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1.  Influences on participant reporting in the World Health Organisation drugs exposure pregnancy registry; a qualitative study 
Background
The World Health Organisation has designed a pregnancy registry to investigate the effect of maternal drug use on pregnancy outcomes in resource-limited settings. In this sentinel surveillance system, detailed health and drug use data are prospectively collected from the first antenatal clinic visit until delivery. Over and above other clinical records, the registry relies on accurate participant reports about the drugs they use. Qualitative methods were incorporated into a pilot registry study during 2010 and 2011 to examine barriers to women reporting these drugs and other exposures at antenatal clinics, and how they might be overcome.
Methods
Twenty-seven focus group discussions were conducted in Ghana, Kenya and Uganda with a total of 208 women either enrolled in the registry or from its source communities. A question guide was designed to uncover the types of exposure data under- or inaccurately reported at antenatal clinics, the underlying reasons, and how women prefer to be asked questions. Transcripts were analysed thematically.
Results
Women said it was important for them to report everything they had used during pregnancy. However, they expressed reservations about revealing their consumption of traditional, over-the-counter medicines and alcohol to antenatal staff because of anticipated negative reactions. Some enrolled participants' improved relationship with registry staff facilitated information sharing and the registry tools helped overcome problems with recall and naming of medicines. Decisions about where women sought care, which influenced medicines used and antenatal clinic attendance, were influenced by pressure within and outside of the formal healthcare system to conform to conflicting behaviours. Conversations also reflected women's responsibilities for producing a healthy baby.
Conclusions
Women in this study commonly take traditional medicines in pregnancy, and to a lesser extent over-the-counter medicines and alcohol. The World Health Organisation pregnancy registry shows potential to enhance their reporting of these substances at the antenatal clinic. However, more work is needed to find optimal techniques for eliciting accurate reports, especially where the detail of constituents may never be known. It will also be important to find ways of sustaining such drug exposure surveillance systems in busy antenatal clinics.
doi:10.1186/s12913-014-0525-1
PMCID: PMC4229602  PMID: 25367130
Pregnancy; Registry; Drug safety; Ghana; Kenya; Uganda; Validity; Qualitative; Alcohol; Medicine use
2.  On the Home Front: Stress for Recently Deployed Army Couples 
Family process  2011;50(2):235-247.
Military couples who have experienced deployment and reintegration in current U.S. military operations frequently experience stress regarding the dangers and effects of such experiences. The current study evaluated a sample of 300 couples with an active duty Army husband and civilian spouse who experienced a deployment within the year prior to the survey (conducted in 2007). Wives generally reported greater levels of emotional stress compared to husbands. Overall, higher levels of stress were found for couples who reported lower income and greater economic strain, perceive the need for more support and are unsure about how to get support, have more marital conflict, and are generally less satisfied with the Army and the current mission. Husband combat exposure was also associated with more stress for husbands and wives. Additionally, for wives, stress was related to greater child behavior problems and a sense of less Army concern for families. The results suggest areas of intervention with military couples to help them cope with the challenges of military life and deployment.
doi:10.1111/j.1545-5300.2011.01357.x
PMCID: PMC4209478  PMID: 21564063
3.  Initiating change locally in bullying and aggression through the school environment (INCLUSIVE): study protocol for a cluster randomised controlled trial 
Trials  2014;15(1):381.
Background
Systematic reviews suggest that interventions that address school organisation are effective in reducing victimisation and bullying. We successfully piloted a school environment intervention modified from international studies to incorporate ‘restorative justice’ approaches. This trial aims to establish the effectiveness and cost-effectiveness of the INCLUSIVE intervention in reducing aggression and bullying in English secondary schools.
Methods
Design: cluster randomised trial.
Participants: 40 state-supported secondary schools. Outcomes assessed among the cohort of students in year 8 (n = approximately 6,000) in intervention year 1.
Intervention: INCLUSIVE is a school-led intervention which combines changes to the school environment with the promotion of social and emotional skills and restorative practices through: the formation of a school action group involving students and staff supported by an external facilitator to review local data on needs, determine priorities, and develop and implement an action plan for revising relevant school policies/rules and other actions to improve relationships at school and reduce aggression; staff training in restorative practices; and a new social and emotional skills curriculum. The intervention will be delivered by schools supported in the first two years by educational facilitators independent of the research team, with a third locally facilitated intervention year.
Comparator: normal practice.
Outcomes: primary: 2 primary outcomes at student level assessed at baseline and at 36 months: Aggressive behaviours in school: Edinburgh Study of Youth Transitions and Crime school misbehaviour subscale (ESYTC)Bullying and victimisation: Gatehouse Bullying Scale (GBS)
Secondary outcomes assessed at baseline, 24 and 36 months will include measures relating to the economic evaluation, psychosocial outcomes in students and staff and school-level truancy and exclusion rates.
Sample size: 20 schools per arm will provide 90% power to identify an effect size of 0.25 SD with a 5% significance level.
Randomisation: eligible consenting schools will be randomised stratified for single sex versus mixed sex schools, school-level deprivation and measures of school attainment.
Discussion
The trial will be run by independent research and intervention teams and supervised by a Trial Steering Committee and a Data Monitoring Committee (DMC).
Trial registration
Current Controlled Trials ISRCTN10751359 (Registered 11 March 2014)
doi:10.1186/1745-6215-15-381
PMCID: PMC4197327  PMID: 25269491
Bullying; Cluster randomised trial; School intervention; Violence prevention; Adolescent
4.  Non-Participation during Azithromycin Mass Treatment for Trachoma in The Gambia: Heterogeneity and Risk Factors 
Background
There is concern that untreated individuals in mass drug administration (MDA) programs for neglected tropical diseases can reduce the impact of elimination efforts by maintaining a source of transmission and re-infection.
