Cost Effectiveness of using Faecal Immunochemical Testing (FIT) as an Initial Diagnostic Investigation for Patients with Lower Gastrointestinal Symptoms Suggestive of Malignancy.

Abstract BackgroundThere has been an increase in the numbers of patients presenting to primary care with suspected colorectal malignancy and subsequently an increase in demand for endoscopy. This study aims to forecast the cost of faecal immunochemical testing (FIT) compared to conventional diagnostic tests as a primary investigation for patients with symptoms suggestive of colorectal malignancy.MethodsRetrospectively, 1950 patients with symptoms suggestive of colorectal malignancy who were referred through primary care and underwent investigations through standard endoscopic evaluation were included. These patients were used to forecast the cost of faecal immunochemical testing creating theoretical data for sensitivity and specificity. Outcome measures included: the number of investigations under current protocol; cost of current investigations; number of predicted false negatives and false positives and positive/negative predictive values using current sensitivity data for FIT; the cost forecast of using FIT as the primary investigation for colorectal malignancy.Results: Median age was 65 (IQR 47-82) with 43.7% male and 56.3% female. A total of 1950 investigations were carried out with a diagnostic yield of 26 cancers (18 colon, 8 rectal), 138 polyps and 29 high risk adenomas (HGD +/- >10mm). In total, £713,948 was spent on the investigations. The commonest investigation was colonoscopy totalling £533,169. The total cost per cancer diagnosis was £27,459. Sensitivity (92.1% CI 86.9-95.3) and specificity (85.8% CI 78.3-90.1) for FIT in colorectal cancer was taken from NICE and was costed via the manufacturer(s). The projected total cost of FIT for the same population using a ≥4μg haemoglobin cut off was £415,680 (£15,554 per cancer). The total cost of high-risk polyps using ≥4μg cut off was £404,427 (sensitivity 71.2% CI 60.5-87.2, specificity 79.8%CI 76.1-83.7) or £13,945 per polyp.Conclusions: FIT is a cheaper and effective alternative test with the potential to replace current expensive methods. The forecast is based on the limited data available for sensitivity/specificity in the current literature. FIT has now been commenced for symptomatic patients in the UK and therefore sensitivity may change in the future.

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Cost effectiveness of using Faecal Immunochemical Testing (FIT) as an initial diagnostic investigation for patients with lower gastrointestinal symptoms suggestive of malignancy

BMC Family Practice ◽

10.1186/s12875-021-01435-7 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

CC Kearsey ◽

C Graham ◽

HS Lobb ◽

J Chacko ◽

R Weatherburn ◽

...

Keyword(s):

Primary Care ◽

High Risk ◽

Diagnostic Yield ◽

Gastrointestinal Symptoms ◽

Theoretical Data ◽

Current Sensitivity ◽

Predictive Values ◽

Colorectal Malignancy ◽

Total Cost ◽

The Cost

Abstract Background There has been an increase in the numbers of patients presenting to primary care with suspected colorectal malignancy and subsequently an increase in demand for endoscopy. This study aims to forecast the cost of faecal immunochemical testing (FIT) compared to conventional diagnostic tests as a primary investigation for patients with symptoms suggestive of colorectal malignancy. Methods Retrospectively, 1950 patients with symptoms suggestive of colorectal malignancy who were referred through primary care and underwent investigations through standard endoscopic evaluation were included. These patients were used to forecast the cost of faecal immunochemical testing creating theoretical data for sensitivity and specificity. Outcome measures included: the number of investigations under current protocol; cost of current investigations; number of predicted false negatives and false positives and positive/negative predictive values using current sensitivity data for FIT; the cost forecast of using FIT as the primary investigation for colorectal malignancy. Results Median age was 65 (IQR 47–82) with 43.7% male and 56.3% female. A total of 1950 investigations were carried out with a diagnostic yield of 26 cancers (18 colon, 8 rectal), 138 polyps and 29 high risk adenomas (HGD ± > 10 mm). In total, £713,948 was spent on the investigations. The commonest investigation was colonoscopy totalling £533,169. The total cost per cancer diagnosis was £27,459. Sensitivity (92.1% CI 86.9–95.3) and specificity (85.8% CI 78.3–90.1) for FIT in colorectal cancer was taken from NICE and was costed via the manufacturer(s). The projected total cost of FIT for the same population using a ≥ 4 μg haemoglobin cut off was £415,680 (£15,554 per cancer). The total cost of high-risk polyps using ≥ 4 μg cut off was £404,427 (sensitivity 71.2% CI 60.5–87.2, specificity 79.8%CI 76.1–83.7) or £13,945 per polyp. Conclusions FIT is a cheaper and effective alternative test with the potential to replace current expensive methods. The forecast is based on the limited data available for sensitivity/specificity in the current literature. FIT has now been commenced for symptomatic patients in the UK and therefore sensitivity may change in the future.

