Severe (level 3) hypoglycaemia occurrence in a real-world cohort of adults with type 1 or 2 diabetes mellitus (iNPHORM, United States).

AIMS: Among adults with insulin- and/or secretagogue-treated diabetes in the United States, very little is known about the real-world descriptive epidemiology of iatrogenic severe (level 3) hypoglycaemia. Addressing this gap, we collected primary, longitudinal data to quantify the absolute frequency of events as well as incidence rates and proportions. MATERIALS AND METHODS: iNPHORM is a US-wide, 12-month ambidirectional panel survey (2020-2021). Adults with type 1 diabetes mellitus (T1DM) or insulin- and/or secretagogue-treated type 2 diabetes mellitus (T2DM) were recruited from a probability-based internet panel. Participants completing ≥1 follow-up questionnaire(s) were analysed. RESULTS: Among 978 respondents [T1DM 17%; mean age 51 (SD 14.3) years; male: 49.6%], 63% of level 3 events were treated outside the health care system (e.g. by family/friend/colleague), and <5% required hospitalization. Following the 12-month prospective period, one-third of individuals reported ≥1 event(s) [T1DM 44.2% (95% CI 36.8%-51.8%); T2DM 30.8% (95% CI 28.7%-35.1%), p = .0404, α = 0.0007]; and the incidence rate was 5.01 (95% CI 4.15-6.05) events per person-year (EPPY) [T1DM 3.57 (95% CI 2.49-5.11) EPPY; T2DM 5.29 (95% CI 4.26-6.57) EPPY, p = .1352, α = 0.0007]. Level 3 hypoglycaemia requiring non-transport emergency medical services was more common in T2DM than T1DM (p < .0001, α = 0.0016). In total, >90% of events were experienced by <15% of participants. CONCLUSIONS: iNPHORM is one of the first long-term, prospective US-based investigations on level 3 hypoglycaemia epidemiology. Our results underscore the importance of participant-reported data to ascertain its burden. Events were alarmingly frequent, irrespective of diabetes type, and concentrated in a small subsample.

Development and validation of a real-world model to predict 1-year Level 3 (severe) hypoglycaemia risk in adults with diabetes (the iNPHORM study, United States).

AIMS: We aimed to develop and internally validate a real-world prognostic model for Level 3 hypoglycaemia risk compatible with outpatient care in the United States. MATERIALS AND METHODS: iNPHORM is a 12-month, US-based panel survey. Adults (18-90 years old) with type 1 diabetes mellitus or insulin- and/or secretagogue-treated type 2 diabetes mellitus were recruited from a nationwide, probability-based internet panel. Among participants completing ≥ 1 follow-up questionnaire(s), we modelled 1-year Level 3 hypoglycaemia risk using Andersen and Gill's Cox survival and penalized regression with multiple imputation. Candidate variables were selected for their clinical relevance and ease of capture at point-of-care. RESULTS: In total, 986 participants [type 1 diabetes mellitus: 17%; men: 49.6%; mean age: 51 (SD: 14.3) years] were analysed. Across follow-up, 035.1 (95% CI: 32.2-38.1)% reported ≥1 Level 3 event(s), and the rate was 5.0 (95% CI: 4.1-6.0) events per person-year. Our final model showed strong discriminative validity and parsimony (optimism corrected c-statistic: 0.77). Numerous variables were selected: age; sex; body mass index; marital status; level of education; insurance coverage; race; ethnicity; food insecurity; diabetes type; glycated haemoglobin value; glycated haemoglobin variability; number, type and dose of various medications; number of SH events requiring hospital care (past year and over follow-up); type and number of comorbidities and complications; number of diabetes-related health care visits (past year); use of continuous/flash glucose monitoring; and general health status. CONCLUSIONS: iNPHORM is the first US-based primary prognostic study on Level 3 hypoglycaemia. Future model implementation could potentiate risk-tailored strategies that reduce real-world event occurrence and overall diabetes burden.

