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PubMed2025

Genome-wide association study meta-analysis provides insights into the etiology of heart failure and its subtypes.

Heart failure (HF) is a major contributor to global morbidity and mortality. While distinct clinical subtypes, defined by etiology and left ventricular ejection fraction, are well recognized, their genetic determinants remain inadequately understood. In this study, we report a genome-wide association study of HF and its subtypes in a sample of 1.9 million individuals. A total of 153,174 individuals had HF, of whom 44,012 had a nonischemic etiology (ni-HF). A subset of patients with ni-HF were stratified based on left ventricular systolic function, where data were available, identifying 5,406 individuals with reduced ejection fraction and 3,841 with preserved ejection fraction. We identify 66 genetic loci associated with HF and its subtypes, 37 of which have not previously been reported. Using functionally informed gene prioritization methods, we predict effector genes for each identified locus, and map these to etiologic disease clusters through phenome-wide association analysis, network analysis and colocalization. Through heritability enrichment analysis, we highlight the role of extracardiac tissues in disease etiology. We then examine the differential associations of upstream risk factors with HF subtypes using Mendelian randomization. These findings extend our understanding of the mechanisms underlying HF etiology and may inform future approaches to prevention and treatment.

Humans↗

PubMed2000

Association between the alpha-adducin gene and hypertension in the HyperGEN Study.

This report from the HyperGEN Study, one of four networks participating in the NHLBI-sponsored Family Blood Pressure Program, presents the results of an association study based on 822 white and 572 black subjects (cases and controls) participating in the HyperGEN Network from five geographically diverse field centers. All cases met the Joint National Committee on Detection and Treatment of High Blood Pressure (JNC VI) criteria for hypertension (Stage I or higher). Each subject was clinically examined for risk factors for hypertension as well as genotyped for the point mutation Gly460Trp at the alpha-adducin locus on chromosome 4p. In the white group, the prevalence of genotypes with one or more Trp alleles was 26% in normotensives, versus 33% in hypertensives randomly selected from the population, and 39% among the multiply affected hypertensive sibships. Overall, in whites, the Trp allele significantly increased the odds of hypertension (P = .0056), with an odds ratio (OR) of 1.73 (95% confidence interval [CI] = 1.17, 2.54). The alpha-adducin gene remained a significant independent predictor of hypertension in a multivariate logistic model even after correcting for other risk factors for hypertension, including gender, age, body mass index (BMI), smoking, LDL cholesterol, triglycerides, urine sodium (Na), and urine potassium (K), (OR = 1.55, 95% CI = 1.03, 2.34). Through the use of regression trees, several gene-by-environment interactions were implicated, suggesting that alpha-adducin appears to be a particularly important risk factor (OR = 4.2) for older (age > 60.5 years), less lean (BMI < 25.8 kg/m2) subjects with moderately high triglycerides (between 145.5 and 218.5 mg/dL). In the black group, the relationship was less clear. Overall, it was protective against hypertension. The prevalence of genotypes with one or more Trp alleles was 24% among normotensive versus 11% in hypertensive black subjects randomly selected from the population, and 13% among multiply affected hypertensive sibships, resulting in an OR of 0.48 (P = .0231; 95% CI = 0.25, 0.90). However, the Trp genotype was no longer a significant independent predictor of hypertension risk in the multivariate logistic model (OR = 0.79; 95% CI = 0.37, 1.67), suggesting that it may be operating through one or more of these other factors. Thus, we conclude that the alpha-adducin gene is a significant, independent risk factor for hypertension in whites, but not in blacks, and may play a particularly important role for subjects with certain constellations of other risk factors.

Alleles↗

PubMed2000

Helmets for preventing head and facial injuries in bicyclists.

