Routine pathology examination in the era of value-based healthcare: the case of haemorrhoids specimens.

Routine pathologic examination of specimens is a common practice with ill-defined value. The present study is the first to investigate the incidence and cost of incidental microscopic lesions in both haemorrhoidectomy and stapled haemorrhoidopexy specimens. Pathological reports of specimens obtained from haemorrhoidectomy and stapled haemorrhoidopexy procedures performed from January 2003 to May 2017 were analysed. Specimens resulting from patients treated for any disease other than haemorrhoids alone were excluded from the study. Unexpected diagnoses in the pathological report were defined as incidental diagnoses. A cost analysis was then performed. In the considered period we performed a total of 3017 procedures complying with our criteria. We found 65 (2.15%) unexpected lesions. Of the incidental diagnosis, 30 (0.99%) altered either the follow-up or the treatment. The incidences of both findings were extremely higher in haemorrhoidectomies specimens (p < 0.0001). We estimated that the cost of 14 years of routine pathological examination of haemorrhoids specimens was 133,351.4 euros, each consequential incidental diagnosis costing 4445.03 euros. The incidence of unexpected lesions in routine pathologic examination of haemorrhoidectomy and haemorrhoidopexy specimens is low but not negligible. The vast majority of incidental findings were found among haemorrhoidectomy specimens. Even though the real value of routine pathological examination of haemorrhoids specimens is still uncertain, from a clinical standpoint we were glad to suggest each patients the best follow-up and/or treatment. Future studies should assess preoperative patient's risk stratification and careful intraoperative macroscopic inspection strategies for selective pathology examination of haemorrhoids specimens.

Esophageal function testing: Billing and coding update.

BACKGROUND AND PURPOSE: Esophageal function testing is being increasingly utilized in diagnosis and management of esophageal disorders. There have been several recent technological advances in the field to allow practitioners the ability to more accurately assess and treat such conditions, but there has been a relative lack of education in the literature regarding the associated Common Procedural Terminology (CPT) codes and methods of reimbursement. This review, commissioned and supported by the American Neurogastroenterology and Motility Society Council, aims to summarize each of the CPT codes for esophageal function testing and show the trends of associated reimbursement, as well as recommend coding methods in a practical context. We also aim to encourage many of these codes to be reviewed on a gastrointestinal (GI) societal level, by providing evidence of both discrepancies in coding definitions and inadequate reimbursement in this new era of esophageal function testing.

Optimal strategies for the diagnosis of community-onset diarrhea in solid organ transplant recipients: Less is more.

BACKGROUND: Diarrhea, a common complication after solid organ transplant (SOT), is associated with allograft failure and death. No evidence-based guidelines exist for the evaluation of diarrhea in SOT recipients. We performed a cost analysis to derive a testing algorithm for the diagnosis of community-onset diarrhea that minimizes costs without compromising diagnostic yields. DESIGN: A cost analysis was performed on a retrospective cohort of 422 SOT admissions for community-onset diarrhea over an 18-month period. A stepwise testing model was applied on a population level to assess test costs relative to diagnostic yields. RESULTS: Over an 18-month period, 1564 diagnostic tests were performed and 127 (8.1%) returned positive. Diagnostic testing accounted for $95 625 of hospital costs. The tests with the lowest cost per decrease in the false-omission rate (FOR) were stool Clostridium difficile polymerase chain reaction (PCR) ($156), serum cytomegalovirus quantitative PCR ($1529), stool norovirus (NV) PCR ($4673), and stool culture ($6804). A time-to-event analysis found no significant difference in the length of hospital stay between patients with and without NV testing (P=.520). CONCLUSIONS: A stepwise testing strategy can reduce costs without compromising diagnostic yields. In the first-stage testing, we recommend assessment for C. difficile, cytomegalovirus, and food-borne bacterial pathogens. For persistent diarrheal episodes, second-stage evaluation should include stool NV PCR, Giardia/Cryptosporidium enzyme immunoassay, stool ova and parasite, reductions in immunosuppressive therapy, and possibly endoscopy. Although NV testing had a relatively low cost per FOR, we recommend NV testing during second-stage evaluation, as an NV diagnosis may not lead to changes in clinical management or further reductions in length of hospital stay.

