Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide

Edited by Priscilla Velentgas, PhD, Nancy A Dreyer, MPH, PhD, Parivash Nourjah, PhD, Scott R Smith, PhD, and Marion M Torchia, PhD.

Rockville (MD): Agency for Healthcare Research and Quality (US); January 2013.

Publication No.: 12(13)-EHC099

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Hardcopy Version at Agency for Healthcare Research and Quality

The Observational CER User's Guide serves as a resource for investigators and stakeholders when designing observational comparative effectiveness research (CER) studies, particularly those with findings that are intended to translate into decisions or actions. The User's Guide provides principles for designing research that will inform health care decisions of patients and other stakeholders. Furthermore, it serves as a reference for increasing the transparency of the methods used in a study and standardizing the review of protocols through checklists provided in every chapter.

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Screening for Post-Traumatic Stress Disorder (PTSD) in Primary Care: A Systematic Review

To minimize treatment delays and to maximize population reach, Veterans Affairs (VA) established a screening program to facilitate identification of post-traumatic stress disorder (PTSD) in their patients as they present in primary care clinics. Such screening programs may be helpful because primary care providers often have difficulty identifying PTSD in their patients and PTSD is frequently undertreated in the primary care setting. The premise of this type of screening program is to facilitate mental health treatment engagement earlier in the course of the illness and to engage patients in treatment who might otherwise not be identified as needing mental health care.

Recently, the Institute of Medicine (IOM) released a report examining the screening, diagnosis, treatment, and rehabilitation services for military Veterans and service members with PTSD in the Department of Veterans Affairs and the Department of Defense. As noted in the IOM report and elsewhere, successful screening programs utilize instruments that are simple, valid, precise, and acceptable both clinically and socially. To identify screening tools that are best suited to the primary care setting, this evidence synthesis report reviews the literature on the feasibility and diagnostic accuracy of screening tools used and evaluated with a gold standard in a primary care setting.

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Screening for Hypertension in Children and Adolescents to Prevent Cardiovascular Disease

Background:

Hypertension in children can be associated with adverse health outcomes and may persist into adulthood, where it presents a significant personal and public health burden. Screening asymptomatic children has the potential to detect hypertension at earlier stages, so that interventions can be initiated which, if effective, could reduce the adverse health effects of childhood hypertension in children and adults.

Purpose:

To assess the effects of screening for hypertension in asymptomatic children and adolescents to prevent cardiovascular disease.

Methods:

We searched the Cochrane Central Register of Controlled Trials and the Cochrane Database of Systematic Reviews (through July 2012) and MEDLINE (1946–July 9, 2012) and manually reviewed reference lists of included studies. Citations were independently reviewed by two investigators, and data extraction performed by one investigator and checked by a second for accuracy. We included studies of screening for hypertension in asymptomatic children and studies of benefits and harms of treatments for children with hypertension. Diagnostic accuracy studies were included if they used a reference standard and allowed calculation of sensitivity and specificity. We excluded studies focusing on secondary hypertension.

Results:

No studies evaluated the effect of screening asymptomatic children for hypertension on subsequent health outcomes, including onset of hypertension. Two studies that assessed accuracy of screening tests for elevated blood pressure found moderate sensitivities (0.65 and 0.72) and specificities (0.75 and 0.92) and low positive predictive values (0.37, 0.17). The association between elevated blood pressure or hypertension in childhood and hypertension in adulthood was assessed in 10 studies, with most studies finding a small but significant association. Seven fair-quality studies found drug interventions were effective at lowering blood pressure after 4 weeks, based on the proportion achieving normotensive status and/or mean reductions in blood pressure. One trial of a drug combined with lifestyle modifications found lower mean blood pressures at 30 months, and one trial of increased exercise found lower mean blood pressures at 8 months, whereas other lifestyle trials found no differences. Of 13 studies assessing harms of interventions, only one study found that adverse event rates were significantly lower for those in the intervention group; all other studies found no difference in adverse events.

Conclusions:

Studies are needed to assess whether screening for hypertension in children and adolescents reduces adverse health outcomes or delays the onset of hypertension. Blood pressure screening may be effective at identifying children with hypertension, though evidence is limited and false-positive rates were high. The presence of hypertension in childhood is associated with hypertension in adults, but with limited evidence available for its association with end-organ damage markers in adults. Drug interventions for hypertension may be effective at lowering blood pressure with few serious side effects; however, studies of longer duration are needed to confirm results from short-term studies. Evidence on the effectiveness of childhood combination drug and lifestyle interventions and lifestyle-only interventions is sparse and mixed, with most studies showing no sustained reduction in blood pressure in childhood. Studies are needed to assess whether treating hypertension in childhood affects subsequent intermediate or clinical outcomes in adulthood.

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