Methodology/Principal Findings
Treatment receipt was recorded against the community census during three MDAs with azithromycin for trachoma in The Gambia, a hypo-endemic setting. Predictors of non-participation were investigated in 1–9 year olds using random effects logistic regression of cross-sectional data for each MDA. Two types of non-participators were identified: present during MDA but not treated (PNT) and eligible for treatment but absent during MDA (EBA). PNT and EBA children were compared to treated children separately. Multivariable models were developed using baseline data and validated using year one and two data, with a priori adjustment for previous treatment status. Analyses included approximately 10000 children at baseline and 5000 children subsequently. There was strong evidence of spatial heterogeneity, and persistent non-participation within households and individuals. By year two, non-participation increased significantly to 10.4% overall from 6.2% at baseline, with more, smaller geographical clusters of non-participating households. Multivariable models suggested household level predictors of non-participation (increased time to water and household head non-participation for both PNT and EBA; increased household size for PNT status only; non-inclusion in a previous trachoma examination survey and younger age for EBA only). Enhanced coverage efforts did not decrease non-participation. Few infected children were detected at year three and only one infected child was EBA previously. Infected children were in communities close to untreated endemic areas with higher rates of EBA non-participation during MDA.
Conclusions/Significance
In hypo-endemic settings, with good coverage and no association between non-participation and infection, efforts to improve participation during MDA may not be required. Further research could investigate spatial hotspots of infection and non-participation in other low and medium prevalence settings before allocating resources to increase participation.
Author Summary
As the target year for Global Elimination of Trachoma (GET2020) approaches, the scale up of mass drug administration (MDA) with azithromycin will lead to more endemic areas becoming low prevalence settings. In such areas, identification of those at highest risk of Chlamydia trachomatis infection and at highest risk of non-participation during MDA could inform control planning, especially if correlation is present. We investigated non-participation in children aged 1–9 years during three annual MDAs in The Gambia, a low prevalence setting. We found evidence that non-participation is associated with household membership and decision-making, as seen in medium and high prevalence settings in East Africa. In addition, we demonstrate geographical heterogeneity (spatial clustering) of non-participation, persistent non-participation behaviour over time and different non-participator types. Between the first and third MDA, non-participation increased significantly overall from 6.2% to 10.4%, whilst spatial clusters became smaller with non-participation more focused in single households or small groups of households. There was no evidence of association between infection and non-participation. In low prevalence settings with no evidence to suggest non-participation as a risk factor for infection, resources to improve participation may not be required. Spatial hotspot analysis could address this research question in areas with more infection.
doi:10.1371/journal.pntd.0003098
PMCID: PMC4148234  PMID: 25165994
5.  Predictors of Extradyadic Sexual Involvement in Unmarried Opposite-Sex Relationships 
Journal of sex research  2012;50(6):598-610.
Using a sample of unmarried individuals in opposite-sex romantic relationships that was representative of the United States (N = 933), the current study prospectively evaluated predictors of extradyadic sexual involvement (ESI) over 20-months. Data were collected with self-report questionnaires via U.S. mail. Participants were 18–35 years old and were 34.9% male. Variables tested as predictors included involved-partner factors such as demographic characteristics, sexual history, and mental health, as well as relationship-related factors including communication, sexual dynamics, and aspects of commitment. Future ESI was significantly predicted by lower baseline relationship satisfaction, negative communication, aggression, lower dedication, absence of plans to marry, suspicion of partner’s ESI, and partner’s ESI. It was not predicted by sexual frequency, sexual dissatisfaction, or cohabitation status. Although more problems with alcohol use, more previous sex partners, and having parents who never married one another predicted future ESI, there were many involved-partner demographic factors that did not predict later ESI (e.g., gender, age, education, religiosity, having divorced parents, and having children). None of the results were moderated by gender. These results suggest that compared to demographic characteristics, relationship dynamics and negative interactions are more strongly predictive of future ESI. Implications for future research are discussed.
doi:10.1080/00224499.2012.666816
PMCID: PMC3407304  PMID: 22524318
extradyadic sexual involvement; unmarried; cohabitation; relationship quality; infidelity
6.  Using health worker opinions to assess changes in structural components of quality in a Cluster Randomized Trial 
Background
The ‘resource readiness’ of health facilities to provide effective services is captured in the structure component of the classical Donabedian paradigm often used for assessment of the quality of care in the health sector. Periodic inventories are commonly used to confirm the presence (or absence) of equipment or drugs by physical observation or by asking those in charge to indicate whether an item is present or not. It is then assumed that this point observation is representative of the everyday status. However the availability of an item (consumables) may vary. Arguably therefore a more useful assessment for resources would be one that captures this fluctuation in time. Here we report an approach that may circumvent these difficulties.
Methods
We used self-administered questionnaires (SAQ) to seek health worker views of availability of key resources supporting paediatric care linked to a cluster randomized trial of a multifaceted intervention aimed at improving this care conducted in eight rural Kenyan district hospitals. Four hospitals received a full intervention and four a partial intervention. Data were collected pre-intervention and after 6 and 18 months from health workers in three clinical areas asked to score item availability using an 11-point scale. Mean scores for items common to all 3 areas and mean scores for items allocated to domains identified using exploratory factor analysis (EFA) were used to describe availability and explore changes over time.