Effectiveness of Nonmydriatic Ultra-Widefield Retinal Imaging to Screen for Diabetic Eye Disease: A Randomized Controlled Trial (Clearsight).

OBJECTIVE: Suboptimal diabetic eye disease screening is a major cause of preventable vision loss. Screening barriers include mydriasis and the need for dedicated screening appointments. The Clearsight trial assessed whether nonmydriatic ultra-widefield (NM UWF) screening on the day of a diabetes clinic visit improved detection of clinically important eye disease versus usual screening. RESEARCH DESIGN AND METHODS: This single-center, randomized, parallel-group controlled trial was conducted at St. Joseph's Health Care, London, Ontario, Canada. Adults with diabetes due for screening were randomized to same-day, on-site screening (NM UWF imaging) on the day of a scheduled diabetes clinic visit or usual screening (encouraged to arrange optometrist screening). The primary outcome was detection of actionable eye disease (AED), defined as the need for an ophthalmology referral or increased ocular surveillance. The primary analysis (modified intention-to-screen) compared the proportions of AED between groups within 1 year of enrollment. RESULTS: Of 740 participants randomized between 7 March 2016 and 17 April 2019, 335 on-site screening and 323 usual screening participants met criteria for the primary analysis. More AED was detected in the on-site screening group than in the usual screening group (50 of 335 [14.9%] vs. 22 of 323 [6.8%]; adjusted odds ratio 2.51; 95% CI 1.49-4.36). The number needed to screen by on-site screening in order to detect 1 additional patient with AED was 13 (95% CI 8-29). CONCLUSIONS: Same-day, on-site screening by NM UWF imaging increased the detection of clinically important diabetic eye disease versus usual screening. Integration of NM UWF imaging into routine diabetes clinic visits improved screening adherence and has the potential to prevent vision loss.

Does Shiftwork Impact Cognitive Performance? Findings from the Canadian Longitudinal Study on Aging (CLSA).

Few large nationwide studies have investigated the relationship between shiftwork and cognitive performance, and little is known about whether and how psychological distress may impact this relationship. This study aimed to examine: (1) the cross-sectional relationship between shiftwork (yes/no) and some aspects of cognitive performance (declarative memory and executive functioning) and (2) the potential moderating effect of psychological distress among 20,610 community-dwelling adults from the comprehensive cohort of the Canadian Longitudinal Study on Aging (CLSA). Differences by sex and retirement status were also explored. Shiftwork was significantly associated with poorer performance for executive functioning (interference condition: ß = 0.47, 95% CI: 0.31 to 0.63; MAT: ß = -0.85, 95% CI: -1.21 to -0.50) but not for declarative memory. Completely and not/partly retired males showed poorer cognitive performance on executive functioning. However, no evidence of a moderating effect by psychological distress was found. Our findings confirm the association between shiftwork and cognitive performance and highlight important health correlates of shiftwork.

Printed educational materials directed at Ontario family physicians do not improve adherence to guideline recommendations for diabetes management: a pragmatic, factorial, cluster randomized controlled trial [ISRCTN72772651].

