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PubMed1998

Natural history of cervical squamous intraepithelial lesions: a meta-analysis.

OBJECTIVE: To define the strengths and weaknesses of existing research on the natural history of cervical squamous intraepithelial lesions (SIL) and to estimate rates of progression and regression without treatment. DATA SOURCES: Studies of women whose cervical smears showed squamous atypia or worse and who were observed for a minimum of 6 months were identified by a search of MEDLINE from 1966 to 1996, Current Contents, the Federal Research in Progress database, and references of review articles and identified studies, and by experts in the field. METHODS OF STUDY SELECTION: Fifteen of 81 studies were eligible for data extraction. To be eligible, studies had to report a minimum of 6 months' follow-up without treatment; relate entry cytologic findings to outcomes; and report entry cytologic findings so that the study population could be stratified into categories of atypical cells of undetermined significance (ASCUS), low-grade SIL, or high-grade SIL. Studies published before 1970 were excluded. TABULATION, INTEGRATION, AND RESULTS: Eligible studies, representing 27,929 patients, were stratified according to entry cytologic findings. The following rates of progression to high-grade SIL at 24 months were found: ASCUS, 7.13% (95% confidence interval [CI] 0.8%, 13.5%); low-grade SIL, 20.81% (6.08%, 35.55%); and high-grade SIL, 23.37% (12.82%, 32.92%). The following rates of invasive cancer at 24 months were found: ASCUS, 0.25% (0%, 2.25%); low-grade SIL, 0.15% (0%, 0.71%); and high-grade SIL, 1.44% (0%, 3.95%). The following rates of regression to normal were found: ASCUS, 68.19% (57.51%, 78.86%); low-grade SIL, 47.39% (35.92%, 58.86%); and high-grade SIL, 35.03% (16.57%, 53.49%). Study heterogeneity was not explained by regression analysis of study level variables. CONCLUSION: Our findings for borderline and low-grade abnormal cervical cytologic results suggest a relatively low risk of invasive cervical cancer with observation up to 24 months and support the clinical policy of early colposcopy for high-grade lesions.

Carcinoma in Situ↗
PubMedDate not supplied

Antioxidant supplements for prevention of gastrointestinal cancers: a systematic review and meta-analysis.

BACKGROUND: Oxidative stress can cause cancer. Our aim was to establish whether antioxidant supplements reduce the incidence of gastrointestinal cancer and mortality. METHODS: With the Cochrane Collaboration methodology, we reviewed all randomised trials comparing antioxidant supplements with placebo for prevention of gastrointestinal cancers. We searched electronic databases and reference lists (February, 2003). Outcome measures were incidence of gastrointestinal cancers, overall mortality, and adverse effects. Outcomes were analysed with fixed-effect and random-effects model meta-analyses and were reported as relative risk with 95% CIs. FINDINGS: We identified 14 randomised trials (n=170,525). Trial quality was generally high. Heterogeneity of results was low to moderate. Neither the fixed-effect (relative risk 0.96, 95% CI 0.88-1.04) nor random-effects meta-analyses (0.90, 0.77-1.05) showed significant effects of supplementation with beta-carotene, vitamins A, C, E, and selenium (alone or in combination) versus placebo on oesophageal, gastric, colorectal, pancreatic, and liver cancer incidences. In seven high-quality trials (n=131727), the fixed-effect model showed that antioxidant significantly increased mortality (1.06, 1.02-1.10), unlike the random-effects meta-analysis (1.06, 0.98-1.15). Low-quality trials showed no significant effect of antioxidant supplementation on mortality. The difference between the mortality estimates in high-quality and low-quality trials was significant (Z=2.10, p=0.04 by test of interaction). beta-carotene and vitamin A (1.29, 1.14-1.45) and beta-carotene and vitamin E (1.10, 1.01-1.20) significantly increased mortality, whereas beta-carotene alone only tended to increase mortality (1.05, 0.99-1.11). In four trials (three with unclear or inadequate methodology), selenium showed significant beneficial effect on the incidence of gastrointestinal cancer. INTERPRETATION: We could not find evidence that antioxidant supplements can prevent gastrointestinal cancers; on the contrary, they seem to increase overall mortality. The potential preventive effect of selenium should be studied in adequate randomised trials.

