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PubMed2006

Ethambutol dosage for the treatment of children: literature review and recommendations.

The currently recommended daily dose of ethambutol (EMB) for the treatment of tuberculosis (TB) in children varies from a maximum daily dose of 15 mg/kg body weight daily (without a range) to 15-20 mg/kg and 20 mg/ kg (range 15-25 mg/kg). Published evidence relating to the dosage, toxicity and pharmacokinetics of EMB in children and adults is reviewed and a dose of EMB for use in childhood is recommended. Using key words 'ethambutol', 'childhood', 'TB', 'pharmacokinetics', 'bioavailability' and 'toxicity', Medline searches were conducted; cross-references were sought from original papers, books and conference proceedings dating from 1961. When English summaries were available, data were extracted from papers in languages other than English. EMB has a dose-related efficacy best seen when given to adults alone or with a single other drug. Together with isoniazid (INH), a dose of 15 mg/kg EMB gave better results than 6 mg/kg, and 25 mg/kg better than 15 mg/kg. The occurrence of ocular toxicity was also dose-related; >40% of adults developed toxicity at doses of >50 mg/ kg, and 0-3% at a dose of 15 mg/kg/daily. Peak serum EMB concentrations increase in relation to dose, but are significantly lower in children receiving the same dosage. In only 2 of 3811 children (0.05%) receiving EMB doses of 15-30 mg/kg was EMB stopped due to possible ocular toxicity; children of all ages can be given EMB in daily doses of 20 mg/kg (range 15-25 mg/kg) and three times weekly intermittent doses of 30 mg/kg body weight without undue concern.

Adult↗
PubMed2004

Treatments for priapism in boys and men with sickle cell disease.

BACKGROUND: Sickle cell disease comprises a group of genetic haemoglobin disorders. The predominant symptom associated with sickle cell disease is pain resulting from the occlusion of small blood vessels by abnormally 'sickle-shaped' red blood cells. There are other complications, including chronic organ damage and prolonged painful erection of the penis, known as priapism. Severity of sickle cell disease is variable, and treatment is usually symptomatic. Priapism affects up to half of all men with sickle cell disease, however there is no consistency in treatment. We therefore need to know the best way of treating this complication in order to offer an effective interventional approach to all affected individuals. OBJECTIVES: To assess the benefits and risks of different treatments for stuttering (repeated short episodes) and fulminant (lasting for six hours or more) priapism in sickle cell disease. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group trials register, which comprises references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. We also searched the internet for further references. Date of the most recent search of the Group's trials register: August 2004. SELECTION CRITERIA: All randomised or quasi-randomised controlled trials comparing non-surgical or surgical treatment with placebo or no treatment, or with another intervention for stuttering or fulminant priapism. DATA COLLECTION AND ANALYSIS: The reviewers independently extracted data and assessed study quality. MAIN RESULTS: Only one study of 11 participants was identified and met the criteria for inclusion in this review. This study compared stilboestrol to placebo. The only outcome specified in this review, which was assessed in the study, was reduction in frequency of stuttering priapism and there was no difference between the groups, relative risk 0.18 (95%CI 0.01 to 2.54). REVIEWERS' CONCLUSIONS: There is no evidence for the benefits or risks of the different treatments for both stuttering and fulminant priapism in sickle cell disease. This systematic review has clearly identified the need for well-designed, adequately-powered, multicentre randomised controlled trials assessing the effectiveness of specific interventions for priapism in sickle cell disease.

Anemia, Sickle Cell↗
PubMed2002

[Pedro Laín Entralgo, physician and humanist].

