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Biomedical subjects

Edward J Mills

Publications and source records attributed to Edward J Mills.

At least 19 recordsLinked to original sources
PubMed2006

Effectiveness of smoking cessation therapies: a systematic review and meta-analysis.

BACKGROUND: Smoking remains the leading preventable cause of premature deaths. Several pharmacological interventions now exist to aid smokers in cessation. These include Nicotine Replacement Therapy [NRT], bupropion, and varenicline. We aimed to assess their relative efficacy in smoking cessation by conducting a systematic review and meta-analysis. METHODS: We searched 10 electronic medical databases (inception to Sept. 2006) and bibliographies of published reviews. We selected randomized controlled trials [RCTs] evaluating interventions for smoking cessation at 1 year, through chemical confirmation. Our primary endpoint was smoking cessation at 1 year. Secondary endpoints included short-term smoking cessation (approximately 3 months) and adverse events. We conducted random-effects meta-analysis and meta-regression. We compared treatment effects across interventions using head-to-head trials and when these did not exist, we calculated indirect comparisons. RESULTS: We identified 70 trials of NRT versus control at 1 year, Odds Ratio [OR] 1.71, 95% Confidence Interval [CI], 1.55-1.88, P =< 0.0001). This was consistent when examining all placebo-controlled trials (49 RCTs, OR 1.78, 95% CI, 1.60-1.99), NRT gum (OR 1.60, 95% CI, 1.37-1.86) or patch (OR 1.63, 95% CI, 1.41-1.89). NRT also reduced smoking at 3 months (OR 1.98, 95% CI, 1.77-2.21). Bupropion trials were superior to controls at 1 year (12 RCTs, OR1.56, 95% CI, 1.10-2.21, P = 0.01) and at 3 months (OR 2.13, 95% CI, 1.72-2.64). Two RCTs evaluated the superiority of bupropion versus NRT at 1 year (OR 1.14, 95% CI, 0.20-6.42). Varenicline was superior to placebo at 1 year (4 RCTs, OR 2.96, 95% CI, 2.12-4.12, P =< 0.0001) and also at approximately 3 months (OR 3.75, 95% CI, 2.65-5.30). Three RCTs evaluated the effectiveness of varenicline versus bupropion at 1 year (OR 1.58, 95% CI, 1.22-2.05) and at approximately 3 months (OR 1.61, 95% CI, 1.16-2.21). Using indirect comparisons, varenicline was superior to NRT when compared to placebo controls (OR 1.66, 95% CI 1.17-2.36, P = 0.004) or to all controls at 1 year (OR 1.73, 95% CI 1.22-2.45, P = 0.001). This was also the case for 3-month data. Adverse events were not systematically different across studies. CONCLUSION: NRT, bupropion and varenicline all provide therapeutic effects in assisting with smoking cessation. Direct and indirect comparisons identify a hierarchy of effectiveness.

Benzazepines↗
PubMed2006

Therapeutic challenges in hepatitis C-infected injection drug using patients.

Hepatitis C Viral (HCV) infection in the injection drug user (IDU) population is a major medical concern. Concurrent substance abuse, co-morbid mental health conditions, poor socioeconomic status and a complex treatment protocol that is often incompatible with the life styles of IDUs combine to account for poor uptake and completion of HCV treatment. This article discusses HCV antiviral treatment issues relevant to IDUs chronically infected with this virus. The effect of non-injected substances of abuse on treatment outcome is considered. Priority issues requiring research are discussed.

Journal Article↗
PubMed2006

Dangerous journey: documenting the experience of Tibetan refugees.

OBJECTIVES: Since the 1950 invasion of Tibet by China, Tibetan refugees have attempted to flee into Nepal over the Himalayan mountains. We documented the experiences of a group of refugees making this journey. METHODS: We conducted semistructured interviews with 50 recent refugees at the Tibetan Refugee Transit Centre in Kathmandu, Nepal. RESULTS: Participants ranged in age from 8 to 56 years, and 21 were female. The average length of their journey from Tibet to Nepal was 34 days. During their journey, a majority of the refugees encountered authorities or became involved in altercations with Nepali Maoist groups. Most of these interactions resulted in extortion and threats of expulsion. Several Tibetans were tortured, beaten with weapons, threatened with being shot, and robbed. Three women were sexually assaulted at gunpoint. CONCLUSIONS: The refugees who took part in this study experienced physical and mental hardships and, often, human rights abuses on their journey to Nepal. International pressure is needed to prevent human rights violations and reduce potential long-term physical and mental health effects associated with this dangerous crossing.

