Risk-of-bias assessment of the randomized clinical trials and systematic reviews on surgical treatments for breast cancer-related lymphedema: A mapping review.

BACKGROUND: Breast cancer treatment is the principal cause of lymphedema in the upper extremities. Breast cancer-related lymphedema (BCRL) treatments were previously based on conservative therapy; surgical treatments are alternative options that could be highly beneficial, especially for patients who are not responsive to conservative therapy. The main aim of this study was to describe and critically assess the risk of bias of randomized clinical trials (RCTs) and systematic reviews (SRs) on surgical treatment for BCRL. METHODS: We conducted an evidence mapping review according to the methodology proposed by Global Evidence Mapping (GEM). An update was done for our previous systematic search in MEDLINE, EMBASE, CENTRAL (Cochrane), and Epistemonikos from the year 2000 onward. We assessed the risk of bias for the RCTs and SRs using the RoB-2 and ROBIS tools, respectively. RESULTS: Two surgical RCTs and eight SRs were found among the 47 surgical studies that met the eligibility criteria. The overall risk-of-bias assessments of these studies were rated as some concerns (six outcomes) and high risk (three outcomes) for the measured outcomes among the RCTs and as a high risk of bias (five studies) and low risk (three studies) for the included SRs. CONCLUSIONS: The overall evidence in the literature on surgical treatment for BCRL is low, as there are few published RCTs and SRs, and the risk-of-bias assessment for the majority was rated as high risk of bias or with some concerns. High-quality studies are needed to improve evidence-based decision-making by surgeons and patients.

GRADE-Based Recommendations for Surgical Repair of Nonruptured Abdominal Aortic Aneurysm.

The objective of this study was to provide evidence-based recommendations for endovascular aneurysm repair (EVAR) versus open surgical repair (OSR) for patients with a nonruptured abdominal aortic aneurysm (AAA). We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analysis statement and adhered to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework. Both low- and high surgical risk patients treated with EVAR showed decreased 30-day mortality, but the low-risk group had no differences in 4-year mortality. Compared with friendly anatomy, patients with hostile anatomy had an increased risk of type I endoleak. Young patients may prefer OSR. Endovascular aneurysm repair was not cost-effective in Europe. Four conditional recommendations were formulated: (1) OSR for low-risk patients up to 80 years old, (2) EVAR for low-risk patients older than 80 years, (3) EVAR for high-risk patients as long as is anatomically feasible, and (4) OSR in patients in whom it is not anatomically feasible to perform EVAR. Based on GRADE criteria, either OSR or EVAR can be suggested to patients with nonruptured AAA taking into account their surgical risk, hostile anatomy, and age. Given the weakness of the recommendations, personal preferences are determinant.

Population-based estimate of the use of intermittent androgen deprivation therapy in prostate cancer patients in Catalonia, Spain.

PURPOSE: To estimate the use of intermittent androgen deprivation (IAD) therapy in patients with prostate cancer (PCa). METHODS: Retrospective, non-interventional study based on electronic pharmacy dispensation data of luteinizing hormone-releasing hormone (LHRH) analogs and anti-androgens in Catalonia (Spain). Intermittency was defined as the percentage of time off treatment (%IAD), which was calculated for the whole sample by dividing the sum of all off-IAD periods by the total time on any LHRH analog regimen. The prevalence of patients on an IAD regimen (PIAD ) was also estimated. A small validation study based on data from clinical records confirmed the excellent sensitivity and specificity of this approach. RESULTS: A total of 515 803 prescriptions for LHRH analog were dispensed over a 5-year period (2008 to 2012) to 35 089 PCa patients. The mean age (±SD) was 77 years (±9). The %IAD in the cohort was 1.7% whereas the 5-year prevalence (PIAD ) was 4.2%. Only 2.5% of patients on IAD were on IAD for >6 months. Of the physicians (n = 1638) who prescribed hormonal treatment, 24% used IAD at least once. Total expenditures for LHRH analogs were 1.2% of total drug expenditure in this population. CONCLUSIONS: This study confirms the validity of the method developed to estimate IAD use based on electronic pharmacy dispensation data. Given the large potential clinical and economic benefits that greater use of IAD could provide, future studies are needed to confirm these findings and to identify new strategies to increase the use of IAD.

