Disease/Condition(s)Gallstone disea

Disease/Condition(s)
Gallstone disease

Guideline Category
Diagnosis
Evaluation
Management
Treatment
Clinical Specialty
Family Practice
Gastroenterology
Internal Medicine
Radiology
Intended Users
Advanced Practice Nurses
Nurses
Physician Assistants
Physicians
Guideline Objective(s)
To offer best practice advice on the care of adults with gallstone disease

Target Population
Adults with or suspected of having gallstone disease

Interventions and Practices Considered
Diagnosis

Liver function tests and ultrasound
Magnetic resonance cholangiopancreatography (MRCP)
Endoscopic ultrasound (EUS)
Referral for further investigation
Management

No treatment for asymptomatic gallbladder stones found in a normal gall bladder
Laparoscopic cholecystectomy for symptomatic gallbladder stones
Percutaneous cholecystostomy
Bile duct clearance
Surgically at time of laparoscopic cholecystectomy
Endoscopic retrograde cholangiopancreatography (ERCP)
Biliary stenting
Avoidance of food and drink triggers
Follow-up for new symptoms
Major Outcomes Considered
Sensitivity and specificity of diagnostic tests
Onset of new symptoms
Length of stay
Complications, such as bile duct injury
Adverse effects
Morbidity and mortality
Quality of life
Cost-effectiveness
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Methodology
Methods Used to Collect/Select the Evidence
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence
Note from the National Guideline Clearinghouse (NGC): This guideline was developed by an Internal Clinical Guidelines team on behalf of the National Institute for Health and Care Excellence (NICE). See the "Availability of Companion Documents" field for the full version of this guidance.

This guideline was developed in accordance with the process set out in 'The guidelines manual (2012)' (see the "Availability of Companion Documents" field). There is more information about how NICE clinical guidelines are developed on the NICE website. A booklet, 'How NICE clinical guidelines are developed: an overview for stakeholders, the public and the NHS' is available (see the "Availability of Companion Documents" field). In instances where the guidelines manual does not provide advice, additional methods are used and are described below.

A total of 8 review questions (1, 2, 3, 4a, 4b, 4c, 5, 6) were identified. A systematic literature was conducted for each review question. Identified references were reviewed against the inclusion and exclusion criteria as described in the review protocols. A literature search for health economic evidence was also completed for all review questions. Evidence reviews, search strategies and inclusion criteria are detailed in the full version of the guideline and the appendices.

Number of Source Documents
Clinical Literature Review

Review Question 1: One study met the eligibility criteria and was included.
Review Question 2: Overall, 23 studies met the eligibility criteria and were included in the review
Review Question 3: One prospective cohort study met the eligibility criteria and was included
Review Question 4a, 4b, 4c and 5: 47 references met the overall inclusion criteria.
Review Question 6: Five studies met the eligibility criteria and were included.
Health Economic Literature Review

Review Question 1: No health economic studies were found for Question 1.
Review Question 2: 2 health economic studies were found.
Review Question 3: No health economic studies were found for Question 3.
Review Question 4a, 4b, 4c and 5: 1 study was retained for Question 4b and 1 study was retained for Question 5.
Review Question 6: No health economic studies were found for Question 6.
See also Appendix E in the full guideline appendices (see "Availability of Companion Documents" field) for flow diagrams of clinical and health economic literature reviews, which detail the total number of studies included for each review question.

Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence
Overall Quality of Outcome Evidence in Grading of Recommendations Assessment, Development and Evaluation (GRADE)

Level Description
High Further research is very unlikely to change confidence in the estimate of effect.
Moderate Further research is likely to have an important impact on confidence in the estimate of effect and may change the estimate.
Low Further research is very likely to have an important impact on confidence in the estimate of effect and is likely to change the estimate.
Very Low Any estimate of effect is very uncertain.
Methods Used to Analyze the Evidence
Meta-Analysis
Review of Published Meta-Analyses
Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence
Note from the National Guideline Clearinghouse (NGC): This guideline was developed by an Internal Clinical Guidelines team on behalf of the National Institute for Health and Care Excellence (NICE). See the "Availability of Companion Documents" field for the full version of this guidance.

Methods for Combining Diagnostic Evidence

Meta-analysis of diagnostic test accuracy data was conducted in accordance with the process set out in the Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy.

A hierarchical, bivariate model was performed in R using MADA code (R Code Team 2012) to generate pooled estimates of sensitivity and specificity.

