A standardized method for measuring intercellular spaces in esophageal biopsies in patients with suspected gastroesophageal reflux disease (the intercellular space ratio).

OBJECTIVE: Dilated intercellular space (DIS) in esophageal biopsies is regarded as a possible early sign of mucosal injury in gastroesophageal reflux disease (GERD). This study presents a standardized approach of intercellular space measurement. MATERIAL AND METHODS: Distal and proximal esophageal biopsies were taken from 19 patients with suspected GERD, and examined with TEM. A grid containing 150 line-crossing points was applied upon each photomicrograph. The number of points falling on the intercellular space was divided by the total number of points of the grid, thereby creating a ratio called the intercellular space ratio (ISR). The ISR method was validated with regard to intra- and interobserver agreement, and was compared to a widely used method for measuring intercellular space diameter developed by Tobey et al. (Tobey NA, Carson JL, Alkiek RA, Orlando RC. Dilated intercellular spaces: a morphological feature of acid reflux-damaged human esophageal epithelium. Gastroenterology 1996;111(5):1200-1205). The ISR was also compared to other markers for GERD. Results. Pearson's correlation coefficients for intra- and interobserver agreement were 0.91 (p < 0.001) and 0.82 (p < 0.001), respectively. The Pearson's correlation coefficient between the ISR and the intercellular space diameter according to Tobey et al., measured in the same micrographs, was 0.32 (p < 0.001). The proximal ISR correlated significantly with the distal ISR (Spearman's rho = 0.57, p = 0.010), and with heartburn symptom score (Spearman's rho = 0.50, p = 0.028). CONCLUSIONS: The ISR showed a high intraobserver and interobserver agreement. It also displayed good external validity when compared to other markers for gastroesophageal reflux. A rather poor correlation was however found between the ISR and the intercellular space diameter measured as described by Tobey et al.

Airway symptoms and sleeping difficulties in operated and non-operated patients with gastroesophageal reflux disease.

INTRODUCTION: Anti-reflux treatment studies have not succeeded in proving a causal relationship between gastroesophageal reflux disease (GERD), airway symptoms and sleeping difficulties. In a recent follow-up study we showed that patients operated for GERD have significantly less heartburn/acid regurgitation symptoms than matched non-operated patients. These two groups probably had different degrees of reflux over a long period of time. It is thus hypothesized that operated patients would report less airway symptoms and sleeping difficulties than comparable non-operated patients. A new follow-up study of the same patients was therefore conducted. MATERIAL AND METHODS: A total of 179 patients operated for GERD and 179 matched non-operated patients with confirmed GERD were sent the Reflux, Airway & Sleep Questionnaire (RASQ), which is a new, validated questionnaire dealing with heartburn/acid regurgitation, airway symptoms, and sleeping difficulties. Answers are given on a 7-point Likert scale and the assessment period is 1 year. RESULTS: Response rates were 68% in both groups. Operated patients reported significantly less reflux symptoms than non-operated patients (p < 0.001). Patients in the surgery group also reported less symptoms in two subscales of the RASQ dealing with airway symptoms: Laryngopharyngitis (p = 0.04) and Bronchitis (p = 0.01). There was a tendency toward less sleeplessness in operated patients, but this was not statistically significant. Snoring was less bothersome in operated patients (p = 0.02). CONCLUSIONS: Patients operated for GERD have less heartburn/acid regurgitation symptoms and less airway symptoms than non-operated patients. The findings lend support to the hypothesis of a causal relationship between gastroesophageal reflux, airway symptoms, and sleeping difficulties.

Validation of the Reflux, Airway and Sleep Questionnaire (RASQ).