Quality assessment of controlled clinical trials published in Orthopaedics and Traumatology journals in Spanish: An observational study through handsearching and evidence mapping.

Few Orthopaedics and Traumatology journals from Latin America and Spain are indexed in major databases; controlled clinical trials published in these journals cannot be exhaustively retrieved using electronic literature searches. We aimed to identify, describe and assess the quality of controlled clinical trials published in Orthopaedics and Traumatology journals from Latin America and Spain through handsearching and evidence mapping methods. We identified controlled clinical trials published in eligible Orthopaedics/Traumatology journals in Spanish until July 2017 by handsearching. Data were extracted for controlled clinical trials main characteristics and the Cochrane risk of bias tool was used to assess the controlled clinical trials methodological quality. In addition, we mapped the main findings of these trials. As a result, we assessed 5631 references in 29 eligible journals of which 57 were controlled clinical trials (1.0%). Controlled clinical trials were published between 1995 and 2017 at a rate of 2.5 per year. Journals from Spain and Mexico published around 63% of the controlled clinical trials identified. The median sample size of patients enrolled was 60 (range = 30-300 participants). About conditions assessed, 38.5% of controlled clinical trials assessed issues related to knee conditions, 15.7% about hip and 10.5% about trauma or spine. The risk of bias domains most affected was selective reporting bias and random sequence generation. In addition, only two and seven trials had low risk of bias in all items related to participant/personnel and outcome assessment blindings, respectively. More than 40% of studies did not report differences on benefits/harms between the interventions assessed. As a conclusion, the number of controlled clinical trials published in Orthopaedics/Traumatology journals from Latin America and Spain is low. These controlled clinical trials had important methodological shortcomings and were judged as unclear or high risk of bias. These trials are now available in CENTRAL for their potential inclusion in systematic reviews and other documents of synthesis.

Opinions and potential solutions regarding dissemination bias from funding agencies of biomedical research in Europe.

RATIONALE, AIMS, AND OBJECTIVES: Several studies have found that about half of research results from clinical trials are never published. Until now, there has been little information on the views that funding agencies of biomedical research in Europe have regarding this issue and its possible solutions. METHODS: An electronic survey was conducted among funding agencies from 34 European countries. Participants were asked about their opinions, policies, and potential solutions regarding dissemination bias. On the basis of the results of this survey and the input of the OPEN Consortium and of representatives of stakeholder groups in the knowledge generation process, we formulated recommendations for funding agencies to reduce dissemination bias. RESULTS: We received responses from 64 funding agencies of biomedical medicine from most European countries, out of 245 that were contacted (26%). Of these, 56 funded research at the national and/or international level and were therefore eligible to participate. Policies encouraging publication increased over time: 33 (58.9%) of agencies enforced them in 2005 compared to 38 (67.6%) in 2012. However, only 13 (23.2%) had knowledge of the publications related to research funded in 2005, 23 (41.1%) were able to provide only an estimate, and 20 (35.7%) did not know at all. Regarding recommendations to control dissemination bias, we propose that funding agencies request the dissemination of research results irrespective of the direction of findings. We also call for measures that allow evaluating funded projects past the contractual period and until dissemination of results. Funding agencies should create publicly accessible databases with information on funded projects and dissemination efforts. CONCLUSION: Despite having policies to encourage publication of results, most funding agencies fail to implement such measures or to ensure compliance. We propose recommendations that could be incorporated in the blueprint of calls for proposals and contracts agreed upon by funding agencies and grant recipients.

Effectiveness and cost-effectiveness of double reading in digital mammography screening: A systematic review and meta-analysis.

