Roman S, Gyawali CP, Savarino E, et al. Ambulatory reflux monitoring for diagnosis of gastro-esophageal reflux disease: Update of the Porto consensus and recommendations from an international consensus group. 2017. Supplementary materials.

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Авторы: Roman S. / Gyawali C.P. / Savarino E.V. / Yadlapati R. / Zerbib F. / Wu J. / Vela M.F. / Tutuian R. / Tatum R.P. / Sifrim D. / Keller J. / Fox M.R. / Pandolfino J.E. / Bredenoord A.J.


Ambulatory reflux monitoring for diagnosis of gastro-esophageal reflux disease: Update of the Porto consensus and recommendations from an international consensus group. 2017. 

Supplementary materials

 

Roman S, Gyawali CP, Savarino E, et al. Ambulatory reflux monitoring for diagnosis of gastro-esophageal reflux disease: Update of the Porto consensus and recommendations from an international consensus group // Neurogastroenterol Motil. 2017;29:e13067.

Methods

 For reach statement, the level of confidence was determined using the GRADE system (Atkins D, Best D, Briss PA, et al. Grading quality of evidence and strength of recommendations. BMJ 2004; 328: 1490).

Briefly, four grades are proposed and defined as follow:

  • High = Further research is unlikely to change our confidence in the estimate of effect.
  • Moderate = Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
  • Low = Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
  • Very low = Any estimate of effect is very uncertain.


To determine the grade of the level of evidence, the following criteria were applied:

1. Type of evidence

    • Randomized trial = high
    • Observational study = low
    • Any other evidence = very low
  • Decrease grade if:
    • Serious (-1) or very serious (-2) limitation to study quality
    • Important inconsistency (-1)
    • Some (-1) or major (-2) uncertainty about directness
    • Imprecise or sparse data (-1)
    • High probability of reporting bias (-1)
  • Increase grade if:
    • Strong evidence of association—significant relative risk of > 2 (< 0.5) based on consistent evidence from two or more observational studies, with no plausible confounders (+1)
    • Very strong evidence of association – significant relative risk of > 5 (< 0.2) based on direct evidence with no major threats to validity (+2)
    • Evidence of a dose response gradient (+1)
    • All plausible confounders would have reduced the effect (+1)

2. Factors that decrease quality of evidence were coded as follow:

  • Limitation: none (L0), serious (L1), very serious (L2)
  • Inconsistent results (IcR)
  • Indirect evidence: some (IE1), major (IE2)
  • Imprecise results (IpR)
  • Publication bias (PB)

3. Factors that increase quality of evidence are coded as follow:

  • Magnitude of effect: large (M1), very large (M2)
  • Dose response gradient (DR)
  • Confounders underestimated true effect (C)

Details regarding the determination of the GRADE category are reported in the tables. 

 

Table S1: Recommendations for the choice of GERD testing

Statements

Quality of evidence

Factors that decrease quality of evidence

Factors that increase quality of evidence

GRADE category

Esophageal pH impedance monitoring may be indicated for interpretation of patients with refractory symptoms despite PPI therapy, prior to and/or following anti-reflux surgery, and for symptoms of cough, frequent belching and rumination syndrome 

Low

L2; IcR; IE1; IpR; PB

M1

Low

pH impedance studies performed on PPI demonstrate a decreased frequency of acid reflux episodes, and an increase in proportion of non-acidic or weakly acidic episodes 

Low

 

M1

Moderate

Data is insufficient to suggest antireflux surgery based solely on an increase in number of reflux episodes detected by impedance 

Low

L2; IcR; IpR; PB

 

Very low

An absolute indication for wireless pH monitoring is in patients intolerant of a pH or pH impedance catheter 

Moderate

L1; IcR; IE1; IpR; PB

M1 ; C

Moderate

Wireless pH monitoring is indicated in patients with a negative catheter based pH study in a patient with ongoing symptoms, to elicit day to day variation in acid exposure and symptom association 

