Agency for Healthcare Research and Quality Evidence-based Practice Center methods for systematically reviewing complex multicomponent health care interventions.

OBJECTIVES: The purpose of this Agency for Healthcare Research and Quality Evidence-based Practice Center methods white paper was to outline approaches to conducting systematic reviews of complex multicomponent health care interventions. STUDY DESIGN AND SETTING: We performed a literature scan and conducted semistructured interviews with international experts who conduct research or systematic reviews of complex multicomponent interventions (CMCIs) or organizational leaders who implement CMCIs in health care. RESULTS: Challenges identified include lack of consistent terminology for such interventions (eg, complex, multicomponent, multidimensional, multifactorial); a wide range of approaches used to frame the review, from grouping interventions by common features to using more theoretical approaches; decisions regarding whether and how to quantitatively analyze the interventions, from holistic to individual component analytic approaches; and incomplete and inconsistent reporting of elements critical to understanding the success and impact of multicomponent interventions, such as methods used for implementation the context in which interventions are implemented. CONCLUSION: We provide a framework for the spectrum of conceptual and analytic approaches to synthesizing studies of multicomponent interventions and an initial list of critical reporting elements for such studies. This information is intended to help systematic reviewers understand the options and tradeoffs available for such reviews.

A systematic review of pneumatic compression for treatment of chronic venous insufficiency and venous ulcers.

INTRODUCTION: As part of a reconsideration of coverage policy, the Centers for Medicare and Medicaid Services requested a systematic review of the evidence on the use of pneumatic compression devices in the home environment for treatment of chronic venous insufficiency (CVI) and venous ulcers. METHODS: Articles were found with a systematic literature search of MEDLINE, EMBASE, and AMED (Allied and Complementary Medicine) databases, hand searches of reference lists, and suggestions of experts. RESULTS: Eight trials that met the inclusion criteria, including several randomized control trials, were found. Most studies were small and may have been underpowered. However, several were well-designed randomized controlled trials. Three studies showed that the devices could alleviate symptoms of CVI. No studies directly measured whether the devices could prevent the occurrence of venous ulcers. Some studies on the treatment of venous ulcers did not show a benefit for pneumatic compression, but other studies showed a benefit for the devices in healing long-standing chronic ulcers that had not healed with other methods. No studies directly compared single-chamber and multiple-chamber devices or studied whether the effectiveness of the pump was dependent on types of treatment used concurrently with the pump. Few adverse events were reported in the trials. Patients generally expressed satisfaction with the pneumatic compression devices, and several studies reported higher compliance than with other compression methods. CONCLUSION: The available data cannot be relied on to inform the optimal choice of compression therapy or optimal protocol for patients with CVI or venous ulcers. Methodologically rigorous research designed to answer these questions would be useful for treatment decisions. The Centers for Medicare and Medicaid Services considered the results of this study and issued a decision that pneumatic compression will only be covered for patients with refractory edema with significant ulceration of the lower extremities after a 6-month trial of standard therapies, such as compression stockings, has failed.

Hyperbaric oxygen for treating wounds: a systematic review of the literature.

OBJECTIVE: To determine whether hyperbaric oxygen (HBO) therapy is an effective adjunct treatment for hypoxic wounds. METHODS: We identified studies from technology assessment reports on HBO and a MEDLINE search from mid-1998 to August 2001. We accepted randomized controlled trials (RCTs), cohorts, and case series that reported original data, included at least 5 patients, evaluated the use of HBO for wound care, and reported clinical outcomes. Demographics, wound conditions, HBO regimen, adverse events, and major clinical outcomes were extracted from each study. RESULTS: Fifty-seven studies, 7 RCTs, 16 nonrandomized studies, and 34 case series involving more than 2000 patients are included in this review. None of the studies used wound tissue hypoxia as a patient inclusion criterion. The study results suggest that HBO may be beneficial as an adjunctive therapy for chronic nonhealing diabetic wounds, compromised skin grafts, osteoradionecrosis, soft tissue radionecrosis, and gas gangrene compared with standard wound care alone. Serious adverse events associated with HBO include seizures and pressure-related traumas, such as pneumothorax. A few deaths in the studies were associated with these adverse events. CONCLUSIONS: The overall study quality is poor, with inadequate or no controls in most studies. The studies suggest that HBO may be helpful for some wounds, but there is insufficient evidence to ascertain the appropriate time to initiate therapy and to establish criteria that determine whether patients will benefit. Serious adverse events may occur. High-quality RCTs that evaluate the short- and long-term risks and benefits of HBO are necessary to better inform clinical decisions.