PURPOSE: Double reading is the strategy of choice for mammogram interpretation in screening programmes. It remains, however, unknown whether double reading is still the strategy of choice in the context of digital mammography. Our aim was to determine the effectiveness and cost-effectiveness of double reading versus single reading of digital mammograms in screening programmes. METHODS: We performed a systematic review by searching the PubMed, Embase, and Cochrane Library databases up to April 2017. We used the QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies) tool and CHEERS (Consolidated Health Economic Evaluation Reporting Standards) checklist to assess the methodological quality of the diagnostic studies and economic evaluations, respectively. A proportion's meta-analysis approach, 95% Confidence Intervals (95% CI) and test of heterogeneity (P values) were used for pooled results. Costs are expressed US$ PPP (United States Dollar purchasing power parities). The PROSPERO ID of this Systematic Review's protocol is CRD42014013804. RESULTS: Of 1473 potentially relevant hits, four high-quality studies were included. The pooled cancer detection rate of double reading was 6.01 per 1000 screens (CI: 4.47‰-7.77‰), and it was 5.65 per 1000 screens (CI: 3.95‰-7.65‰) for single reading (P=0.76). The pooled proportion of false-positives of double reading was 47.03 per 1000 screens (CI: 39.13‰-55.62‰) and it was 40.60 per 1000 screens (CI: 38.58‰-42.67‰) for single reading (P=0.12). One study reported, for double reading, an ICER (Incremental Cost-Effectiveness Ratio) of 16,684 Euros (24,717 US$ PPP; 2015 value) per detected cancer. Single reading+CAD (computer-aided-detection) was cost-effective in Japan. CONCLUSION: The evidence of benefit for double reading compared to single reading for digital mammography interpretation is scarce. Double reading seems to increase operational costs, have a not significantly higher false-positive rate, and a similar cancer detection rate.

Cost-Effectiveness of Double Reading versus Single Reading of Mammograms in a Breast Cancer Screening Programme.

OBJECTIVES: The usual practice in breast cancer screening programmes for mammogram interpretation is to perform double reading. However, little is known about its cost-effectiveness in the context of digital mammography. Our purpose was to evaluate the cost-effectiveness of double reading versus single reading of digital mammograms in a population-based breast cancer screening programme. METHODS: Data from 28,636 screened women was used to establish a decision-tree model and to compare three strategies: 1) double reading; 2) double reading for women in their first participation and single reading for women in their subsequent participations; and 3) single reading. We calculated the incremental cost-effectiveness ratio (ICER), which was defined as the expected cost per one additionally detected cancer. We performed a deterministic sensitivity analysis to test the robustness of the ICER. RESULTS: The detection rate of double reading (5.17‰) was similar to that of single reading (4.78‰; P = .768). The mean cost of each detected cancer was €8,912 for double reading and €8,287 for single reading. The ICER of double reading versus single reading was €16,684. The sensitivity analysis showed variations in the ICER according to the sensitivity of reading strategies. The strategy that combines double reading in first participation with single reading in subsequent participations was ruled out due to extended dominance. CONCLUSIONS: From our results, double reading appears not to be a cost-effective strategy in the context of digital mammography. Double reading would eventually be challenged in screening programmes, as single reading might entail important net savings without significantly changing the cancer detection rate. These results are not conclusive and should be confirmed in prospective studies that investigate long-term outcomes like quality adjusted life years (QALYs).

Identification and description of controlled clinical trials published in Spanish Gynaecology and Obstetrics journals and risk of bias assessment of trials on assisted reproductive techniques.

OBJECTIVES: To identify and describe controlled clinical trials (CCTs) published in Spanish Gynaecology and Obstetrics journals. In addition, to assess the quality of the CCTs on Assisted Reproduction Techniques (ART) identified in this project. STUDY DESIGN: In order to identify eligible CCTs, all Spanish Gynaecology and Obstetrics journals were handsearched. Handsearching was conducted following the guidelines provided by the Cochrane Collaboration, which state that each journal article must be carefully reviewed, including original articles and other types of studies, letters to the editor, abstracts, and conference presentations. The results of the handsearching process were compared with an electronic search conducted in MEDLINE (PubMed). A descriptive analysis of the main characteristics of the identified CCTs was performed, as well as a methodological assessment of CCTs on ART. RESULTS: Sixteen Gynaecology and Obstetrics journals were identified, four of which have been indexed in MEDLINE at some point, although not currently. The journal with the most CCTs was "Progresos de Obstetricia y Ginecología". A total of 235 CCTs were published in these journals, of which 29 were on ART. Most CCTs (216, 91.9%) were carried out in a hospital setting; 201 (89.4%) were unicentric. Obstetrics was the most studied subspecialty (46.4%). Among CCTs on ART, the risk of bias was predominantly high. CONCLUSIONS: The number of CCTs published in Spanish Gynaecology and Obstetrics journals is limited. CCTs on ART present deficiencies in the report of results and low methodological quality. It is advised that authors and journals adhere to the CONSORT statement and to the Cochrane Collaboration recommendations to reduce risk of bias when designing and disseminating research projects.

