scholarly journals Faecal immunochemical testing (FIT): Sources of analytical variation based on three years of routine testing in the context of DG30

Author(s):  
Tim James ◽  
Brian D Nicholson ◽  
Rhiannon Marr ◽  
Maria Paddon ◽  
James E East ◽  
...  

AbstractAimsTo determine analytical capabilities of a commonly used faecal immunochemical test (FIT) to detect haemoglobin (Hb) in the context of NICE guidance DG30, and the likely use of FIT to reprioritise patients delayed by the COVID-19 pandemic.MethodsData obtained from independent verification studies and clinical testing of the HM-JACKarc FIT method in routine primary care practice were analysed to derive analytical performance characteristics.ResultsDetection capabilities for the FIT method were 0.5 µg/g (limit of blank), 1.1 (limit of detection) and 15.0 µg/g (limit of quantification). 31 of 33 (94%) non-homogenised specimens analysed in triplicate were consistently categorised relative to 10 µg/g compared to all 33 (100%) homogenised specimens. Imprecision in non-homogenised specimens was higher (median 27.8%, (range 20.5% - 48.6%)) than in homogenised specimens (10.2%, (7.0 to 13.5%)). Considerable variation was observed in sequential clinical specimens from individual patients but no positive or negative trend in specimen degradation was observed (p=0.26).ConclusionsThe FIT method is capable of detecting Hb at concentrations well below the DG30 threshold of 10 µg/g. However, total imprecision is considerable when including sampling variation. Binary categorisation against a single defined threshold above and below 10 µg/g was more consistent and improved following specimen homogenisation. This approach may be more appropriate when reporting results for symptomatic patients tested in primary care, including those who have had definitive investigation delayed by the COVID-19 pandemic and need to be re-prioritised.Key MessagesFaecal immunochemical testing (FIT) is increasingly used to detect blood at low haemoglobin (Hb) concentrations in specimens from symptomatic primary care patients but the analytical characteristics in this context have not been fully documented.A commonly used FIT method showed good capability in a routine UK clinical setting to detect Hb at the NICE recommended threshold of 10µg/g. Imprecision estimates were considerable when sampling was considered, even above the limit of quantification of 15 µg/g.Analytical variability appears too high for reliable reporting of quantitative Hb concentrations: reporting positive or negative results around a threshold of 10µg/g appears more appropriate after sample homogenisation.Dichotomous FIT reporting is likely to be an important tool to risk stratify patients with lower GI cancer symptoms who have had their test deferred due to the COVID-19 pandemic

2019 ◽  
Vol 10 ◽  
pp. 215013271986126 ◽  
Author(s):  
Joseph A. Akambase ◽  
Nathaniel E. Miller ◽  
Gregory M. Garrison ◽  
Paul Stadem ◽  
Heather Talley ◽  
...  

Background: Depression is common in the primary care setting and tobacco use is more prevalent among individuals with depression. Recent research has linked smoking to poorer outcomes of depression treatment. We hypothesized that in adult primary care patients with the diagnosis of depression, current smoking would have a negative impact on clinical outcomes, regardless of treatment type (usual primary care [UC] vs collaborative care management [CCM]). Methods: A retrospective chart review study of 5155 adult primary care patients with depression in a primary care practice in southeast Minnesota was completed. Variables obtained included age, gender, marital status, race, smoking status, initial Patient Health Questionnaire–9 (PHQ-9), and 6-month PHQ-9. Clinical remission (CR) was defined as 6-month PHQ-9 <5. Persistent depressive symptoms (PDS) were defined as PHQ-9 ≥10 at 6 months. Treatment in both CCM and UC were compared. Results: Using intention to treat analysis, depressed smokers treated with CCM were 4.60 times as likely (95% CI 3.24-6.52, P < .001) to reach CR and were significantly less likely to have PDS at 6 months (adjusted odds ratio [AOR] 0.19, 95% CI 0.14-0.25, P < .001) compared with smokers in UC. After a 6-month follow-up, depressed smokers treated with CCM were 1.75 times as likely (95% CI 1.18-2.59, P = .006) to reach CR and were significantly less likely to have PDS (AOR 0.45, 95% CI 0.31-0.64, P < .001) compared with smokers in UC. Conclusions: CCM significantly improved depression outcomes for smokers at 6 months compared with UC. However, in the UC group, smoking outcomes were not statistically different at 6 months for either remission or PDS. Also, nonsmokers in CCM had the best clinical outcomes at 6 months in both achieving clinical remission and reduction of PDS when compared with smokers in UC as the reference group.


