Informed consent for stochastic effects of ionising radiation in diagnostic imaging.

The ethical and legal principles underpinning the requirement for informed consent for medical procedures are widely accepted. A recent BJR article has applied these principles to the issue of consent to ionising radiation (IR) from diagnostic imaging (DI), but the authors chose to put aside the practical problems associated with this. These problems should not be underestimated and arise from: uncertainties about the existence and magnitude of risk of stochastic effects of IR exposure in DI; the delayed manifestation of its effects; the heterogeneity of risk related to factors associated with individual sensitivity to IR, and dose variation even within examination classes and across clinical indications; and the difficulty of communication of these uncertainties and variations to patients. This article discusses these practical issues associated with consent for IR in DI.

Diagnostic imaging: Doing the right thing.

Inappropriate diagnostic imaging (DI) is a burgeoning issue and embraces its overuse and its misapplication. The obverse problem is one of underuse - that is when patients who should undergo imaging fail to do so. This article attempts to define these problems, examines the causes and effects and suggests some potential solutions.

Painless Visible Haematuria in Adults: An Algorithmic Approach Guiding Management.

There is consensus that visible haematuria may be a sign of serious underlying disease, including malignancy, and warrants a thorough diagnostic evaluation. This is usually undertaken by a combination of clinical examination, cystoscopic evaluation, and urinary tract imaging. A decision support tool has been developed in the form of an algorithmic flow chart as part of a suite of on-line evidence-based and consensus-based guidelines Diagnostic Imaging Pathways (DIP): www.imagingpathways.health.wa.gov.au (Online clinical decision-making tool: Dulku G. Painless Macroscopic Haematuria. Diagnostic Imaging Pathways; September 2015) to provide imaging recommendations for adult patients with unexplained, painless visible haematuria. A literature review, including reference to several international consensus-based expert guidelines, has been employed to develop this tool. The choice of first line imaging method is dependent on the risk stratification into high or low risk for the development of renal and urologic malignancies. Ultrasound is vital in the initial assessment of haematuria particularly in radiation sensitive patients, low-risk patients, and in young men <40 years. Computed tomographic urography (CTU) is a sensitive and specific method for the detection of urothelial malignancy particularly in high-risk patients. Magnetic resonance urography (MRU) provides better contrast resolution than CTU without exposure to ionising radiation or requiring intravenous (IV) contrast administration, making it more suitable for examination of paediatric and pregnant patients and patients with renal impairment. Cystoscopy remains the gold standard in the detection of lower urinary tract (bladder) urothelial tumours. Until randomised clinical trials comparing different diagnostic modalities or strategies prospectively and outcome studies are available, consensus-based practice recommendations similar to ours are nonetheless warranted to reduce the variation in haematuria management.

Salvage Ultrasound-guided Targeted Cryoablation of The Perispermatic Cord For Persistent Chronic Scrotal Content Pain After Microsurgical Denervation Of The Spermatic Cord.

OBJECTIVE: To assesses the efficacy of ultrasound-guided targeted cryoablation (UTC) of the perispermatic cord as a salvage treatment for patients who failed microsurgical denervation of the spermatic cord. METHODS: Retrospective review of 279 cases (221 patients: 58 bilateral) undergoing UTC between November 2012 and July 2016, performed by 2 fellowship trained microsurgeons. UTC was performed using a 16-gauge cryo needle (Endocare, HealthTronics, Austin, TX). Branches of the genitofemoral, ilioinguinal, and inferior hypogastric nerves were cryoablated medial and lateral to the spermatic cord at the level of the external inguinal ring. Level of pain was measured preoperatively and postoperatively using the visual analog scale and Pain Index Questionnaire-6 (QualityMetric Inc., Lincoln, RI). RESULTS: Median age was 43 years, operative duration 20 minutes, and postoperative follow-up 36 months (24-60). Subjective visual analog scale outcomes: 75% significant reduction in ain (11% complete resolution and 64% ≥50% reduction in pain). Objective Pain Index Questionnaire-6 outcomes: 53% significant reduction at 1 month (279 cases), 55% at 3 month (279 cases), 60% at 6 month (279 cases), 63% at 1 year (279 cases), 65% at 2 years (275 cases), 64% at 3 years (232 cases), 59% at 4 years (128 cases) and 64% at 5 years (53 cases) post-op. COMPLICATIONS: 2 wound infections, 4 penile pain cases (resolved in a few months). CONCLUSION: UTC of the perispermatic cord is a safe potential treatment option for the salvage management of persistent chronic scrotal pain in patients who have failed microsurgical denervation of the spermatic cord.

Interobserver Variation of Colonic Polyp Measurement at Computed Tomography Colonography.

