Does this patient have an infection of a chronic wound?

CONTEXT: Chronic wounds (those that have not undergone orderly healing) are commonly encountered, but determining whether wounds are infected is often difficult. The current reference standard for the diagnosis of infection of a chronic wound is a deep tissue biopsy culture, which is an invasive procedure. OBJECTIVES: To determine the accuracy of clinical symptoms and signs to diagnose infection in chronic wounds and to determine whether there is a preferred noninvasive method for culturing chronic wounds. DATA SOURCES: We searched multiple databases from inception through November 18, 2011, to identify studies focusing on diagnosis of infection in a chronic wound. STUDY SELECTION: Original studies were selected if they had extractable data describing historical features, symptoms, signs, or laboratory markers or were radiologic studies compared with a reference standard for diagnosing infection in patients with chronic wounds. Of 341 studies initially retrieved, 15 form the basis of this review. These studies include 985 participants with a total of 1056 chronic wounds. The summary prevalence of wound infection was 53%. DATA EXTRACTION: Three authors independently assigned each study a quality grade, using previously published criteria. One author abstracted operating characteristic data. DATA SYNTHESIS: An increase in the level of pain (likelihood ratio range, 11-20) made infection more likely, but its absence (negative likelihood ratio range, 0.64-0.88) did not rule out infection. Other items in the history and physical examination, in isolation or in combination, appeared to have limited utility when infection was diagnosed in chronic wounds. Routine laboratory studies had uncertain value in predicting infection of a chronic wound. CONCLUSIONS: The presence of increasing pain may make infection of a chronic wound more likely. Further evidence is required to determine which, if any, type of quantitative swab culture is most diagnostic.

Investigator experiences with financial conflicts of interest in clinical trials.

BACKGROUND: Financial conflicts of interest (fCOI) can introduce actions that bias clinical trial results and reduce their objectivity. We obtained information from investigators about adherence to practices that minimize the introduction of such bias in their clinical trials experience. METHODS: Email survey of clinical trial investigators from Canadian sites to learn about adherence to practices that help maintain research independence across all stages of trial preparation, conduct, and dissemination. The main outcome was the proportion of investigators that reported full adherence to preferred trial practices for all of their trials conducted from 2001-2006, stratified by funding source. RESULTS: 844 investigators responded (76%) and 732 (66%) provided useful information. Full adherence to preferred clinical trial practices was highest for institutional review of signed contracts and budgets (82% and 75% of investigators respectively). Lower rates of full adherence were reported for the other two practices in the trial preparation stage (avoidance of confidentiality clauses, 12%; trial registration after 2005, 39%). Lower rates of full adherence were reported for 7 practices in the trial conduct (35% to 43%) and dissemination (53% to 64%) stages, particularly in industry funded trials. 269 investigators personally experienced (n = 85) or witnessed (n = 236) a fCOI; over 70% of these situations related to industry trials. CONCLUSION: Full adherence to practices designed to promote the objectivity of research varied across trial stages and was low overall, particularly for industry funded trials.

Financial Conflicts of Interest Checklist 2010 for clinical research studies.

A conflict of interest is defined as "a set of conditions in which professional judgment concerning a primary interest (such as a patient's welfare or the validity of research) tends to be unduly influenced by a secondary interest (such as financial gain)" [Thompson DF. Understanding financial conflicts of interest. N Engl J Med 1993;329(8):573-576]. Because financial conflict of interest (fCOI) can occur at different stages of a study, and because it can be difficult for investigators to detect their own bias, particularly retrospectively, we sought to provide funders, journal editors and other stakeholders with a standardized tool that initiates detailed reporting of different aspects of fCOI when the study begins and continues that reporting throughout the study process to publication. We developed a checklist using a 3-phase process of pre-meeting item generation, a stakeholder meeting and post-meeting consolidation. External experts (n = 18), research team members (n = 12) and research staff members (n = 4) rated or reviewed items for some or all of the 7 major iterations. The resulting Financial Conflicts of Interest Checklist 2010 consists of 4 sections covering administrative, study, personal financial, and authorship information, which are divided into 6 modules and contain a total of 15 items and their related sub-items; it also includes a glossary of terms. The modules are designed to be completed by all investigators at different points over the course of the study, and updated information can be appended to the checklist when it is submitted to stakeholder groups for review. We invite comments and suggestions for improvement at http://www.openmedicine.ca/fcoichecklist and ask stakeholder groups to endorse the use of the checklist.

Treatment of pressure ulcers: a systematic review.