Anticarcinogenic Agents↗
PubMed1999

Oral aspirin in postoperative pain: a quantitative systematic review.

OBJECTIVES: A systematic review of the analgesic efficacy and adverse effects of single-dose aspirin compared with placebo in postoperative pain. DESIGN: Published studies were identified from systematic searching of bibliographic databases and reference lists of retrieved reports. Summed pain intensity and pain relief data were extracted and converted into dichotomous information to yield the number of patients with at least 50% pain relief. This was used to calculate the relative benefit and number-needed-to-treat for one patient to achieve at least 50% pain relief. For adverse effects, relative risk and number-needed-to-harm were calculated. Sensitivity analyses were planned to test the impact of different pain models, pain measurements, sample sizes, quality of study design, and study duration on the results. RESULTS: Seventy-two randomized single-dose trials met our inclusion criteria, with 3253 patients given aspirin, and 3297 placebo. Significant benefit of aspirin over placebo was shown for aspirin 600/650 mg, 1000 mg and 1200 mg, with numbers-needed-to-treat for at least 50% pain relief of 4.4 (4.0-4.9), 4.0 (3.2-5.4) and 2.4 (1.9-3.2) respectively. Single-dose aspirin 600/650 mg produced significantly more drowsiness and gastric irritation than placebo, with numbers-needed-to-harm of 28 (19-52) and 38 (22-174) respectively. Type of pain model, pain measurement, sample size, quality of study design, and study duration had no significant impact on the results. CONCLUSIONS: There was a clear dose-response for pain relief with aspirin, even though these were single dose studies. Adverse effects, drowsiness and gastric irritation were also evident in the single dose studies. The pain relief achieved with aspirin was very similar milligram for milligram to that seen with paracetamol.

Administration, Oral↗
PubMed2001

Defining a dose-response relationship with radiotherapy for prostate cancer: is more really better?

PURPOSE: Data were reviewed addressing the association between radiation therapy (RT) dose and treatment outcome for localized prostate cancer to help clarify the existence of a potential dose-response relationship. METHODS AND MATERIALS: Articles were identified through the MEDLINE database, CancerLit database, and reference lists of relevant articles. Studies were categorized into four groups based upon the endpoint analyzed, including biochemical control (BC), local control (LC), pathologic control (PC), and cause-specific survival (CSS). The impact of increasing RT dose with each endpoint was recorded. RESULTS: Twenty-two trials involving a total of 11,297 patients were identified. Of the 11 trials addressing the association of RT dose with LC, 9 showed statistically significant improvements. Of the 12 trials that reported BC with RT dose, all showed statistically significant improvements. Two out of 4 studies analyzing PC with increasing dose showed a positive correlation. Finally, 3 out of 9 studies addressing RT dose with CSS showed statistically significant improvements. Despite inconclusive results, patients with poor risk features (e.g., prostate-specific antigen [PSA] > or = 10, Gleason score [GS] > or = 7, or tumor stage > or = T2b) were most likely to benefit from increasing dose with respect to each endpoint. However, the optimal RT dose and the magnitude of benefit of dose escalation could not be identified. CONCLUSIONS: Although RT dose appears to correlate with various measures of treatment outcome, objective, high-quality data addressing this critical issue are still lacking. At the present time, the absolute improvement in outcome due to dose escalation, the subset of patients benefitting most, and the optimal dose remain to be defined.

Clinical Trials as Topic↗
PubMed1999

Evaluating interventions that promote the use of rear seats for children.

