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Research ArticleMethodology

Developing an International Register of Clinical Prediction Rules for Use in Primary Care: A Descriptive Analysis

Claire Keogh, Emma Wallace, Kirsty K. O’Brien, Rose Galvin, Susan M. Smith, Cliona Lewis, Anthony Cummins, Grainne Cousins, Borislav D. Dimitrov and Tom Fahey
The Annals of Family Medicine July 2014, 12 (4) 359-366; DOI: https://doi.org/10.1370/afm.1640
Claire Keogh
1HRB Centre for Primary Care Research, Department of General Practice, Royal College of Surgeons in Ireland, Dublin, Ireland
PhD
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Emma Wallace
1HRB Centre for Primary Care Research, Department of General Practice, Royal College of Surgeons in Ireland, Dublin, Ireland
MB
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Kirsty K. O’Brien
1HRB Centre for Primary Care Research, Department of General Practice, Royal College of Surgeons in Ireland, Dublin, Ireland
PhD
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Rose Galvin
1HRB Centre for Primary Care Research, Department of General Practice, Royal College of Surgeons in Ireland, Dublin, Ireland
PhD
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Susan M. Smith
1HRB Centre for Primary Care Research, Department of General Practice, Royal College of Surgeons in Ireland, Dublin, Ireland
MD
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Cliona Lewis
1HRB Centre for Primary Care Research, Department of General Practice, Royal College of Surgeons in Ireland, Dublin, Ireland
MB
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Anthony Cummins
1HRB Centre for Primary Care Research, Department of General Practice, Royal College of Surgeons in Ireland, Dublin, Ireland
MB
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Grainne Cousins
1HRB Centre for Primary Care Research, Department of General Practice, Royal College of Surgeons in Ireland, Dublin, Ireland
2Department of Pharmacy, Royal College of Surgeons in Ireland, Dublin, Ireland
PhD
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Borislav D. Dimitrov
1HRB Centre for Primary Care Research, Department of General Practice, Royal College of Surgeons in Ireland, Dublin, Ireland
3Academic Unit of Primary Care and Population Sciences, University of Southampton, Southampton, United Kingdom
DM/PhD
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Tom Fahey
1HRB Centre for Primary Care Research, Department of General Practice, Royal College of Surgeons in Ireland, Dublin, Ireland
MD
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  • For correspondence: tomfahey@rcsi.ie
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  • Author's response: Clinical Prediction Rules
    Tom Fahey
    Published on: 18 August 2014
  • Prediction in primary care: models or rules?
    Ewout W Steyerberg
    Published on: 24 July 2014
  • Where now with clinical prediction rules?
    Matthew Thompson
    Published on: 22 July 2014
  • Much overdue!
    Mark H. Ebell
    Published on: 17 July 2014
  • Published on: (18 August 2014)
    Page navigation anchor for Author's response: Clinical Prediction Rules
    Author's response: Clinical Prediction Rules
    • Tom Fahey, Professor

    We thank Professors Ebell, Thompson and Steyerberg for their comments and suggestions. They raise important issues about Clinical Prediction Rules (CPRs) which we would like to expand upon:

    We agree Professor Steyerberg that there needs to be greater consistency in relation to terminology, both at a methodological and clinical level. We would argue that there is a continuum from prognostic modelling (covariates...

    Show More

    We thank Professors Ebell, Thompson and Steyerberg for their comments and suggestions. They raise important issues about Clinical Prediction Rules (CPRs) which we would like to expand upon:

    We agree Professor Steyerberg that there needs to be greater consistency in relation to terminology, both at a methodological and clinical level. We would argue that there is a continuum from prognostic modelling (covariates that produce a probability estimate between 0 to 100%), that is subsequently dichotomised into treatment or no treatment thresholds (the "decision" component that is outlined by Reilly and Evans).[1] The next step is to incorporate patient preferences into an individual's probability estimate. We have adopted this approach using individualised decision analysis in relation to patients considering blood pressure lowering treatment,[2] the medical and surgical options for women with heavy menstrual periods,[3] and for women considering vaginal birth after initial caesarean section.[4] We agree that ICT software will be able to compute probabilities and present recommendations in a more manageable format. In the same way, we need to be clear as to which constituency the information is being provided. Computer-based clinical decision support systems (CDSSs) utilise CPR data (either as a probabilistic estimate or a decision recommendation based on probabilistic estimate), which are directed towards health professionals. Decision aids can incorporate probabilistic estimates from CPRs and incorporate patient's values and preferences. Decision aids are directed towards patients rather than health professionals. We feel that these distinctions and overlaps are needed when thinking about CPRs, their usage and future development.

