Explanatory and pragmatic attitudes in therapeutical trials

Schwartz, D.; Lellouch, J

doi:10.1016/0021-9681(67)90041-0

Cited by 1,161 publications

(710 citation statements)

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“…The study was designed as a pragmatic [24][25] randomized, doubleblind trial of a 15-day course of subcutaneous octreotide versus placebo after control of upper digestive bleeding from any portal hypertensive source in cirrhotic patients. Early rebleeding, from any source, within 15 days after randomization, was the primary measure of treatment efficacy; 42-day rebleeding rate was also assessed as a secondary measure.…”

Section: Methodsmentioning

confidence: 99%

“…Because it was our policy to treat patients with sclerotherapy and/or ␤-blockers as soon as possible after a bleeding episode for long-term prevention of rebleeding, 9 we planned this study as a pragmatic trial [24][25] in which sclerotherapy and/or ␤-blockers were allowed during the experimental treatment. Patients not suitable for sclerotherapy and/or ␤-blockers were separately randomized and analyzed.…”

mentioning

confidence: 99%

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Octreotide compared with placebo in a treatment strategy for early rebleeding in cirrhosis. A double blind, randomized pragmatic trial

et al. 1998

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␤-Blockers and sclerotherapy prevent long-term upper digestive rebleeding in cirrhosis but they seem ineffective for early rebleeding. We compared octreotide with a placebo for the prevention of early rebleeding in cirrhotic patients. After control of acute upper digestive bleeding, 262 consecutive cirrhotic patients were randomized to octreotide 100 g subcutaneously three times a day for 15 days (n ‫؍‬ 131) or to the placebo (n ‫؍‬ 131), in a double blind pragmatic trial in which ␤-blockers and/or sclerotherapy were allowed together with the experimental treatment. Separate randomization and analysis were performed according to whether patients were eligible for ␤-blockers and/or sclerotherapy (101 placebo, 97 octreotide) or not (30 placebo, 34 octreotide). Rebleeding within 15 days was the primary measure of treatment efficacy; 6-week rebleeding rate was also assessed as a secondary measure. Fifteen-day cumulative proportions of patients rebleeding were 28% in the placebo group and 24% in the octreotide group (P ‫؍‬ .40); corresponding figures among the 198 patients eligible to ␤-blockers and/or sclerotherapy were 26% and 16% (P ‫؍‬ .05) and among the 64 not eligible for these treatments 33% and 49% (P ‫؍‬ .29). Among patients eligible to ␤-blockers and/or sclerotherapy, a significant reduction of rebleeding episodes (35 vs. 18, P ‫؍‬ .03), blood transfusions (75 vs. 50, P ‫؍‬ .04), and days of stay in hospital (1,544 vs. 1,190, P ‫؍‬ .0001) was also found in the octreotide group: this beneficial effect was confirmed 6 weeks after randomization. Following upper digestive bleeding in cirrhosis, almost 50% of patients rebleed and 30% die within 6 weeks.

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Section: Methodsmentioning

confidence: 99%

mentioning

confidence: 99%

Octreotide compared with placebo in a treatment strategy for early rebleeding in cirrhosis. A double blind, randomized pragmatic trial

et al. 1998

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“…It has four stages: ‗development', ‗efficacy and short- (sometimes an expert centre) with a single or a few skilled operators. [25] While information about safety and efficacy of new interventional procedures is important for decision-makers, it is unlikely that it will be sufficient, because there are wider considerations when deciding whether or not to introduce a new procedure. A study exploring perceptions of UK National Health Service decision-makers regarding national guidance on the safety and efficacy of new interventional procedures showed that additional information over and above safety and efficacy would be useful to help decide whether or not the new technology should be offered to patients in routine care.…”

Section: A Framework For the Evaluation Of A New Interventional Procementioning

confidence: 99%

A framework for the evaluation of new interventional procedures

et al. 2012

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Objectives: The introduction of new interventional procedures is less regulated than for other health technologies such as pharmaceuticals. Decisions are often taken on evidence of efficacy and short-term safety from small-scale usually observational studies. This reflects the particular challenges of evaluating interventional procedures -the extra facets of skill and training and the difficulty defining a ‗new' technology. Currently, there is no framework to evaluate new interventional procedures before they become available in clinical practice as opposed to new pharmaceuticals. This paper proposes a framework to guide the evaluation of a new interventional procedure. The framework also suggests the types of studies or data collection methods that can be used to satisfy each stage.Conclusions: This paper makes a first step on a framework for generating evidence on new interventional procedures. The difficulties and limitations of applying such a framework are discussed.

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“…Naturalistic studies include 'pragmatic trials' under life-like conditions as well as observational studies based on post-marketing surveillance. This is unfortunate, because naturalistic studies are the best way to assess comparative and cost effectiveness in routine use [12,13].…”

Section: Criticisms Of Current Pharmaceutical and Medical Device Evalmentioning

confidence: 99%

Regulating the economic evaluation of pharmaceuticals and medical devices: a European perspective

Cookson

Hutton²

2003

Health Policy

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Explanatory and pragmatic attitudes in therapeutical trials

Cited by 1,161 publications

References 4 publications

Octreotide compared with placebo in a treatment strategy for early rebleeding in cirrhosis. A double blind, randomized pragmatic trial

Octreotide compared with placebo in a treatment strategy for early rebleeding in cirrhosis. A double blind, randomized pragmatic trial

A framework for the evaluation of new interventional procedures

Regulating the economic evaluation of pharmaceuticals and medical devices: a European perspective

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