Do radiological research articles apply the term "pilot study" correctly? Systematic review.

AIM: To determine what proportion of radiological studies used the term "pilot" correctly. MATERIAL AND METHODS: Indexed studies describing themselves as a "pilot" in their title were identified from four indexed radiological journals. The aim was to identify 20 consecutive, eligible studies from each journal, as this sample size was deemed sufficient to be representative as to how this methodological description was employed by authors of radiological articles. Data were extracted relating to study design and data presented. The review was reported according to PRISMA guidelines. RESULTS: The search string used identified 658 records across the four targeted journals. Ultimately, 78 reviews describing 5,572 patients were selected for systematic review. Median sample size was just 20 patients. No individual study qualified as a genuine pilot study when assessed against the a priori criteria. In reality, the large majority (66 studies, 84.6%) were framed as studies of diagnostic test accuracy. A significant proportion (21 studies, 26.9%) was retrospective, and the overwhelming majority were conducted in single centres (76 centres, 94.7%). Most (55 studies, 70.5%) stated no rationale for their sample size, and no study presented a formal power calculation. CONCLUSION: Radiological "pilot" studies are mostly underpowered studies of diagnostic test accuracy. In order to have scientific credibility, authors, reviewers, and editors of radiological journals are encouraged to familiarise themselves with different methodological study designs and their precise implications.

What Exactly is Meant by "Loss of Domain" for Ventral Hernia? Systematic Review of Definitions.

Large ventral hernias are a significant surgical challenge. "Loss of domain" (LOD) expresses the relationship between hernia and abdominal volume, and is used to predict operative difficulty and success. This systematic review assessed whether different definitions of LOD are used in the literature. The PubMed database was searched for articles reporting large hernia repairs that explicitly described LOD. Two reviewers screened citations and extracted data from selected articles, focusing on the definitions used for LOD, study demographics, study design, and reporting surgical specialty. One hundred and seven articles were identified, 93 full-texts examined, and 77 were included in the systematic review. Sixty-seven articles were from the primary literature, and 10 articles were from the secondary literature. Twenty-eight articles (36%) gave a written definition for loss of domain. These varied and divided into six broad groupings; four described the loss of the right of domain, six described abdominal strap muscle contraction, five described the "second abdomen", five describing large irreducible hernias. Six gave miscellaneous definitions. Two articles gave multiple definitions. Twenty articles (26%) gave volumetric definitions; eight used the Tanaka method [hernia sac volume (HSV)/abdominal cavity volume] and five used the Sabbagh method [(HSV)/total peritoneal volume]. The definitions used for loss of domain were not dependent on the reporting specialty. Our systematic review revealed that multiple definitions of loss of domain are being used. These vary and are not interchangeable. Expert consensus on this matter is necessary to standardise this important concept for hernia surgeons.

Effect of faecal occult blood positivity on detection rates and positive predictive value of CT colonography when screening for colorectal neoplasia.

AIM: To determine the detection rates and positive predictive value (PPV) of computed tomography (CT) colonography (CTC) according to the magnitude of faecal occult blood test (FOBt) positivity. MATERIALS AND METHODS: Anonymised data from individuals undergoing CTC after a positive FOBt in the English Bowel Cancer Screening Programme were analysed. The detection of colorectal cancer (CRC), advanced neoplasia, and ≥ 6 mm polyps were stratified by the number of positive FOBt windows. The PPV was calculated by reference to subsequent endoscopy results. The influence of the FOBt result on detection rates was estimated with multilevel logistic regression. PPV, CRC stage, and location were compared across groups according to FOBt positivity. RESULTS: Four thousand, six hundred and one individuals were included (mean = 66.7 years, 54.2% men). Detection rates of CRC and advanced neoplasia increased with greater numbers of positive FOBt windows (odds ratio [OR] for CRC = 1.41; 95% confidence interval [CI]: 1.31-1.52; OR for advanced neoplasia = 1.17; 95%CI: 1.12-1.23; both p < 0.0001). The PPV was significantly greater at higher FOBt levels (p = 0.020). The number of positive FOBt windows had no significant effect on stage (p = 0.30) or location (p = 0.20) of confirmed CRC. CONCLUSIONS: The magnitude of FOBt positivity influences the PPV and detection rates when screening for colorectal neoplasia. CTC may be particularly useful for FOBt patients with few positive test windows.

