Participation in a Clinical Trial Enhances Adherence and Persistence to Treatment

Onzenoort, Hein A W van; Menger, Frederique E.; Neef, Cees; Verberk, Willem J.; Kroon, Abraham A.; Leeuw, Peter W. de; Kuy, Paul-Hugo M. van der

doi:10.1161/hypertensionaha.111.171074

Cited by 107 publications

(86 citation statements)

References 23 publications

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“…If the present trends in incidence and prevalence continue without change, it is estimated that one-third of Americans will have diabetes by 2050, portending even higher rates of morbidity and mortality as a result of poor glycemic control (13 RCTs have been the "gold standard" of study design because they tightly control the setting and delivery of interventions, minimize the effect of external factors on outcomes, and lead to a random distribution of unmeasured confounders. Yet the degree to which results obtained under RCT conditions can be extrapolated to real life remains an open question (14,15). Indeed, it is important to be aware of the ways in which clinical trial results might inflate expectations of treatment efficacy.…”

Section: Why Is Our Large and Ever-growing Diabetes Toolbox Not Leadimentioning

confidence: 99%

“…Indeed, it is important to be aware of the ways in which clinical trial results might inflate expectations of treatment efficacy. First, therapy interventions are often more focused in the unusual setting of the clinical trial, where patients may benefit from more frequent face-to-face visits, convenient access to therapy, closer monitoring, and wider availability of educational resources and support services (14,(16)(17)(18). Second, trial participants are often more concerned with their health and treatment and thus more motivated to actively participate in their own care.…”

Section: Why Is Our Large and Ever-growing Diabetes Toolbox Not Leadimentioning

confidence: 99%

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Type 2 Diabetes in the Real World: The Elusive Nature of Glycemic Control

2017

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Despite U.S. Food and Drug Administration (FDA) approval of over 40 new treatment options for type 2 diabetes since 2005, the latest data from the National Health and Nutrition Examination Survey show that the proportion of patients achieving glycated hemoglobin (HbA 1c ) <7.0% (<53 mmol/mol) remains around 50%, with a negligible decline between the periods 2003-2006 and 2011-2014. The Healthcare Effectiveness Data and Information Set reports even more alarming rates, with only about 40% and 30% of patients achieving HbA 1c <7.0% (<53 mmol/mol) in the commercially insured (HMO) and Medicaid populations, respectively, again with virtually no change over the past decade. A recent retrospective cohort study using a large U.S. claims database explored why clinical outcomes are not keeping pace with the availability of new treatment options. The study found that HbA 1c reductions fell far short of those reported in randomized clinical trials (RCTs), with poor medication adherence emerging as the key driver behind the disconnect. In this Perspective, we examine the implications of these findings in conjunction with other data to highlight the discrepancy between RCT findings and the real world, all pointing toward the underrealized promise of FDA-approved therapies and the critical importance of medication adherence. While poor medication adherence is not a new issue, it has yet to be effectively addressed in clinical practicedoften, we suspect, because it goes unrecognized. To support the busy health care professional, innovative approaches are sorely needed. ACHIEVEMENT OF HbA 1c GOALS IN THE REAL WORLDLarge randomized controlled trials (RCTs) have clearly demonstrated that achieving and sustaining optimal glycemic control prevents or delays the development of microvascular and macrovascular disease (1-3). Although the risk of developing diabetesrelated complications rises steadily when glycated hemoglobin (HbA 1c ) values are in excess of 6.5% (48 mmol/mol) (4,5), an HbA 1c of ,7% (,53 mmol/mol) is generally considered a target goal for diabetes management (6). In truth, it is now widely recognized that individualizing the HbA 1c goal for each patient is critically important, especially when the presence of comorbidities necessitates less stringent targets (6). However, most government and private insurer reports continue to use 7% as a point of reference; therefore, we focus herein on this marker of glycemic control.Despite our growing understanding of diabetes and the availability of new medications and technologies, a substantial number of individuals are not at their glycemic goal. Of note, recent data indicate that 85.6% of adults with diagnosed diabetes are treated with diabetes medication (7). Results from the National Health and Nutrition Examination Survey (NHANES) indicate that only about 50% of American adults with diabetes are achieving HbA 1c ,7.0% (,53 mmol/mol) (8), and it is estimated that only 64% are reaching individualized glycemic goals (9). These findings are noteworthy

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Section: Why Is Our Large and Ever-growing Diabetes Toolbox Not Leadimentioning

confidence: 99%

Section: Why Is Our Large and Ever-growing Diabetes Toolbox Not Leadimentioning

confidence: 99%

Type 2 Diabetes in the Real World: The Elusive Nature of Glycemic Control

2017

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“…First, a much larger proportion of children attended regularly and received fluoride-containing varnish in the trial than is evident in the general population in England. The children who consented to participate in the trial, as in any trial, 92 are more likely to adhere to treatment regimes than children in the general population. As the trial was a CTIMP there was close monitoring of fidelity to delivery of the intervention as per protocol.…”

