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Table 3 Overview of the characteristics that were recorded for each trial included in the analysis, grouped by category

From: Analysis of the characteristics and the degree of pragmatism exhibited by pragmatic-labelled trials of antineoplastic treatments

Category

Characteristic

General aspects

Type(s) of neoplasm(s)

Year in which the trial was started♦

Year in which the trial was completed♦

Study duration∟

Year in which the main results were published*

Journal in which the main results were published*

Impact factor of journal in which the main results were published*°

Digital object identifier of consulted publication(s)

Trial registry identifier(s)

Availability of protocol

Design elements

Clinical phaseâ–²

Use of randomization

Use of blindingâ—Š

Number of study arms

Intervention(s)

Type of intervention(s)

(e.g. pharmacotherapy, surgery, radiotherapy, etc.)

Comparator(s)

Type of comparator(s)

(active or placebo; standard of care or not)∩

Primary endpoint(s)/outcome measure(s)

Secondary endpoint(s)/outcome measure(s)

Organizational facets

Number of participants†

Site-level setting

(monocentric or multicentric)∆

Country-level setting

(national or international)â– 

Countries in which the trial took place

Legal sponsorship⃞

Funding source

(commercial or non-commercial/academic)±

  1. ♦Information on when the studies were initiated and finalized was obtained from the trial registry records. If such data were missing from these files, they were extracted from other sources (e.g. journal articles)
  2. (∟) Calculated by subtracting the year in which the trial was started from the year in which it was completed
  3. *If the main results of the study had not (yet) been published, these characteristics were instead documented for publications discussing the interim results of the trial or, absent any such articles or abstracts, its setup
  4. °Impact factors were taken from Web of Science® journal metrics. If the 2021 impact factor was unavailable, the 2020 one was used as a substitute
  5. â–²Note that the clinical phase concept is not applicable to studies primarily investigating any non-pharmacological interventions other than gene therapies
  6. â—ŠA trial was considered single-blinded if either the patients participating in the study or the healthcare professionals administering the intervention were unaware of the treatment allocation, and double-blinded if both parties were. Masking on the part of outcome assessors and data analysts was left out of consideration
  7. ∩The assessment of whether or not a specific comparator treatment constituted standard of care was based on how it was described in the source materials that were scrutinized for each trial
  8. †This characteristic reflects the number of participants that were randomized or allocated to receive a study treatment. For ongoing trials that are still recruiting patients, it represents the planned sample size
  9. ∆This characteristic denotes whether the study was conducted in a single center or across multiple centers
  10. â– This characteristic indicates whether the trial was rolled out in a single country or across multiple countries
  11. ⃞Information on the legal sponsorship of the studies was collected from the trial registry records
  12. ±A trial was deemed to have a commercial funding source if it received material or financial support from companies
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BMC Medical Research Methodology

ISSN: 1471-2288

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