BACKGROUND: The concept of "advanced polyps" is well accepted and is defined as polyps ≥10 mm and/or those having a villous component and/or demonstrating areas of dysplasia. Of these parameters, computed tomography colonography (CTC) can only document size. The accepted management of CTC-detected "advanced polyps" is to recommend excision if feasible, whereas the management of "intermediate" (6-9 mm) polyps is more controversial, and interval surveillance may be acceptable. Therefore, distinction between 6-9 mm and ≥10 mm is important. METHODS: Datasets containing 26 polyps originally reported as between 8-12 mm in diameter were reviewed independently by 4 CTC-accredited radiologists. Observers tabulated the largest measurement for each polyp on axial, coronal, sagittal, and endoluminal views at lung-window settings. These measurements were also compared to those determined by the computer-aided detection (CAD) software. RESULTS: The interobserver reliability intra-class correlation coefficient (ICC) for sagittal projection was 0.80 ("excellent" category of Hosmer and Lemeshow [2004]), 0.71 for axial ("acceptable"), 0.69 for coronal, and 0.41 for endoluminal ("unacceptable"). The largest of sagittal/axial/coronal measurement gave the best reliability with the smallest variance (ICC = 0.80; 95% CI 0.67-0.89). For 8 of 26 polyps, at least one radiologist's measurement placed the polyp in a different category compared to a colleague. For the majority of the polyps, the CAD significantly overestimated the readings compared to the largest of the manual measurements with an average difference of 1.6 mm (P < .0001 for sagittal/axial/coronal). This resulted in 33% of polyps falling into a different category-10% were lower and 23% were higher (P < .034). CONCLUSION: It is apparent that around the cutoff point of 10 mm between "advanced" and "intermediate" polyps, interobserver performance is variable.

Targeted Robotic Assisted Microsurgical Denervation of the Spermatic Cord for the Treatment of Chronic Orchialgia or Groin Pain: A Single Center, Large Series Review.

PURPOSE: Microsurgical denervation of the spermatic cord is a treatment option for chronic orchialgia refractory to conservative treatment. A recent study showed specific nerve fibers as the possible cause of chronic orchialgia. Our goal was to present the outcomes of ligation of these nerves using a technique of targeted robotic assisted microsurgical denervation of the spermatic cord. MATERIALS AND METHODS: We retrospectively reviewed the records of 772 patients who underwent targeted robotic assisted microsurgical denervation of the spermatic cord from October 2007 to July 2016. Selection criteria were chronic testicular pain more than 3 months in duration, failed conservative treatments, negative neurological and urological workup, and temporary resolution of pain with a local anesthetic spermatic cord block. Targeted robotic assisted microsurgical denervation of the spermatic cord was performed. Pain was assessed preoperatively and postoperatively using a subjective visual analog scale and objectively with the standardized and validated PIQ-6 (Pain Impact Questionnaire-6) score. RESULTS: Followup data were available on 860 cases. During a median followup of 24 months (range 1 to 70) 718 cases (83%) showed a significant reduction in pain and 142 (17%) had no change in pain by subjective visual analog scale scoring. Of cases with a significant reduction in pain 426 (49%) had complete resolution and 292 (34%) had a 50% or greater reduction. Objective PIQ-6 analysis showed a significant reduction in pain in 67% of patients 6 months postoperatively, in 68% at 1 year, in 77% at 2 years, in 86% at 3 years and in 83% at 4 years. CONCLUSIONS: Targeted robotic assisted microsurgical denervation of the spermatic cord is an effective, minimally invasive approach with potential long-term durability in patients with refractory chronic orchialgia.

The role of imaging in the surveillance and diagnosis of hepatocellular cancer.

A decision support tool has been developed as part of a suite of on-line evidence-based and consensus-based guidelines Diagnostic imaging Pathways (DIP): www.imagingpathways.health.wa.gov.au) in the form of an algorithmic flow chart with supporting evidence and consensus to inform referrers to diagnostic imaging and radiologists as to the optimum strategy for surveillance and diagnosis of primary hepatocellular cancer (HCC) in those patients with risk factors of this disease. A literature review, including reference to several international consensus-based expert guidelines, has been employed to develop this tool.

Towards appropriate imaging: Tips for practice.

BACKGROUND: The best use of diagnostic imaging is a challenge for many health professionals and the health system. Potential hazards of inappropriate imaging include exposure to ionising radiation, false positive and negative results, unexpected incidental findings, overdiagnosis and cost. OBJECTIVE: Using a fictional case, we aim to illuminate and discuss some of the challenges to appropriate diagnostic imaging and offer some solutions. DISCUSSION: While normal imaging results can reassure a patient, abnormal incidental findings can sometimes cause harm. When serious disease is very unlikely, verbal reassurance may be more appropriate than imaging. We remind doctors of the risks of ionising radiation, including how to access resources to estimate these risks and the need to ensure that the potential benefit of the test outweighs the risk - the process of justification. We point readers to imaging guidelines to help guide decision-making, such as the 'Diagnostic imaging pathways' resource. We look forward to relationships between radiologists and general practitioners characterised by collaboration and consultation, rather than just ordering and reporting.