Results
SAQ were collected from 1,156 health workers. EFA identified 11 item domains across the three departments. Mean availability scores for these domains were often <5/10 at baseline reflecting lack of basic resources such as oxygen, nutrition and second line drugs. An improvement in mean scores occurred in 8 out of 11 domains in both control and intervention groups. A calculation of difference in difference of means for intervention vs. control suggested an intervention effect resulting in greater changes in 5 out of 11 domains.
Conclusion
Using SAQ data to assess resource availability experienced by health workers provides an alternative to direct observations that provide point prevalence estimates. Further the approach was able to demonstrate poor access to resources, change over time and variability across place.
doi:10.1186/1472-6963-14-282
PMCID: PMC4082497  PMID: 24974166
Quality improvement; Child health; Paediatrics; Health services research
7.  Reasons for Divorce and Recollections of Premarital Intervention: Implications for Improving Relationship Education 
Couple & family psychology  2013;2(2):131-145.
The study presents findings from interviews of 52 divorced individuals who received the Prevention and Relationship Enhancement Program (PREP) while engaged to be married. Using both quantitative and qualitative methods, the study sought to understand participant reasons for divorce (including identification of the “final straw”) in order to understand if the program covered these topics effectively. Participants also provided suggestions based on their premarital education experiences so as to improve future relationship education efforts. The most commonly reported major contributors to divorce were lack of commitment, infidelity, and conflict/arguing. The most common “final straw” reasons were infidelity, domestic violence, and substance use. More participants blamed their partners than blamed themselves for the divorce. Recommendations from participants for the improvement of premarital education included receiving relationship education before making a commitment to marry (when it would be easier to break-up), having support for implementing skills outside of the educational setting, and increasing content about the stages of typical marital development. These results provide new insights into the timing and content of premarital and relationship education.
doi:10.1037/a0032025
PMCID: PMC4012696  PMID: 24818068
divorce; relationship education; couples; premarital; prevention
8.  Implementing telestroke to reduce the burden of stroke in Louisiana 
Cardiovascular diseases (heart diseases and stroke) are the leading cause of death in the United States. People living in rural areas have disproportionately high mortality rates due to stroke mainly due to lack of specialty services. Timely intervention is a critical factor in determining the prognosis for acute stroke and thousands of lives can be saved by recognizing/treating a stroke patient within an hour. This paper deals with telestroke, a unique intervention implemented in Louisiana that incorporated latest technology to integrate with advanced clinical protocols in treating acute stroke. People living in remote and rural areas of Louisiana were greatly benefited from this initiative and several lives saved as a result of timely intervention. Expanding these initiatives to larger populations and other states will greatly reduce the stroke mortality.
doi:10.1016/j.jcdr.2013.02.015
PMCID: PMC3758068  PMID: 24023480
Stroke; Telemedicine; Disparities
9.  Relationships between Soldiers' PTSD Symptoms and Spousal Communication during Deployment 
Journal of traumatic stress  2011;24(3):352-355.
Social support, including support from spouses, may buffer against posttraumatic stress disorder (PTSD) symptoms. The current study assessed whether the frequency of spousal communication during a recent deployment, a potentially important source of support for soldiers, was related to postdeployment PTSD symptoms. Data came from 193 married male Army soldiers who returned from military deployment within the past year. For communication modalities conceptualized as “delayed” (i.e., letters, care packages, and e-mails), greater spousal communication frequency during deployment was associated with lower postdeployment PTSD symptom scores, but only at higher levels of marital satisfaction (p = .009). At lower marital satisfaction, more “delayed” spousal communication during deployment was associated with more PTSD symptoms (p = .042). For communication modalities conceptualized as “interactive” (i.e., phone calls, instant messaging, instant messaging with video), the same general direction of effects was seen, but the interaction between communication frequency and marital satisfaction predicting PTSD symptoms did not reach significance.
doi:10.1002/jts.20649
PMCID: PMC3914218  PMID: 21618290
10.  Impact of Intermittent Screening and Treatment for Malaria among School Children in Kenya: A Cluster Randomised Trial 
PLoS Medicine  2014;11(1):e1001594.
Katherine Halliday and colleagues conducted a cluster randomized controlled trial in Kenyan school children in an area of low to moderate malaria transmission to investigate the effect of intermittent screening and treatment of malaria on health and education.
Please see later in the article for the Editors' Summary
Background
Improving the health of school-aged children can yield substantial benefits for cognitive development and educational achievement. However, there is limited experimental evidence of the benefits of alternative school-based malaria interventions or how the impacts of interventions vary according to intensity of malaria transmission. We investigated the effect of intermittent screening and treatment (IST) for malaria on the health and education of school children in an area of low to moderate malaria transmission.
Methods and Findings
A cluster randomised trial was implemented with 5,233 children in 101 government primary schools on the south coast of Kenya in 2010–2012. The intervention was delivered to children randomly selected from classes 1 and 5 who were followed up for 24 months. Once a school term, children were screened by public health workers using malaria rapid diagnostic tests (RDTs), and children (with or without malaria symptoms) found to be RDT-positive were treated with a six dose regimen of artemether-lumefantrine (AL). Given the nature of the intervention, the trial was not blinded. The primary outcomes were anaemia and sustained attention. Secondary outcomes were malaria parasitaemia and educational achievement. Data were analysed on an intention-to-treat basis.