This speech of the president of the Chilean Academy of Medicine, Dr Alejandro Goic, is a tribute to the memory of the Spanish physician, scholar, historian, writer and intellectual Dr. Pedro Laín Entralgo, who died in Madrid on June 4, 2001, at the age of 93. On that occasion, the Spanish newspaper "El Pais" defined him as the last humanist. The Spanish civil war started when Laín was 28 years old and he aligned with Franco's supporters. In 1940, when he founded the magazine "El Escorial", he was separated from the official party. He and other intellectuals declared themselves in an "interior exile". His autobiographical book, "Lightening the burden on the conscience" refers to his painful personal history. He obtained the History of Medicine chair, at the Complutense University, at the age of 34 and remained at that post until his retirement in 1978. His intellectual production is magnificent and calls to a mutual understanding, hope, friendship and love. Outstanding, among others, are his books "The wait and hope", "Theory and reality of the other", "Spain as a problem", "Medicine and history", "The clinical history", "Patient physician relationship", "Medical anthropology". He directed the collective work composed of seven volumes, called "Universal History of Medicine". He was a member of the Royal Academies for Language, History and Medicine. In Chile, he was named honorary member of the Faculty of Medicine of the University of Chile and of the Academies of Language, History and Medicine. He dictated a course of Medical Anthropology that had a profound impact on the thought of Chilean physicians. In 1949 he wrote that Chile was the most solid state of Latin America and that "Chile needs to leave his traditional calm, through a historical gesture, and create the river beds required by his magnificent spiritual and geographical gifts. There is a lack of a beautiful craziness". It was an invocation for an understanding with our neighboring countries "for ever and ever".

Anthropology↗
PubMed2000

[Terminologia anatomica: a new reference work for anatomy].

The Nomina anatomica (6th edition in 1989) was the standard anatomical nomenclature until recently. It has been succeeded by the Terminologia anatomica (TA) by resolution of the International Federation of Associations of Anatomists in 1999. By now the TA has been published as a book and on cd-rom. The objective of the TA is to further uniformize the anatomical terminology, also internationally, and especially to democratize it, i.e. to ensure that it accommodates the needs of clinicians and medical scientists. The number of anatomical terms listed has grown to more than 7500. The increase is caused mainly by the insertion of clinical anatomical and neuro-anatomical names. A number of incorrect or misleading terms have been replaced. Each Latin term has a unique code number and is supplied with an English equivalent (International anatomical terminology; IAT) the spelling of which in either UK English or American English is considered equally correct. Based on the TA every language can formulate its own anatomical nomenclature. The nomenclature is presented per system or organ tract. An alphabetic index follows TA as well as the English IAT list. The use of eponyms is discouraged, but a list of well-known ones is appended to facilitate accessibility of older literature. Relevant suggestions about amendments are eagerly awaited and a broad basis of endorsement among the medical scientific world is hoped for. This journal will adopt the TA/IAT from now on as the work of reference regarding anatomical terms.

Anatomy↗
PubMed2001

Heparins and mechanical methods for thromboprophylaxis in colorectal surgery.

BACKGROUND: Colorectal surgery implies higher risk of postoperative thromboembolic complications as deep venous thrombosis (DVT) and pulmonary embolism (PE) than general surgery. The best prophylaxis in general surgery is heparin and graded compression stockings. No systematic review on combination prophylaxis or on thrombosis prophylaxis in colorectal surgery has been published. OBJECTIVES: To compare the incidence of postoperative thromboembolism after colorectal surgery using prophylactic methods focussing on heparins and mechanical methods alone and in combinations. SEARCH STRATEGY: Electronic searches was performed in MEDLINE, EMBASE back to 1970. Abstract books from major congresses were handsearched as were reference lists from previously performed reviews. SELECTION CRITERIA: RCT or CCT comparing prophylactic interventions and/or placebo. Outcomes were ascending venography, 125 I-fibrinogen uptake test, ultrasound methods, pulmonary scintigraphy. Studies, using thermographic methods, other isotopic methods, plethysmographic methods, and purely clinical methods as the only diagnostic measure were excluded. 558 studies were identified - 477 were excluded. Only 3 of the identified studies focused exclusively on colorectal surgery. Studies of general surgery contain considerable numbers of colorectal patients. The authors of 66 studies in general and/or abdominal surgery were contacted for retrieving the results from the colorectal patients. Answers were received from very few. 19 studies entered this review. DATA COLLECTION AND ANALYSIS: All studies and all data extraction were performed independently by at least two of the authors. Outcome was deep venous thrombosis and/or pulmonary embolism. Analysis of bleeding complications were unfeasible. 12 meaningful outcomes were analysed by means of the fixed effects model with Peto Odds Ratios. MAIN RESULTS: Heparins versus no treatment: Any kind of heparincompared to no treatment or placebo (comparison 07.03, 11 studies). Heparin is better in preventing DVT and/or PE with a Peto Odds ratio at 0.32 (95% Confidence Interval 0.20-0.53) Unfractionated heparin versus low molecular weight heparin (comparison 08.03, 4 studies). The two treatments were found equally effective in preventing DVT and/or PE with a Peto Odds ratio 1.01 (95% Confidence Interval 0.67-1.52). Mechanical methods (comparison 10.3, 2 studies). The combination of graded compression stockings and LDH is better than LDH alone in preventing DVT and/or PE with a Peto Odds ratio at 4.17 (95% Confidence Interval 1.37-12.70). REVIEWER'S CONCLUSIONS: The optimal prophylaxis in colorectal surgery is the combination of graduated compression stockings and low-dose unfractionated heparin. The unfractionated heparin can be replaced with low molecular weight heparin.

