For your written assignment, please write 2000 words on the following topic within clinical decision-making and diagnostic theory (50%).
Please review the two assigned papers on the use of faecal elastase to diagnose chronic pancreatitis and complete the following:
- Summarize whether the studies have been carried in accordance with the STARD diagnostic accuracy framework. You do not need to include all of the points of the STARD framework for each paper but pick out areas that have been covered particularly well, those that you think have not been well described or have errors in terms of the ability to predict diagnostic accuracy. Give each paper an overall score out of 25 for how well the study was conducted in accordance with the STARD guidelines (see checklist attached).(20%)
- Based on your assessment of the two papers, do you think that the faecal elastase is a useful and accurate test to diagnose chronic pancreatitis?(10%)
- Evaluate the use of faecal elastase in current clinical practice. Is the current use in diagnostic practice supported by the evidence from studies of diagnostic accuracy?(20%)
Untitled Document STARD checklist for the reporting of studies of diagnostic accuracy. First official version, January 2003. Section and Topic Item # On page # TITLE/ABSTRACT/ KEYWORDS 1 Identify the article as a study of diagnostic accuracy (recommend MeSH heading ’sensitivity and specificity’). INTRODUCTION 2 State the research questions or study aims, such as estimating diagnostic accuracy or comparing accuracy between tests or across participant groups. METHODS Participants 3 Describe the study population: The inclusion and exclusion criteria, setting and locations where the data were collected. 4 Describe participant recruitment: Was recruitment based on presenting symptoms, results from previous tests, or the fact that the participants had received the index tests or the reference standard? 5 Describe participant sampling: Was the study population a consecutive series of participants defined by the selection criteria in items 3 and 4? If not, specify how participants were further selected. 6 Describe data collection: Was data collection planned before the index test and reference standard were performed (prospective study) or after (retrospective study)? Test methods 7 Describe the reference standard and its rationale. 8 Describe technical specifications of material and methods involved including how and when measurements were taken, and/or cite references for index tests and reference standard. 9 Describe definition of and rationale for the units, cutoffs and/or categories of the results of the index tests and the reference standard. 10 Describe the number, training and expertise of the persons executing and reading the index tests and the reference standard. 11 Describe whether or not the readers of the index tests and reference standard were blind (masked) to the results of the other test and describe any other clinical information available to the readers. Statistical methods 12 Describe methods for calculating or comparing measures of diagnostic accuracy, and the statistical methods used to quantify uncertainty (e.g. 95% confidence intervals). 13 Describe methods for calculating test reproducibility, if done. RESULTS Participants 14 Report when study was done, including beginning and ending dates of recruitment. 15 Report clinical and demographic characteristics of the study population (e.g. age, sex, spectrum of presenting symptoms, comorbidity, current treatments, recruitment centers). 16 Report the number of participants satisfying the criteria for inclusion that did or did not undergo the index tests and/or the reference standard; describe why participants failed to receive either test (a flow diagram is strongly recommended). Test results 17 Report time interval from the index tests to the reference standard, and any treatment administered between. 18 Report distribution of severity of disease (define criteria) in those with the target condition; other diagnoses in participants without the target condition. 19 Report a cross tabulation of the results of the index tests (including indeterminate and missing results) by the results of the reference standard; for continuous results, the distribution of the test results by the results of the reference standard. 20 Report any adverse events from performing the index tests or the reference standard. Estimates 21 Report estimates of diagnostic accuracy and measures of statistical uncertainty (e.g. 95% confidence intervals). 22 Report how indeterminate results, missing responses and outliers of the index tests were handled. 