Survey among 78 studies showed that Lasagna's law holds in Dutch primary care research

Wouden, Johannes C. van der; Blankenstein, Annette H.; Huibers, Marcus J.H.; Windt, D.A.W.M. van der; Stalman, W.A.B.; Verhagen, Arianne P.

doi:10.1016/j.jclinepi.2006.11.010

Cited by 99 publications

(100 citation statements)

References 8 publications

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“…26 To detect a change in score of 2.3 points on the HIT-6 with 80% power at a 5% significance level and an intracluster coefficient of 0.01-0.02, we needed to recruit 60 primary care practices with 900 potential patients.…”

Section: Sample Size Calculationmentioning

confidence: 99%

A proactive approach to migraine in primary care: a pragmatic randomized controlled trial

Smelt

Blom

Dekker

et al. 2012

CMAJ

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Section: Sample Size Calculationmentioning

confidence: 99%

A proactive approach to migraine in primary care: a pragmatic randomized controlled trial

Smelt

Blom

Dekker

et al. 2012

CMAJ

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“…6 Louis Lasagna famously observed that when trial recruitment starts, "the supply of suitable patients becomes a fraction of what it was assumed to be before the trial began." 7 Failure to enrol and retain a target sample reduces a study's statistical power, compromising its prospect of delivering a statistically informative answer to the primary question grounding its design and review. Abortive studies also poorly utilize scarce human and material resources, and deplete the supply of eligible candidates for other investigations.…”

Section: Introductionmentioning

confidence: 99%

Unsuccessful trial accrual and human subjects protections: An empirical analysis of recently closed trials

et al. 2014

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“…Inspection of the community venues during preliminary fieldwork suggested that more than a sufficient number of men should have been available, but few were available when it came to recruiting them. This may be an example of the operation of Lasagna's law 109 in a community setting.…”

Section: Discussionmentioning

confidence: 99%

Modifying Alcohol Consumption to Reduce Obesity (MACRO): development and feasibility trial of a complex community-based intervention for men

Crombie

Cunningham

Irvine

et al. 2017

Health Technol Assess

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Background Obese men who consume alcohol are at a greatly increased risk of liver disease; those who drink > 14 units of alcohol per week have a 19-fold increased risk of dying from liver disease. Objectives To develop an intervention to reduce alcohol consumption in obese men and to assess the feasibility of a randomised controlled trial (RCT) to investigate its effectiveness. Design of the intervention The intervention was developed using formative research, public involvement and behaviour change theory. It was organised in two phases, comprising a face-to-face session with trained laypeople (study co-ordinators) followed by a series of text messages. Participants explored how alcohol consumption contributed to weight gain, both through direct calorie consumption and through its effect on increasing food consumption, particularly of high-calorie foodstuffs. Men were encouraged to set goals to reduce their alcohol consumption and to make specific plans to do so. The comparator group received an active control in the form of a conventional alcohol brief intervention. Randomisation was carried out using the secure remote web-based system provided by the Tayside Clinical Trials Unit. Randomisation was stratified by the recruitment method and restricted using block sizes of randomly varying lengths. Members of the public were involved in the development of all study methods. Setting Men were recruited from the community, from primary care registers and by time–space sampling (TSS). The intervention was delivered in community settings such as the participant’s home, community centres and libraries. Participants Men aged 35–64 years who had a body mass index (BMI) of > 30 kg/m2 and who drank > 21 units of alcohol per week. Results The screening methods successfully identified participants meeting the entry criteria. Trial recruitment was successful, with 69 men (36 from 419 approached in primary care, and 33 from 470 approached via TSS) recruited and randomised in 3 months. Of the 69 men randomised, 35 were allocated to the intervention group and 34 to the control group. The analysis was conducted on 31 participants from the intervention group and 30 from the control group. The participants covered a wide range of ages and socioeconomic statuses. The average alcohol consumption of the men recruited was 47.2 units per week, more than twice that of the entry criterion (> 21 units per week). Most (78%) engaged in binge drinking (> 8 units in a session) at least weekly. Almost all (95%) exceeded the threshold for a 19-fold increase in the risk of dying from liver disease (BMI of > 30 kg/m2 and > 14 units of alcohol per week). Despite this, they believed that they were at low risk of harm from alcohol, possibly because they seldom suffered acute harms (e.g. hangovers) and made few visits to a general practitioner or hospital. Intervention The intervention was delivered with high fidelity. A high follow-up rate was achieved (98%) and the outcomes for the full RCT were measured. A process evaluation showe...

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Survey among 78 studies showed that Lasagna's law holds in Dutch primary care research

Cited by 99 publications

References 8 publications

A proactive approach to migraine in primary care: a pragmatic randomized controlled trial

A proactive approach to migraine in primary care: a pragmatic randomized controlled trial

Unsuccessful trial accrual and human subjects protections: An empirical analysis of recently closed trials

Modifying Alcohol Consumption to Reduce Obesity (MACRO): development and feasibility trial of a complex community-based intervention for men

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