OBJECTIVE: To evaluate interventions that promote the use of the rear seat among children riding in motor vehicles. SEARCH STRATEGIES: Using the Cochrane Collaboration search strategy, we searched in electronic databases and reference lists of past reviews and review articles. We also searched among studies from government and research agencies in the United States and abroad, and contacted experts in the field. SELECTION CRITERIA: Studies for selection had to be evaluations of interventions in defined populations, with a clear description of the program and the outcomes evaluated. Outcomes had to be measured in an objective manner, and there needed to be a comparison group. DATA COLLECTION AND ANALYSIS: Six studies met the selection criteria. Changes in the proportion of observed children traveling in the rear seats before and after the implementation of the intervention were the main outcome of interest. MAIN RESULTS: Two studies evaluating the effectiveness of educational campaigns promoting the use of the rear seat found increases in the proportion of children riding in the rear seats, but only in one study were the increases statistically significant (from 86% to 91%). The four remaining studies reported changes in seating location as a side effect of legislation requiring child restraint use among children traveling in the front seats. In two of these four studies, the percentage of children riding in the rear seats significantly increased from 49% to 62% and from 88% to 98%. In the remaining two studies there were small, but not statistically significant, changes in the proportion of children riding in the rear seats, with percentages remaining around 60% and 85%. CONCLUSIONS: Interventions aimed at promoting the use of rear seats by children traveling in motor vehicles have been rare. Only one educational program whose only objective was to promote rear seating location was found and this 1973 Danish study had a positive impact. The other educational campaign, a pilot program that also focused on improving child restraint use, had no significant impact in promoting seating of children in the rear. We did not find any evaluation of legislation prohibiting children to sit in the front seats. Legislation requiring proper child restraint use in the front seats (and thus, compelling unrestrained children to seat in the rear) has produced, for the most part, a nonsignificant increase in the proportions of children sitting in the rear.

Automobile Driving↗
PubMed1997

Cost-benefit analyses in the health-care literature: don't judge a study by its label.

OBJECTIVES: To assess whether health-care related economic evaluations labeled as "cost benefit analyses" (CBA) meet a contemporary definition of CBA methodology and to assess the prevalence of methods used for assigning monetary units to health outcomes. DATA SOURCES: Medline, Current Contents, and HSTAR databases and reference lists of review articles, 1991-1995. STUDY SELECTION: Economic analyses labeled as CBAs were included. Agreement on study selection was assessed. STUDY EVALUATION: CBA studies were classified according to standard definitions of economic analytical techniques. For those valuing health outcomes in monetary units (bona fide CBAs), the method of valuation was classified. RESULTS: 53% of 95 studies were reclassified as cost comparisons because health outcomes were not appraised. Among the 32% considered bona fide CBAs, the human capital approach was employed to value health states in monetary units in 70%. Contingent valuation methods were employed infrequently (13%). CONCLUSIONS: Studies labeled as CBAs in the health-care literature often offer only partial program evaluation. Decisions based only on resource costs are unlikely to improve efficiency in resource allocation. Among bona fide CBAs, the human capital approach was most commonly used to valuing health, despite its limitations. The results of health-care related CBAs should be interpreted with extreme caution.

Cost-Benefit Analysis↗
PubMed2000

Applying for grant funds: there's help around the corner.

Scientists should know where to get help when they write grant proposals. Books, videos, consultants and colleagues can all be useful. The World Wide Web is an excellent resource for finding competitors, collaborators and a wealth of other useful information such as funding agencies, available grant money, pertinent articles and form pages for grant applications. Software is available to help you make an outline of your proposal, prepare the required figures and tables and build a database of references from which to create a bibliography. This article will point you in the right direction for a plethora of information and resources.

Information Services↗
PubMed2003

Twenty thousand ORFan microbial protein families for the biologist?

The genomes of most newly sequenced organisms contain a significant fraction of ORFs (open reading frames) that match no other sequence in the databases. We refer to these singleton ORFs as sequence ORFans. Because little can be learned about ORFans by homology, the origin and functions of ORFans remain a mystery. However, in this era of full genome sequencing, it seems that ORFans have been underemphasized. In this minireview, we draw attention to the increasing number of ORFans and to the consequences of this growth to biological research in the postgenomic era.

Animals↗
PubMed2003

Comparing methodological quality and consistency of international guidelines for the management of patients with chronic heart failure.

BACKGROUND: Guidelines (GLs) for the management of heart failure (HF) are of great importance in order to define and disseminate therapeutic recommendations based on scientific evidence. The aim was to analyse and to compare the methodological quality of HF GLs as well as to evaluate the consistency of therapeutic recommendations. METHODS: Eleven international GLs for the management of chronic HF were identified by search of the internet, electronic databases and references of published literature. Their methodological quality was assessed by two different appraisal instruments: (1) according to the US National Guideline Clearinghouse (NGC) on a scale from 0 to 17 points, (2) according to the German Guideline Clearinghouse (Agency for Quality in Medicine, AQUMED) on a scale from 0 to 44 points. Clinical criteria for assessment of the consistency of the recommendations included diagnostic testing, pharmacological and non-pharmacological treatment. RESULTS: The quality scores of the GLs varied substantially with a range of 1.5-15.5 points (NGC) and 8-30 points (AQUMED). The greatest variation was found in the dimensions "development" and "evidence". Only 3 of the 11 GLs (approximately 30%) were rated as methodologically well prepared. The recommendations on diagnostic procedures and medical management were rather consistent among the different GLs. CONCLUSIONS: Published international GL recommendations on medical management of patients with chronic HF are broadly consistent. The methodological quality of the GLs, however, varies to a great extent. Improvement is needed in most methodological aspects, especially in the dimensions "evidence" and "applicability".