BACKGROUND: Each year, in the United states, approximately 900 persons die from injuries due to bicycle crashes and over 500,000 persons are treated in emergency departments. Head injury is by far the greatest risk posed to bicyclists, comprising one-third of emergency department visits, two-thirds of hospital admissions, and three-fourths of deaths. Facial injuries to cyclists occur at a rate nearly identical to that of head injuries. Although it makes inherent sense that helmets would be protective against head injury, establishing the real-world effectiveness of helmets is important. A number of case-control studies have been conducted demonstrating the effectiveness of bicycle helmets. Because of the magnitude of the problem and the potential effectiveness of bicycle helmets, the objective of this review is to determine whether bicycle helmets reduce head, brain and facial injury for bicyclists of all ages involved in a bicycle crash or fall. OBJECTIVES: To determine whether bicycle helmets reduce head, brain and facial injury for bicyclists of all ages involved in a bicycle crash or fall. SEARCH STRATEGY: We searched The Cochrane Controlled Trials Register, MEDLINE, EMBASE, Sport, ERIC, NTIS, Expanded Academic Index, CINAHL, PsycINFO, Occupational Safety and Health, and Dissertations Abstracts. We checked reference lists of past reviews and review articles, studies from government agencies in the United States, Europe and Australia, and contacted colleagues from the International Society for Child and Adolescent Injury Prevention, World Injury Network, CDC funded Injury Control and Research Centers, and staff in injury research agencies around the world. SELECTION CRITERIA: Controlled studies that evaluated the effect of helmet use in a population of bicyclists who had experienced a crash. We required that studies have complete outcome ascertainment, accurate exposure measurement, appropriate selection of the comparison group and elimination or control of factors such as selection bias, observation bias and confounding. DATA COLLECTION AND ANALYSIS: Five published studies met the selection criteria. Two abstractors using a standard abstraction form independently abstracted data. Odds ratios with 95% CI were calculated for the protective effect of helmet for head and facial injuries. Study results are presented individually. Head and brain injury results were also summarized using meta-analysis techniques. MAIN RESULTS: No randomized controlled trials were found. This review identified five well conducted case control studies which met our selection criteria. Helmets provide a 63%-88% reduction in the risk of head, brain and severe brain injury for all ages of bicyclists. Helmets provide equal levels of protection for crashes involving motor vehicles (69%) and crashes from all other causes (68%). Injuries to the upper and mid facial areas are reduced 65%. REVIEWER'S CONCLUSIONS: Helmets reduce bicycle-related head and facial injuries for bicyclists of all ages involved in all types of crashes including those involving motor vehicles.

Bicycling↗

PubMed2004

Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence.

BACKGROUND: Buprenorphine has recently been reported to be an alternative to methadone and LAAM for maintenance treatment of opioid dependent individuals, differing results are reported concerning its relative effectiveness indicating the need for an integrative review. OBJECTIVES: To evaluate the effects of buprenorphine maintenance against placebo and methadone maintenance in retaining patients in treatment and in suppressing illicit drug use. SEARCH STRATEGY: We searched the following databases up to 2001, inclusive: Cochrane Drugs and Alcohol Review Group Register, the Cochrane Controlled Trials Register, MEDLINE, EMBASE, Current Contents, Psychlit, CORK [www. state.vt.su/adap/cork], Alcohol and Drug Council of Australia (ADCA) [www.adca.org.au], Australian Drug Foundation (ADF -VIC) [www.adf.org.au], Centre for Education and Information on Drugs and Alcohol (CEIDA) [www.ceida.net.au], Australian Bibliographic Network (ABN), and Library of Congress databases, available NIDA monographs and the College on Problems of Drug Dependence Inc. proceedings, the reference lists of all identified studies and published reviews and authors of identified RCT's were asked about any other published or unpublished relevant RCT. SELECTION CRITERIA: Randomised clinical trials of buprenorphine maintenance compared with either placebo or methadone maintenance for opioid dependence. DATA COLLECTION AND ANALYSIS: Reviewers evaluated the papers separately and independently, rating methodological quality of concealment of allocation; data were extracted independently for meta-analysis and double-entered. MAIN RESULTS: Thirteen studies met the inclusion criteria, all were randomised clinical trials, all but one were double-blind. The method of concealment of allocation was not clearly described in 11 of the studies, otherwise methodological quality was good. Buprenorphine given in flexible doses appeared statistically significantly less effective than methadone in retaining patient in treatment (RR= 0.82; 95% CI: 0.69-0.96). Low dose buprenorphine is not superior to low dose methadone. High dose buprenorphine does not retain more patients than low dose methadone, but may suppress heroin use better. There was no advantage for high dose buprenorphine over high dose methadone in retention (RR=0.79; 95% CI:0.62-1.01), and high dose buprenorphine was inferior in suppression of heroin use. Buprenorphine was statistically significantly superior to placebo medication in retention of patients in treatment at low doses (RR=1.24; 95% CI: 1.06-1.45), high doses (RR=1.21; 95% CI: 1.02-1.44), and very high doses (RR=1.52; 95% CI: 1.23-1.88). However, only high and very high dose buprenorphine suppressed heroin use significantly above placebo. REVIEWERS' CONCLUSIONS: Buprenorphine is an effective intervention for use in the maintenance treatment of heroin dependence, but it is not more effective than methadone at adequate dosages.

Buprenorphine↗

PubMed2003

Calcitonin for metastatic bone pain.

