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Whelan TJ, O'Brien MA, Villasis-Keever M, et al. Impact of Cancer-Related Decision Aids. Rockville (MD): Agency for Healthcare Research and Quality (US); 2002 Jul. (Evidence Reports/Technology Assessments, No. 46.)

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

Cover of Impact of Cancer-Related Decision Aids

Impact of Cancer-Related Decision Aids.

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Appendix D: Guidelines for Decision Aid Relevance Form

  1. The STATUS box is completed after all other parts of the form.
    • "Include" means that the article will go on for further data extraction.
    • "Exclude" means that the article will be excluded from further consideration pending consensus.
    • "Uncertain" means that further discussion about the article will occur in order to achieve consensus. If any other section of the form is coded as uncertain or unclear, the status MUST be coded as uncertain.
  2. All articles (except those in a foreign language) will be screened independently first by 2 reviewers. Afterwards, these same two reviewers will discuss the article together and complete a consensus form. Consensus forms must be coded as either status include or status exclude, and no other part of the screening form should be coded as unclear or uncertain.
  3. For all options on the screening form labeled "Other", screeners must provide specification in the associated text box. The two larger text boxes hold a maximum of 30 characters; the two smaller ones hold a maximum of 10 characters. Any text in these boxes should be recorded on the running lists, which are located on the bulletin board in HSC-3H22, so that other screeners can maintain consistency by using the same specifications.
  4. For any article which the two assigned reviewers have difficulty reaching consensus or want additional opinions, please provide the article with a note/request to any 3rd. screener for their input.
  5. If an article arises where consensus is difficult to reach and the issue is an importat one for the group to be aware of, please:
    • give it to all other screeners, ask for it to be passed along and then returned to you with all input and/or
    • arrange to have a brief group discussion.
An intervention designed primarily to help patients or patients and clinicians together, with making cancer-related health care decisions when options are available for prevention, screening, and treatment. At a minimum, it should target some component of decision-making (e.g., information exchange, involvement in the decision process).

The following interventions will be excluded:
  1. interventions designed to support informed consent (they do not involve decision making).
  2. Interventions designed for general education (they may not offer options, may advocate a particular action or may not ask for any decision to be made).

Guidelines for Specific Portions of the Relevance Form


Primary Study

  • Must be a report on an experiment or investigation of an intervention, or an outcome measure related to an explicit decision-making process.
  • It must not be a position paper or any type of review.


Focus of Study

  1. Wherever possible, broad cancer groupings such as "Head & Neck" or "Abdominal" should be delineated into the more specific groups identified on the screening form.
  2. Hodgkin's Disease will be coded as lymphoma.
  3. Uterine and endometrial cancers will be coded as Corpus Uteri.
  4. Skin cancers that are NOT melanoma will be coded as Other & Specify Type.
  5. Decision Aids surrounding genetic screening will be coded as screening decisions.
  6. Part I and Part II MUST be completed in all cases.
  7. Not Specified will be used for articles where the decision is of a general nature and is applicable to 3 or more specific focal diseases (e.g. a decision to take antioxidants or not in the prevention of several types of cancer).
  8. For focal disease, the screener must specify a description when coding "Other" (maximum readable 30 characters).


Type of Study

  1. Tools/Interventions to assist decision making must have the following characteristics:
    • Must explicitly present more than one option (of which one can be take no action or maintain status quo).
    • Must not advocate/advise a particular course of action or present information in a manner biased towards one or another option.
    • Must target some phase of the decision making process (i.e. structuring the patient-physician encounter, information elicitation or transfer, deliberation, etc.) and occur prior to the actual decision.
  2. Outcome measures must be instruments that would be used to assess decision-making or to evaluate decision-making interventions. For example, a study validating the "Decisional Conflict Scale" would be retrieved because this scale is used to evaluate some decision aid interventions.
  3. Interventions or decisions not primarily targeting some aspect of cancer care will be excluded, unless the study describes the development or validation of a decision aid or an outcome measure.
    • We will exclude interventions or decisions surrounding the management of Benign Prostatic Hyperplasia (BPH).
    • We will exclude interventions or decisions surrounding Hormone Replacement Therapy unless the sample has cancer presently / had it in the past / or is at HIGH risk for developing it.
    • Interventions (educational, behavioral, etc) regarding smoking cessation will be excluded, unless the sample has cancer presently/had it in the past/or have additional risk factors for developing it.
  4. The option of "informed consent intervention" should be used to exclude studies only when the intervention is labeled as an informed consent in the article.
  5. Exclusion Codes for Educational Interventions (code all that apply)
    1..............Intervention does not require a specific decision at some point after the intervention
    2..............Intervention describes only ONE option
    3..............Intervention advocates a particular course of action; e.g., screening (mammography, PSA, etc.), or prevention (smoking cessation, etc.).
    4..............Intervention occurs post-decision
    5..............Intervention is designed to counsel patients about how to communicate with clinicians
    6..............Other (Specify - maximum readable 10 characters )


Purpose of the Study

  1. Development of a decision aid
    • Includes pilot testing of a decision aid/intervention or a part thereof.
  2. Evaluating the intervention
    • Includes evaluating the intervention with respect to outcome measures or user experience.
  3. Validation of intervention or outcome measure
    • Includes reliability and validity testing of a decision aid intervention or an outcome measure.
  4. Mathematical Models
    • Articles about mathematical models and techniques (e.g., utility analysis, probability trade-off techniques) will be excluded if the purpose is general modeling of the decision making process. They will be included if and only if they are applied within the context of an intervention to assist the patient or patient & clinician in making a specific, cancer-related decision.


