Parental experience of bedside handover during childbirth: A qualitative interview study.

BACKGROUND: It has been described that bedside reporting can contribute to patient safety and increase patient involvement in healthcare. To our knowledge, however, there is no existing research on bedside handover during labour. AIM: The aim of this study was to examine the patient's experiences of bedside handover during labour. METHOD: A qualitative design was used. Nineteen couples were interviewed after childbirth regarding their experiences of bedside handover during delivery. Twelve of those had experienced bedside handover and were, thereby, included in the study. The interviews were performed in a delivery ward in Stockholm during January 2018. The material was analysed according to content analysis. RESULTS: Four main categories emerged from the data: non-verbal communication, verbal communication, concerns, and birth experience. In general, bedside handover was perceived to be positive, the participants felt they were treated professionally, and that they had been involved during the handover. One advantage with the handover was the possibility for parents to confirm the sharing of information during the handover, which made them feel secure. Moreover, most of the parents reported they received good treatment and had a good labour experience. Parents' experiences of bedside handover and midwives' support were summarised as follows: midwives used common words and avoided using medical terminology, and they kept eye contact with the woman and her partner. CONCLUSION: Bedside handover was experienced by both parents as a way of being positively included in the care of their newborn. The caregivers were described as being attentive, respectful, and were good listeners.

Development and first validation of the COPD Assessment Test.

There is need for a validated short, simple instrument to quantify chronic obstructive pulmonary disease (COPD) impact in routine practice to aid health status assessment and communication between patient and physician. Current health-related quality of life questionnaires provide valid assessment of COPD, but are complex, which limits routine use. The aim of the present study was to develop a short validated patient-completed questionnaire, the COPD Assessment Test (CAT), assessing the impact of COPD on health status. 21 candidate items identified through qualitative research with COPD patients were used in three prospective international studies (Europe and the USA, n = 1,503). Psychometric and Rasch analyses identified eight items fitting a unidimensional model to form the CAT. Items were tested for differential functioning between countries. Internal consistency was excellent: Cronbach's alpha = 0.88. Test re-test in stable patients (n = 53) was very good (intra-class correlation coefficient 0.8). In the sample from the USA, the correlation with the COPD-specific version of the St George's Respiratory Questionnaire was r = 0.80. The difference between stable (n = 229) and exacerbation patients (n = 67) was five units of the 40-point scale (12%; p<0.0001). The CAT is a short, simple questionnaire for assessing and monitoring COPD. It has good measurement properties, is sensitive to differences in state and should provide a valid, reliable and standardised measure of COPD health status with worldwide relevance.

Expectation and experiences of childbirth in primiparae with caesarean section.

OBJECTIVE: The aim of this study was to examine the expectations and experiences in women undergoing a caesarean section on maternal request and compare these with women undergoing caesarean section with breech presentation as the indication and women who intended to have vaginal delivery acting as a control group. A second aim was to study whether assisted delivery and emergency caesarean section in the control group affected the birth experience. DESIGN: A prospective group-comparison cohort study. SETTING: Danderyd Hospital, Stockholm, Sweden. SAMPLE: First-time mothers (n= 496) were recruited to the study in week 37-39 of gestation and follow up was carried out 3 months after delivery. Comparisons were made between 'caesarean section on maternal request', 'caesarean section due to breech presentation' and 'controls planning a vaginal delivery'. METHODS: The instrument used was the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ). MAIN OUTCOME MEASURES: Expectations prior to delivery and experiences at 3 months after birth. RESULTS: Mothers requesting a caesarean section had more negative expectations of a vaginal delivery (P < 0.001) and 43.4% in this group showed a clinically significant fear of delivery. Mothers in the two groups expecting a vaginal delivery, but having an emergency caesarean section or an assisted vaginal delivery had more negative experiences of childbirth (P < 0.001). CONCLUSIONS: Women requesting caesarean section did not always suffer from clinically significant fear of childbirth. The finding that women subjected to complicated deliveries had a negative birth experience emphasises the importance of postnatal support.

New parents' experience of information and sense of security related to postnatal care: A systematic review.