BACKGROUND: Pain is the most frequent symptom experienced by cancer patients, its intensity dependent on the site of the tumour. Tumours that compromise bone or nervous structures due to the bone destruction process are the most painful. There are several treatments to deal with pain (and other symptoms) caused by bone metastasis. The hormone, calcitonin, has the potential to relieve pain, and also retain bone density, thus reducing the risk of fractures. OBJECTIVES: To assess the effectiveness of calcitonin in controlling metastatic bone pain and reducing bone complications (hypercalcemia, fractures and nervous compression) in patients with bone metastases. SEARCH STRATEGY: Electronic searches were performed in MEDLINE (1966-2001), EMBASE (1974-2001), the Cochrane Central Register of Controlled Trials (Issue 2, 2001), specialised registers of the Cochrane Cancer Network and of the Cochrane Pain, Palliative and Supportive Care Group. Registers of clinical trials in progress were also searched. SELECTION CRITERIA: Studies were included if they were randomised, double-blind clinical trials of patients with metastatic bone pain, treated with calcitonin, where the major outcome measure was pain, assessed at four weeks or longer. DATA COLLECTION AND ANALYSIS: Study selection and data extraction were performed by two independent reviewers. Only two studies (90 patients) were eligible for inclusion in the review and therefore meta-analysis of the data was not possible. Intention-to-treat analysis was performed by imputing all missing values as adverse outcomes. MAIN RESULTS: Of the two small studies included in the review, one study showed a non-significant effect of calcitonin in the number of patients with total pain reduction (RR 2.50; CI 95%, 0.55 to 11.41). The second study provided no evidence that calcitonin reduced analgesia consumption (RR 1.05; CI 95%, 0.90 to 1.21) in patients with painful bone metastases. There was no evidence that calcitonin was effective in controlling complications due to bone metastases; for improving quality of life; or patients' survival. Although not statistically significant, a greater number of adverse effects were observed in the groups given calcitonin in the two included studies (RR 3.35, CI 95%, 0.72 to 15.66). REVIEWER'S CONCLUSIONS: The limited evidence currently available for systematic review does not support the use of calcitonin to control pain from bone metastases. Until new studies provide additional information on this treatment, other therapeutic approaches should be considered.

Bone Neoplasms↗

PubMed2005

Surgical resection and whole brain radiation therapy versus whole brain radiation therapy alone for single brain metastases.

BACKGROUND: The treatment of brain metastasis is generally palliative, with whole brain radiation therapy (WBRT), since the majority have uncontrollable systemic cancer. In certain circumstances, such as single brain metastases, death may be more likely from brain involvement than systemic disease. In this group, surgical resection has been proposed to relieve symptoms and prolong survival. OBJECTIVES: To assess the clinical effectiveness of surgical resection plus WBRT versus WBRT alone in the treatment of single brain metastasis. SEARCH STRATEGY: The Cochrane Cancer Network Specialised trials register (July 2003), Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 1 2003), MEDLINE (1966 to July 2003), EMBASE (1980 to July 2003), CANCERLIT (1980 to July 2003), BIOSIS (1985 to July 2003) and SCIENCE CITATION INDEX (1981 to July 2003) were searched. References of identified studies were hand searched, as was the Journal of Neuro-Oncology over the previous 10 years and Neuro-Oncology over the past 2 years, including all conference abstracts. Specialists in neuro-oncology were also contacted. SELECTION CRITERIA: Randomized controlled trials (RCTs) comparing surgery and WBRT with WBRT alone, in patients with single brain metastasis. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. MAIN RESULTS: Three RCTs were identified, with 195 patients in total. No significant difference in survival was noted hazard ratio (HR) 0.74 (95% confidence interval (CI) 0.39 to 1.40, p = 0.35), although there was a high degree of heterogeneity between trials. One trial has shown surgery and WBRT to increase the duration of functionally independent survival (FIS) HR 0.42 (95% CI 0.22 to 0.80, p < 0.008). There is a trend for surgery and WBRT to reduce the number of deaths due to neurological cause odds ratio (OR) 0.57 (95% CI 0.29 to 1.10, p = 0.09). Adverse effects were not found to be statistically more common in any group. AUTHORS' CONCLUSIONS: Surgery and WBRT may improve FIS but not overall survival. There is a trend that it may reduce the proportion of deaths due to neurological cause. All these results were in a highly selected group of patients. Operating on metastases does not confer significantly more adverse effects.

Brain Neoplasms↗

PubMed2004

Oral versus intravenous antibiotic treatment for febrile neutropenia in cancer patients.

