The trials and tribulations of performing within the research arena.
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Biomedical Research↗
Biomedical subjects
N Siegfried
Publications and source records attributed to N Siegfried.
Micronutrient supplementation in children and adults with HIV infection.
BACKGROUND: The scale and impact of the HIV/AIDS pandemic has made the search for simple, affordable, safe, and effective public health interventions all the more urgent. Micronutrient supplements hold the promise of meeting these criteria, but their widespread use needs to be based on sound scientific evidence of effectiveness and safety. OBJECTIVES: To assess whether micronutrient supplements are effective in reducing morbidity and mortality in adults and children with HIV infection. SEARCH STRATEGY: The Cochrane Library (CENTRAL), EMBASE, MEDLINE, AIDSearch, CINAHL, and conference proceedings were searched, and pharmaceutical manufacturers and researchers in the field were contacted to locate any ongoing or unpublished trials. SELECTION CRITERIA: Randomised controlled trials comparing the effects of micronutrient supplements (vitamins, trace elements, and combinations of these) with placebo or no treatment on mortality and morbidity in HIV-infected individuals. DATA COLLECTION AND ANALYSIS: Two reviewers independently appraised trial quality and extracted data. Study authors were contacted for additional data where necessary. A meta-analysis was not deemed appropriate due to significant heterogeneity between trials. MAIN RESULTS: Fifteen trials were included. Six trials comparing vitamin A/beta-carotene with placebo in adults failed to show any effects on mortality, morbidity, CD4 and CD8 counts, or on viral load. Four trials of other micronutrients in adults did not affect overall mortality, although there was a reduction in mortality in a low CD4 subgroup. In a large Tanzanian trial in pregnant and lactating women, daily multivitamin supplementation was associated with a number of benefits to both mothers and children: a reduction in maternal mortality from AIDS-related causes; a reduced risk of progression to stage four disease; fewer adverse pregnancy outcomes; less diarrhoeal morbidity; and a reduction in early-child mortality among immunologically- and nutritionally-compromised women. Vitamin A alone reduced all-cause mortality and improved growth in a small sub-group of HIV-infected children in one hospital-based trial, and reduced diarrhoea-associated morbidity in a small HIV-infected sub-group of infants in another trial. AUTHORS' CONCLUSIONS: There is no conclusive evidence at present to show that micronutrient supplementation effectively reduces morbidity and mortality among HIV-infected adults. It is reasonable to support the current WHO recommendations to promote and support adequate dietary intake of micronutrients at RDA levels wherever possible. There is evidence of benefit of vitamin A supplementation in children. The long-term clinical benefits, adverse effects, and optimal formulation of micronutrient supplements require further investigation.
Adult↗
Treatment for methaqualone dependence in adults.
BACKGROUND: Methaqualone is a potent quinazoline, a class of sedative-hypnotics, that has a high potential for abuse. While the oral use of methaqualone (Quaalude, Mandrax) has waned in western countries since the mid-late 1980's, the practice of smoking methaqualone is a serious public health problem in South Africa, other parts of Africa and India. In the context of diminishing resources devoted to substance abuse treatment in regions affected by methaqualone abuse, it would be desirable to base treatment on the best evidence available. This review aimed to provide health care workers, policy-makers and consumers with the necessary information to make decisions regarding effective treatment of this highly dependence-producing drug. OBJECTIVES: To compare the effectiveness of any type of pharmacological or behavioural treatment administered in either an in-patient or out-patient setting compared with either a placebo or no treatment or a waiting list, or with another form of treatment administered in either an in- or out-patient setting. SEARCH STRATEGY: The authors searched the following databases: Cochrane Drugs and Alcohol Group'Register of Trials (February 2004); Cochrane Central Register of Controlled Trials (CENTRAL-The Cochrane Library, Issue 2, 2004); MEDLINE (OVID - January 1966 to february 2004), PsycInfo (OVID - January 1967 to february 2004). Relevant conference proceedings and reference lists of relevant articles were hand-searched. Broad internet searches were conducted and contact made with experts in the field. SELECTION CRITERIA: All randomised controlled trials and quasi-randomised trials of the effectiveness of treatment programmes (in- or out-patient) for methaqualone dependence and abuse were considered for inclusion in this review. DATA COLLECTION AND ANALYSIS: The authors independently assessed study eligibility and quality. MAIN RESULTS: No studies were found that met the inclusion criteria. AUTHORS' CONCLUSIONS: To date, no randomized controlled trials appear to have been conducted. Consequently, the effectiveness of inpatient versus outpatient treatment, psychosocial treatment versus no treatment, and pharmacological treatments versus placebo for methaqualone abuse or dependence has yet to be established.