BACKGROUND: Becoming a parent is often a tumultuous experience and a great challenge. The transition when a child is born is described affecting the parents and their relationship psychically, physically, mentally and emotionally. Information within care should be relevant and supportive. Furthermore information within the context of care should be relevant, supportive and helpful to parents in handling their new situation and increasing their self-reliance. AIM: To provide a contextualised understanding of how parents experience postnatal care in relation to information and sense of security". METHOD: A systematic search was undertaken at PubMed and CINAHL database for literature published between January 2002 and August 2017. Inclusion criteria focused on postnatal care. Eight of the studies used qualitative methods and two of the studies used quantitative methods, as a result the findings could not be combined using meta-analysis or meta-synthesis, instead narrative synthesis of the findings were used. RESULTS: Ten studies were included. The analysis revealed three categories related to parent's experience of information and sense of security during the postnatal period. These categories were; Expectations on the care; Own resources; and Confirmation. Support from staff and family is described as significant for the parents' sense of security. During the first postnatal week, the emotions were characterized by anxiety and/or fear. Parents prefer a "non-judgmental" attitude from the staff and to be met as an individual. CONCLUSION: Family -centred care such as continuity, participation, individually adaptation, consistent, information and preparation for parenting appear to be important components for parents' sense of security in postnatal care.

The gastro-oesophageal reflux disease impact scale: a patient management tool for primary care.

BACKGROUND: Symptoms of gastro-oesophageal reflux disease have a substantial impact on patients' everyday lives. AIM: To develop and test a short questionnaire to aid patient-doctor communication. METHODS: The Gastro-oesophageal Reflux Disease Impact Scale was developed from a systematic literature review, focus groups of patients and primary care physicians, and patient cognitive interviews. A psychometric validation study was conducted based on two consultations in new (n = 100) or chronic (n = 105) gastro-oesophageal reflux disease patients. RESULTS: The Gastro-oesophageal Reflux Disease Impact Scale demonstrated internal consistency (Cronbach's alpha ranged from 0.68 to 0.82), reproducibility (intraclass correlation coefficient in stable patients ranged from 0.61 to 0.72) and construct validity (Spearman correlations with Quality of Life in Reflux and Dyspepsia instrument and Reflux Disease Questionnaire: 0.5-0.8 in both patient groups). Effect sizes in new and chronic gastro-oesophageal reflux disease patients ranged from 0.9 to 1.5 and 0.32 to 0.42, respectively. Doctors reported altering their treatment decision based on information provided by the Gastro-oesophageal Reflux Disease Impact Scale in 35% of patients, and 77% of doctors found it to be useful. CONCLUSIONS: The Gastro-oesophageal Reflux Disease Impact Scale demonstrated good psychometric properties in newly diagnosed gastro-oesophageal reflux disease patients and those already receiving treatment. This simple communication tool is a useful aid for managing primary care patients with gastro-oesophageal reflux disease.

Symptom overlap in patients with upper gastrointestinal complaints in the Canadian confirmatory acid suppression test (CAST) study: further psychometric validation of the reflux disease questionnaire.

BACKGROUND: The reflux disease questionnaire (RDQ) is a short, patient-completed instrument. AIMS: To investigate the psychometric characteristics of the RDQ in patients with heartburn-predominant (HB) and non-heartburn predominant (NHB) dyspepsia. METHODS: HB (n = 388) and NHB (n = 733) patients were randomized to esomeprazole 40 mg daily or twice daily for 1 week, followed by 3 weeks of esomeprazole 40 mg daily. RESULTS: High factor loadings (0.78-0.86) supported the 'regurgitation' dimension of the RDQ. Overlapping factor loadings in the 'heartburn' and 'dyspepsia' dimensions suggested symptom overlap. All dimensions demonstrated high internal consistency (Cronbach's alpha: 0.79-0.90). Intra-class correlation coefficients over 4 weeks were good (0.66-0.85). The RDQ showed good responsiveness over 4 weeks of treatment, with high effect sizes (> or =0.80). Moderate or large symptom improvements were reported by 90% and 77% of HB and NHB patients, respectively, following treatment. Patients who responded to acid suppression also experienced symptom benefits in all RDQ dimensions. CONCLUSIONS: The RDQ is reliable, valid and responsive to change in HB and NHB patients. The symptom overlap is important but need not play a major role in determining treatment strategy as both patient groups benefited from proton pump inhibitor treatment.