Moderate

L1; IE1; IpR; PB

M1; DR; C

Moderate

Reflux monitoring (catheter based pH, wireless pH, or pH impedance) should be performed off of PPI to demonstrate abnormal reflux prior to antireflux surgery 

Low

L1; IcR; IE1; IpR; PB

M2; DR; C

Very low

Reflux monitoring (catheter based pH, wireless pH, or pH impedance) should be performed off of PPI to demonstrate abnormal reflux in the setting of PPI nonresponse 

Low

L1; IcR; IE1; IpR; PB

M2; DR; C

Very low

Reflux monitoring in the form of pH impedance should be performed on PPI in settings with prior evidence for reflux (prior positive pH testing, esophagitis, BE > 1cm, peptic stricture) 

Moderate

L1; IcR; IE1; IpR; PB

 

Moderate

Pharyngeal reflux monitoring has no value to guide clinical management 

Low

L1; IcR; IE1; IpR; PB

 

Very low

Manometry with impedance is indicated to distinguish rumination from GERD related regurgitation and to distinguish reflux-cough from cough-reflux sequence

Low

L1; IE1; PB

 

Very low

 

 

Table S2: Recommendations for the analysis of pH and/or pH-impedance monitoring 

Statements

Quality of evidence

Factors that decrease quality of evidence

Factors that increase quality of evidence

GRADE category

For ambulatory reflux monitoring, the minimum duration of recording for adequate impressions should be 16 hours or more 

Low

 

 

Low

In ambulatory reflux monitoring, upright and recumbent periods should be reported separately, with exclusion of mealtimes 

Moderate

L1; IcR; IE1; IpR; PB

M1; DR; C

Moderate

Automated analysis of pH impedance studies is adequate for acid reflux events 

Low

L1; IE1; PB

 

Very low

Automated analysis overestimates non-acidic or weakly acidic events. 

Low

L1; IE1; PB

 

Very low

Manual review of the 2 minutes preceding each symptom event in pH impedance studies is necessary 

Low

L1; IE1; PB

 

Very low

Low baseline impedance makes interpretation of pH-impedance studies difficult 

Low

L0

 

Low

Baseline impedance <500 ohms might suggest an additional process, e.g. Barrett’s esophagus, a motor disorder, eosinophilic esophagitis, inflammation, fibrosis, etc 

Moderate

L0; IE1

L1; DR; C

High

 

 

Table S3: Acid exposure criteria: Thresholds for normality and abnormality using esophageal pH monitoring alone 

Statements

Quality of evidence

Factors that decrease quality of evidence

Factors that increase quality of evidence

GRADE category

AET > 6% is consistently abnormal

High

L1; IcR; IE1; IpR; PB

M2 ; DR ; C

High

AET <4% is consistently normal

Moderate

L1; IcR; IE1; IpR; PB

M1 ; DR ; C

Moderate

Additional clinical and instrumental factors should be considered to establish or refute a diagnosis of GERD for AET between 4-6% 

Moderate

L1; IcR; IE1; IpR; PB

DR ; C

Moderate

AET should be reported separately for upright, recumbent, and total time 

High

L1; IcR; IE1; IpR; PB

M1 ; DR ; C

Moderate

 

 

Table S4: Reflux detection and acid exposure criteria: Thresholds for normality and abnormality using esophageal pH-impedance monitoring 

Statements

Quality of evidence

Factors that decrease quality of evidence

Factors that increase quality of evidence

GRADE category

Similar AET threshold are used for pH impedance monitoring as for pH monitoring alone 

Low

L0; IcR; IE1; IpR; PB

 

Low

The same thresholds are used when pH impedance monitoring is performed of or on PPI therapy 

Low

L1; IcR; IE1; IpR; PB

 

Low

AET > 6% is consistently abnormal 

Low

L1; IcR; IE1; IpR; PB

 

Low

AET < 4% is consistently normal 

Low

L1; IcR; IE1; IpR; PB

 