Anticoagulants↗
PubMed2001

Lithium for maintenance treatment of mood disorders.

BACKGROUND: Mood disorders are common, disabling and tend to be recurrent. They carry a high risk of suicide. Maintenance treatment, aimed at the prevention of relapse, is therefore of vital importance. Lithium has been used for some years as the mainstay of maintenance treatment in bipolar affective disorder, and to a lesser extent in unipolar disorder. However, the efficacy and effectiveness of prophylactic lithium therapy has been disputed. Low suicide rates in lithium-treated patients have led to claims that lithium has a specific anti-suicidal effect. If so, this is of considerable importance as treatments for mental disorders in general have not been shown convincingly to be effective in suicide prevention. OBJECTIVES: 1. To investigate the efficacy of lithium treatment in the prevention of relapse in recurrent mood disorders. 2. To examine the effect of lithium treatment on consumers' general health and social functioning, its acceptability to consumers, and the side-effects of treatment. 3. To investigate the hypothesis that lithium has a specific effect in reducing the incidence of suicide and deliberate self-harm in persons with mood disorders. SEARCH STRATEGY: The Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register (CCDANCTR) and The Cochrane Controlled Clinical Trials Register (CCTR) were searched. Reference lists of relevant papers and major text books of mood disorder were examined. Authors, other experts in the field and pharmaceutical companies were contacted for knowledge of suitable trials, published or unpublished. Specialist journals concerning lithium were hand searched. SELECTION CRITERIA: Randomised controlled trials comparing lithium with placebo, where the stated intent of treatment was maintenance or prophylaxis. Participants were males and females of all ages with diagnoses of mood disorder. Discontinuation studies (in which all participants had been stable on lithium for some time before being randomised to either continued lithium treatment or placebo substitution) were excluded. DATA COLLECTION AND ANALYSIS: Data were extracted from the original reports independently by two reviewers. The main outcomes studied were related to the objectives stated above. Data were analysed for all diagnoses of mood disorder and for bipolar and unipolar disorder separately. Data were analysed using Review Manager version 4.0. MAIN RESULTS: Nine studies were included in the review, reporting on 825 participants randomly allocated to lithium or placebo. Lithium was found to be more effective than placebo in preventing relapse in mood disorder overall, and in bipolar disorder. The most consistent effect was found in bipolar disorder (random effects OR 0.29; 95% CI 0.09 to 0.93 ). In unipolar disorder, the direction of effect was in favour of lithium, but the result (when heterogeneity between studies was allowed for) did not reach statistical significance. Considerable heterogeneity was found between studies in all groups of patients. The direction of effect was the same in all studies; no study found a negative effect for lithium. Heterogeneity may have been due to differences in selection of participants, and to differing exposures to lithium in the pre-study phase resulting in variable influence of a discontinuation effect. There was little reported data on overall health and social functioning of participants under the different treatment conditions, or on the participants' own views of their treatment. Descriptive analysis showed that assessments of general health and social functioning generally favoured lithium. Small absolute numbers of deaths and suicides, and the absence of data on non-fatal suicidal behaviours, made it impossible to draw meaningful conclusions about the place of lithium therapy in suicide prevention. REVIEWER'S CONCLUSIONS: This systematic review indicates that lithium is an efficacious maintenance treatment for bipolar disorder. In unipolar disorder the evidence of efficacy is less robust. This review does not cover the relative efficacy of lithium compared with other maintenance treatments, which is at present unclear. There is no definitive evidence from this review as to whether or not lithium has an anti-suicidal effect. Systematic reviews and large scale randomised studies comparing lithium with other maintenance treatments (e.g. anti-convulsants, antidepressants) are necessary. Outcomes relating to death and suicidal behaviour should be included in all future maintenance studies of mood disorder.

