Telephone-based assessments to minimize missing data in longitudinal depression trials: A project IMPACTS study report

Claassen, Cynthia A.; Kurian, Ben; Trivedi, Madhukar H.; Grannemann, Bruce D.; Tuli, Ekta; Pipes, Ronny; Preston, Anne Marie; Flood, Ariell

doi:10.1016/j.cct.2008.08.001

Cited by 15 publications

(15 citation statements)

References 39 publications

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“…Telephone assessments of mRS and BI likely suffer from the same shortcomings, although some have shown them to be as reliable as face-to-face evaluations [43,44,45,46]. On the other hand, telephone-based assessments improve subject retention and minimize missing data in longitudinal studies [47]. Trial-related training for assessing mRS, BI, and NIHSS in the CHIMES-E study was not performed.…”

Section: Discussionmentioning

confidence: 99%

CHInese Medicine NeuroAiD Efficacy on Stroke Recovery - Extension Study (CHIMES-E): A Multicenter Study of Long-Term Efficacy

et al. 2015

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Background: The CHInese Medicine NeuroAiD Efficacy on Stroke recovery (CHIMES) study was an international randomized double-blind placebo-controlled trial of MLC601 (NeuroAiD) in subjects with cerebral infarction of intermediate severity within 72 h. CHIMES-E (Extension) aimed at evaluating the effects of the initial 3-month treatment with MLC601 on long-term outcome for up to 2 years. Methods: All subjects randomized in CHIMES were eligible for CHIMES-E. Inclusion criteria for CHIMES were age ≥18, baseline National Institute of Health Stroke Scale of 6-14, and pre-stroke modified Rankin Scale (mRS) ≤1. Initial CHIMES treatment allocation blinding was maintained, although no further study treatment was provided in CHIMES-E. Subjects received standard care and rehabilitation as prescribed by the treating physician. mRS, Barthel Index (BI), and occurrence of medical events were ascertained at months 6, 12, 18, and 24. The primary outcome was mRS at 24 months. Secondary outcomes were mRS and BI at other time points. Results: CHIMES-E included 880 subjects (mean age 61.8 ± 11.3; 36% women). Adjusted OR for mRS ordinal analysis was 1.08 (95% CI 0.85-1.37, p = 0.543) and mRS dichotomy ≤1 was 1.29 (95% CI 0.96-1.74, p = 0.093) at 24 months. However, the treatment effect was significantly in favor of MLC601 for mRS dichotomy ≤1 at 6 months (OR 1.49, 95% CI 1.11-2.01, p = 0.008), 12 months (OR 1.41, 95% CI 1.05-1.90, p = 0.023), and 18 months (OR 1.36, 95% CI 1.01-1.83, p = 0.045), and for BI dichotomy ≥95 at 6 months (OR 1.55, 95% CI 1.14-2.10, p = 0.005) but not at other time points. Subgroup analyses showed no treatment heterogeneity. Rates of death and occurrence of vascular and other medical events were similar between groups. Conclusions: While the benefits of a 3-month treatment with MLC601 did not reach statistical significance for the primary endpoint at 2 years, the odds of functional independence defined as mRS ≤1 was significantly increased at 6 months and persisted up to 18 months after a stroke.

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Section: Discussionmentioning

confidence: 99%

CHInese Medicine NeuroAiD Efficacy on Stroke Recovery - Extension Study (CHIMES-E): A Multicenter Study of Long-Term Efficacy

et al. 2015

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“…Although this approach resulted in lower enrollment and higher decline rates than the more time-intensive in-clinic recruitment method, it yielded higher retention rates and significantly higher survey response rates. This may indicate a more thought-out decision to participate and a higher level of patient engagement when more time is afforded for building rapport with potential participants, as has been demonstrated in other studies [21,22]. Since we did not try the in-clinic approach in these clinics, we cannot know whether it would have had the same consequences it did on the clinics we approached later, or if clinicians and their patients would have found it acceptable.…”

Section: Discussionmentioning

confidence: 89%

Lessons learned from the conduct of a multisite cluster randomized practical trial of decision aids in rural and suburban primary care practices