BACKGROUND: Fever occurring in a neutropenic patient remains a common life-threatening complication of cancer chemotherapy. The common practice is to admit the patient to hospital and treat empirically with intravenous broad-spectrum antibiotics. Oral therapy could be an alternative approach for selected patients. OBJECTIVES: To compare the efficacy of oral antibiotics versus intravenous (IV) antibiotic therapy in febrile neutropenic cancer patients. SEARCH STRATEGY: We searched the Cochrane Cancer Network Register of trials (November 2002), the Cochrane Library (issue 2, 2002), MEDLINE (1966 to 2002), EMBASE (January 1980 to 2002) and LILACS (1982 to 2002). We searched several databases for ongoing trials. We checked the conference proceedings of the Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) 1995 to 2002 and all references of included studies and major reviews were scanned. SELECTION CRITERIA: Randomised controlled trials comparing oral antibiotic/s to intravenous antibiotic/s for the treatment of neutropenic cancer patients with fever. The comparison between the two could be started initially (initial oral), or following an initial course of intravenous antibiotic treatment (sequential). DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial eligibility, methodological quality and extracted data. Data concerning mortality, treatment failures and adverse events were extracted from included studies assuming an "intention-to-treat" basis for the outcome measures whenever possible. Relative risks (RR) with 95% confidence intervals (CI) for dichotomous data were estimated. MAIN RESULTS: Fifteen trials (median mortality 0, range 0 to 8.8%) were included in the analyses. The mortality rate was similar comparing oral to intravenous antibiotic treatment (RR 0.91, 95% CI 0.51 to 1.62, 7 trials, 1223 patients). Treatment failure rates were also similar (RR 0.94, 95% CI 0.84 to 1.05, all trials). No significant heterogeneity was shown for all comparisons but adverse events. This effect was stable in a wide range of patients. Quinolones alone or combined with another antibiotics were used with comparable results. Adverse reactions, mostly gastrointestinal were more common with oral antibiotics. REVIEWERS' CONCLUSIONS: Based on the present data, oral treatment is an acceptable alternative to intravenous antibiotic treatment in febrile neutropenic cancer patients (excluding patients with acute leukaemia) who are haemodynamically stable, without organ failure, not having pneumonia, infection of a central line or a severe soft-tissue infection. The wide confidence interval for mortality allows the present use of oral treatment in groups of patients with an expected low risk for mortality, and further research should be aimed at clarifying the definition of low risk patients.

Administration, Oral↗

PubMed2026

Strategies to improve recruitment to randomised trials.