Methods for Combining Direct and Indirect Evidence (Network Meta-Analysis)

Conventional 'pairwise' meta-analysis involves the statistical combination of direct evidence about pairs of interventions that originate from two or more separate studies (for example, where there are two or more studies comparing A vs B).

In situations where there are more than two interventions, pairwise meta-analysis of the direct evidence alone is of limited use. This is because multiple pairwise comparisons need to be performed to analyse each pair of interventions in the evidence, and these results can be difficult to interpret. Furthermore, direct evidence about interventions of interest may not be available. For example studies may compare A vs B and B vs C, but there may be no direct evidence comparing A vs C. Network meta-analysis overcomes these problems by combining all evidence into a single, internally consistent model, synthesising data from direct and indirect comparisons, and providing estimates of relative effectiveness for all comparators and the ranking of different interventions.

The evidence in Section 4.6 in the full version of the guideline was analysed using network meta-analysis, to inform decisions about managing common bile duct stones.

Synthesis

Hierarchical Bayesian Network Meta-Analysis (NMA) was performed using WinBUGS version 1.4.3. The models used reflected the recommendations of the NICE Decision Support Unit's Technical Support Documents (TSDs) on evidence synthesis, particularly TSD 2 ('A generalised linear modelling framework for pairwise and network meta-analysis of randomised controlled trials'; see http://www.nicedsu.org.uk External Web Site Policy). The WinBUGS code provided in the appendices of TSD 2 was used without substantive alteration to specify synthesis models.

Results were reported summarising 10,000 samples from the posterior distribution of each model, having first run and discarded 50,000 'burn-in' iterations. Three separate chains with different initial values were used.

Prior Distributions

Non-informative prior distributions were used in all models. Trial-specific baselines and treatment effects were assigned N(0, 1000) priors, and the between-trial standard deviations used in random-effects models were given U(0, 5) priors. These are consistent with the recommendations in TSD 2 for dichotomous outcomes.

Choice of Reference Option

To undertake an NMA, one option in the network must be specified as a common 'reference' option. The model will estimate the effects of all other options in comparison this. The choice of reference option is mathematically arbitrary; however, it may have implications for the computational efficiency of the network and/or the interpretability of outputs. For these reasons, the option that had been compared with the highest number of the other options was chosen as the reference.

Reported Outputs

The NMA outputs shown in this guideline (see Appendix H.7.5 in the full guideline appendices [see the "Availability of Companion Documents" field]) are as follows:

Network diagram, showing the availability of evidence. In these diagrams:
Node size is proportional to the total number of participants across the evidence base that were randomised to receive the treatment in question
The width of connecting lines is proportional to the number of trial-level comparisons available.
Table of input data, showing the evidence used in the model.
Relative effect matrix, showing an estimate of effect for each intervention compared with each of its comparators. An estimate of effect based on direct evidence only (using pairwise frequentist meta-analysis with the same fixed or random-effects models as the NMA) is also presented for comparisons where data are available.
Plot of the relative effectiveness, including the results of the NMA of each intervention compared with the reference treatment (see Appendix E.2.4 in the full guideline appendices) and any direct estimate available for the same comparison.
Tabulated rank probabilities, giving the probability of each treatment being best (that is, ranked #1) and its median rank with 95% credible interval (CrI). In these outputs, higher ranking always reflects what is best for the patient (for example, higher rates of disease eradication, lower rates of adverse events, higher IQ, lower blood pressure, and so on).
Histograms demonstrating the probability of each treatment being at each possible rank ('rankograms')
Applying Grading of Recommendations Assessment, Development and Eval

ผลลัพธ์ (ไทย) 1:

โรค / เงื่อนไขโรคนิ่วประเภทผลงานการวินิจฉัยประเมินผลจัดการรักษาคลินิกพิเศษปฏิบัติครอบครัววิทยาทางเดินอาหารอายุรกรรมรังสีวิทยาผู้ใช้ที่กำหนดไว้พยาบาลปฏิบัติการขั้นสูงพยาบาลผู้ช่วยแพทย์แพทย์ผลงาน Objective(s)ให้คำแนะนำปฏิบัติที่สุดในการดูแลของผู้ใหญ่ด้วยโรคนิ่วประชากรเป้าหมายผู้ใหญ่มี หรือสงสัยมีโรคนิ่วมาตรการและแนวทางปฏิบัติในการพิจารณาการวินิจฉัยทดสอบการทำงานของตับและอัลตร้าซาวด์การสั่นพ้องแม่เหล็ก cholangiopancreatography (MRCP)อัลตร้าซาวด์ส่องกล้อง (EUS)อ้างอิงเพื่อการตรวจสอบเพิ่มเติมจัดการไม่รักษาหินแสดงอาการถุงน้ำดีในน้ำดีเป็นปกติCholecystectomy ผ่านกล้องสำหรับหินถุงน้ำดีอาการPercutaneous cholecystostomyท่อน้ำดีเคลียร์ในเวลา cholecystectomy ส่องกล้องผ่าตัดCholangiopancreatography retrograde ส่องกล้อง (ERCP)Biliary stentingหลีกเลี่ยงของทริกเกอร์ที่อาหารและเครื่องดื่มติดตามอาการอย่างใหม่พิจารณาผลลัพธ์ที่สำคัญความไวและ specificity เทคเริ่มมีอาการอาการใหม่ความยาวของภาวะแทรกซ้อน เช่นบาดเจ็บของท่อน้ำดีผลข้างเคียงMorbidity และการตายคุณภาพชีวิตประหยัดค่าใช้จ่ายกลับไปด้านบนวิธีการที่วิธีใช้เลือก/รวบรวมหลักฐานค้นหาฐานข้อมูลอิเล็กทรอนิกส์อธิบายวิธีการที่ใช้ในการเลือก/รวบรวมหลักฐานNote from the National Guideline Clearinghouse (NGC): This guideline was developed by an Internal Clinical Guidelines team on behalf of the National Institute for Health and Care Excellence (NICE). See the "Availability of Companion Documents" field for the full version of this guidance.This guideline was developed in accordance with the process set out in 'The guidelines manual (2012)' (see the "Availability of Companion Documents" field). There is more information about how NICE clinical guidelines are developed on the NICE website. A booklet, 'How NICE clinical guidelines are developed: an overview for stakeholders, the public and the NHS' is available (see the "Availability of Companion Documents" field). In instances where the guidelines manual does not provide advice, additional methods are used and are described below.A total of 8 review questions (1, 2, 3, 4a, 4b, 4c, 5, 6) were identified. A systematic literature was conducted for each review question. Identified references were reviewed against the inclusion and exclusion criteria as described in the review protocols. A literature search for health economic evidence was also completed for all review questions. Evidence reviews, search strategies and inclusion criteria are detailed in the full version of the guideline and the appendices.Number of Source DocumentsClinical Literature ReviewReview Question 1: One study met the eligibility criteria and was included.ตรวจทานคำถาม 2: โดยรวม การศึกษา 23 เกณฑ์สิทธิ และในการทบทวนตรวจทานคำถาม 3: ศึกษา cohort อนาคตหนึ่งเกณฑ์สิทธิ และถูกรวมตรวจทานคำถาม 4a, 4b, 4c และ 5:47 อ้างอิงตามเงื่อนไขการรวมโดยรวมตรวจทานคำถาม 6: 5 ศึกษาเกณฑ์สิทธิ และถูกรวมการทบทวนวรรณกรรมทางเศรษฐกิจสุขภาพคำถามทบทวน 1: การศึกษาเศรษฐกิจสุขภาพไม่พบใน 1 คำถามคำถามทบทวนที่ 2:2 สุขภาพเศรษฐกิจศึกษาพบตรวจทานคำถาม 3: การศึกษาเศรษฐกิจสุขภาพไม่พบสำหรับคำถาม 3ตรวจทานคำถาม 4a, 4b, 4c และ 5:1 ศึกษาถูกเก็บไว้สำหรับคำถาม 4b และศึกษา 1 ถูกสะสมสำหรับ 5 คำถามตรวจทานคำถาม 6: การศึกษาเศรษฐกิจสุขภาพไม่พบสำหรับ 6 คำถามดูภาคผนวก E ใน appendices ผลงานเต็ม (ให้ดูที่ฟิลด์ "พร้อมใช้งานของตัวช่วยเอกสาร") สำหรับไดอะแกรมการไหลของทางคลินิก และสุขภาพประกอบการเศรษฐกิจ ซึ่งจำนวนรวมสำหรับแต่ละคำถามทบทวนศึกษารายละเอียดวิธีที่ใช้ในการประเมินคุณภาพและความแข็งแรงของหลักฐานน้ำหนักตามแบบจัดอันดับ (แผนงานที่กำหนด)ประเมินแผนงานเพื่อความเข้มแข็งหลักฐานคุณภาพโดยรวมของพยานหลักฐานผลการจัดเกรดของคำแนะนำประเมิน พัฒนาและประเมินผล (เกรด)คำอธิบายเกี่ยวกับระดับวิจัยต่อสูงมากน่าจะเปลี่ยนความเชื่อมั่นในการประเมินผลได้วิจัยต่อปานกลางจะมีผลสำคัญต่อความมั่นใจในการประเมินผล และอาจเปลี่ยนแปลงการประเมินLow Further research is very likely to have an important impact on confidence in the estimate of effect and is likely to change the estimate.Very Low Any estimate of effect is very uncertain.Methods Used to Analyze the EvidenceMeta-AnalysisReview of Published Meta-AnalysesSystematic Review with Evidence TablesDescription of the Methods Used to Analyze the EvidenceNote from the National Guideline Clearinghouse (NGC): This guideline was developed by an Internal Clinical Guidelines team on behalf of the National Institute for Health and Care Excellence (NICE). See the "Availability of Companion Documents" field for the full version of this guidance.Methods for Combining Diagnostic EvidenceMeta-analysis of diagnostic test accuracy data was conducted in accordance with the process set out in the Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy.A hierarchical, bivariate model was performed in R using MADA code (R Code Team 2012) to