Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study

OBJECTIVE: To examine whether the association of inadequate or unclear allocation concealment and lack of blinding with biased estimates of intervention effects varies with the nature of the intervention or outcome. DESIGN: Combined analysis of data from three meta-epidemiological studies based on collections of meta-analyses. DATA SOURCES: 146 meta-analyses including 1346 trials examining a wide range of interventions and outcomes. MAIN OUTCOME MEASURES: Ratios of odds ratios quantifying the degree of bias associated with inadequate or unclear allocation concealment, and lack of blinding, for trials with different types of intervention and outcome. A ratio of odds ratios <1 implies that inadequately concealed or non-blinded trials exaggerate intervention effect estimates. RESULTS: In trials with subjective outcomes effect estimates were exaggerated when there was inadequate or unclear allocation concealment (ratio of odds ratios 0.69 (95% CI 0.59 to 0.82)) or lack of blinding (0.75 (0.61 to 0.93)). In contrast, there was little evidence of bias in trials with objective outcomes: ratios of odds ratios 0.91 (0.80 to 1.03) for inadequate or unclear allocation concealment and 1.01 (0.92 to 1.10) for lack of blinding. There was little evidence for a difference between trials of drug and non-drug interventions. Except for trials with all cause mortality as the outcome, the magnitude of bias varied between meta-analyses. CONCLUSIONS: The average bias associated with defects in the conduct of randomised trials varies with the type of outcome. Systematic reviewers should routinely assess the risk of bias in the results of trials, and should report meta-analyses restricted to trials at low risk of bias either as the primary analysis or in conjunction with less restrictive analyses.

Healthcare provider perspectives on parental refusal of medical interventions: A qualitative study

Background. Healthcare providers in pediatrics are faced with parents making medical decisions for their children. Refusal to consent to interventions can have life threatening sequelae, yet healthcare workers are provided little training in handling refusals. The healthcare provider's experience in parental refusal has not been well described, yet is an important first step in addressing this problem. ^ Specific aims. Describe: (1) the decision-making processes made by healthcare providers when parents refuse medical interventions for their children, (2) the source of healthcare workers' skills in handling situations of refusal, and (3) the perspectives of healthcare workers on parental refusals in the inpatient setting. ^ Methods. Nurses, physicians and respiratory therapists (RT) were recruited via e-mail at Texas Children's Hospital (TCH). Interview questions were developed using Social Cognitive Theory constructs and validated. One-on-one in-depth, one hour semi-structured interviews were held at TCH, audio recorded and transcribed. Coding and analysis were done using ATLAS ti. The constant comparative method was applied to describe emergent themes that were reviewed by an independent expert. ^ Results. Interviews have been conducted with nurses (n=6), physicians and practitioners (n=6), social workers (n=3) and RT (n=3) comprising 13 females and 5 males with 3–25 years of experience. Decision-making processes relate to the experience of the caregiver, familiarity with the family, and the acuity of the patient. Healthcare workers' skills were obtained through orientation processes or by trial-and-error. Themes emerged that related to the importance of: (1) Communication, where the initial discussion about a medical procedure should be done with clarity and an understanding of the parents' views; (2) Perceived loss of control by parents, a key factor in their refusal of interventions; and (3) Training, the need for skill development to handle refusals. ^ Conclusions. Effective training involving clarity in communication and a preservation of perceived control by parents is needed to avoid the current trial-and-error experience of healthcare workers in negotiating refusal situations. Such training could lessen the more serious outcomes of parental refusal. ^