Patterns of recurrence of gastrointestinal stromal tumour (GIST) following complete resection: implications for follow-up.

AIM: To determine the frequency, time course and sites of recurrence following surgical resection of gastrointestinal stromal tumours (GIST) and to evaluate the performance of a risk-based surveillance protocol in detection of recurrence. METHODS: Eighty-one patients on surveillance following complete resection of GIST were included. Patients were stratified into risk groups according to accepted histopathological criteria. Computed tomography (CT) examinations were retrospectively reviewed to determine rates, sites and imaging characteristics of recurrence and to assess compliance with the local follow-up protocol. RESULTS: The median time of follow-up was 41 months. Nineteen patients suffered recurrence, all of whom were in the high-risk group. Fifty-eight percent of relapses occurred within 1 year and 84% within 3 years. Even within the high-risk group, patients with relapse had significantly larger (mean 15 versus 10.4 cm, p < 0.05) and more mitotically active primary tumours (mean 33.7 versus 5.6 mitoses per 50 high-power fields; p < 0.05) than those with no relapse. Relapse was to the liver in 12 cases (63%) and to the omentum and mesentery in nine cases (47%), and was asymptomatic in three-quarters of patients. CONCLUSIONS: The high incidence of GIST recurrence in the high-risk group in the first 3 years after surgery supports the use of intensive imaging surveillance in this period. Relapse is often asymptomatic and commonly occurs to the liver, omentum and mesentery. Stratification by tumour factors may enable improved tailoring of surveillance protocols within the high-risk group in the future.

CT colonography in the English Bowel Cancer Screening Programme: national survey of current practice.

AIM: To obtain information regarding the provision of computed tomography colonography (CTC) services to the National Health Service (NHS) Bowel Cancer Screening Programme (BCSP). MATERIALS AND METHODS: Specialist screening practitioners at the 58 BCSP screening centres and lead BCSP radiologists at 110 hospitals performing CTC for the Programme were contacted and completed a semi-structured questionnaire administered by telephone. Responses were collated and descriptive statistics derived. RESULTS: One hundred and seven (98%) SSPs and 103 (94%) radiologists were surveyed. All screening centres had access to CTC at 110 hospital sites. All sites used CTC for failed or contraindicated colonoscopy, 24% used it for patients taking anticoagulants, and 17% for those with fear of colonoscopy. Patient preference was not an indication at any site. Multidetector CT (100%), carbon dioxide insufflators (94%), and CTC software (95%) were almost universal. Ninety-one percent of radiographers and 98% of radiologists were trained in CTC image acquisition and interpretation, respectively. Seventy-five percent of the radiologists were gastrointestinal subspecialists and two-thirds had interpreted more than 300 examinations in clinical practice, although 5% had interpreted fewer than 100. Eighty-one percent of radiologists favoured some form of accreditation for CTC interpretation. CONCLUSIONS: CTC is widely available to the BCSP. Appropriate hardware and software is almost ubiquitous. Most radiographers and radiologists offering CTC to the BCSP have received specific training. Formal service evaluation is patchy. The majority of radiologists would welcome national accreditation for CTC.

Contemporary imaging of rectus diastasis and the abdominal wall.

Diastasis of the rectus abdominis muscles (rectus diastasis, RD) is common, particularly in postpartum women. Although imaging is not always mandatory for assessment, several cross-sectional imaging techniques, in particular ultrasound (US), computed tomography (CT) and magnetic resonance imaging (MRI) can depict the abdominal wall in exquisite detail. They permit simultaneous assessment of the degree and craniocaudal extent of RD, evaluation for co-existent hernia and subjective judgement of muscle quality. Increasingly, dynamic imaging techniques show both static anatomy and muscle movement and function. In this review, we highlight the imaging findings of RD, associated hernia, and potential mimics.

Identifying predictors of ventral hernia recurrence: systematic review and meta-analysis.