BACKGROUND: Printed educational materials (PEMs) have long been used to inform clinicians on evidence-based practices. However, the evidence for their effects on patient care and outcomes is unclear. In Ontario, despite widely available clinical practice guidelines recommending antihypertensives and cholesterol-lowering agents for patients with diabetes, prescriptions remain low. We aimed to determine whether PEMs can influence physicians to intensify prescribing of these medications. METHODS: A pragmatic, 2 × 2 factorial, cluster randomized controlled trial was designed to ascertain the effect of two PEM formats on physician prescribing: a postcard-sized message ("outsert") or a longer narrative article ("insert"). Ontario family physician practices (clusters) were randomly allocated to receive the insert, outsert, both or neither. Physicians were eligible if they were in active practice and their patients were included if they were over 65 years with a diabetes diagnosis; both were unaware of the trial. Administrative databases at ICES (formerly the Institute for Clinical Evaluative Sciences) were used to link patients to their physician and to analyse prescribing patterns at baseline and 1 year following PEM mailout. The primary outcome was intensification defined as the addition of a new antihypertensive or cholesterol-lowering agent, or dose increase of a current drug, measured at the patient level. Analyses were by intention-to-treat and accounted for the clustering of patients to physicians. RESULTS: We randomly assigned 4231 practices (39% of Ontario family physicians) with a total population of 185,526 patients (20% of patients with diabetes in Ontario primary care) to receive the insert, outsert, both, and neither; among these, 4118 practices were analysed (n = 1025, n = 1037, n = 1031, n = 1025, respectively). No significant treatment effect was found for the outsert (odds ratio (OR) 1.01, 95% confidence interval (CI) 0.98 to 1.04) or the insert (OR 0.99, 95% CI 0.96 to 1.02). Percent of intensification in the four arms was similar (approximately 46%). Adjustment for physician characteristics (e.g., age, sex, practice location) had no impact on these findings. CONCLUSIONS: PEMs have no effect on physician's adherence to recommendations for the management of diabetes-related complications in Ontario. Further research should investigate the effect of other strategies to narrow this evidence-to-practice gap. TRIAL REGISTRATION: ISRCTN72772651 . Retrospectively registered 21 July 2005.

Relationships between sleep and internalizing problems in early adolescence: Results from Canadian National Longitudinal Survey of Children and Youth.

BACKGROUND: Both inadequate sleep and internalizing problems, such as symptoms of anxiety and depression, are prevalent among adolescents with sparse epidemiological literature outlining sex-specific relationships at this critical age. OBJECTIVE: To examine cross-sectional and prospective relationships between self-reported sleep problems, indicated by sleep duration, difficulties getting to sleep and changes in difficulties getting to sleep with internalizing problems in early adolescence. METHODS: This study was a secondary analysis of data from the Canadian National Longitudinal Survey of Children and Youth. Multivariable linear regression was used to estimate cross-sectional and longitudinal associations. Relevant family and social context variables were controlled for in multivariable analyses. Family functioning was assessed as a potential effect modifier. RESULTS: There were 993 and 736 participants [longitudinal cohort entry age of 10 or 11 years; 49% male] in longitudinal and cross-sectional analyses, respectively. Most cross-sectional multivariable analyses of sleep duration and internalizing problems revealed no statistical associations. Difficulties sleeping and concurrent internalizing problems were positively associated in 12/13 year old females (ß = 1.77 [0.94, 2.61], R2 = 17%) and males (ß = 1.18 [0.36, 2.01], R2 = 16%). High persistent difficulties sleeping in females aged 12/13 to 14/15 years also positively predicted internalizing problems in females age 14/15 years (ß = 1.90 [0.52, 3.29], R2 = 21%) while controlling for initial internalizing symptoms. Family functioning was not found to be an effect modifier. CONCLUSION: Findings highlight the potential role of difficulties sleeping for adolescents' mental health. Public health initiatives to promote sleep hygiene in this population subgroup are critical to prevent the potential long-term health impact of sleep problems.

Association of Arthritis Onset with Influenza: Analysis of the Canadian Early Inflammatory Arthritis Cohort.

OBJECTIVE: To evaluate seasonal patterns of early inflammatory arthritis (IA) onset and potential associations with IA symptom onset. METHODS: The Canadian Early Arthritis Cohort (CATCH) is an inception cohort study of adults with early (12 months or less) IA. We used patient reports of symptom onset as a proxy of IA onset and examined the seasonal distribution of IA onset over 10 years. Influenza time series was based on laboratory-confirmed influenza A and B from the Canadian FluWatch surveillance from 2010-2016. Bivariate analysis of influenza and IA was performed using cross-correlations with different time lags and Poisson regression. IA and influenza were recorded as monthly total frequencies. RESULTS: Of 2519 IA patients, 88% had confirmed rheumatoid arthritis (RA). Significantly, more IA onsets occurred in winter compared with other seasons (P = 0.03); although IA onset was more frequent in January, the difference between months was not statistically significant. Compared to months with the lowest influenza rates, months with the highest influenza rates had a statistically significant, but trivial, increase of 0.003% in the incidence of IA (incidence rate ratio (95% confidence interval): 1.00003 (1.00005; 1.000053), P = 0.02). CONCLUSION: Although IA symptom onset occurs more frequently in winter, we found that flu outbreaks were not associated with a meaningful increase in IA symptom onset in a large, well-characterized cohort of Canadian adults over 6 years.

