Diagnosing GERD: GerdQ-based Algorithm vs Endoscopy
Diagnosing GERD: GerdQ-based Algorithm vs Endoscopy
Background The diagnosis of gastro-oesophageal reflux disease (GERD) remains challenging. An algorithm, facilitated by a questionnaire, may provide a more structured and cost-effective care of patients.
Aim To compare symptom control achieved with empirical therapy for GERD, in an algorithm based on the GerdQ (new structured pathway, NSP), with that of current care after endoscopy (ordinary clinical pathway, OCP).
Methods Patients with symptoms of GERD, but without alarm features, were randomised in an open, parallel-group study and followed for 4–8 weeks. In the NSP, GerdQ score was used as a basis for both diagnosis and a treatment algorithm. Patients with high likelihood of GERD were treated empirically with a PPI whereas patients with low likelihood of GERD received therapy chosen by the clinician. In the OCP, diagnosis and treatment were based on endoscopy or pH-metry findings. The statistical hypothesis was non-inferiority of NSP to OCP.
Results A total of 147 patients (86.5%) in the NSP and 133 patients (80.1%) in the OCP arm were responders. Overall, NSP was non-inferior to OCP, but not superior (P = 0.14). Patients with high likelihood of GERD had significantly better symptom relief in the NSP (P = 0.03), whereas those with low likelihood of GERD showed a numerical difference in favour of an endoscopy-based approach (OCP). NSP saved 146 € per patient.
Conclusions A symptom-based approach using GerdQ reduced health care costs without loss in efficacy. Patients with high likelihood GERD benefited from empirical treatment. An algorithm based on GerdQ may provide physicians with a tool for a more structured care of patients (ClinicalTrials.gov NCT00842387).
Gastro-oesophageal reflux disease (GERD) is a widespread disorder with a prevalence of 10–20% among adults in Western countries, when defined as at least weekly symptoms of heartburn and/or regurgitation. As a consequence of the high prevalence of GERD in the general population health care resource utilisation is substantial. Moreover, since symptoms largely affect an employed population, a considerable productivity loss is associated with GERD.
The diagnosis of GERD is difficult and both symptom evaluation and invasive investigations have some obvious limitations. Symptom evaluation by physician interview can often lead to misinterpretation as both symptom burden and symptom localisation can be difficult to determine. Invasive investigations have traditionally been used to differentiate between erosive and non-erosive GERD and to detect complications, but neither oesophagogastroduodenoscopy (OGD) nor 24-h pH-metry has the adequate sensitivity to be accepted as a diagnostic gold standard. The diagnosis is further hampered by poor correlation between symptom load and endoscopic findings. Even though reflux symptoms are strongly associated with the development of oesophageal adenocarcinoma the absolute risk of developing cancer is very low in the typical GERD patient who has no alarm features. Endoscopically, GERD also seems to show minor changes over time with progression from non-erosive to more severe reflux oesophagitis or Barrett's oesophagus in a minority of patients. Current international guidelines therefore recommend symptom-based diagnosis and therapy unless alarm symptoms such as dysphagia, weight loss or haemorrhage mandate prompt endoscopy.
Consequently, there is a need for optimising the management of GERD patients by implementing symptom-based management algorithms, preferably facilitated by a patient-completed questionnaire. Several different questionnaires have been developed to facilitate the diagnosis of GERD, but many of them lack proper validation or lack the simplicity required to be an integrated part of routine care. The GerdQ is a self-administered six-item questionnaire that was recently developed as a tool to improve and standardise symptom-based diagnosis and evaluation of treatment response in patients with GERD.
We aimed to evaluate the use of GerdQ in an algorithm to diagnose and select medical therapy, as an alternative to routinely performed OGD before initiating therapy, in patients with symptoms of GERD, but with no alarm features.
Abstract and Introduction
Abstract
Background The diagnosis of gastro-oesophageal reflux disease (GERD) remains challenging. An algorithm, facilitated by a questionnaire, may provide a more structured and cost-effective care of patients.
Aim To compare symptom control achieved with empirical therapy for GERD, in an algorithm based on the GerdQ (new structured pathway, NSP), with that of current care after endoscopy (ordinary clinical pathway, OCP).
Methods Patients with symptoms of GERD, but without alarm features, were randomised in an open, parallel-group study and followed for 4–8 weeks. In the NSP, GerdQ score was used as a basis for both diagnosis and a treatment algorithm. Patients with high likelihood of GERD were treated empirically with a PPI whereas patients with low likelihood of GERD received therapy chosen by the clinician. In the OCP, diagnosis and treatment were based on endoscopy or pH-metry findings. The statistical hypothesis was non-inferiority of NSP to OCP.
Results A total of 147 patients (86.5%) in the NSP and 133 patients (80.1%) in the OCP arm were responders. Overall, NSP was non-inferior to OCP, but not superior (P = 0.14). Patients with high likelihood of GERD had significantly better symptom relief in the NSP (P = 0.03), whereas those with low likelihood of GERD showed a numerical difference in favour of an endoscopy-based approach (OCP). NSP saved 146 € per patient.
Conclusions A symptom-based approach using GerdQ reduced health care costs without loss in efficacy. Patients with high likelihood GERD benefited from empirical treatment. An algorithm based on GerdQ may provide physicians with a tool for a more structured care of patients (ClinicalTrials.gov NCT00842387).
Introduction
Gastro-oesophageal reflux disease (GERD) is a widespread disorder with a prevalence of 10–20% among adults in Western countries, when defined as at least weekly symptoms of heartburn and/or regurgitation. As a consequence of the high prevalence of GERD in the general population health care resource utilisation is substantial. Moreover, since symptoms largely affect an employed population, a considerable productivity loss is associated with GERD.
The diagnosis of GERD is difficult and both symptom evaluation and invasive investigations have some obvious limitations. Symptom evaluation by physician interview can often lead to misinterpretation as both symptom burden and symptom localisation can be difficult to determine. Invasive investigations have traditionally been used to differentiate between erosive and non-erosive GERD and to detect complications, but neither oesophagogastroduodenoscopy (OGD) nor 24-h pH-metry has the adequate sensitivity to be accepted as a diagnostic gold standard. The diagnosis is further hampered by poor correlation between symptom load and endoscopic findings. Even though reflux symptoms are strongly associated with the development of oesophageal adenocarcinoma the absolute risk of developing cancer is very low in the typical GERD patient who has no alarm features. Endoscopically, GERD also seems to show minor changes over time with progression from non-erosive to more severe reflux oesophagitis or Barrett's oesophagus in a minority of patients. Current international guidelines therefore recommend symptom-based diagnosis and therapy unless alarm symptoms such as dysphagia, weight loss or haemorrhage mandate prompt endoscopy.
Consequently, there is a need for optimising the management of GERD patients by implementing symptom-based management algorithms, preferably facilitated by a patient-completed questionnaire. Several different questionnaires have been developed to facilitate the diagnosis of GERD, but many of them lack proper validation or lack the simplicity required to be an integrated part of routine care. The GerdQ is a self-administered six-item questionnaire that was recently developed as a tool to improve and standardise symptom-based diagnosis and evaluation of treatment response in patients with GERD.
We aimed to evaluate the use of GerdQ in an algorithm to diagnose and select medical therapy, as an alternative to routinely performed OGD before initiating therapy, in patients with symptoms of GERD, but with no alarm features.
Source...