BACKGROUND: Ventra hernias are increasing in prevalence and many recur despite attempted repair. To date, much of the literature is underpowered and divergent. As a result there is limited high quality evidence to inform surgeons succinctly which perioperative variables influence postoperative recurrence. This systematic review aimed to identify predictors of ventral hernia recurrence. METHODS: PubMed was searched for studies reporting prognostic data of ventral hernia recurrence between 1 January 1995 and 1 January 2018. Extracted data described hernia type (primary/incisional), definitions of recurrence, methods used to detect recurrence, duration of follow-up, and co-morbidity. Data were extracted for all potential predictors, estimates and thresholds described. Random-effects meta-analysis was used. Bias was assessed with a modified PROBAST (Prediction model Risk Of Bias ASsessment Tool). RESULTS: Screening of 18 214 abstracts yielded 274 individual studies for inclusion. Hernia recurrence was defined in 66 studies (24.1 per cent), using 41 different unstandardized definitions. Three patient variables (female sex, age 65 years or less, and BMI greater than 25, 30, 35 or 40 kg/m2), five patient co-morbidities (smoking, diabetes, chronic obstructive pulmonary disease, ASA grade III-IV, steroid use), two hernia-related variables (incisional/primary, recurrent/primary), six intraoperative variables (biological mesh, bridged repair, open versus laparoscopic surgery, suture versus mesh repair, onlay/retrorectus, intraperitoneal/retrorectus), and six postoperative variables (any complication, surgical-site occurrence, wound infection, seroma, haematoma, wound dehiscence) were identified as significant prognostic factors for hernia recurrence. CONCLUSION: This study summarized the current evidence base for predicting ventral hernia recurrence. Results should inform best practice and future research.

European guidelines on achalasia: United European Gastroenterology and European Society of Neurogastroenterology and Motility recommendations.

INTRODUCTION: Achalasia is a primary motor disorder of the oesophagus characterised by absence of peristalsis and insufficient lower oesophageal sphincter relaxation. With new advances and developments in achalasia management, there is an increasing demand for comprehensive evidence-based guidelines to assist clinicians in achalasia patient care. METHODS: Guidelines were established by a working group of representatives from United European Gastroenterology, European Society of Neurogastroenterology and Motility, European Society of Gastrointestinal and Abdominal Radiology and the European Association of Endoscopic Surgery in accordance with the Appraisal of Guidelines for Research and Evaluation II instrument. A systematic review of the literature was performed, and the certainty of the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation methodology. Recommendations were voted upon using a nominal group technique. RESULTS: These guidelines focus on the definition of achalasia, treatment aims, diagnostic tests, medical, endoscopic and surgical therapy, management of treatment failure, follow-up and oesophageal cancer risk. CONCLUSION: These multidisciplinary guidelines provide a comprehensive evidence-based framework with recommendations on the diagnosis, treatment and follow-up of adult achalasia patients.

Survey of hospital clinicians' preferences regarding the format of radiology reports.

AIM: To determine hospital consultants' preferences for the format and content of radiology reports. MATERIALS AND METHODS: Ninety-nine questionnaires were sent to consultant staff with responsibility for requesting ultrasound examinations. The participants were invited to rank a variety of hypothetical reports in order of preference. They were also asked whether they felt other commonly included features of a radiology report were of value. Rank data were analysed by the Friedman statistic, Fisher's multiple comparisons least significant difference test, and the Kemeny-Young method. RESULTS: Forty-nine responses were received. There was a preference for more detailed reports that included a clinical comment by the radiologist, for both normal and abnormal results (p<0.05). Reports presented in tables were preferred. The combination of a detailed tabular report with a radiologist's comment was the most popular single structure, preferred by 43% of respondents for normal reports and 51% for abnormal reports. CONCLUSION: Detailed reports with a radiologists' comment are preferred to briefer reports, even for normal examinations. Tabular reports are preferred to prose, with the combination of a detailed report presented in a tabular format accompanied by a radiologist's comment being the most preferred style.

A systematic methodological review of non-randomised interventional studies of elective ventral hernia repair: clear definitions and a standardised minimum dataset are needed.