Double versus single reading of mammograms in a breast cancer screening programme: a cost-consequence analysis.

OBJECTIVES: To assess the costs and health-related outcomes of double versus single reading of digital mammograms in a breast cancer screening programme. METHODS: Based on data from 57,157 digital screening mammograms from women aged 50-69 years, we compared costs, false-positive results, positive predictive value and cancer detection rate using four reading strategies: double reading with and without consensus and arbitration, and single reading with first reader only and second reader only. Four highly trained radiologists read the mammograms. RESULTS: Double reading with consensus and arbitration was 15 % (Euro 334,341) more expensive than single reading with first reader only. False-positive results were more frequent at double reading with consensus and arbitration than at single reading with first reader only (4.5 % and 4.2 %, respectively; p < 0.001). The positive predictive value (9.3 % and 9.1 %; p = 0.812) and cancer detection rate were similar for both reading strategies (4.6 and 4.2 per 1000 screens; p = 0.283). CONCLUSIONS: Our results suggest that changing to single reading of mammograms could produce savings in breast cancer screening. Single reading could reduce the frequency of false-positive results without changing the cancer detection rate. These results are not conclusive and cannot be generalized to other contexts with less trained radiologists. KEY POINTS: • Double reading of digital mammograms is more expensive than single reading. • Compared to single reading, double reading yields a higher proportion of false-positive results. • The cancer detection rate was similar for double and single readings. • Single reading may be a cost-effective strategy in breast cancer screening programmes.

A survey study identified global research priorities for decreasing maternal mortality.

OBJECTIVES: The aim of this study was to identify and prioritize research gaps to help decrease maternal mortality. STUDY DESIGN AND SETTING: We conducted a two-stage survey. We provided participants (Cochrane Collaboration experts) with a list of 319 problem/population, intervention, comparison, and outcome questions built from 178 Cochrane systematic reviews. Questions were classified according to causes of maternal death. Respondents of the first round refined the research questions and prioritized them by eliminating those that were considered of low priority, according to four criteria. They also included additional questions. In the second round, respondents prioritized 62 questions. RESULTS: The overall response rates for the first and second rounds were 47% (73 of 155) and 17% (363 of 2,121), respectively. Participants ranked 62 of the research questions as "very relevant." Approximately 20% of all questions that were identified in Cochrane reviews and two-third of questions of the second round were considered of "very high priority." More women (235) than men (128) participated in the survey. We did not find statistically significant differences when comparing the groups of very relevant questions by the type of respondent, income, country, and round. CONCLUSION: We identified research priorities by mapping and improving the understanding of research needs in low- and middle-income settings internationally.

A randomized controlled trial to assess the efficacy and cost-effectiveness of urinary catheters with silver alloy coating in spinal cord injured patients: trial protocol.

BACKGROUND: Patients with non-acute spinal cord injury that carry indwelling urinary catheters have an increased risk of urinary tract infection (UTIs). Antiseptic Silver Alloy-Coated Silicone Urinary Catheters seems to be a promising intervention to reduce UTIs; however, actual evidence cannot be extrapolated to spinal cord injured patients. The aim of this trial is to make a comparison between the use of antiseptic silver alloy-coated silicone urinary catheters and the use of standard urinary catheters in spinal cord injured patients to prevent UTIs. METHODS/DESIGN: The study will consist in an open, randomized, multicentre, and parallel clinical trial with blinded assessment. The study will include 742 spinal cord injured patients who require at least seven days of urethral catheterization as a method of bladder voiding. Participants will be online centrally randomized and allocated to one of the two study arms (silver alloy-coated or standard catheters). Catheters will be used for a maximum period of 30 days or removed earlier if the clinician considers it necessary. The main outcome will be the incidence of UTIs by the time of catheter removal or at day 30 after catheterization, the event that occurs first. Intention-to-treat analysis will be performed, as well as a primary analysis of all patients. DISCUSSION: The aim of this study is to assess whether silver alloy-coated silicone urinary catheters improve ITUs in spinal cord injured patients. ESCALE is intended to be the first study to evaluate the efficacy of the silver alloy-coated catheters in spinal cord injured patients. TRIAL REGISTRATION: NCT01803919.