Effect of a Community Health Worker-Delivered Parental Education and Counseling Intervention on Anemia Cure Rates in Rural Indian Children: A Pragmatic Cluster Randomized Clinical Trial.

IMPORTANCE: Iron deficiency anemia, the largest cause of anemia worldwide, adversely affects cognitive development in children. Moreover, the imperceptible childhood anemia prevalence reduction in response to anemia control measures is associated with tremendous social and economic cost. OBJECTIVE: To evaluate the effects of community-based parental education/counseling when combined with usual treatment on children's anemia cure rate. DESIGN, SETTING, AND PARTICIPANTS: A pragmatic cluster randomized clinical trial in children aged 12 to 59 months from 55 villages from the rural Chamrajnagar district in southern India was conducted between November 2014 and July 2015; 6-month follow-up ended in January 2016. Villages were randomly assigned to either usual treatment (n = 27) or to the intervention (n = 28). Among 1144 participating children, 534 were diagnosed as having anemia (hemoglobin levels <11 g/dL and >7.9 g/dL; to convert to grams per liter, multiply by 10) and constituted the study sample in this analysis. Data were analyzed between July 2016 and September 2017. INTERVENTIONS: Iron and folic acid (IFA), 20 mg/d, 5 times daily per week, for 5 months (usual treatment) or health worker-delivered education/counseling combined with usual treatment (intervention). MAIN OUTCOMES AND MEASURES: The primary outcome was anemia cure rate defined as hemoglobin level at or greater than 11 g/dL during follow-up. RESULTS: Of the children included in the study, the mean age was 30 months, with a slightly higher ratio of boys to girls. Of 534 children with anemia (intervention n = 303; usual treatment n = 231), 517 were reassessed after 6 months (intervention n = 298; usual treatment n = 219) while 17 were lost to follow-up (intervention n = 5 and usual treatment n = 12). Anemia cure rate was higher in children in the intervention group compared with children receiving usual treatment (55.7% [n = 166 of 298] vs 41.4% [n = 90 of 219]). The risk ratio derived through multilevel logistic regression was 1.37 (95% CI, 1.04-1.70); the model-estimated risk difference was 15.1% (95% CI, 3.9-26.3). Intervention-group children demonstrated larger mean hemoglobin increments (difference, intervention vs control: 0.25 g/dL; 95% CI, 0.07-0.44 g/dL) and improved IFA adherence (61.7%; 95% CI, 56.2-67.3 vs 48.4%; 95% CI, 41.7-55.1 consumed >75% of tablets provided). Adverse events were mild (intervention: 26.8%; 95% CI, 21.8-31.9 vs usual treatment: 21%; 95% CI, 15.6-26.4). To cure 1 child with anemia, 7 mothers needed to be counseled (number needed to treat: 7; 95% CI, 4-26). CONCLUSIONS AND RELEVANCE: Parental education and counseling by a community health worker achieved perceivable gains in curing childhood anemia. Policy makers should consider this approach to enhance population level anemia control. TRIAL REGISTRATION: ISRCTN identifier: ISRCTN68413407.

Selective Laser Trabeculoplasty versus Argon Laser Trabeculoplasty in Glaucoma Patients Treated Previously with 360° Selective Laser Trabeculoplasty: A Randomized, Single-Blind, Equivalence Clinical Trial.