BACKGROUND: Ventral hernias (VHs) often recur after surgical repair and subsequent attempts at repair are especially challenging. Rigorous research to reduce recurrence is required but such studies must be well-designed and report representative and comprehensive outcomes. OBJECTIVE: We aimed to assesses methodological quality of non-randomised interventional studies of VH repair by systematic review. METHODS: We searched the indexed literature for non-randomised studies of interventions for VH repair, January 1995 to December 2017 inclusive. Each prospective study was coupled with a corresponding retrospective study using pre-specified criteria to provide matched, comparable groups. We applied a bespoke methodological tool for hernia trials by combining relevant items from existing published tools. Study introduction and rationale, design, participant inclusion criteria, reported outcomes, and statistical methods were assessed. RESULTS: Fifty studies (17,608 patients) were identified: 25 prospective and 25 retrospective. Overall, prospective studies scored marginally higher than retrospective studies for methodological quality, median score 17 (IQR: 14-18) versus 15 (IQR 12-18), respectively. For the sub-categories investigated, prospective studies achieved higher median scores for their, 'introduction', 'study design' and 'participants'. Surprisingly, no study stated that a protocol had been written in advance. Only 18 (36%) studies defined a primary outcome, and only 2 studies (4%) described a power calculation. No study referenced a standardised definition for VH recurrence and detection methods for recurrence varied widely. Methodological quality did not improve with publication year or increasing journal impact factor. CONCLUSION: Currently, non-randomised interventional studies of VH repair are methodologically poor. Clear outcome definitions and a standardised minimum dataset are needed.

A systematic methodological review of reported perioperative variables, postoperative outcomes and hernia recurrence from randomised controlled trials of elective ventral hernia repair: clear definitions and standardised datasets are needed.

BACKGROUND: This systematic review assesses the perioperative variables and post-operative outcomes reported by randomised controlled trials (RCTs) of VH repair. This review focuses particularly on definitions of hernia recurrence and techniques used for detection. OBJECTIVE: Our aim is to identify and quantify the inconsistencies in perioperative variable and postoperative outcome reporting, so as to justify future development of clear definitions of hernia recurrence and a standardised dataset of such variables. METHODS: The PubMed database was searched for elective VH repair RCTs reported January 1995 to March 2016 inclusive. Three independent reviewers performed article screening, and two reviewers independently extracted data. Hernia recurrence, recurrence rate, timing and definitions of recurrence, and techniques used to detect recurrence were extracted. We also assessed reported post-operative complications, standardised operative outcomes, patient reported outcomes, pre-operative CT scan hernia dimensions, intra-operative variables, patient co-morbidity, and hernia morphology. RESULTS: 31 RCTs (3367 patients) were identified. Only 6 (19.3%) defined hernia recurrence and methods to detect recurrence were inconsistent. Sixty-four different clinical outcomes were reported across the RCTs, with wound infection (30 trials, 96.7%), hernia recurrence (30, 96.7%), seroma (29, 93.5%), length of hospital stay (22, 71%) and haematoma (21, 67.7%) reported most frequently. Fourteen (45%), 11 (35%) and 0 trials reported CT measurements of hernia defect area, width and loss of domain, respectively. No trial graded hernias using generally accepted scales. CONCLUSION: VH RCTs report peri- and post-operative variables inconsistently, and with poor definitions. A standardised minimum dataset, including definitions of recurrence, is required.

Diffusion-weighted imaging for evaluating inflammatory activity in Crohn's disease: comparison with histopathology, conventional MRI activity scores, and faecal calprotectin.

PURPOSE: To evaluate whether the extent of enteric diffusion-weighted imaging (DWI) signal abnormality reflects inflammatory burden in Crohn's disease (CD), and to compare qualitative and quantitative grading. METHODS: 69 CD patients (35 male, age 16-78) undergoing MR enterography with DWI (MRE-D) and the same-day faecal calprotectin (cohort 1) were supplemented by 29 patients (19 male, age 16-70) undergoing MRE-D and terminal ileal biopsy (cohort 2). Global (cohort 1) and terminal ileal (cohort 2) DWI signal was graded (0 to 3) by 2 radiologists and segmental apparent diffusion coefficient (ADC) calculated. Data were compared to calprotectin and a validated MRI activity score [MEGS] (cohort 1), and a histopathological activity score (eAIS) (cohort 2) using nonparametric testing and rank correlation. RESULTS: Patients with normal (grades 0 and 1) DWI signal had lower calprotectin and MEGS than those with abnormal signal (grades 2 and 3) (160 vs. 492 µg/l, p = 0.0004, and 3.3 vs. 21, p < 0.0001), respectively. Calprotectin was lower if abnormal DWI affected <10 cm of small bowel compared to diffuse small and large bowel abnormality (236 vs. 571 µg, p = 0.009). The sensitivity and specificity for active disease (calprotectin > 120 µg/l) were 83% and 52%, respectively. There was a negative correlation between ileal MEGS and ADC (r = -0.41, p = 0.017). There was no significant difference in eAIS between qualitative DWI scores (p = 0.42). Mean ADC was not different in those with and without histological inflammation (2077 vs. 1622 × 10-6mm2/s, p = 0.10) CONCLUSIONS: Qualitative grading of DWI signal has utility in defining the burden of CD activity. Quantitative ADC measurements have poor discriminatory ability for segmental disease activity.

