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A systematic technical approach to the Ross operation.

The Ross operation is a technically demanding procedure. The pressure on the surgeon to produce consistently good results from the very first operation is great, since he is not afforded the luxury of a very soft "learning curve", as is the case with many technically difficult operations, due to the availability of acceptable and safe alternatives for most Ross candidates. We have felt this pressure from the outset and this has motivated a commitment to the development of a systematic surgical technique in an attempt to achieve consistently excellent results. Maintenance of normal autograft spatial geometry after translocation to the aortic position is necessary to ensure proper leaflet coaptation and to avoid autograft insufficiency, and this is the underlying principle upon which this technique is based. Most Ross operations are now performed as total aortic root replacements with a free-standing autograft, However, the autograft is soft and compliant, and will adapt to the dimensions of the more solid tissue into which it is inserted, the aortic annulus proximally and ascending aorta distally, and root replacement will not guarantee that normal autograft geometry will be maintained unless there is a correct size match between the autograft and the aortic annulus and sino-tubular junction, and the autograft is not distorted in other ways. A systematic technical approach to the Ross operation so that size mismatch is avoided and autograft geometry is maintained has been developed and is described in step-by-step detail. In the first third of this series of 85 patients, two patients had moderate (2+) and three patients had mild (1+) immediate postoperative autograft insufficiency. As our understanding of the important sizing and orientation issues has increased and the systematic technique has evolved, the incidence of early autograft insufficiency has essentially been eliminated. In the latter 2/3 of the series, all patients had less than mild autograft insufficiency, except one patient who had mild (1+) insufficiency. We believe that these results validate the principles on which this systematic technical approach is based and that the methods described will help both current and future Ross surgeons perform consistently successful operations.

Anastomosis, Surgical↗

Systematic clinical auditing in complementary medicine: rationale, concept, and a pilot study.

A scientific evaluation of complementary medical practices commonly used in healthcare is urgently required. Although randomized clinical trials are the primary tool for such an evaluation, for a number of conceptual and pragmatic reasons, they should not be the only tool. The authors propose systematic clinical auditing as a concept to (1) provide information on the "epidemiology" of complementary medical practices, (2) make the processes used in the daily practice of these complementary methods clearly intelligible, and (3) give a preliminary estimation of outcomes. Systematic clinical auditing uses mainly observational studies of large samples of patients. A pilot study was conducted to investigate the feasibility of using a systematic clinical audit in a hospital for traditional Chinese medicine in Germany. All 1597 patients admitted between February 1, 1992, and August 31, 1993, were included in the study. Patients' characteristics, diagnoses, and preventive and therapeutic interventions were recorded, and patients were asked to rate the intensity of their main complaints (on scale of 1 to 10) at admission; at discharge; and at 2, 6, and 12 months after admission. About two thirds of all patients had chronic pain complaints; the most common diagnosis was migraine (n = 244). Nearly all patients received acupuncture and Chinese herbal therapy; 61% received tuina massages, and 16% received qigong. The mean intensity of main complaints was 7.0 (2.0, SD) at admission, 4.6 (2.4) at discharge, and 5.5 (2.7) 12 months after admission. In the authors' opinion, systematic clinical auditing is a valuable tool for collecting basic information on structural characteristics, processes, and outcomes in complementary medicine and for determining representative and relevant questions for future randomized clinical trials.

Complementary Therapies↗

A guide to interpreting discordant systematic reviews.

Systematic reviews are becoming prominent tools to guide health care decisions. As the number of published systematic reviews increases, it is common to find more than 1 systematic review addressing the same or a very similar therapeutic question. Despite the promise for systematic reviews to resolve conflicting results of primary studies, conflicts among reviews are now emerging. Such conflicts produce difficulties for decision-makers (including clinicians, policy-makers, researchers and patients) who rely on these reviews to help them make choices among alternative interventions when experts and the results of trials disagree. The authors provide an adjunct decision tool--a decision algorithm--to help decision-makers select from among discordant reviews.

Algorithms↗

[Catheter infection in intensive care: influence of systematic replacement of central venous catheters on a guide wire every 4 days].