Amino acid formula as a new strategy for diagnosing cow's milk allergy in infants: is it cost-effective?

AIMS: To estimate the cost-effectiveness of a new strategy that uses an amino acid formula in the elimination diet of infants with suspected cow's milk allergy (CMA). MATERIALS AND METHODS: This pharmacoeconomic study was developed from the perspective of the Brazilian Public Healthcare System. The new strategy proposes using an amino acid formula in the diagnostic elimination diet of infants (≤24 months) with suspected CMA. The rationale is that infants who do not respond to the amino acid formula do not suffer from CMA. Patients with a positive oral challenge test receive a therapeutic elimination diet based on Brazilian Food Allergy Guidelines. This approach was compared to the current recommendations of the Brazilian Food Allergy Guidelines. A decision model was constructed using TreeAge Pro 2012 software. Model inputs were based on a literature review and the opinions of a panel of experts. A univariate sensitivity analysis of incremental cost-effectiveness ratios was performed. RESULTS: The mean cost per patient of the new amino acid formula strategy was R$3,341.57, while the cost of the current Brazilian guidelines strategy was R$3,641.08. The mean number of symptom-free days per patient, which was used as an indicator of effectiveness, was 900.6 and 875.7 days, respectively. The new strategy is, therefore, dominant. In the sensitivity analysis, the dominance was maintained with parameter variation. LIMITATIONS: In the absence of information in the literature, some premises were defined by a panel of specialists. CONCLUSIONS: The new strategy, which uses an amino acid formula in the elimination diagnostic diet followed by an oral food challenge, is a dominant pharmacoeconomic approach that has a lower cost and results in an increased number of symptom-free days.

[Estimation of hospital costs of colorectal cancer in Catalonia (Spain)]. / Estimación del coste hospitalario del cáncer colorrectal en Cataluña.

OBJECTIVE: To assess the hospital cost associated with colorectal cancer (CRC) treatment by stage at diagnosis, type of cost and disease phase in a public hospital. METHODS: A retrospective analysis was conducted of the hospital costs associated with a cohort of 699 patients diagnosed with CRC and treated for this disease between 2000 and 2006 in a teaching hospital and who had a 5-year follow-up from the time of diagnosis. Data were collected from clinical-administrative databases. Mean costs per patient were analysed by stage at diagnosis, cost type and disease phase. RESULTS: The mean cost per patient ranged from 6,573 Euros for patients with a diagnosis of CRC in situ to 36,894 € in those diagnosed in stage III. The main cost components were surgery-inpatient care (59.2%) and chemotherapy (19.4%). Advanced disease stages were associated with a decrease in the relative weight of surgical and inpatient care costs and an increase in chemotherapy costs. CONCLUSIONS: This study provides the costs of CRC treatment based on clinical practice, with chemotherapy and surgery accounting for the major cost components. This cost analysis is a baseline study that will provide a useful source of information for future studies on cost-effectiveness and on the budget impact of different therapeutic innovations in Spain.

Home-based screening for biliary atresia using infant stool colour cards: a large-scale prospective cohort study and cost-effectiveness analysis.