Chronic Disease↗
PubMed2005

Brain reserve and dementia: a systematic review.

BACKGROUND: Behavioural brain reserve is a property of the central nervous system related to sustained and complex mental activity which can lead to differential expression of brain injury. Behavioural brain reserve has been assessed using autobiographical data such as education levels, occupational complexity and mentally stimulating lifestyle pursuits. So far there have been several epidemiological reports but no systematic review to put conflicting results into context. Our aim was to quantitatively review evidence for the effect of brain reserve on incident dementia. METHOD: Cohort studies of the effects of education, occupation, premorbid IQ and mental activities on dementia risk were of interest. Abstracts were identified in MEDLINE (1966-September 2004), CURRENT CONTENTS (to September, 2004), PsychINFO (1984-September 2004), Cochrane Library Databases and reference lists from relevant articles. Twenty-two studies met inclusion criteria. Key information was extracted by both reviewers onto a standard template with a high level of agreement. Studies were combined through a quantitative random-effects meta-analysis. RESULTS: Higher brain reserve was associated with a lowered risk for incident dementia (summary odds ratio, 0.54; 95% confidence interval, 0.49-0.59). This effect was found over a median of 7.1 years follow-up and resulted from integrating data across more than 29000 individuals. Notably, increased complex mental activity in late life was associated with lower dementia rates independent of other predictors; a dose-response relationship was also evident between extent of complex mental activities in late life and dementia risk. CONCLUSIONS: This study demonstrates robust evidence that complex patterns of mental activity in the early, mid- and late-life stages is associated with a significant reduction in dementia incidence. Randomized control trials based on brain-reserve principles are now required.

Brain↗
PubMed2006

Brain reserve and cognitive decline: a non-parametric systematic review.

BACKGROUND: A previous companion paper to this report (Valenzuela and Sachdev, Psychological Medicine 2006, 36, 441-454) suggests a link between behavioural brain reserve and incident dementia; however, the issues of covariate control and ascertainment bias were not directly addressed. Our aim was to quantitatively review an independent set of longitudinal studies of cognitive change in order to clarify these factors. METHOD: Cohort studies of the effects of education, occupation, and mental activities on cognitive decline were of interest. Abstracts were identified in MEDLINE (1966-September 2004), CURRENT CONTENTS (to September 2004), PsychINFO (1984-September 2004), Cochrane Library Databases and reference lists from relevant articles. Eighteen studies met inclusion criteria. Key information was extracted by both reviewers onto a standard template with a high level of agreement. Cognitive decline studies were integrated using a non-parametric method after converting outcome data onto a common effect size metric. RESULTS: Higher behavioural brain reserve was related to decreased longitudinal cognitive decline after control for covariates in source studies (phi=1.70, p<0.001). This effect was robust to correction for both multiple predictors and multiple outcome measures and was the result of integrating data derived from more than 47000 individuals. CONCLUSIONS: This study affirms that the link between behavioural brain reserve and incident dementia is most likely due to fundamentally different cognitive trajectories rather than confound factors.

Brain↗
PubMed2000

Eye movement desensitization and reprocessing in the treatment of post-traumatic stress disorder: a review of an emerging therapy.