Adolescent↗
PubMed2006

Epidemiology and reporting of randomized trials employing re-randomization of patient groups: a systematic survey.

Trials employing re-randomization of some or all participants provide opportunities for determining optimal dosing and dosing schedules, potential disease modifying effects, direct comparisons between drugs, and salvage therapy for patients failing their assigned treatments. To date, no data exists about their prevalence, epidemiology, or quality. We undertook a systematic review of all trials re-randomizing patients. Using explicit search criteria, we searched 11 electronic databases independently, in duplicate. We additionally searched pharmaceutical company websites for unpublished studies. We extracted data on the epidemiology of trials, year published, characteristics of the purpose of the re-randomization, what groups of patients were re-randomized, and methodological issues, including allocation, concealment, sequence generation, blinding, intention to treat, and appropriate sample size calculations. We found 65 trials. All trials were reported in English. Of these, 21 employed re-randomization to determine optimal dosing, 8 for optimal dose-scheduling, 3 for salvage therapy, 0 for estimating disease modifying effects, 24 as direct comparison trials, 9 as standard efficacy trials--that did not require re-randomization, and 3 as withdrawal of treatment trials. The median sample size of the period prior to re-randomization is 180 [interquartile range (IQR) 83-480] and after re-randomization is 104 [IQR 36 to 246]. Studies lost a median of 8% of eligible patients from period 1 to period 2 [IQR 0 to 17]. Studies were published between 1975 and 2005, with the vast majority (71%) published since 1995. The findings of our review indicate that trials employing re-randomization are relatively rare, have poor reporting of important methodological features, and, in some circumstances, fail to take advantage of the benefits that re-randomization can permit.

Dose-Response Relationship, Drug↗
PubMed2006

Adherence to antiretroviral therapy in sub-Saharan Africa and North America: a meta-analysis.

CONTEXT: Adherence to antiretroviral therapy is a powerful predictor of survival for individuals living with human immunodeficiency virus (HIV) and AIDS. Concerns about incomplete adherence among patients living in poverty have been an important consideration in expanding the access to antiretroviral therapy in sub-Saharan Africa. OBJECTIVE: To evaluate estimates of antiretroviral therapy adherence in sub-Saharan Africa and North America. DATA SOURCES: Eleven electronic databases were searched along with major conference abstract databases (inclusion dates: inception of database up until April 18, 2006) for all English-language articles and abstracts; and researchers and treatment advocacy groups were contacted. Study Selection and Data Abstraction To best reflect the general population, studies of mixed populations in both North America and Africa were selected. Studies evaluating specific populations such as men only, homeless individuals, or drug users, were excluded. The data were abstracted in duplicate on study adherence outcomes, thresholds used to determine adherence, and characteristics of the populations. A random-effects meta-analysis was performed in which heterogeneity was examined using multivariable random-effects logistic regression. A sensitivity analysis was performed using Bayesian methods. DATA SYNTHESIS: Thirty-one studies from North America (28 full-text articles and 3 abstracts) and 27 studies (9 full-text articles and 18 abstracts) from sub-Saharan Africa were included. African studies represented 12 sub-Saharan countries. Of the North American studies, 71% used patient self-report to assess adherence; this was true of 66% of the African assessments. Studies reported similar thresholds for adherence monitoring (eg, 100%, >95%, >90%, >80%). A pooled analysis of the North American studies (17,573 patients total) indicated a pooled estimate of 55% (95% confidence interval, 49%-62%; I2, 98.6%) of the populations achieving adequate levels of adherence. Our pooled analysis of African studies (12,116 patients total) indicated a pooled estimate of 77% (95% confidence interval, 68%-85%; I2, 98.4%). Study continent, adherence thresholds, and study quality were significant predictors of heterogeneity. Bayesian analysis was used as an alternative statistical method for combining adherence rates and provided similar findings. CONCLUSION: Our findings indicate that favorable levels of adherence, much of which was assessed via patient self-report, can be achieved in sub-Saharan African settings and that adherence remains a concern in North America.

