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A Review of Recruitment, Adherence and Drop-Out Rates in Omega-3 Polyunsaturated Fatty Acid Supplementation Trials in Children and Adolescents.
van der Wurff, ISM, Meyer, BJ, de Groot, RHM
Nutrients. 2017;(5)
Abstract
INTRODUCTION The influence of n-3 long-chain polyunsaturated fatty acids (n-3 LCPUFA) supplementation on health outcomes has been studied extensively with randomized controlled trials (RCT). In many research fields, difficulties with recruitment, adherence and high drop-out rates have been reported. However, what is unknown is how common these problems are in n-3 LCPUFA supplementation studies in children and adolescents. Therefore, this paper will review n-3 LCPUFA supplementation studies in children and adolescents with regard to recruitment, adherence and drop-out rates. METHODS The Web of Science, PubMed and Ovid databases were searched for papers reporting on RCT supplementing children and adolescents (2-18 years) with a form of n-3 LCPUFA (or placebo) for at least four weeks. As a proxy for abiding to CONSORT guidelines, we noted whether manuscripts provided a flow-chart and provided dates defining the period of recruitment and follow-up. RESULTS Ninety manuscripts (reporting on 75 studies) met the inclusion criteria. The majority of the studies did not abide by the CONSORT guidelines: 55% did not provide a flow-chart, while 70% did not provide dates. The majority of studies provided minimal details about the recruitment process. Only 25 of the 75 studies reported an adherence rate which was on average 85%. Sixty-five of the 75 studies included drop-out rates which were on average 17%. CONCLUSION Less than half of the included studies abided by the CONSORT guidelines (45% included a flow chart, while 30% reported dates). Problems with recruitment and drop-out seem to be common in n-3 LCPUFA supplementation trials in children and adolescents. However, reporting about recruitment, adherence and dropout rates was very heterogeneous and minimal in the included studies. Some techniques to improve recruitment, adherence and dropout rates were identified from the literature, however these techniques may need to be tailored to n-3 LCPUFA supplementation studies in children and adolescents.
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Recommendation to Reduce Patients' Blood Pressure and Cholesterol Medication Costs.
Fielding, JE, Rimer, BK, Johnson, RL, Orleans, CT, Calonge, N, Clymer, JM, Glanz, K, Goetzel, RZ, Green, LW, Ramirez, G, et al
Preventing chronic disease. 2015;:E209
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Reducing Medication Costs to Prevent Cardiovascular Disease: A Community Guide Systematic Review.
Njie, GJ, Finnie, RK, Acharya, SD, Jacob, V, Proia, KK, Hopkins, DP, Pronk, NP, Goetzel, RZ, Kottke, TE, Rask, KJ, et al
Preventing chronic disease. 2015;:E208
Abstract
INTRODUCTION Hypertension and hyperlipidemia are major cardiovascular disease risk factors. To modify them, patients often need to adopt healthier lifestyles and adhere to prescribed medications. However, patients' adherence to recommended treatments has been suboptimal. Reducing out-of-pocket costs (ROPC) to patients may improve medication adherence and consequently improve health outcomes. This Community Guide systematic review examined the effectiveness of ROPC for medications prescribed for patients with hypertension and hyperlipidemia. METHODS We assessed effectiveness and economics of ROPC for medications to treat hypertension, hyperlipidemia, or both. Per Community Guide review methods, reviewers identified, evaluated, and summarized available evidence published from January 1980 through July 2015. RESULTS Eighteen studies were included in the analysis. ROPC interventions resulted in increased medication adherence for patients taking blood pressure and cholesterol medications by a median of 3.0 percentage points; proportion achieving 80% adherence to medication increased by 5.1 percentage points. Blood pressure and cholesterol outcomes also improved. Nine studies were included in the economic review, with a median intervention cost of $172 per person per year and a median change in health care cost of -$127 per person per year. CONCLUSION ROPC for medications to treat hypertension and hyperlipidemia is effective in increasing medication adherence, and, thus, improving blood pressure and cholesterol outcomes. Most ROPC interventions are implemented in combination with evidence-based health care interventions such as team-based care with medication counseling. An overall conclusion about the economics of the intervention could not be reached with the small body of inconsistent cost-benefit evidence.