Quality assessment of asthma clinical practice guidelines: a systematic appraisal.

BACKGROUND: The quality and potential impact of available clinical guidelines for asthma management have not been systematically evaluated. We, therefore, evaluated the quality of clinical practice guidelines (CPGs) for asthma. METHODS: We performed a systematic search of scientific literature published between 2000 and 2010 to identify and select CPGs related to asthma management. We searched guideline databases, guideline developers' websites, and the MEDLINE database of the US National Library of Medicine. Four independent reviewers assessed the eligible guidelines using the Appraisal of Guidelines Research & Evaluation (AGREE) II instrument. We calculated the overall agreement among reviewers with the intraclass correlation coefficient (ICC). RESULTS: Eighteen CPGs published between the years 2000 and 2010 were selected from a total of 1,005 references. The overall agreement among reviewers was moderate (ICC: 0.78; 95% CI, 0.62-0.90). The mean scores for each AGREE domain were: scope and purpose, 44.1% (range: 10.0%-79.0%); stakeholder involvement, 33.8% (range: 4.0%-66.0%); rigor of development, 32.4% (range: 8.0%-64.0%); clarity and presentation, 52.1% (range: 17.0%-85.0%); applicability, 21.1% (range: 3%-55%); and editorial independence, 25% (range: 0%-58%). None of the appraised guidelines had a score > 60% (recommended). One-half of the appraised guidelines were recommended with modifications (nine of 18) or not recommended (nine of 18) for use in clinical practice. We observed improvement over time in overall quality of the guidelines (P = .01; guidelines published in the period 2001-2006 vs 2007-2009). CONCLUSIONS: The quality of guidelines for asthma care is low, although it has improved over time. Greater efforts are needed to provide high-quality guidelines that can be used as reliable tools for clinical decision-making in this field.

Characteristics of randomized trials published in Latin America and the Caribbean according to funding source.

INTRODUCTION: Few studies have assessed the nature and quality of randomized controlled trials (RCTs) in Latin America and the Caribbean (LAC). METHODS AND FINDINGS: The aims of this systematic review are to evaluate the characteristics (including the risk of bias assessment) of RCT conducted in LAC according to funding source. A review of RCTs published in 2010 in which the author's affiliation was from LAC was performed in PubMed and LILACS. Two reviewers independently extracted data and assessed the risk of bias. The primary outcomes were risk of bias assessment and funding source. A total of 1,695 references were found in PubMed and LILACS databases, of which 526 were RCTs (N = 73.513 participants). English was the dominant publication language (93%) and most of the RCTs were published in non-LAC journals (84.2%). Only five of the 19 identified countries accounted for nearly 95% of all RCTs conducted in the region (Brazil 70.9%, Mexico 10.1%, Argentina 5.9%, Colombia 3.8%, and Chile 3.4%). Few RCTs covered priority areas related with Millennium Development Goals like maternal health (6.7%) or high priority infectious diseases (3.8%). Regarding children, 3.6% and 0.4% RCT evaluated nutrition and diarrhea interventions respectively but none pneumonia. As a comparison, aesthetic and sport related interventions account for 4.6% of all trials. A random sample of RCTs (n = 358) was assessed for funding source: exclusively public (33.8%); private (e.g. pharmaceutical company) (15.3%); other (e.g. mixed, NGO) (15.1%); no funding (35.8%). Overall assessments for risk of bias showed no statistically significant differences between RCTs and type of funding source. Statistically significant differences favoring private and others type of funding was found when assessing trial registration and conflict of interest reporting. CONCLUSION: Findings of this study could be used to provide more direction for future research to facilitate innovation, improve health outcomes or address priority health problems.

Quality assessment of clinical practice guidelines for the prescription of antidepressant drugs during pregnancy.