BACKGROUND: Eye Movement Desensitization and Reprocessing (EMDR) is a relatively new form of psychotherapy for post-traumatic stress disorder. We critically reviewed randomized controlled trials of EMDR. METHODS: A wide range of electronic databases and reference lists of articles obtained were searched and relevant experts were consulted. Studies were critically appraised according to established criteria. RESULTS: We found 16 published randomized controlled trials (RCTs) comparing EMDR with alternative psychotherapy treatments, variants of EMDR and with delayed treatment groups. Studies were generally small (mean number of patients = 35) and of variable methodological quality, with only five reporting blinding of outcome assessors to treatment allocation, and in some cases with high loss to follow-up. In most cases EMDR was shown to be effective at reducing symptoms up to 3 months after treatment. In one case benefit was maintained up to 9 months and in another (uncontrolled) follow-up treatment effect was present at 15 months. Two studies suggest that EMDR is as effective as exposure therapies, three claim greater effectiveness in comparison to relaxation training, and three claim superiority over delayed treatment groups. Of the studies examining specific treatment components, two found that treatment with eyes moving was more effective than eyes fixed, while three studies found the two procedures to be of equal effectiveness. CONCLUSION: The evidence in support of EMDR is of limited quality but results are encouraging for this inexpensive, simple therapy. Further research is warranted in larger samples with longer periods of follow-up.

Desensitization, Psychologic↗
PubMed1998

Physicians' patterns of using a computerized collection of guidelines for primary care.

Physician's Desk Reference and Database is a Finnish collection of computerized primary care guidelines. The program has been in clinical use since 1989. For this study, a function producing a log file of all searches was added to the program. Two hundred twenty-seven users returned log files that contained 15,267 searches. The users made 3.12 (range 1-10.4) searches per day. The average time needed to find and read an article was 4.9 minutes. Sufficient facts were found in 71% of the searches. Dermatology was the most popular field of interest, followed by infectious diseases and cardiology.

Adult↗
PubMed2005

Is physical fitness decreased in survivors of childhood leukemia? A systematic review.

The aim of this review is to determine whether physical fitness, assessed by peak oxygen uptake (VO(2peak)) measurement, is reduced in survivors of acute lymphoblastic leukemia (ALL) compared to healthy children. A systematic literature search (up to June 2004) was performed using Medline, Sportdiscus, Cinahl, Embase, Cochrane and PEDro database and reference tracking. The VO(2peak) (ml kg(-1) min(-1)) reached during a maximal exercise test until volitional exhaustion was used as the main outcome for this review. In all, 17 studies were identified in the literature. Data from three studies (102 ALL survivors, age ranging from 7 to 19 years) were pooled in a meta-analysis. Although there was a significant heterogeneity between the included studies (P=0.0006), the standardized mean difference (SMD) value of -0.61 (P=0.07) indicated that VO(2peak) tended to be reduced in survivors of childhood ALL compared to healthy control subjects, that is, decrease of -5.97 ml kg(-1) min(-1) (95% confidence interval (CI): (-12.35, 0.41); P=0.07) or -13% (95 % CI: (-27, 0.004)). Physical fitness tends to be reduced in survivors of ALL during childhood, which suggests the need for this population group to engage in regular physical activities with the purpose of increasing their functional capacity. Although more research is needed, this functional improvement might ameliorate the quality of life of ALL survivors as physical and outdoors activities are an essential part of daily routine during childhood.

Child↗
PubMed2003

Modelling the combined effects of pH, temperature and sodium chloride stresses on the thermal inactivation of Bacillus subtilis spores in a buffer system.

AIMS: The inactivation of Bacillus subtilis 168 spores subjected to the combined stress of pH, temperature and sodium chloride in a buffer system was modelled. METHODS AND RESULTS: Bacillus subtilis 168 spore suspension in 50 mmol l-1 potassium phosphate buffer was heated in an open system using a block heater. A second order polynomial equation was used to describe the relationship between pH, temperature, sodium chloride concentration and the logarithm of the decimal reduction time (D-value) of the spores. Response surface graphs were constructed to predict the inactivation within the experimental domain. The data obtained were also compared with those reported for B. subtilis in different media and foods included in a large reference-based database of thermal inactivation (ThermoKill Database, TKDB R9100), which was constructed in the laboratory. CONCLUSIONS: All the variables studied seemed to have a significant effect on the inactivation of B. subtilis 168 spores in potassium phosphate buffer. The coefficient of determination, r2, and an analysis of the residuals from the model indicated the adequacy of the model to predict the inactivation of B. subtilis spores within the range of the experimental variables studied. SIGNIFICANCE AND IMPACT OF THE STUDY: The findings of this study will enable a better understanding of the inactivation of B. subtilis spores under the influence of the studied environmental variables. The model can be used by food industries to assess and monitor the shelf life of food products in the event of a chance contamination by B. subtilis spores.