Imaging for chronic abdominal pain in adults.

Diagnostic imaging is often not indicated in chronic abdominal pain. In particular, undifferentiated abdominal pain is rarely an indication for a CT scan. CT scanning is overused even when imaging is required. Other modalities may be preferable. A normal CT scan does not rule out cancer. Alarm symptoms, including anaemia, blood in the stool, waking at night with gastrointestinal symptoms, and weight loss, should be investigated. The most appropriate modality depends on the symptoms. Clinical information on request forms for CT scans should be specific and include the suspected condition as this helps the radiologist to determine an appropriate imaging protocol.

Clinical imaging guidelines part 1: a proposal for uniform methodology.

Inappropriate imaging can lead to unnecessary medical radiologic exposures and cost and may not answer the clinical question. Imaging referral guidelines inform the justification of radiologic procedures and facilitate the choice of the best test first, but their acceptance by referrers, use, and value may be limited by shortcomings in the methodology of development. Focusing on common, essential elements of methodology will help guideline developers. In 2012 and 2013, the International Atomic Energy Agency hosted Technical Meetings on Radiation Protection of Patients Through the Development of Appropriateness Criteria in Diagnostic Imaging. Participants identified and agreed on issues concerning development of imaging referral guidelines. Items based on the Appraisal of Guidelines for Research and Evaluation II instrument were amended with additional items including development and consensus group composition. Consensus was sought on 28 items, 18 of which were agreed should be uniform, and 10 should allow for regional differences. Further work is required to encourage, provide, and identify higher quality evidence and to agree on a grading system for recommendations. Many key areas are common to guideline developers globally, opening the way for international collaboration to help demystify, simplify, and justify.

Pulmonary embolism: are we there yet?

INTRODUCTION: Clinical prediction rules (such as Wells model) are a reliable assessment tool for diagnostic work-up of suspected pulmonary embolism (PE). When used as part of a clinical algorithm and in combination with a D-Dimer, the model can safely exclude PE in low-risk groups and indicate when further investigations are unnecessary. The purpose of this study was to investigate the level of adherence to local diagnostic imaging guidelines for suspected PE and to ascertain the impact of interventions. METHODS: Retrospective search of all patients referred from the Emergency Department (ED) of Royal Perth Hospital for computed tomography pulmonary angiography (CTPA) or V/Q scan between 11 September 2005 to 10 March 2006 (pre-intervention) and 1 January 2008 to 31 March 2008 (post-intervention) was conducted. The guidelines on 'Diagnostic Imaging Pathways' were considered as gold standard. Interventions included orienting ED doctors to guidelines and modified request forms for mandatory completion of Wells score. A prevalence- and bias-adjusted kappa (PABAK) score analysed the level of agreement between documentation on notes (R-score) and stamp (S-score). RESULTS: Thirty-five per cent (n = 187) and 22% (n = 109) deviated from the pathway pre-intervention and post-intervention, respectively (13% absolute reduction; P = 0.017). Stamp compliance was only 55% despite mandatory filling requirement. PABAK for 'PE as most likely diagnosis' was 0.25 for V/Q group and - 0.26 for CTPA. In addition, 44/60 (73%) had an intermediate or high S-score, yet only 11 of those 44 had a matched intermediate to high R-Score. CONCLUSIONS: Interventions reduced inappropriate practice but did not eliminate it completely. Compliance issues may be managed in the future via the introduction of electronic request linked to decision support.

Low-dose computed tomography versus plain abdominal radiography in the investigation of an acute abdomen.

BACKGROUND: To compare low-dose abdominal computed tomography (LDCT) with plain abdominal radiography (AR) in the primary investigation of acute abdominal pain to determine if there is a difference in diagnostic yield, the number of additional investigations required and hospital length of stay (LOS). METHODS: This randomized controlled trial was approved by the institutional review board, and informed consent was obtained. Patients presenting to the emergency department with an acute abdomen and who would normally be investigated with AR were randomized to either AR or LDCT. The estimated radiation dose of the LDCT protocol was 2-3 mSv compared to 1.1 mSv for AR. Pearson's chi-square and the independent samples t-test were used for the statistical analysis. RESULTS: A total of 142 patients were eligible, and after exclusions and omitting those with incomplete data, 55 patients remained for analysis in the AR arm and 53 in the LDCT arm. A diagnosis could be obtained in 12 (21.8%) patients investigated with AR compared to 34 (64.2%) for LDCT (P < 0.001). Twenty-eight (50.9%) patients in the AR group required further imaging during their admission compared to 14 (26.4%) in the LDCT group (P= 0.009). There was no difference in the median hospital LOS (3.84 days for AR versus 4.24 days for LDCT, P= 0.83). CONCLUSION: LDCT demonstrates a superior diagnostic yield over AR and reduces the number of subsequent imaging tests for a minimal cost in radiation exposure. However, there is no difference in the overall hospital LOS between the two imaging strategies.