Newborn skin temperature two days postpartum during breastfeeding related to different labour ward practices.

AIM: To investigate (1) the skin temperature pattern in newborns two days after birth in connection to breastfeeding and to examine (2) if the administration of epidural analgesia (EDA) and oxytocin (OT) infusion during labour influences this parameter at this point of time. METHOD: Forty-seven mother-infant pairs were included in the study: nine mothers had received OT stimulation during labour (OT group), 20 mothers had received an EDA and OT during labour (EDA group), while 18 mothers had received neither EDA nor OT stimulation during labour (control group). A skin temperature electrode was attached between the newborn's shoulder blades. The newborn was placed skin-to-skin on the mother's chest and covered with a blanket. The temperature was recorded immediately after the newborn was put on the mother's chest and at 5, 10, 20 and 30 min. RESULTS: The temperature measured when the newborns were put skin-to-skin on their mothers' chest was significantly higher in the infants of the EDA group (35.07 degrees C) when compared to the control group (34.19 degrees C, p=0.025). Skin temperature increased significantly (p=0.001) during the entire experimental period in the infants belonging to the control group. The same response was observed in infants whose mothers received OT intravenously during labour (p=0.008). No such rise was observed in infants whose mothers were given an EDA during labour. CONCLUSION: The results show that the skin temperature in newborns rises when newborns are put skin-to-skin to breastfeed two days postpartum. This effect on temperature may be hampered by medical interventions during labour such as EDA.

Predictors of treatment response in patients with non-erosive reflux disease.

BACKGROUND: Up to 40% of patients with non-erosive reflux disease (NERD) fail to respond to proton pump inhibitor therapy. AIM: To determine useful prognostic factors for response to and suppression in NERD. METHODS: A pooled analysis from three multicentre, double-blind trials of patients with a normal endoscopy and heartburn for 4 days or more during the 7 days prior to the start of each treatment. Patients received omeprazole 20 mg, esomeprazole 20 mg or esomeprazole 40 mg/day for 4 weeks. Complete resolution of heartburn was defined as no heartburn during the last week. RESULTS: Of 2458 patients included, complete heartburn resolution was achieved in 63% at the end of 4 weeks treatment. Response on days 5-7 provided an 85% probability of complete resolution of heartburn at 4 weeks; the probability of complete heartburn resolution at 4 weeks in those with moderate to severe symptoms on days 5-7 was 22%. Sensitivity and specificity of no heartburn on days 5-7 was 55% and 83% respectively. Patient demographics, duration of symptoms, medications used, other symptoms and body mass index were not predictors. CONCLUSION: Assessment of heartburn resolution during the first week of therapy was the best predictor of treatment success at 4 weeks in non-erosive reflux disease, but was suboptimal as a test.

Validation of a symptom diary for patients with gastro-oesophageal reflux disease.

BACKGROUND: Symptom diaries are potentially attractive but, because of concerns about patient compliance, they have had limited use in clinical trials. We assessed the validity and responsiveness of a symptom diary for patients with gastro-oesophageal reflux disease. METHODS: We included 215 patients with gastro-oesophageal reflux disease after starting treatment for 4 weeks with 40 mg esomeprazole once daily. Patients recorded whether they experienced night-time heartburn (yes/no), the severity of daytime heartburn on a scale from 1 (no heartburn) to 4 (severe heartburn) and their antacid use. Patients also completed a number of disease-specific and preference-based Health-related Quality of Life questionnaires at baseline and follow-up. RESULTS: Consistent with a priori predictions, daytime heartburn showed moderate to strong correlations with the Quality of Life in Reflux and Dyspepsia questionnaire (0.36-0.67) and four scales of symptom severity (0.36-0.70) for baseline, follow-up and change scores, but low correlations with the Standard Gamble. Responsiveness of the daytime heartburn item was excellent with a mean change from baseline to follow-up of -1.3 (95% CI -1.4 to -1.1) and a standardized response mean of 1.33 while responsiveness of the daily antacid use item was moderate (mean change scores -1.8 tablets taken, 95% CI -2.3 to -1.3 and standardized response mean of 0.64). CONCLUSIONS: The excellent psychometric properties of this simple gastro-oesophageal reflux disease diary make it an attractive measure for future trials.