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Evaluation of a faecal calprotectin care pathway for use in primary care

Primary Health Care Research & Development ◽

10.1017/s1463423616000049 ◽

2016 ◽

Vol 17 (05) ◽

pp. 428-436 ◽

Cited By ~ 15

Author(s):

James Turvill ◽

Shaun O’Connell ◽

Abigail Brooks ◽

Karen Bradley-Wood ◽

James Laing ◽

...

Keyword(s):

Primary Care ◽

Clinical Decision Making ◽

Diagnostic Yield ◽

Care Pathway ◽

Gastrointestinal Symptoms ◽

Clinical Decision ◽

Traffic Light ◽

Faecal Calprotectin ◽

Predictive Values ◽

Light System

BackgroundNational Institute for Health and Care Excellence have recommended faecal calprotectin (FC) testing as an option in adults with lower gastrointestinal symptoms for whom specialist investigations are being considered, if cancer is not suspected and it is used to support a diagnosis of inflammatory bowel disease (IBD) or irritable bowel syndrome. York Hospital and Vale of York Clinical Commissioning Group have developed an evidence-based care pathway to support this recommendation for use in primary care. It incorporates a higher FC cut-off value, a ‘traffic light’ system for risk and a clinical management pathway.ObjectivesTo evaluate this care pathway.MethodsThe care pathway was introduced into five primary care practices for a period of six months and the clinical outcomes of patients were evaluated. Negative and positive predictive values (NPV and PPV) were calculated. GP feedback of the care pathway was obtained by means of a web-based survey. Comparator gastroenterology activity in a neighbouring trust was obtained.ResultsThe care pathway for FC in primary care had a 97% NPV and a 40% PPV. This was better than GP clinical judgement alone and doubled the PPV compared with the standard FC cut-off (<50 mcg/g), without affecting the NPV. In total, 89% of patients with IBD had an FC>250 mcg/g and were diagnosed by ‘straight to test’ colonoscopy within three weeks. The care pathway was considered helpful by GPs and delivered a higher diagnostic yield after secondary care referral (21%) than the conventional comparator pathway (5%).ConclusionsA care pathway for the use of FC that incorporates a higher cut-off value, a ‘traffic light’ system for risk and supports clinical decision making can be achieved safely and effectively. It maintains the balance between a high NPV and an acceptable PPV. A modified care pathway for the use of FC in primary care is proposed.

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Development of a prediction model to aid primary care physicians in early identification of women at high risk of developing endometriosis: cross-sectional study

BMJ Open ◽

10.1136/bmjopen-2019-030346 ◽

2019 ◽

Vol 9 (12) ◽

pp. e030346

Author(s):

Nina Julie Verket ◽

Ragnhild Sørum Falk ◽

Erik Qvigstad ◽

Tom Gunnar Tanbo ◽

Leiv Sandvik

Keyword(s):