OBJECTIVES: Determine whether systematic replacement of central venous catheters on a guide wire every 4 days leads to a lower rate of catheter infection. METHODS: We conducted a prospective randomized study comparing systematic catheter replacement with the standard procedure where one-way catheters are left in situ as needed. RESULTS: The study included 150 patients and 170 catheters. Catheter replacement on a guide wire was performed 169 times. The rate of infection was not significantly different between the group of patients with replacement (3.7 for 1000 catheter days) and the group with systematic replacement (5.4 for 1000 catheter days). No mechanical complications occurred during the replacement procedures on guide wires. CONCLUSION: We do not recommend systematically replacing catheters on a guide wire for the prevention of catheter infection. This procedure may however be indicated in case of suspected catheter infection as no mechanical of infectious complications occurred.

Adult↗

[Evidence-based medicine. 3. Systematic reviews: a tool for clinical practice, permanent education and health policy decisions. Italian Group on Evidence-Based Medicine-GIMBE].

The reviews of research, summarizing a great amount of studies in a manageable format, are invaluable tools for physicians, inundated with enormous amount of biomedical information. However, narrative reviews are often misleading because, mixing together opinions of authors and results of research, the relation between clinical recommendation and evidence is partial and based on a biased citation of primary studies. In contrast to narrative reviews, the systematic reviews assemble, critically appraise, and synthesize the results of primary studies addressing a specific topic. Additionally their authors use strategies for minimizing bias and random error. The science of systematic reviews is now supported by the Cochrane Collaboration, an international network established for "preparing, maintaining and disseminating systematic reviews of the effects of health care". The authors provide tools for searching, critically appraising and using in practice the systematic reviews, which use can help physicians to improve the transfer of research in clinical practice, a task obliged by limitation of financial resources to physicians of any health service.

Bibliographies as Topic↗

Ibuprofen versus acetaminophen for acute mild-to-moderate pain management in pediatric populations: a systematic review and meta-analysis of their efficacy.