Africa South of the Sahara↗
PubMed2006

Barriers to participation in clinical trials of cancer: a meta-analysis and systematic review of patient-reported factors.

BACKGROUND: Enrolling participants onto clinical trials of cancer presents an important challenge. We aimed to identify the concerns of patients with cancer about, and the barriers to, participation in clinical trials. METHODS: We did a systematic review to assess studies of barriers to participation in experimental trials and randomised trials for validity and content. We estimated the frequency with which patients identified particular issues by pooling across studies that presented data for barriers to participation in clinical trials as proportions. FINDINGS: We analysed 12 qualitative studies (n=722) and 21 quantitative studies (n=5452). Two qualitative studies inquired of patients who were currently enrolled onto clinical trials, and ten inquired of patients who were eligible for enrolment onto various clinical trials. Barriers to participation in clinical trials were protocol-related, patient-related, or physician-related. The most common reasons cited as barriers included: concerns with the trial setting; a dislike of randomisation; general discomfort with the research process; complexity and stringency of the protocol; presence of a placebo or no-treatment group; potential side-effects; being unaware of trial opportunities; the idea that clinical trials are not appropriate for serious diseases; fear that trial involvement would have a negative effect on the relationship with their physician; and their physician's attitudes towards the trial. Meta-analysis confirmed the findings of our systematic review. INTERPRETATION: The identification of such barriers to the participation in clinical trials should help trialists to develop strategies that will keep to a maximum participation and cooperation in cancer trials, while informing and protecting prospective participants adequately.

Clinical Trials as Topic↗
PubMed2006

The impact of conflict on HIV/AIDS in sub-Saharan Africa.

Sub-Saharan Africa disproportionately represents the largest incidence of both HIV/AIDS and internal conflicts. The impact of conflict on HIV incidence is largely unknown. Current epidemiological evidence paradoxically suggests that in most populations affected by conflict, HIV prevalence is lower than surrounding communities. However, in situations of conflict, the most vulnerable populations, such as women and children, are at increased risk for HIV through sexual violence, forced occupational exposure and an absence of access to health care or testing. Together, these dimensions of conflict create a complex and challenging situation for prevention of HIV/AIDS and delivery of care to conflict-affected populations. We examine the complexity of monitoring HIV/AIDS in conflict settings. We argue that increased efforts are needed to protect vulnerable populations and design health-delivery systems that are sustainable in settings of conflict.

Acquired Immunodeficiency Syndrome↗
PubMed2006

Adherence to HAART: a systematic review of developed and developing nation patient-reported barriers and facilitators.

BACKGROUND: Adherence to highly active antiretroviral therapy (HAART) medication is the greatest patient-enabled predictor of treatment success and mortality for those who have access to drugs. We systematically reviewed the literature to determine patient-reported barriers and facilitators to adhering to antiretroviral therapy. METHODS AND FINDINGS: We examined both developed and developing nations. We searched the following databases: AMED (inception to June 2005), Campbell Collaboration (inception to June 2005), CinAhl (inception to June 2005), Cochrane Library (inception to June 2005), Embase (inception to June 2005), ERIC (inception to June 2005), MedLine (inception to June 2005), and NHS EED (inception to June 2005). We retrieved studies conducted in both developed and developing nation settings that examined barriers and facilitators addressing adherence. Both qualitative and quantitative studies were included. We independently, in duplicate, extracted data reported in qualitative studies addressing adherence. We then examined all quantitative studies addressing barriers and facilitators noted from the qualitative studies. In order to place the findings of the qualitative studies in a generalizable context, we meta-analyzed the surveys to determine a best estimate of the overall prevalence of issues. We included 37 qualitative studies and 47 studies using a quantitative methodology (surveys). Seventy-two studies (35 qualitative) were conducted in developed nations, while the remaining 12 (two qualitative) were conducted in developing nations. Important barriers reported in both economic settings included fear of disclosure, concomitant substance abuse, forgetfulness, suspicions of treatment, regimens that are too complicated, number of pills required, decreased quality of life, work and family responsibilities, falling asleep, and access to medication. Important facilitators reported by patients in developed nation settings included having a sense of self-worth, seeing positive effects of antiretrovirals, accepting their seropositivity, understanding the need for strict adherence, making use of reminder tools, and having a simple regimen. Among 37 separate meta-analyses examining the generalizability of these findings, we found large heterogeneity. CONCLUSIONS: We found that important barriers to adherence are consistent across multiple settings and countries. Research is urgently needed to determine patient-important factors for adherence in developing world settings. Clinicians should use this information to engage in open discussion with patients to promote adherence and identify barriers and facilitators within their own populations.

