Systematic review: symptom assessment using patient-reported outcomes in gastroesophageal reflux disease and dyspepsia

Chassany, Olivier; Shaheen, Nicholas J.; Karlsson, Maria; Hughes, Nesta; Rydén, Anna

doi:10.3109/00365521.2012.712999

Cited by 12 publications

(9 citation statements)

References 47 publications

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“…In its guidance for industry, the US Food and Drug Administration recommends that questionnaires generally use short recall periods or ask patients to describe their current or recent state [5]. Asking patients to think back over a long period can reduce the accuracy of recall for all but the most memorable or stressful events [6], and may also make it more likely that the response is influenced by the patients' current state [7].…”

Section: Introductionmentioning

confidence: 99%

“…PRO instruments for evaluating GERD symptoms are used to measure symptom intensity and frequency in clinical trial settings, and are valuable tools when assessing symptoms and deciding on disease management in primary care [6]. When asking patients to recall their GERD symptoms, the duration of the recall period used may be influenced by practical considerations.…”

Section: Introductionmentioning

confidence: 99%

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Comparison of Daily versus Weekly Recording of Gastroesophageal Reflux Disease Symptoms in Patients with a Partial Response to Proton Pump Inhibitor Therapy

et al. 2016

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Comparison of Daily versus Weekly Recording of Gastroesophageal Reflux Disease Symptoms in Patients with a Partial Response to Proton Pump Inhibitor Therapy

et al. 2016

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“…Similarly, this finding has been noted in prior published research. 23 , 73 , 77 , 80 To illustrate, a recent review identified 65 questionnaires in use for the assessment of symptoms and outcome measures in GERD intervention trials alone. 73 …”

Section: Discussionmentioning

confidence: 99%

Design characteristics of comparative effectiveness trials for the relief of symptomatic dyspepsia: A systematic review

Elliott

Steel

Leech

et al. 2021

Integrative Medicine Research

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Background Dyspepsia represents a symptom domain rather than a diagnostic condition and covers a wide range of complex, underlying pathophysiologies that are not well understood. The review explores comparative effectiveness interventions for the treatment of symptomatic dyspepsia along a pragmatic-explanatory continuum. The aim is to identify relevant design characteristics applicable to future upper gastrointestinal comparative effectiveness research employing integrative medicine. Methods Medline, CINAHL, Scopus, Cochrane Central Register of Controlled Trials (CENTRAL) and WHO Clinical Trials were systematically searched until January 2019. Included articles were original research with two or more comparative intervention arms for the primary outcome; relief of symptomatic dyspepsia. Evaluation of the studies was conducted using the pragmatic-explanatory continuum indicator summary (PRECIS-2) tool. Results Thirty-six articles were included in the review. A total of 68 Patient Reported Outcome Measurements (PROMs), utilizing 50 different formats were deployed across the studies. The appraisal process revealed eligibility, flexibility in adherence, flexibility in delivery and organization domains further aligned towards an explanatory design. Conclusion This review identified three design characteristics relevant for future comparative effectiveness research for the treatment of upper gastrointestinal disorders in a community setting. Extensive exclusion eligibility criteria limited the generalization of comparative effectiveness study results by removing sub-groups of the target populations more at risk of dyspeptic symptoms. The requirement for entry endoscopy was found to be common and not always pragmatically justifiable. Development of validated PROMs appropriate for a generic application to upper gastrointestinal disorders would be advantageous for future comparative effectiveness research within integrative medicine.

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“…In recent decades, there has been increasing integration of PROMs into cancer registries to collect outcomes such as overall quality of life, functional and psychosocial well-being, lifestyle behaviours and supportive care needs 45. Clinicians and patients may place different emphasis on symptom impacts and expectations from their treatment 46. The collection of PROMs is an important step in understanding patients’ experience of their symptoms and management and the impact of the disease and its treatment on their quality of life.…”

Section: Strengths and Limitationsmentioning

confidence: 99%

The Upper Gastrointestinal Cancer Registry (UGICR): a clinical quality registry to monitor and improve care in upper gastrointestinal cancers

et al. 2019

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PurposeThe Upper Gastrointestinal Cancer Registry (UGICR) was developed to monitor and improve the quality of care provided to patients with upper gastrointestinal cancers in Australia.ParticipantsIt supports four cancer modules: pancreatic, oesophagogastric, biliary and primary liver cancer. The pancreatic cancer (PC) module was the first module to be implemented, with others being established in a staged approach. Individuals are recruited to the registry if they are aged 18 years or older, have received care for their cancer at a participating public/private hospital or private clinic in Australia and do not opt out of participation.Findings to dateThe UGICR is governed by a multidisciplinary steering committee that provides clinical governance and oversees clinical working parties. The role of the working parties is to develop quality indicators based on best practice for each registry module, develop the minimum datasets and provide guidance in analysing and reporting of results. Data are captured from existing data sources (population-based cancer incidence registries, pathology databases and hospital-coded data) and manually from clinical records. Data collectors directly enter information into a secure web-based Research Electronic Data Capture (REDCap) data collection platform. The PC module began with a pilot phase, and subsequently, we used a formal modified Delphi consensus process to establish a core set of quality indicators for PC. The second module developed was the oesophagogastric cancer (OGC) module. Results of the 1 year pilot phases for PC and OGC modules are included in this cohort profile.Future plansThe UGICR will provide regular reports of risk-adjusted, benchmarked performance on a range of quality indicators that will highlight variations in care and clinical outcomes at a health service level. The registry has also been developed with the view to collect patient-reported outcomes (PROs), which will further add to our understanding of the care of patients with these cancers.

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Systematic review: symptom assessment using patient-reported outcomes in gastroesophageal reflux disease and dyspepsia

Abstract: There is considerable heterogeneity in the methodology used to develop PRO instruments for upper GI disease. Adherence to best practices in PRO development and validation may improve the quality and utility of these measures, leading to improved communication in clinical practice.

Cited by 12 publications

References 47 publications

Comparison of Daily versus Weekly Recording of Gastroesophageal Reflux Disease Symptoms in Patients with a Partial Response to Proton Pump Inhibitor Therapy

Comparison of Daily versus Weekly Recording of Gastroesophageal Reflux Disease Symptoms in Patients with a Partial Response to Proton Pump Inhibitor Therapy

Design characteristics of comparative effectiveness trials for the relief of symptomatic dyspepsia: A systematic review

The Upper Gastrointestinal Cancer Registry (UGICR): a clinical quality registry to monitor and improve care in upper gastrointestinal cancers

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