PURPOSE: The effectiveness of selective laser trabeculoplasty (SLT) was compared with argon laser trabeculoplasty (ALT) in a randomized clinical trial for patients with medically uncontrolled open-angle glaucoma who have previously received 360° SLT. DESIGN: An active equivalence parallel armed randomized control trial. PARTICIPANTS: Patients with open-angle glaucoma including pigmentary dispersion syndrome and pseudoexfoliation syndrome were enrolled into the study from 7 different sites across Canada. METHODS: One setting of 180° of either SLT or ALT was assigned randomly and applied to each participant. MAIN OUTCOME MEASURES: The change in intraocular pressure (IOP) from baseline to 12 months was compared between the 2 groups. RESULTS: A total of 132 patients were recruited, 2 of which dropped out early in the study, leaving 130 patients who completed the study as per protocol. For those, the study's primary outcome was calculated. The IOP change at 1 year in comparison to baseline for SLT vs. ALT was found to be different by 0.33 mmHg between the 2 groups (3.16 for SLT and 2.83 for ALT) and was not statistically significant (P = 0.71) Further analysis, though, showed that SLT had a significantly lower IOP reduction at early time points: 1 week and 1 month, but this effect was lost by 3 months. Corresponding to this finding was the strong trend for ALT to fail more quickly than SLT. Although repeatable, the first repeat SLT reduced IOP to only about half compared with initial SLT treatment. CONCLUSIONS: The comparison at 12 months following the laser therapy showed that both modalities lowered the IOP with approximately 3 mmHg, yet essentially all of the time-to-failure analyses favored SLT over ALT. The repeat SLT effect was found to be half of the initial treatment.

Lipoprotein(a) and secondary prevention of atherothrombotic events: A critical appraisal.

Elevated plasma concentrations of lipoprotein(a) [Lp(a)] are an independent, and possibly causal, risk factor for atherothrombotic diseases including coronary heart disease. The principal evidence base for this comes from large population studies focusing on first atherothrombotic events. However, inconsistent findings have been reported from studies investigating the impact of elevated Lp(a) on atherothrombotic events in subjects with preexisting cardiovascular disease. This question is very important because the secondary prevention population is recommended for Lp(a) screening by some guidelines and could be an important target group for Lp(a)-lowering therapies that are currently on the horizon. In this review, we survey the secondary prevention literature as it relates to Lp(a) and identify some possible confounding factors that may underlie the inconsistent findings, such as index event bias.

Untreated illness and recovery in clients of an early psychosis intervention program: a 10-year prospective cohort study.

PURPOSE: To investigate whether duration of untreated psychosis (DUP) and duration of untreated illness (DUI) are associated with measures of both subjective and objective recovery 10 years after a first episode of psychosis. METHODS: A cohort of 65 clients from an early psychosis intervention program completed a battery of outcome measures 10 years following initial treatment for first-episode psychosis (FEP). The outcomes of interest were self-perceived recovery scores (Maryland Assessment of Recovery in People with Serious Mental Illness Scale) and occupational activity, defined as engagement in work and/or school on a full/part-time basis. Multiple linear and logistic regression analyses were used to estimate the associations between DUP and DUI with each measure of recovery, adjusting for potential confounding factors. RESULTS: We did not find a statistically significant association between DUP and either occupational activity (OR = 1.26, 95% CI 0.81-1.95) or self-perceived recovery score (ß = - 0.73, 95% CI - 2.42 to 0.97). However, we found a significant negative association between DUI and self-perceived recovery score (ß = - 0.52, 95% CI - 0.87 to - 0.16). CONCLUSIONS: Our findings suggest that DUI may have a stronger influence than DUP on recovery from FEP at 10-year follow-up. This suggests the potential value in targeted interventions for people with a long DUI to increase the likelihood of achieving recovery after the first episode of psychosis.

A randomised trial of non-mydriatic ultra-wide field retinal imaging versus usual care to screen for diabetic eye disease: rationale and protocol for the Clearsight trial.