Crohn's disease activity: quantitative contrast-enhanced ultrasound assessment.

OBJECTIVES: To determine whether quantitative parameters from contrast-enhanced ultrasound examination (CE-US) of the bowel wall correlate with endoscopic inflammatory activity in Crohn's disease and to assess its utility in the follow-up of patients on treatment. METHODS: This was a prospective study of 30 patients with Crohn's disease requiring colonoscopy or flexible sigmoidoscopy. The Crohn's disease activity index (CDAI), serum C-reactive protein (CRP) and Crohn's disease endoscopic index of severity (CDEIS) were calculated. CE-US was performed within 7 days of endoscopy using intravenous perflutren lipid microsphere and repeated a median of 45.5 days following treatment. Time-intensity curves of bowel wall enhancement were generated to derive the area under the curve (AUC), time to peak intensity (TTP) and peak intensity (PI). RESULTS: In separate multivariate regression models, the AUC, TTP and PI showed no significant association with endoscopic activity whilst controlling for CDAI and CRP. However, the reductions in CDAI and CRP following treatment were mirrored by significant reductions in TTP (P = 0.05). CONCLUSIONS: CE-US does not appear to predict for Crohn's disease endoscopic activity independent of simple parameters such as CDAI and CRP. However, it may be useful in the serial assessment of patients on treatment.

CT grading scales for splenic injury: why can't we agree?

INTRODUCTION: Computed tomography (CT) has been proven to be able to accurately diagnose splenic injury. Many have published CT splenic injury grading scales to quantify the extent of injury. However, these scales have failed at predicting clinical outcomes and therefore cannot be used to accurately predict the need for intervention. We hypothesised that low interrater reliability is the reason why these scales have failed at predicting clinical outcomes. METHODS AND MATERIALS: This is a retrospective study of patients who were admitted to the Royal Perth Hospital with blunt splenic injury as coded in the trauma registry. The abdominal CT images of these patients were reviewed by three consultant radiologists and were graded using the six different splenic injury grading scales. We assessed interrater reliability between each of the scales using generalised kappa and proportion of agreement calculations. RESULTS: The images of 64 patients were reviewed. The interrater reliability yielded a generalised kappa score of 0.32-0.60 and proportion of agreement ranging from 34.4% to 65.5%. CONCLUSION: The six studied CT splenic injury grading scales did not have a high enough interrater reliability to be adequate for clinical use. The poor interrater reliability is likely to contribute to the failure of the scales at predicting clinical outcomes. Further research to improve the interrater reliability is recommended.

For discussion: obtaining consent for ionising radiation: has the time come?

The aim of this paper is to promote debate on the issues surrounding the provision of information to, and the obtaining of valid consent from patients exposed to ionising radiation (IR) from diagnostic and interventional imaging procedures. This is especially pertinent in view of recent interest in the risks of IR expressed in the medical and lay press.

Reducing inappropriate diagnostic practice through education and decision support.

OBJECTIVE: To quantify non-compliance of diagnostic practice with recommendations in Diagnostic Imaging Pathways and the impact of interventions to reduce non-compliance. DESIGN: Retrospective audits, followed by intervention and re-audits. SETTING: Emergency department (ED) of Royal Perth Hospital. PARTICIPANTS: Six hundred and thirty-eight patients (first audit) and 423 patients (second audit) presenting to the ED with one of the four conditions: suspected pulmonary embolism, ankle injury, suspected renal colic or non-traumatic acute abdominal pain. INTERVENTIONS: Education of clinicians on Diagnostic Imaging Pathways recommendations for the four conditions. Decision support through the introduction of request forms, which required 'proof' of adherence to diagnostic pathways. MAIN OUTCOME MEASURES: Percentage of patients with a deviation from recommended diagnostic practice. RESULTS: Overall, 56% of patients had evidence of inappropriate diagnostic practice prior to interventions, with a reduction of 16% following the interventions. CONCLUSION: The reduction was significant but inappropriate practice was not eliminated. For as long as decision-support systems are 'stand-alone' applications, achieving full compliance is dependent on continuous and expensive processes of education and enforcement. A better understanding of why clinicians fail to follow recommended practice is required, and decision support must be better embedded into clinical workflow.