Using a prognostic medical device for early identification of pressure ulcers: protocol for study design.

BACKGROUND: An objective, physiological measurement taken using a medical device may reduce the incidence of pressure ulcers through earlier detection of problems signs before visual signs appear. Research in this field is hampered by variations in clinical practice and patient-level confounders. AIM: The authors outline key considerations for designing a protocol for a study to assess the efficacy and safety of a prognostic medical device in reducing pressure ulcer incidence in a hospital, including comparators, randomisation, sample size, ethics and practical issues. METHOD: Key issues relating to methodology and ethics are considered alongside a theoretical protocol, which could support future researchers in wound care trials. RESULTS: A prospective, three-armed, multi-centre, stratified cluster-randomised controlled trial is proposed. The third arm is recommended as it is expected that patients will need to be moved for the medical device to be used and repositioning is a preventive strategy. A minimum of 16 200 patients in 33 wards would needed to be recruited to achieve statistical significance. Ethical considerations in terms of consent or assent need to be considered. CONCLUSION: The hypothetical study designed to evaluate the effectiveness of a diagnostic or prognostic medical device in reducing pressure ulcer incidence in secondary care, while accounting for biases, would require large sample sizes and involves risks of inter-operator and inter-device reliability, heterogeneity of users and the vague clinical interpretation of device results. Robust research in this field has the potential to influence or change policy and practice relating to the prevention of pressure ulcers in secondary care.

A complex case of dysphagia with dual aetiology.

A woman in her early 60s was referred with dysphagia and chest pain to a tertiary referral centre specialising in oesophageal disorders. Cardiac symptom origin and sinister oesophageal pathology had been excluded at her local hospital in NHS Scotland. Under multidisciplinary team oversight, reinvestigation of mucosal pathology and oesophageal motility ultimately uncovered both Type III achalasia and eosinophilic oesophagitis. This case demonstrates the benefit of including provocative testing during high-resolution manometry to reproduce relevant dysphagia and the importance of stopping proton-pump inhibitors long enough to uncover excessive eosinophils which could otherwise be masked. Ultimately, tailored management for both conditions separately was required to achieve symptoms resolution.

Assessing the diagnostic yield of achalasia using provocative testing in high-resolution esophageal manometry: Serial diagnostic study.

BACKGROUND: Chicago Classification v4.0 recommends that if achalasia is demonstrated with single water swallows (SWS); provocative testing is not required. We determine whether provocative testing in patients with suspected achalasia can change manometric findings and reproduce symptoms. METHODS: Between 2016 and 2022, 127 consecutive manometry studies of patients with achalasia were retrospectively analyzed. All patients underwent SWS, a solid meal (SM) and/or a rapid drink challenge (RDC). Demographic data, fluoroscopy, gastroscopy, and pre-and post-treatment Eckardt scores were collated. KEY RESULTS: Of 127 achalasia patients (50.6 ± 16.6 years and 54.6% male), all completed a SM and 116 (91.3%) completed RDC; overall 83 were naïve (65.4%) to previous therapy. 15.4% patients with normal integrated relaxation pressure (IRP) on SWS demonstrated obstruction with RDC. SM gave a different achalasia phenotype in 44.9% of patients (p ⟨ 0.001). Twelve patients with normal IRP during SWS had persistent/recurrent obstruction during provocative testing; 83.3% had previous achalasia therapy. None of 13 patients with Type III (TIII) achalasia with SWS exhibited a change in manometric findings with provocative testing. Impedance bolus heights were lower in patients with TIII achalasia and those with normal IRP with SWS. During the SM, symptoms were reproduced in 56.7% of patients. Forty-six of 103 patients (44.7%) underwent therapy based upon the final achalasia subtype which was defined by the provocative test result of the high-resolution manometry (HRM) study. All treatments were effective, regardless of the achalasia subtype. CONCLUSIONS AND INFERENCES: Manometric findings remain unchanged when TIII achalasia is diagnosed with SWS. In patients with normal IRP, Type I, or Type II achalasia during SWS, provocative testing can alter achalasia phenotype or uncover achalasia where diagnosis is unclear. Further, it can reproduce symptoms. Such findings can personalize and guide effective therapeutic decisions.

