Evidence map›Paper›PMID 16796762›Full record

ArticleBMC medical research methodology2006

Circular instead of hierarchical: methodological principles for the evaluation of complex interventions.

Harald Walach, Torkel Falkenberg, Vinjar Fønnebø, George Lewith, Wayne B Jonas

Abstract read
In one paragraph

Article in BMC medical research methodology, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 64 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
64citing papers in PubMed, 5 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

64 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
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  5. The evidence for Shiatsu: a systematic review of Shiatsu and acupressure.BMC complementary and alternative medicine · 2011
    Pooled it
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  10. Article
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  12. Review
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  18. Effects of an intervention program with health education and hatha yoga on the health of professionals with musculoskeletal symptoms.Revista brasileira de medicina do trabalho : publicacao oficial da Associacao Nacional de Medicina do Trabalho-ANAMT · 2020
    Article
  19. Article
  20. Statement to an Insufficient Systematic Review onEvidence-based complementary and alternative medicine : eCAM · 2020
    Article

4 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Harald WalachUniversity of Northampton & Samueli Institute - European Office, School of Social Sciences, Park Campus, Northampton NN2 7AL, UK. harald.walach@northampton.ac.uk
Torkel Falkenberg
Vinjar Fønnebø
George Lewith
Wayne B Jonas

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe reasoning behind evaluating medical interventions is that a hierarchy of methods exists which successively produce improved and therefore more rigorous evidence based medicine upon which to make clinical decisions. At the foundation of this hierarchy are case studies, retrospective and prospective case series, followed by cohort studies with historical and concomitant non-randomized controls. Open-label randomized controlled studies (RCTs), and finally blinded, placebo-controlled RCTs, which offer most internal validity are considered the most reliable evidence. Rigorous RCTs remove bias. Evidence from RCTs forms the basis of meta-analyses and systematic reviews. This hierarchy, founded on a pharmacological model of therapy, is generalized to other interventions which may be complex and non-pharmacological (healing, acupuncture and surgery). DISCUSSION: The hierarchical model is valid for limited questions of efficacy, for instance for regulatory purposes and newly devised products and pharmacological preparations. It is inadequate for the evaluation of complex interventions such as physiotherapy, surgery and complementary and alternative medicine (CAM). This has to do with the essential tension between internal validity (rigor and the removal of bias) and external validity (generalizability). SUMMARY: Instead of an Evidence Hierarchy, we propose a Circular Model. This would imply a multiplicity of methods, using different designs, counterbalancing their individual strengths and weaknesses to arrive at pragmatic but equally rigorous evidence which would provide significant assistance in clinical and health systems innovation. Such evidence would better inform national health care technology assessment agencies and promote evidence based health reform.

Indexed as

Outcome Assessment, Health CareRandomized Controlled Trials as TopicReproducibility of ResultsResearch DesignTechnology Assessment, BiomedicalEvidence-Based MedicineHumansPlacebosSensitivity and SpecificityPlacebos

Identifiers

PMID16796762
PMCPMC1540434

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.