Evaluation of obesity interventions targeting adults in the occupational setting

The study of obesity and its causes has evolved into one of the most important public health issues in the United States (Office of Disease Prevention and Health Promotion, 2007). Obesity is linked to several chronic conditions, such as cardiovascular disease, diabetes and some cancers (National Center for Chronic Disease Prevention and Health Promotion, 2008b) and the public health concern resides in the present morbidity and mortality associated with obesity and related conditions (National Heart, Lung and Blood Institute, 1998). Furthermore, obesity and its related conditions present economic challenges to employers in terms of medical health care, sick leave, short-term disability and long-term disability benefits utilized by employees (Østbye, Dement, and Krause, 2007). Recently, articles covering intervention programs targeting obesity in the occupational setting have surfaced in the body of scientific literature. The increased interest in this area stems from the fact that employees in the United States spend more time in the work environment than many industrialized nations, including Japan and most of Western Europe (Organisation for Economic Co-operation and Development, 2006). Moreover, scientific literature supports the idea of investing in healthy human capital to promote productivity and output from employees (Berger, Howell, Nicholson, & Sharda, 2003). The time spent in the work environment, the business need for healthy employees, and the public health concern create an opportunity for planning, implementation and analysis of interventions for effectiveness. This paper aims to identify those intervention programs that focus on the occupational setting related to obesity, to analyze the overall effect of diet, physical fitness and behavioral change interventions targeting overweight and obesity in the occupational setting, and to evaluate the details and effectiveness of components, such as, intervention setting, target participant group, content, industry and length of follow up. Once strengths and weaknesses of the interventions are evaluated, ideas will be suggested for implementation in the future.^

Effectiveness of healthcare waste management interventions in developing countries

Inefficiencies during the management of healthcare waste can give rise to undesirable health effects such as transmission of infections and environmental pollution within and beyond the health facilities generating these wastes. Factors such as prevalence of diseases, conflicts, and the efflux of intellectual capacity make low income countries more susceptible to these adverse health effects. The purpose of this systematic review was to describe the effectiveness of interventions geared towards better managing the generation, collection, transport, treatment and disposal of medical waste, as they have been applied in lower and middle income countries.^ Using a systematic search strategy and evaluation of study quality, this study reviewed the literature for published studies on healthcare waste management interventions carried out in developing countries, specifically the low and lower middle income countries from year 2000 to the current year. From an initially identified set of 829 studies, only three studies ultimately met all inclusion, exclusion and high quality criteria. A multi component intervention in Syrian Arab Republic, conducted in 2007 was aimed at improving waste segregation practice in a hospital setting. There was an increased use of segregation boxes and reduced rates of sharps injury among staff as a result of the intervention. Another study, conducted in 2008, trained medical students as monitors of waste segregation practice in an Indian teaching hospital. There was improved practice in wards and laboratories but not in the intensive care units. The third study, performed in 2008 in China, consisted of modification of the components of a medical waste incinerator to improve efficiency and reduce stack emissions. Gaseous pollutants emitted, except polychlorodibenzofurans (PCDF) were below US EPA permissible exposure limits. Heavy metal residues in the fly ash remained unchanged.^ Due to the paucity of well-designed studies, there is insufficient evidence in literature to conclude on the effectiveness of interventions in low income settings. There is suggestive but insufficient evident that multi-component interventions aimed at improving waste segregation through behavior modification, provision of segregation tools and training of monitors are effective in low income settings.^

Predictive validity of the personal background and preparation survey and effectiveness of targeted interventions among health science community college students

Existing data, collected from 1st-year students enrolled in a major Health Science Community College in the south central United States, for Fall 2010, Spring 2011, Fall 2011 and Spring 2012 semesters as part of the "Online Navigational Assessment Vehicle, Intervention Guidance, and Targeting of Risks (NAVIGATOR) for Undergraduate Minority Student Success" with CPHS approval number HSC-GEN-07-0158, was used for this thesis. The Personal Background and Preparation Survey (PBPS) and a two-question risk self-assessment subscale were administered to students during their 1st-year orientation. The PBPS total risk score, risk self-assessment total and overall scores, and Under Representative Minority Student (URMS) status were recorded. The purpose of this study is to evaluate and report the predictive validity of the indicators identified above for Adverse Academic Status Events (AASE) and Nonadvancement Adverse Academic Status Events (NAASE) as well as the effectiveness of interventions targeted using the PBPS among a diverse population of health science community college students. The predictive validity of the PBPS for AASE has previously been demonstrated among health science professions and graduate students (Johnson, Johnson, Kim, & McKee, 2009a; Johnson, Johnson, McKee, & Kim, 2009b). Data will be analyzed using binary logistic regression and correlation using SPSS 19 statistical package. Independent variables will include baseline- versus intervention-year treatments, PBPS, risk self-assessment, and URMS status. The dependent variables will be binary AASE and NAASE status. ^ The PBPS was the first reliable diagnostic and prescriptive instrument to establish documented predictive validity for student Adverse Academic Status Events (AASE) among students attending health science professional schools. These results extend the documented validity for the PBPS in predicting AASE to a health science community college student population. Results further demonstrated that interventions introduced using the PBPS were followed by approximately one-third reduction in the odds of Nonadvancement Adverse Academic Status Events (NAASE), controlling for URMS status and risk self-assessment scores. These results indicate interventions introduced using the PBPS may have potential to reduce AASE or attrition among URMS and nonURMS attending health science community colleges on a broader scale; positively impacting costs, shortages, and diversity of health science professionals.^