    We agree with Professor Thompson that asking health professionals what CPR tools they find useful is helpful. We do think that prognostic and diagnostic modelling is likely to increase, so rather than calling for a moratorium our register is an attempt to outline areas of need and requirement where researchers should concentrate efforts. As Professor Ebell remarks, it is indeed striking how some clinical domains attract many CPRs, whilst there appears to be a paucity in other clinical areas.

    In summary, we acknowledge that our paper raises more questions about CPRs, from a methodological and clinical standpoint, than it answers. We do feel that, in the right clinical context,[5] CPRs will provide important, evidence-based information, that will enable more effective and cost effective clinical care.

    References
    1. Reilly BM, Evans AT. Translating clinical research into clinical practice: impact of using prediction rules to make decisions. Annals of Internal Medicine 2006;144:201-9.
    2. Montgomery A, Fahey T, Peters T. Decision analysis and information video plus leaflet for newly diagnosed hypertensive patients: a factorial randomised controlled trial. Br J Gen Pract 2003; 53: 446-453.
    3. Protheroe J, Bower P, Chew-Graham C, Peters T, Fahey T. Effectiveness of a Computerized Decision Aid in Primary Care on Decision Making and Quality of Life in Menorrhagia: Results of the MENTIP randomized controlled trial. Medical Decision Making 2007;27:575-584.
    4. Montgomery A, Emmet C, Fahey T, Patel R, Jones C, Ricketts I, Peters T, Murphy DJ. A randomised controlled trial of two decision aids for mode of delivery among women with a previous caesarean section. BMJ 2007;334:1305, doi:10.1136/bmj.39217.671019.55.
    5. Heneghan C, Glasziou P, Thompson M, Rose P, Balla J, Lasserson D, Scott C, Perera R. Diagnostic strategies used in primary care. BMJ. 2009;338:b946. doi: 10.1136/bmj.b946

    Competing interests: No competing interests

    Show Less
    Competing Interests: None declared.
  • Published on: (24 July 2014)
    Page navigation anchor for Prediction in primary care: models or rules?
    Prediction in primary care: models or rules?
    • Ewout W Steyerberg, Professor of Medical Decision Making

    This paper presents a laudable effort, i.e. a systematic source for evidence on clinical prediction models and rules. As with other reviews, we note three phases of evolution: development, validation, and impact assessment. It is however remarkable that relatively many validation studies were identified, compared e.g. to what we found with the PROGRESS group (http://w...

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    This paper presents a laudable effort, i.e. a systematic source for evidence on clinical prediction models and rules. As with other reviews, we note three phases of evolution: development, validation, and impact assessment. It is however remarkable that relatively many validation studies were identified, compared e.g. to what we found with the PROGRESS group (http://www.ncbi.nlm.nih.gov/pubmed/23393430).

    A number of other reflections, specifically on the naming of "prediction rules":

    • Should we say 'model' or 'rule'? The difference may seem trivial, but Reilly et al (http://www.ncbi.nlm.nih.gov/pubmed/16461965) make a clear point on this issue. These authors explain that a prediction model provides probability estimates. These range between 0 and 100%. A prediction rule requires that we define a cut-off point to classify patients as low vs high risk. This cut-off is the decision threshold. It is often difficult to determine, since it requires the weighting of false-positive vs false-negative decisions. If a false-positive decision is of relatively low importance in comparison to a false-negative decision, a low threshold should be used. This is e.g. reasonable for giving antibiotics in case of suspicion of a severe infection. In contrast, a higher cut-off is necessary in case of more invasive tests, such as doing a biopsy in case of suspicion of prostate cancer.
    • Prediction rules may also be derived with specific methods, such as classification trees, which define groups of patients with lower to higher risk. This approach is especially popular in trauma research, despite its inferior predictive performance (http://www.ncbi.nlm.nih.gov/pubmed/22026551).
    • The transportability between secondary and primary setting may always be a challenge. Systematic differences in prevalence of diagnoses and incidences of outcomes are common. The adaptation of a prediction model may be easier than adaptation of a rule, e.g. the Ottawa Ankle Rule.
    • An advantage of a rule may be that it is simpler, and hence easier to remember. In the near future, more and more prediction models will be available through the web, or through specific Apps. This may make that any model can be presented to the user (physician and/or patient), whatever the underlying mathematical complexity.
    • Even if we agree on the preference for presenting models that provide continuous predictions between 0 and 100%, the specific naming is open for debate. In the PROGRESS group, some prefer naming as 'Risk prediction model', or RPM, while others prefer 'Clinical prediction model', or CPM. The latter term is also followed in my book on 'Clinical Prediction Models' (Springer 2009, http://www.clinicalpredictionmodels.org/).