BACKGROUND: Recruiting participants to randomised controlled trials (RCTs) is challenging. Identifying effective recruitment strategies would benefit health research: poor recruitment leads to underpowered trials, reducing the reliability of findings and increasing the risk of wasted resources, ethical concerns, and trial failure. Evidence to inform recruitment strategies is increasingly generated through Studies Within A Trial (SWATs), which are methodological studies embedded within host RCTs. This is an update of a review last published in 2018. OBJECTIVES: Primary: to quantify the effects of strategies to improve recruitment of participants to RCTs. Secondary: to evaluate recruitment strategies' cost-effectiveness and impact on retention, and the equity, diversity, and inclusion (EDI) characteristics of recruited participants. SEARCH METHODS: We used MEDLINE, Embase, and six other databases to identify the studies included in the review. We also sought unpublished recruitment SWATs through social media and targeted email dissemination to trial methodology networks. The latest search date was 16 February 2023. SELECTION CRITERIA: We included randomised SWATs evaluating trial recruitment strategies embedded in healthcare and non-healthcare trials. We excluded quasi-randomised, hypothetical, questionnaire-only, retention-only, or clinician incentive studies. DATA COLLECTION AND ANALYSIS: Primary outcome: proportion of eligible participants or centres recruited. SECONDARY OUTCOMES: cost-effectiveness, retention rates, and EDI characteristics of included participants. We conducted random-effects meta-analysis for strategies evaluated in at least two studies; otherwise, we synthesised results narratively. We reported effects as risk differences (RDs) with 95% confidence intervals (CIs), and assessed between-trial heterogeneity. We used GRADE to assess the certainty of evidence for the primary outcome. We expressed cost-effectiveness as the incremental cost per additional participant recruited in pounds sterling (GBP). MAIN RESULTS: We identified 91 eligible studies (53 new to this update), providing 94 comparisons and involving at least 176,747 participants. Eighty-one studies involved strategies aimed at trial participants, while 10 evaluated strategies aimed at recruiters. All were healthcare studies. We found 65 recruitment strategies; 49 were evaluated in a single study. Only five strategies were supported by high-certainty evidence according to GRADE criteria, and we focus on these strategies in the summary below. Open-label trials versus blinded, placebo trials. Open-label trials recruited more participants than blinded trials (RD 10%, 95% CI 8% to 12%; 3 studies, 9004 participants), corresponding to approximately 10 additional participants per 100 approached. The studies involved mostly women in the UK and Estonia. No cost or retention data were reported. Telephone reminder versus no telephone reminder. Telephone reminders to people who did not respond to an initial postal invitation boosted recruitment by 6% (95% CI 3% to 9%; 2 studies, 1450 participants), in trials with low underlying recruitment (we are less certain for trials with over 10% recruitment). The studies involved people with a mean age of 58 years in Canada and Norway. No cost or retention data were reported. Recruitment primer letter versus no letter. Pre-recruitment letters and leaflets designed to encourage participation made little or no difference to recruitment (absolute improvement 1%, 95% CI -1% to 2%; 2 studies, 5376 participants), and were associated with increased costs compared to not sending a primer (incremental cost: GBP 2.08). The studies involved mostly older white people in the UK and Ireland. Multimedia information via a digital link/QR code plus paper participant information leaflet (PIL) versus paper PIL alone. This made little or no difference to recruitment (absolute improvement 0%, 95% CI -1% to 1%; 7 studies, 11,612 participants) and retention (absolute improvement 0%, 95% CI -2% to 3%; 5 studies, 7403 participants), and increased costs compared to not including multimedia information (incremental cost: GBP 0.78). The studies involved people in the UK. Optimised, user-tested PIL versus standard PIL. Optimising participant information leaflets (e.g. through user-testing the leaflet with the target population to shape its content, format, and appearance) made little or no difference to recruitment: absolute improvement was 0% (95% CI 0% to 1%; 6 studies, 27,805 participants). The studies involved people in the UK. Only one study reported EDI data; participants were mostly older women. No cost or retention data were reported. We had moderate-certainty evidence for 13 other strategies; confidence was often reduced because the results came from single studies. Seven strategies involved changes to how potential participants received information; four involved changes to trial conduct; one targeted the recruiter or recruitment site; and one tested non-monetary incentives. We had much less confidence in the other 47 comparisons because the studies had design flaws, were single studies, or had very uncertain results. Costs were reported in only 17 of 91 studies. Strategy impact on retention was reported in 15 studies. All but one study (99%) were from high-income countries. The most reported demographics were age (49 studies), sex (32 studies), gender (27 studies), and education level (16 studies). AUTHORS' CONCLUSIONS: The evidence on strategies to improve trial recruitment remains broad but lacks depth. Of 65 strategies evaluated, only five were supported by high-certainty evidence. Open-label trial designs and telephone reminders to non-responders increased recruitment, while optimised participant information leaflets, recruitment primer letters, and multimedia information provided alongside a paper participant information leaflet had little or no effect. Reporting of participant characteristics was poor, limiting assessment of equity, diversity, and inclusion across most studies. Evidence is heavily skewed toward high-income countries. Future research must prioritise evaluations in low-to-middle-income settings and consistently report cost, retention, and EDI outcomes. We strongly urge the methodology research community to strengthen the evidence base by prioritising replications of existing strategies over the development and testing of new ones. FUNDING: National Institute for Health and Care Research (Advanced Fellowship, Adwoa Parker, reference:NIHR302256). Health Research Board, Republic of Ireland, Evidence Synthesis Ireland (grant ESI-2021-001) REGISTRATION: This review updates an earlier Cochrane review, which was first published in 2002 and subsequently updated in 2007, 2010, and 2018. Previous versions of the review and their protocols are available at: https://doi.org/10.1002/14651858.MR000013.pub2 https://doi.org/10.1002/14651858.MR000013.pub3 https://doi.org/10.1002/14651858.MR000013.pub4 https://doi.org/10.1002/14651858.MR000013.pub5 https://doi.org/10.1002/14651858.MR000013.pub6.

Randomized Controlled Trials as Topic↗

PubMed1998

Changes in the legislation on the use of daytime running lights by motor vehicles and their effect on road safety in Hungary.

