Dataset Information

Assessment of research waste part 1: an exemplar from examining study design, surrogate and clinical endpoints in studies of calcium intake and vitamin D supplementation.

ABSTRACT:

Background

Research waste is estimated to be very common, but assessments of its prevalence and scope are rare. As an example, we assessed research waste in clinical research on calcium intake (assessing study design and endpoint type) and vitamin D supplementation (assessing endpoint type).

Methods

We examined 404 randomised controlled trials (RCTs) and observational studies of calcium intake (diet or supplements) and bone mineral density (BMD) or fracture, and 547 RCTs of vitamin D supplements, and assessed the proportion of studies that used surrogate or clinical endpoints. For studies with BMD or fracture as an endpoint, we estimated when the 'tipping' point occurred indicating the need for RCTs with fracture as an endpoint (based on cumulative meta-analyses of BMD RCTs, and chronological review of observational studies), and whether each study published at least 5y after the tipping point was novel, added new clinical knowledge or was research waste.

Results

Observational studies of calcium intake and BMD or fracture outnumbered RCTs by 3.3-4.5 times. For both calcium intake and vitamin D supplements, studies using surrogate endpoints outnumbered studies using clinical endpoints by 1.6-3 times. Of 41 RCT publications of calcium intake and BMD or fracture published at least 5y after the tipping point in 1994, we considered that 19 (46%) lacked novelty, another 13 (32%) added no new clinical knowledge, and 30 (73%) were research waste. Of 204 observational study publications of calcium intake and BMD or fracture, 197 (96%) lacked novelty, another 5 (2%) added no new clinical knowledge, and 202 (99%) were research waste. Of 39 RCTs of vitamin D supplementation and BMD or fracture published at least 5y after the tipping point in 1999, 14 (36%) lacked novelty, another 13 (33%) added no new clinical knowledge, and 27 (69%) were research waste.

Conclusions

A high proportion of studies of calcium intake since 2000 (95%) and trials of vitamin D supplements since 2005 (69%) on BMD or fracture represent research waste.

SUBMITTER: Bolland MJ

PROVIDER: S-EPMC6180413 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Publications

Assessment of research waste part 1: an exemplar from examining study design, surrogate and clinical endpoints in studies of calcium intake and vitamin D supplementation.

Bolland Mark J MJ Avenell Alison A Grey Andrew A

BMC medical research methodology 20181010 1

<h4>Background</h4>Research waste is estimated to be very common, but assessments of its prevalence and scope are rare. As an example, we assessed research waste in clinical research on calcium intake (assessing study design and endpoint type) and vitamin D supplementation (assessing endpoint type).<h4>Methods</h4>We examined 404 randomised controlled trials (RCTs) and observational studies of calcium intake (diet or supplements) and bone mineral density (BMD) or fracture, and 547 RCTs of vitami ...[more]

PMID: 30305046

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Project description:Background: The purpose of this study was to assess the vitamin D supplementation intake status among children from different nationalities in the UAE, to determine vitamin D intake practices through diet and lifestyle, and the barriers that parents in the UAE face with providing vitamin D supplementation to their children. Methods: A cross-sectional observational questionnaire-based survey study design was used.. The study was conducted in the U.A.E and the study participants were parents of children from ages 4-15 years. The questionnaire used in this study was both self-administered and interviewer-administered while inquiring the questions from the parents. A convenience sampling technique was used to collect the data. The response rate of participants was expected to be 63%, the margin of error was 5% and the level of confidence was 95%. Results: A total of 248 participants (203 mothers, 39 fathers and 6 caregivers) completed the study. Participants reported that the supplements used the most by children were vitamin D supplements (21.85%), followed by multivitamins (21.8%) and calcium supplements (5.6%) and 27.8% of participants in this study reported to no supplementation at all. The rate of vitamin D supplementation among children was higher in those families with higher income levels, parents/caregivers who were more educated, those families who attained health insurance. However, there was no statistical significance between these correlations. Conclusion: The study concluded that challenges like the educational and financial background of parents, family-income level, and health insurance status could help aid in addressing the overall burden of vitamin D deficiency among young children in the UAE. Pediatricians and health care professionals could use our study and use it as an aid to provide screening on lifestyle, sun light exposure, and dietary modifications and also educate parents why and how vitamin D is crucial for their children.

Dataset Information

Assessment of research waste part 1: an exemplar from examining study design, surrogate and clinical endpoints in studies of calcium intake and vitamin D supplementation.

Background

Methods

Results

Conclusions

Publications

Assessment of research waste part 1: an exemplar from examining study design, surrogate and clinical endpoints in studies of calcium intake and vitamin D supplementation.

Similar Datasets

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