During the intervention period, an average of 88.3% children in intervention schools were screened at each round, of whom 17.5% were RDT-positive. 80.3% of children in the control and 80.2% in the intervention group were followed-up at 24 months. No impact of the malaria IST intervention was observed for prevalence of anaemia at either 12 or 24 months (adjusted risk ratio [Adj.RR]: 1.03, 95% CI 0.93–1.13, p = 0.621 and Adj.RR: 1.00, 95% CI 0.90–1.11, p = 0.953) respectively, or on prevalence of P. falciparum infection or scores of classroom attention. No effect of IST was observed on educational achievement in the older class, but an apparent negative effect was seen on spelling scores in the younger class at 9 and 24 months and on arithmetic scores at 24 months.
Conclusion
In this setting in Kenya, IST as implemented in this study is not effective in improving the health or education of school children. Possible reasons for the absence of an impact are the marked geographical heterogeneity in transmission, the rapid rate of reinfection following AL treatment, the variable reliability of RDTs, and the relative contribution of malaria to the aetiology of anaemia in this setting.
Trial registration
www.ClinicalTrials.gov NCT00878007
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Every year, more than 200 million cases of malaria occur worldwide and more than 600,000 people, mostly children living in sub-Saharan Africa, die from this mosquito-borne parasitic infection. Malaria can be prevented by controlling the night-biting mosquitoes that transmit Plasmodium parasites and by sleeping under insecticide-treated nets to avoid mosquito bites. Infection with malaria parasites causes recurring flu-like symptoms and needs to be treated promptly with antimalarial drugs to prevent the development of anaemia (a reduction in red blood cell numbers) and potentially fatal damage to the brain and other organs. Treatment also reduces malaria transmission. In 1998, the World Health Organization and several other international bodies established the Roll Back Malaria Partnership to provide a coordinated global approach to fighting malaria. In 2008, the Partnership launched its Global Malaria Action Plan, which aims to control malaria to reduce the current burden, to eliminate malaria over time country by country, and, ultimately, to eradicate malaria.
Why Was This Study Done?
In recent years, many malaria-endemic countries (countries where malaria is always present) have implemented successful malaria control programs and reduced malaria transmission levels. In these countries, immunity to malaria is now acquired more slowly than in the past, the burden of clinical malaria is shifting from very young children to older children, and infection rates with malaria parasites are now highest among school-aged children. Chronic untreated Plasmodium infection, even when it does not cause symptoms, can negatively affect children's health, cognitive development (the acquisition of thinking skills), and educational achievement. However, little is known about how school-based malaria interventions affect the health of children or their educational outcomes. In this cluster randomized trial, the researchers investigate the effect of intermittent screening and treatment (IST) of malaria on the health and education of school children in a rural area of southern Kenya with low-to-moderate malaria transmission. Cluster randomized trials compare the outcomes of groups (“clusters”) of people randomly assigned to receive alternative interventions. IST of malaria involves periodical screening of individuals for Plasmodium infection followed by treatment of everyone who is infected, including people without symptoms, with antimalarial drugs.
What Did the Researchers Do and Find?
The researchers enrolled more than 5,000 children aged between 5 and 20 years from 101 government primary schools in Kenya into their 24-month study. Half the schools were randomly selected to receive the IST intervention (screening once a school term for infection with a malaria parasite with a rapid diagnostic test [RDT] and treatment of all RDT-positive children, with or without malaria symptoms, with six doses of artemether-lumefantrine), which was delivered to randomly selected children from classes 1 and 5 (which contained younger and older children, respectively). During the study, 17.5% of the children in the intervention schools were RDT-positive at screening on average. The prevalences of anaemia and parasitemia (the proportion of children with anaemia and the proportion who were RDT-positive, respectively) were similar in the intervention and control groups at the 12-month and 24-month follow-up and there was no difference between the two groups in classroom attention scores at the 9-month and 24-month follow-up. The IST intervention also had no effect on educational achievement in the older class but, unexpectedly, appeared to have a negative effect on spelling and arithmetic scores in the younger class.
What Do These Findings Mean?
These findings indicate that, in this setting in Kenya, IST as implemented in this study provided no health or education benefits to school children. The finding that the educational achievement of younger children was lower in the intervention group than in the control group may be a chance finding or may indicate that apprehension about the finger prick needed to take blood for the RDT had a negative effect on the performance of younger children during educational tests. The researchers suggest that their failure to demonstrate that the school-based IST intervention they tested had any long-lasting health or education benefits may be because, in a low-to-moderate malaria transmission setting, most of the children screened did not require treatment and those who did lived in focal high transmission regions, where rapid re-infection occurred between screening rounds. Importantly, however, these findings suggest that school screening using RDT could be an efficient way to identify transmission hotspots in communities that should be targeted for malaria control interventions.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001594.
This study is further discussed in a PLOS Medicine Perspective by Lorenz von Seidlein
Information is available fro m the World Health Organization on malaria (in several languages); the 2012 World Malaria Report provides details of the current global malaria situation
The US Centers for Disease Control and Prevention provide information on malaria (in English and Spanish), including a selection of personal stories about children with malaria
Information is available from the Roll Back Malaria Partnership on the global control of malaria and on the Global Malaria Action Plan (in English and French); its website includes a fact sheet about malaria in Kenya
MedlinePlus provides links to additional information on malaria (in English and Spanish)
More information about this trial is available
More information about malaria control in schools is provided in the toolkit
doi:10.1371/journal.pmed.1001594
PMCID: PMC3904819  PMID: 24492859
11.  How experiences become data: the process of eliciting adverse event, medical history and concomitant medication reports in antimalarial and antiretroviral interaction trials 
Background
Accurately characterizing a drug’s safety profile is essential. Trial harm and tolerability assessments rely, in part, on participants’ reports of medical histories, adverse events (AEs), and concomitant medications. Optimal methods for questioning participants are unclear, but different methods giving different results can undermine meta-analyses. This study compared methods for eliciting such data and explored reasons for dissimilar participant responses.