Community-based interventions for the prevention of burns and scalds in children

Background Burns and scalds are a significant cause of morbidity and mortality in children. Successful counter-measures to prevent burn and scald-related injury have been identified. However, evidence indicating the successful roll-out of these counter-measures into the wider community is lacking. Community-based interventions in the form of multi-strategy, multi-focused programmes are hypothesised to result in a reduction in population-wide injury rates. This review tests this hypothesis with regards to burn and scald injury in children. Objectives To assess the effects of community-based interventions, defined as coordinated, multi-strategy initiatives, for reducing burns and scalds in children aged 14 years and under. Search strategy We searched the Cochrane Injuries Group's specialised register, CENTRAL, MEDLINE, EMBASE, CINAHL, PsycINFO, National Research Register and the Web of Knowledge. We also handsearched selected journals and checked the reference lists of selected publications. The searches were last updated in May 2007. Selection criteria Included studies were those that reported changes in medically attended burn and scald-related injury rates in a paediatric population (aged 14 years and under), following the implementation of a controlled community-based intervention. Data collection and analysis Two authors independently assess studies for eligibility and extracted data. Due to heterogeneity between the included studies, a pooled analysis was not appropriate. Main results Of 39 identified studies, four met the criteria for inclusion. Two of the included studies reported a significant decrease in paediatric burn and scald injury in the intervention compared with the control communities. The failure of the other two studies to show a positive result may have been due to limited time-frame for the intervention and/or failure to adequately implement the counter-measures in the communities. Authors' conclusions There are a very limited number of research studies allowing conclusions to be drawn about the effectiveness of community-based injury prevention programmes to prevent burns and scalds in children. There is a pressing need to evaluate high-quality community-based intervention programmes based on efficacious counter-measures to reduce burns and scalds in children. It is important that a framework for considering the problem of burns and scalds in children from a prevention perspective be articulated, and that an evidence-based suite of interventions be combined to create programme guidelines suitable for implementation in communities throughout the world.

Using the theory of planned behaviour to understand binge drinking:the importance of beliefs for developing interventions

Objectives. To elicit students' salient beliefs in relation to binge drinking, and to examine the extent to which individual salient beliefs predict theory of planned behaviour (TPB) constructs in relation to binge drink, and actual drinking behaviour assessed later that evening. Design. Longitudinal, over a single evening. Methods. 192 students were recruited as they entered a campus bar at the beginning of the evening. They completed questionnaires with open-ended questions eliciting beliefs concerning binge drinking, and ratings scales assessing standard TPB constructs in relation to binge drinking. At the end of the evening, 181 completed a second questionnaire and recorded the number of alcoholic drinks they had consumed. Results. Beliefs were reliably coded (all kappas =0.79). Students with higher intentions to binge drink were more likely to believe that their friends approved of binge drinking, and that (lack of) money would make it difficult. Students who reported drinking more alcohol at the end of the evening were more likely to believe that getting drunk is an advantage/what they would like about binge drinking tonight, that their sports teams would approve, and that celebrating, drinking patterns, and environment would make it easy to binge drink. Conclusions. The present study has identified the individually salient beliefs relating to drinking behaviour that the TPB states should be addressed by interventions to alter behaviour, and which that should be assessed as mediators in intervention research. As a whole, these findings highlight the importance of perceived peer norms in binge drinking in this population, and support the idea of interventions to challenge the perception of social pressure to binge drink. ©2011 The British Psychological Society.

