Datasets:

marianna13
/

litarch

+{"file": "taid37_NBK285099/appf.nxml", "text": "\n\n\nBackground Care in RCTs of Mixed or Non-descriptive Chronic Ulcers\n\n\n\nBackground Care in RCTs of Mixed or Non-descriptive Chronic Ulcers", "pairs": [], "interleaved": []}
+{"file": "taid37_NBK285099/apph.nxml", "text": "\n\n\nEvidence- RCTS of pressure ulcers (additional data on 20 selected studies)\n\n\n\nEvidence- RCTS of pressure ulcers (additional data on 20 selected studies)", "pairs": [], "interleaved": []}
+{"file": "taid37_NBK285099/appg.nxml", "text": "\n\n\nEvidence- RCTs of diabetic ulcers (additional data on 20 selected studies)\n\n\n\nEvidence- RCTs of diabetic ulcers (additional data on 20 selected studies)", "pairs": [], "interleaved": []}
+{"file": "taid37_NBK285099/appc.nxml", "text": "\n\n\nBackground Care in RCTS of Pressure Ulcers\n\n\n\nBackground Care in RCTS of Pressure Ulcers", "pairs": [], "interleaved": []}
+{"file": "taid37_NBK285099/appi.nxml", "text": "\n\n\nEvidence- RCTS of venous ulcers (additional data on 20 selected studies)\n\n\n\nEvidence- RCTS of venous ulcers (additional data on 20 selected studies)", "pairs": [], "interleaved": []}
+{"file": "taid37_NBK285099/appd.nxml", "text": "\n\n\nBackground Care in RCTS of Venous Ulcers\n\n\n\nBackground Care in RCTS of Venous Ulcers", "pairs": [], "interleaved": []}
+{"file": "taid37_NBK285099/appb.nxml", "text": "\n\n\nBackground Care in RCTS of Diabetic Ulcers\n\n\n\nBackground Care in RCTS of Diabetic Ulcers", "pairs": [], "interleaved": []}
+{"file": "taid37_NBK285099/summary.nxml", "text": "The basic concepts of chronic wound care appear to be well understood. There appears to be general consensus about the use of the basic treatment modalities for chronic wound care among authoritative bodies issuing clinical practice guidelines and opinion leaders writing surgical textbook chapters. However, their recommendations often are vague, not comprehensive, and lacking in specific details. There is also considerable variation in the frequency of reported use of treatment modalities across different types of ulcers and in the use of specific treatment modalities for specific ulcers. The findings suggest that certain elements of usual care will vary with ulcer type. Most common are offloading and debridement for diabetic ulcers and compression for venous ulcers while other treatment modalities such as cleansing and antibiotics are common to a certain degree across ulcer types. These observations are consistent with generally accepted clinical principles and based on sound pathophysiological rationales. We did not review dermatological, nursing, and podiatry textbooks. However, given the general consensus in the literature on the basic treatment modalities, it is unlikely that there will be significant variations in their recommendations.\nWe analyzed over 140 RCTs published from 1997 onward. The largest number of trials was found for venous ulcers, followed by diabetic ulcers and pressure ulcers. There was only one trial of arterial ischemic ulcers, so no reliable conclusions can be drawn. Dressings are universally used in all types of wounds as they were reported in about 90% of all the trials. However, saline wet-to-dry dressings were used in 50% of the diabetic ulcer trials, in 40% of the pressure ulcer trials, but in only 5% of the venous ulcer trials. Hydrocolloid dressings were used in about 40% of both venous ulcer and pressure ulcer trials but in less than 15% of the diabetic ulcer trials. As expected, the rate of compression bandage use was high (83%) in venous ulcer trials although they were also used in several diabetic ulcer trials. The rate of debridement is high (81%) in diabetic ulcer trials but mentioned in less than one-half of the venous and pressure ulcer trials. A high rate (79%) of prescribing pressure offloading was reported in diabetic ulcer trials but only in 48% of pressure ulcer trials. Cleansing was reported in 30 to 52% of trials of various wound types. The use of antibiotics was reported in about one-third of the diabetic ulcer trials and much less often in trials of other types of ulcers.\nThe large number of RCTs available for diabetic, pressure, and venous ulcers is deceptive in that they yielded limited information about the usual care, how different treatment modalities should be used and how they should be used in combination. Many of the trials compared one product against the product of another manufacturer (i.e., one dressing versus another dressing). Practical clinical information such as the frequency of application, or combination or sequencing of treatment modalities is generally inadequately reported in these trials.\nOther than the reporting of complete wound closure, the conformance with the FDA Draft Guidance Document recommendations on outcome assessment of the 20 largest trials that we examined was low in each of the 3 wound categories of diabetic, pressure, and venous ulcers.