Critical review of laboratory investigations in clinical practice guidelines: proposals for the description of investigation

Abstract

Background : Correct information provided by guidelines may reduce laboratory test related errors during the preanalytical, analytical and post-analytical phase and increase the quality of laboratory results. Methods : Twelve clinical practice guidelines were reviewed regarding inclusion of important laboratory investigations. Based on the results and the authors ' experience, two checklists were developed: one comprehensive list including topics that authors of guidelines may consider and one consisting of minimal standards that should be covered for all laboratory tests recommended in clinical practice guidelines. The number of topics addressed by the guidelines was related to involvement of laboratory medicine specialists in the guideline development process. Results : The comprehensive list suggests 33 preanalytical, 37 analytical and 10 post-analytical items. The mean percentage of topics dealt with by the guidelines was 33 % (median 30 % , range 17 % -55 % ) and inclusion of a laboratory medicine specialist in the guideline committee significantly increased the number of topics addressed. Information about patient status, biological and analytical interferences and sample handling were scarce in most guidelines even if the inclusion of a laboratory medicine specialist in the development process seemingly led to increased focus on, e.g., sample type, sample handling and analytical variation. Examples underlining the importance of including laboratory items are given. Conclusions : Inclusion of laboratory medicine specialist in the guideline development process may increase the focus on important laboratory related items even if this information is usually limited. Two checklists are suggested to help guideline developers to cover all important topics related to laboratory testing.

Why are clinical practice guidelines not followed?

“…We studied a number of (inter)national guidelines and developed a checklist to help guideline authors. We also determined which aspects of the total testing process were the areas which needed most encouragement [36]. The checklist contains 80 points: 33 pre-analytical, 37 analytical and 10 postanalytical.…”

Harmonization in laboratory medicine: the complete picture

“…Clinical practice guidelines are systematically developed statements intended to assist practitioners and patients in making decisions about appropriate healthcare for specific clinical circumstances, namely in test requesting. It has recently been observed that the inclusion of laboratory medicine specialists in the guideline development process may increase the focus on important laboratory-related items, including appropriateness in test requesting and related procedures [ 46 ]. Therefore, harmonization initiatives based on current evidence should be welcomed, even if the need for a more ' personalized ' approach based on individual needs and following the mantra ' the right test for the right patient at the right time ' remains the major goal in improvement initiatives.…”

Patient Safety in Laboratory Medicine. The Big Picture ten years later

“…Infine è noto [43] come le linee guida cliniche abbiano generalmente una bassa considerazione per gli aspetti considerati laboratoristici, rispettando in media solo in un terzo dei casi le necessarie informazioni riguardo lo stato dei pazienti, le interferenze biologiche e analitiche e il trattamento dei campioni, e che l'inserimento di uno specialista di laboratorio nei comitati/gruppi di preparazione di line guida cliniche migliora la situazione rendendone circa la metà esaustive sotto il profilo dei mezzi diagnostici. La necessità della presenza dei laboratoristi nei gruppi di produzione, adozione, adattamento e validazione delle linee guida deve essere ben presente sia a livello professionale sia a livello istituzionale.…”