PubMed · 11418547
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E A Balas. Information systems can prevent errors and improve quality.. https://doi.org/10.1136/jamia.2001.0080398
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Clinical prediction rules should help the medical doctors to increase the accuracy of diagnostic and prognostic assessments in situations where decision making is complex. A decision rule is a clinical tool that quantifies the contributions that various components of the history, physical examination, laboratory results and imaging techniques make toward the diagnosis or prognosis in an individual patient. Before decision rules are broadly used in a clinical situation they have to be validated. This can be done by using part of the original data to perform a validation. To answer the question about the generalizability of the rules they have to be tested in an additional, prospectively collected data set.
OBJECTIVES: To describe and evaluate two different models of a clinical informaticist service. DESIGN: A case study approach, using various qualitative methods to illuminate the complexity of the project groups' experiences. SETTING: UK primary health care. INTERVENTIONS: Two informaticist projects to provide evidence based answers to questions arising in clinical practice and thereby support high quality clinical decision making by practitioners. RESULTS: The projects took contrasting and complementary approaches to establishing the service. One was based in an academic department of primary health care. The service was academically highly rigorous, remained true to its original proposal, included a prominent research component, and involved relatively little personal contact with practitioners. This group achieved the aim of providing general information and detailed guidance to others intending to set up a similar service. The other group was based in a service general practice and took a much more pragmatic, flexible, and facilitative approach. They achieved the aim of a credible, acceptable, and sustainable service that engaged local practitioners beyond the innovators and enthusiasts and secured continued funding. CONCLUSION: An informaticist service should be judged on at least two aspects of quality---an academic dimension (the technical quality of the evidence based answers) and a service dimension (the facilitation of questioning behaviour and implementation). This study suggests that, while the former may be best achieved within an academic environment, the latter requires a developmental approach in which pragmatic service considerations are addressed.
Clinical trials have documented the single-agent efficacy of radioimmunotherapy (RIT) in lymphoma, and several combination therapy studies are now in progress. RIT agents are currently becoming generally available for clinical use in lymphoma therapy. Solid tumors, which are notoriously less responsive to any single agent, have demonstrated clinically useful responses, albeit temporary, and multimodality studies have been instituted. However, a sincere debate continues regarding the basic parameters to be used to define appropriate therapeutic dosing when using this modality in clinical cancer care. It is a good time to reevaluate relevant dose response information from preclinical and clinical RIT. Preclinical studies have demonstrated abundant evidence of dose response in tumor and normal tissue in homogenous model systems; however, substantive variation occurs between the dose responses of tumors with low and variable (or shed) antigen expression, as well as between histologically different tumor models. Clinical studies of various heavily pretreated patient populations given several very different RIT pharmaceuticals have led to disparate conclusions regarding patient dosing methods and dosimetric predictions of toxicity and efficacy. Single-study data on previously untreated lymphoma patients with similar histology has demonstrated a correlation of imaging dosimetry with toxicity and tumor response. High-dose therapy with bone marrow support has also demonstrated a high tumor response rate and nonmarrow normal organ toxicities that correlate with the calculated dose to those organs from imaging. In iodine-131 ((131)I)--anti-CD20 studies, (131)I was demonstrated to have variable excretion, and estimated total-body radiation dose from tracer study proved a predictive surrogate for marrow toxicity. Yttrium-90 ((90)Y)--anti-CD20, which has little (90)Y excretion from the body, demonstrated the injected dose per body weight to be more predictive of marrow toxicity than indium-111 ((111)In) tracer dosimetry methods in heavily pretreated patients, and showed maximal safety with standard mCi/kg therapy dosing. Variations in clinical RIT choices, dosing methods, and dosimetry methods emphasize the need to review the relevant information to date. Future clinical trial designs, the sophistication of dosimetry, treatment planning, and clinical treatment decisions should all be focused on achieving the best benefit-risk relationship for each patient.