As of 1 March 1993, a partial (relating only to semi-motorways and main roads), and as of 1 June 1994, a total (relating to all roads) legal obligation to use DRL came into force outside built-up areas in Hungary. This paper examines the effectiveness of this regulation as an accident countermeasure. In view of the fact that it became possible to use one part of the road network as a comparison group during the period of partial obligation, a comparison group investigation has been carried out in addition to the analysis based on the odds ratio method familiar from earlier studies. The different methods provided different results, the probable causes of which are discussed in the present study. The result of the comparison group analysis are consistent not only with the hypothesis that DRL reduces certain types of collisions, but also with the results of a meta-analysis of 17 studies that have evaluated the effects on accidents of using DRL on cars. By using this method, it was possible to detect in the experimental group a 13.0% reduction in the number of frontal and 'crossing' vehicle collisions in daylight, in good visibility conditions, during the after period. The number of frontal and crossing collisions decreased without a simultaneous increase in rear-end collisions: the number of the latter has not significantly changed. Thus, the hypothesis that it is more reliable to estimate the collision-reducing effect of DRL on the basis of accidents only occurring in good visibility conditions, rather than on the basis of the total number of daylight accidents, has been justified by this study. The causes of this, as well as the difficulties and confounding factors arising when the odds ratio method is used, are dealt with in this work. By analyzing over a longer time series, it was possible to verify that the positive road safety effect is not a mere novelty effect, and is not simply due to the 'regression to the mean'.

Accident Prevention↗

PubMed2004

Breast cancer treatment in clinical practice compared to best evidence and practice guidelines.

There is sparse evidence on community practice patterns in treating women with breast cancer. This study compared care of women with breast cancer with evidence from meta-analyses and US National Comprehensive Cancer Network (NCCN) clinical guidelines. Records of 4395 women with breast cancer were abstracted from practices of 19 surgeon oncologists in six specialty practices in the Philadelphia region during 1995-1999. Patients were followed through December 2001. Low-frequency data were obtained on all patients. All other data were from a random sample of 464 women, minimum of 50 patients per practice. Actual care provided was compared to NCCN guidelines and results of meta-analyses. Fewer than half the women received treatments reflecting meta-analysis results or NCCN guidelines, by disease stage/TNM status. Adherence to either standard varied from 0% for LCIS to 87% for stages IIA or IIB node positive. There are multiple interactive reasons for low adherence to guidelines or meta-analyses results, including insufficient health system supports to clinicians, inadequate organisation and delivery systems and ineffective continuing medical education. The paucity of written information from patient records on physician/patient interactions limits the understanding of treatment decisions.

Adult↗

PubMed2000

Antibiotics and return visits for respiratory illness: a comparison of pooled versus hierarchical statistical methods.

BACKGROUND: Antibiotic prescribing for respiratory illness has been associated with small reductions in return visits in an analysis of a large practice-based network. In this study, we apply hierarchical analytical methods that account for the clustering of patients by practices to identify whether antibiotic prescribing by primary care physicians reduces subsequent visits for 6 acute respiratory illnesses-upper respiratory infection, pharyngitis, bronchitis, otitis media, sinusitis, and cough. METHODS: The study data came from 318 family physicians and internists in 45 practices in the Practice Partner Research Network from January 1995 through December 1996, with 255,564 active patients. Patients treated with antibiotics were compared with those who were not on the frequency of revisit within the next 14 days. A simple pooling model and 3 hierarchical statistical models (fixed-effects, random-effects, and Bayesian) were used to compare the odds-ratios for return visits. RESULTS: Statistically significant results were found only for bronchitis and sinusitis by the hierarchical models, but the simple pooling model produced statistically significant results for all study conditions. CONCLUSION: We conclude that antibiotics may reduce return visits for patients with bronchitis and sinusitis, but not for patients with other respiratory illness (upper respiratory infection, pharyngitis, otitis media, or cough). Studies of large clinical databases should use methods of analysis that account for the grouping of patients by practice to avoid false positive associations (type I errors.)

Academic Medical Centers↗

PubMed2001

Studies of Pediatric Liver Transplantation (SPLIT): year 2000 outcomes.

BACKGROUND: Initiated in 1995, the Studies of Pediatric Liver Transplantation (SPLIT) registry database is a cooperative research network of pediatric transplantation centers in the United States and Canada. The primary objectives are to characterize and follow trends in transplant indications, transplantation techniques, and outcomes (e.g., patient/graft survival, rejection, growth parameters, and immunosuppressive therapy.) METHODS: As of June 15, 2000, 29 centers registered 1144 patients, 640 of whom received their first liver-only transplant while registered in SPLIT. Patients are followed every 6 months for 2 years and yearly thereafter. Data are submitted to a central coordinating center. RESULTS: One/two-year patient survival and graft loss estimates are 0.85/0.82 and 0.77/0.72, respectively. Risk factors for death include: in ICU at transplant (relative risk (RR)=2.63, P<0.05) and height/weight deficits of two or more standard deviations (RR=1.67, P<0.05). Risk factors for graft loss include: in ICU at transplant (RR=1.77, P<0.05) and receiving a cadaveric split organ compared with a whole organ (RR=2.3, P<0.05). The percentage of patients diagnosed with hepatic a. and portal v. thrombosis were 9.7% and 7%, respectively; 15% had biliary complications within 30 days. At least one re-operation was required in 45%. One/two-year rejection probability estimates are 0.60/0.66. Tacrolimus, as primary therapy posttransplant, reduces first rejection risk (RR=0.70, P<0.05). Eighty-nine percent of school-aged children are in school full-time, 18 months posttransplant. CONCLUSIONS: This report provides one of the first descriptions of characteristics and clinical courses of a multicenter pediatric transplant population. Observations are subject to patient selection biases but are useful for generating hypothesis for future studies.

