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- Bolling-Sternevald, Elisabeth, et al.
(författare)
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Effect of Profound Acid Suppression in Functional Dyspepsia : a Double-Blind, Randomized, Placebo-Controlled Trial
- 2002
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Ingår i: Scandinavian Journal of Gastroenterology. - : Informa UK Limited. - 0036-5521 .- 1502-7708. ; 37:12, s. 1395-1402
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Tidskriftsartikel (refereegranskat)abstract
- Background: Functional dyspepsia (FD) is defined as persistent or recurrent pain/discomfort centred in the upper abdomen, where no structural explanation for the symptoms is found. The role of drug treatment remains controversial. The aim in this study was to evaluate the effect of omeprazole 20 mg twice daily (b.i.d) and to test methods for symptom assessment.Methods: 197 patients fulfilling the criteria for FD were randomly allocated to double-blind treatment with omeprazole 20 mg b.i.d ( n = 100) or placebo ( n = 97) for 14 days. Patients with a known gastrointestinal disorder or with main symptoms indicating gastro-oesophageal reflux disease or irritable bowel syndrome were excluded. Helicobacter pylori testing and 24-h intra-oesophageal 24-h pH-metry were performed before randomization. The patients recorded dyspeptic symptoms on diary cards.Results: A stringent endpoint, 'complete symptom relief on the last day of treatment', was the primary efficacy variable. For the APT cohort, this was achieved in 29.0% and 17.7% on omeprazole and placebo, respectively (95% CI of difference (11.3%): -0.4%-23.0%, P = 0.057). Similar figures in the PP cohort were 31.0% and 15.5%, respectively (95% CI of difference (15.5%): 3.2%-27.7%, P = 0.018). The benefit of omeprazole in the PP cohort was confirmed by secondary endpoints such as, no dyspeptic symptoms on the last 2 days of treatment and overall treatment response. H. pylori status and the level of oesophageal acid exposure did not significantly influence the response to therapy.Conclusion: A subset of patients with FD will respond to therapy with omeprazole.
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| 4. |
- Beno, Anja, et al.
(författare)
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Does employer involvement in primary health care enhance return to work for patients with stress-related mental disorders? a cluster randomized controlled trial
- 2023
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Ingår i: BMC Primary Care. - 2731-4553. ; 24:1
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Tidskriftsartikel (refereegranskat)abstract
- BackgroundStress-related disorders have become a major challenge for society and are associated with rising levels of sick leave. The provision of support to facilitate the return to work (RTW) for this patient group is of great importance. The aim of the present study was to evaluate whether a new systematic procedure with collaboration between general practitioners (GPs), rehabilitation coordinators (RCs) and employers could reduce sick leave days for this patient group.MethodEmployed patients with stress-related diagnoses seeking care at primary health care centres (PHCCs) were included in either the intervention group (n = 54), following the systematic intervention procedure, or the control group (n = 58), receiving treatment as usual (TAU). The intervention included a) a training day for participant GPs and RCs, b) a standardised procedure for GPs and RCs to follow after training, c) the opportunity to receive clinical advice from specialist physicians in the research group. Outcome measures for RTW were sick leave days.ResultsThe median number of registered gross sick leave days was lower for the control group at six, 12 and 24 months after inclusion, but the difference was not statistically significant. The control group had significantly fewer net sick leave days at three months (p = 0.03) at six months (p = 0.00) and at 12-months follow-up (p = 0.01). At 24 months, this difference was no longer significant.ConclusionsThe PRIMA intervention, which applied a standardized procedure for employer involvement in the rehabilitation process for patients with stress-related disorders, actually increased time to RTW compared to TAU. However, at 24 months, the benefit of TAU could no longer be confirmed. The study was registered on 16/01/2017 (ClinicalTrials.gov, NCT03022760).
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| 5. |
- Björk, Lisa, 1981, et al.