Primary Care ◽

Family History ◽

High Risk ◽

Prediction Model ◽

Early Identification ◽

Primary Care Physicians ◽

Lasso Regression ◽

Cross Sectional ◽

Predictive Values ◽

History Of

ObjectivesTo identify predictors of disease among a few factors commonly associated with endometriosis and if successful, to combine these to develop a prediction model to aid primary care physicians in early identification of women at high risk of developing endometriosis.DesignCross-sectional anonymous postal questionnaire study.SettingWomen aged 18–45 years recruited from the Norwegian Endometriosis Association and a random sample of women residing in Oslo, Norway.Participants157 women with and 156 women without endometriosis.Main outcome measuresLogistic and least absolute shrinkage and selection operator (LASSO) regression analyses were performed with endometriosis as dependent variable. Predictors were identified and combined to develop a prediction model. The predictive ability of the model was evaluated by calculating the area under the receiver operating characteristic curve (AUC) and positive predictive values (PPVs) and negative predictive values (NPVs). To take into account the likelihood of skewed representativeness of the patient sample towards high symptom burden, we considered the hypothetical prevalences of endometriosis in the general population 0.1%, 0.5%, 1% and 2%.ResultsThe predictors absenteeism from school due to dysmenorrhea and family history of endometriosis demonstrated the strongest association with disease. The model based on logistic regression (AUC 0.83) included these two predictors only, while the model based on LASSO regression (AUC 0.85) included two more: severe dysmenorrhea in adolescence and use of painkillers due to dysmenorrhea in adolescence. For the prevalences 0.1%, 0.5%, 1% and 2%, both models ascertained endometriosis with PPV equal to 2.0%, 9.4%, 17.2% and 29.6%, respectively. NPV was at least 98% for all values considered.ConclusionsExternal validation is needed before model implementation. Meanwhile, endometriosis should be considered a differential diagnosis in women with frequent absenteeism from school or work due to painful menstruations and positive family history of endometriosis.

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Post-traumatic knee MRI findings and associations with patient, trauma, and clinical characteristics: a subgroup analysis in primary care in the Netherlands

British Journal of General Practice ◽

10.3399/bjgp17x693653 ◽

2017 ◽

Vol 67 (665) ◽

pp. e851-e858 ◽

Cited By ~ 1

Author(s):

Kim van Oudenaarde ◽

Nynke M Swart ◽

Johan L Bloem ◽

Sita MA Bierma-Zeinstra ◽

Paul R Algra ◽

...

Keyword(s):

Primary Care ◽

The Netherlands ◽

Subgroup Analysis ◽

Clinical Characteristics ◽

Diagnostic Yield ◽

Mri Findings ◽

Predictive Values ◽

Post Traumatic ◽

Mean Differences ◽

Active Patients

BackgroundThe added value of magnetic resonance imaging (MRI) in primary care is still being debated. A high diagnostic yield can be expected in young and active patients with post-traumatic knee complaints.AimTo determine the frequency of MRI abnormalities in young and active patients (aged 18–45 years) and the associations with patient, trauma, and clinical characteristics.Design and settingA subgroup analysis of 174 patients, aged 18–45 years with knee trauma of <6 months, allocated to MRI in a randomised controlled trial on the yield of MRI in primary care. Patients were recruited by 150 GPs in the Netherlands from October 2012 to November 2015.MethodAssociations were expressed using mean differences, odds ratio (OR) and predictive values.ResultsSixty-seven out of 174 patients (39%) had a positive MRI finding, predominantly anterior cruciate ligament (ACL) ruptures (22%) and/or traumatic meniscal tears (15%). Patients with a pre-existing musculoskeletal comorbidity had a two-fold lower prevalence of positive MRI findings (21%), OR 3.0 (95% confidence interval [CI] = 1.3 to 7.0). A ‘sports related trauma’ showed the highest OR of 4.6 (95% CI = 2.2 to 9.3) for a positive MRI finding. Clinical scores were statistically, significantly worse in patients with positive MRI findings, with mean differences ranging from 10 to 20%. Furthermore, increasing duration of complaints was correlated with decreasing prevalence rates of positive MRI findings. Overall, a popping sound and direct swelling showed the highest positive predictive value of 65% for the presence of positive MRI findings.ConclusionThe results from this study enable a preselection of patients to increase the diagnostic yield of MRI in primary care.

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Primary-to-secondary care referral experience of suspected colorectal malignancy in young adults

Annals of The Royal College of Surgeons of England ◽

10.1308/rcsann.2016.0123 ◽

2016 ◽

Vol 98 (5) ◽

pp. 308-313 ◽

Cited By ~ 2

Author(s):

K Patel ◽

T Doulias ◽

T Hoad ◽

C Lee ◽

JC Alberts

Keyword(s):