Antidepressant use during the gestational period remains a controversial issue. The objective of this study was to appraise the quality of the available clinical practice guidelines (CPGs) that includes recommendations for antidepressant use during pregnancy. We systematically searched for documents published between January 2000 and September 2010 in MEDLINE / TRIP database and on clearing houses and main scientific societies' websites. Four appraisers evaluated each guideline using the Appraisal of Guidelines for Research and Evaluation tool (AGREE II). Intra-class correlation coefficients (ICC) with 95% confidence intervals (CI) were calculated as an overall indicator of agreement. Twelve CPGs were included from a total of 539 references. Only two guidelines were specifically addressed to pregnant women. The overall agreement among reviewers was high (ICC: 0.94, 95% CI: 0.86-0.98). The mean scores and standard deviation (SD) for each of the AGREE II domains were: scope and purpose: 84.4% (12); stakeholder involvement: 67.4% (29.8); rigor of development: 68.6% (19.8); clarity and presentation: 83.4% (17.4); applicability: 44% (37.3); and editorial independence: 62.1% (30.4). After standardizing the scores of the 12 guidelines, 5 were considered as being "recommended", 5 as "recommended with modifications, and 2 as "not recommended". Among the five recommended guidelines, two were specifically conceived to the gestational period. CPGs containing recommendations for antidepressant use during pregnancy were of moderate to high quality. Future guidelines should take into account the observed drawbacks in some domains, and specifically focus a more in depth approach of depression during pregnancy.

Magnetic resonance imaging in the preoperative assessment of patients with primary breast cancer: systematic review of diagnostic accuracy and meta-analysis.

OBJECTIVES: To estimate the diagnostic accuracy of magnetic resonance imaging (MRI) in detecting additional lesions and contralateral cancer not identified using conventional imaging in primary breast cancer. METHODS: We have conducted a systematic review and meta-analyses to estimate diagnostic accuracy indices and the impact of MRI on surgical management. RESULTS: Fifty articles were included (n = 10,811 women). MRI detected additional disease in 20% of women and in the contralateral breast in 5.5%. The summary PPV of ipsilateral additional disease was 67% (95% CI 59-74%). For contralateral breast, the PPV was 37% (95% CI 27-47%). For ipsilateral lesions, MRI devices ≥1.5 Tesla (T) had higher PPV (75%, 95% CI 64-83%) than MRI with <1.5 T (59%, 95% CI 53-71%). Similar results were found for contralateral cancer, PPV 40% (95% CI 29-53%) and 19% (95% CI 8-39%) for high- and low-field equipments, respectively. True positive MRI findings prompted conversion from wide local excision (WLE) to more extensive surgery in 12.8% of women while in 6.3% this conversion was inappropriate. CONCLUSIONS: MRI shows high diagnostic accuracy, but MRI findings should be pathologically verified because of the high FP rate. Future research on this emerging technology should focus on patient outcome as the primary end-point.

Quality assessment of clinical practice guidelines in perioperative care: a systematic appraisal.

BACKGROUND: Surgical care is an important burden in healthcare, and the complications and harm related to surgery are of special concern. Clinical practice guidelines in perioperative care should provide the opportunity to minimise these risks and improve surgical outcomes, but their quality has not yet been evaluated systematically. OBJECTIVE: To evaluate the quality of clinical practice guidelines (CPGs) for the prevention of perioperative adverse events. MATERIALS AND METHODS: A systematic search of scientific literature published between 1990 and 2008 was undertaken to identify and select CPGs related to the treatment of surgical patients, particularly those seeking to prevent surgical adverse events. The authors searched the main guideline databases and guideline developer websites, and completed the search in MEDLINE. Three independent reviewers assessed the eligible guidelines using the Appraisal of Guidelines for Research and Evaluation (AGREE) instrument. Their degree of agreement was evaluated with the intraclass correlation coefficient (ICC). RESULTS: Twenty-two CPGs were chosen for evaluation from a total of 6181 references. The overall agreement among reviewers was moderate (ICC: 0.68; 95% CI 0.46 to 0.84). The scores for each of the AGREE domains were: scope and purpose 80.9% (range: 40.7-100%); stakeholder involvement 51.3% (range: 8.3-88.8%); rigour of development 61.2% (range: 26.9-96.8%); clarity and presentation 69.7% (range: 33.3-94.4%); applicability 42.5% (range: 7.4-92.5%); and editorial independence 57% (range: 27.7-100%). Most of the appraised guidelines could be recommended (n = 10) or recommended with provisos (n = 10) for use in clinical practice. Guidelines developed by research agencies or guideline developers were of a higher quality than those developed by scientific societies. The authors did not detect any improvement over time in guideline quality. CONCLUSIONS: The quality of guidelines for perioperative care is moderate. Measures should be taken to guarantee that CPGs are based on the best available evidence and rigorously developed and reported. Greater efforts are needed to provide high-quality guidelines that serve as a useful and reliable tool for clinical decision-making in this field.