Esophagogastric junction contractile integral (EGJ-CI) complements reflux disease severity and provides insight into the pathophysiology of reflux disease.

BACKGROUND: Esophagogastric junction contractile integral (EGJ-CI) has not come into routine use due to methodological discrepancies and its unclear clinical utility. We aimed to determine which method of calculating EGJ-CI was best at discriminating between common reflux disease states. METHODS: High-resolution manometry (HRM) and pH-Impedance measurements were acquired for 100 patients; 25 Barrett's esophagus (>3 cm/acid exposure time (AET) > 6), 25 endoscopy-negative reflux disease (ENRD; AET >6), 25 borderline reflux (AET 4-6), 25 functional heartburn (FH; AET <4), constituting the developmental cohort. EGJ-CI was calculated at 20 mmHg, 2 mmHg, and 0 mmHg isobaric contour. Empirical associations, univariable, multivariable and ROC analyses were performed between EGJ-CI and manometric/pH-impedance metrics. A validation cohort (n = 25) was used to test the new EGJ-CI cutoff. KEY RESULTS: Significant correlations with AET were observed when EGJ-CI was calculated with an isobaric threshold of 20 mmHg (p < 0.001). Significant differences in EGJ-CI were observed between patients with FH and Barrett's esophagus (p = 0.004) and with ENRD (p = 0.01); however, LES basal pressure was unable to differentiate between these disease states (p = 0.09, p = 0.25, respectively). ROC analysis on the developmental cohort found that EGJ-CI 21.2 mmHg.cm demonstrated sensitivity 72% and specificity 72% between patients with reflux (Barrett's esophagus/ENRD) and FH. In the validation cohort, 92.8% with a low EGJ-CI had good/moderate improvement in symptoms following therapy compared to 54.5% with raised EGJ-CI (p = 0.026). CONCLUSIONS AND INFERENCES: This study re-affirms EGJ-CI as a reliable discriminator between reflux disease (Barrett's esophagus/ENRD) and FH. In borderline reflux patients, patients with a lower EGJ-CI score (<21.2 mmHg) appear to respond better to anti-reflux therapies compared to those with a higher value.

Low prevalence of positive hydrogen breath tests in patients with functional gastrointestinal conditions and hypermobile Ehlers-Danlos syndrome.

BACKGROUND: Using hydrogen breath testing (HBT) to diagnose small intestinal bacterial overgrowth (SIBO) remains controversial in patients with functional gastrointestinal (GI) disorders, and unknown in those with hypermobility Ehlers-Danlos syndrome (hEDS). We assessed prevalence of positive HBTs in these groups, evaluated the predictive value of GI symptoms and the potential role of proton pump inhibitors (PPIs) on test results. METHODS: Sequential patients referred for HBT to a tertiary unit were classified into the following groups: GI maldigestion/malabsorption, GI sensorimotor disorders, hEDS, and functional GI disorders. All underwent standardized HBT, and the yield was assessed against symptoms and PPI use. KEY RESULTS: A total of 1062 HBTs were performed over 3 years (70% female, mean age 48 ± 16 years). Overall, 7.5% (80/1062) patients had a positive HBT. Prevalence of positive HBT was highest in patients with GI maldigestion/malabsorption (17.9%; DOR 16.16, p < 0.001), GI sensorimotor disorders (15.9%; DOR 8.84, p < 0.001), compared to functional GI disorders (1.6%; DOR 1.0) (p < 0.0001). None of the hEDS patients tested positive for HBT. A positive HBT was independently associated with increased age (DOR 1.03; p < 0.001) and symptoms of diarrhea (DOR 3.95; p < 0.0001). Patients on PPIs tended towards a positive HBT than patients off PPIs (16.1% vs 6.9%; DOR 2.47; p < 0.0001). CONCLUSIONS & INFERENCES: Less than 2% of patients with functional GI disorders, and none of the patients with hEDS had a positive HBT. Pre-test probability was higher in patients with: GI structural or neurological disorders; use of long-term PPIs and symptoms of diarrhea. These criteria may be helpful in making appropriate therapeutic decisions and avoiding unnecessary hydrogen breath testing.