UNLABELLED: Ibuprofen and acetaminophen are the most widely used analgesics in pediatric practice for the management of acute mild-to-moderate pain. Despite their widespread use, the comparative analgesic efficacy of these two agents in children remains a subject of ongoing debate, with existing evidence largely derived from heterogeneous clinical settings and small individual trials. Therefore, this study aimed to systematically review and meta-analyze randomized controlled trials comparing the analgesic efficacy of ibuprofen versus acetaminophen in pediatric populations with acute mild-to-moderate pain. A systematic literature search was conducted up to May 2026 in PubMed, Scopus, and Web of Science. The review was conducted and reported in accordance with the PRISMA-Children and Adolescents (PRISMA-C) 2026 reporting guideline. Eligible studies were randomized controlled trials comparing ibuprofen with acetaminophen in children and adolescents (defined as individuals aged 0 to&#x2009;<&#x2009;18&#xa0;years) with acute pain, reporting at least one extractable efficacy outcome. Continuous outcomes were synthesized as standardized mean differences (Hedges' g) using random-effects models; dichotomous outcomes were pooled as risk ratios (RRs) with 95% confidence intervals. Risk of bias was assessed using the Cochrane RoB 2 tool and certainty of evidence was evaluated using the GRADE framework. Eight randomized controlled trials enrolling 1325 participants were included. Three pediatric trials contributed to the primary continuous pain outcome meta-analysis (n&#x2009;=&#x2009;196 analyzable participants), yielding a pooled SMD of&#x2009;-&#x2009;0.28 (95% CI&#x2009;-&#x2009;0.57 to 0.00; p&#x2009;=&#x2009;0.052; I2&#x2009;=&#x2009;0%), indicating a small effect favoring ibuprofen that did not reach conventional statistical significance. Given the small number of contributing studies (k&#x2009;=&#x2009;3), the I2 statistic should be interpreted with caution as it has limited power to detect heterogeneity in this context. For the dichotomous pain freedom outcome (2 trials, n&#x2009;=&#x2009;114), no significant difference was observed (pooled RR 1.03, 95% CI 0.53-1.99; p&#x2009;=&#x2009;0.93; I2&#x2009;=&#x2009;0%). A prespecified sensitivity analysis including an adult soft-tissue injury trial attenuated the pooled effect toward the null (SMD&#x2009;-&#x2009;0.15, 95% CI&#x2009;-&#x2009;0.38 to 0.09; p&#x2009;=&#x2009;0.23; I2&#x2009;=&#x2009;36.6%). Narrative synthesis of additional studies generally demonstrated comparable analgesic efficacy between the two agents across postoperative and outpatient pediatric settings. The overall certainty of evidence was rated as low for both primary outcomes, primarily due to imprecision and indirectness. CONCLUSION: Current evidence from randomized controlled trials does not demonstrate a superiority of ibuprofen over acetaminophen for acute mild-to-moderate pain management in children. Both agents appear to provide clinically meaningful analgesia across heterogeneous pediatric pain settings. The clinical choice between agents should be guided by individual patient factors, including contraindications to NSAIDs, the inflammatory nature of the pain etiology, and patient-specific characteristics. The low certainty of evidence underscores the need for adequately powered, methodologically rigorous trials to definitively establish the comparative efficacy of these two analgesics in the pediatric population. WHAT IS KNOWN: &#x2022; Ibuprofen and acetaminophen are the two most widely used non-opioid analgesics for acute mild-to-moderate pain in children, and both are recommended as first-line agents by major international guidelines. &#x2022; Prior meta-analyses in mixed pediatric-adult populations have suggested a modest analgesic advantage of ibuprofen over acetaminophen, but pediatric-specific evidence has remained limited and methodologically heterogeneous. WHAT IS NEW: &#x2022; This systematic review and meta-analysis, restricted to randomized controlled trials in pediatric populations, found that ibuprofen showed a small effect favoring pain reduction compared with acetaminophen (SMD&#x2009;-&#x2009;0.28, p&#x2009;=&#x2009;0.052), although this did not reach conventional statistical significance. &#x2022; The analgesic advantage of ibuprofen may be more pronounced in pain etiologies with a significant inflammatory component (e.g., fractures). At the same time, both agents appear broadly equivalent in most other acute pediatric pain settings, supporting individualized analgesic selection based on clinical context and patient-specific factors.

Humans↗

Teach-Back in Clinical Communication: A Systematic Review and Meta-analysis.

BACKGROUND: Teach-back has been identified as a high-quality clinical communication strategy. Our aim was to synthesize current literature on teach-back effectiveness. METHODS: We searched MEDLINE, Embase, and CINAHL Complete databases to identify relevant studies published between 2018 and 2026. We also included pre-2018 studies identified in prior systematic reviews. Studies were eligible for inclusion if they involved adult patients and/or care partners, delivered teach-back in a single encounter, had a comparator group, and reported proximal/intermediate patient outcomes (as defined in our conceptual model). Two independent investigators screened each citation at the title/abstract and full-text levels and assessed risk of bias. Study characteristics and results were extracted. When meta-analysis was performed, we used standardized mean differences (SMD) to estimate summary effects. We assessed certainty of evidence (COE) using Grading of Recommendations Assessment, Development and Evaluation (GRADE) domains. RESULTS: Our systematic review included 18 randomized controlled trials (RCTs) involving 1985 participants. Across 9 RCTs assessing knowledge acquisition, conceptual inconsistencies precluded meta-analysis. Overall, there was no clear pattern of the effect of teach-back on knowledge (very low COE). In a meta-analysis of 5 RCTs assessing self-efficacy (416 participants), we found that teach-back interventions led to a large increase in self-efficacy relative to usual care (SMD&#x2009;=&#x2009;2.40; 95%CI 0.37-4.44) (very low COE). In a meta-analysis of 7 RCTs assessing adherence to health behaviors (571 participants), teach-back interventions led to a large increase in adherence (SMD&#x2009;=&#x2009;1.04; 95%CI 0.45-1.64) (low COE). Meta-analyses for both self-efficacy and adherence had large confidence intervals that ranged from small to large effect sizes and had substantial heterogeneity. DISCUSSION: In this systematic review and meta-analysis, we did not identify a clear benefit of teach-back on knowledge acquisition but did find evidence that teach-back improves self-efficacy and self-reported, short-term adherence to health behaviors.

clinical communication↗

Comparing the efficacy and safety of unilateral versus bilateral spinal anesthesia: a meta-analysis and systematic review.