Author(s):  
William Sadler

Abstract When reporting concentrations of substances in biological specimens it has been virtually universal practice to suppress negative results, initially by left-censoring negative results to zero and more recently by left-censoring to values such as Limit of Blank (LoB), Limit of Detection (LoD) or even Limit of Quantification (LoQ). Negative concentrations are obviously nonsensical and current reporting practices place proper emphasis on assisting the clinician. However, it is easily overlooked that negative concentrations are merely artefacts of data reduction and while adjusting them is sensible clinical practice there are potentially adverse consequences for statistical analysis, in particular for those parametric summaries and analyses which rely on reliable estimates of low-end uncertainty. This article puts a case for the availability of negative results, describes complications with respect to estimating variance functions and discusses practical workarounds.


2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S658-S658
Author(s):  
Karen L Gilbert

Abstract Overview: An estimated 5.7 million Americans are affected by Alzheimer’s disease (AD; 2018 Alzheimer’s disease facts and figures, 2018, p. 367). Cognitive impairment fails to be identified in the primary care setting as often as 76% of the time (Moyer, 2014, p. 793). Screening can identify patients with emerging impairment who might otherwise appear cognitively intact Grober, Wakefield, Ehrlich, Mabie & Lipton, 2017, p.191). Early identification of cognitive impairment promotes evaluation of treatable causes (Possin et al., 2018, p. 150), and access to early treatment for irreversible disease, facilitating future planning (Swallow, 2017, pp. 57, 63). Methods: This quantitative study’s aim was to identify patients with occult cognitive impairment. After training staff in a Palm Beach County Florida primary care practice, the Brief Interview of Mental Status (BIMS) was administered to patients aged 45 years and older. Results: Seven of 120 screened patients, with no known AD diagnosis, scored as moderately impaired. One of these patients was 64 years of age, the remaining six ranged from age 71 to 93. Fourteen patients scored at the lowest range of “cognitively intact,” eight were under age 65. Conclusion: Cognitive screening of primary care patients with no known diagnosis of AD identified approximately 7% scoring as moderately impaired; an additional 12% scored at the lowest range of “cognitively intact,” suggesting a potentially emerging cognitive impairment warranting follow up evaluation for treatable causes, developing AD, or a related neurocognitive disorder.


2016 ◽  
Vol 2016 ◽  
pp. 1-9 ◽  
Author(s):  
Anika Thielmann ◽  
Biljana Gerasimovska-Kitanovska ◽  
Krzysztof Buczkowski ◽  
Tuomas H. Koskela ◽  
Vildan Mevsim ◽  
...  

Background.Patients use self-care to relieve symptoms of common colds, yet little is known about the prevalence and patterns across Europe.Methods/Design.In a cross-sectional study 27 primary care practices from 14 countries distributed 120 questionnaires to consecutive patients (≥18 years, any reason for consultation). A 27-item questionnaire asked for patients’ self-care for their last common cold.Results.3,074 patients from 27 European sites participated. Their mean age was 46.7 years, and 62.5% were females. 99% of the participants used ≥1 self-care practice. In total, 527 different practices were reported; the age-standardized mean was 11.5 (±SD 6.0) per participant. The most frequent self-care categories were foodstuffs (95%), extras at home (81%), preparations for intestinal absorption (81%), and intranasal applications (53%). Patterns were similar across all sites, while the number of practices varied between and within countries. The most frequent single practices were water (43%), honey (42%), paracetamol (38%), oranges/orange juice (38%), and staying in bed (38%). Participants used 9 times more nonpharmaceutical items than pharmaceutical items. The majority (69%) combined self-care with and without proof of evidence, while ≤1% used only evidence-based items.Discussion.This first cross-national study on self-care for common colds showed a similar pattern across sites but quantitative differences.


