Candyce Hamel

AMSTAR 2: a critical appraisal tool for systematic reviews that include randomised or non-randomised studies of healthcare interventions, or both

The number of published systematic reviews of studies of healthcare interventions has increased rapidly and these are used extensively for clinical and policy decisions. Systematic reviews are subject to a range of biases and increasingly include non-randomised studies of interventions. It is important that users can distinguish high quality reviews. Many instruments have been designed to evaluate different aspects of reviews, but there are few comprehensive critical appraisal instruments. AMSTAR was developed to evaluate systematic reviews of randomised trials. In this paper, we report on the updating of AMSTAR and its adaptation to enable more detailed assessment of systematic reviews that include randomised or non-randomised studies of healthcare interventions, or both. With moves to base more decisions on real world observational evidence we believe that AMSTAR 2 will assist decision makers in the identification of high quality systematic reviews, including those based on non-randomised studies of healthcare interventions.

Male responsibility and maternal morbidity: a cross-sectional study in two Nigerian states

BackgroundNigeria continues to have high rates of maternal morbidity and mortality. This is partly associated with lack of adequate obstetric care, partly with high risks in pregnancy, including heavy work. We examined actionable risk factors and underlying determinants at community level in Bauchi and Cross River States of Nigeria, including several related to male responsibility in pregnancy.MethodIn 2009, field teams visited a stratified (urban/rural) last stage random sample of 180 enumeration areas drawn from the most recent censuses in each of Bauchi and Cross River states. A structured questionnaire administered in face-to-face interviews with women aged 15-49 years documented education, income, recent birth history, knowledge and attitudes related to safe birth, and deliveries in the last three years. Closed questions covered female genital mutilation, intimate partner violence (IPV) in the last year, IPV during the last pregnancy, work during the last pregnancy, and support during pregnancy. The outcome was complications in pregnancy and delivery (eclampsia, sepsis, bleeding) among survivors of childbirth in the last three years. We adjusted bivariate and multivariate analysis for clustering.FindingsThe most consistent and prominent of 28 candidate risk factors and underlying determinants for non-fatal maternal morbidity was intimate partner violence (IPV) during pregnancy (ORa 2.15, 95%CIca 1.43-3.24 in Bauchi and ORa 1.5, 95%CI 1.20-2.03 in Cross River). Other spouse-related factors in the multivariate model included not discussing pregnancy with the spouse and, independently, IPV in the last year. Shortage of food in the last week was a factor in both Bauchi (ORa 1.66, 95%CIca 1.22-2.26) and Cross River (ORa 1.32, 95%CIca 1.15-1.53). Female genital mutilation was a factor among less well to do Bauchi women (ORa 2.1, 95%CIca 1.39-3.17) and all Cross River women (ORa 1.23, 95%CIca 1.1-1.5).InterpretationEnhancing clinical protocols and skills can only benefit women in Nigeria and elsewhere. But the violence women experience throughout their lives – genital mutilation, domestic violence, and steep power gradients – is accentuated through pregnancy and childbirth, when women are most vulnerable. IPV especially in pregnancy, womens fear of husbands or partners and not discussing pregnancy are all within mens capacity to change.

Effectiveness of Personal Protective Equipment for Healthcare Workers Caring for Patients with Filovirus Disease: A Rapid Review.

Background A rapid review, guided by a protocol, was conducted to inform development of the World Health Organization’s guideline on personal protective equipment in the context of the ongoing (2013–present) Western African filovirus disease outbreak, with a focus on health care workers directly caring for patients with Ebola or Marburg virus diseases. Methods Electronic databases and grey literature sources were searched. Eligibility criteria initially included comparative studies on Ebola and Marburg virus diseases reported in English or French, but criteria were expanded to studies on other viral hemorrhagic fevers and non-comparative designs due to the paucity of studies. After title and abstract screening (two people to exclude), full-text reports of potentially relevant articles were assessed in duplicate. Fifty-seven percent of extraction information was verified. The Grading of Recommendations Assessment, Development and Evaluation framework was used to inform the quality of evidence assessments. Results Thirty non-comparative studies (8 related to Ebola virus disease) were located, and 27 provided data on viral transmission. Reporting of personal protective equipment components and infection prevention and control protocols was generally poor. Conclusions Insufficient evidence exists to draw conclusions regarding the comparative effectiveness of various types of personal protective equipment. Additional research is urgently needed to determine optimal PPE for health care workers caring for patients with filovirus.