Antimanic Agents↗
PubMed1999

Old Testament biblical references to tuberculosis.

Two probable references to tuberculosis are found in Old Testament books of the Bible dating to a time when the Israelites lived in Egypt, which is known from archeological evidence to be an area where tuberculosis was then prevalent. Other putative biblical references to tuberculosis are less credible.

Bible↗
PubMed2006

Mapping the literature of home health nursing.

OBJECTIVES: The purpose of this study was to identify core journals in home health nursing and to determine how well these journals were covered by indexing and abstracting services. The study was part of the project for mapping the nursing literature of the Medical Library Association's Nursing and Allied Health Resource Section. METHODS: A citation analysis of two core journals was done to determine distribution of references by format types and age of citations and dispersion of the literature, according to Bradford's Law of Scattering. The analysis of indexing coverage for Zone 1 and 2 was also provided. RESULTS: The study showed that 64.2% of citations came from journals, versus 22.9% from books and 12.9% from other publications. PubMed/ MEDLINE rated highest in average indexing coverage of Zone 1 and 2 journals, followed by CINAHL. PsycINFO, SocioAbstracts, and EBSCO Health Business FullTEXT showed practically no coverage for the home health nursing literature. CONCLUSION: As expected, journal articles were found to be the primary source for referencing and books, the secondary source. In regard to bibliographic control, no databases provided full coverage of the journals in the field of home health nursing. PubMed/MEDLINE and CINAHL gave better results in combination, because CINAHL tended to cover more nursing journals, while PubMed/MEDLINE did better with medical titles.

Abstracting and Indexing↗
PubMed2004

Treatment for avascular necrosis of bone in people with sickle cell disease.

BACKGROUND: Avascular necrosis of bone is a frequent and severe complication of sickle cell disease and its treatment is not standardised. It is therefore important to gather evidence about the safety and effectiveness of different interventions. OBJECTIVES: To determine the impact of surgery compared to non-surgical management on both the short- and the long-term outcomes (efficacy, safety, and adverse events) for people with sickle cell disease-related avascular necrosis. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group trials register, which comprises references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. Additional randomized controlled trials were sought from the reference lists of the trials found and reviews identified by the search strategy. Date of the most recent search: April 2004. SELECTION CRITERIA: All randomized or quasi-randomized controlled trials (published or unpublished). DATA COLLECTION AND ANALYSIS: One ongoing clinical trial has been identified but no data are available for inclusion in the review. MAIN RESULTS: Five trials were identified by the searches. Four trials were not eligible for inclusion and one is an ongoing clinical trial. REVIEWERS' CONCLUSIONS: We were unable to find any evidence from completed randomized controlled trials assessing treatments for avascular necrosis in people with sickle cell disease. We await the results of an ongoing clinical trial to assess the benefits and risks of a surgical approach compared to a non-surgical approach as a means of improving survival and quality of life for people with sickle cell disease-related avascular necrosis of bone.

Anemia, Sickle Cell↗
PubMed2001

Counselling for depression in primary care.