BACKGROUND: Unilateral spinal anesthesia has gained increasing attention in recent years. Emerging evidence suggests that it provides comparable analgesia to conventional bilateral spinal anesthesia while reducing adverse effects, and its efficacy and safety compared to bilateral spinal anesthesia remains controversial. OBJECTIVE: This systematic review and meta-analysis aims to evaluate and compare the efficacy and safety of unilateral versus bilateral spinal anesthesia. DESIGN: Systematic reviews and meta-analysis of randomized controlled trials (RCTs). DATA SOURCES: A systematic search was conducted across PubMed, EMBASE, and Cochrane Library from inception to December 10, 2024. ELIGIBILITY CRITERIA: Included studies were randomized controlled trials involving adult patients (&#x2265;18&#x2009;years) undergoing surgery under spinal anesthesia, comparing unilateral versus bilateral spinal anesthesia for efficacy and adverse effects. Studies that focused exclusively on either unilateral or bilateral spinal anesthesia were excluded. The comparator group used the same local anesthetic as the experimental group, with no restrictions on adjuncts (e.g. fentanyl, morphine). RESULTS: Nineteen randomized controlled trials including 1191 patients met the inclusion criteria. Compared with bilateral spinal anesthesia, unilateral spinal anesthesia has a longer onset of sensory blockade (MD = 2.58, 95% CI: 0.93 to 4.22, p&#x2009;=&#x2009;0.002), a shorter duration of sensory blockade (MD&#x2009;=&#x2009;-27.83, 95% CI: -39.25 to -16.42, p&#x2009;<&#x2009;0.00001). In addition, unilateral spinal anesthesia significantly reduced the incidence of hypotension (RR = 0.40, 95% CI: 0.31 to 0.52, p&#x2009;<&#x2009;0.0001), nausea and vomiting (RR = 0.20, 95% CI: 0.07 to 0.56, p&#x2009;=&#x2009;0.002), and post-dural puncture headache (RR = 0.44, 95% CI: 0.23 to 0.81, p&#x2009;=&#x2009;0.009). No statistically significant differences were observed in bradycardia and urinary retention. Collectively, these findings support unilateral spinal anesthesia as a strategy that may enhance perioperative safety while maintaining adequate anesthetic efficacy in appropriately selected patients. CONCLUSIONS: Unilateral spinal anesthesia may offer a favorable balance between anesthetic efficacy and safety compared with bilateral spinal anesthesia, although its clinical utility may depend on surgical duration and patient characteristics.

Humans↗

Views and Experiences of People With Dementia, Informal Caregivers and Professionals on Eating and Drinking Difficulties: A Qualitative Systematic Review.

AIM: This study aims to explore the views and experiences of people with dementia, informal caregivers and professionals regarding eating and drinking difficulties. DESIGN: A qualitative systematic review was conducted. METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-analysis guidelines were used to conduct this systematic review. The quality of the included studies was assessed using the Joanna Briggs Institute Critical Appraisal Checklist for Qualitative Research, and the data were thematically synthesised using Thomas and Harden's three-stage method. DATA SOURCES: Six electronic databases (PubMed, EMBASE, Cochrane Library, Web of Science, CINAHL and PsycINFO) were searched from their respective inception dates to August 2025 to identify relevant studies. RESULTS: Thematic analysis of the 16 included studies identified four key themes: (1) Physiological and psychological changes in people with dementia and caregivers; (2) factors influencing eating and drinking in people with dementia; (3) needs and recommendations for people with dementia, informal caregivers and professionals; (4) selection of eating methods for end-stage people with dementia. CONCLUSIONS: Eating and drinking difficulties affect the well-being of both patients and caregivers. A good dining environment improves mealtime pleasure but demands caregivers' time and energy. All parties emphasised the importance of effective communication. In end-stage dementia, professional assistance is crucial for enteral nutrition decisions. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: Collaboration among patients, caregivers and professionals is vital for creating tailored nutritional plans and improving mealtime environments, thereby enhancing nutritional intake. In advanced dementia, providers must provide balanced information on comfort feeding versus enteral nutrition to aid decision-making. IMPACT: What problems were addressed in this study? This study addressed the lack of a consolidated, tri-perspective understanding of eating and drinking difficulties in dementia care settings. What are the main findings? Four key themes were identified: physiological and psychological changes, influencing factors, stakeholder needs and end-of-life decision-making. Where and on whom will the research have an impact? This will impact care practices for people with dementia and inform the training and support of informal caregivers and healthcare professionals.