OBJECTIVE: Biliary atresia (BA), a leading cause of paediatric liver failure and liver transplantation, manifests by three weeks of life as jaundice with acholic stools. Poor outcomes due to delayed diagnosis remain a problem worldwide. We evaluated and assessed the cost-effectiveness of methods of introducing a BA Infant Stool Colour Card (ISCC) screening programme in Canada. SETTING AND METHODS: A prospective study at BC Women's Hospital recruited consecutive healthy newborns through six incrementally more intensive screening approaches. Under the baseline "passive" strategy, families received ISCCs at maternity, with instructions to monitor infant stool colour daily and return the ISCC by mail at age 30 days. Additional strategies were: ISCC mailed to family physician; reminder letters or telephone calls to families or physicians. Random telephone surveys of ISCC non-returners assessed total card utilization. Primary outcome was ISCC utilization rate expressed as a composite outcome of the ISCC return rate and non-returned ISCC use. Markov modelling was used to predict incremental costs and life years gained from screening (passive and reminder), compared with no screening, over a 10-year time horizon. RESULTS: 6,187 families were enrolled. Card utilization rates in the passive screening strategy were estimated at 60-94%. For a Canadian population, the increase in cost for passive screening, compared with no screening, is $213,584 and the gain in life years is 9.7 ($22,000 per life-year gained). CONCLUSIONS: A BA ISCC screening programme targeting families of newborns is feasible in Canada. Passive distribution of ISCC at maternity is potentially effective and highly cost-effective.

Medical resource utilization and associated costs in patients with ulcerative colitis in the UK: a chart review analysis.

OBJECTIVE: Limited evidence is available on the economic burden of ulcerative colitis (UC) in the UK, particularly relating to the impact of relapse frequency on direct medical costs. This study identifies and assesses medical resource utilization (MRU) and associated direct costs in mild and moderate UC patients in the UK. PATIENTS AND METHODS: A retrospective chart review of patients with mild-to-moderate UC diagnosed at least 1 year before the study was performed. From 33 general practitioner (GP) and 34 gastroenterologist sites, charts of the last three UC patients fulfilling the inclusion criteria were reviewed. Descriptive statistics were calculated for MRU and 2011 costs (GB£) by number of relapses. RESULTS: The study population included 201 patients with a mean age of 39.9 years; 44% were women and the mean disease duration was 7.4 years. UC-related costs of each MRU category increased with the number of relapses. Comparing patients without relapse with those with more than two relapses, the mean annual UC-related costs were £14 versus £2556 for hospitalizations; £218 versus £988 for visits (including nurse, GP, specialist, and other visits); £21 versus £1303 for procedures; £17 versus £188 for diagnostics; and £1168 versus £6660 for all-cause total costs. Age, sex, and site of data reporting (GP vs. gastroenterologist) were not associated with MRU or costs. CONCLUSION: Patients with mild-to-moderate UC incurred considerable costs that increased markedly with the number of relapses. These findings support the importance of maintenance therapies in UC that reduce or prevent relapses. Quantifying the relationship between relapse rate and costs will inform future health economic studies.

Cost-effectiveness of Barrett's oesophagus screening and surveillance.

Endoscopic screening and surveillance of patients with Barrett's oesophagus to detect oesophageal cancer at earlier stages is contentious. As a consequence, their cost-effectiveness is also debatable. Current health economic evidence shows mixed results for demonstrating their value, mainly due to varied assumptions around progression rates to cancer, quality of life and treatment pathways. No randomized controlled trial exists to definitively support the efficacy of surveillance programs and one is unlikely to be undertaken. Contemporary treatment, cost and epidemiological data to contribute to cost-effectiveness analyses are needed. Risk assessment to stratify patients at low- or high-risk of developing cancer should improve cost-effectiveness outcomes as higher gains will be seen for those at higher risk, and medical resource use will be avoided in those at lower risk. Rapidly changing technologies for imaging, biomarker testing and less-invasive endoscopic treatments also promise to lower health system costs and avoid adverse events in patients.

Diverticular disease hospital cost impact analysis: evaluation of testings and surgical procedures in inpatient and outpatient admissions.