BACKGROUND: There is wide clinician and patient support for counselling in primary care, particularly in the UK. This review examines the effectiveness and cost effectiveness of counselling for psychological and psychosocial problems in the primary care setting. OBJECTIVES: To assess the effects of counselling in primary care by reviewing cost and outcome data for patients with psychological and psychosocial problems considered suitable for counselling. SEARCH STRATEGY: The search strategy included electronic searching of databases (including the CCDAN Register of RCTs and CCTs) along with handsearching of a specialist journal. Published and unpublished sources (clinical trials, books, dissertations, agency reports etc.) were searched, and their reference lists scanned. Contact was made with subject experts and CCDAN members. SELECTION CRITERIA: Randomised and controlled patient preference trials comparing counselling in primary care with usual general practitioner care for patients with psychological and psychosocial problems considered suitable for counselling. Trials completed before the end of April 1998 were included in the review. DATA COLLECTION AND ANALYSIS: Trials were independently assessed by at least two reviewers for appropriateness of inclusion and methdological quality. MAIN RESULTS: Four trials, involving 678 participants, of whom 487 were followed up, were included. Data for psychological symptom levels (four trials) were pooled statistically. Patients receiving counselling had significantly better psychological symptom levels post intervention than patients receiving usual general practitioner care (standardised mean difference -0.30, 95% CI, (-0.49 to - 0.11). The effect remained statistically significant when the results from studies with less rigorous methodology were excluded in a sensitivity analysis. Patients who received counselling tended to be more satisfied with their treatment (three trials). Health service utilisation data were reported in all trials reviewed, but only one trial undertook a cost analysis. No clear cost advantage was associated with either counselling or usual general practice care. REVIEWER'S CONCLUSIONS: Patients who received counselling were more likely to have improved psychological symptom levels than those who did not receive counselling. Levels of satisfaction with counselling were high. There is limited information about the cost effectiveness of counselling, with one study reporting no clear cost advantage with either counselling or general practice care. The four trials included in this review were all pragmatic trials of counselling in primary care in the UK, which reflect the reality of clinical provision in this context. There were methdological weaknesses identified in the studies, which should be taken into account when considering the results. The evidence base will be extended by trials of counselling which are nearing completion.

Controlled Clinical Trials as Topic↗
PubMed2006

Mapping the literature of nurse practitioners.

OBJECTIVES: This study was designed to identify core journals for the nurse practitioner specialty and to determine the extent of their indexing in bibliographic databases. METHODS: As part of a larger project for mapping the literature of nursing, this study followed a common methodology based on citation analysis. Four journals designated by nurse practitioners as sources for their practice information were selected. All cited references were analyzed to determine format types and publication years. Bradford's Law of Scattering was applied to identify core journals. Nine bibliographic databases were searched to estimate the index coverage of the core titles. RESULTS: The findings indicate that nurse practitioners rely primarily on journals (72.0%) followed by books (20.4%) for their professional knowledge. The majority of the identified core journals belong to non-nursing disciplines. This is reflected in the indexing coverage results: PubMed/MEDLINE more comprehensively indexes the core titles than CINAHL does. CONCLUSION: Nurse practitioners, as primary care providers, consult medical as well as nursing sources for their information. The implications of the citation analysis findings are significant for collection development librarians and indexing services.

Abstracting and Indexing↗
PubMed2003

Antidepressants for generalized anxiety disorder.

BACKGROUND: Pharmacological treatments have been successfully used to treat Generalized Anxiety Disorder (GAD). The mainstay for the pharmacological treatment of GAD in past decades has been the use of benzodiazepine and non benzodiazepine anxiolytics. Data emerging over the last two decades have shown that antidepressants may be equally effective to anxiolytics for treating GAD. The use of antidepressants for treating GAD may be advantageous, due to the fact that GAD presents a high co morbidity ratio with major depressive disorder (62%) and dysthymia (37%). OBJECTIVES: To assess the efficacy and acceptability of antidepressants for treating generalized anxiety disorder. SEARCH STRATEGY: Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register - CCDANCTR (up to May 2002), Anxiety Neurosis (up to May 2002) and Cochrane Controlled Trials Register (CENTRAL/CCTR) (up to May 2002), MEDLINE (1966 to May 2002), LILACS (1982 to May 2002); reference searching; personal communication; conference abstracts and book chapters on the treatment of generalized anxiety disorder. SELECTION CRITERIA: Randomised controlled trials were included. Exclusion criteria were: non randomised studies; studies which included patients with generalized anxiety disorder and another Axis I co-morbidity. DATA COLLECTION AND ANALYSIS: The data from studies were extracted independently by two reviewers and relative risks, weighted mean difference and number needed to treat were estimated. People who died or dropped out were regarded as having had no improvement. MAIN RESULTS: Antidepressants (imipramine, venlafaxine and paroxetine) were found to be superior to placebo in treating GAD. The calculated NNT for antidepressants in GAD is 5.15. Dropout rates did not differ between antidepressants. Only one study presented data on imipramine and trazodone. Imipramine was chosen as the reference drug and, therefore, data on trazodone could not be included in the meta analysis. Only one study was conducted among children and adolescents (Rynn 2001). The latter study showed very promising results of sertraline in children and adolescents with GAD, which warrants its replication in larger samples. REVIEWER'S CONCLUSIONS: The available evidence suggests that antidepressants are superior to placebo in treating GAD. There is evidence from one trial suggesting that paroxetine and imipramine have a similar efficacy and tolerability. There is also evidence from placebo-controlled trials suggesting that these drugs are well tolerated by GAD patients. Further trials of antidepressants for GAD will help to demonstrate which antidepressants should be used for which patients.