Humans↗

Systematic reviews and meta-analysis: a structured review of the methodological literature.

OBJECTIVE: To systematically review methods for systematic review/meta-analysis in order to identify the different methodological and statistical methods that have been proposed. A summary of the main findings is presented here, with emphasis given to health services research topics. METHODS: A thorough systematic search for methodological papers was carried out using a variety of methods, including the use of electronic databases. Approximately 1000 potentially relevant references were identified, a number of them from education, psychology and sociology. RESULTS: After briefly reviewing the procedural methods required to carry out a review, and the basic statistical methods used to combine study estimates, less established methods are discussed. These include methods for dealing with publication bias, meta-regression, meta-analysis of individual patient data, the synthesis of non-randomized evidence alone and in combination with randomized studies. Bayesian modelling and economic evaluation through meta-analysis. Recommendations for meta-analytical practice are given; these are either distilled from previous guidelines, or constructed where there appears to be a broad consensus across the literature. CONCLUSIONS: It is hoped that this review will provide a consistent and comprehensive, but concise, description of the methods available for synthesizing evidence, that it will promote better quality reviews of the results of health services research and identify specific areas which require methodological development.

Bayes Theorem↗

Patient Ethnicity and Staff Use of Restraints and Restrictive Practice in Inpatient Psychiatric Services: A Systematic Review.

Restrictive practices such as restraints, seclusion, and forced medication are only intended to be used when the threat is at a level whereby an individual is likely to inflict harm on themselves or another individual. Demographic variations, including ethnicity, may be associated with the use of these practices. However, there is no systematic review on patient ethnicity specifically. The review therefore aimed to establish whether a patient's ethnic identity was associated with staff use of restrictive practices in inpatient psychiatric services. The systematic review followed the Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines. Four databases were searched (PsycINFO, Medline, Embase, and CINAHL). Methodological quality was assessed using the Critical Appraisal Skills Program Checklists. Fifteen studies met the inclusion criteria. A variety of ethnicities were identified within the studies. These were driven by the location of the study. Seclusion (14 studies), forced medication (4), and physical restraint (4) were explored. There were mixed findings, with ethnicity shown to predict restrictive practices in studies having larger participant numbers, longer follow-up periods and less methodological bias. It remains unclear whether ethnicity is a genuinely independent predictor of restraint and coercive practices or interacts with other risk factors. Staff working in inpatient settings should be aware of how unconscious biases might affect clinical practice. Recruiting a diverse workforce from minority ethnic groups into inpatient psychiatric services would be a positive step. However, support for these staff members is important, and all staff should be equipped to respond to ethnic diversity. Future research should explore beyond patient-level factors.

Humans↗

Instruments to Assess Bidirectional Intimate Partner Violence: A Systematic Review.