Stop this waste of people, animals and money

Our evidence disputes this view. We spent 12 months rigorously characterizing nearly 2,000 biomedical articles from more than 200 journals thought likely to be predatory. More than half of the corresponding authors hailed from highand upper-middle-income countries as defined by the World Bank. Of the 17% of sampled articles that reported a funding source, the most frequently named funder was the US National Institutes of Health (NIH). The United States produced more articles in our sample than all other countries save India. Harvard University (with 9 articles) in Cambridge, Massachusetts, and the University of Texas (with Predatory journals are easy to please. They seem to accept papers with little regard for quality, at a fraction of the cost charged by mainstream openaccess journals. These supposedly scholarly publishing entities are murky operations, making money by collecting fees while failing to deliver on their claims of being open access and failing to provide services such as peer review and archiving. Despite abundant evidence that the bar is low, not much is known about who publishes in this shady realm, and what the papers are like. Common wisdom assumes that the hazard of predatory publishing is restricted mainly to the developing world. In one famous sting, a journalist for Science sent a purposely flawed paper to 140 presumed predatory titles (and to a roughly equal number of other open-access titles), pretending to be a biologist based in African capital cities. At least two earlier, smaller surveys found that most authors were in India or elsewhere in Asia. A campaign to warn scholars about predatory journals has concentrated its efforts in Africa, China, India, the Middle East and Russia. Frequent, aggressive solicitations from predatory publishers are generally considered merely a nuisance for scientists from rich countries, not a threat to scholarly integrity. Stop this waste of people, animals and money

Does contracting of health care in Afghanistan work? Public and service-users' perceptions and experience

BackgroundIn rebuilding devastated health services, the government of Afghanistan has provided access to basic services mainly by contracting with non-government organisations (NGOs), and more recently the Strengthening Mechanism (SM) of contracting with Provincial Health Offices. Community-based information about the publics views and experience of health services is scarce.MethodsField teams visited households in a stratified random sample of 30 communities in two districts in Kabul province, with health services mainly provided either by an NGO or through the SM and administered a questionnaire about household views, use, and experience of health services, including payments for services and corruption. They later discussed the findings with separate community focus groups of men and women. We calculated weighted frequencies of views and experience of services and multivariate analysis examined the related factors.ResultsThe survey covered 3283 households including 2845 recent health service users. Some 42% of households in the SM district and 57% in the NGO district rated available health services as good. Some 63% of households in the SM district (adjacent to Kabul) and 93% in the NGO district ordinarily used government health facilities. Service users rated private facilities more positively than government facilities. Government service users were more satisfied in urban facilities, if the household head was not educated, if they had enough food in the last week, and if they waited less than 30 minutes. Many households were unwilling to comment on corruption in health services; 15% in the SM district and 26% in the NGO district reported having been asked for an unofficial payment. Despite a policy of free services, one in seven users paid for treatment in government facilities, and three in four paid for medicine outside the facilities. Focus groups confirmed people knew payments were unofficial; they were afraid to talk about corruption.ConclusionsHouseholds used government health services but preferred private services. The experience of service users was similar in the SM and NGO districts. People made unofficial payments in government facilities, whether SM or NGO run. Tackling corruption in health services is an important part of anti-corruption measures in Afghanistan.