INTRODUCTION: Suboptimal screening for diabetic eye disease is a major cause of preventable vision loss. Screening barriers include mydriasis and the extra time patients need to attend dedicated eye screening appointments. In the Clearsight trial, we are testing whether screening by non-mydriatic ultra-wide field (NM UWF) imaging on the day patients attend their diabetes outpatient clinic visit improves detection of clinically important eye disease compared with usual screening. METHODS AND ANALYSIS: Patients with diabetes due for a screening eye exam by the 2013 Canadian Diabetes Association (CDA) practice guidelines are being randomised to on-site screening by NM UWF imaging on the day of their clinic visit or to usual screening where, per CDA guidelines, they are encouraged to arrange an exam by an optometrist. The primary outcome is actionable eye disease (AED) based on a need for referral to ophthalmology and/or increased ocular surveillance. The primary analysis will use an intention-to-screen approach that compares the proportions of detected AED between on-site and usual screening groups under a superiority hypothesis in favour of on-site screening. With 740 randomised participants, the study will have 80% power to detect ≥5% absolute increase in the AED rate among on-site screening versus usual screening participants. This difference translates into a number-needed-to-screen by on-site screening of 20 to detect 1 additional person with AED. ETHICS AND DISSEMINATION: The protocol was approved by the institutional review board of Western University. The findings of the trial will be disseminated directly to participants and through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: ClinicalTrials.Gov NCT02579837 (registered 16 October 2015). PROTOCOL ISSUE DATE: 18 November 2015.

On the estimation of intracluster correlation for time-to-event outcomes in cluster randomized trials.

Cluster randomized trials (CRTs) involve the random assignment of intact social units rather than independent subjects to intervention groups. Time-to-event outcomes often are endpoints in CRTs. Analyses of such data need to account for the correlation among cluster members. The intracluster correlation coefficient (ICC) is used to assess the similarity among binary and continuous outcomes that belong to the same cluster. However, estimating the ICC in CRTs with time-to-event outcomes is a challenge because of the presence of censored observations. The literature suggests that the ICC may be estimated using either censoring indicators or observed event times. A simulation study explores the effect of administrative censoring on estimating the ICC. Results show that ICC estimators derived from censoring indicators or observed event times are negatively biased. Analytic work further supports these results. Observed event times are preferred to estimate the ICC under minimum frequency of administrative censoring. To our knowledge, the existing literature provides no practical guidance on the estimation of ICC when substantial amount of administrative censoring is present. The results from this study corroborate the need for further methodological research on estimating the ICC for correlated time-to-event outcomes. Copyright © 2016 John Wiley & Sons, Ltd.

Risk Score for Predicting Mortality in Flail Chest.

BACKGROUND: Flail chest injuries are associated with high mortality and morbidity. Despite evidence that operative repair of flail chest is beneficial, it is rarely done. We sought to create a simple risk score using available preoperative covariates to calculate individual risk of mortality in flail chest. METHODS: A logistic regression model was trained on Ontario Trauma Registry data to generate a mortality risk score. The final model was validated for calibration and discrimination and corrected for optimism. RESULTS: The model uses five risk factors that are readily obtained during the initial assessment of the trauma patient: age, Glasgow Coma Score, ventilation, cardiopulmonary resuscitation, and number of comorbidities. It was determined that less than 6 points is consistent with 1% observed mortality, 6 to 10 points predicts 5% mortality, 11 to 15 points predicts 22% mortality, and 16 or more points predicts 46% mortality. CONCLUSIONS: We have developed a simple model that can be easily applied at bedside to predict mortality in patients with flail chest by accessing a spreadsheet program in an application or other handheld computer device. This model has the potential to be a useful tool for surgeons considering operative repair of flail chest.

The Karnataka Anemia Project 2--design and evaluation of a community-based parental intervention to improve childhood anemia cure rates: study protocol for a cluster randomized controlled trial.

