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.

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.

First-time mothers' wish for a planned caesarean section: deeply rooted emotions.

BACKGROUND: international estimates suggest that caesarean section on maternal request range from 4% to 18% of all caesarean section. An increasing number of surveys have investigated women's reasons for a caesarean section in the absence of a medical indication but few studies have solely studied first-time mothers motivation for this request. OBJECTIVE: to describe the underlying reasons for the desire for a caesarean section in the absence of medical indication in pregnant first-time mothers. METHOD: a qualitative descriptive study, with content analysis of interviews with 12 first-time mothers. FINDINGS: the overarching theme formulated to illustrate the central interpreted meaning of the underlying desire for a planned caesarean section was based on deeply rooted emotions'. Four categories were identified as related to the request for a caesarean section on maternal request. The categories was identified as 'always knowing that there are no other options than a caesarean section', 'caesarean section as a more controlled and safe way of having a baby', own negative experiences of health care and having problems dealing with other people's reaction about their mode of delivery. CONCLUSION: the results show that for these first-time mothers deeply rooted emotions described as stronger than fear of birth were behind their wish for a planned caesarean section.

The impact of a computer assisted learning programme on the ability to interpret cardiotochography. A before and after study.

OBJECTIVE: To evaluate if a computer assisted learning programme could bring about a higher degree of individuals who correctly classified cardiotochography (CTG) recordings in a non-selected population of midwives and physicians. STUDY DESIGN: A before and after study. SETTING: Södersjukhuset, Stockholm, Sweden. SUBJECTS: One hundred and thirty midwives and 49 physicians at the maternity unit, September 2009-April 2010. A computer assisted learning programme for interpreting CTG patterns has been created. All 179 individuals included made the first interpretation and the 135 individuals also completing the education made the second interpretation. A third randomly selected interpretation was performed immediately following the second; permitting two participants to classify a CTG together. Comparison between the before and after-test was based on the Fisher exact test. MAIN OUTCOME MEASURE: The proportion of individuals who correctly classified CTGs before and after the training. RESULTS: Sixty four percentage of the individuals classified the CTGs correctly before and 66% after the training (P=0.76). There was no difference between the two professional groups. Normal CTGs were correctly identified by 36% of the individuals before and in 80% after the training (P=0.065). Corresponding figures for pathological CTGs were 83% and 85% (P=1.00), respectively. CONCLUSION: We found no improvement in the proportion of individuals who classified CTGs correctly after the completion of a computer assisted learning programme in fetal monitoring. The baseline level of competence was higher than expected.

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.

Short- and long-term decrease of blood pressure in women during breastfeeding.

BACKGROUND AND AIMS: The benefits of breastfeeding for infants are well known. Recently data have started to emerge showing that breastfeeding may also induce positive effects in the mother. This study aimed to investigate the pattern of maternal blood pressure before, during, and after a breastfeed 2 days postpartum. Additionally, blood pressure during the following 25-week breastfeeding period was investigated. METHODS: Sixty-six primiparae with normal deliveries were consecutively recruited. Blood pressure was measured at -5, 10, 30, and 60 minutes in connection with a morning breastfeed. Thirty-three women continued to measure blood pressure before and after breastfeeding for 25 weeks. RESULTS: Blood pressure fell significantly in response to breastfeeding 2 days after birth. The fall in systolic and diastolic blood pressure amounted to 8.8 (SD = 11.00) and 7.7 (SD = 9.3) mm Hg, respectively. During the 25-week follow-up period a significant fall of basal blood pressure (systolic, df = 3, F = 7.843, p < 0.001; diastolic, df = 3, F = 5.453, p = 0.002) was observed. The total fall in systolic and diastolic blood pressure amounted to a mean of 15 (SD = 10.4) mm Hg and 10 (SD = 9.7) mm Hg, respectively. In addition, blood pressure fell significantly in response to individual breastfeeding sessions during the entire observation period. CONCLUSIONS: In conclusion, both systolic and diastolic blood pressures fall during a breastfeeding session, and pre-breastfeeding blood pressure decreases during at least the first 6 months of a breastfeeding period in a homelike environment. This study lends further support to the health-promoting effects of breastfeeding.

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.

Accounting for the effect of GERD symptoms on patients' health-related quality of life: supporting optimal disease management by primary care physicians.