Low

The threshold for abnormal number of reflux episodes on pH impedance is 80 or more 

Low

L1; IcR; IE1; IpR; PB

 

Low

The threshold for normal number of reflux episodes on pH impedance is 40 or fewer

Low

L1; IcR; IE1; IpR; PB

 

Low

Additional clinical and instrumental factors should be considered to establish or refute a diagnosis of GERD for 40-80 reflux episodes on pH impedance

Low

L2; IcR; IE1; IpR; PB

 

Low

 

 

Table S5: Symptom reflux association 

Statements

Quality of evidence

Factors that decrease quality of evidence

Factors that increase quality of evidence

GRADE category

The most bothersome or dominant symptom being studied should be used for symptom reflux association 

Consensus/ Evidence lacking

 

 

Consensus/ Evidence lacking

Separate symptom reflux association testing for a secondary symptom is possible, but not for more than 2 symptoms 

Consensus/ Evidence lacking

 

 

Consensus/ Evidence lacking

At least 3 events per symptom must be reported for calculation of symptom-reflux association 

Consensus/ Evidence lacking

 

 

Consensus/ Evidence lacking

Symptom reflux association is reported for the entire duration of the pH or pH impedance study, and is not broken down by upright or recumbent periods 

Moderate

L0

 

Moderate

The only time window to be used for symptoms following a reflux event is 2 minutes 

Moderate

L0

 

Moderate

When pH testing is used, only pH drops below the threshold of pH 4 are used to designate reflux episodes, and drops of 1 pH unit not reaching the threshold of pH 4 do not constitute a reflux episode 

Moderate

L0

 

Moderate

When pH impedance testing is used for symptom reflux association, all reflux events detected by impedance is used in calculation of reflux episodes 

High

L0

 

High

Symptom Index (SI) and Symptom Association Probability (SAP) have value in pH and pH-impedance monitoring 

Moderate

L0

M1

High

SI and SAP are complementary and cannot be directly compared to each other 

Very low

 

 

Very low

For all reflux monitoring, the 2 minute period prior to each symptom event and 2 minute period following each reflux episode should be evaluated prior to calculating the SI 

Moderate

L0

 

Moderate

The Ghillebert Probability Estimate (GPE) can substitute the Wuesten method of calculation of SAP when necessary 

Very low

L1; IcR; IE1

 

Very low

Abnormal AET with both SAP and SI positive represents the strongest evidence for reflux 

Moderate

IE1

 

Moderate

SAP and SI both positive represents stronger symptom reflux association compared to either alone

Low

LE1; IR; IE1; IpR

 

Very low

Evaluate SI only if SAP is positive

Low

 

 

Low

There is weak predictability of PPI response with a positive symptom reflux association parameter, particularly SAP 

Moderate

L1; IE1

 

Low

If SAP and SI are both positive, the probability of PPI response is greater than if both tests are negative

Moderate

L1; IE1

 

Low

 

 

Table S6: Additional tests for diagnosis of GERD 

Statements

Quality of evidence

Factors that decrease quality of evidence

Factors that increase quality of evidence

GRADE category

Measurement of airway and pharyngeal pH cannot be recommended as a tool for the diagnosis or exclusion of GERD

High

L1; IcR; IE1; IpR,; PB

DR ; C

Moderate

Baseline mucosal impedance, particularly when measured during a swallow free period (mean nocturnal baseline impedance) may be a complementary tool to differentiate functional symptoms from reflux disease, however currently there is not enough evidence for clinical use

Moderate

L0; IE1

DR

Moderate

The post reflux swallow induced peristaltic wave index may have similar complementary value; however currently there is not enough evidence for clinical use

Low

L0

DR; C

Low

 

Roman S, Gyawali CP, Savarino E, et al. Ambulatory reflux monitoring for diagnosis of gastro-esophageal reflux disease: Update of the Porto consensus and recommendations from an international consensus group // Neurogastroenterol Motil. 2017;29:e13067.



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