PsycBITE™ Selection Criteria

PsycBITE™ Selection Criteria

 

Trials posted on PsycBITE™ must meet five eligibility criteria, as follows:

  1. the report is published as a full-length paper in a peer-reviewed scientific journal,
  2. the population treated is human, with brain impairment of acquired aetiology (including progressive conditions) that involves structural/morphological changes,
  3. the population is older than 5 years of age,
  4. treatment comprises at least one intervention that is psychologically-based and/or targets at least one psychological consequence of ABI, and
  5. the report provides empirical data regarding treatment efficacy.


Therefore the types of reports that are not included on PsycBITE™ are those that do not meet:
  • criterion 1 regarding types of publication (hence, abstracts, monographs, conference proceedings, books and book chapters are excluded),
  • criterion 2 regarding population with acquired brain impairment (hence, populations where the aetiology is congenital, such as those with developmental disability, learning disability, and schizophrenia and other mental health disorders are also excluded. Moreover, if the study uses mixed populations (e.g., 'a disabled sample', which may or may not include people with acquired brain impairment), then the subgroup with acquired brain impairment must be specifically identified and treated as an independent group in statistical analyses),
  • criterion 3 regarding age group (populations under 5 years of age are excluded because of brain maturational issues),
  • criterion 4 regarding treatment type is intentionally broad, in order to capture any treatment that is either psychologically-based or targets a psychological issue, although at this stage research designs using pharmacological treatments in isolation are excluded, and
  • criterion 5 regarding research design (although a broad range of research designs is included (see below) those that do not provide empirical data are excluded. Hence, case reports restricted to a description of the client/patient or treatment, editorials and non-systematic (narrative reviews) are excluded).


With respect to the last criterion, there are five main research designs yielding empirical data regarding treatment efficacy that are eligible for inclusion on PsycBITE™: systematic reviews, randomised controlled trials, non-randomised controlled trials, case series and single subject design. These designs span the gamut of levels of evidence (see table) from level 1 (systematic reviews) to level IV (case series). The reason that a range of classes of evidence is included is detailed elsewhere (Tate et al., in submission). In order to maximise the usefulness of PsycBITE™, a guiding principle in its development has been to determine the scope of all available evidence for all therapies pertinent to the psychological consequences of acquired brain impairment, rather than those restricted to a small number of rehabilitation procedures (e.g., cognitive therapies), clinical conditions (e.g., traumatic brain injury), or levels of evidence (e.g., randomised controlled trials).

The decision to include all levels of evidence finds support in statements made by the peak Australian research institution, the National Health and Medical Research Council (NHMRC). That body recognises "that this ideal [clinical trials using designs with the highest levels of evidence] may be difficult to attain in the case of public health and social science interventions: these important areas of health care should not be disadvantaged by the rigid application of a 'hierarchy' of evidence" (NHMRC, 1999, p.14).

The different research designs represent different classes of evidence, the first four of which are described by the BMJ website, NHMRC and other sources are as follows:

  1. Systematic Review (SRW)

A systematic review is an overview of primary studies which contains an explicit statement of objectives, materials, and methods and has been conducted according to explicit and reproducible methodology. A meta analysis may be included in this category. It is a mathematical synthesis of the results of two or more primary studies that addressed the same hypothesis in the same way. A meta analysis must be a component of a systematic review or adhere to systematic review methodology to be included in PsycBITE™.

  • Randomised Controlled Trial (RCT)

    • An RCT compares at least two treatments/interventions (one of which can be a no-treatment control or a wait-list control condition), which involves random allocation (participants are randomly allocated to groups for either the intervention/treatment being studied or control/placebo using a random mechanism, such as coin toss, random number table, or computer-generated random numbers) and the outcomes are compared. Pseudo or intended-to-be-randomised trials are also included in this category where participants are allocated to groups for intervention/treatment or control/placebo using a non-random method (such as alternate allocation or by odd or even hospital numbers).

  • Non-Randomised Controlled Trial (non-RCT)

    • This type of trial is similar to an RCT in that it compares at least two treatments/interventions (one of which can be a no-treatment control or a wait-list control condition) with the exception that participants have not been randomly allocated to groups. Participants with the outcome or disease are selected and information is obtained about the previous exposure to the treatment/intervention or other factor being studied.

  • Case Series (CS)

    • A group/s of participants are exposed to one treatment/intervention where outcomes are measured in participants before and after exposure to the treatment / intervention.

  • Single Subject Design (SSD)

    • This type of trial compares the effectiveness of interventions using the same (single) participant as his/her own control by assessing treatment effects over several different points in time. The single-case trial may take the form of variations of an ABAB (cross-over) or multiple baseline design.


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