Methods
Participants from open-label antimalarial and antiretroviral interaction trials in two distinct sites (South Africa, n = 18 [all HIV positive]; Tanzania, n = 80 [86% HIV positive]) were asked about ill health and treatment use by sequential use of (1) general enquiries without reference to particular conditions, body systems or treatments, (2) checklists of potential health issues and treatments, (3) in-depth interviews. Participants’ experiences of illness and treatment and their reporting behaviour were explored qualitatively, as were trial clinicians’ experiences with obtaining participant reports. Outcomes were the number and nature of data by questioning method, themes from qualitative analyses and a theoretical interpretation of participants’ experiences.
Results
There was an overall cumulative increase in the number of reports from general enquiry through checklists to in-depth interview; in South Africa, an additional 12 medical histories, 21 AEs and 27 medications; in Tanzania an additional 260 medical histories, 1 AE and 11 medications. Checklists and interviews facilitated recognition of health issues and treatments, and consideration of what to report. Information was sometimes not reported because participants forgot, it was considered irrelevant or insignificant, or they feared reporting. Some medicine names were not known and answers to questions were considered inferior to blood tests for detecting ill health. South African inpatient volunteers exhibited a “trial citizenship”, working to achieve researchers’ goals, while Tanzanian outpatients sometimes deferred responsibility for identifying items to report to trial clinicians.
Conclusions
Questioning methods and trial contexts influence the detection of adverse events, medical histories and concomitant medications. There should be further methodological work to investigate these influences and find appropriate questioning methods.
doi:10.1186/1471-2288-13-140
PMCID: PMC3832682  PMID: 24229315
Clinical trial; Safety; Harm; Pharmacovigilance; Malaria; HIV; Elicitation; Social context; South Africa; Tanzania
12.  Evaluating harm associated with anti-malarial drugs: a survey of methods used by clinical researchers to elicit, assess and record participant-reported adverse events and related data 
Malaria Journal  2013;12:325.
Background
Participant reports of medical histories, adverse events (AE) and non-study drugs are integral to evaluating harm in clinical research. However, interpreting or synthesizing results is complicated if studies use different methods for ascertaining and assessing these data. To explore how these data are obtained in malaria drug studies, a descriptive online survey of clinical researchers was conducted during 2012 and 2013.
Methods
The survey was advertised through e-mails, collaborators and at conferences. Questions aimed to capture the detail, rationale and application of methods used to obtain relevant data within various study designs and populations. Closed responses were analysed using proportions, open responses through identifying repeating ideas and underlying concepts.
Results
Of fifty-two respondents from 25 counties, 87% worked at an investigational site and 75% reported about an interventional study. Studies employed a range of methods to elicit, assess and record participant-reported AEs and related data. Questioning about AEs in 31% of interventional studies was a combination of general (open questions about health) and structured (reference to specific health-related items), 26% used structured only and 18% general only. No observational studies used general questioning alone. A minority incorporated pictorial tools. Rationales for the questioning approach included: standardization of assessment or data capture, specificity or comprehensiveness of data sought, avoidance of suggestion, feasibility, and understanding participants’ perceptions. Most respondents considered the approach they reported was optimal, though several reconsidered this. Four AE grading, and three causality assessment approaches were reported. Combining general and structured questions about non-study drug use were considered useful for revealing and identifying specific medicines, while pictures could enhance reports, particularly in areas of low literacy.
Conclusions
It is critical to evaluate the safety of anti-malarial drugs being deployed in large, diverse populations. Many studies would be suitable for contributing to a larger body of evidence for answering questions on harm. However this survey showed that various methods are used to obtain relevant data, which could influence study results. As the best practices for obtaining such data are unclear, anti-malarial clinical researchers should work towards consensus about the selection and/or design of optimal methods.
doi:10.1186/1475-2875-12-325
PMCID: PMC3848530  PMID: 24041367
Anti-malarial; Malaria; Harm; Adverse event; Concomitant medication; Adherence; Assessment; Safety; Method; Harmonize
13.  First steps: study protocol for a randomized controlled trial of the effectiveness of the Group Family Nurse Partnership (gFNP) program compared to routine care in improving outcomes for high-risk mothers and their children and preventing abuse 
Trials  2013;14:285.
Background
Evidence from the USA suggests that the home-based Family Nurse Partnership program (FNP), extending from early pregnancy until infants are 24 months, can reduce the risk of child abuse and neglect throughout childhood. FNP is now widely available in the UK. A new variant, Group Family Nurse Partnership (gFNP) offers similar content but in a group context and for a shorter time, until infants are 12 months old. Each group comprises 8 to 12 women with similar expected delivery dates and their partners. Its implementation has been established but there is no evidence of its effectiveness.
Methods/Design
The study comprises a multi-site randomized controlled trial designed to identify the benefits of gFNP compared to standard care. Participants (not eligible for FNP) must be either aged < 20 years at their last menstrual period (LMP) with one or more previous live births, or aged 20 to 24 at LMP with low educational qualifications and no previous live births. ‘Low educational qualifications’ is defined as not having both Maths and English Language GCSE at grade C or higher or, if they have both, no more than four in total at grade C or higher. Exclusions are: under 20 years and previously received home-based FNP and, in either age group, severe psychotic mental illness or not able to communicate in English. Consenting women are randomly allocated (minimized by site and maternal age group) when between 10 and 16 weeks pregnant to either to the 44 session gFNP program or to standard care after the collection of baseline information. Researchers are blind to group assignment.