Adult↗
HIV and male circumcision--a systematic review with assessment of the quality of studies.
This Cochrane systematic review assesses the evidence for an interventional effect of male circumcision in preventing acquisition of HIV-1 and HIV-2 by men through heterosexual intercourse. The review includes a comprehensive assessment of the quality of all 37 included observational studies. Studies in high-risk populations consisted of four cohort studies, 12 cross-sectional studies, and three case-control studies; general population studies consisted of one cohort study, 16 cross-sectional studies, and one case-control study. There is evidence of methodological heterogeneity between studies, and statistical heterogeneity was highly significant for both general population cross-sectional studies (chi(2)=132.34; degrees of freedom [df]=15; p<0.00001) and high-risk cross-sectional studies (chi(2)=29.70; df=10; p=0.001). Study quality was very variable and no studies measured the same set of potential confounding variables. Therefore, conducting a meta-analysis was inappropriate. Detailed quality assessment of observational studies can provide a useful visual aid to interpreting findings. Although most studies show an association between male circumcision and prevention of HIV, these results may be limited by confounding, which is unlikely to be adjusted for.
Africa South of the Sahara↗
Male circumcision for prevention of heterosexual acquisition of HIV in men.
BACKGROUND: The findings from observational studies, reviews and meta-analyses, supported by biological theories, that circumcised men appear less likely to acquire human immunodeficiency virus (HIV) has contributed to the recent ground swell of support for considering male circumcision as a strategy for preventing sexually acquired infection. We sought to elucidate and appraise the global evidence from published and unpublished studies that circumcision can be used as an intervention to prevent HIV infection. OBJECTIVES: 1) To assess the evidence of an interventional effect of male circumcision for preventing acquisition of HIV-1 and HIV-2 by men through heterosexual intercourse 2) To examine the feasibility and value of performing individual person data (IPD) meta-analysis SEARCH STRATEGY: We searched online for published and unpublished studies in The Cochrane Library (issue 2, 2002), MEDLINE (April 2002), EMBASE (February 2002) and AIDSLINE (August 2001). We also searched databases listing conference abstracts, scanned reference lists of articles and contacted authors of included studies. SELECTION CRITERIA: We searched for randomized and quasi-randomized controlled trials of male circumcision or, in their absence, observational studies that compare acquisition rates of HIV-1 and HIV-2 infection in circumcised and uncircumcised heterosexual men. DATA COLLECTION AND ANALYSIS: Independent reviewers selected studies, assessed study quality and extracted data. We stratified studies based on study design and on whether they included participants from the general population or high-risk groups (such as patients treated for sexually transmitted infections). We expressed findings as crude and adjusted odds ratios (OR) together with their 95% confidence intervals (CI) and conducted a sensitivity analysis to explore the effect of adjustment on study results. We investigated whether the method of circumcision ascertainment influenced study outcomes. MAIN RESULTS: We identified no completed randomized controlled trials. Three randomized controlled trials are currently underway or commencing shortly. We found 34 observational studies: 16 conducted in the general population and 18 in high-risk populations. It seems unlikely that potential confounding factors were completely accounted for in any of the included studies. In particular, important risk factors, such as religion and sexual practices, were not adequately accounted for in many of the included studies. General population study results:The single cohort study (N = 5516) showed a significant difference in HIV transmission rates between circumcised and uncircumcised men [OR = 0.58; 95% CI: 0.36 to 0.96]. Results for the 14 cross-sectional studies were inconsistent, with point estimates for unadjusted odds ratios varying between 0.28 and 1.73. Six studies had statistically significant results, four in the direction of benefit and two in the direction of harm. The test for heterogeneity between the cross-sectional studies was highly significant (chi-square = 77.59; df = 13; P-value < 0.00001). Nine studies reported adjusted odds ratios with eight in the direction of benefit, ranging from 0.26 to 0.80. Use of adjusted results tended to show stronger evidence of an association although they remained heterogenous (chi-square = 75.2; df = 13; P-value < 0.00001). Only one case-control study was found (N = 51) which had a non-significant result [OR = 1.90; 95% CI: 0.50 to 7.20]. High-risk group study results:The four cohort studies identified found a protective effect from circumcision with point estimates for unadjusted odds ratios varying from 0.10 to 0.39. Two of these studies had statistically significant results. Two studies reported adjusted odds ratios, both protective with one being significant. The chi-square test for between-study heterogeneity was not significant (chi-square = 5.21; df = 3; P-value = 0.16). All eleven cross-sectional studies reporting unadjusted results found benefit from circumcision, eight of which had statistically significant results. Estimates of effnal studies reporting unadjusted results found benefit from circumcision, eight of which had statistically significant results. Estimates of effect varied from an unadjusted odds ratio of 0.10 to 0.66. Between-study heterogeneity was significant with the chi-square = 29.77; df = 10; P-value = 0.0009. Four of these studies reported adjusted odds ratios ranging from 0.20 to 0.59 and all were significant. One additional cross-sectional study only reported an adjusted odds ratio in the direction of benefit which was statistically significant. All three case-control studies found a protective effect of circumcision on HIV status, two being statistically significant. Point estimates varied from unadjusted odds ratios of 0.37 to 0.88. One reported an adjusted odds ratio showing a significant protective effect. Adverse effects:No studies reported on the adverse effects of circumcision. In most studies, circumcision had taken place during childhood or adolescence before the studies commenced. REVIEWER'S CONCLUSIONS: We found insufficient evidence to support an interventional effect of male circumcision on HIV acquisition in heterosexual men. The results from existing observational studies show a strong epidemiological association between male circumcision and prevention of HIV, especially among high-risk groups. However, observational studies are inherently limited by confounding which is unlikely to be fully adjusted for. In the light of forthcoming results from RCTs, the value of IPD analysis of the included studies is doubtful. The results of these trials will need to be carefully considered before circumcision is implemented as a public health intervention for prevention of sexually transmitted HIV.