Colorectal Cancer ◽

Primary Care ◽

Abdominal Pain ◽

Secondary Care ◽

Gastrointestinal Symptoms ◽

Significant Risk ◽

District General Hospital ◽

Performance Score ◽

Colorectal Malignancy ◽

Presenting Symptoms

Introduction Colorectal cancer in patients younger than 50 years of age is increasing steadily in the UK with limited guidelines available indicating need for secondary care referral. The aims of this study were to report the cancer incidence in those aged under 50 years referred to secondary care with suspected colorectal malignancy and also to analyse the quality of those referrals. Methods A total of 197 primary care referrals made between 2008 and 2014 to a UK district general hospital for suspected colorectal malignancy were analysed. All confirmed cancers were further evaluated regarding presenting symptoms, tumour characteristics and clinical outcomes. Each referral was given a referral performance score (out of 9) dependant on relevant information documented. Results The overall malignancy rate was 9.1% (11 male and 7 female patients). The median age in this cohort was 41.5 years (interquartile range [IQR]: 37–49 years). Abdominal pain was the only presenting symptom to differ significantly when comparing malignant with non-malignant patients (44.4% vs 21.8% respectively, p=0.042). The median time period between referral date and colorectal specialist consultation was 11 days (IQR: 7–13 days) and the median referral performance score was 5 (range: 3–9). Conclusions Malignancy is prevalent in patients under 50 years of age who are referred to secondary care for suspected colorectal cancer. Those referred with abdominal pain in the presence of other high risk lower gastrointestinal symptoms are at significant risk of having a malignancy. Major deficiencies are apparent in urgent primary care referrals, highlighting the need for further national guidance to aid early diagnosis of colorectal cancer in the young.

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Diagnostic Accuracy of Point-of-Care Fecal Calprotectin and Immunochemical Occult Blood Tests for Diagnosis of Organic Bowel Disease in Primary Care: The Cost-Effectiveness of a Decision Rule for Abdominal Complaints in Primary Care (CEDAR) Study

Clinical Chemistry ◽

10.1373/clinchem.2011.177980 ◽

2012 ◽

Vol 58 (6) ◽

pp. 989-998 ◽

Cited By ~ 47

Author(s):

Liselotte Kok ◽

Sjoerd G Elias ◽

Ben J M Witteman ◽

Jelle G Goedhard ◽

Jean W M Muris ◽

...

Keyword(s):

Primary Care ◽

Diagnostic Accuracy ◽

Bowel Disease ◽

Point Of Care ◽

Occult Blood ◽

Fecal Calprotectin ◽

Lower Abdomen ◽

Predictive Values ◽

Primary Care Patients ◽

The Cost

Abstract BACKGROUND Fecal biomarker tests that differentiate between organic bowel disease (OBD) and non-OBD in primary care patients with persistent lower-abdomen complaints could reduce the number of unnecessary referrals for endoscopy. We quantified the accuracy of fecal calprotectin and immunochemical occult blood (iFOBT) point-of-care (POC) tests and a calprotectin ELISA in primary care patients with suspected OBD. METHODS We performed biomarker tests on fecal samples from 386 patients with lower-abdomen complaints suggestive for OBD. Endoscopic and histological diagnosis served as reference. RESULTS OBD was diagnosed in 99 patients (prevalence 25.9%); 19 had adenocarcinoma, 53 adenoma, and 27 inflammatory bowel disease. Sensitivity for OBD was 0.64 (95% CI 0.54–0.72) for calprotectin POC, 0.56 (0.46–0.66) for iFOBT POC, and 0.74 (0.65–0.82) for calprotectin ELISA; specificities were 0.53 (0.48–0.59), 0.83 (0.78–0.87), and 0.47 (0.41–0.53), respectively. Negative predictive values (NPVs) were 0.81 (0.74–0.86), 0.85 (0.80–0.88), and 0.84 (0.78–0.89); positive predictive values (PPVs) varied from 0.32 (0.26–0.39) and 0.33 (0.27–0.39) (calprotectin tests) to 0.53 (0.44–0.63) (iFOBT POC). Combining the 2 POC tests improved sensitivity [0.79 (0.69–0.86)] and NPV [0.87 (0.81–0.91)] but lowered specificity [0.49 (0.44–0.55)] and PPV [0.35 (0.29–0.42)]. When adenomas ≤1 cm were considered non-OBD, the NPV of all tests improved to >0.90 [combined POC tests, 0.97 (0.93–0.99)]. CONCLUSIONS Diagnostic accuracy of the tests alone or combined was insufficient when all adenomas were considered OBD. When only adenomas >1 cm were considered OBD, all tests could rule out OBD to a reasonable extent, particularly the combined POC tests. The tests were less useful for inclusion of OBD.

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Treated Colorectal Cancer: What is the Cost to Primary Care?