The primary outcomes at 12 months are child abuse potential based on the revised Adult-Adolescent Parenting Inventory and parent/infant interaction coded using the CARE Index based on a video-taped interaction. Secondary outcomes are maternal depression, parenting stress, health related quality of life, social support, and use of services.
Discussion
This is the first study of the effectiveness of gFNP in the UK. Results should inform decision-making about its delivery alongside universal services, potentially enabling a wider range of families to benefit from the FNP curriculum and approach to supporting parenting.
Trial registration
ISRCTN78814904.
doi:10.1186/1745-6215-14-285
PMCID: PMC3846406  PMID: 24011061
Early intervention; Child abuse; Nurse; Young parents
14.  The Good Schools Toolkit to prevent violence against children in Ugandan primary schools: study protocol for a cluster randomised controlled trial 
Trials  2013;14:232.
Background
We aim to evaluate the effectiveness of the Good School Toolkit, developed by Raising Voices, in preventing violence against children attending school and in improving child mental health and educational outcomes.
Methods/design
We are conducting a two-arm cluster randomised controlled trial with parallel assignment in Luwero District, Uganda. We will also conduct a qualitative study, a process evaluation and an economic evaluation. A total of 42 schools, representative of Luwero District, Uganda, were allocated to receive the Toolkit plus implementation support, or were allocated to a wait-list control condition. Our main analysis will involve a cross-sectional comparison of the prevalence of past-week violence from school staff as reported by children in intervention and control primary schools at follow-up.
At least 60 children per school and all school staff members will be interviewed at follow-up. Data collection involves a combination of mobile phone-based, interviewer-completed questionnaires and paper-and-pen educational tests. Survey instruments include the ISPCAN Child Abuse Screening Tools to assess experiences of violence; the Strengths and Difficulties Questionnaire to measure symptoms of common childhood mental disorders; and word recognition, reading comprehension, spelling, arithmetic and sustained attention tests adapted from an intervention trial in Kenya.
Discussion
To our knowledge, this is the first study to rigorously investigate the effects of any intervention to prevent violence from school staff to children in primary school in a low-income setting. We hope the results will be informative across the African region and in other settings.
Trial registration
clinicaltrials.gov NCT01678846
doi:10.1186/1745-6215-14-232
PMCID: PMC3734010  PMID: 23883138
Corporal punishment; Primary school; Violence; Uganda; Mental health; Education
15.  Hospital outcomes for paediatric pneumonia and diarrhoea patients admitted in a tertiary hospital on weekdays versus weekends: a retrospective study 
BMC Pediatrics  2013;13:74.
Background
Quality of patient care in hospitals has been shown to be inconsistent during weekends and night-time hours, and is often associated with reduced patient monitoring, poor antibiotic prescription practices and poor patient outcomes. Poorer care and outcomes are commonly attributed to decreased levels of staffing, supervision and expertise and poorer access to diagnostics. However, there are few studies examining this issue in low resource settings where mortality from common childhood illnesses is high and health care systems are weak.
Methods
This study uses data from a retrospective cross-sectional study aimed at “evaluating the uptake of best practice clinical guidelines in a tertiary hospital” with a pre and post intervention approach that spanned the period 2005 to 2009. We evaluated a primary hypothesis that mortality for children with pneumonia and/or dehydration aged 2–59 months admitted on weekends differed from those admitted on weekdays. A secondary hypothesis that poor quality of care could be a mechanism for higher mortality was also explored. Logistic regression was used to examine the association between mortality and the independent predictors of mortality.
Results
Our analysis indicates that there is no difference in mortality on weekends compared to weekdays even after adjusting for the significant predictors of mortality (OR = 1.15; 95% CI 0.90 -1.45; p = 0.27). There were similarly no significant differences between weekends and weekdays for the quality of care indicators, however, there was an overall improvement in mortality and quality of care through the period of study.
Conclusion
Mortality and the quality of care does not differ by the day of admission in a Kenyan tertiary hospital, however mortality remains high suggesting that continued efforts to improve care are warranted.
doi:10.1186/1471-2431-13-74
PMCID: PMC3655904  PMID: 23663546
Children; Pneumonia; Diarrhea; Weekend versus weekday; Quality of health care
16.  The Effects of Marriage Education for Army Couples with a History of Infidelity 
Journal of Family Psychology  2012;26(1):26-35.
While existing literature has begun to explore risk factors which may predict differential response to marriage education, a history of couple infidelity has not been examined to determine whether infidelity moderates the impacts of marriage education. The current study evaluated self-report marital satisfaction and communication skills in a sample of 662 married Army couples randomly assigned to marriage education (i.e., PREP) or a no-treatment control group and assessed prior to intervention, post intervention and at 1 year after intervention. Of these, 23.4% couples reported a history of infidelity in their marriage. Multilevel modeling analyses indicated that having a history of infidelity significantly moderated the impact of PREP for marital satisfaction, with a trend for a similar effect on communication skills. However, couples with a history of infidelity assigned to PREP did not reach the same levels of marital satisfaction after intervention seen in the group of couples without infidelity assigned to PREP, although they did show comparable scores on communication skills after intervention. Implications of these findings for relationship education with couples with a history of infidelity are discussed.
doi:10.1037/a0026742
PMCID: PMC3282465  PMID: 22229880
Marriage Education; Infidelity; Couples; Marriage; Extramarital
17.  Comparison of Alternative Evidence Summary and Presentation Formats in Clinical Guideline Development: A Mixed-Method Study 
PLoS ONE  2013;8(1):e55067.