Adolescent↗

PubMed2003

Dialysis, kidney transplantation, or pancreas transplantation for patients with diabetes mellitus and renal failure: a decision analysis of treatment options.

Patients with type 1 diabetes mellitus and end-stage renal disease may remain on dialysis or undergo cadaveric kidney transplantation, living kidney transplantation, sequential pancreas after living kidney transplantation, or simultaneous pancreas-kidney transplantation. It is unclear which of these options is most effective. The objective of this study was to determine the optimal treatment strategy for type 1 diabetic patients with renal failure using a decision analytic Markov model. Input data were obtained from the published medical literature, the United Network for Organ Sharing registry, and patient interviews. The outcome measures were life expectancy (in life-years [LY]) and quality-adjusted life expectancy (in quality-adjusted life-years [QALY]). Living kidney transplantation was associated with 18.30 LY and 10.29 QALY; pancreas after kidney transplantation, 17.21 LY and 10.00 QALY; simultaneous pancreas-kidney transplantation, 15.74 LY and 9.09 QALY; cadaveric kidney transplantation, 11.44 LY and 6.53 QALY; dialysis, 7.82 LY and 4.52 QALY. The results were sensitive to the value of several key variables. Simultaneous pancreas-kidney transplantation had the greatest life expectancy and quality-adjusted life expectancy when living kidney transplantation was excluded from the analysis. These data indicate that living kidney transplantation is associated with the greatest life expectancy and quality-adjusted life expectancy for type 1 diabetic patients with renal failure. Treatment strategies involving pancreas transplantation should be considered for patients with frequent metabolic complications of diabetes and for those patients who favor kidney-pancreas transplantation over kidney transplantation alone. For patients without a living donor, simultaneous pancreas-kidney transplantation is associated with the greatest life expectancy.

Adult↗

PubMed2004

The effects of position on oxygen saturation in acute stroke: a systematic review.

OBJECTIVE: To investigate the effect of body position on oxygen saturation in the acute stages post stroke. DESIGN: Systematic review. METHODS: Databases: PREMEDLINE and MEDLINE, Psychinfo, EMBASE, CINAHL, PEDro, all EBM Reviews and Scottish Intercollegiate Guidelines Network (SIGN). KEYWORDS: combinations of cerebrovascular accident/stroke/hemiplegia/ cerbrovascular disorders and position or posture or sitting or standing/lying/supine/ side lying, with oxygen saturation/oxygen levels/blood gas analysis/hypoxia/sleep apnea syndrome/obstructive sleep disorder/Cheyne Stokes breathing. LIMITS: English language, human, adults and clinical trials. The quality of relevant papers was independently reviewed using criteria based on the SIGN guidelines for randomized controlled trials and methods described by Rywdik et al. RESULTS: There were four relevant studies involving 183 patients: three high quality and one poor quality. Heterogeneity in the testing positions, selection criteria, outcome measures and analysis methods prevented meta-analysis. There was strong evidence that body position did not affect oxygen saturation in acute stroke patients without relevant (respiratory) co-morbidities. There was limited evidence that sitting in a chair had a beneficial effect and lying positions had a deleterious effect on oxygen saturation in acute stroke patients with respiratory co-morbidities. CONCLUSIONS: Acute stroke patients without respiratory co-morbidities can adopt any body position, people with respiratory co-morbidities should be positioned as upright as possible.

Blood Gas Analysis↗

PubMed2026

Health risk assessment of inorganic arsenic: an umbrella review.

