Comparing alternative design options for chronic disease prevention interventions

Golfam, Mohammad; Beall, Reed F.; Brehaut, Jamie; Saeed, Sara; Relton, Clare; Ashbury, Fredrick D.; Little, Julian

doi:10.1111/eci.12371

Cited by 11 publications

(4 citation statements)

References 55 publications

(86 reference statements)

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“…Clinically, RCT findings must take precedence, but observational data may identify crucial knowledge gaps in more inclusive populations, approximating real-world conditions, over a longer follow-up duration. Hybrid designs may be needed, especially in dementia prevention, wherein the challenges in RCT design to control the risk factors in large and representative older populations for a sufficient duration may be nearly insurmountable …”

Section: Discussionmentioning

confidence: 99%

Association of Systolic Blood Pressure With Dementia Risk and the Role of Age, U-Shaped Associations, and Mortality

et al. 2022

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IMPORTANCEThe optimal systolic blood pressure (SBP) to minimize the risk of dementia in older age is unknown.OBJECTIVE To investigate whether the association between SBP and dementia risk is U-shaped and whether age and comorbidity play a role in this association. DESIGN, SETTING, AND PARTICIPANTSThis cohort study used an individual participant data approach to analyze 7 prospective, observational, population-based cohort studies that were designed to evaluate incident dementia in older adults. These studies started between 1987 and 2006 in Europe and the US. Participants had no dementia diagnosis and had SBP and/or diastolic blood pressure (BP) data at baseline and incident dementia status during follow-up. Data analysis was conducted from November 7, 2019, to October 3, 2021.EXPOSURES Baseline systolic BP. MAIN OUTCOMES AND MEASURES All-cause dementia (defined using Diagnostic and Statistical Manual of Mental Disorders [Third Edition Revised] or Diagnostic and Statistical Manual of Mental Disorders [Fourth Edition] and established at follow-up measurements or in clinical practice), mortality, and combined dementia and mortality were the outcomes. Covariates included baseline antihypertensive medication use, sex, educational level, body mass index, smoking status, diabetes, stroke history, myocardial infarction history, and polypharmacy. Cox proportional hazards regression models were used, and nonlinear associations were explored using natural splines. RESULTSThe study analyzed 7 cohort studies with a total of 17 286 participants, among whom 10 393 were women (60.1%) and the mean (SD) baseline age was 74.5 (7.3) years. Overall, dementia risk was lower for individuals with higher SBP, with the lowest risk associated with an SBP of approximately 185 mm Hg (95% CI, 161-230 mm Hg; P = .001). Stratified by overlapping 10-year baseline age groups, the lowest dementia risk was observed at somewhat lower systolic BP levels in those older than 75 years (158 [95% CI, mm Hg to 170 [95% CI, 160-260] mm Hg). For mortality, there was a clear U-shaped association, with the lowest risk at 160 mm Hg (95% CI, 154-181 mm Hg; P < .001). This U-shape occurred across all age groups, with the lowest dementia risk associated with an SBP of 134 mm Hg (95% CI, 102-149 mm Hg; P = .03) in those aged 60 to 70 years and increasing to between 155 mm Hg (95% CI, 150-166 mm Hg; P < .001) and 166 mm Hg (95% CI, 154-260 mm Hg; P = .02) for age groups between 70 and 95 years. Combined dementia and mortality risk curves closely resembled those for mortality. Associations of diastolic BP with dementia risk were generally similar but were less distinct.CONCLUSIONS AND RELEVANCE This cohort study found that dementia risk was lower for older individuals with higher SBP levels and that more distinctly U-shaped associations appeared for those older than 75 years, but these associations cannot be explained by SBP-associated changes in mortality risk. The findings may warrant future trials on tailored BP management in older age groups that take life expec...

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Section: Discussionmentioning

confidence: 99%

Association of Systolic Blood Pressure With Dementia Risk and the Role of Age, U-Shaped Associations, and Mortality

et al. 2022

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“…Ten patients declined due to an extra hospital visit for baseline assessments; an alternative option is to conduct base assessments in participants’ homes or organize transport to facilitate participation. In combination with suggested improvements for a definitive trial, a multicenter approach should be considered to expand the catchment area and the number of eligible patients, as well as other options for alternative designs as was recommended in a recent review [54].…”

Section: Discussionmentioning

confidence: 99%

Feasibility of preoperative supervised home-based exercise in older adults undergoing colorectal cancer surgery – A randomized controlled design

et al. 2019

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Preoperative physical exercise is emerging as a growing field of research globally. There are still challenges in recruiting vulnerable older people, and time constraints in preoperative cancer care to consider. We therefore evaluated the feasibility of short-term supervised home-based exercise in older people prior to colorectal cancer surgery. This feasibility study was conducted between September 2016 and June 2018. People ≥70 years scheduled for colorectal cancer surgery were recruited and randomized to an intervention group receiving supervised home-based physical exercise at a high level of estimated exertion or a standard care group following the standard preoperative path. The exercise (respiratory, strength, and aerobic) consisted of 2–3 supervised sessions a week in the participants’ homes, for at least 2–3 weeks or until surgery, and a self-administered exercise program in between. The primary outcome was process feasibility, including aspects specifically related to recruitment rate, compliance to the intervention, and acceptability. The secondary outcome was scientific feasibility including treatment safety, description of dose level and response, and estimation of treatment results. Twenty-three participants were included (recruitment rate 35%). A median of 6 supervised sessions was conducted over a 17-day exercise period. Compliance with the supervised sessions was 97%, and participants found the intervention acceptable. Concerning the self-administered exercise, a median of 19 inspiratory muscle training, 6 functional strength, and 8.5 aerobic sessions were reported. Challenges reported by program instructors were time constraints and difficulties in achieving high exercise intensities on the Borg CR-10 scale. A statistically significant between-group difference was only found in inspiratory muscle strength, favoring the intervention group (p<0.01). A short-term preoperative supervised home-based physical exercise intervention can be conducted, with respect to compliance and acceptability, in older people with similar physical status as in this study prior to colorectal cancer surgery. However, modifications are warranted with respect to improving recruitment rates and achieving planned intensity levels prior to conducting a definitive trial.

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“…Results of systematic reviews show that less than 50% of recruited patients meet the strict eligibility criteria preset for RCTs. The strict criteria are applied to control for patients' personal and health characteristics that potentially confound the treatments' effects; however, their application yields, on average, small sample sizes 6 . Consequently, the evidence generated from RCTs is of limited applicability to the various subgroups of patients seeking treatment in practice and not represented in the RCTs 7,8 —an issue of external validity.…”

Section: Drive For the Revolutionmentioning

confidence: 99%

A revolution against the evidence‐based movement

Sidani

2023

Evaluation Clinical Practice

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Comparing alternative design options for chronic disease prevention interventions

Cited by 11 publications

References 55 publications

Association of Systolic Blood Pressure With Dementia Risk and the Role of Age, U-Shaped Associations, and Mortality

Association of Systolic Blood Pressure With Dementia Risk and the Role of Age, U-Shaped Associations, and Mortality

Feasibility of preoperative supervised home-based exercise in older adults undergoing colorectal cancer surgery – A randomized controlled design

A revolution against the evidence‐based movement

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