Reporting of methodologic information on trial registries for quality assessment: a study of trial records retrieved from the WHO search portal.

BACKGROUND: Although randomized clinical trials (RCTs) are considered the gold standard of evidence, their reporting is often suboptimal. Trial registries have the potential to contribute important methodologic information for critical appraisal of study results. METHODS AND FINDINGS: The objective of the study was to evaluate the reporting of key methodologic study characteristics in trial registries. We identified a random sample (n = 265) of actively recruiting RCTs using the World Health Organization International Clinical Trials Registry Platform (ICTRP) search portal in 2008. We assessed the reporting of relevant domains from the Cochrane Collaboration's 'Risk of bias' tool and other key methodological aspects. Our primary outcomes were the proportion of registry records with adequate reporting of random sequence generation, allocation concealment, blinding, and trial outcomes. Two reviewers independently assessed each record. Weighted overall proportions in the ICTRP search portal for adequate reporting of sequence generation, allocation concealment, blinding (including and excluding open label RCT) and primary outcomes were 5.7% (95% CI 3.0-8.4%), 1.4% (0-2.8%), 41% (35-47%), 8.4% (4.1-13%), and 66% (60-72%), respectively. The proportion of adequately reported RCTs was higher for registries that used specific methodological fields for describing methods of randomization and allocation concealment compared to registries that did not. Concerning other key methodological aspects, weighted overall proportions of RCTs with adequately reported items were as follows: eligibility criteria (81%), secondary outcomes (46%), harm (5%) follow-up duration (62%), description of the interventions (53%) and sample size calculation (1%). CONCLUSIONS: Trial registries currently contain limited methodologic information about registered RCTs. In order to permit adequate critical appraisal of trial results reported in journals and registries, trial registries should consider requesting details on key RCT methods to complement journal publications. Full protocols remain the most comprehensive source of methodologic information and should be made publicly available.

Is it appropriate to implant kidneys from elderly donors in young recipients?

BACKGROUND: Kidneys from elderly donors tend to be implanted in recipients who are also elderly. We present the results obtained after 10 years of evolution on transplanting elderly kidneys into young recipients. METHODS: Ninety-one consecutive transplants are studied, carried out in our center with kidneys from cadaver donors older than 60 years implanted in recipients younger than 60 years. The control group is made up of 91 transplants, matched with those from the study group, whose donor and recipient were younger than 60 years. RESULTS: There were no differences between groups with regard to recipient age, sex, cause of death and renal function of the donor, hepatitis C and cytomegalovirus serologies, cold ischemia time, tubular necrosis, immediate diuresis, need for dialysis, human leukocyte antigen incompatibilities, hypersensitized patients, acute rejection, waiting time on dialysis, and days of admission. Survival in both groups at 1, 5, and 10 years was 97.6%, 87.2%, and 76.6% vs. 98.8%, 87.5%, and 69.5% for the patient (P=0.642), 92.9%, 81.3%, and 64.2% vs. 93.9%, 76.4%, and 69.5% for the graft (P=0.980), and 94.4%, 92.6%, and 77.4% vs. 94.3%, 86.7%, and 84.4% for the graft with death censured (P=0.747), respectively. Creatininaemias at 1, 5, and 10 years were 172, 175, and 210 vs. 139, 134, and 155 (P<0.05). CONCLUSIONS: We conclude that patient and graft survival on transplanting kidneys from elderly donors to young recipients is superimposable on that obtained with young donors. However, renal function is better in the group of young donors.