Intimate partner violence (IPV) is a significant public health issue that affects individuals, families, and society in profound ways. Over the years, research has often shown that such IPV is predominantly one-sided, with men as perpetrators and women as victims. However, more recent studies have revealed that IPV is frequently bidirectional, with both partners potentially being victims, perpetrators, or both. Despite this growing awareness, little is known about the tools used to assess bidirectional violence (BV). This systematic review aims to synthesize the published scientific literature on the instruments used to assess bidirectional IPV among adult men and women. Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, a search was conducted across databases such as PubMed, B-on, Web of Science, and Scielo. Fifty studies published between 2012 and 2024 met the inclusion criteria. Most of the studies were conducted with community samples recruited through online questionnaires. The Conflict Tactics Scale emerged as the most used instrument for evaluating BV, demonstrating robust psychometric properties. BV prevalence rates ranged from 2% to 98.4% and remained generally consistent across different instruments, except in the case of male reports. However, the limited number of studies on interpartner agreements and the reliance on single-partner self-reports pose challenges to the accuracy of these estimates. While this systematic review provides a comprehensive overview of the instruments used to assess BV, it underscores the need for future research to develop more precise, context-sensitive tools, that incorporate reports from both partners to improve the accuracy of BV assessment.

Humans↗

Remotely Supervised, Home-Based Transcranial Direct Current Stimulation for Major Depressive Disorder: Systematic Review and Meta-Analysis.

BACKGROUND: Major depressive disorder affects over 280 million people worldwide, and access to effective treatment remains limited. Transcranial direct current stimulation (tDCS) is a noninvasive option, and portable devices now allow for home-based delivery under varying degrees of remote supervision. OBJECTIVE: This study aimed to systematically review and meta-analyze the efficacy, safety, feasibility, and acceptability of home-based and remotely supervised tDCS for depressive disorders. METHODS: Following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 and PRISMA-S (Preferred Reporting Items for Systematic Reviews and Meta-Analyses literature search extension) guidelines, we searched MEDLINE, Embase, Web of Science, the Cochrane databases, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform up to July 2025, with backward and forward citation searching. Two reviewers independently screened records, extracted data, and assessed risk of bias (version 2 of the Cochrane risk-of-bias tool for randomized trials, Newcastle-Ottawa Scale for observational studies, and Critical Appraisal Skills Programme for qualitative studies) and certainty of evidence (Grading of Recommendations Assessment, Development, and Evaluation; GRADE). RESULTS: This review included 12 distinct studies (16 reports), of which 6 (50%) were randomized sham-controlled trials forming the meta-analytic pool. Active home-based tDCS produced a small, statistically significant improvement over sham (pooled Hedges g=0.36, 95% CI 0.06-0.66; P=.03; I2=34.3%). The effect was not robust to removal of the single largest positive trial (omitting the one study from 2025: g=0.39, 95% CI -0.12 to 0.91), and trial-level results were mixed: the 2 largest trials (one unsupervised [n=210] and one self-administered [n=141]) were negative on their primary depression outcomes, whereas the largest real-time supervised trial (n=174) was positive (between-group 95% CI 0.51-4.01; P=.01). This estimate was concordant in direction with an independent peer-reviewed meta-analysis of overlapping trials, which reported a pooled Montgomery-&#xc5;sberg Depression Rating Scale reduction (weighted mean difference -2.74, 95% CI -4.19 to -1.29) and Hamilton Depression Rating Scale reduction (weighted mean difference -2.24, 95% CI -4.16 to -1.49), attenuating to nonsignificance (P>.05) in major depressive disorder without comorbid cognitive impairment. The pooled effect fell at or near the minimal clinically important difference. GRADE certainty was moderate. Adverse events were predominantly mild: one pilot study was terminated early for skin lesions, and one nonfatal suicide attempt occurred in an unsupervised trial. CONCLUSIONS: Home-based and remotely supervised tDCS produces a small, statistically significant but clinically modest antidepressant effect that is sensitive to the inclusion of the largest positive trial, with the 2 largest trials being negative. The available controlled evidence does not establish supervision intensity as a determinant of efficacy. Current data are insufficient to recommend routine clinical adoption; adequately powered trials with standardized supervision and longer follow-up are needed.

Humans↗

Sex differences of endogenous sex hormones and risk of type 2 diabetes: a systematic review and meta-analysis.