Quality of life following liposuction and conservative treatment of arm lymphedema.

Arm lymphedema can produce an additional burden from a psychosocial point of view. Although edema reduction through treatment can be an advantage in terms of reduced weight of the arm and simplified clothing needs, the purpose of the present study was to register changes in psychosocial parameters during one year after treatment. Thirty-five patients underwent liposuction combined with postoperative CCT (Controlled Compression Therapy), while 14 received CCT alone. Edema volume and range of motion in the shoulder joint were measured and effects on quality of life were assessed with various questionnaires. Liposuction+CCT removed the arm lymphedema completely, whereas CCT alone reduced it by half. The treatments improved range of motion in the shoulder joint and patients' quality of life in relationship to the volume reduction. Liposuction+CCT improves patients' quality of life, particularly qualities related to the volume reduction and hence qualities associated with everyday activities. CCT is beneficial too, but the effect is less obvious than when combined with surgery, probably because the edema reduction is less. The consequences of arm lymphedema for more psychologically oriented qualities and social life in general seem to be less serious and we found few notable effects of treatment in these domains.

Quality of life in acute and maintenance treatment of non-erosive and mild erosive gastro-oesophageal reflux disease.

BACKGROUND: Quality of life has been assessed in a large, multicentre randomized, open label study. AIM: To evaluate the economic and clinical consequences of two different maintenance treatment modalities, administered to 6017 gastro-oesophageal reflux disease patients at 451 gastroenterological centres in Italy. METHODS: Adult gastro-oesophageal reflux disease patients received, at enrolment, an acute treatment of esomeprazole 40 mg/day for 4 weeks and, if successfully treated, were randomized into two maintenance treatment strategies: esomeprazole 20 mg/day or esomeprazole on demand for 6 months. A baseline endoscopy allowed the exclusion of grade II-IV oesophagitis according to Savary-Miller's classification. Burden of gastro-oesophageal reflux disease was measured at baseline by the generic questionnaire Short-Form 36 and by a disease specific instrument, quality of life in reflux and dyspepsia (QOLRAD), also administered at start and conclusion of maintenance period. Investigators were required to collect patient judgement about the degree of satisfaction with treatment effect on heartburn, with a 7-point scale. RESULTS: A comparison between Short-Form 36 scores and the normative source of the Italian general population suggested that symptomatic gastro-oesophageal reflux disease patients experience a worse quality of life than the general population. At the end of the 4-week treatment with esomeprazole 40 mg all (QOLRAD) dimensions showed a statistically significant (P < 0.0001) and clinically meaningful improvement. Satisfaction level towards treatment was reported high in the total enrolled population after acute treatment with esomeprazole 40 mg/day (96.2% satisfied and 64.4% very satisfied). A statistically significant difference in (QOLRAD) scores was registered at the end of maintenance phase in favour of the continuous regimen, nevertheless the size of this difference was very small in all dimensions; similarly, the proportion of patients very satisfied was slightly higher in the continuous treatment arm (64.5%) than in the on-demand arm (59.7%). CONCLUSIONS: Gastro-oesophageal reflux disease can significantly impair health-related quality of life and esomeprazole therapy allows immediate relief in the acute phase of the disease. Quality of life improvement was maintained during the 6-month follow-up with a slight difference in term of quality of life in reflux and dyspepsia scores and patients' satisfaction in favour of the continuous treatment strategy.

Improvement in quality of life and exercise capacity after coronary bypass surgery.