23 Report estimates of variability of diagnostic accuracy between subgroups of participants, readers or centers, if done. 24 Report estimates of test reproducibility, if done. DISCUSSION 25 Discuss the clinical applicability of the study findings. Faecal elastase 1: not helpful in diagnosing chronic pancreatitis associated with mild to moderate exocrine pancreatic insuYciency P G Lankisch, I Schmidt, H König, D Lehnick, R Knollmann, M Löhr, S Liebe Abstract Background/Aim—The suggestion that estimation of faecal elastase 1 is a valuable new tubeless pancreatic function test was evaluated by comparing it with faecal chy- motrypsin estimation in patients catego- rised according to grades of exocrine pancreatic insuYciency (EPI) based on the gold standard tests, the secretin- pancreozymin test (SPT) and faecal fat analysis. Methods—In 64 patients in whom EPI was suspected, the following tests were per- formed: SPT, faecal fat analysis, faecal chymotrypsin estimation, faecal elastase 1 estimation. EPI was graded according to the results of the SPT and faecal fat analysis as absent, mild, moderate, or severe. The upper limit of normal for fae- cal elastase 1 was taken as 200 µg/g, and for faecal chymotrypsin 3 U/g stool. Levels between 3 and 6 U/g stool for faecal chymotrypsin are usually considered to be suspicious for EPI. In this study, both 3 and 6 U/g stool were evaluated as the upper limit of normal. Results—Exocrine pancreatic function was normal in 34 patients, of whom 94, 91, and 79% had normal faecal elastase 1 and faecal chymotrypsin levels (<3 u/g="" and="">3><6 u/g)="" respectively.="" thirty="" patients="" had="" epi,="" of="" whom="" 53,="" 37,="" and="" 57%="" had="" abnormal="" faecal="" enzyme="" levels="" (diverences="" not="" sig-="" nificant).="" when="" epi="" was="" graded="" as="" mild,="" moderate,="" or="" severe,="" 63%="" of="" patients="" had="" mild="" to="" moderate="" epi,="" and="" 37%="" had="" severe="" epi.="" in="" the="" latter="" group,="" between="" 73="" and="" 91%="" of="" patients="" had="" abnormal="" faecal="" enzymes.="" in="" the="" group="" with="" mild="" to="" moderate="" epi,="" abnormal="" test="" results="" were="" obtained="" for="" both="" faecal="" enzymes="" in="" less="" than="" 50%="" of="" the="" patients="" (diverences="" not="" significant).="" some="" 40%="" of="" the="" patients="" had="" pancreatic="" calcifications.="" there="" were="" no="" significant="" diverences="" for="" either="" faecal="" enzyme="" between="" the="" two="" groups="" with="" and="" without="" pancreatic="" calcifications.="" in="" 62%="" of="" the="" patients="" who="" underwent="" an="" endo-="" scopic="" retrograde="" cholangiopancreatog-="" raphy="" (ercp),="" abnormal="" duct="" changes="" were="" found.="" again,="" there="" were="" no="" signifi-="" cant="" diverences="" for="" either="" faecal="" enzyme="" between="" the="" two="" groups="" with="" abnormal="" and="" normal="" ercp.="" conclusion—estimation="" of="" faecal="" elastase="" 1="" is="" not="" distinctly="" superior="" to="" the="" traditional="" faecal="" chymotrypsin="" estima-="" tion.="" the="" former="" is="" particularly="" helpful="" only="" in="" detecting="" severe="" epi,="" but="" not="" the="" mild="" to="" moderate="" form,="" which="" poses="" the="" more="" frequent="" and="" diycult="" clinical="" prob-="" lem="" and="" does="" not="" correlate="" significantly="" with="" the="" severe="" morphological="" changes="" seen="" in="" chronic="" pancreatitis.="" (gut="" 1998;42:551–554)="" keywords:="" faecal="" elastase="" 1;="" faecal="" chymotrypsin;="" secretin-pancreozymin="" test;="" faecal="" fat="" analysis;="" exocrine="" pancreatic="" insuyciency;="" diagnosis="" the="" diagnosis="" of="" chronic="" pancreatitis="" is="" usually="" based="" on="" abnormal="" results="" from="" pancreatic="" function="" tests="" and="" morphological="" examin-="" ation.1="" for="" the="" evaluation="" of="" exocrine="" pancre-="" atic="" function,="" there="" are="" both="" direct="" and="" indirect="" tests.="" the="" gold="" standard="" is="" the="" secretin-="" pancreozymin="" test="" (spt)="" or="" one="" of="" its="" modifi-="" cations.="" however,="" these="" can="" only="" be="" carried="" out="" at="" qualified="" gastroenterological="" centres="" since="" the="" test="" is="" time="" consuming,="" invasive,="" and="" expensive.2="" 3="" therefore="" a="" number="" of="" indirect="" tests="" of="" pancreatic="" function="" that="" measure="" pancreatic="" enzymes="" in="" serum,="" such="" as="" pancre-="" atic="" isoamylase="" and="" immunoreactive="" trypsin,="" or="" split="" products="" in="" serum="" or="" urine,="" such="" as="" the="" nbt-paba="" test="" or="" the="" pancreolauryl="" test,="" or="" faecal="" contents="" of="" enzymes,="" such="" as="" chymo-="" trypsin,="" have="" been="" developed="" and="" evaluated="" for="" diagnosing="" exocrine="" pancreatic="" insuyciency="" (epi).