Bacillus subtilis↗
PubMed2001

Nipple-sparing mastectomy in breast cancer: a viable option?

BACKGROUND: In women with breast cancer for whom breast-conserving therapy (BCT) is not the best option, a nipple and areola complex-(NAC) sparing mastectomy with immediate reconstruction has been proposed as a good and safe alternative to conventional, more radical mastectomy. Surgeons hesitate to perform this operation for fear of recurrence of tumour in the NAC due to undetected nipple involvement (NI) of the tumour. In order to determine whether a NAC-sparing mastectomy is a viable option, the frequency and predictive factors of NI by the tumour were studied in the literature. METHODS: A literature survey was performed by searching the Medline database. Other references were derived from the material perused. RESULTS AND CONCLUSIONS: NI is found in up to 58% of mastectomy specimens and correlates with tumour size, tumour-areola or tumour-nipple distance, positive lymph nodes and clinical suspicion. Best candidates for NAC-sparing mastectomy are patients with a small tumour (T1) at a large distance (>4-5 cm) from the nipple. However, in these patients BCT has excellent results with low complications and recurrence rates. Considering the incidence of NI in larger tumours (T2 average 33%, T3 average >50%) a NAC-sparing mastectomy may carry an unacceptable high risk for local relapse and should therefore not be advocated.

Breast Neoplasms↗
PubMed2001

Safety aspects of pharmacological GH therapy in adults.

The consequences of "pharmacological" growth hormone administration have been studied in a number of conditions, including those characterized by high rates of catabolism. The majority of studies have reported favourable effects on metabolism but recent reports indicate that GH treatment results in increased mortality in critically ill humans. The objective of the study was to assess the safety of large doses of rhGH therapy in human adults. Original trials were identified by searching MEDLINE (1966-March 2000) and the Cochrane database (2000). References of all identified trials were also inspected for more studies. All relevant trials in which GH had been administered to non-GH-deficient (GHD) adult humans were selected from. Outcomes such as death, clinically significant change in function, change in length of hospital stay or need for treatment, and adverse effects were sought. Studies were selected, quality-assessed and passed suitable for inclusion by two independent reviewers. Those studies that were placebo-controlled with satisfactory randomization were considered for inclusion. Twenty-one reports were included in the review. A wide range of patient groups were studied by a variety of investigators, employing a range of doses and duration of GH treatment. The study protocols differed markedly. The majority of studies were small and were designed and/or powered to enable identification of specific effects on nutritional status, protein metabolism, level of function or quality of life. Only two studies were designed to assess safety issues and mortality. In these, GH treatment was associated with a marked increase in mortality in critically ill ICU patients, with a range of diagnoses. Multi-organ failure and the effects of sepsis/infection accounted for most of the excess mortality. In addition morbidity, in terms of length of ICU stay, was increased by GH administration. Other less marked effects were increased fluid retention and hyperglycaemia as a consequence of GH administration. Functional improvement following GH therapy was documented in some studies. There have been few studies assessing the safety aspects of "pharmacological" GH treatment in adult humans. Two well-designed reports indicate that GH administration results in increased morbidity and mortality in a wide variety of critically ill subjects across a spectrum of age ranges. The mechanism(s) of the GH-associated mortality remain poorly understood. Based on current trial evidence, pharmacological GH treatment cannot be recommended for widespread use in critically ill subjects. Well-conducted and reported randomized trials are still needed to inform practice as to whether GH administration will be safe in specific illness categories.

Adolescent↗
PubMedDate not supplied

[Technique evaluation for orthopedic use of Robodoc].

AIM: The aim of this study was to assess the clinical benefit and rate of complications of robot-assisted primary total hip replacement. METHODS: Electronic bibliographic databases, the reference lists of relevant articles and various health services research-related resources were analysed and selected studies were assessed using defined quality criteria. RESULTS: 57 publications and three HTA-reports were assessed. Only two prospective randomised controlled studies could be identified. There was no proof of clinical benefit but rather an increased incidence of complications. CONCLUSION: Patients must be informed on the risks, complications, benefits and especially alternatives to a robot-assisted operation. The importance of HTA reports to evaluate new or established procedures will even increase in Germany especially in the recent medico-legal context.

Arthroplasty, Replacement, Hip↗