(författare)
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Involving the employer to enhance return to work among patients with stress-related mental disorders - study protocol of a cluster randomized controlled trial in Swedish primary health care
- 2018
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Ingår i: Bmc Public Health. - : Springer Science and Business Media LLC. - 1471-2458. ; 18
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Tidskriftsartikel (refereegranskat)abstract
- Background: Work-related stress has become a major challenge for social security and health care systems, employers and employees across Europe. In Sweden, sickness absence particularly due to stress-related disorders has increased excessively in recent years, and the issue of how to improve sustainable return to work in affected employees is high up on the political agenda. The literature on interventions for return to work in patients with common mental disorders is still inconclusive. This randomized controlled trial (RCT) aims to contribute with knowledge about how physicians and rehabilitation coordinators in primary health care can involve the employer in the rehabilitation of patients with stress-related disorders. The objective is to evaluate whether the early involvement of the patient's employer can reduce the time for return to work compared to treatment as usual. A process study will complete the RCT with information about what prerequisites primary health caregivers need to succeed with this endeavor. Methods: Twenty-two primary care centers were randomized to either intervention or control group. At the intervention centers, physicians and rehabilitation coordinators underwent training, providing them with both knowledge and practical tools to involve the employer in rehabilitation. At the patient level, employed patients with an ICD-10 F43 diagnosis were eligible for participation (n=132). Difference in proportion of patients on full- or part-time sick leave at three, six and 12 months after inclusion will be investigated. Register data, logbooks and interviews with coordinators and physicians at both intervention and control centers will be used for process evaluation. Discussion: Although the issue of how to tackle work-related stress can be recognized all across Europe, Sweden face an urgent need to curb the disproportional increase of stress-related disorders in the sick-leave statistics. Since physicians are limited by time constraints, the rehabilitation coordinator may be a helpful resource to take this contact. The current study will contribute to knowledge about how this collaboration can be organized to facilitate employer involvement and reduce time to return to work among patients suffering from work related stress.
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| 7. |
- Bolling-Sternevald, Elisabeth, et al.
(författare)
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Is it possible to predict treatment response to a proton pump inhibitor in functional dyspepsia?
- 2003
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Ingår i: Alimentary Pharmacology and Therapeutics. - : Wiley-Blackwell. - 0269-2813 .- 1365-2036. ; 18:1, s. 117-124
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Tidskriftsartikel (refereegranskat)abstract
- Background: The efficacy of proton pump inhibitors in functional dyspepsia is modest and the prognostic factors are almost unknown.Methods: Data were pooled on patients (n = 826) with a diagnosis of functional dyspepsia from two placebo-controlled trials who were treated with omeprazole, 10 or 20 mg once daily, for 4 weeks. Self-administered questionnaires for the assessment of symptoms and health-related quality of life were completed before entry, and epigastric pain/discomfort was recorded on diary cards. Treatment success was defined as the complete absence of epigastric pain/discomfort on each of the last 3 days of week 4. Prognostic factors were identified by multiple logistic regression analysis.Results: The most discriminating predictor of treatment success (P < 0.0001) was the number of days with epigastric pain/discomfort during the first week of treatment. Fewer days with symptoms during the first week led to higher response rates at 4 weeks. In addition, age > 40 years, bothersome heartburn, low scores for bloating, epigastric pain and diarrhoea, history of symptoms for < 3 months and low impairment of vitality at baseline were identified as positive predictors of outcome.Conclusions: Early response to treatment with a proton pump inhibitor, during the first week, seems to predict the outcome after 4 weeks in patients with functional dyspepsia.
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| 8. |
- Bolling-Sternevald, Elisabeth, et al.
(författare)
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Self-administered symptom questionnaires in patients with dyspepsia and their yield in discriminating between endoscopic diagnoses
- 2002
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Ingår i: Digestive diseases. - : S. Karger AG. - 0257-2753 .- 1421-9875. ; 20:2, s. 191-198
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND/AIMS: Symptoms are generally considered to be poor predictors of organic findings in patients with dyspepsia. We aimed at evaluating whether specific gastrointestinal symptoms, identified by self-administered questionnaires, correlate with specific endoscopic diagnoses and discriminate organic from functional dyspepsia. METHODS: Adult patients with pain or discomfort centred in the upper abdominal region were consecutively enrolled. Patients with heartburn, acid regurgitation, or defaecation and bowel habit problems as their predominant symptoms were excluded. Three self-administered questionnaires were applied before an oesophagogastroduodenoscopy was performed. RESULTS: Among the 799 patients, 50.6% had a normal endoscopy. Endoscopic diagnoses comprised: non-erosive oesophagitis (7.5%), erosive oesophagitis (11.1%), Barrett's oesophagus (1.1%), gastritis/duodenitis (8.4%), gastric ulcer (4.5%), duodenal ulcer (8.3%), and cancer (1.3%). Non-dominant heartburn and acid regurgitation were significantly more common in patients with organic dyspepsia, whereas hunger pains and rumbling occurred more often in those with functional dyspepsia. Multivariate analyses demonstrated that younger age, female gender, high scores for hunger pain, rumbling, hard stools, low scores for heartburn, and acid regurgitation predicted functional dyspepsia. CONCLUSIONS: Self-administered questionnaires revealed differences in the symptom patterns between patients with functional and organic dyspepsia. Furthermore, the health-related well-being in patients with functional and organic dyspepsia centred was impaired to the same extent.
