Statistical handling of drop‐outs in longitudinal clinical trials

Heyting, A.; Tolboom, Jeroen; Essers, Jeroen

doi:10.1002/sim.4780111603

Cited by 227 publications

(125 citation statements)

References 17 publications

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“…25,26 A logistic regression for the variable "assessed at trial end" (yes = 1, no = 0) was estimated over a constant term and adolescent mother status (the only variable associated with loss). The probability of being assessed was calculated and inverse probability weights computed.…”

Section: Discussionmentioning

confidence: 99%

Integrating a Parenting Intervention With Routine Primary Health Care: A Cluster Randomized Trial

et al. 2015

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OBJECTIVE: More than 200 million children globally do not attain their developmental potential.We hypothesized that a parent training program could be integrated into primary health center visits and benefit child development. METHODS:We conducted a cluster randomized trial in the Caribbean (Jamaica, Antigua, and St Lucia). Fifteen centers were randomly assigned to the control (n = 250 mother-child pairs) and 14 to the intervention (n = 251 mother-child pairs) groups. Participants were recruited at the 6-to 8-week child health visit. The intervention used group delivery at 5 routine visits from age 3 to 18 months and comprised short films of child development messages, which were shown in the waiting area; discussion and demonstration led by community health workers; and mothers' practice of activities. Nurses distributed message cards and a few play materials. Primary outcomes were child cognition, language, and hand-eye coordination and secondary outcomes were caregiver knowledge, practices, maternal depression, and child growth, measured after the 18-month visit.RESULTS: Eight-five percent of enrolled children were tested (control = 210, intervention = 216). Loss did not differ by group. Multilevel analyses showed significant benefits for cognitive development (3.09 points; 95% confidence interval: 1.31 to 4.87 points; effect size: 0.3 SDs). There were no other child benefits. There was a significant benefit to parenting knowledge (treatment effect: 1.59; 95% confidence interval: 1.01 to 2.17; effect size: 0.4).CONCLUSIONS: An innovative parenting intervention, requiring no additional clinic staff or mothers' time, was integrated into health services, with benefits to child cognitive development and parent knowledge. This is a promising strategy that merits further evaluation at scale.

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Section: Discussionmentioning

confidence: 99%

Integrating a Parenting Intervention With Routine Primary Health Care: A Cluster Randomized Trial

et al. 2015

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“…(Heytig et al, 1992;Wooldridge, 2002) A logistic regression for the variable "assessed at trial end" (yes 1, no 0) was estimated over a constant term and variables associated with loss (for 3 country analyses adolescent mother status; for analyses with Jamaica only, adolescent mother status and household crowding). The probability of being assessed was calculated and inverse probability weights computed as 1 divided by the estimated probability of being assessed.…”

Section: Discussionmentioning

confidence: 99%

Delivering Parenting Interventions through Health Services in the Caribbean

Walker¹,

Powell²,

Chang³

et al. 2015

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work is licensed under a Creative Commons IGO 3.0 AttributionNonCommercial-NoDerivatives (CC-IGO BY-NC-ND 3.0 IGO) license (http://creativecommons.org/licenses/by-nc-nd/3.0/igo/ legalcode) and may be reproduced with attribution to the IDB and for any non-commercial purpose, as provided below. No derivative work is allowed.Any dispute related to the use of the works of the IDB that cannot be settled amicably shall be submitted to arbitration pursuant to the UNCITRAL rules. The use of the IDB's name for any purpose other than for attribution, and the use of IDB's logo shall be subject to a separate written license agreement between the IDB and the user and is not authorized as part of this CC-IGO license.Following a peer review process, and with previous written consent by the Inter-American Development Bank (IDB), a revised version of this work may also be reproduced in any academic journal, including those indexed by the American Economic Association's EconLit, provided that the IDB is credited and that the author(s) receive no income from the publication. Therefore, the restriction to receive income from such publication shall only extend to the publication's author(s). With regard to such restriction, in case of any inconsistency between the Creative Commons IGO 3.0 Attribution-NonCommercial-NoDerivatives license and these statements, the latter shall prevail.Note that link provided above includes additional terms and conditions of the license.The opinions expressed in this publication are those of the authors and do not necessarily reflect the views of the Inter-American Development Bank, its Board of Directors, or the countries they represent. AbstractIntegrating early childhood interventions with health and nutrition services has been recommended, however there is limited information on interventions that are effective and feasible for delivery through health services. In this trial we developed and evaluated a parenting program that could be integrated into primary health center visits. The intervention used group delivery at five routine visits from age 3-18 months, and comprised: short films of child development messages, shown in the waiting area; discussion and demonstration led by community health workers; and mothers' practice of activities. Nurses gave out and reviewed message cards with mothers, together with a few play materials. A cluster randomized trial was conducted in the Caribbean (Jamaica, Antigua and St Lucia) in 29 health centers. Centers, stratified by the 3 countries, were randomized to control (n=15) or health center intervention (n=14).We also adapted the Jamaica home visit intervention to increase feasibility at scale, and evaluated this together with the group intervention in Jamaica only. Participants were recruited at the 6-8 week child health visit. Primary outcomes were child cognition, language and hand-eye coordination, and secondary outcomes caregiver knowledge, practices, maternal depression, and child growth, measured after the 18 month visit. Multilevel analyses comparing...

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“…To avoid this problem, missing data imputation becomes an important part of analysing economic data. Within this study, the last observation carried forward was used to impute missing data in order to calculate total costs and QALYs (Heyting et al, 1992). Figure 1 shows that 444 patients (out of 674) or 66% had a valid baseline QoL assessment; 230/338 (68%) in the IFN group Table 1 Comparison of samples analysed For the EORTC QLQ-C30 v1 function scales a higher score represents a better level of functioning.…”

Section: Discussionmentioning

confidence: 99%

Quality of life and cost-effectiveness of interferon-alpha in malignant melanoma: results from randomised trial

et al. 2006

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A definitive conclusion regarding the value of low-dose extended duration adjuvant interferon-alpha therapy in the treatment of malignant melanoma is only possible once data on health-related quality of life (HRQoL) and costs have been considered. This trial randomised 674 patients to interferon alpha-2a (3 megaunits three times per week for 2 years or until recurrence) or placebo. Health-related quality of life (QoL) was to be assessed up to 60 months using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30. Data for the economic analysis, including cost information and the EQ-5D were also collected. Patients in the observation (OBS) group had significantly better mean follow-up quality of on five dimensions of the EORTC QLQ-C30 functional scales: role functioning (P ¼ 0.033), emotional functioning (P ¼ 0.003), cognitive functioning (P ¼ 0.001), social functioning (P ¼ 0.003) and global health status (P ¼ 0.001). Patients in the OBS group had significantly better mean follow-up symptom scores on seven dimensions of the EORTC QLQ-C30 V1 symptom scales. Economic data showed that costs were d3066 higher in the interferon group and produces an incremental cost per quality-adjusted life year of d41 432 at 5 years. The results show that interferon has significant effects on QoL and symptomatology and is unlikely to be cost-effective in this patient group in the UK.

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Statistical handling of drop‐outs in longitudinal clinical trials

Cited by 227 publications

References 17 publications

Integrating a Parenting Intervention With Routine Primary Health Care: A Cluster Randomized Trial

Integrating a Parenting Intervention With Routine Primary Health Care: A Cluster Randomized Trial

Delivering Parenting Interventions through Health Services in the Caribbean

Quality of life and cost-effectiveness of interferon-alpha in malignant melanoma: results from randomised trial

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