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Hypertension and Health Behaviors in Females Across the Lifespan.
Krousel-Wood, M
The American journal of the medical sciences. 2015;(1):36-41
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The cardiovascular polypill: clinical data and ongoing studies.
Castellano, JM, Bueno, H, Fuster, V
International journal of cardiology. 2015;:S8-14
Abstract
Cardiovascular risk modification in terms of comprehensive medical therapy (antithrombotic therapy, lipid-lowering therapy, antihypertensive medication) and lifestyle modification (healthy diet, regular exercise, weight loss, smoking cessation) is the cornerstone of secondary prevention. It is now clear that even in those undergoing PCI or bypass surgery, appropriate lifestyle modification and aggressive medical therapy are paramount for optimizing long-term outcomes. However, what has emerged from studies that examined the role of medical therapy in the context of coronary heart disease is that only ∼50% of the patients in these studies are achieving target treatment goals for blood pressure, lipid and glycemic control. Non-adherence is thought to be a very large contributor to this problem; across all health-care categories, non-adherence is estimated to account for $290 billion of annual health-care expenditure in the United States and €1.25 billion in European Union, with poor adherence to CVD medication accounting for 9% of all European CVD events. Socioeconomic factors may have a role in patients' discontinuing their medications, and a major initiative to combat this problem is the increasing focus on the polypill. The idea of combining numerous medications into a single tablet to reduce CV risk was first proposed more than a decade ago. This combined formulation not only significantly enhances patient convenience and adherence but also drives savings for the healthcare systems. Several randomized clinical trials have consistently demonstrated the effects of polypills on CV risk factors and adherence, and major trials are underway to study the effect on hard clinical outcomes.
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Motivational interviewing to promote adherence behaviors in pediatric type 1 diabetes.
Powell, PW, Hilliard, ME, Anderson, BJ
Current diabetes reports. 2014;(10):531
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Abstract
Suboptimal regimen adherence among youth with type 1 diabetes (T1D) is a common challenge for patients, families, and providers. Motivational interviewing (MI) is a brief communication style designed to elicit intrinsic motivation and strengthen commitment to behavior change goals. As pediatric MI research expands, a critical review of its evidence base and applicability to promote adherence behaviors for youth with T1D is needed. This review introduces the core tenets of MI and clinical applications in T1D, synthesizes the existing MI research in T1D, and discusses the next steps in MI research. Overall, mixed results for MI interventions in T1D reflect variations in research study design and clinical implementation. Targeting adherence rather than glycemic outcomes typically demonstrates greater results, highlighting the promise of MI to facilitate meaningful and enduring improvements in youths' T1D adherence behaviors.
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Good cop, bad cop: quality of parental involvement in type 1 diabetes management in youth.
Young, MT, Lord, JH, Patel, NJ, Gruhn, MA, Jaser, SS
Current diabetes reports. 2014;(11):546
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Sustained parental involvement in diabetes management has been generally advised to counteract the deteriorating adherence and glycemic control often seen during adolescence, yet until recently, little attention has been given to the optimal amount, type, and quality of parental involvement to promote the best health outcomes for adolescents with type 1 diabetes (T1D). This review synthesizes research regarding the involvement of caregivers-primarily mothers and fathers-of youth with T1D, with a focus on biopsychosocial outcomes. The recent literature on parental involvement in diabetes management highlights a shift in focus from not only amount but also the types (e.g., monitoring, problem-solving) and quality (e.g., warm, critical) of involvement in both mothers and fathers. We provide recommendations for ways that both parents can remain involved to facilitate greater collaboration in shared direct and indirect responsibility for diabetes care and improve outcomes in youth with T1D.
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A "hot" topic in dyslipidemia management--"how to beat a flush": optimizing niacin tolerability to promote long-term treatment adherence and coronary disease prevention.