BACKGROUND: Childhood anemia is highly prevalent worldwide. Improving the hemoglobin level of preschool age children could yield substantial benefits in cognitive and psychosocial development and overall health. While evidence-based recommendations for reducing childhood anemia in high anemia prevalence countries are available, there is no experimental evidence of community centered education and counseling programs, as a route to improved acceptance of iron supplements, demonstrating beneficial effects on anemia outcomes. We report on the evaluation protocol of a complex educational intervention led by the community lay health worker (LHW) and delivered to mothers of 12-59-month-old anemic children living in and visiting village day care centers in a large district of southern India. METHODS AND DESIGN: The study is designed as a cluster randomized controlled trial. The intervention is based on the social cognitive theory and aims to promote among mothers, anemia awareness, dietary modifications to increase iron intake in the child, and recognition of the need for enhanced adherence to supplemental iron in the anemic child. From 270 eligible villages in the study area, a sample of 60 villages will be randomized to intervention [n = 30] or to treatment as usual [n = 30] of the study. LHWs in the intervention arm will be trained to administer the following intervention components to mothers of anemic children: 1] monthly distribution of Iron and folic acid (IFA) supplements to mothers of anemic children, and 2] five monthly counseling sessions of mothers of anemic children covering: a] anemia awareness education b] IFA adherence counseling and assessment, c] dietary modification to improve iron intake, and d] hygiene and sanitation. LHWs in the control arm will distribute IFA to mothers of anemic children as in the intervention arm but will not provide monthly education and counseling support. The primary outcome is the difference between the two experimental groups in anemia cure rates of children found to be anemic at baseline. Secondary outcomes, assessed as differences between all participants in both experimental groups, are: change in mothers' knowledge regarding anemia; 24 hour dietary iron intake; net improvement in individual hemoglobin values; serum ferritin; and the difference in overall cluster level childhood anemia prevalence. All outcomes will be measured 6 months after the start of the intervention. Multilevel linear and logistic regression models will be used to analyze differences between intervention and control groups in outcome variables. DISCUSSION: This trial is designed to evaluate the effectiveness of an intervention intended to improve anemia cure rates in anemic children living in villages of Chamarajnagar, Karnataka a large district in south India. The extensive study of secondary endpoints will be used to identify possible weak points in the compliance to intervention delivery and uptake. This evaluation is one of the few large randomized trials evaluating the impact of an education and counseling intervention to reduce childhood anemia prevalence. TRIAL REGISTRATION: This trial was registered with ISRCTN.com (identifier: ISRCTN68413407) on 17 September 2013.

The quality of modern cross-sectional ecologic studies: a bibliometric review.

The ecologic study design is routinely used by epidemiologists in spite of its limitations. It is presently unknown how well the challenges of the design are dealt with in epidemiologic research. The purpose of this bibliometric review was to critically evaluate the characteristics, statistical methods, and reporting of results of modern cross-sectional ecologic papers. A search through 6 major epidemiology journals identified all cross-sectional ecologic studies published since January 1, 2000. A total of 125 articles met the inclusion requirements and were assessed via common evaluative criteria. It was found that a considerable number of cross-sectional ecologic studies use unreliable methods or contain statistical oversights; most investigators who adjusted their outcomes for age or sex did so improperly (64%), statistical validity was a potential issue for 20% of regression models, and simple linear regression was the most common analytic approach (31%). Many authors omitted important information when discussing the ecologic nature of their study (31%), the choice of study design (58%), and the susceptibility of their research to the ecological fallacy (49%). These results suggest that there is a need for an international set of guidelines that standardizes reporting on ecologic studies. Additionally, greater attention should be given to the relevant biostatistical literature.

Balance impairment as a risk factor for falls in community-dwelling older adults who are high functioning: a prospective study.