Effectiveness of the interventions in preventing the progression of pre-frailty and frailty in older adults:a systematic review protocol

REVIEW QUESTION / OBJECTIVE : The objective of this review is to identify the effectiveness of the interventions in preventing progression of pre-frailty and frailty in older adults. More specifically, the review questions are: - What is the effectiveness of interventions in preventing or reducing frailty in older adults? - How does effectiveness vary with degree of frailty? - Are there factors that influence the effectiveness of interventions? - What is the economic feasibility of interventions for pre-frailty and frailty? INCLUSION CRITERIA : Types of participants This review will consider studies that include older adults (female and male) aged 65 years and over, explicitly identified as pre-frail or frail by the researchers or associated medical professionals according to a pre-specified scale or index, and who have received health care and support services in any type of setting (primary care, nursing homes, hospitals). This review will exclude studies that: - Include participants who have been selected because they have one specific illness - Consider people with a terminal diagnosis only. - Types of intervention(s)/phenomena of interest: The clinical/medical component of the review will consider studies that evaluate any type of interventions to prevent the progression of pre-frailty and frailty in older adults. These interventions will include, but will not be limited to, physical activity, multifactorial intervention, psychosocial intervention, health and social care provision, and cognitive, nutrition or medication/medical maintenance and adherence focused interventions. The economic component of the review will consider studies that have performed any type of health economic analysis of ...

Identifying the Structure and Fate of Wastewater Derived Organic Micropollutants by High-resolution Mass Spectrometry

Human activities represent a significant burden on the global water cycle, with large and increasing demands placed on limited water resources by manufacturing, energy production and domestic water use. In addition to changing the quantity of available water resources, human activities lead to changes in water quality by introducing a large and often poorly-characterized array of chemical pollutants, which may negatively impact biodiversity in aquatic ecosystems, leading to impairment of valuable ecosystem functions and services. Domestic and industrial wastewaters represent a significant source of pollution to the aquatic environment due to inadequate or incomplete removal of chemicals introduced into waters by human activities. Currently, incomplete chemical characterization of treated wastewaters limits comprehensive risk assessment of this ubiquitous impact to water. In particular, a significant fraction of the organic chemical composition of treated industrial and domestic wastewaters remains uncharacterized at the molecular level. Efforts aimed at reducing the impacts of water pollution on aquatic ecosystems critically require knowledge of the composition of wastewaters to develop interventions capable of protecting our precious natural water resources.

The goal of this dissertation was to develop a robust, extensible and high-throughput framework for the comprehensive characterization of organic micropollutants in wastewaters by high-resolution accurate-mass mass spectrometry. High-resolution mass spectrometry provides the most powerful analytical technique available for assessing the occurrence and fate of organic pollutants in the water cycle. However, significant limitations in data processing, analysis and interpretation have limited this technique in achieving comprehensive characterization of organic pollutants occurring in natural and built environments. My work aimed to address these challenges by development of automated workflows for the structural characterization of organic pollutants in wastewater and wastewater impacted environments by high-resolution mass spectrometry, and to apply these methods in combination with novel data handling routines to conduct detailed fate studies of wastewater-derived organic micropollutants in the aquatic environment.

In Chapter 2, chemoinformatic tools were implemented along with novel non-targeted mass spectrometric analytical methods to characterize, map, and explore an environmentally-relevant “chemical space” in municipal wastewater. This was accomplished by characterizing the molecular composition of known wastewater-derived organic pollutants and substances that are prioritized as potential wastewater contaminants, using these databases to evaluate the pollutant-likeness of structures postulated for unknown organic compounds that I detected in wastewater extracts using high-resolution mass spectrometry approaches. Results showed that application of multiple computational mass spectrometric tools to structural elucidation of unknown organic pollutants arising in wastewaters improved the efficiency and veracity of screening approaches based on high-resolution mass spectrometry. Furthermore, structural similarity searching was essential for prioritizing substances sharing structural features with known organic pollutants or industrial and consumer chemicals that could enter the environment through use or disposal.