\nThe quality of information provided in the RCTs of chronic wound management we examined for this report is generally poor. There is a large degree of variation in the reporting of the use of different basic wound treatment modalities. Not a single wound treatment modality, among those evaluated, was uniformly reported in all the trials. Compression bandages are considered the cornerstone treatment for venous ulcers, yet only 83% of the trials reported it as usual care in the control group. It is difficult to ascertain whether the relatively low rate of reporting of treatment modalities was indeed because the investigators did not use it as part of usual care in the trials or if the information simply was not reported. It is possible that some of these treatment modalities might have been considered to be so basic and essential to chronic wound care that the investigators did not bother to include them in their report. Over 40% of the trials did not report information about the duration of chronic wounds. Incomplete information from these trials makes it difficult to determine the reliability of these data and interpret their results.", "pairs": [], "interleaved": []}
+{"file": "taid37_NBK285099/methods.nxml", "text": "We performed a systematic review of the literature to extract information about the background care given to patients in the control group in randomized controlled trials (RCTs) as a proxy for standard of care. Analyses were restricted to RCTs because these studies generally have the most complete description of the background care information compared with other less rigorous study designs. In this report, treatment modalities prescribed in the control groups will be referred to as \u201cusual care.\u201d Clinical practice guidelines and selected surgical textbooks were reviewed for recommendations from authoritative bodies or opinion leaders on chronic wound management to identify major chronic wound treatment modalities and to complement our review of RCTs.\nLiterature Search\nWe searched clinical practice guidelines, surgical textbooks, and RCTs in June and July of 2004. Searches for guidelines and textbooks were not meant to be exhaustive. They were intended to provide guidance on the range of treatment modalities generally recommended. We searched for clinical trial articles published since 1997, because the goal of this report is to summarize the usual care practice in recent clinical trials of chronic wound treatments.\nClinical Practice Guidelines\nWe searched the National Guidelines Clearinghouse (www.ngc.gov) and MEDLINE for clinical practice guidelines on the management of chronic wounds and these were examined for information pertaining to standard of care. In addition, our surgical consultant contacted several major surgical societies in the US for potential guidelines not included in the Clearinghouse but found none.\nSurgical Textbooks\nWe examined chapters on wound care in a convenient sample of textbooks available on the surgical textbook shelves at the Tufts and Harvard medical school libraries for specific recommendations about usual care for chronic wounds.\nRandomized Controlled Trials\nWe searched for English-language studies in MEDLINE, CINAHL, and the Cochrane Controlled Trials Registry databases on June 30 of 2004. Following consultation with AHRQ and CMS, we limited our literature search to articles published since 1997, which was the publication year of the first UK NHS chronic wounds TAs. A total of 2,762 unique citations were identified. After screening titles and abstracts, 277 articles were retrieved for review.\nInclusion Criteria\nAs a set of minimum inclusion criteria, we accepted English language RCTs evaluating treatments of chronic wounds with any number of human subjects. In general, chronic wounds are defined as wounds that do not heal completely after receiving standard medical treatment for 30 days. Because the focus of this report is not on the evaluation of clinical outcomes, there is less concern about the potential bias that may be introduced by including studies that did not clearly state the duration of wound. Therefore, we accepted RCTs that included mixed duration ulcers in which some of the ulcers might have received standard medical treatment for less than 30 days, as well as studies that did not clearly specify wound duration. In our judgment most of the ulcers were likely to have been treated for at least 30 days.\nTypes of Chronic Wounds\nIn this report we considered the following types of chronic wounds: ischemic ulcers due to peripheral arterial occlusive disease, ulcers due to venous disease, diabetic foot ulcers (usually neurotrophic), and decubitus ulcers due to pressure. Ulcers secondary to ischemic arterial occlusive disease usually undergo revascularization to correct inadequate regional perfusion and in general are not the subject of RCTs. An exception to this is the concomitant use of hyperbaric oxygen, a form of treatment outside the realm of usual care. Because the focus of this report is not on the outcomes of treatments, we accepted trials of any duration of treatment. For completeness, studies that included different types of ulcers and did not provide clear delineation of subgroups of wound types are reported in a separate table of mixed wounds. However, this group of studies was not analyzed because of the uncertainty of the wound category and duration.