Antiretroviral Therapy, Highly Active↗
PubMed2006

Lesotho embarks on universal HIV testing.

On 1 December 2005, this past World AIDS Day, Lesotho embarked on the "Know Your Status" initiative to provide country-wide voluntary counselling and testing (VCT) for HIV/AIDS. In a country of two million people with a 29 percent HIV infection rate, the universal testing initiative may help prevent a humanitarian and economic crisis capable of destroying the country. However, the initiative raises human rights concerns.

AIDS Serodiagnosis↗
PubMed2005

Prevalence of mental disorders and torture among Tibetan refugees: a systematic review.

BACKGROUND: Many Tibetan refugees flee Tibet in order to escape physical and mental hardships, and to access the freedoms to practice their culture and religion. We aimed to determine the prevalence of mental illnesses within the refugee population and determine the prevalence of previous torture reported within this population. METHODS: We performed a systematic literature search of 10 electronic databases from inception to May 2005. In addition, we searched the internet, contacted all authors of located studies, and contacted the Tibetan Government-in-exile, to locate unpublished studies. We included any study reporting on prevalence of mental illness within the Tibetan refugee populations. We determined study quality according to validation, translation, and interview administration. We calculated proportions with exact confidence intervals. RESULTS: Five studies that met our inclusion criteria (total n = 410). All studies were conducted in North India and 4 were specifically in adult populations. Four studies provided details on the prevalence of torture and previous imprisonment within the populations. The prevalence of post-traumatic stress disorder ranged from 11-23%, anxiety ranged from 25-77%, and major depression ranged from 11.5-57%. CONCLUSION: Our review indicates that the prevalence of serious mental health disorders within this population is elevated. The reported incidence of torture and imprisonment is a possible contributor to the illnesses. Non-government organizations and international communities should be aware of the human rights abuses being levied upon this vulnerable population and the mental health outcomes that may be associated with it.

Journal Article↗
PubMed2005

EDTA chelation therapy for cardiovascular disease: a systematic review.

BACKGROUND: Numerous practitioners of both conventional and complementary and alternative medicine throughout North America and Europe claim that chelation therapy with EDTA is an effective means to both control and treat cardiovascular disease. These claims are controversial, and several randomized controlled trials have been completed dealing with this topic. To address this issue we conducted a systematic review to evaluate the best available evidence for the use of EDTA chelation therapy in the treatment of cardiovascular disease. METHODS: We conducted a systematic review of 7 databases from inception to May 2005. Hand searches were conducted in review articles and in any of the trials found. Experts in the field were contacted and registries of clinical trials were searched for unpublished data. To be included in the final systematic review, the studies had to be randomized controlled clinical trials. RESULTS: A total of seven articles were found assessing EDTA chelation for the treatment of cardiovascular disease. Two of these articles were subgroup analyses of one RCT that looked at different clinical outcomes. Of the remaining five studies, two smaller studies found a beneficial effect whereas the other three exhibited no benefit for cardiovascular disease from the use of EDTA chelation therapy. Adverse effects were rare but those of note included a few cases of hypocalcemia and a single case of increased creatinine in a patient on the EDTA intervention. CONCLUSION: The best available evidence does not support the therapeutic use of EDTA chelation therapy in the treatment of cardiovascular disease. Although not considered to be a highly invasive or harmful therapy, it is possible that the use of EDTA chelation therapy in lieu of proven therapy may result in causing indirect harm to the patient.

