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

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