AIM: To review, from a primary care physician (PCP) perspective, the use of patient-reported outcome (PRO) instruments for assessment of gastro-oesophageal reflux disease (GERD) symptoms, their impact on health-related quality of life (HRQL) and the effectiveness of therapy. RESULTS: While generic and disease-specific PRO instruments have been used in the assessment of GERD, the latter can be considered to be more appropriate as they focus only on problems relevant to the disease in question (and therefore tend to be more responsive to change). Such instruments include the Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire and the Gastrointestinal Symptom Rating Scale and the Reflux Disease Questionnaire (RDQ). Their use indicates that GERD symptoms are troublesome and significantly reduce patients' HRQL, and that effective treatment of GERD improves HRQL. The GERD Impact Scale (GIS) questionnaire, primarily developed for use within primary care, can also help to determine the impact of symptoms on patients' everyday lives and, in turn, the benefit of appropriately targeted therapy. Notably, these PRO instruments were developed from focus groups of GERD patients, and only aspects rated of highest importance are used in the final instruments. Consequently, PCPs can feel confident that these questionnaires encompass the most relevant points that they are likely to ask in terms of how symptoms affect patients' everyday lives. CONCLUSIONS: Primary care physicians are encouraged to make wider use of PRO instruments within routine practice to improve communication with their GERD patients that, in turn, could lead to improved clinical outcomes and greater patient satisfaction.

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.

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.

Long-term management of patients with symptoms of gastro-oesophageal reflux disease -- a Norwegian randomised prospective study comparing the effects of esomeprazole and ranitidine treatment strategies on health-related quality of life in a general practitioners setting.

This article reports quality of life (QoL) aspects of a study that investigated the efficacy of three treatment regimens in gastro-oesophageal reflux disease patients. Following a 4-week symptom-control phase (esomeprazole 40 mg once daily), patients were randomised to 6 months' esomeprazole 20 mg once daily continuously (n = 658), on-demand (n = 634) or ranitidine 150 mg twice daily continuously (n = 610). Esomeprazole 40 mg once daily improved QoL during the symptom-control phase. At 6 months, both esomeprazole regimens were more effective than ranitidine in all dimensions of the Quality of Life in Reflux and Dyspepsia questionnaire (p < 0.0001). Esomeprazole continuous and on-demand led to a significant improvement in symptoms (Overall Treatment Evaluation questionnaire) compared with ranitidine (continuous: 80.2%, on-demand: 77.8%, vs. ranitidine 47.0%; p < 0.001). Esomeprazole once daily continuously maintained QoL better than esomeprazole on-demand and was associated with greater patient satisfaction. In conclusion, esomeprazole 20 mg once daily continuously and on-demand were more effective than ranitidine continuously for maintaining QoL.

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.

Validación psicométrica de la traducción al español de la escala de evaluación de síntomas gastrointestinales (GSRS) y del cuestionario de calidad de vida de reflujo y dispepsia (QOLRAD) en los pacientes con enfermedad por reflujo gastroesofágico / Psychometric validation of translation to spanish of the gastrointestinal symptoms rating scale (GSRS) and quality of life in reflux and dyspepsia (QOLRAD) in patients with gastroesophageal reflux disease

Introducción. Los síntomas de pirosis y su impacto en la calidad de vida relacionada con la salud (CVRS) son con frecuencia evaluados en los ensayos clínicos. Cuando un cuestionario es traducido a un idioma diferente al que se originó es necesaria una validación lingüística, aunque no es suficiente a menos que hayan sido verificadas las características psicométricas. El objetivo del trabajo es documentar las características psicométricas de la traducción al español de la escala de evaluación de síntomas gastrointestinales (GSRS) y del cuestionario de calidad de vida de reflujo y dispepsia (QOLRAD). Material y método. Ciento cincuenta y ocho pacientes con síntomas de pirosis (edad: 51,0; DE: 16,3 años; varones: 42,4%) completaron la traducción al español de la GSRS, la versión de pirosis del QOLRAD, el Short-Form-36 (SF-36) y la escala hospitalaria de ansiedad y depresión (HAD). Setenta y seis pacientes fueron citados a una segunda visita pasada una semana para completar de nuevo la GSRS y el QOLRAD. Resultados. La fiabilidad de la consistencia interna de la GSRS fue 0,59-0,83 y la del QOLRAD 0,87-0,95, y la fiabilidad del test-retest de la GSRS fue 0,44-0,63 y del QOLRAD 0,77-0,85. La puntuación de los dominios importantes de la GSRS «reflujo», «dolor abdominal» e «indigestión» y todos los del QOLRAD se correlacionaron significativamente. El dominio «dolor abdominal» de la GSRS tuvo una fuerte correlación (negativa) con los dominios relevantes del SF-36. Los dominios del QOLRAD se correlacionaron significativamente con todos los dominios relacionados del SF-36. Conclusiones. Las características psicométricas de la traducción al español de la GSRS y del QOLRAD fueron buenas, con una fiabilidad y validez satisfactorias. Sin embargo, la fiabilidad test-retest del dominio «reflujo» de la GSRS no fue óptima