2018 ◽  
Vol 7 (1) ◽  
pp. e000066 ◽  
Author(s):  
Mark D Williams ◽  
Craig N Sawchuk ◽  
Nathan D Shippee ◽  
Kristin J Somers ◽  
Summer L Berg ◽  
...  

Primary care patients frequently present with anxiety with prevalence ratios up to 30%. Brief cognitive–behavioural therapy (CBT) has been shown in meta-analytic studies to have a strong effect size in the treatment of anxiety. However, in surveys of anxious primary care patients, nearly 80% indicated that they had not received CBT. In 2010, a model of CBT (Coordinated Anxiety Learning and Management (CALM)) adapted to primary care for adult anxiety was published based on results of a randomised controlled trial. This project aimed to integrate an adaptation of CALM into one primary care practice, using results from the published research as a benchmark with the secondary intent to spread a successful model to other practices. A quality improvement approach was used to translate the CALM model of CBT for anxiety into one primary care clinic. Plan-Do-Study-Act steps are highlighted as important steps towards our goal of comparing our outcomes with benchmarks from original research. Patients with anxiety as measured by a score of 10 or higher on the Generalized Anxiety Disorder 7 item scale (GAD-7) were offered CBT as delivered by licensed social workers with support by a PhD psychologist. Outcomes were tracked and entered into an electronic registry, which became a critical tool upon which to adapt and improve our delivery of psychotherapy to our patient population. Challenges and adaptations to the model are discussed. Our 6-month response rates on the GAD-7 were 51%, which was comparable with that of the original research (57%). Quality improvement methods were critical in discovering which adaptations were needed before spread. Among these, embedding a process of measurement and data entry and ongoing feedback to patients and therapists using this data are critical step towards sustaining and improving the delivery of CBT in primary care.


2020 ◽  
Author(s):  
Brian D Nicholson ◽  
Tim J James ◽  
Maria Paddon ◽  
Steve Justice ◽  
Jason L Oke ◽  
...  

Objective: To ascertain the diagnostic performance of faecal immunochemical test (FIT) in symptomatic primary care patients, to provide objective data on which to base referral guidelines. Design: Stool samples from routine primary care practice in Oxfordshire, UK were analysed using the HM-JACKarc FIT method between March 2017 to March 2020. Clinical details described on the test request were recorded. Patients were followed up for up-to 36 months in linked hospital records for evidence of benign and serious (colorectal cancer, high-risk adenomas and bowel inflammation) colorectal disease. The diagnostic accuracy of FIT is reported by gender, age, and FIT threshold. Results: In 9,896 adult patients with at least 6 months of follow-up, a FIT result ≥10 ug/g had an overall sensitivity for colorectal cancer of 90.5% (95% CI 84.9%-96.1%), women 90.0 (80.7-99.3), men 90.8 (83.7-97.8); overall specificity 91.3 (90.8-91.9), women 92.4 (91.8-93.1), men 89.8 (88.8-90.7); overall Positive Predictive Value (PPV) 10.1 (8.15-12.0), women 7.64 (5.24-10.0), men 12.5 (9.52-15.5)); and an overall Negative Predictive Value (NPV) 99.9 (99.8-100.0), women 99.8 (99.7-100.), men 99.9 (99.9-100.0). The PPV and specificity of FIT were higher for serious colorectal disease combined and the sensitivity and NPV were lower than for colorectal cancer alone. The Area Under the Curve (AUC) for all patients did not change substantially by increasing the minimum age of testing. In this population, 10% would be further investigated to detect 91% of the cancers at 10ug/g and 3% further investigated to detect 54% of the cancers at 150ug/g. The number needed to scope to detect one cancer at was ten using FIT at 10ug/g. Conclusion: A FIT threshold of 10ug/g is appropriate to triage adult patients presenting to primary care with symptoms of serious colorectal disease. FIT may provide an appropriate approach to reprioritising patients colorectal cancer symptoms whose tests have been delayed by the COVID-19 pandemic.