CONTEXT: Inconsistent data suggest that endogenous sex hormones may have a role in sex-dependent etiologies of type 2 diabetes, such that hyperandrogenism may increase risk in women while decreasing risk in men. OBJECTIVE: To systematically assess studies evaluating the association of plasma levels of testosterone, sex hormone-binding globulin (SHBG), and estradiol with risk of type 2 diabetes. DATA SOURCES: Systematic search of EMBASE and MEDLINE (1966-June 2005) for English-language articles using the keywords diabetes, testosterone, sex-hormone-binding-globulin, and estradiol; references of retrieved articles; and direct author contact. STUDY SELECTION: From 80 retrieved articles, 43 prospective and cross-sectional studies were identified, comprising 6974 women and 6427 men and presenting relative risks (RRs) or hormone levels for cases and controls. DATA EXTRACTION: Information on study design, participant characteristics, hormone levels, and risk estimates were independently extracted by 2 investigators using a standardized protocol. DATA SYNTHESIS: Results were pooled using random effects and meta-regressions. Cross-sectional studies indicated that testosterone level was significantly lower in men with type 2 diabetes (mean difference, -76.6 ng/dL; 95% confidence interval [CI], -99.4 to -53.6) and higher in women with type 2 diabetes compared with controls (mean difference, 6.1 ng/dL; 95% CI, 2.3 to 10.1) (P<.001 for sex difference). Similarly, prospective studies showed that men with higher testosterone levels (range, 449.6-605.2 ng/dL) had a 42% lower risk of type 2 diabetes (RR, 0.58; 95% CI, 0.39 to 0.87), while there was suggestion that testosterone increased risk in women (P = .06 for sex difference). Cross-sectional and prospective studies both found that SHBG was more protective in women than in men (P< or =.01 for sex difference for both), with prospective studies indicating that women with higher SHBG levels (>60 vs < or =60 nmol/L) had an 80% lower risk of type 2 diabetes (RR, 0.20; 95% CI, 0.12 to 0.30), while men with higher SHBG levels (>28.3 vs < or =28.3 nmol/L) had a 52% lower risk (RR, 0.48; 95% CI, 0.33 to 0.69). Estradiol levels were elevated among men and postmenopausal women with diabetes compared with controls (P = .007). CONCLUSIONS: This systematic review indicates that endogenous sex hormones may differentially modulate glycemic status and risk of type 2 diabetes in men and women. High testosterone levels are associated with higher risk of type 2 diabetes in women but with lower risk in men; the inverse association of SHBG with risk was stronger in women than in men.

Diabetes Mellitus, Type 2↗

Nasal and paranasal sinus carcinoma: are we making progress? A series of 220 patients and a systematic review.

BACKGROUND: The authors reviewed treatment results in patients with nasal and paranasal sinus carcinoma from a large retrospective cohort and conducted a systematic literature review. METHODS: Two hundred twenty patients who were treated between 1975 and 1994 with a minimum follow-up of 4 years were reviewed retrospectively. A systematic review of published articles on patients with malignancies of the nasal and paranasal sinuses during the preceding 40 years was performed. RESULTS: The 5-year survival rate was 40%, and the local control rate was 59%. The 5-year actuarial survival rate was 63%, and the local control rate was 57%. Factors that were associated statistically with a worse prognosis, with results expressed as 5-year actuarial specific survival rates, included the following: 1) histology, with rates of 79% for patients with glandular carcinoma, 78% for patients with adenocarcinoma, 60% for patients with squamous cell carcinoma, and 40% for patients with undifferentiated carcinoma; 2) T classification, with rates of 91%, 64%, 72%, and 49% for patients with T1, T2, T3, and T4 tumors, respectively; 3) localization, with rates of 77% for patients with tumors of the nasal cavity, 62% for patients with tumors of the maxillary sinus, and 48% for patients with tumors of the ethmoid sinus; 4) treatment, with rates of 79% for patients who underwent surgery alone, 66% for patients who were treated with a combination of surgery and radiation, and 57% for patients who were treated exclusively with radiotherapy. Local extension factors that were associated with a worse prognosis included extension to the pterygomaxillary fossa, extension to the frontal and sphenoid sinuses, the erosion of the cribriform plate, and invasion of the dura. In the presence of an intraorbital invasion, enucleation was associated with better survival. In multivariate analysis, tumor histology, extension to the pterygomaxillary fossa, and invasion of the dura remained significant. Systematic review data demonstrated a progressive improvement of results for patients with squamous cell and glandular carcinoma, maxillary and ethmoid sinus primary tumors, and most treatment modalities. CONCLUSIONS: Progress in outcome for patients with nasal and paranasal carcinoma has been made during the last 40 years. These data may be used to make baseline comparisons for evaluating newer treatment strategies.