BACKGROUND: Outcome after coronary artery bypass grafting is usually evaluated by exercise stress testing. Increased exercise capacity and reduced angina pectoris have been equated with improved quality of life, but this represents a limited view. OBJECTIVE: To prospectively evaluate the effects of coronary artery bypass grafting on quality of life and exercise capacity and their interrelationship. METHODS: In a consecutive series of patients (N = 2365) who underwent coronary artery bypass grafting, we administered a questionnaire to assess quality of life before and 2 years after surgery. A standardized exercise test was performed during the year before surgery and 2 years after. A preoperative exercise test was performed by 726 patients. Among these patients, 462 completed a quality-of-life questionnaire preoperatively and 578 did so postoperatively. Preoperative and postoperative exercise tests were obtained from 362 patients. RESULTS: The improvement in quality of life was related to the severity of preoperative angina (P < .001) and female sex (P = .004) and was inversely related to preoperative exercise performance (P = .04). The improvement in exercise capacity was greater among men (P < .001) and was inversely related to preoperative exercise capacity (P < .001). CONCLUSIONS: The greatest improvement in quality of life after coronary artery bypass grafting appeared in those patients with the most impaired exercise capacity, those with the most severe angina pectoris, and women. Improvement in exercise capacity was greatest in patients with the poorest preoperative exercise capacity and in men. These findings indicate that exercise testing is of limited value as a measure of quality of life and that assessment by a questionnaire has a complementary place.

Quality of life in adults with growth hormone (GH) deficiency: response to treatment with recombinant human GH in a placebo-controlled 21-month trial.

We examined the effect of GH supplementation on the psychological capacity and sense of well-being in 36 patients with adult-onset GH deficiency (GHD). Recombinant human GH was given in a 21-month cross-over, double blind trial, and quality of life was assessed by using three self-rating questionnaires: the Hopkins Symptom Check List (HSCL), the Nottingham Health Profile (NHP), and the Psychological General Well-Being index. In addition, at the final examination the spouses completed a short questionnaire concerning their partner. Before treatment, the patients had lowered quality of life as determined by the HSCL and NHP inventories, and a correlation between the duration of GHD and the reported symptoms was observed. Upon treatment, the HSCL score was lower (better) after placebo administration (mean +/- SD, 84 +/- 21.3) than at baseline (89 +/- 18.9; P = NS) and fell to 80.2 +/- 18.5 (P < 0.001) when active drug was given. The subscales regarding anxiety, fearfulness, and cognition were the most sensitive. It was apparent that the effect determined after GH therapy in part was due to a placebo effect. With NHP, the dimensions of energy and emotions responded most to treatment. Further, the spouses observed their partners to be improved in several aspects of mood and behavior (P < 0.05 to P < 0.0001) when active drug was given. The data thus demonstrate that GH, which is known to have multiple somatic effects, produces an improvement in the quality of life of adults with GHD.

Can sensory stimulation improve the functional outcome in stroke patients?

After obtaining informed consent, we randomized 78 patients with severe hemiparesis of the left or right side within 10 days of stroke onset: 40 to a control group receiving daily physiotherapy and occupational therapy, and 38 to a group that, in addition, we treated with sensory stimulation (acupuncture) twice a week for 10 weeks. The median age was 76 years for both groups. Motor function, balance, and ADL (Barthel's Index) were assessed before the start of treatment and at 1 and 3 months after stroke onset; ADL was also assessed after 12 months. We assessed the quality of life (QL) using the Nottingham Health Profile 3, 6, and 12 months after stroke onset. Patients given sensory stimulation recovered faster and to a larger extent than the controls, with a significant difference for balance, mobility, ADL, QL, and days spent at hospitals/nursing homes. Whether acupuncture per se is responsible for the differences requires further study.

Improvement in various estimates of quality of life after coronary artery bypass grafting in patients with and without a history of hypertension.