BACKGROUND: Airway symptoms and sleeplessness in patients with gastroesophageal reflux disease (GERD) may be of importance. This study validates a new questionnaire dealing with such symptoms. MATERIAL AND METHODS: The Reflux, Airway and Sleep Questionnaire (RASQ) is self-administered, asks about 18 symptoms or diagnoses possibly related to GERD answered on a seven-point Likert scale and with a 1-year recall period. There are questions about heartburn/regurgitation, sleeplessness, snoring, pneumonia, and upper airway infections, as well as various bronchial and laryngeal symptoms. The study included 305 patients diagnosed with GERD (n = 65), laryngitis (n = 32), asthma (n = 30), chronic obstructive pulmonary disease (n = 45), acute bronchitis (n = 39), pneumonia (n = 42), or upper airway infection (n = 52) during the last year, and 708 matched healthy controls. Concurrent validity was based on comparisons between patients and controls. Convergent validity for sleeplessness and snoring were tested by comparing the RASQ with the Pittsburgh Sleep Quality Index (PSQI) and the Epworth Sleepiness Scale (ESS). Test-retest reliability was examined in patients with GERD with stable symptoms (n = 29). RESULTS: Response rates were 64% for patients and 55% for controls. Scores for RASQ as a total and all subscales were significantly higher in patients than in controls. Sleeplessness scores correlated significantly to the global PSQI score. Snoring correlated significantly with both the ESS and relevant aspects of the PSQI. Test-retest reliability and Cronbach's alpha were satisfactory, with coefficients ranging between 0.65-0.95 and 0.88-0.92, respectively. CONCLUSION: The RASQ appears to be well suited for measuring typical reflux symptoms as well as airway symptoms and sleep disturbances.

What causes treatment failure - the patient, primary care, secondary care or inadequate interaction in the health services?

BACKGROUND: Optimal treatment gives complete relief of symptoms of many disorders. But even if such treatment is available, some patients have persisting complaints. One disorder, from which the patients should achieve complete relief of symptoms with medical or surgical treatment, is gastroesophageal reflux disease (GERD). Despite the fact that such treatment is cheap, safe and easily available; some patients have persistent complaints after contact with the health services. This study evaluates the causes of treatment failure. METHODS: Twelve patients with GERD and persistent complaints had a semi-structured interview which focused on the patients' evaluation of treatment failure. The interviews were taped, transcribed and evaluated by 18 physicians, (six general practitioners, six gastroenterologists and six gastrointestinal surgeons) who completed a questionnaire for each patient. The questionnaires were scored, and the relative responsibility for the failure was attributed to the patient, primary care, secondary care and interaction in the health services. RESULTS: Failing interaction in the health services was the most important cause of treatment failure, followed by failure in primary care, secondary care and the patient himself; the relative responsibilities were 35%, 28%, 27% and 10% respectively. There was satisfactory agreement about the causes between doctors with different specialities, but significant inter-individual differences between the doctors. The causes of the failures differed between the patients. CONCLUSIONS: Treatment failure is a complex problem. Inadequate interaction in the health services seems to be important. Improved communication between parts of the health services and with the patients are areas of improvement.

Disease knowledge after an educational program in patients with GERD--a randomized controlled trial.

BACKGROUND: Patient education has proved beneficial in several but not all chronic disease. Inconsistent findings may rely on varying educational effects of various programs and differential effects on subgroups of patients. Patients' increase in disease knowledge may serve as a feedback to the educator on how well the education program works - but may not be associated to relevant clinical outcomes like quality of life (QoL). This study aimed to investigate the effects of a group based education program for patients with gastroesophageal reflux disease (GERD) on disease knowledge and the association between knowledge and QoL. METHODS: Patients with GERD were randomly allocated to education (102 patients) or control (109 patients). The education program was designed as a structured dialogue conveying information about pathophysiology, pharmacological and non-pharmacological treatment of GERD, patients' rights and use of healthcare. Outcomes were a 24 item knowledge test on GERD (score 0-24) 2 and 12 months after the educational program and disease specific and general QoL (Digestive symptoms and disease impact, DSIQ, and General Health Questionnaire, GHQ). RESULTS: Patients allocated to education achieved higher knowledge test scores than controls at 2 months (17.0 vs. 13.1, p<0.001) and at 12 months (17.1 vs. 14.0, p<0.001) follow-up. Knowledge test score was positively associated with having completed advanced school and inversely related to psychiatric illness and poor QoL as perceived by the patients at the time of inclusion. Overall, changes in knowledge test score were not associated with change in QoL. CONCLUSION: A group based education program for patients with GERD designed as a structured dialogue increased patients' disease knowledge, which was retained after 1 year. Changes in GERD-knowledge were not associated with change in QoL. TRIAL REGISTRATION: ClinicalTrials.gov: NCT0061850.