CONTEXT: Many treatments for pressure ulcers are promoted, but their relative efficacy is unclear. OBJECTIVE: To systematically review published randomized controlled trials (RCTs) evaluating therapies for pressure ulcers. DATA SOURCES AND STUDY SELECTION: The databases of MEDLINE, EMBASE, and CINAHL were searched (from inception through August 23, 2008) to identify relevant RCTs published in the English language. DATA EXTRACTION: Methodological characteristics and outcomes were extracted by 3 investigators. DATA SYNTHESIS: A total of 103 RCTs met inclusion criteria. Of these, 83 did not provide sufficient information about authors' potential financial conflicts of interest. Methodological quality was variable. Most trials were conducted in acute care (38 [37%]), mixed care (25 [24%]), or long-term care (22 [21%]) settings. Among 12 RCTs evaluating support surfaces, no clear evidence favored one support surface over another. No trials compared a specialized support surface with a standard mattress and repositioning. Among 7 RCTs evaluating nutritional supplements, 1 higher-quality trial found that protein supplementation of long-term care residents improved wound healing compared with placebo (improvement in Pressure Ulcer Scale for Healing mean [SD] score of 3.55 [4.66] vs 3.22 [4.11], respectively; P < .05). Other nutritional supplement RCTs showed mixed results. Among 54 RCTs evaluating absorbent wound dressings, 1 found calcium alginate dressings improved healing compared with dextranomer paste (mean wound surface area reduction per week, 2.39 cm(2) vs 0.27 cm(2), respectively; P<.001). No other dressing was superior to alternatives. Among 9 RCTs evaluating biological agents, several trials reported benefits with different topical growth factors. However, the incremental benefit of these biological agents over less expensive standard wound care remains uncertain. No clear benefit was identified in 21 RCTs evaluating adjunctive therapies including electric current, ultrasound, light therapy, and vacuum therapy. CONCLUSIONS: Little evidence supports the use of a specific support surface or dressing over other alternatives. Similarly, there is little evidence to support routine nutritional supplementation or adjunctive therapies compared with standard care.

National evaluation of policies on individual financial conflicts of interest in Canadian academic health science centers.

BACKGROUND: Conflicts of interest (COI) in research are an important emerging topic of investigation and are frequently cited as a serious threat to the integrity of human participant research. OBJECTIVE: To study financial conflicts of interest (FCOI) policies for individual investigators working in Canadian academic health centers. DESIGN: Survey instrument containing 61 items related to FCOI. SETTING: All Canadian academic health science centers (universities with faculties of medicine, faculties of medicine and teaching hospitals) were requested to provide their three primary FCOI policies. MEASUREMENTS: Number of all centers and teaching hospitals with policies addressing each of the 61 items related to FCOI. MAIN RESULTS: Only one item was addressed by all 74 centers. Thirteen items were present in fewer than 25% of centers. Fewer than one-quarter of hospitals required researchers to disclose FCOI to research participants. The role of research ethics boards (REBs) in hospitals was marginal. LIMITATIONS: Asking centers to identify only three policies may not have inclusively identified all FCOI policies in use. Additionally, policies at other levels might apply. For instance, all institutions receiving federal grant money must comply with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. CONCLUSIONS: Canadian centers within the same level (for instance, teaching hospitals) differ significantly in the areas that their policies address and these policies differ widely in their coverage. Presently, no single policy in any Canadian center informs researchers about the broad range of individual FCOI issues. Canadian investigators need to understand the environment surrounding FCOI, be able to access and follow the relevant policies and be confident that they can avoid entering into a FCOI.

Oral drug therapy for multiple neglected tropical diseases: a systematic review.

CONTEXT: The neglected tropical diseases include 13 conditions that occur in areas of extreme poverty and are poverty promoting. The neglected tropical diseases produce a disease burden almost as great as that associated with human immunodeficiency virus/AIDS, tuberculosis, or malaria, yet are virtually unknown by health care workers in North America, because they occur almost exclusively in the poorest regions of the world. Seven of the most prevalent diseases have existing oral drug treatments. Identifying treatments that are effective against more than 1 disease could facilitate efficient and inexpensive treatment. OBJECTIVES: To systematically review the evidence for drug treatments and to increase awareness that neglected tropical diseases exist and that treatments are available. DATA SOURCES AND STUDY SELECTION: Using a MEDLINE search (1966 through June 2007), randomized controlled trials (RCTs) were reviewed that examined simultaneous treatment of 2 or more of the 7 most prevalent neglected tropical diseases using oral drug therapy. DATA SYNTHESIS: Twenty-nine RCTs were identified, of which 3 targeted 4 diseases simultaneously, 20 targeted 3 diseases, and 6 targeted 2 diseases. Trials were published between 1972 and 2005 and baseline prevalence of individual diseases varied among RCTs. Albendazole plus diethylcarbamazine significantly reduced prevalence of elephantiasis (16.7% to 5.3%), hookworm (10.3% to 1.9%), roundworm (34.5% to 2.3%), and whipworm (55.5% to 40.3%). Albendazole plus ivermectin significantly reduced prevalence of elephantiasis (12.6% to 4.6%), hookworm (7.8% to 0%), roundworm (33.5% to 6.1%), and whipworm (42.7% to 8.9%). Levamisole plus mebendazole significantly reduced prevalence of hookworm (94.0% to 71.8%), roundworm (62.0% to 1.4%), and whipworm (93.1% to 74.5%). Pyrantel-oxantel significantly reduced hookworm (93.4% to 85.2%), roundworm (22.8% to 1.4%), and whipworm (86.8% to 59.5%), while albendazole alone significantly reduced prevalence of hookworm (8.1% to 1.3%), roundworm (28.4% to 0.9%), and whipworm (51.9% to 31.9%). No RCT examined treatment of river blindness or trachoma as part of an intervention to target 2 or more neglected tropical diseases. Adverse events were generally inadequately reported. CONCLUSIONS: At least 2 of the most prevalent neglected tropical diseases can be treated simultaneously with existing oral drug treatments, facilitating effective and efficient treatment. Increasing awareness about neglected tropical diseases, their global impact, and the availability of oral drug treatments is an essential step in controlling these diseases.