OBJECTIVE: To describe various estimates of the quality of life (QOL) prior to and for 2 years after coronary artery bypass grafting (CABG) for patients with a history of hypertension compared with nonhypertensives. METHODS: Patients in western Sweden in whom CABG had been performed between 1988 and 1991 participated. Their QOL was estimated from the Physical Activity Score, the Nottingham Health Profile, and the Psychological General Well-being Index. RESULTS: All three questionnaires detected a significant improvement in QOL already at 3 months, which persisted at 1 and 2 years both for hypertensive and for nonhypertensive patients. With the Physical Activity Score and the Psychological General Well-being Index the improvement in QOL of hypertension patients was less marked 3 months after the operation compared with that of nonhypertensives (P < 0.05). Two years after the CABG improvement was less marked for hypertensive patients than it was for nonhypertensive patients in terms of the Physical Activity Score (P < 0.01). With the Nottingham Health Profile the improvement was similar for hypertensive and nonhypertensive patients at each evaluation after the operation. With all three measures the results indicated that hypertensive patients had a worse QOL that did nonhypertensive patients. However, in a multivariate analysis considering other risk indicators simultaneously, a history of hypertension did not appear as an independent risk indicator for an adverse QOL 2 years after CABG. CONCLUSION: There was a significant improvement in various QOL estimates after CABG both for hypertensive and for nonhypertensive patients. The degree of improvement tended to be less marked for hypertensive patients than it was for nonhypertensive patients, especially 3 months after the operation and concerning physical activities. Hypertensives had a worse QOL than did nonhypertensives. However, the differences were small and could mainly be explained in terms of factors other than hypertension.

Differences in the subjective well-being and symptoms of normotensives, borderline hypertensives and hypertensives.

In this study, previously untreated subjects were randomly recruited from a blood pressure screening programme. After repeated measurement of blood pressure levels, the subjects were divided into three major groups: normotensives (n = 95), borderline hypertensives (n = 69) and hypertensives (n = 30). Three self-administered standardized questionnaires were used to measure different aspects of subjective well-being and symptoms: the Nottingham Health Profile (NHP), the Subjective Symptoms Assessment Profile (SSAP) and the Minor Symptoms Evaluation Profile (MSEP). The results indicate gradual differences between the three groups, the most pronounced symptoms being seen among the hypertensives. Statistically significant differences were found for cardiac and gastrointestinal symptoms as well as for emotional reactions, home life, social life, sex life and sleep. The differences in well-being and subjective symptoms noted between the groups are important in the evaluation of new antihypertensive agents. Self-administered questionnaires of the type used in this study could also be valuable in identifying symptoms and disturbances in subjective well-being related to the antihypertensive medication per se.

Acute and long-term effects on myocardial ischemia of intermittent and continuous transdermal nitrate therapy in stable angina.

The aim of this study was to compare the efficacy and safety of continuous and intermittent transdermal nitrate therapy using ambulatory electrocardiographic (Holter) monitoring. Eighty-five patients with stable angina pectoris and positive exercise test results participated during their concomitant antiischemic medication in a randomized open trial lasting 12 weeks. After a 3-week run-in period with continuous therapy (10 mg/24 hours), patients were randomized to either continuous- or intermittent-therapy groups. In the intermittent-therapy group the patients removed their patch at night (the mean patch-off period was 10 hours). Forty-eight-hour Holter monitoring was performed in each patient after randomization, and again after 2 and 12 weeks. Eighteen patients withdrew, 9 in each group. A total of 11,194 hours of electrocardiography were recorded and 607 ischemic episodes were detected, of which 79% were asymptomatic and 95% appeared during daytime. The number of ischemic episodes per 48 hours with intermittent therapy was 3.1 +/- 0.7 (mean +/- SEM) after randomization, 1.8 +/- 0.4 at 2 weeks and 2.0 +/- 0.6 at 12 weeks. With continuous therapy the respective numbers were 3.8 +/- 1.1, 3.5 +/- 0.9 and 4.2 +/- 1.2. The differences were not statistically significant because a large number of patients (30%) had no ischemic episodes on Holter recording. However, when examining 47 patients with episodes during the study, the number of episodes was significantly reduced in the intermittent-therapy group (p less than 0.05 at 12 weeks). The changes in asymptomatic and symptomatic episodes were concordant. No changes and differences between the treatment groups were seen in nighttime episodes.(ABSTRACT TRUNCATED AT 250 WORDS)

Psychosocial predictors of mortality in the Cardiac Arrhythmia Suppression Trial-1 (CAST-1).