Cardiovascular Diseases↗
PubMed2005

Vitamin supplementation for prevention of mother-to-child transmission of HIV and pre-term delivery: a systematic review of randomized trial including more than 2800 women.

BACKGROUND: Observational studies have suggested that low serum vitamin levels are associated with increased mother-to-child transmission (MTCT) of HIV and increased preterm delivery. We aimed to determine the efficacy of vitamins on the prevention of MTCT and preterm delivery by systematically reviewing the available randomized controlled trials [RCTs]. We conducted systematic searches of 7 electronic databases. We extracted data from the RCTs independently, in duplicate. RESULTS: We included 4 trials in our review. Of the three trials on Vitamin A, two suggested no difference in MTCT, while the third and largest trial (n = 1078) suggested an increased risk of MTCT (Relative Risk 1.35, 95% Confidence Interval [CI], 1.11-1.66, P = 0.009). Two of the vitamin A trials addressed the impact of supplementation on pre-term delivery; one suggested a benefit (RR 0.65, 95% CI, 0.44-0.94) and the other no difference. All three vitamin A trials found no significant effect on infant mortality at 1 year. Of the two trials that looked at multivitamin use, only one addressed the prevention of MTCT, and found a non-significant RR of 1.04 (95% CI, 0.82-1.32). Two of the multivitamin trials found no significant effects on pre-term delivery. The single multivitamin trial examining children's mortality at 1 year yielded a non-significant RR of 0.91 (95% CI, 0.17-1.17). CONCLUSION: Randomized trials of vitamins to prevent MTCT have yielded conflicting results without strong evidence of benefit and have failed to exclude the possibility of harm.

Journal Article↗
PubMed2005

Changing attitudes towards polio vaccination: a randomized trial of an evidence-based presentation versus a presentation from a polio survivor.

We compared the impact of epidemiological evidence and anecdotal evidence on changing vaccination attitudes amongst alternative medical students. Ninety-seven students were randomized to either an evidence-based lecture on the benefits of the polio vaccine on population health or a presentation from a visibly affected victim of polio. We compared change in responses to a survey measuring vaccination attitudes between the two groups. The follow-up rate was 73%. There was no statistically significant difference between the two groups in change in response to any of the survey questions. In a post hoc analysis we found that 25% of students were less likely to recommend the vaccine after being provided with evidence supporting vaccination. These findings suggest that confronting deeply held beliefs regarding vaccination may paradoxically strengthen these belief systems.

Adult↗
PubMed2005

The quality of randomized trial reporting in leading medical journals since the revised CONSORT statement.

If randomized controlled trials (RCTs) are to fulfill their potential to allow health care providers to make informed inferences about the validity of the trials upon which they base their clinical practice, then the reporting of key methodological factors must improve. The revised Consolidated Standards for Reporting Trials (CONSORT) were developed to improve the suboptimal reporting of RCTs. We aimed to determine the extent to which RCTs report key methodological factors included in the revised CONSORT recommendations following publication of these recommendations. We conducted an observational study of RCTs published between July 2002 and June 2003 in 5 leading general medicine journals. We determined the proportion and 95% confidence intervals of RCTs that reported sequence generation, allocation concealment, randomization implementation, blinding status of participants, health care providers, outcome assessors, and data analysts, sample size justification, method of analysis (e.g. intention-to-treat), and a participant flow diagram. We included a total of 253 RCTs. RCTs reported: sequence generation 80% (95% CI 75-80%), allocation concealment 48% (95% CI 42-54%), randomization implementation 55% (95% CI 49-61%), blinding status of participants 40% (34-46%), health care providers 17% (95% CI 13-22%), outcome assessors 47% (95% CI 41-53%), data analysts 15% (10-19%), sample size justification 83% (95% CI 78-87%), method of analysis 87% (95% CI 83-91%)), and participant flow diagrams 86% (95% CI 82-90%). Although reporting of some CONSORT recommendations is high, reporting of several essential recommendations remains suboptimal. Authors need to comply with and journals need to enforce reporting of the revised CONSORT recommendations.

Humans↗