Ruud

LeBlanc

Mullan

et al. 2013

Trials

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BackgroundThe decision aids for diabetes (DAD) trial explored the feasibility of testing the effectiveness of decision aids (DAs) about coronary prevention and diabetes medications in community-based primary care practices, including rural clinics that care for patients with type 2 diabetes.MethodsAs originally designed, we invited clinicians in eight practices to participate in the trial, reviewed the patient panel of clinicians who accepted our invitation for potentially eligible patients, and contacted these patients by phone, enrolling those who accepted our invitation. As enrollment failed to meet targets, we recruited four new practices. After discussing the study with the clinicians and receiving their support, we reviewed all clinic panels for potentially eligible patients. Clinicians were approached to confirm participation and patient eligibility, and patients were approached before their visit to provide written informed consent. This in-clinic approach required study coordinators to travel and stay longer at the clinics as well as to screen more patient records for eligibility. The in-clinic approach was associated with better recruitment rates, lower patient retention and outcome completion rates, and a better intervention effect.ResultsWe drew four lessons: 1) difficulties identifying potentially eligible patients threaten the viability of practical trials of DAs; 2) to improve the recruitment yield, recruit clinicians and patients for the study at the clinic, just before their visit; 3) approaches that improve recruitment may be associated with reduced retention and survey response; and 4) procedures that involve working closely with the practice may improve recruitment and may also affect the quality of the implementation of the interventions.ConclusionSuccess in practice-based trials in usual primary care including rural clinics may require the smallest possible research footprint on the practice while implementing a streamlined protocol favoring in-clinic, in-person interactions with clinicians and patients.Trial registrationClinicalTrials.gov NCT01029288

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“…Study-specific education of study-associated staff has also been reported as important in engaging parents in studies [19]. While it was essential that trial-associated CC staff were well informed [1], all education and information delivery in this study was designed to minimise the risk of contamination between study arms.…”

Section: Methodsmentioning

confidence: 99%

Recruitment and retention strategies and the examination of attrition bias in a randomised controlled trial in children’s centres serving families in disadvantaged areas of England

Hindmarch

Hawkins

McColl

et al. 2015

Trials

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BackgroundFailure to retain participants in randomised controlled trials and longitudinal studies can cause significant methodological problems. We report the recruitment and retention strategies of a randomised controlled trial to promote fire-related injury prevention in families with pre-school children attending children’s centres in disadvantaged areas in England.MethodsThirty-six children’s centres were cluster randomised into one of three arms of a 12-month fire-related injury prevention trial. Two arms delivered safety interventions and there was one control arm. Retention rates compared the numbers of participants responding to the 12-month questionnaire to the number recruited to the trial. Multivariable random effects logistic regression was used to explore factors independently associated with participant retention.ResultsThe trial exceeded its required sample size through the use of multiple recruitment strategies. All children’s centres remained in the study, despite increased reorganisation. Parent retention was 68% at 12 months, ranging from 65% to 70% across trial arms and from 62% to 74% across trial sites. There was no significant difference in the rates of retention between trial arms (p = 0.58) or between trial sites (p = 0.16). Retention was significantly lower amongst mothers aged 16–25 years than older mothers [adjusted odds ratio (AOR) 0.57, 95% CI 0.41, 0.78], those living in non-owner occupied accommodation than in owner occupied accommodation (AOR 0.53, 95% CI 0.38, 0.73) and those living in more disadvantaged areas (most versus least disadvantaged quintiles AOR 0.50, 95% CI 0.30, 0.82).ConclusionsStudies recruiting disadvantaged populations should measure and report attrition by socioeconomic factors to enable determination of the extent of attrition bias and estimation of its potential impact on findings. Where differential attrition is anticipated, consideration should be given to over-sampling during recruitment and targeted and more intensive strategies of participant retention in these sub-groups. In transient populations collection of multiple sources of contact information at recruitment and throughout the study may aid retention.Trial registrationClinicaltrials.gov identifier: NCT01452191; Date of registration: 10 October 2011, ISRCTN65067450.

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Telephone-based assessments to minimize missing data in longitudinal depression trials: A project IMPACTS study report

Cited by 15 publications

References 39 publications

CHInese Medicine NeuroAiD Efficacy on Stroke Recovery - Extension Study (CHIMES-E): A Multicenter Study of Long-Term Efficacy

CHInese Medicine NeuroAiD Efficacy on Stroke Recovery - Extension Study (CHIMES-E): A Multicenter Study of Long-Term Efficacy

Lessons learned from the conduct of a multisite cluster randomized practical trial of decision aids in rural and suburban primary care practices

Recruitment and retention strategies and the examination of attrition bias in a randomised controlled trial in children’s centres serving families in disadvantaged areas of England

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