I then applied this comprehensive methodological and computational non-targeted analysis workflow to micropollutant fate analysis in domestic wastewaters (Chapter 3), surface waters impacted by water reuse activities (Chapter 4) and effluents of wastewater treatment facilities receiving wastewater from oil and gas extraction activities (Chapter 5). In Chapter 3, I showed that application of chemometric tools aided in the prioritization of non-targeted compounds arising at various stages of conventional wastewater treatment by partitioning high dimensional data into rational chemical categories based on knowledge of organic chemical fate processes, resulting in the classification of organic micropollutants based on their occurrence and/or removal during treatment. Similarly, in Chapter 4, high-resolution sampling and broad-spectrum targeted and non-targeted chemical analysis were applied to assess the occurrence and fate of organic micropollutants in a water reuse application, wherein reclaimed wastewater was applied for irrigation of turf grass. Results showed that organic micropollutant composition of surface waters receiving runoff from wastewater irrigated areas appeared to be minimally impacted by wastewater-derived organic micropollutants. Finally, Chapter 5 presents results of the comprehensive organic chemical composition of oil and gas wastewaters treated for surface water discharge. Concurrent analysis of effluent samples by complementary, broad-spectrum analytical techniques, revealed that low-levels of hydrophobic organic contaminants, but elevated concentrations of polymeric surfactants, which may effect the fate and analysis of contaminants of concern in oil and gas wastewaters.

Taken together, my work represents significant progress in the characterization of polar organic chemical pollutants associated with wastewater-impacted environments by high-resolution mass spectrometry. Application of these comprehensive methods to examine micropollutant fate processes in wastewater treatment systems, water reuse environments, and water applications in oil/gas exploration yielded new insights into the factors that influence transport, transformation, and persistence of organic micropollutants in these systems across an unprecedented breadth of chemical space.

Psychosocial interventions for reducing the harmful effects of war and conflict-related violence on young children aged 0-11 years (Protocol)

Children living in a conflict-affected society can be exposed to daily violence in their communities and, as such, may be at risk of a range of harmful effects. Psychosocial interventions in conflict-affected areas aim to improve outcomes for children and can be treatment or prevention focused. The literature mainly focuses on psychological effects e.g. PTSD or anxiety disorders. Until recently, rather less attention was paid to the influence of mediating variables (cultural context or personal capacity) and their importance in reducing harmful effects.

This systematic review will assess the effectiveness of interventions in reducing the harmful effects of war and conflict-related violence on young children. It will also determine whether the interventions have differential effects depending on age and gender.

Children living in conflict-affected societies have unique needs for support and services. As such, any intervention delivered should be designed and implemented using the best available evidence. Professionals, policy makers and service provider will benefit from this review as to ‘what works’ for this vulnerable population and further exploration (via a Ph.D.) is planned to further extend the impact of this review.

Pathologies of Patriarchy: Death, Suffering, Care and Coping in the Gendered Gaps of HIV/AIDS Interventions in Nigeria

Thesis (Ph.D.)--University of Washington, 2016-08

Do Psychosocial Interventions Improve Quality of Life and Wellbeing in Adults with Neuromuscular Disorders? A Systematic Review and Narrative Synthesis

Background: Quality of life and well-being are frequently restricted in adults with neuromuscular disorders. As such, identification of appropriate interventions is imperative. Objective: The objective of this paper was to systematically review and critically appraise quantitative studies (RCTs, controlled trials and cohort studies) of psychosocial interventions designed to improve quality of life and well-being in adults with neuromuscular disorders. Method: A systematic review of the published and unpublished literature was conducted. Studies meeting inclusion criteria were appraised using a validated quality assessment tool and results presented in a narrative synthesis. Results: Out of 3,136 studies identified, ten studies met criteria for inclusion within the review. Included studies comprised a range of interventions including: cognitive behavioural therapy, dignity therapy, hypnosis, expressive disclosure, gratitude lists, group psychoeducation and psychologically informed rehabilitation. Five of the interventions were for patients with Amyotrophic Lateral Sclerosis (ALS). The remainder were for patients with post-polio syndrome, muscular dystrophies and mixed disorders, such as Charcot-Marie-Tooth disease, myasthenia gravis and myotonic dystrophy. Across varied interventions and neuromuscular disorders, seven studies reported a short-term beneficial effect of intervention on quality of life and well-being. Whilst such findings are encouraging, widespread issues with the methodological quality of these studies significantly compromised the results. Conclusion: There is no strong evidence that psychosocial interventions improve quality of life and well-being in adults with neuromuscular disorders, due to a paucity of high quality research in this field. Multi-site, randomised controlled trials with active controls, standardised outcome measurement and longer term follow-ups are urgently required.

