Evidence map›Paper›PMID 28332032›Full record

ArticleThe patient2017

Qualitative Assessment of the Symptoms and Impact of Pancreatic Exocrine Insufficiency (PEI) to Inform the Development of a Patient-Reported Outcome (PRO) Instrument.

Colin D Johnson, Rob Arbuckle, Nicola Bonner, Gary Connett, Enrique Dominguez-Munoz, Philippe Levy, Doris Staab, Nicola Williamson, Markus M Lerch

2 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in The patient, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 34 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 3 pooled it
3.5field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06691893 phase3recruitingnot on this mapstarted 2025, after this paper: background citation

A Randomized Controlled Trial to Evaluate the Efficacy of Immobilized Lipase (RELiZORB) During Enteral Nutrition in Patients With Exocrine Pancreatic Insufficiency Secondary to Acute Pancreatitis

TypeinterventionalSponsorMassachusetts General HospitalRan2025 to 2027Enrolled60ConditionsExocrine Pancreatic Insufficiency (EPI), PancreatitisArmsRELiZORB
NCT07697352 phase3not yet recruitingnot on this mapstarted 2026, after this paper: background citation

A Randomised, Double-Blind, Non-Inferiority Trial Comparing Microbial and Porcine Pancreatic Enzyme Replacement Therapy in Chronic Pancreatitis

TypeinterventionalSponsorAsian Institute of Gastroenterology, IndiaRan2026 to 2027Enrolled134ConditionsPancreatitis, Chronic, Exocrine Pancreatic Insufficiency (EPI)ArmsDietary Supplement: Pancreatic enzyme preparation from microbial source that contains amylase (6650 DU), lipase (13000 FIP), and protease (7120 HUT, 15 SAPU, 3000 PC)., Standard of care porcine pancreatic enzyme preparation: amylase (8000 U), lipase (25000 U), and protease (1000 U)
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 3 syntheses or guidelines pooled it, 62 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Observational
  5. Review
  6. High Frequency of Pancreatic Exocrine Insufficiency Among Patients with Abdominal Pain, Bloating, and Malodorous Flatus: Hidden Pancreatic InsufficiencyThe Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2026
    Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Understanding data visualization techniques in qualitative studies used to develop and validate patient-reported outcome measures: a targeted literature review.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2025
    Review
  15. Article
  16. Article
  17. Article
  18. Validity and Diagnostic Ability of Pancreatic Exocrine Insufficiency Questionnaire in Turkish Patients.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2024
    Article
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 7 institutions in 4 countries.

Colin D JohnsonDepartment of Surgery, University of Southampton and University Hospital Southampton NHS Foundation Trust, Tremona Road, Southampton, Hampshire, SO16 6YD, UK.
Rob ArbucklePatient-Centered Outcomes, Adelphi Values, Adelphi Mill, Bollington, Cheshire, SK10 5JB, UK.
Nicola BonnerPatient-Centered Outcomes, Adelphi Values, Adelphi Mill, Bollington, Cheshire, SK10 5JB, UK.
Gary ConnettUK National Institute for Health Research Southampton Respiratory Biomedical Research Unit, Southampton Children's Hospital and University Hospital Southampton NHS Foundation Trust, Tremona Road, Southampton, Hampshire, SO16 6YD, UK.
Enrique Dominguez-MunozDepartment of Gastroenterology, University Hospital of Santiago de Compostela, Santiago de Compostela, Spain.
Philippe LevyService de Pancréatologie-Gastroentérologie, Pôle des Maladies de l'Appareil Digestif, APHP DHU UNITY, Université Denis Diderot-Paris VII Hôpital Beaujon, 92118, Clichy Cedex, France.
Doris StaabCystic Fibrosis Department, Charité University Hospital, Augustenburger Platz 1, 13353, Berlin, Germany.
Nicola WilliamsonPatient-Centered Outcomes, Adelphi Values, Adelphi Mill, Bollington, Cheshire, SK10 5JB, UK. nicola.williamson@adelphivalues.com.
Markus M LerchDepartment of Medicine A, University Medicine Greifswald, Sauerbruchstrasse, 17489, Greifswald, Germany.
Adelphi Group (United Kingdom) · GBAssistance Publique – Hôpitaux de Paris · FRCharité - Universitätsmedizin Berlin · DEUniversidade de Santiago de Compostela · ESUniversitätsmedizin Greifswald · DEUniversity Hospital Southampton NHS Foundation Trust · GBUniversity of Southampton · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPancreatic exocrine insufficiency (PEI) affects patients with chronic pancreatitis (CP) and cystic fibrosis (CF) who produce insufficient digestive pancreatic enzymes. Common symptoms include steatorrhoea, diarrhea, and abdominal pain.

objectiveThe objective of the study was to develop and test the content validity of a patient-reported outcome (PRO) instrument assessing PEI symptoms and their impact on health-related quality of life.

methodsInstrument development was supported by a literature review, expert physician interviews (n = 10: Germany 4, UK 3, France 3), and exploratory, qualitative, concept-elicitation interviews with patients with CF and CP with PEI (n = 61: UK 29, Germany 18, France 14) and expert physicians (n = 10). Cognitive debriefing of the draft instrument was then performed with patients with PEI (n = 37: UK 24, Germany 8, France 5), and feasibility was assessed with physicians (n = 3). For all interviews, verbatim transcripts were qualitatively analysed using thematic analysis methods and Atlas.ti computerized qualitative software. All themes were data driven rather than a priori.

resultsPatient interviews elicited symptoms and impacts not reported in the literature. Six symptom concepts emerged: pain, bloating, bowel symptoms, nausea/vomiting, eating problems, and tiredness/fatigue. Six impact domains were also identified. A 45-item instrument was developed in English, French, and German for testing in cognitive debriefing patient interviews. Following cognitive debriefing, 18 items were deleted.

conclusionRigorous qualitative patient research and expert clinical input supported development of a PEI-specific PRO with the potential to aid management and monitoring of unmet needs among patients with PEI. The next step is to perform psychometric evaluation of the resulting instrument.

Indexed as

Patient Reported Outcome MeasuresQuality of LifeAdolescentAdultAgedAged, 80 and overChildCystic FibrosisEuropeExocrine Pancreatic InsufficiencyFemaleHealth StatusHumansInterviews as TopicMaleMental HealthChronic PancreatitisCognitive DebriefingCystic FibrosisExpert PhysicianPancreatic Exocrine Insufficiency

Identifiers

PMID28332032
PMCPMC5605612
OpenAlexW2603955566

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.