Antidepressive Agents↗
PubMed2002

Splenectomy versus conservative management for acute sequestration crises in people with sickle cell disease.

BACKGROUND: Acute splenic sequestration crises are a complication of sickle cell disease, with high mortality rates and frequent recurrence in survivors of first attacks. Splenectomy and blood transfusion, with their consequences, are the mainstay of long term management used in different parts of the world. OBJECTIVES: To assess whether splenectomy (total or partial) to prevent acute splenic sequestration crises in people with sickle cell disease improved survival and decreased morbidity in patients with sickle cell disease, as compared with regular blood transfusion. SEARCH STRATEGY: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group specialist trials register which comprises references identified from comprehensive electronic database searches, hand searching relevant journals and hand searching abstract books of conference proceedings Additional randomized controlled trials were sought from the reference lists of the studies found and reviews identified by the search strategy. Date of the most recent search: December 2001 SELECTION CRITERIA: All randomized or quasi-randomized controlled trials comparing splenectomy (total or partial) to prevent recurrence of acute splenic sequestration crises to no treatment or blood transfusion in people with sickle cell disease. DATA COLLECTION AND ANALYSIS: No trials of splenectomy for acute splenic sequestration were found. MAIN RESULTS: No trials of splenectomy for acute splenic sequestration were found. REVIEWER'S CONCLUSIONS: Splenectomy, if full, will prevent further sequestration and if partial, may reduce the recurrence of acute splenic sequestration crises but there is lack of evidence from trials that it improves survival and decreases morbidity in sickle cell disease. There is a need for a well-designed, adequately powered randomised controlled trial to assess the benefits and risks of splenectomy compared to transfusion programmes as a means of improving survival and decreasing mortality from ASS in people with sickle cell disease.

Acute Disease↗
PubMed1996

A dissection of the chapter "Tools for Research" in Peter Singer's Animal Liberation.

The book Animal Liberation, by philosopher Peter Singer, is frequently referred to as the bible of the animal liberation/rights movement(ALARM). Thus, Singer is regarded as a major moral standard-bearer of the ALARM. Some have suggested that his book provides "intellectual rigor" to the moral arguments for animals' equality with humans, which had previously been based largely on emotionalism and sentimentality. We have analyzed the contents of the chapter "Tools for Research" which criticizes the use of animals in biomedical research as well as for drug and product-safety testing. In order to discredit these practices, Singer "documents" his arguments with 138 "notes", some of which are to the same reference and others of which contain multiple references. Of the 132 difference references, we attempted to verify the accuracy of 49 of them. Of these, 16 (33%) were inaccurate or we could not find. In addition, Singer mischaracterizes the cited studies in various ways. He quotes selectively and out of context from numerous research projects. He never mentions the objectives of these projects, except occasionally when, in our opinion, he distorts or trivializes them. Singer also cites supposedly damning "evidence" published by other antivivisectionists, even though this "evidence" has been refuted in the literature. Singer supposedly embraces utilitarianism, a philosophy which holds that the harm done by a practice should be balanced against the gain realized from it. However, he makes virtually no attempt to consider objectively the benefits that have been realized from animal-based medical research and he greatly exaggerates the costs. To him, animal research is "all pain and no gain." We believe that Singer's moral arguments for animal equality are not convincing. The lack of objectivity and the reliance upon distortion and selective quotation that characterize Singer's "scholarship" are surprising when one considers that he presents himself as an ethicist and moralist.

Animal Rights↗
PubMedDate not supplied

Scope and impact of financial conflicts of interest in biomedical research: a systematic review.