Background
Best formats for summarising and presenting evidence for use in clinical guideline development remain less well defined. We aimed to assess the effectiveness of different evidence summary formats to address this gap.
Methods
Healthcare professionals attending a one-week Kenyan, national guideline development workshop were randomly allocated to receive evidence packaged in three different formats: systematic reviews (SRs) alone, systematic reviews with summary-of-findings tables, and ‘graded-entry’ formats (a ‘front-end’ summary and a contextually framed narrative report plus the SR). The influence of format on the proportion of correct responses to key clinical questions, the primary outcome, was assessed using a written test. The secondary outcome was a composite endpoint, measured on a 5-point scale, of the clarity of presentation and ease of locating the quality of evidence for critical neonatal outcomes. Interviews conducted within two months following completion of trial data collection explored panel members’ views on the evidence summary formats and experiences with appraisal and use of research information.
Results
65 (93%) of 70 participants completed questions on the prespecified outcome measures. There were no differences between groups in the odds of correct responses to key clinical questions. ‘Graded-entry’ formats were associated with a higher mean composite score for clarity and accessibility of information about the quality of evidence for critical neonatal outcomes compared to systematic reviews alone (adjusted mean difference 0.52, 95% CI 0.06 to 0.99). There was no difference in the mean composite score between SR with SoF tables and SR alone. Findings from interviews with 16 panelists indicated that short narrative evidence reports were preferred for the improved clarity of information presentation and ease of use.
Conclusions
Our findings suggest that ‘graded-entry’ evidence summary formats may improve clarity and accessibility of research evidence in clinical guideline development.
Trial Registration
Controlled-Trials.com ISRCTN05154264
doi:10.1371/journal.pone.0055067
PMCID: PMC3555827  PMID: 23372813
18.  Individual differences in simultaneous color constancy are related to working memory 
Few studies have investigated the possible role of higher-level cognitive mechanisms in color constancy. Following-up on previous work with successive color constancy (Allen, Beilock, & Shevell, J. Exp. Psychol. Learn. 37, 1014, 2011), the current study examined the relation between simultaneous color constancy and working memory – the ability to maintain a desired representation while suppressing irrelevant information. Higher working-memory was associated with poorer simultaneous color constancy for a chromatically complex stimulus, but was not associated with simultaneous color constancy for a chromatically simple stimulus. Ways in which the executive attention mechanism of working memory may play a role in color constancy when observers are not required to maintain a representation of a color in memory (as was the case here) are discussed. This finding supports a role for higher-level cognitive mechanisms in color constancy, and is the first to demonstrate a relation between simultaneous color constancy and a complex cognitive ability.
PMCID: PMC3494405  PMID: 22330405
19.  Marriage Education in the Army: Results of a Randomized Clinical Trial 
Although earlier studies have demonstrated promising effects of relationship education for military couples, these studies have lacked random assignment. The current study evaluated the short-term effects of relationship education for Army couples in a randomized clinical trial at two sites (476 couples at Site 1 and 184 couples at Site 2). At both sites, participant satisfaction with the program was high. Intervention and control couples were compared on relative amounts of pre-intervention to post-intervention change. At Site 1, not all variables showed the predicted intervention effects, although we found significant and positive intervention effects for communication skills, confidence that the marriage can survive over the long haul, positive bonding between the partners, and satisfaction with sacrificing for the marriage or the partner. However, at Site 2, we found significant and positive intervention effects for communication skills only. Possible site differences as moderators of intervention effects are discussed.
doi:10.1080/15332691.2011.613309
PMCID: PMC3377183  PMID: 22737042
relationship education; military couples; communication skills; sacrifice
20.  Assessment and management of the orthopedic and other complications of Proteus syndrome 
Purpose
A multidisciplinary workshop was convened at the National Institutes of Health (NIH) to discuss the management of the orthopedic and other complications of Proteus syndrome (PS), a progressive, disproportionate overgrowth disorder. While PS poses many complex challenges, the focus of the workshop was the management of the asymmetric and disorganized skeletal overgrowth that characterizes this multisystem disorder.
Methods
Workshop participants developed recommendations for clinical research and patient management and surveillance to maximize the benefits and reduce the risks of surgical and other interventions.
Results
Recommendations for clinical care and management included assessments of skeletal overgrowth and its progression with modalities such as X-ray, magnetic resonance imaging (MRI), dual-energy X-ray absorptiometry, and computerized tomography (CT) imaging. The recommendations also cover the assessment of non-orthopedic complications of PS that significantly impact surgical risk, such as pulmonary embolism and lung bullae. Surgical considerations in PS include assessment of the contribution of contractures to deformities and prophylactic soft-tissue release, aggressive and early use of epiphysiodesis and epiphysiostasis, amputation, and spinal bracing.
Conclusion
Decisions on the timing of orthopedic procedures in children with PS are challenging because they entail balancing the risks of intervention in this high-risk and complex population against the increasing morbidity that patients experience with progressive bony overgrowth. If surgery is delayed too long, the condition may become inoperable. We hope that these recommendations will help clinicians gather appropriate data and assist their patients in making timely treatment decisions.
doi:10.1007/s11832-011-0350-6
PMCID: PMC3179535  PMID: 23024722
Proteus syndrome; Overgrowth; Scoliosis; Limb-length inequality
21.  Protocol for a drugs exposure pregnancy registry for implementation in resource-limited settings 
Background
The absence of robust evidence of safety of medicines in pregnancy, particularly those for major diseases provided by public health programmes in developing countries, has resulted in cautious recommendations on their use. We describe a protocol for a Pregnancy Registry adapted to resource-limited settings aimed at providing evidence on the safety of medicines in pregnancy.