Comparative quantitative assessment of global small bowel motility using magnetic resonance imaging in chronic intestinal pseudo-obstruction and healthy controls.

BACKGROUND: Chronic intestinal pseudo-obstruction (CIPO) is characterized by dilatation of the bowel lumen and abnormal motility. In this study, we aimed to quantify small bowel dysmotility in CIPO using a validated pan-intestinal motility assessment technique based on motion capture magnetic resonance imaging (MRI) compared to normal controls. In addition, we explored if motility responses of CIPO patients to neostigmine challenge differed from healthy volunteers. METHODS: Twenty healthy volunteers (mean age 28, range 22-48) and 11 CIPO patients (mean age 47, range 19-90) underwent MRI enterography to capture global small bowel motility. Eleven controls and seven CIPO patients further underwent a randomized placebo-controlled crossover study of either intravenous neostigmine (0.5 mg) or saline with motility MRI repeated at a mean of 3 weeks. Motility was quantified in regions of interest placed to encompass the whole small bowel volume using a validated, postprocessing technique to give a global motility index in arbitrary units (AU). Baseline and stimulated motility was compared using Wilcoxon rank-sum paired T-tests. KEY RESULTS: Baseline global small bowel motility was significantly lower in CIPO patients compared to controls (mean 0.25 AU vs 0.35 AU, p < 0.001). Motility in both groups increased significantly after neostigmine (0.06 AU increase, p = 0.016 in CIPO and 0.06 AU increase, p = 0.002 in controls). Three patients with scleroderma had a reduced response to neostigmine. CONCLUSIONS & INFERENCES: Global small bowel motility in CIPO patients is significantly lower than controls and response to the pro-kinetic agent neostigmine may differ according to disease phenotype. Software-quantified bowel motility using cine MRI has potential as a future tool to investigate enteric dysmotility.

Magnetic resonance imaging-quantified small bowel motility is a sensitive marker of response to medical therapy in Crohn's disease.

BACKGROUND: Magnetic resonance enterography (MRE) can measure small bowel motility, reduction in which reflects inflammatory burden in Crohn's Disease (CD). However, it is unknown if motility improves with successful treatment. AIM: To determine if changes in segmental small bowel motility reflect response to anti-TNFα therapy after induction and longer term. METHODS: A total of 46 patients (median 29 years, 19 females) underwent MRE before anti-TNFα treatment; 35 identified retrospectively underwent repeat MRE after median 55 weeks of treatment and 11 recruited prospectively after median 12 weeks. Therapeutic response was defined by physician global assessment (retrospective group) or a ≥3 point drop in the Harvey-Bradshaw Index (prospective group), C-reactive protein (CRP) and the MaRIA score. Two independent radiologists measured motility using an MRE image-registration algorithm. We compared motility changes in responders and nonresponders using the Mann-Whitney test. RESULTS: Anti-TNFα responders had significantly greater improvements in motility (median = 73.4% increase from baseline) than nonresponders (median = 25% reduction, P < 0.001). Improved MRI-measured motility was 93.1% sensitive (95%CI: 78.0-98.1%) and 76.5% specific (95% CI: 52.7-90.4%) for anti-TNFα response. Patients with CRP normalisation (<5 mg/L) had significantly greater improvements in motility (median = 73.4% increase) than those with persistently elevated CRP (median = 5.1%, P = 0.035). Individuals with post-treatment MaRIA scores of <11 had greater motility improvements (median = 94.7% increase) than those with post-treatment MaRIA score >11 (median 15.2% increase, P = 0.017). CONCLUSIONS: Improved MRI-measured small bowel motility accurately detects response to anti-TNFα therapy for Crohn's disease, even as early as 12 weeks. Motility MRI may permit early identification of nonresponse to anti-TNFα agents, allowing personalised treatment.