Inorganic arsenic (iAs) is a toxic environmental pollutant linked to serious health risks, prompting global regulatory efforts. This study identifies major health conditions associated with iAs exposure using text network analysis, and assesses health risk assessments through an umbrella review and dose-response analysis. It synthesizes previous systematic reviews to offer a broader perspective on iAs-related health effects. An optimized text network analysis-based search strategy was applied across multiple databases to identify relevant systematic reviews. An umbrella review framework was employed to synthesize and reinterpret findings across systematic reviews. The methodological quality of included systematic reviews was assessed using the A MeaSurement Tool to Assess systematic Reviews 2 tool. Extracted data on study characteristics, exposure levels, and risk estimates were analyzed to evaluate the dose-response relationship between iAs exposure and health outcomes. From 922 systematic reviews, 36 were included and categorized into 10 health condition groups. For example, seven SRs found a significant dose-response relationship between iAs and bladder cancer, with one systematic review reporting relative risks of 2.70, 4.20, and 5.80 at 10, 50, and 150 µg/L, respectively. Individual study analysis further showed that each 10 µg/L increase in iAs raised bladder cancer risk by 3.11 % (p=0.003). iAs exposure is associated with hypertension, diabetes, cardiovascular disease, and adverse fetal outcomes. Dose-dependent increases in bladder cancer, lung cancer, and hypertension risks were observed. These findings support more precise health risk assessments and regulatory strategies.

Humans↗

PubMed1992

The impact of stressful life events and social support on drinking among older adults: a general population survey.

This article is an analysis of stressful life events, the buffering hypothesis, and alcohol use in a national sample of 1,418 respondents 60 years of age and over. The results indicate that older adults who experience stressful losses are significantly more likely to drink excessively than those who have not experienced such losses or who have experienced them to a lesser extent. Increased drinking among older adults may therefore be a reaction to life circumstances in which alcohol represents an attempt to cope with traumatic loss, personal as well as within the kinship network. Supportive resources of spouse, family, friends, and church appear to have a stress-buffering effects that reduces the excessive-drinking response to life crisis. Data suggest, however, that older persons are vulnerable to the magnitude of losses experienced as they grow older and lose more of their family, friends, and peers. These stressors appear to seriously impact their drinking behavior and are not effectively buffered. Respondents report that drinking may increase during periods of prolonged exposure to emotionally depleting life change and loss, when supportive needs may exceed the capacities of personal and social support resources.

Adaptation, Psychological↗

PubMed1994

Multifactorial analysis of renal transplants reported to the United Network for Organ Sharing Registry: a 1994 update.

1. From a multivariate log-linear analysis of 57,303 renal transplants between 1988 and 1994, the top 10 factors influencing one-year and 3-year cadaveric graft survival rates were ranked as follows: [table: see text] 2. Center effects accounted for 30% and 28% of all assignable variations in one-year and 3-year outcomes, respectively. Although center variation dominated 32 other variables, most factors were relatively independent of transplant center. 3. Novel to our own multifactorial analyses of the UNOS Kidney Transplant Registry were 6 pretransplant factors (recipient pretransplant dialysis, pregnancy, PRA technique, donor disposition and preservation, and ABO compatibility). Survival rates over the various combinations of these new factors were not significantly different. 4. For the first time in our multivariate analyses, 4 posttransplantation factors (delayed graft function, rejection episodes prior to discharge, induction and maintenance drug therapies) were included in the log-linear model. It is noteworthy that graft survival in both transplant periods was seriously imperiled following delayed graft function or rejection prior to discharge, yet the accounting for these pseudo-outcome variables did not alter the influence of the remaining 31 transplant factors. Finally, maintenance drug therapies strongly influenced short-term outcomes but did not influence long-term results, except for a noteworthy trend toward increased survival rates for FK506 therapy.

Adolescent↗

PubMed1994

Managed care plan performance since 1980. A literature analysis.

OBJECTIVE: To compare the health care utilization, expenditure, quality of care, and satisfaction since 1980 of enrollees in managed care and indemnity plans. DATA SOURCES AND STUDY SELECTION: Studies selected met the following criteria: data from 1980 forward, private insurance or Medicare enrollees, a comparison group, a reasonable attempt at statistical adjustment for noncomparable managed care and indemnity plan enrollees, and peer-reviewed findings (with two exceptions). Few studies on preferred provider organization plan performance met the selection criteria. DATA SYNTHESIS: Compared with indemnity plans, health maintenance organization plans had somewhat lower hospital admission rates, 1% to 20% shorter hospital length of stay, the same or more physician office visits per enrollee, less use of expensive procedures and tests, greater use of preventive services, mixed results on outcomes, and somewhat lower enrollee satisfaction with services but higher satisfaction with costs. The evidence does not support the hypothesis that prepaid group practice or staff model health maintenance organizations are more effective than individual practice association or network model health maintenance organizations. CONCLUSIONS: Although this literature analysis found several clear patterns of results, several factors, including unmeasured selection bias, diverse and rapidly changing health plans and local market conditions, and relatively few research results, suggest that generalizations must be made with caution.

Health Care Costs↗