BACKGROUND: Diverticular Disease (DD) is a common condition in Italy and in other western countries. There is not much data concerning DD's impact on budget and activity in hospitals. METHODS: The aim is to detect the clinical workload and the financial impact of diverticular disease in hospitals.Retrospective observational study of all patients treated for diverticular disease during the period of seven years in AOU Federico II. Analysis of inpatient and outpatient investigations, treatment, hospitalization and financial refunds. RESULTS: A total of 738 patients were treated and 840 hospital discharge records were registered. There were a total number of 4101 hospitalization days and 753 outpatient accesses. The investigations generated were 416 endoscopies, 197 abdominal CT scans, 177 abdominal ultrasound scans, 109 X-rays tests. A total of 193 surgical operations were performed. The total cost of this activity was € 1.656.802 or 0.2% of the total budget of the hospital. € 1.346.218, were attributable to the department of general surgery, 0.9% of the department's budget . CONCLUSIONS: The limited impact of diverticular disease on the budget and activity of AOU Federico II of Naples is mainly due to the absence of an emergency department.

[On the question of the development of medical-economic standard of diagnostics of oncologic diseases of the upper gastrointestinal tract in outpatient clinics of Saint Petersburg].

The authors investigated general principles and specific development of medico-economic standard-based data-processing system, "Expert-MES", for early diagnosis of tumors of the upper gastrointestinal tract. The method of calculating the actual cost of diagnostic measures is demonstrated with regard to necessary volumes. The possibilities of monitoring the implementation of MES in request of patients for examination in outpatient clinics are evaluated.

[Referrals to a gastroenterology outpatient clinic from primary care: evaluation of two programs]. / Derivación a las consultas de gastroenterología desde atención primaria: evaluación de dos programas.

OBJECTIVES: To analyze the effect of implementing a high-resolution clinic (HRC) and an increasing resolution capacity program in primary care (IRCPPC) for referrals to a gastroenterology outpatient clinic from primary care and the resources used. METHODS: A retrospective and observational study based on a review of referral sheets and databases was performed. We analyzed the number and reason for referrals, delay times and resource consumption in two periods: before (first 4 months of 2007) and after (first 4 months of 2009) the launch of the IRCPPC and HRC. RESULTS: In the first and second periods, 881 and 1076 patients, respectively, referred from primary health care were evaluated in the gastroenterology clinic, with a decrease in the delay time in the second period (80.8 ± 64.34 days vs 36.1 ± 29.12 days, p < 0.001). The most frequent reasons for referral were dyspepsia (27.7%), high-risk of colorectal cancer (17.1%), disturbance of bowel rhythm (18.2%), abdominal pain (16%), and gastroesophageal reflux (11.2%), with no differences between the two periods. Although delay times until the first visit (10.8 ± 9.03 days vs 42.8 ± 28.67 days, p < 0.001) and until discharge (39.6 ± 80.65 days vs 128.6 ± 135.34 days, p < 0.001) were lower in referrals to the HRC, the number of visits (3.6 ± 2.20 vs 3.2 ± 1.95, p = 0.015) and the cost of referrals (592.7 ± 421.50 € vs 486.0 ± 309.66 €, p < 0.001) was higher. CONCLUSIONS: In the study period the number of referrals increased, while the delay time decreased. Although the HRC reduces delay times, it is associated with an increase in health resource use.

A million-dollar work-up for abdominal pain: is it worth it?

BACKGROUND AND AIM: Pain-predominant-functional gastrointestinal disorders (PP-FGIDs) are common. The diagnosis is clinical and there are no biological markers to characterize these conditions. Despite limited evidence, investigations are commonly performed. The aim of the study was to investigate diagnostic practices, yield, and costs in children with PP-FGIDs. PATIENTS AND METHODS: Charts of all of the children older than 4 years diagnosed as having abdominal pain were reviewed. Results and costs of diagnostic investigations were analyzed. RESULTS: Of 243 children with abdominal pain, 122 (50.2%) had PP-FGIDs (79 girls, mean age 12.7 years). All of the children underwent diagnostic work-up. Complete blood cell count was done in 91.8% of patients. None had elevated white blood cells, platelets, and low albumin. Six had either elevated erythrocyte sedimentation rate or C-reactive protein, but none had elevation of both; 4 of these 6 cases underwent endoscopies with normal results in 3 cases; Helicobacter pylori was found in 1 case. One child had elevated tissue transglutaminase 1 only antibodies with normal endoscopy. Amylase, lipase, direct bilirubin, stool cultures, and ova or parasites were always normal. One child had intermittent elevation of aspartate aminotransferase and alanine transaminase. There were no significant abnormalities in urinalysis or electrolytes. Abdominal x-rays were done in 38.5%, showing only retained stools in 13% of these patients. Abdominal ultrasound and computed tomography scan were done in 23.7% and 9% of cases, respectively, but were of no clinical value; 33.6% patients had esophagogastroduodenoscopy (9.7% abnormal: Helicobacter pylori, chemical gastritis, esophagitis) and 17.2% had colonoscopy (9.5% abnormal: rare fork crypts, lymphoid hyperplasia). Total costs: $744,726. Average cost per patient: $6104.30. CONCLUSIONS: In children with PP-FGIDs, investigations are common, costs are substantial, and yield is minimal.