="" none="" has="" become="" an="" accepted="" gold="" standard="" for="" doctors="" in="" clinical="" practice="" outside="" of="" gastroenterological="" centres.="" therefore="" the="" isolation="" of="" pancreatic="" elastase="" 1="" and="" its="" further="" characterisation="" as="" a="" human-="" and="" pancreas-="" specific="" enzyme="" that="" is="" not="" degraded="" during="" intestinal="" transport="" and="" that="" is="" enriched="" 5-="" to="" 6-fold="" in="" faeces="" compared="" with="" duodenal="" juice="" is="" of="" interest.4–6="" a="" highly="" sensitive="" enzyme="" linked="" immunosorbent="" assay="" (elisa)="" for="" human="" faecal="" and="" duodenal="" elastase="" 1="" using="" two="" specific="" monoclonal="" antibodies="" is="" commer-="" cially="" available.4–6="" preliminary="" studies7–10="" seem="" to="" indicate="" that="" faecal="" elastase="" 1="" estimation="" is="" a="" valuable="" test="" of="" pancreatic="" function="" and="" could="" become="" a="" new="" gold="" standard="" indirect="" test="" of="" pancreatic="" function.11="" the="" aim="" of="" our="" study="" was="" to="" evaluate="" faecal="" elastase="" 1="" estimations="" in="" patients="" categorised="" according="" to="" grades="" of="" epi="" based="" on="" the="" gold="" standard="" tests,="" spt="" and="" fae-="" cal="" fat="" analysis.="" furthermore,="" we="" aimed="" to="" find="" out="" whether="" this="" new="" test="" is="" really="" better="" than="" the="" traditionally="" used="" estimation="" of="" faecal="" chy-="" motrypsin.="" gut="" 1998;42:551–554="" 551="" department="" of="" internal="" medicine,="" municipal="" hospital="" of="" lüneburg,="" lüneburg,="" germany="" p="" g="" lankisch="" i="" schmidt="" h="" könig="" department="" for="" statistics="" and="" econometrics,="" university="" of="" göttingen,="" göttingen,="" germany="" d="" lehnick="" university="" of="" rostock,="" rostock,="" germany="" r="" knollmann="" m="" löhr="" s="" liebe="" correspondence="" to:="" professor="" p="" g="" lankisch,="" medizinische="" klinik,="" staedtisches="" krankenhaus,="" boegelstrasse="" 1,="" d-21339="" lueneburg,="" germany.="" accepted="" for="" publication="" 23="" september="" 1997="" http://gut.bmj.com="" methods="" exocrine="" pancreatic="" function="" was="" tested="" in="" 64="" patients="" sent="" to="" our="" department="" within="" 24="" months="" with="" suspected="" epi="" by="" means="" of="" spt,12="" 13="" quantitative="" faecal="" fat="" analysis,14="" and="" faecal="" chymotrypsin="" (boehringer-mannheim,="" mannheim,="" germany)="" and="" elastase="" 1="" (schebo-="" tech,="" d-35435="" wettenberg,="" germany)="" estima-="" tions.="" the="" latter="" three="" tests="" were="" performed="" on="" three="" stool="" samples="" collected="" over="" 24="" hours="" for="" three="" days,="" and="" mean="" values="" were="" determined.="" normal="" values="" were:="" (a)="" spt:="" after="" secretin="" administration,="" fluid="" secretion="">67 ml/30 min, bicarbonate concentration >70 mmol/l, bicar- bonate output >6.5 mmol/30 min; after cholecystokinin-pancreozymin administration, amylase output >12 000 U/30 min, lipase out- put >65 000 U/30 min, and trypsin output >30 U/30 min; (b) faecal fat <7 g/day;="" (c)="" faecal="" elastase="" 1="">200 µg/g stool; (d) faecal chymo- trypsin <3 u/g stool. since values between 3 and 6 u/g are indicative of epi, both measurements—that is, 3 and 6 u/g stool— were taken as the upper limit of normal. exocrine pancreatic function was evaluated as normal or abnormal according to the result of the spt. in the case of an abnormal test result, epi was classified as mild (reduced output of one or more enzymes; bicarbonate concentra- tion and faecal fat excretion normal), moderate (reduced enzyme output and bicarbonate con- centration; faecal fat excretion normal) or severe (reduced enzyme output and bicarbo- nate concentration plus steatorrhoea).3 13 for morphological evaluation of the pancreas, a plain abdominal x ray of the pancreatic area or an ultrasound examination of the pancreas was performed to detect pancreatic calcifications in patients with epi. in addition, an endoscopic retrograde cholangiopancreatography (ercp) was performed when indicated; the results were expressed in terms of the cambridge classification.15 16 for statistical evaluation of the test results, sensitivity and specificity rates as well as the mcnemar and the fisher’s exact tests were used. results faecal elastase 1 was abnormal in two (6%) of 34 patients with non-pancreatic disease and a normal spt, and faecal chymotrypsin was abnormal in three (9%) and seven (21%) of these patients, taking 3 and 6 u/g stool respec- tively as the upper limit of normal. thus the specificity of the elastase 1 determination was 94%, and that for chymotrypsin 91 and 79%, depending on the upper limit of normalcy (table 1; mcnemar test: p = 1 and p = 0.18, diverences not significant). faecal elastase 1 was abnormal in 16 u/g="" stool.