Psychosocial variables predict the recurrence of clinical events in symptomatic patients, controlling for measures of disease severity. The Cardiac Arrhythmia Suppression Trial-1, a pharmacologic test of the arrhythmia suppression and mortality hypothesis among postmyocardial infarction patients, allowed a prospective test of the relationship of distress, perceived support, social interaction, life stress, and other variables, to mortality, adjusting statistically for ejection fraction, arrhythmia rates, and other known risk factors for coronary heart disease. Results indicated that the treatment medications, encainide and flecainide, were powerful predictors of mortality. Although the psychosocial variables were significant as univariate predictors, these variables were not significant as predictors in a multivariate model that included drug treatment. When the data analysis was restricted to patients randomized to placebo, thereby eliminating the antiarrhythmic drug effect, the level of perceived social support was a significant multivariate predictor of mortality, adjusting for measures of disease severity. The adjusted hazards ratio for a 1-point decrease in the perceived support score is equal to 1.46, based on the multivariate model.

Development and validation of a disease-specific treatment satisfaction questionnaire for gastro-oesophageal reflux disease.

BACKGROUND: Currently, no disease-specific, patient-based, treatment satisfaction instruments related to gastro-oesophageal reflux disease exist. AIM: To develop and validate a treatment satisfaction questionnaire for gastro-oesophageal reflux disease (TSQ-G). METHODS: A new questionnaire was developed from patient focus groups, clinician input and literature review. A validation study was conducted in treated gastro-oesophageal reflux disease patients. Ancillary measures included the Medical Outcomes Study Short Form-36, Quality of Life in Reflux and Dyspepsia, Gastrointestinal Symptom Rating Scale, Socially Desirable Response Scale, Patient Satisfaction Questionnaire-18 and physician and patient measures of symptoms and satisfaction. Statistical analyses included exploratory factor analysis, Cronbach's alpha, intra-class correlations, analyses of variance and t-tests. RESULTS: A total of 198 gastro-oesophageal reflux disease patients participated in the study, with a mean age of 50.7 years, 68% female and 84% Caucasian. The physician-rated severity of gastro-oesophageal reflux disease was mild (32%), moderate (50%) and severe (18%); 83% were on proton pump inhibitors. The final TSQ-G consisted of 28 items with seven sub-scales; Cronbach's alpha ranged from 0.58 to 0.94. Correlations with the expected sub-scales of the ancillary measures were moderate to strong. The TSQ-G sub-scales discriminated significantly between levels of physician-rated disease severity, symptom days and patient and physician ratings of satisfaction. CONCLUSIONS: The TSQ-G has excellent reliability and construct validity and appears to be a useful tool for the evaluation of treatment satisfaction in gastro-oesophageal reflux disease patients.

The Visceral Sensitivity Index: development and validation of a gastrointestinal symptom-specific anxiety scale.

BACKGROUND: Anxiety related to gastrointestinal sensations, symptoms or the contexts in which these may occur is thought to play a significant role in the pathophysiology as well as in the health outcomes of patients with irritable bowel syndrome. AIM: To develop a valid and reliable psychometric instrument that measures gastrointestinal symptom-specific anxiety. METHODS: External and internal expert panels as well as a patient focus group evaluated a large pool of potential item stems gathered from the psychological and gastrointestinal literature. Potential scale items were then administered to 96 patients diagnosed with irritable bowel syndrome along with a set of validating questionnaires. Final item selection was based upon rigorous empirical criteria and the psychometric properties of the final scale were examined. RESULTS: A final unidimensional 15-item scale, the Visceral Sensitivity Index, demonstrated excellent reliability as well as good content, convergent, divergent and predictive validity. CONCLUSIONS: The findings suggest that the Visceral Sensitivity Index is a reliable, valid measure of gastrointestinal symptom-specific anxiety that may be useful for clinical assessment, treatment outcome studies, and mechanistic studies of the role of symptom-related anxiety in patients with irritable bowel syndrome.