Circumcision, Male↗
Effects of an oral multivitamin-mineral combination on stress.
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Administration, Oral↗
Where to practise evidence-based medicine?
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Decision Making↗
Improving services for people with a psychotic disorder and problematic substance use: a multifaceted approach to project evaluation.
OBJECTIVE: The objective of this study was to conduct a multifaceted formative evaluation of the Central Sydney Area Health Service (CSAHS) Psychosis and Substance Use Project. METHOD: Four evaluative methods were used: (i) description and interpretation of the Project's documented processes and outcomes; (ii) a benchmark comparison of the Project processes and outcomes against three of the 11 National Standards for Mental Health Services; (iii) a survey of the Project's key stakeholders; and (iv) interviews with 12 purposefully sampled key informants. RESULTS: The Project achieved its aim to develop a strategy to improve services for people with comorbid psychosis and problematic substance use. Three of the five Project objectives were fully achieved: examination of current clinical services, development of a clinical services plan, and development of a staff education programme. The Project partially achieved two objectives: development of an information system, and a research agenda. The Project and CSAHS performed well when measured against three of the National Mental Health Standards. Project participants perceived the Project to have been successful and worth continuing, identified some shortcomings and made recommendations for the second phase. CONCLUSIONS: The participatory approach to the Project and the evaluation was successful. With some improvements the Project is worth continuing into a second phase. A multifaceted approach and qualitative research methods are useful for formative evaluation of health service programmes.
Australia↗
Treatment programmes for people with both severe mental illness and substance misuse.
BACKGROUND: Substance misuse in the context of severe mental illness can have detrimental effects. A variety of treatments exist, but the drive has been to provide programmes integrating treatment of both substance misuse and severe mental illness. Such programmes require additional resources and may require radical redesign of service delivery systems. OBJECTIVES: To evaluate the effectiveness of treatment programmes within psychiatric care for people with problems of both substance misuse and serious mental illness. SEARCH STRATEGY: Biological Abstracts (1985-1998), CINAHL (1982-1998), The Cochrane Library (Issue 3, 1998), The Cochrane Schizophrenia Group's Register of trials (August 1998), EMBASE (1980-1998), MEDLINE (1966-1998), PsycLIT (1974-1998) and Sociofile (1974-1998) were comprehensively searched. Citations of all trials were searched and further studies sought from published trials and their authors. SELECTION CRITERIA: All randomised trials of any programme of substance misuse treatment for people with serious mental illness and current problems of substance misuse. DATA COLLECTION AND ANALYSIS: Citations and, where possible, abstracts were independently inspected by reviewers, papers ordered, re-inspected and quality assessed. Data were also independently extracted. For homogeneous dichotomous data the Peto odds ratio (OR), and 95% confidence intervals (CI) were calculated on an intention-to-treat basis. MAIN RESULTS: Six relevant studies, four of which were small, were identified. In general, the quality of design and reporting was not high. Clinically important outcomes such as relapse of severe mental illness, violence to others, patient or carer satisfaction, social functioning and employment were not reported. There is no clear evidence supporting an advantage of any type of substance misuse programme for those with serious mental illness over the value of standard care. No one programme is clearly superior to another. REVIEWER'S CONCLUSIONS: The problems posed by substance misuse in the context of severe mental illness will not go away. The current momentum for integrated programmes is not based on good evidence. Implementation of new specialist substance misuse services for those with serious mental illnesses should be within the context of simple, well designed controlled clinical trials.