Clinical medicine Oncology ◽

10.4137/cmo.s877 ◽

2009 ◽

Vol 3 ◽

pp. CMO.S877

Author(s):

D.A.L. Macafee ◽

J. West ◽

J.H. Scholefield ◽

D.K. Whynes

Keyword(s):

Colorectal Cancer ◽

Primary Care ◽

Early Stage ◽

Geometric Mean ◽

Retrospective Case ◽

Total Cost ◽

Stage Disease ◽

The Cost ◽

Direct Primary ◽

Care Costs

Background Colorectal cancer is the second commonest cause of cancer death and the cost to primary care has not been estimated. Aim To determine the direct primary care costs of colorectal cancer care. Design Retrospective case note review. Setting Nottingham, United Kingdom. Methods We identified people with colorectal cancer between 1995 and 1998, from computerised pathology records. Colorectal cancer related resources consumed in primary care, from hospital discharge to death, were identified from retrospective notes review. Outcome measures were costs incurred by the General Practitioner (GP) and the total cost to primary care. We used multiple linear regression to identify predictors of cost. Results Of 416 people identified from pathology records, the median age at primary operation of the 135 (33%) people we selected was 74.2 (IQR 14.4) years, 75 (56%) were male. The median GP cost was: Dukes A £61.0 (IQR 516.2) and Dukes D £936.2 (1196.2) p < 0.01. The geometric mean ratio found Dukes D cancers to be 10 times as costly as Dukes A. The median total cost was: Dukes A £1038.3 (IQR 5090.6) and Dukes D £1815.2 (2092.5) p = 0.06. Using multivariate analysis, Dukes stage was the most important predictor of GP costs. For total costs, the presence of a permanent stoma was the most predictive variable, followed by adjuvant therapy and advanced Dukes stage (Dukes C and D). Conclusions Contrary to hospital based care costs, late stage disease (Dukes D) costs substantially more to general practice than any other stage. Stoma care products are the most costly prescribable item. Costs savings may be realised in primary care by screening detection of early stage colorectal cancers.

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Direct cost of systemic arterial hypertension and its complications in the circulatory system from the perspective of the Brazilian public health system in 2019

PLoS ONE ◽

10.1371/journal.pone.0253063 ◽

2021 ◽

Vol 16 (6) ◽

pp. e0253063

Author(s):

Daniel da Silva Pereira Curado ◽

Dalila Fernandes Gomes ◽

Thales Brendon Castano Silva ◽

Paulo Henrique Ribeiro Fernandes Almeida ◽

Noemia Urruth Leão Tavares ◽

...

Keyword(s):

Public Health ◽

Primary Care ◽

Health System ◽

Public Health System ◽

Antihypertensive Drugs ◽

Circulatory System ◽

Total Cost ◽

Systemic Arterial Hypertension ◽

Circulatory System Diseases ◽

The Cost

Introduction Systemic arterial hypertension (SAH), a global public health problem and the primary risk factor for cardiovascular diseases, has a significant financial impact on health systems. In Brazil, the prevalence of SAH is 23.7%, which caused 203,000 deaths and 3.9 million DALYs in 2015. Objective To estimate the cost of SAH and circulatory system diseases attributable to SAH from the perspective of the Brazilian public health system in 2019. Methods A prevalence-based cost-of-illness was conducted using a top-down approach. The population attributable risk (PAR) was used to estimate the proportion of circulatory system diseases attributable to SAH. The direct medical costs were obtained from official Ministry of Health of Brazil records and literature parameters, including the three levels of care (primary, secondary, and tertiary). Deterministic univariate analyses were also conducted. Results The total cost of SAH and the proportion of circulatory system diseases attributable to SAH was Int$ 581,135,374.73, varying between Int$ 501,553,022.21 and Int$ 776,183,338.06. In terms only of SAH costs at all healthcare levels (Int$ 493,776,445.89), 97.3% were incurred in primary care, especially for antihypertensive drugs provided free of charge by the Brazilian public health system (Int$ 363,888,540.14). Stroke accounted for the highest cost attributable to SAH and the third highest PAR, representing 47% of the total cost of circulatory diseases attributable to SAH. Prevalence was the parameter that most affected sensitivity analyses, accounting for 36% of all the cost variation. Conclusion Our results show that the main Brazilian strategy to combat SAH was implemented in primary care, namely access to free antihypertensive drugs and multiprofessional teams, acting jointly to promote care and prevent and control SAH.

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