Effectiveness of non-pharmacological interventions to prevent falls in older people: a systematic overview. The SENATOR Project ONTOP Series

Background: Falls are common events in older people, which cause considerable morbidity and mortality. Non-pharmacological interventions are an important approach to prevent falls. There are a large number of systematic reviews of non-pharmacological interventions, whose evidence needs to be synthesized in order to facilitate evidence-based clinical decision making. Objectives: To systematically examine reviews and meta-analyses that evaluated non-pharmacological interventions to prevent falls in older adults in the community, care facilities and hospitals. Methods: We searched the electronic databases Pubmed, the Cochrane Database of Systematic Reviews, EMBASE, CINAHL, PsycINFO, PEDRO and TRIP from January 2009 to March 2015, for systematic reviews that included at least one comparative study, evaluating any non-pharmacological intervention, to prevent falls amongst older adults. The quality of the reviews was assessed using AMSTAR and ProFaNE taxonomy was used to organize the interventions. Results: Fifty-nine systematic reviews were identified which consisted of single, multiple and multi-factorial non-pharmacological interventions to prevent falls in older people. The most frequent ProFaNE defined interventions were exercises either alone or combined with other interventions, followed by environment/assistive technology interventions comprising environmental modifications, assistive and protective aids, staff education and vision assessment/correction. Knowledge was the third principle class of interventions as patient education. Exercise and multifactorial interventions were the most effective treatments to reduce falls in older adults, although not all types of exercise were equally effective in all subjects and in all settings. Effective exercise programs combined balance and strength training. Reviews with a higher AMSTAR score were more likely to contain more primary studies, to be updated and to perform meta-analysis. Conclusions: The aim of this overview of reviews of non-pharmacological interventions to prevent falls in older people in different settings, is to support clinicians and other healthcare workers with clinical decision-making by providing a comprehensive perspective of findings.

What Are Effective Program Characteristics of Self-Management Interventions in Patients With Heart Failure? : An Individual Patient Data Meta-analysis

Background To identify those characteristics of self-management interventions in patients with heart failure (HF) that are effective in influencing health-related quality of life, mortality, and hospitalizations. Methods and Results Randomized trials on self-management interventions conducted between January 1985 and June 2013 were identified and individual patient data were requested for meta-analysis. Generalized mixed effects models and Cox proportional hazard models including frailty terms were used to assess the relation between characteristics of interventions and health-related outcomes. Twenty randomized trials (5624 patients) were included. Longer intervention duration reduced mortality risk (hazard ratio 0.99, 95% confidence interval [CI] 0.97–0.999 per month increase in duration), risk of HF-related hospitalization (hazard ratio 0.98, 95% CI 0.96–0.99), and HF-related hospitalization at 6 months (risk ratio 0.96, 95% CI 0.92–0.995). Although results were not consistent across outcomes, interventions comprising standardized training of interventionists, peer contact, log keeping, or goal-setting skills appeared less effective than interventions without these characteristics. Conclusion No specific program characteristics were consistently associated with better effects of self-management interventions, but longer duration seemed to improve the effect of self-management interventions on several outcomes. Future research using factorial trial designs and process evaluations is needed to understand the working mechanism of specific program characteristics of self-management interventions in HF patients.

Modeling the risk of malaria for travelers to areas with stable malaria transmission

Background: Malaria is an important threat to travelers visiting endemic regions. The risk of acquiring malaria is complex and a number of factors including transmission intensity, duration of exposure, season of the year and use of chemoprophylaxis have to be taken into account estimating risk. Materials and methods: A mathematical model was developed to estimate the risk of non-immune individual acquiring falciparum malaria when traveling to the Amazon region of Brazil. The risk of malaria infection to travelers was calculated as a function of duration of exposure and season of arrival. Results: The results suggest significant variation of risk for non-immune travelers depending on arrival season, duration of the visit and transmission intensity. The calculated risk for visitors staying longer than 4 months during peak transmission was 0.5% per visit. Conclusions: Risk estimates based on mathematical modeling based on accurate data can be a valuable tool in assessing risk/benefits and cost/benefits when deciding on the value of interventions for travelers to malaria endemic regions.