Jacobson, TA
Mayo Clinic proceedings. 2010;(4):365-79
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Niacin is the most effective lipid-modifying agent for raising high-density lipoprotein cholesterol levels, but it also causes cutaneous vasodilation with flushing. To determine the frequency of flushing in clinical trials, as well as to delineate counseling and treatment approaches to prevent or manage flushing, a MEDLINE search was conducted of English-language literature from January 1, 1985, through April 7, 2009. This search used the title keywords niacin or nicotinic acid crossed with the Medical Subject Headings adverse effects and human. Niacin flushing is a receptor-mediated, mainly prostaglandin D(2)-driven phenomenon, the frequency, onset, and duration of which are largely determined by the distinct pharmacological and metabolic profiles of different niacin formulations. Subjective assessments include ratings of redness, warmth, itching, and tingling. In clinical trials, most (>60%) niacin users experienced mild or moderate flushing, which tended to decrease in frequency and severity with continued niacin treatment, even with advancing doses. Approximately 5% to 20% of patients discontinued treatment because of flushing. Flushing may be minimized by taking niacin with meals (or at bedtime with a low-fat snack), avoiding exacerbating factors (alcohol or hot beverages), and taking 325 mg of aspirin 30 minutes before niacin dosing. The current review advocates an initially slow niacin dose escalation from 0.5 to 1.0 g/d during 8 weeks and then from 1.0 to 2.0 g in a single titration step (if tolerated). Through effective counseling, treatment prophylaxis with aspirin, and careful dose escalation, adherence to niacin treatment can be improved significantly. Wider implementation of these measures should enable higher proportions of patients to reach sufficient niacin doses over time to prevent cardiovascular events.
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Benefits of statin therapy and compliance in high risk cardiovascular patients.
Lardizabal, JA, Deedwania, PC
Vascular health and risk management. 2010;:843-53
Abstract
Cardiovascular disease (CVD) remains the top cause of global mortality. There is considerable evidence that supports the mortality and morbidity benefit of statin therapy in coronary heart disease (CHD) and stroke, both in primary and secondary prevention settings. Data also exist pointing to the advantage of statin treatment in other high-risk CVD conditions, such as diabetes, CKD, CHF, and PVD. National and international clinical guidelines in the management of these CVD conditions all advocate for the utilization of statin therapy in appropriate patients. However, overall compliance to statin therapy remains suboptimal. Patient-, physician-, and economic-related factors all play a role. These factors need to be considered in devising approaches to enhance adherence to guideline-based therapies. To fully reap the benefits of statin therapy, interventions which improve long-term treatment compliance in real-world settings should be encouraged.
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Evidence-based gender findings for children affected by HIV and AIDS - a systematic overview.
Sherr, L, Mueller, J, Varrall, R
AIDS care. 2009;(S1):83-97
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This review (under the International Joint Learning Initiative on Children and AIDS) provides a detailed evidence analysis of gender, children and AIDS. Six systematic reviews provide the most up to date evidence base on research surrounding children and HIV on key topics of treatment resistance and adherence, schooling, nutrition, cognitive development and orphaning and bereavement. Traditional systematic review techniques were used to identify all published studies on four key topics, then studies were selected according to adequacy criteria (sufficient size, control group and adequate measures). A gender analysis was performed on included studies, detailing whether gender was measured, results were analysed by gender or any gender-based findings. For family studies, both the gender of the parents and gender of the child are needed. Secondary analysis by gender was performed on existing systematic reviews for treatment resistance and adherence. Of the 12 studies on treatment resistance, 11 did not look at gender. One found boys at a seven-fold risk compared to girls. For medication adherence, gender was not significant. Of the 15 studies on schooling, 12 analysed findings by gender with an overall female disadvantage. Of the 14 studies on nutrition, nine analysed by gender with mixed findings. Of the 54 studies on cognitive development, 17 provided gender data, but only four analysed by gender with few differences established. Of the 15 studies on bereavement, seven analysed data by gender again with mixed findings. Major policies fail to provide gender data for young children. WHO, UNAIDS and the international data sets are not gathered or coded by gender for young children (generally under 15 years of age) despite well-established gender challenges in later life. This review shows that the current evidence base is inadequate. Data on gender variation and outcome are urgently needed to inform policy and research on children and HIV.