Section: A 2003 Cochrane Reviewmentioning

confidence: 99%

A randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services: the Northern Ireland Caries Prevention In Practice (NIC-PIP) trial

Tickle

O’Neill

Donaldson

et al. 2016

Health Technol Assess

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BackgroundDental caries is the most common disease of childhood. The NHS guidelines promote preventative care in dental practices, particularly for young children. However, the cost-effectiveness of this policy has not been established.ObjectiveTo measure the effects and costs of a composite fluoride intervention designed to prevent caries in young children attending dental services.DesignThe study was a two-arm, parallel-group, randomised controlled trial, with an allocation ratio of 1 : 1. Randomisation was by clinical trials unit, using randomised permuted blocks. Children/families were not blinded; however, outcome assessment was blinded to group assessment.SettingThe study took place in 22 NHS dental practices in Northern Ireland, UK.ParticipantsThe study participants were children aged 2–3 years, who were caries free at baseline.InterventionsThe intervention was composite in nature, comprising a varnish containing 22,600 parts per million (p.p.m.) fluoride, a toothbrush and a 50-ml tube of toothpaste containing 1450 p.p.m. fluoride; plus standardised, evidence-based prevention advice provided at 6-monthly intervals over 3 years. The control group received the prevention advice alone.Main outcome measuresThe primary outcome measure was conversion from caries-free to caries-active states. Secondary outcome measures were the number of decayed, missing or filled tooth surfaces in primary dentition (dmfs) in caries-active children, the number of episodes of pain, the number of extracted teeth and the costs of care. Adverse reactions (ARs) were recorded.ResultsA total of 1248 children (624 randomised to each group) were recruited and 1096 (549 in the intervention group and 547 in the control group) were included in the final analyses. A total of 87% of the intervention children and 85% of control children attended every 6-month visit (p = 0.77). In total, 187 (34%) children in the intervention group converted to caries active, compared with 213 (39%) in the control group [odds ratio (OR) 0.81, 95% confidence interval (CI) 0.64 to 1.04;p = 0.11]. The mean number of tooth surfaces affected by caries was 7.2 in the intervention group, compared with 9.6 in the control group (p = 0.007). There was no significant difference in the number of episodes of pain between groups (p = 0.81). However, 164 out of the total of 400 (41%) children who converted to caries active reported toothache, compared with 62 out of 696 (9%) caries-free children (OR 7.1 95% CI 5.1 to 9.9;p < 0.001). There was no statistically significant difference in the number of teeth extracted in caries-active children (p = 0.95). Ten children in the intervention group had ARs of a minor nature. The average direct dental care cost was £155.74 for the intervention group and £48.21 for the control group over 3 years (p < 0.05). The mean cost per carious surface avoided over the 3 years was estimated at £251.00.LimitationsThe usual limitations of a trial such as generalisability and understanding the underlying reasons for the outcomes apply. There is no mean willingness-to-pay threshold available to enable assessment of value for money.ConclusionsA statistically significant effect could not be demonstrated for the primary outcome. Once caries develop, pain is likely. There was a statistically significant difference in dmfs in caries-active children in favour of the intervention. Although adequately powered, the effect size of the intervention was small and of questionable clinical and economic benefit.Future workFuture work should assess the caries prevention effects of interventions to reduce sugar consumption at the population and individual levels. Interventions designed to arrest the disease once it is established need to be developed and tested in practice.Trial registrationCurrent Controlled Trials ISRCTN36180119 and EudraCT 2009-010725-39.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 71. See the NIHR Journals Library website for further project information.

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“…In a retrospective cohort study, the benefits of participation in clinical trials irrespective of the treatment allocation were illustrated by better persistence and adherence to prescribed medication in the long term. 23 The trend toward continuing reanalysis of data gathered some time ago is not without potential flaws. It is proving more and more difficult to show incremental benefit of new therapies over standard therapy in control groups that are on background therapy marked by high statin, antiplatelet, and other antihypertensive therapy rates, as well as more overweight and obesity and less tobacco use than in the past.…”

Section: Old Ground New Findingsmentioning

confidence: 99%

Recent Clinical Trials of Hypertension Management

Jennings

2013

Hypertension

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Participation in a Clinical Trial Enhances Adherence and Persistence to Treatment

Cited by 107 publications

References 23 publications

Type 2 Diabetes in the Real World: The Elusive Nature of Glycemic Control

Type 2 Diabetes in the Real World: The Elusive Nature of Glycemic Control

A randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services: the Northern Ireland Caries Prevention In Practice (NIC-PIP) trial

Recent Clinical Trials of Hypertension Management

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