death in Australia. There is an opportunity in family practice to detect problems and intervene with people at risk of alcohol-related harm before complications occur. However, family practitioners (FPs) report low levels of confidence in managing patients with drinking problems. The aim of this study was to determine whether the interactive training session using the 'Drink-less' package led to improvement in FPs' self-reported level of confidence in detecting and providing interventions for risky alcohol consumption. METHOD: FPs in urban and rural New South Wales were invited to training sessions in their local area. An introductory overview preceded a practical skills- based session, using the Drink-less package. Participants completed before and after evaluation forms. RESULTS: While 49% (CI 43 – 55) of the attending FPs indicated at baseline that they felt confident in identifying at-risk drinkers, this proportion rose to 90% (95% CI: 87 – 93) post-session, and they also reported increases in confidence from 36% (95% CI: 31 – 41) to 90% in their ability to advise patients. Urban FPs reported lower levels of confidence than rural FPs, both pre- and post-session. CONCLUSION: Training sessions in the Drink-less intervention resulted in increased self-reported confidence in detection and brief intervention for alcohol problems. Further research is needed to determine the duration of this effect and its influence on practice behaviour