generate pooled estimates of sensitivity and specificity.Methods for Combining Direct and Indirect Evidence (Network Meta-Analysis)Conventional 'pairwise' meta-analysis involves the statistical combination of direct evidence about pairs of interventions that originate from two or more separate studies (for example, where there are two or more studies comparing A vs B).In situations where there are more than two interventions, pairwise meta-analysis of the direct evidence alone is of limited use. This is because multiple pairwise comparisons need to be performed to analyse each pair of interventions in the evidence, and these results can be difficult to interpret. Furthermore, direct evidence about interventions of interest may not be available. For example studies may compare A vs B and B vs C, but there may be no direct evidence comparing A vs C. Network meta-analysis overcomes these problems by combining all evidence into a single, internally consistent model, synthesising data from direct and indirect comparisons, and providing estimates of relative effectiveness for all comparators and the ranking of different interventions.The evidence in Section 4.6 in the full version of the guideline was analysed using network meta-analysis, to inform decisions about managing common bile duct stones.SynthesisHierarchical Bayesian Network Meta-Analysis (NMA) was performed using WinBUGS version 1.4.3. The models used reflected the recommendations of the NICE Decision Support Unit's Technical Support Documents (TSDs) on evidence synthesis, particularly TSD 2 ('A generalised linear modelling framework for pairwise and network meta-analysis of randomised controlled trials'; see http://www.nicedsu.org.uk External Web Site Policy). The WinBUGS code provided in the appendices of TSD 2 was used without substantive alteration to specify synthesis models.Results were reported summarising 10,000 samples from the posterior distribution of each model, having first run and discarded 50,000 'burn-in' iterations. Three separate chains with different initial values were used.Prior DistributionsNon-informative prior distributions were used in all models. Trial-specific baselines and treatment effects were assigned N(0, 1000) priors, and the between-trial standard deviations used in random-effects models were given U(0, 5) priors. These are consistent with the recommendations in TSD 2 for dichotomous outcomes.Choice of Reference OptionTo undertake an NMA, one option in the network must be specified as a common 'reference' option. The model will estimate the effects of all other options in comparison this. The choice of reference option is mathematically arbitrary; however, it may have implications for the computational efficiency of the network and/or the interpretability of outputs. For these reasons, the option that had been compared with the highest number of the other options was chosen as the reference.Reported OutputsThe NMA outputs shown in this guideline (see Appendix H.7.5 in the full guideline appendices [see the "Availability of Companion Documents" field]) are as follows:Network diagram, showing the availability of evidence. In these diagrams:Node size is proportional to the total number of participants across the evidence base that were randomised to receive the treatment in questionThe width of connecting lines is proportional to the number of trial-level comparisons available.
Table of input data, showing the evidence used in the model.
Relative effect matrix, showing an estimate of effect for each intervention compared with each of its comparators. An estimate of effect based on direct evidence only (using pairwise frequentist meta-analysis with the same fixed or random-effects models as the NMA) is also presented for comparisons where data are available.
Plot of the relative effectiveness, including the results of the NMA of each intervention compared with the reference treatment (see Appendix E.2.4 in the full guideline appendices) and any direct estimate available for the same comparison.
Tabulated rank probabilities, giving the probability of each treatment being best (that is, ranked #1) and its median rank with 95% credible interval (CrI). In these outputs, higher ranking always reflects what is best for the patient (for example, higher rates of disease eradication, lower rates of adverse events, higher IQ, lower blood pressure, and so on).
Histograms demonstrating the probability of each treatment being at each possible rank ('rankograms')
Applying Grading of Recommendations Assessment, Development and Eval