BACKGROUND: Screening should have simple and easy-to-administer methods that identify impairments associated with future fall risk, but there is a lack of literature supporting validation for their use. OBJECTIVE: The aim of this study was to evaluate the independent contribution of balance assessment on future fall risk, using 5 methods to quantify balance impairment, for the outcomes "any fall" and "any injurious fall" in community-dwelling older adults who are higher functioning. DESIGN: This was a prospective cohort study. METHODS: A sample of 210 community-dwelling older adults (70% male, 30% female; mean age=79.9 years, SD=4.7) received a comprehensive geriatric assessment at baseline, which included the Berg Balance Scale to measure balance. Information on daily falls was collected for 12 months by each participant's monthly submission of a falls log calendar. RESULTS: Seventy-eight people (43%) fell, of whom 54 (30%) sustained an injurious fall and 32 (18%) had recurrent falls (> or =2 falls). Different balance measurement methods identified different numbers of people as impaired. Adjusted relative risk (RR) estimates for an increased risk of any fall were 1.58 (95% confidence interval [CI]=1.06, 2.35) for self-report of balance problems, 1.58 (95% CI=1.03, 2.41) for one-leg stance, and 1.46 (95% CI=1.02, 2.09) for limits of stability. An adjusted RR estimate for an increased risk of an injurious fall of 1.95 (95% CI=1.15, 3.31) was found for self-report of balance problems. Limitations The study was a secondary analysis of data. CONCLUSIONS: Not all methods of evaluating balance impairment are associated with falls. The number of people identified as having balance impairment varies with the measurement tool; therefore, the measurement tools are not interchangeable or equivalent in defining an at-risk population. The thresholds established in this study indicate individuals who should receive further comprehensive fall assessment and treatment to prevent falls.

Modifiable Risk Factors Identify People Who Transition from Non-fallers to Fallers in Community-Dwelling Older Adults: A Prospective Study.

PURPOSE: To identify modifiable risk factors associated with the transition from non-faller to faller in community-dwelling older adults. METHOD: A prospective study design was used. Adults aged 60 to 90 years (n=90, mean age=79.7 years, 63% male) who did not report falling in the past year were included. A comprehensive geriatric assessment was performed at study baseline, and daily falls data were collected monthly for 1 year. Multivariable regression using a modified Poisson model on fall status (yes/no) and a Cox proportional hazards model for time to first fall were used to identify risk factors. RESULTS: Twenty-four people (27%) fell. Modifiable risk factors were present in 67% of study participants, and fall risk increased as the number of risk factors increased. The most common activities performed prior to falling were walking and using stairs. Fall risk doubled ([relative risk=2.00; 95%CI: 1.13-3.56) per unit increase in the number of risk factors (lower-extremity weakness, balance impairment, and ≥4 prescription medications). CONCLUSIONS: Among older adults who were self-reported non-fallers, falls were a common outcome, and modifiable risk factors were present in the majority of the sample. The absence of a fall history does not rule out the need to screen for other risk factors for falls. Functional lower-extremity weakness, balance impairment as measured by the Berg Balance Scale (score <50), and number of risk factors were independent predictors for the transition in status from non-faller to faller. Further research is required to define effective interventions to prevent first falls.

Quantifying the magnitude of risk for balance impairment on falls in community-dwelling older adults: a systematic review and meta-analysis.

OBJECTIVES: To evaluate and summarize the evidence linking balance impairment as a risk factor for falls in community-dwelling older adults. STUDY DESIGN AND SETTING: Systematic review and meta-analysis. English language articles in MEDLINE, EMBASE, CINAHL (1988-2009), under keywords of accidental falls, aged, risk factors, and hip, radius, ulna, and humerus fractures; and bibliographies of retrieved articles. Community-dwelling older adults in a prospective study, at least 1-year duration, age more than 60 years, and samples not specific to a single disease-defined population were included. Sample size, inclusion/exclusion criteria, demographics, clinical balance measurement scale, type of fall outcome, method of fall ascertainment, length of follow-up, and odds ratio (OR) or risk ratio (RR) were extracted. Studies must have reported adjustment for confounders. Random effects meta-analysis to generate summary risk estimate was used. A priori evaluation of sources of heterogeneity was performed. RESULTS: Twenty-three studies met the selection criteria. A single summary measure could not be calculated because of the nonequivalence of the OR and RR, producing an overall fall risk of RR of 1.42 (1.08, 1.85) and OR of 1.98 (1.60, 2.46). CONCLUSIONS: Balance impairment imparts a moderate increase on fall risk in community-dwelling older adults. The type of fall outcome, the length of follow-up, and the balance measurement tool impact the magnitude of the association. Specific balance measurement scales were identified with associations for an increased fall risk, but further research is required to refine recommendations for their use in clinical practice.