Sign Language and Spoken Language for Children With Hearing Loss: A Systematic Review

CONTEXT: Permanent hearing loss affects 1 to 3 per 1000 children and interferes with typical communication development. Early detection through newborn hearing screening and hearing technology provide most children with the option of spoken language acquisition. However, no consensus exists on optimal interventions for spoken language development. OBJECTIVE: To conduct a systematic review of the effectiveness of early sign and oral language intervention compared with oral language intervention only for children with permanent hearing loss. DATA SOURCES: An a priori protocol was developed. Electronic databases (eg, Medline, Embase, CINAHL) from 1995 to June 2013 and gray literature sources were searched. Studies in English and French were included. STUDY SELECTION: Two reviewers screened potentially relevant articles. DATA EXTRACTION: Outcomes of interest were measures of auditory, vocabulary, language, and speech production skills. All data collection and risk of bias assessments were completed and then verified by a second person. Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) was used to judge the strength of evidence. RESULTS: Eleven cohort studies metinclusion criteria, of which 8 included only children with severe to profound hearing loss with cochlear implants. Language development was the most frequently reported outcome. Other reported outcomes included speech and speech perception. LIMITATIONS: Several measures and metrics were reported across studies, and descriptions of interventions were sometimes unclear. CONCLUSIONS: Very limited, and hence insufficient, high-quality evidence exists to determine whethersign language in combination with oral language is more effective than oral language therapy alone. More research is needed to supplement the evidence base.

Do sugar-sweetened beverages cause adverse health outcomes in children? A systematic review protocol

BackgroundChronic diseases, such as cardiovascular disease and type 2 diabetes, impose significant burden to public health. Most chronic diseases are associated with underlying preventable risk factors, such as elevated blood pressure, blood glucose, and lipids, physical inactivity, excessive sedentary behaviours, overweight and obesity, and tobacco usage. Sugar-sweetened beverages are known to be significant sources of additional caloric intake, and given recent attention to their contribution in the development of chronic diseases, a systematic review is warranted. We will assess whether the consumption of sugar-sweetened beverages in adults is associated with adverse health outcomes and what the potential moderating factors are.Methods/DesignOf interest are studies addressing sugar-sweetened beverage consumption, taking a broad perspective. Both direct consumption studies as well as those evaluating interventions that influence consumption (e.g. school policy, educational) will be relevant. Non-specific or multi-faceted behavioural, educational, or policy interventions may also be included subject to the level of evidence that exists for the other interventions/exposures. Comparisons of interest and endpoints of interest are pre-specified. We will include randomized controlled trials, controlled clinical trials, interrupted time series studies, controlled before-after studies, prospective and retrospective comparative cohort studies, case-control studies, and nested case-control designs. The MEDLINE®, Embase, The Cochrane Library, CINAHL, ERIC, and PsycINFO® databases and grey literature sources will be searched. The processes for selecting studies, abstracting data, and resolving conflicts are described. We will assess risk of bias using design-specific tools. To determine sets of confounding variables that should be adjusted for, we have developed causal directed acyclic graphs and will use those to inform our risk of bias assessments. Meta-analysis will be conducted where appropriate; parameters for exploring statistical heterogeneity and effect modifiers are pre-specified. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach will be used for determining the quality of evidence for outcomes.Systematic review registrationPROSPEROCRD42014009638

Reproductive and sexual health in the Maldives: analysis of data from two cross-sectional surveys

BackgroundThe Maldives faces challenges in the provision of health services to its population scattered across many small islands. The government commissioned two separate reproductive health surveys, in 1999 and 2004, to inform their efforts to improve reproductive and sexual health services.MethodsA stratified random sample of islands provided the study base for a cluster survey in 1999 and a follow-up of the same clusters in 2004. In 1999 the household survey enquired about relevant knowledge, attitudes and practices and views and experience of available reproductive health services, with a focus on women aged 15-49 years. The 2004 household survey included some of the same questions as in 1999, and also sought views of men aged 15-64 years. A separate survey about sexual and reproductive health covered 1141 unmarried youth aged 15-24 years.ResultsThere were 4087 household respondents in 1999 and 4102 in 2004. The contraceptive prevalence rate (CPR) for modern methods was 33% in 1999 and 34% in 2004. Antenatal care improved: more women in 2004 than in 1999 had at least four antenatal care visits (90.0% v 65.1%) and took iron supplements (86.7% v 49.6%) during their last pregnancy. The response rate for the youth survey was only 42% (varying from 100% in some islands to 12% in sites in the capital). The youth respondents had some knowledge gaps (one third did not know if people with HIV could look healthy and less than half thought condoms could protect against HIV), and some unhelpful attitudes about gender and reproductive health.ConclusionsThe two household surveys were commissioned as separate entities, with different priorities and data capture methods, rather than being undertaken as a specific research study. The direct comparisons we could make indicated an unchanged CPR and improvements in antenatal care, with the Maldives ahead of the South Asia region for antenatal care. The low response rate in the youth survey limited interpretation of the findings. But the survey highlighted areas requiring attention. Surveys not undertaken primarily for research purposes have important limitations but can provide useful information.