Comorbidity↗
Trauma and alcohol.
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Accidents, Traffic↗
Experience, knowledge and attitudes of mental health staff regarding patients' problematic drug and alcohol use.
OBJECTIVE: The aim of this study was to assess the experience, knowledge and attitudes of mental health staff regarding patients' problematic drug and alcohol use in order to provide direction for planned drug and alcohol education. METHOD: A 47-item questionnaire was developed and individually posted to all mental health staff employed by Central Sydney Area Health Service (n = 536). RESULTS: Three hundred and thirty-eight (63%) staff members completed the questionnaire. Thirty-six percent of respondents had received drug and alcohol training and 41% had drug and alcohol work experience. Drug and alcohol training and work experience were associated with increased drug and alcohol knowledge. Respondents' perception of their knowledge and competence was positively correlated with their actual knowledge. Most staff reported having regular contact with patients with psychotic illnesses and drug and alcohol problems. The majority considered the management of this patient group difficult and currently inadequate. Seventy percent believed that as mental health professionals they had a role to play in the management of their patients' drug and alcohol problems. Almost all (95%) were willing to participate in further education and training in this area. CONCLUSIONS: Mental health staff are often confronted with drug and alcohol problems in patients with psychotic illnesses. They perceive a need for drug and alcohol education and training specific to the management of these patients. Future research will need to evaluate outcomes of education and training programs for both staff and patients.
Adult↗
A review of comorbidity: major mental illness and problematic substance use.
OBJECTIVE: The aim of this paper is to critically review the literature on major mental illness and problematic substance use in order to provide clinicians and policy-makers with evidence to support proposed directions for management of the above. METHOD: The available literature was accessed using computerised databases and manual searching. RESULTS: The predominantly North American-based literature is largely descriptive. Those studies which attempt empirical evaluation are limited by methodological weaknesses which include small sample sizes, short follow-up periods, inadequate measurement of substance use, lack of experimental design, and treatment drift over time. However, there is consensus among most studies regarding prevalence rates and treatment. CONCLUSIONS: Problematic substance use is the most common comorbid condition among people with a major mental illness and is associated with poorer patient outcomes. There is evidence to suggest that the integration of mental health and drug and alcohol services will result in improved detection, assessment and management of comorbidity. Integration refers to the provision of comprehensive services by a single service with staff who are competent in both mental health and drug and alcohol skills. A tolerant, non-confrontational approach to substance use is most appropriate for people with a major mental illness. Treatment programs need to recognise the longitudinal nature of substance abuse and dependence. More research needs to be conducted in this field in order to establish guidelines for effective management.
Australia↗
Profile of drinking behaviour and comparison of self-report with the CAGE questionnaire and carbohydrate-deficient transferrin in a rural Lesotho community.
This paper aims to: (1) profile the drinking behaviour of a rural Lesotho community facing relocation; (2) compare the following measures of hazardous drinking in this community: quantity/frequency self-report, the CAGE questionnaire and carbohydrate-deficient transferrin (CDT) levels; (3) describe community awareness of, and attitude towards, treatment services. As part of a larger baseline survey of community health status, households in 29 villages in Lesotho were randomly sampled. Consenting adults (n = 348) participated in a face-to-face interview about alcohol use, which included the CAGE. Blood was taken from participants for CDT determination. Fifty-three per cent of men (37/69) and 19% of women (53/279) reported drinking alcohol. Thirty-six per cent of men (25/69) and 9% of women (25/279) were classified as hazardous drinkers defined as drinking 350 g (males) or 225 g (females) of alcohol/week, or 'engaged in bouts of heavy drinking 1 to 2 days a month or more during the past 12 months'. Hazardous drinkers were significantly more likely to be male and older, but did not differ from the rest of the sample on marital status. Using hazardous drinking as the standard, CAGE (score > or = 2) had a positive predictive value (PPV) of 75% for men and 62% for women. The parameters for CDT must be interpreted with caution as the cut-offs for hazardous drinking, especially for women's drinking, were lower than the usual cut-offs in published CDT studies. However, the high specificities for CDT in men (100%; 19/19) and in women (77%; 110/142) are consistent with other studies, but the low PPV of 14% (5/37) for men and women combined suggests that CDT is not effective as a predictor of hazardous drinking in this population. There was high awareness of available treatment services among participants, and most believed treatment to be beneficial. Overall, the study provides a comprehensive baseline profile of drinking behaviour in this community, but did not show the CAGE questionnaire or CDT profile to be useful in in this community.
Adolescent↗