Recreational physical activity and cancer risk in subsites of the colon (the Nord-Trøndelag Health Study).

Physical activity may reduce colon cancer risk, but the underlying mechanisms remain unclear. Relating physical activity to cancer risk in anatomic segments of the colon may advance our understanding of possible mechanisms. We conducted a prospective study of 59,369 Norwegian men and women who were followed up for cancer incidence and mortality. Cox proportional hazards models were used to estimate multivariably adjusted hazard ratios (HR) and 95% confidence intervals (95% CI). All statistical tests were two sided. During 17 years of follow-up, 736 colon cancers and 294 rectal cancers were diagnosed. Overall, we found an inverse association between recreational physical activity and colon cancer risk, but subsite analyses showed that the association was confined to cancer in the transverse and sigmoid colon. The adjusted HR, comparing people who reported high versus no physical activity, was 0.44 (95% CI, 0.25-0.78) for cancer in the transverse colon and 0.48 (95% CI, 0.31-0.75) for cancer in the sigmoid colon. The corresponding HR for cancer mortality was 0.33 (95% CI, 0.14-0.76) for the transverse colon and 0.29 (95% CI, 0.15-0.56) for the sigmoid colon. For rectal cancer, there was no association with physical activity in these data. In conclusion, the inverse association of recreational physical activity with cancer risk and mortality in the transverse and sigmoid segments of the colon may point at increased colon motility and reduced fecal transit time as possible underlying mechanisms.

Patient education in gastro-oesophageal reflux disease: a randomized controlled trial.

OBJECTIVES: Gastro-oesophageal reflux disease (GORD) is chronic, affects 8-20% of the population, impairs quality of life (QoL) and generates substantial health-related costs. Patient education is intended to improve patients' disease-related competency, potentially enabling them to deal more efficiently with their disease, eventually improving QoL and reducing healthcare cost. This study aimed to investigate the effects of a group-based education programme for patients with mild GORD. METHODS: Patients with GORD were randomly allocated to education (n=102) or control (n=109). The education programme was designed as a structured dialogue conveying medical information about the pathophysiology and prognosis, pharmacological and nonpharmacological treatment of GORD, patients' rights and use of healthcare. Outcomes were measured using general QoL [General Health Questionnaire-30 (GHQ-30)], disease-specific QoL [Digestive Symptoms and Impact Questionnaire (DSIQ)], global QoL and healthcare use at 2 and 12 months after the educational programme. RESULTS: No statistically significant differences were found in GHQ-30, DSIQ or global QoL at 2 or 12 months' follow-up between the GORD-education group and controls. In the GORD-education group, patients who had completed primary school education only showed improved QoL at 12 months on both GHQ and DSIQ, whereas patients who had completed advanced schooling showed no change. No difference was found between the groups in their use of healthcare. CONCLUSION: A group-based education programme for patients with mild GORD showed no effect on QoL or use of healthcare. Subgroup analyses showed improved QoL only in patients with primary school education, who had been allocated to GORD education.

Digestive symptoms and their psychosocial impact: validation of a questionnaire.