El escrutinio diagnóstico limitado puede disminuir el impacto económico directo del síndrome de intestino irritable (SII) / Limited diagnostic testing can decrease the direct economic impact of irritable bowel syndrome

Background: The economic impact of irritable bowel syndrome (IBS) in México in terms of excessive diagnostic testing can be considerably reduced if the recommendations of the Latín American Consensus (LATAM) for IBS are followed. Aim: To estímate the economic impact of IBS in terms of excessive diagnostic testing. Material and Methods: Based on a previously published study the costs of diagnostic testing for IBS were compared to the theoretical costs according to the recommendations of the consensus. These costs were compared to estímate the economic impact of excessive diagnostic testing. A cost-minimization analysis was also done. Results: For the lowest socioeconomic level in academic medicine, the excessive diagnostic testing had an approximate cost of US$21.38, compared to US$1.72 if the LATAM Consensus recommendations would have been followed, representing a saving of 92.0 percent. The cost for the highest socioeconomic level in academic medicine was US$1080.36 versus US$103.60 (a saving of 90.4 percent) and for prívate medicine, the costs were US$3121.60 versus US$159.90 (a saving of 94.9 percent) if the recommendations would have been followed. Conclusions: Limited diagnostic testing recommended by the LATAM Consensus for IBS can significantly decrease the economic impact of this disease in México.

The proton pump inhibitor (PPI) test in GERD: does it still have a role?

The proton pump inhibitor (PPI) test is a short course of high-dose PPI, used to diagnose gastroesophageal reflux disease (GERD). This diagnostic strategy is commonly used globally, primarily because of its availability, simplicity, and high sensitivity. The PPI test has been proven to be a sensitive tool for diagnosing GERD in noncardiac chest pain patients and in preliminary trials in extraesophageal manifestations of GERD. Several recent meta-analyses reevaluated the value of the PPI test in patients with classic GERD-related symptoms and noncardiac chest pain. Although the results were conflicting, the PPI test remains a popular tool for determining the presence of GERD. Attempts to challenge the PPI test without offering attractive alternatives are unlikely to alter clinical practice.

Implementation of colon cancer screening: techniques, costs, and barriers.

Colorectal cancer and breast cancer are the only cancer sites for which evidence on the efficacy of screening is available from randomized trials. The trials on colon cancer screening in the United States and Europe used the fecal occult blood test as the primary screen, but randomized trial data are not yet available on endoscopy (flexible sigmoidoscopy to 60 cm), and no randomized, controlled trials of colonoscopy as a screening test are in progress. This article reviews colorectal cancer screening from an epidemiologist's perspective to provide the theoretic evidence-based underpinning for the role of the gastroenterologist in colorectal screening.

[Limited diagnostic testing can decrease the direct economic impact of irritable bowel syndrome]. / El escrutinio diagnóstico limitado puede disminuir el impacto económico directo del síndrome de intestino irritable (SII).