    In all, the current study is a valuable effort which deserves strong support, also in the context of keeping the registry up to date. Various methodological debates may come up from a more detailed look at the contents of each study in the registry. The naming issue of 'prediction model' or 'prediction rule' is just a start.

    Competing interests: I receive royalties from Springer for my book Clinical Prediction Models.

    Show Less
    Competing Interests: None declared.
  • Published on: (22 July 2014)
    Page navigation anchor for Where now with clinical prediction rules?
    Where now with clinical prediction rules?
    • Matthew Thompson, Professor of Family Medicine

    A long overdue 'stock take' of the state of clinical prediction rules in primary care. We often teach that prediction rules are the 'pinnacle' of rationale/evidence-based diagnostic/prognostic clinical tests, as they should (emphasis on should!) help clinicians identify and use clinical features which have been shown to be (or not, as this article shows!) most useful in ruling in/out a condition. Equally though, whenever I...

    Show More

    A long overdue 'stock take' of the state of clinical prediction rules in primary care. We often teach that prediction rules are the 'pinnacle' of rationale/evidence-based diagnostic/prognostic clinical tests, as they should (emphasis on should!) help clinicians identify and use clinical features which have been shown to be (or not, as this article shows!) most useful in ruling in/out a condition. Equally though, whenever I ask a clinical audience to name clinical prediction rules, mostly they run out of ideas after the usual suspects of Ottawa rule, Centor criteria.... etc.

    Claire Keogh et al's article tells us why - only about half of rules have any validation, and a tiny number have their impact assessed. Perhaps clinicians are right to be wary of them? Maybe, but as a method for improving diagnostic/prognostic ability, this seems a pity. So what should researchers and clinicians do now? Expanding the 'stock take' of the current state of play as the Dublin group suggest will be useful. I suggest three further steps: 1) Lets ask primary care clinicians what clinical prediction rules they actually want (to stop researchers coming up with rules that are never likely to be used), 2) For these priority areas lets see what prediction rules already exist, how further validation could be done using existing data sets (or electronic health record databases), and target these for impact studies, 3) Perhaps time for research funders to consider this rational approach to funding new derivation studies, unless there is a good reason. Is a moratorium too harsh?!

    Competing interests: None declared

    Show Less
    Competing Interests: None declared.
  • Published on: (17 July 2014)
    Page navigation anchor for Much overdue!
    Much overdue!
    • Mark H. Ebell, Associate Professor

    Sometimes, you read an article, and think, "Darn, I wish I would have thought of that!" This is one of those articles. I've developed and validated several clinical decision rules for end of life care and influenza, have coded over 400 for Essential Evidence, and written a book on the topic. Why didn't I think of this?

    In any case, jealousy aside, great article and well done! It is striking how many articles addressed...

    Show More

    Sometimes, you read an article, and think, "Darn, I wish I would have thought of that!" This is one of those articles. I've developed and validated several clinical decision rules for end of life care and influenza, have coded over 400 for Essential Evidence, and written a book on the topic. Why didn't I think of this?

    In any case, jealousy aside, great article and well done! It is striking how many articles addressed cardiovascular, respiratory and musculoskeletal problems, and how few addressed other domains relevant to the family physician. It is also clear that we need more studies in the primary care setting, to avoid spectrum bias.

    As more physicians use EHRs, it is important that the pain and inconvenience of the mediocre user interfaces be balanced at least in part by the provision of high quality decision support. We need clinical decision rules validated in the primary care setting to provide that decision support.

    Best, Mark Ebell MD, MS

    Competing interests: None declared

    Show Less
    Competing Interests: None declared.
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Developing an International Register of Clinical Prediction Rules for Use in Primary Care: A Descriptive Analysis
Claire Keogh, Emma Wallace, Kirsty K. O’Brien, Rose Galvin, Susan M. Smith, Cliona Lewis, Anthony Cummins, Grainne Cousins, Borislav D. Dimitrov, Tom Fahey
The Annals of Family Medicine Jul 2014, 12 (4) 359-366; DOI: 10.1370/afm.1640

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Developing an International Register of Clinical Prediction Rules for Use in Primary Care: A Descriptive Analysis
Claire Keogh, Emma Wallace, Kirsty K. O’Brien, Rose Galvin, Susan M. Smith, Cliona Lewis, Anthony Cummins, Grainne Cousins, Borislav D. Dimitrov, Tom Fahey
The Annals of Family Medicine Jul 2014, 12 (4) 359-366; DOI: 10.1370/afm.1640
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Keywords

  • clinical prediction rule
  • decision aid
  • score card
  • decision making
  • clinical decision support systems
  • primary care

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