Characteristics of Sample

  1. Focal Disease is the type of cancer around which the preventative, screening or treatment decision is structured. The level of specificity may vary with each article (e.g., lung cancer or non-small-cell lung cancer). Alternatively, this includes any illness secondary to a) the focal cancer or b) any treatment or screening procedures targeting the focal cancer (e.g. pneumonia secondary to chemotherapy).
  2. Related Non-Focal Disease is a type of cancer which is different from the focal disease.
  3. At Risk Patients - the article should state that the sample studied was at risk for the focal disease.
  4. Any sample of women greater than 40 years will be coded as at risk (regardless of whether stated in the article) when the article is about mammography.
  5. Any sample of men greater than 50 years will be coded as at risk (regardless of whether stated in the article) when the article is about PSA screening.
  6. Any sample of women who are either sexually active or greater than 17 years of age will be coded as at risk when the article is about cervical smear screening.
  7. Any sample of men or women greater than or equal to 50 years of age will be coded as at risk (regardless of whether stated in the article) when the article is about colon cancer screening.


Design of Primary Study (see algorithm attached)

  1. Randomized controlled trial - An epidemiological experiment in which subjects in a population are randomly allocated into groups, usually called study and control groups, to receive or not to receive an experimental preventative or therapeutic procedure, maneuver, or intervention.
  2. Controlled trial (quasi-randomized) - Quasi-Experiment: a situation in which the investigator lacks full control over the allocation and/or timing of the intervention but nonetheless conducts the study as if it were an experiment, allocating subjects to groups. These types of studies must have some form of comparison/reference group.
  3. Controlled before-after designs - Two or more groups of patients or subjects receiving a procedure, maneuver, or intervention; or a control intervention or non-intervention, with outcomes measured at baseline and post-intervention. Allocation to intervention in control groups is not under the control of the investigator.
  4. Case-control - A retrospective study of persons with the disease (or other characteristic of interest), and a suitably matched control (comparison, reference) group of other persons without the disease.
  5. Pre-post intervention - Single group of patients or subjects who receive the same experimental procedure, maneuver, or intervention, with outcomes measured at baseline and post-intervention.
  6. Survey - An investigation in which information is systematically collected (e.g. face-to-face inquiry, by self-completed questionnaires, by telephone, postal service), at one point in time.
  7. Qualitative study - Researchers look for the social context and point of view of the units (subjects, patients). The approach is primarily inductive, and concern is related to discovery and description. Usually the analysis is presented in narrative rather than numeric form.
  8. Case series - Description of a group of subjects that have something in common. These people had received the intervention and the researchers gathered information related to their outcomes.
  9. Case study - A paper that contains the description of one subject or patient related to some condition in particular.
  10. Other - For studies that are not any of the above designs, the screener should code "Other" and specify a description (maximum 30 readable characters).


Hypothetical Decisions

  • Any situation where the patient is being asked to make an authentic decision which is necessary given their current medical condition is NOT hypothetical.
  • Situations where the sample is not asked to make a decision during the study period or where the authors use a Background Papers proxy/surrogate outcome measure for the decision (e.g., degree of interest in a screening test) are not necessarily hypothetical. If there is any doubt, the reviewer should code as uncertain and then discuss the issue with the second reviewer when meeting for consensus.
  • For any article where the focus is about clinical trial entry (real or hypothetical), and the intervention does not clearly fit our criteria for a decision aid; the status should be coded as uncertain.
  • Codes for decisions that ARE hypothetical:
    01..........The options considered in the decision are not medically available or real.
    02..........The sample is not a member of the target population for the decision.
    03..........Both 01 and 02.
    04..........Decision is hypothetical only for a portion or subgroups of the total sample.

Any articles that will be kept as a background paper should be classified according to the following codes, and the screener should check all codes that apply:

  1. Any review (narrative or systematic) dated 1990 or more current, which focuses on:
    • Decisions aids/interventions
    • Patients/patients-physicians decision making
    • Information transfer (patient ← → clinician)
    • Clinician-patient communication
    • Decision-related needs of patient populations
  2. Any seminal paper dated (preferably dated 1990 or more current) which focuses on:
    • Decisions aids/interventions
    • Patients/patients-physicians decision making
    • Information transfer (patient ← → clinician)
    • Clinician-patient communication
    • Decision-related needs of patient populations
    This includes any position paper
  3. Any literature dated 1995 or more current that investigates or describes the decision-related needs of patient populations, including special patient populations (e.g., children, ethnic minorities, low SES groups, clinical trial participants). We will NOT retrieve general interviews/surveys investigating patients' perceptions or experiences unless they are explicitly related to a decision or the creation of a tool. ALSO, any abstracts or collection thereof from presentations given at cancer meetings or from any meetings relevant to cancer-related decision aids (where relevance can not be established from a title or abstract) will be retrieved if dated 1998 or more current.
  4. Guidelines
  5. Consensus Conference Report
  6. Contains Definitions
  7. Other (Specify - maximum 10 readable characters )

Remember to check the final STATUS box at the top of the page.

If 'Include' AT CONSENSUS, please highlight the reference list for appropriate citations and submit them fr the article retrieval process***Appropriate References to be retrieved must explicitly have the following in the title:

patient OR preferences OR any cancer consumer AND decision making ORAND hit word involvement OR participation OR other decision term

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