Introduction. Pyrosis symptoms and their impact on the quality of life related with health (QLRH) are frequently evaluated in clinical trials. When a questionnaire is translated into a language other than the original, it is necessary to have a linguistic validation, although this is not sufficient unless the psychometric characteristics have been verified. This study aims to document the psychometric characteristics of the translation to spanish of the gastrointestinal symptoms rating scale (GSRS) and quality of life in reflux and dyspepsia (QOLRAD). Material and method. One hundred fifty eight patients with pyrosis symptoms (age: 51.0; SD: 16.3 years; men: 42.4%) completed the translation to spanish of the GSRS, the pyrosis version of the QOLRAD, the Short-Form-36 (SF-36) and the hospital of anxiety and depression (HAD) scale. Seventy six patients were given an appointment for a second visit after one week, to fill out the GSRS and QOLRAD again. Results. The reliability of the internal consistence of the GSRS was 0.59-0.83 and that of the QOLRAD: 0.87-0.95, and test-retest reliability of the GSRS was 0.44-0.63 and QOLRAD: 0.77-0.85. Score of the important domains of the GSRS «reflux», «abdominal pain» and «indigestion» and above all those of the QOLRAD correlated significantly. The domain «abdominal pain» of the GSRS had a strong correlation (negative) with the relevant domains of the SF-36. The QOLRAD domains significantly correlated with all the related domains of the SF-36. Conclusions. The psychometric characteristics of the translation to spanish of the GSRS and QOLRAD were good, with satisfactory reliability and validity. However, the test-retest reliability of the «reflux» domain of the GSRS was not optimum

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.

[Psychometric validation of translation to Spanish of the gastrointestinal symptoms rating scale (GSRS) and quality of life in reflux and dyspepsia (QOLRAD) in patients with gastroesophageal reflux disease]. / Validación psicométrica de la traducción al español de la escala de evaluación de síntomas gastrointestinales (GSRS) y del cuestionario de calidad de vida de reflujo y dispepsia (QOLRAD) en los pacientes con enfermedad por reflujo gastroesofágico.

INTRODUCTION: Pyrosis symptoms and their impact on the quality of life related with health (QLRH) are frequently evaluated in clinical trials. When a questionnaire is translated into a language other than the original, it is necessary to have a linguistic validation, although this is not sufficient unless the psychometric characteristics have been verified. This study aims to document the psychometric characteristics of the translation to Spanish of the gastrointestinal symptoms rating scale (GSRS) and quality of life in reflux and dyspepsia (QOLRAD). MATERIAL AND METHOD: One hundred fifty eight patients with pyrosis symptoms (age: 51.0; SD: 16.3 years; men: 42.4%) completed the translation to Spanish of the GSRS, the pyrosis version of the QOLRAD, the Short-Form-36 (SF-36) and the hospital of anxiety and depression (HAD) scale. Seventy six patients were given an appointment for a second visit after one week, to fill out the GSRS and QOLRAD again. RESULTS: The reliability of the internal consistence of the GSRS was 0.59-0.83 and that of the QOLRAD: 0.87-0.95, and test-retest reliability of the GSRS was 0.44-0.63 and QOLRAD: 0.77-0.85. Score of the important domains of the GSRS "reflux", "abdominal pain" and "indigestion" and above all those of the QOLRAD correlated significantly. The domain "abdominal pain" of the GSRS had a strong correlation (negative) with the relevant domains of the SF-36. The QOLRAD domains significantly correlated with all the related domains of the SF-36. CONCLUSIONS: The psychometric characteristics of the translation to Spanish of the GSRS and QOLRAD were good, with satisfactory reliability and validity. However, the test-retest reliability of the "reflux" domain of the GSRS was not optimum.

Do physicians correctly assess patient symptom severity in gastro-oesophageal reflux disease?

BACKGROUND: The accuracy of physicians' assessment of the severity of gastro-oesophageal reflux disease is unclear. AIM: To correlate physician and patient assessment of gastro-oesophageal reflux disease severity and its response to treatment. METHODS: Adult uninvestigated gastro-oesophageal reflux disease patients (n = 217) completed symptom and health-related quality of life questionnaires at baseline and after treatment with esomeprazole 40 mg p.o. daily. Pearson coefficients quantified correlations between physician assessments and patient responses. RESULTS: At baseline, the strongest correlations were heartburn severity (0.31), overall symptom severity (0.44) and a domain of the quality of life in reflux and dyspepsia questionnaire (0.31) (P < 0.001). Correlations of change with treatment were greater than baseline correlations: heartburn (0.39), overall symptoms (0.50) and global rate of change -- stomach problems (0.72, all P < 0.001). The mean difference between the physicians' assessment of change and the patients' global rating of change was 0.20 (95% confidence intervals: 0.10-0.29) with physicians overestimating benefit. CONCLUSIONS: Correlations were often significant, although weak to moderate and better with symptom severity than with health-related quality of life instruments as well as with change after therapy than at baseline. Increasing attention to health-related quality of life may help physicians better understand patients' experience. In clinical trials, treatment success should be assessed by the patient as well as the physician.

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.