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Endocrine research knowledge gap

Endocrine: one in five studies addressing knowledge gaps

The paper explored the integrity of the pipeline connecting knowledge gaps with ongoing research using ES guidelines.

A systematic evaluation of the Endocrine Society (ES) clinical practice guidelines portfolio from 2008 to 2014 has found that researchers “are addressing only one in five knowledge gaps identified in clinical practice recommendations in endocrinology.” The review by researchers from the Knowledge and Evaluation Research Unit, Division of Endocrinology, Diabetes, Metabolism and Nutrition, Mayo Clinic, Rochester, MN, concludes that by linking the research agenda to evidence gaps in guidelines may improve both the efficiency of the research enterprise and the translation of evidence into practice by increasing the value and reducing the waste in research.

The paper, ‘Is the endocrine research pipeline broken? A systematic evaluation of the Endocrine Society clinical practice guidelines and trial registration’, published in BMC Medicine, explored the integrity of the pipeline connecting knowledge gaps with ongoing research using ES guidelines.

In 2005, the ES adopted the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) Group system, which rates the panel’s confidence in the risk estimates of favourable and unfavourable outcomes. It classifies the quality of the body of evidence supporting a recommendation into one of four categories: high, moderate, low and very low quality (VLQ).

The researchers conducted a systematic evaluation of the available ES clinical practice guidelines to identify clinical recommendations that are based on VLQ evidence and that potentially reflect knowledge gaps in endocrinology. Using the ES guideline web site, they identified and retrieved all ES clinical practice guidelines issued from 2008 to 2014.

They then identified the research questions relevant to these knowledge gaps in terms of patients, interventions, comparisons, and outcomes (PICO). For each VLQ evidence item, they drafted a research question that a clinical trial could answer using the PICO format (e.g. Patients – patients with large adrenal pheochromocytomas; Intervention – minimally invasive adrenalectomy; Comparison – open resection adrenalectomy; Outcome – complete tumour resection, tumour rupture avoidance, and local recurrence rates). To calibrate this process, two researchers independently produced these questions for 11 recommendations with an initial agreement of 80%. This process was repeated until the agreement was 100%, achieved after 20 recommendations.

They then searched the clinicaltrials.gov database for active studies (randomised and observational) addressing the questions identified from the guidelines.

They identified 25 Clinical Practice Guidelines from the ES with 660 recommendations, of which 209 (32%) were supported by VLQ evidence. After excluding 78 (12%) best practice statements, the total was 131 (20%) recommendations based on VLQ evidence (Figure 1). The majority of the guidelines supported the care of patients with pituitary, gonadal, and adrenal disorders and most recommendations supported by VLQ evidence came from these guidelines (24%; Figure 2).

Figure 1: Selection process. ES, Endocrine Society; VLQ, Very low quality

Figure 2: Proportion of recommendations based on VLQ evidence with and without active research studies. VLQ, Very low quality; Rec., Recommendation; AR., Active research; PAG, Pituitary adrenal and gonad axis; CVD, Cardiovascular disease. Numbers in percentage correspond to recommendations based on VLQ evidence with active research

Active research was identified for 28 (21 %) of these 131 recommendations represented by 69 clinical studies (mean of 2.5 studies per each recommendation – when taking into consideration those with active research; Figure 1). Of these, 35 (51%) were randomised trials and 34 (49%) were observational. Thirteen reported industry funding and six were multi-centre studies. Of the 69 active studies, 42 (60%) were in the guidelines of thyroid dysfunction during pregnancy, testosterone therapy in adult men, and diagnosis of Cushing syndrome which had a total of 32 recommendations supported by VLQ evidence, of which 15 had at least one active research study.

Most of the identified clinical trials addressed knowledge gaps affecting recommendations for patients with thyroid disorders (70 %); the least dealt with were gaps in the evidence for care of patients with diabetes, obesity, and cardiovascular disease (16%; Figure 2).

“Important knowledge gaps are evident in ten of every 50 ES clinical practice guideline recommendations, of which the research enterprise is actively addressing, at best, two,” they write. “Moreover, of the active trials, 60% are trying to improve the quality of evidence in only three of the 25 guidelines. In some cases, several studies are actively addressing the same question.”

To access this paper, please click here

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