CONTEXT: Despite increasing awareness about the potential impact of financial conflicts of interest on biomedical research, no comprehensive synthesis of the body of evidence relating to financial conflicts of interest has been performed. OBJECTIVE: To review original, quantitative studies on the extent, impact, and management of financial conflicts of interest in biomedical research. DATA SOURCES: Studies were identified by searching MEDLINE (January 1980-October 2002), the Web of Science citation database, references of articles, letters, commentaries, editorials, and books and by contacting experts. STUDY SELECTION: All English-language studies containing original, quantitative data on financial relationships among industry, scientific investigators, and academic institutions were included. A total of 1664 citations were screened, 144 potentially eligible full articles were retrieved, and 37 studies met our inclusion criteria. DATA EXTRACTION: One investigator (J.E.B.) extracted data from each of the 37 studies. The main outcomes were the prevalence of specific types of industry relationships, the relation between industry sponsorship and study outcome or investigator behavior, and the process for disclosure, review, and management of financial conflicts of interest. DATA SYNTHESIS: Approximately one fourth of investigators have industry affiliations, and roughly two thirds of academic institutions hold equity in start-ups that sponsor research performed at the same institutions. Eight articles, which together evaluated 1140 original studies, assessed the relation between industry sponsorship and outcome in original research. Aggregating the results of these articles showed a statistically significant association between industry sponsorship and pro-industry conclusions (pooled Mantel-Haenszel odds ratio, 3.60; 95% confidence interval, 2.63-4.91). Industry sponsorship was also associated with restrictions on publication and data sharing. The approach to managing financial conflicts varied substantially across academic institutions and peer-reviewed journals. CONCLUSIONS: Financial relationships among industry, scientific investigators, and academic institutions are widespread. Conflicts of interest arising from these ties can influence biomedical research in important ways.

Academies and Institutes↗
PubMed2003

Lactational amenorrhea for family planning.

BACKGROUND: 50 % of pregnancies are unwanted. For several reasons including difficulty in obtaining contraceptives, no or ineffective contraception is used to prevent these unwanted pregnancies. The Lactational Amenorrhoea Method(LAM) however is a contraceptive method available and accessible for many women. OBJECTIVES: To assess in fully breastfeeding women, staying amenorrheic, the efficacy of the Lactational Amenorrhoea Method as a contraceptive method. The efficacy of LAM, as defined in 1988 in Bellagio, was compared with alternative definitions of LAM; the outcomes were measured using pregnancy and menstruation life tables. SEARCH STRATEGY DATA SOURCES: MEDLINE searches from 1966 until 2002 and EMBASE from 1988 until 2002; reference lists of studies and review articles; books related to LAM; published abstracts from breastfeeding, reproductive health, contraceptive conferences; and e-mail communication with coordinators of such studies. SELECTION CRITERIA: From 454 potentially relevant studies 154 investigated the risk of pregnancy during LAM or lactational amenorrhea. Two reviewers applied the following inclusion criteria: prospective study, cases and -if available- controls had to be sexually active, pregnancy had to be confirmed by physical examination or a pregnancy test. Life table menstruation rates and life table pregnancy rates were taken as endpoints. Thirteen publications, reporting on 9 intervention groups and 2 control groups, met the inclusion criteria and were included in this systematic review. Their quality was assessed. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data, disagreements were resolved through discussion. Because of the heterogeneity of the included studies, the studies were analyzed using narrative methods. MAIN RESULTS: For the outcome two controlled studies of LAM users reported life table pregnancy rates at 6 months of 0.45 and 2.45 percent and 5 uncontrolled studies of LAM users reported 0-7.5 percent. Life table pregnancy rates of women fully breastfeeding and amenorrheic but not using any contraceptive method were 0.88 in one study and 0.9-1.2 percent (95% CI 0. 0-2.4 ) in a second study, depending on the definition of menstruation used. The life table menstruation rate at 6 months in all studies varied between 11.1-39.4 percent. REVIEWER'S CONCLUSIONS: No clear difference in life table pregnancy rates was found between women using LAM and supported in doing so, and fully breastfeeding, amenorroic women not using any method. Because the length of lactation amenorrhoea of women using LAM is too different between populations studied, and population specific, it is uncertain whether LAM extends lactational amenorrhoea.

Amenorrhea↗
PubMed2002

Antibiotic duration for treating uncomplicated, symptomatic lower urinary tract infections in elderly women.