\nUsual Care Treatment Modalities\nSpecific treatments in the control arms of the RCTs were categorized into one of the following 6 treatment modalities: debridement, cleansing, dressing, compression bandage, antibiotics, and pressure offloading. Debridement methods were further categorized into surgical and non-surgical (i.e., enzymatic) debridement. In addition, dressings were categorized into non-occlusive, semi-occlusive, and occlusive. Non-occlusive dressing includes ointment/cream and dry gauze. Semi-occlusive dressing includes saline wet-to-dry, wet dressing, paraffin gauze, and Vaseline gauze. Occlusive dressings include Unna boot and various hydrocolloids. Management of chronic wounds should include treating the underlying condition and co-morbidities, which might include optimizing blood glucose control in patients with diabetic ulcers, ensuring adequate nutrition status in debilitated patients, revascularization in patients with ischemic artery disease, and pain management. While these treatments modalities are important aspects of total patient management, they are not directed at the treatment of the wound and are not considered in this report.\nStudy Design\nRCTs, non-randomized controlled comparison studies, and cohort studies were initially included in the analysis. We found after preliminary assessment of the literature that 84% of the retrieved studies were RCTs. Excluding the small number of non-randomized studies would have little impact on the results. Focusing on RCTs, as they most likely represent the highest quality of evidence, will improve the reliability of the conclusions. Therefore, after consultation with CMS and AHRQ, only RCTs were included in this report.\nWe also included RCTs without a clear control group (e.g., RCTs that compare one type of dressing with another type of dressing, or trials that compare one type of compression bandage with another type of compression bandage). In that case, treatments in all arms of the RCT were extracted, and the usual care for the modality in comparison consisted of more than one treatment (e.g., 2 different types of bandages for compression).\nAnalysis of the Literature\nThe review of RCTs focused on determining the frequency of specific treatment modalities that had been used in the control arms for each of the 4 different types of wounds. We also sought to describe the characteristics of the RCTs by wound type. Because authors often do not completely report information about the trial, the lack of description of treatment modalities in an article should not be interpreted as a lack of use of a specific treatment modality. For example, some authors might have taken certain basic treatment modalities for granted (e.g., antibiotics treatment for infected wounds). Therefore, the information on the frequency of various treatment modalities as a proxy of standard of care should be interpreted accordingly.\nConformance of RCTs to Recommendations in the FDA Draft Guidance Document for the Industry\nThe FDA Draft Guidance Document for the Industry was used as another source of recommendations for usual care in clinical trials testing wound care products. This document also discussed certain design issues that should be addressed in future trials. We reviewed the FDA draft guidance document for the industry to identify recommended elements of outcomes assessment and trial design in the evaluation of wound care products.\nFor outcomes assessment, these elements include: assessment of partial or complete wound closures, and measurement of wound size pre- and post-debridement. According to the FDA document, prospectively defined partial wound healing (including wound size change) may be used as supportive evidence for the beneficial biological activities of a product or procedure. However, this is not an acceptable surrogate for complete wound healing. An exception is partial wound healing that facilitates surgical closure. Assessment of the wound size and infection status should be conducted after surgical debridement. Enzymatic debridement agents should be avoided because these are applied as topical agents and may confound the results of wound product trials. Measurement of wound size should be standardized with photographic imaging procedures at each clinic visit.\nSystemic antibiotic therapy may be necessary during the course of the trial because wounds do not heal in the presence of infection. A trial should document the antimicrobial usage in the study population before and during the trial and the FDA Draft Guidance Document recommends that the study protocol discuss whether the study treatment should be continued in the event of an infection.\nIn consultation with AHRQ and CMS, we selected approximately 20 of the largest RCTs from each of the diabetic ulcer, pressure ulcer, and venous ulcer categories for additional analyses according to several outcomes recommended in the FDA Draft Guidance Document. The frequency of reporting of the following items were noted:\n\npartial wound closurecomplete wound closure2 months post-wound closure assessmentwound size pre- and post-debridementphotographic imaging methods to assess wound size\npartial wound closure\ncomplete wound closure\n2 months post-wound closure assessment\nwound size pre- and post-debridement\nphotographic imaging methods to assess wound size\nIn addition, CMS also requested an analysis of the reporting of wound care provider.", "pairs": [], "interleaved": []}
+{"file": "taid37_NBK285099/appe.nxml", "text": "\n\n\nBackground Care in RCT of Arterial Ulcers\n\n\n\nBackground Care in RCT of Arterial Ulcers", "pairs": [], "interleaved": []}