OBJECTIVE: Questionnaires evaluating digestive symptoms and their psychosocial impact have not been extensively validated in Norwegian populations. In this study a self-administered questionnaire developed in Norway is evaluated for this purpose. MATERIAL AND METHODS: The questionnaire, the Digestive Symptoms and Impact Questionnaire, DSIQ, was developed by a cooperative group of general practitioners and gastroenterologists. The DSIQ contains 18 similarly structured global-type questions focusing on the patient's own judgement. The validation was based on 567 patients with dyspeptic symptoms or reflux symptoms referred to gastroscopy from general practice. RESULTS: Eighty percent of the patients responded to all the questions. All response categories were used for all questions. Factor analysis revealed 4 subscales: abdominal pain and bowel symptoms; gastric dysfunction; health impairment and impairment of everyday life. A question about reflux symptoms was retained as a subscale on its own. Overall score was established by calculating the mean of all question responses. Test-retest reliability in stable patients (intraclass correlation coefficient, range 0.80- 0.91) and internal consistency reliability (Cronbach's alpha, range 0.65-0.91) were satisfactory. Criterion validity was supported by significant correlations to patients' globally estimated quality of life and the General Health Questionnaire (GHQ-30). Responsiveness in spontaneously improved patients or patients given effective treatment ranged from moderate to highly responsive (responsiveness statistic range from 0.54 to 2.83). CONCLUSIONS: The DSIQ is a self-administered, simple and well-validated method for evaluating digestive symptoms and their psychosocial impact. The DSIQ shows satisfactory internal consistency reliability, test-retest reliability, responsiveness and criterion validity.

Long-term outcome of surgically and medically treated patients with gastroesophageal reflux disease: a matched-pair follow-up study.

OBJECTIVE: A recent randomized study has shown that the long-term effects of continuous medical treatment of gastroesophageal reflux disease (GERD) with a proton-pump inhibitor are comparable to those of open fundoplication. We compared the long-term effects of anti-reflux surgery with those of medical care according to clinical practice. MATERIAL AND METHODS: This is a questionnaire-based 3-10 years follow-up study of 373 patients with GERD operated on in two hospitals with either open or laparoscopic fundoplication, and pair-matched non-operated controls treated medically according to clinical practice. The controls were matched for hospital, age, sex, follow-up time, degree of esophagitis, presence of hiatus hernia and Barrett's esophagus. The questionnaires used for symptoms and health-related quality of life (QoL) were the Gastrointestinal Symptoms Rating Scale and the Psychological General Well-Being Index, respectively. RESULTS: Response rates were about 80%, and 179 pairs of operated patients and controls remained for analysis (102 based on laparoscopic and 77 on open fundoplication). Independently of the surgical technique, the operated patients suffered at the follow-up from significantly (p <0.001) fewer reflux symptoms than the non-operated controls, the mean scores being 1.34 and 2.51, respectively. The operated patients suffered from slightly more symptoms of indigestion (p <0.05). No consistent significant differences between the groups were found for QoL. Significant differences in QoL in favor of the operated patients were found when dealing only with the 43 pairs with no concurrent disease. CONCLUSION: The study shows that in our area anti-reflux surgery is more effective in relieving reflux symptoms than medical care according to clinical practice.

[Mutual evaluation as a method of quality assurance in hospital units]. / Gjensidig evaluering som kvalitetssikringsmetode for sykehusenheter.

BACKGROUND: Mutual visit schemes have been used in quality assurance of general practice. We have examined the effect of mutual evaluation in the quality assurance of patient care in hospital units. MATERIAL AND METHODS: Four university hospital units for medical gastroenterology received and performed one visit each. The visits were performed by one doctor and two nurses and lasted two days. The visit resulted in written reports that were first discussed locally and subsequently jointly in connection with a seminar. The evaluation was based on reported experiences, proposed improvements and surveys of patient satisfaction before and after the mutual evaluation process. A method was developed for surveying patient satisfaction with outpatient endoscopy. RESULTS AND INTERPRETATION: The mutual evaluation created enthusiasm, increased understanding and generated many proposals for improvement. Some improvement was observed in patients' satisfaction with the information given. The study suggests that mutual evaluation is a suitable method for quality assurance of patient care in hospital units.