Methods/Design
Sentinel health facilities are chosen where women come for prenatal care and are likely to come for delivery. Staff capacity is improved to provide better care during the pregnancy, to identify visible birth defects at delivery and refer infants with major anomalies for surgical or clinical evaluation and treatment. Consenting women are enrolled at their first antenatal visit and careful medical, obstetric and drug-exposure histories taken; medical record linkage is encouraged. Enrolled women are followed up prospectively and their histories are updated at each subsequent visit. The enrolled woman is encouraged to deliver at the facility, where she and her baby can be assessed.
Discussion
In addition to data pooling into a common WHO database, the WHO Pregnancy Registry has three important features: First is the inclusion of pregnant women coming for antenatal care, enabling comparison of birth outcomes of women who have been exposed to a medicine with those who have not. Second is its applicability to resource-poor settings regardless of drug or disease. Third is improvement of reproductive health care during pregnancies and at delivery. Facility delivery enables better health outcomes, timely evaluation and management of the newborn, and the collection of reliable clinical data. The Registry aims to improves maternal and neonatal care and also provide much needed information on the safety of medicines in pregnancy.
doi:10.1186/1471-2393-12-89
PMCID: PMC3500715  PMID: 22943425
Pregnancy Registry; Congenital anomaly; Pharmacovigilance; Teratogenicity; Drug exposure; Antiretrovirals; Antimalarials; Birth defects; Neonates; Safety; Resource-limited settings
23.  Distress in Spouses of Service Members with Symptoms of Combat-Related PTSD: Secondary Traumatic Stress or General Psychological Distress? 
Combat-related posttraumatic stress disorder (PTSD) is linked with elevated psychological distress in service members’/veterans’ spouses. Researchers use a variety of terms to describe this distress, and recently, secondary traumatic stress and secondary traumatic stress disorder (STS/STSD) have become increasingly commonly used. Although STS/STSD connotes a specific set of symptoms that are linked to service members’/veterans’ symptoms, researchers often use general measures of distress or generically worded measures of PTSD symptoms to assess STS/STSD. To determine how often scores on such measures appear to be an accurate reflection of STS/STSD, we examined responses to a measure of PTSD symptoms in 190 wives of male service members with elevated levels of PTSD symptoms. Wives rated their own PTSD symptoms, and then answered questions about their attributions for the symptoms they endorsed. Fewer than 20% of wives who endorsed symptoms on the PTSD measure attributed these symptoms completely to their husbands’ military experiences. Moreover, compared with wives who attributed symptoms only to events in their own lives, wives who attributed symptoms completely or partially to their husbands’ military experiences had a greater overlap between some of their responses on the PTSD measure and their responses to a measure of general psychological distress. These results suggest that most wives of service members/veterans with PTSD experience generic psychological distress that is not conceptually consistent with STS/STSD, although a subset does appear to endorse a reaction consistent with this construct. Implications of these findings for intervention and research with this vulnerable population are discussed.
doi:10.1037/a0023994
PMCID: PMC3156850  PMID: 21639635
Marital Relationship; Military Personnel; Stress Disorders; Posttraumatic; War
24.  Working memory is related to perceptual processing: A case from color perception 
We explored the relation between individual differences in working memory (WM) and color constancy, the phenomenon of color perception that allows us to perceive the color of an object as relatively stable under changes in illumination. Successive color constancy (measured by first viewing a colored surface under a particular illumination and later recalling it under a new illumination) was better for higher-WM individuals than for lower-WM individuals. Moreover, the magnitude of this WM difference depended on how much contextual information was available in the scene, which typically improves color constancy. By contrast, simple color memory, measured by viewing and recalling a colored surface under the same illumination, showed no significant relation to WM. This study reveals a relation between WM and a low-level perceptual process not previously thought to operate within the confines of attentional control, and provides a first account of the individual differences in color constancy known about for decades.
doi:10.1037/a0023257
PMCID: PMC3130841  PMID: 21480748
working memory; color memory; individual differences; color constancy
25.  Nemitin, a Novel Map8/Map1s Interacting Protein with Wd40 Repeats 
PLoS ONE  2012;7(4):e33094.
In neurons, a highly regulated microtubule cytoskeleton is essential for many cellular functions. These include axonal transport, regional specialization and synaptic function. Given the critical roles of microtubule-associated proteins (MAPs) in maintaining and regulating microtubule stability and dynamics, we sought to understand how this regulation is achieved. Here, we identify a novel LisH/WD40 repeat protein, tentatively named nemitin (neuronal enriched MAP interacting protein), as a potential regulator of MAP8-associated microtubule function. Based on expression at both the mRNA and protein levels, nemitin is enriched in the nervous system. Its protein expression is detected as early as embryonic day 11 and continues through adulthood. Interestingly, when expressed in non-neuronal cells, nemitin displays a diffuse pattern with puncta, although at the ultrastructural level it localizes along the microtubule network in vivo in sciatic nerves. These results suggest that the association of nemitin to microtubules may require an intermediary protein. Indeed, co-expression of nemitin with microtubule-associated protein 8 (MAP8) results in nemitin losing its diffuse pattern, instead decorating microtubules uniformly along with MAP8. Together, these results imply that nemitin may play an important role in regulating the neuronal cytoskeleton through an interaction with MAP8.
doi:10.1371/journal.pone.0033094
PMCID: PMC3327699  PMID: 22523538

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