BACKGROUND: The economic impact of irritable bowel syndrome (IBS) in Mexico in terms of excessive diagnostic testing can be considerably reduced if the recommendations of the Latin American Consensus (LATAM) for IBS are followed. AIM: To estimate the economic impact of IBS in terms of excessive diagnostic testing. MATERIAL AND METHODS: Based on a previously published study, the costs of diagnostic testing for IBS were compared to the theoretical costs according to the recommendations of the consensus. These costs were compared to estimate the economic impact of excessive diagnostic testing. A cost-minimization analysis was also done. RESULTS: For the lowest socioeconomic level in academic medicine, the excessive diagnostic testing had an approximate cost of U.S. $21.38, compared to U.S. $1.72 if the LATAM Consensus recommendations would have been followed, representing a saving of 92.0%. The cost for the highest socioeconomic level in academic medicine was U.S. $1080.36 versus U.S. $103.60 (a saving of 90.4%) and for private medicine, the costs were U.S. $3121.60 versus U.S. $159.90 (a saving of 94.9%) if the recommendations would have been followed. CONCLUSIONS: Limited diagnostic testing recommended by the LATAM Consensus for IBS can significantly decrease the economic impact of this disease in Mexico

Clinical usefulness of gastric-juice analysis in 2007: the stone that the builders rejected has become the cornerstone.

BACKGROUND: Gastric juice is usually discarded during upper-GI endoscopy. OBJECTIVE: By using a novel device, the Mt 21-42, we evaluated the potential of this important organic fluid in clinical practice, exploring its contribution to the diagnosis of Helicobacter pylori infection and atrophic gastritis of the oxyntic mucosa (AGOM). DESIGN AND PATIENTS: A multicenter study (17,907 patients; 10 endoscopy units) estimated the frequency of diagnosis of AGOM and H pylori infection in routine endoscopic practice. A prospective study (216 patients) at 1 of these units aimed to determine the real prevalence of these conditions and the possible benefits of gastric juice analysis. We considered gastric juice pH and ammonium concentration, endoscopic and histologic features, serologic parameters for atrophy and H pylori, gastric acid secretion, and costs. RESULTS: We found that H pylori infection and, even more markedly, AGOM were greatly underdiagnosed in routine endoscopic practice (20.1% and 0.8% vs 49.1% and 12.5% in the prospective study, respectively), because of the intrinsic limitations of the conventional tests and lack/inappropriateness of biopsy planning. Gastric-juice analysis proved to be a cheap, simple, and effective way to prevent such underdiagnosis and allowed detection of atrophic gastritis and H pylori in 96% and 98% of cases, and saved costs (cost-effectiveness ratio 209 vs 274-5047). CONCLUSIONS: Gastric juice provided a valuable source of clinicopathologic information that, properly analyzed, allowed detection of the main risk factors for gastric cancer (H pylori and atrophic gastritis), overcoming the diagnostic limitations associated with these conditions and also producing time and cost savings.

Which test is best for Helicobacter pylori? A cost-effectiveness model using decision analysis.

GPs face a potential dilemma in deciding which test to use for detection of Helicobacter pylori. For patients with dyspepsia, the National Institute for Health and Clinical Excellence (NICE) advises primary care practitioners to adopt a 'test and treat' policy before considering a referral for gastroscopy. There are many ways of testing: serology, urea breath test, and faecal antigen test. NICE does not advocate any preferred single test for detecting H. pylori. In the current study a multi-stakeholder 2-day workshop was established to agree and populate a cost-effectiveness decision analysis model. The aim was to analyse the three types of tests available for H. pylori and to determine which is the most practical and cost effective. Agreement on the costs and diagnostic values to be entered into the decision-analytic model was achieved. Results indicate that the faecal antigen test was the most effective in terms of true outcomes and cost. One thousand virtual patients were allocated to each of the three tests. Serology had 903, urea breath test had 961, and the faecal antigen test had 968 true positive outcomes. Data indicate that the faecal antigen test is the preferable strategy for diagnosis of H. pylori in primary care. This has implications for implementing new testing processes and for commissioning new diagnostic pathways for use in primary care.