="" since="" values="" between="" 3="" and="" 6="" u/g="" are="" indicative="" of="" epi,="" both="" measurements—that="" is,="" 3="" and="" 6="" u/g="" stool—="" were="" taken="" as="" the="" upper="" limit="" of="" normal.="" exocrine="" pancreatic="" function="" was="" evaluated="" as="" normal="" or="" abnormal="" according="" to="" the="" result="" of="" the="" spt.="" in="" the="" case="" of="" an="" abnormal="" test="" result,="" epi="" was="" classified="" as="" mild="" (reduced="" output="" of="" one="" or="" more="" enzymes;="" bicarbonate="" concentra-="" tion="" and="" faecal="" fat="" excretion="" normal),="" moderate="" (reduced="" enzyme="" output="" and="" bicarbonate="" con-="" centration;="" faecal="" fat="" excretion="" normal)="" or="" severe="" (reduced="" enzyme="" output="" and="" bicarbo-="" nate="" concentration="" plus="" steatorrhoea).3="" 13="" for="" morphological="" evaluation="" of="" the="" pancreas,="" a="" plain="" abdominal="" x="" ray="" of="" the="" pancreatic="" area="" or="" an="" ultrasound="" examination="" of="" the="" pancreas="" was="" performed="" to="" detect="" pancreatic="" calcifications="" in="" patients="" with="" epi.="" in="" addition,="" an="" endoscopic="" retrograde="" cholangiopancreatography="" (ercp)="" was="" performed="" when="" indicated;="" the="" results="" were="" expressed="" in="" terms="" of="" the="" cambridge="" classification.15="" 16="" for="" statistical="" evaluation="" of="" the="" test="" results,="" sensitivity="" and="" specificity="" rates="" as="" well="" as="" the="" mcnemar="" and="" the="" fisher’s="" exact="" tests="" were="" used.="" results="" faecal="" elastase="" 1="" was="" abnormal="" in="" two="" (6%)="" of="" 34="" patients="" with="" non-pancreatic="" disease="" and="" a="" normal="" spt,="" and="" faecal="" chymotrypsin="" was="" abnormal="" in="" three="" (9%)="" and="" seven="" (21%)="" of="" these="" patients,="" taking="" 3="" and="" 6="" u/g="" stool="" respec-="" tively="" as="" the="" upper="" limit="" of="" normal.="" thus="" the="" specificity="" of="" the="" elastase="" 1="" determination="" was="" 94%,="" and="" that="" for="" chymotrypsin="" 91="" and="" 79%,="" depending="" on="" the="" upper="" limit="" of="" normalcy="" (table="" 1;="" mcnemar="" test:="" p="1" and="" p="0.18," diverences="" not="" significant).="" faecal="" elastase="" 1="" was="" abnormal="" in="">3 u/g stool. since values between 3 and 6 u/g are indicative of epi, both measurements—that is, 3 and 6 u/g stool— were taken as the upper limit of normal. exocrine pancreatic function was evaluated as normal or abnormal according to the result of the spt. in the case of an abnormal test result, epi was classified as mild (reduced output of one or more enzymes; bicarbonate concentra- tion and faecal fat excretion normal), moderate (reduced enzyme output and bicarbonate con- centration; faecal fat excretion normal) or severe (reduced enzyme output and bicarbo- nate concentration plus steatorrhoea).3 13 for morphological evaluation of the pancreas, a plain abdominal x ray of the pancreatic area or an ultrasound examination of the pancreas was performed to detect pancreatic calcifications in patients with epi. in addition, an endoscopic retrograde cholangiopancreatography (ercp) was performed when indicated; the results were expressed in terms of the cambridge classification.15 16 for statistical evaluation of the test results, sensitivity and specificity rates as well as the mcnemar and the fisher’s exact tests were used. results faecal elastase 1 was abnormal in two (6%) of 34 patients with non-pancreatic disease and a normal spt, and faecal chymotrypsin was abnormal in three (9%) and seven (21%) of these patients, taking 3 and 6 u/g stool respec- tively as the upper limit of normal. thus the specificity of the elastase 1 determination was 94%, and that for chymotrypsin 91 and 79%, depending on the upper limit of normalcy (table 1; mcnemar test: p = 1 and p = 0.18, diverences not significant). faecal elastase 1 was abnormal in 16>7>6>