Adolescent↗

Does the non-randomized controlled study have a place in the systematic review? A pilot study.

BACKGROUND: A major issue in any systematic review is deciding which trials or studies to include and which to exclude. The Cochrane Collaboration and similar respected organizations have traditionally viewed the randomized trial (RCT) as the only acceptable evidence on treatment outcome. However, many systematic reviews are indeterminate because they include insufficient RCTs whilst they reject large numbers of non-randomized controlled studies. This is particularly true in forensic mental health, a domain where RCT methodology can be problematic. Systematic reviews could become more informative if reviewers knew when, and under what circumstances, non-randomized designs are acceptable for inclusion alongside RCTs. METHOD: This pilot study explores whether good-quality, controlled, non-randomized studies can be reliable surrogates for RCTs. We examined two published reviews from the Cochrane Schizophrenia Group. We compared outcomes between (a) randomized trials (that had been included) and non-randomized studies (that had been excluded), and (b) between high- and low-quality studies using an established quality checklist. RESULTS: In the first review, effect scores were similar for randomized and non-randomized studies and relatively insensitive to study quality. In the second review, the treatment effect was considerably lower for the RCT group - here, however, studies of high-quality showed much smaller effect scores than those of low-quality on two separate outcomes. CONCLUSIONS: Non-randomized controlled studies of high quality can produce outcomes that approximate to those found in RCTs. Trial quality may have a greater impact on treatment effect size than randomization alone, suggesting that randomization should not be seen as a reliable proxy for overall quality. The problems and issues still to be resolved are discussed with recommendations for future research.

Humans↗

Distant healing--an "update" of a systematic review.

AIM: To update our published systematic review of clinical trials of distant healing. DESIGN: Systematic review. DATA SOURCES: Medline, Embase, Cochrane Library and personal files. STUDY SELECTION: Any type of clinical study of any type of distant healing published between 2000 and December 2002. DATA EXTRACTION: For each included study, essential data were extracted and summarised in narrative form. RESULTS: 8 non-randomised and 9 randomised clinical trials were located. The majority of the rigorous trials do not to support the hypothesis that distant healing has specific therapeutic effects. The results of two studies furthermore suggest that distant healing can be associated with adverse effects. CONCLUSION: Since the publication of our previous systematic review in 2000, several rigorous new studies have emerged. Collectively they shift the weight of the evidence against the notion that distant healing is more than a placebo.

Clinical Trials as Topic↗

[Diagnosis and immediate therapeutic management of limb injuries. A systematic review of the literature].

OBJECTIVE: Limb injuries are often underestimated in the diagnostic procedures initiated in the resuscitation room. Missed diagnosis is therefore a frequent consequence in this issue. A systematic analysis of evidence-based procedures was therefore investigated in this paper. METHODS: Clinical trials were systematically collected (Medline, Cochrane and hand searches) and classified into evidence levels (1 to 5 according to the Oxford system). RESULTS: Following admission of a multiple trauma patient vital functions have to be established in first priority. After stabilization a systematic clinical investigation and consecutive specific radiological procedures should rule out extremity injuries. These are the only evidence-based criteria leading to a complete detection of all limb injuries. All other aspects are only based on clinical experience or the opinion of expert committees. CONCLUSION: The quality of shock room management is mostly dependent on the experience of the " trauma team" (and especially of the trauma leader). Guidelines and specific trauma algorithms can provide a helpful instrument in this issue.

Arm Injuries↗