BACKGROUND: Urinary tract infections are common in elderly patients. Authors of non systematic literature reviews often recommend longer treatment durations (7-14 days) for older patients than for younger women, but the scientific evidence for such recommendations is not clear. OBJECTIVES: To determine the optimal duration of antibiotic treatment for uncomplicated symptomatic lower urinary tract infections in elderly women. SEARCH STRATEGY: We contacted known investigators and pharmaceutical companies marketing antibiotics used to treat urinary tract infections, screened the reference list of identified articles, reviews and books, and searched the following data bases: MEDLINE, EMBASE, CINAHL, Healthstar, Popline, Gerolit, Bioethics Line, The Cochrane Library, Dissertation Abstracts International, Index to Scientific & Technical Proceedings. SELECTION CRITERIA: All randomized controlled trials in which different treatment durations of oral antibiotics for uncomplicated symptomatic lower urinary tract infections in elderly women were compared. We excluded patients with fever or flank pain and those with complicating factors. Trials with treatment durations longer than 14 days or designed for prevention of urinary tract infection were also excluded. No language restriction was applied. DATA COLLECTION AND ANALYSIS: The quality of all selected trials was assessed and data extracted by the reviewers. Main outcome measures were persistence of urinary symptoms (short-term and long-term efficacy), effect on mental and functional status and adverse drug reactions. To compare the different treatment durations, we defined the following categories of duration: single dose, short course (3-6 days) and long course (7-14 days). Relative risk (RR) and 95% confidence intervals (CI) were calculated for each trial and outcome and were then combined using a random effects model. MAIN RESULTS: Thirteen trials were included in this review. Six trials compared single dose with short-term treatment (3-6 days), three studies single dose with long-term treatment (7-14 days) and four trials short-term with long term treatment. Eight trials also included younger patients, but provided a subgroup analysis for elderly women. The methodological quality of all trials was low. All trials reported results of bacteriological cure rate; less often clinical outcomes (e.g. improvement or cure of symptoms) were analyzed. Only five trials compared the same antibiotic given for a different length of time. We performed a separate analysis for these trials. The rate of persistent bacteriuria rate at short-term (two weeks post-treatment) was better in the longer treatment group (3-14 days) than in the single dose group (RR 1.84, 95% CI 1.18 to 2.86). However, the rate of persistent bacteria at long term and the clinical cure rate showed no statistically significant difference between the two groups. Patients showed a preference for single dose treatment (RR 0.73, 95% CI 0.66 to 0.88), however this was based on only one trial comparing the same antibiotic. The comparison of short (3-6 days) and longer treatments (7-14 days) did not show any significant difference, but the number of included studies and sample size were low. REVIEWER'S CONCLUSIONS: This review suggests that single dose antibiotic treatment is less effective but may be better accepted by the patients than longer treatment durations (3-14 days). In addition there was no significant difference between short course (3-6 days) versus longer course (7-14 days) antibiotics. The methodological quality of the identified trials was poor and the optimal treatment duration could not be determined. We therefore need more appropriately designed randomized controlled trials testing the effect, - on clinical relevant outcomes -, of different treatment durations of a given antibiotic in a strictly defined population of elderly women.

Aged↗
PubMed2002

HbVar: A relational database of human hemoglobin variants and thalassemia mutations at the globin gene server.

We have constructed a relational database of hemoglobin variants and thalassemia mutations, called HbVar, which can be accessed on the web at http://globin.cse.psu.edu. Extensive information is recorded for each variant and mutation, including a description of the variant and associated pathology, hematology, electrophoretic mobility, methods of isolation, stability information, ethnic occurrence, structure studies, functional studies, and references. The initial information was derived from books by Dr. Titus Huisman and colleagues [Huisman et al., 1996, 1997, 1998]. The current database is updated regularly with the addition of new data and corrections to previous data. Queries can be formulated based on fields in the database. Tables of common categories of variants, such as all those involving the alpha1-globin gene (HBA1) or all those that result in high oxygen affinity, are maintained by automated queries on the database. Users can formulate more precise queries, such as identifying "all beta-globin variants associated with instability and found in Scottish populations." This new database should be useful for clinical diagnosis as well as in fundamental studies of hemoglobin biochemistry, globin gene regulation, and human sequence variation at these loci.

Databases, Genetic↗