2016 ◽  
Vol 34 (7) ◽  
pp. 665-670 ◽  
Author(s):  
Christina Tieu ◽  
Rajeev Chaudhry ◽  
Darrell R. Schroeder ◽  
Frank A. Bock ◽  
Gregory J. Hanson ◽  
...  

Background: Advance care planning (ACP) is an instrumental mechanism aimed at preserving patient autonomy. Numerous interventions have been proposed to facilitate the implementation of ACP; however, rates of completed advance directives (ADs) are universally low. Patient electronic portal messaging is a newer tool in patient–provider communication which has not been studied as a method to promote ACP. In this study, we hypothesized that the use of ACP-specific patient electronic messages would increase rates of AD completion in patients aged 65 years and older in an academic primary care practice. Methods: All primary care patients, aged 65+, who had previously enrolled in a patient electronic messaging system, within an academic primary care practice, were included for randomization. Two hundred patients were randomized to receive an electronic message. The primary outcome was the proportion of patients in each group who completed an AD, 3 months after intervention. Secondary outcomes included clinical utility of the completed ADs and proportion of patients who viewed their electronic messages. Results: The intervention group completed an AD 5.5% of the time when compared to 2% in the control group (odds ratio 3.2 [1.6-6.3]). Up to 74.5% of patients opened their electronic messages. Conclusion: Among primary care patients aged 65 years and older, use of AD-specific electronic messaging statistically significantly increased the rate of AD completion, but the absolute number of completed AD remained relatively low. These data suggest that this valuable communication tool holds opportunities for further improvement. Older, frailer adults were more likely to complete an AD, and prompted directives were more likely to include a written expression of the individual’s health-care values and preference.


2021 ◽  
Vol 12 ◽  
pp. 215013272110030
Author(s):  
Megan A. O’Grady ◽  
Joseph Conigliaro ◽  
Svetlana Levak ◽  
Jeanne Morley ◽  
Sandeep Kapoor ◽  
...  

Introduction/Objectives: Despite increasing need, there are large gaps in provision of care for unhealthy alcohol use. Primary care practices have become increasingly important in providing services for unhealthy alcohol use, yet little is known about the reasons patients engage in these services and their views on acceptability of such programs. The purpose of this study was to examine primary care patients’ reasons for engagement, experiences with, and acceptability of a primary care practice-based program for treating unhealthy alcohol use. Methods: This qualitative study was conducted in a primary care practice that was developing a collaborative care model for treating unhealthy alcohol use in primary care. Semi-structured interviews were conducted with 24 primary care patients. Data were analyzed using conventional qualitative content analysis. Results: Findings suggest that patients engaged for both internal (concerns about drinking and health) and external reasons (family or provider concern). Patient experiences in the program were shaped by their affective responses (enjoyable, enlightening), as well as therapeutic benefits (gaining new insights about drinking; staff/provider support). Acceptability was driven by core program elements (medication, therapy, integration) as well as positive impacts on drinking cognition and behavior and flexible, patient-centered approaches. Conclusions: Offering flexible and comprehensive programs with mutiple elements and both abstinence and moderation goals could also improve patient engagement and views on acceptability. Primary care practices will need to be thoughtful about the resources needed to implement these programs in terms of staffing, training, and program support.


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