A systematic review of adverse events of rifapentine and isoniazid compared to other treatments for latent tuberculosis infection

Tuberculosis (TB) remains a common cause of death globally. A regimen of 12 doses of isoniazid (INH) and rifapentine given once weekly (INH/RPT‐3) has recently been recommended by the World Health Organization for the treatment of latent TB infection (LTBI). We aimed to determine whether the INH/RPT‐3 regimen had similar or lesser rates of adverse events compared to other LTBI regimens, namely INH for 9 months, INH for 6 months, rifampin for 3 to 4 months, and rifampin plus INH for 3 to 4 months.

Incidence, causes, and consequences of preventable adverse drug reactions occurring in inpatients: A systematic review of systematic reviews

Background Preventable adverse drug reactions (PADRs) in inpatients are associated with harm, including increased length of stay and potential loss of life, and result in elevated costs of care. We conducted an overview of reviews (i.e., a systematic review of systematic reviews) to determine the incidence of PADRs experienced by inpatients. Secondary review objectives were related to assessment of the effects of patient age, setting, and clinical specialty on PADR incidence. Methods The protocol was registered in PROSPERO (CRD42016043220). We performed a search of Medline, Embase, and the Cochrane Library, limiting languages of publication to English and French. We included published systematic reviews that reported quantitative data on the incidence of PADRs in patients receiving acute or ambulatory care in a hospital setting. The full texts of all primary studies for which PADR data were reported in the included reviews were obtained and data relevant to review objectives were extracted. Quality of the included reviews was assessed using the AMSTAR-2 tool. Both narrative summaries of findings and meta-analyses of primary study data were undertaken. Results Thirteen systematic reviews encompassing 37 unique primary studies were included. Across primary studies, the PADR incidence was highly varied, ranging from 0.006 to 13.3 PADRs per 100 patients, with a pooled incidence estimate of 0.59 PADRs per 100 patients. Substantial heterogeneity was present across both reviews and primary studies with respect to review/study objectives, patient age, hospital setting, medical discipline, definitions and assessment tools used, event detection methods, endpoints of interest, and units of measure. Thirteen primary studies used prospective event detection methods and had a pooled PADR incidence of 3.13 (2.87–3.38) PADRs per 100 patients; however, extreme statistical heterogeneity (I2 = 97%) indicated this finding should be considered with caution. Subgroup meta-analyses demonstrated that PADR incidence varied significantly with event detection method (prospective > retrospective > voluntary reporting methods), hospital setting (ICU > wards), and medical discipline (medical > surgical). High statistical heterogeneity (I2 > 80%) was present across all analyses, indicating results should be interpreted with caution. Effects of patient age could not be assessed due to poor reporting of age groups used in primary studies. Discussion The method of event detection appeared to significantly influence PADR incidence, with prospective methods having the highest reported PADR rate. This finding is in agreement with the background literature. High methodological and statistical heterogeneity across primary studies evaluating adverse drug events reduces the validity of the overall PADR incidence derived from the meta-analyses of the pooled data. Data pooled from studies using only prospective methods of event detection should provide an overall estimate closest to the true PADR incidence; however, our estimate should be considered with caution due to the statistical heterogeneity found in this group of studies. Future studies should employ prospective methods of detection. This review demonstrates that the true overall incidence of PADRs is likely much greater than the overall pooled incidence estimate of 0.59 PADRs per 100 patients obtained when event detection method was not taken into consideration.