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| 9. |
- Cederberg, Matilda, et al.
(författare)
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Effects of a Person-Centered eHealth Intervention for Patients on Sick Leave Due to Common Mental Disorders (PROMISE Study): Open Randomized Controlled Trial
- 2022
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Ingår i: Jmir Mental Health. - : JMIR Publications Inc.. - 2368-7959. ; 9:3
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Tidskriftsartikel (refereegranskat)abstract
- Background: Sick leave due to common mental disorders (CMDs) is a public health problem in several countries, including Sweden. Given that symptom relief does not necessarily correspond to return to work, health care interventions focusing on factors that have proven important to influence the return to work process, such as self-efficacy, are warranted. Self-efficacy is also a central concept in person-centered care. Objective: The aim of this study is to evaluate the effects of a person-centered eHealth intervention for patients on sick leave due to CMDs. Methods: A randomized controlled trial of 209 patients allocated to either a control group (107/209, 51.2%) or an intervention group (102/209, 48.8%) was conducted. The control group received usual care, whereas the intervention group received usual care with the addition of a person-centered eHealth intervention. The intervention was built on person-centered care principles and consisted of telephone support and a web-based platform. The primary outcome was a composite score of changes in general self-efficacy (GSE) and level of sick leave at the 6-month follow-up. An intention-to-treat analysis included all participants, and a per-protocol analysis consisted of those using both the telephone support and the web-based platform. Results: At the 3-month follow-up, in the intention-to-treat analysis, more patients in the intervention group improved on the composite score than those in the control group (20/102, 19.6%, vs 10/107, 9.3%; odds ratio [OR] 2.37, 95% CI 1.05-5.34; P=.04). At the 6-month follow-up, the difference was no longer significant between the groups (31/100, 31%, vs 25/107, 23.4%; OR 1.47, 95% CI 0.80-2.73; P=.22). In the per-protocol analysis, a significant difference was observed between the intervention and control groups at the 3-month follow-up (18/85, 21.2%, vs 10/107, 9.3%; OR 2.6, 95% CI 1.13-6.00; P=.02) but not at 6 months (30/84, 35.7%, vs 25/107, 23.4%; OR 1.8, 95% CI 0.97-3.43; P=.06). Changes in GSE drove the effects in the composite score, but the intervention did not affect the level of sick leave. Conclusions: A person-centered eHealth intervention for patients on sick leave due to CMDs improved GSE but did not affect the level of sick leave.
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| 10. |
- Cederberg, Matilda, et al.
(författare)
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Person-centred eHealth intervention for patients on sick leave due to common mental disorders: study protocol of a randomised controlled trial and process evaluation (PROMISE)
- 2020
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Ingår i: BMJ Open. - : BMJ. - 2044-6055. ; 10:9
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Tidskriftsartikel (refereegranskat)abstract
- INTRODUCTION: The number of people dealing with common mental disorders (CMDs) is a major concern in many countries, including Sweden. Sickness absence resulting from CMDs is often long-lasting and advancing return to work is a complex process impacted by several factors, among which self-efficacy appears to be an important personal resource. Person-centred care (PCC) has previously shown positive effects on self-efficacy however this needs to be further investigated in relation to patients with CMDs and in an eHealth context. METHODS AND ANALYSIS: This study is an open randomised controlled trial comparing a control group receiving standard care with an intervention group receiving standard care plus PCC by telephone and a digital platform. The primary outcome measure is a composite score of changes in sick leave and self-efficacy. Participants will include 220 primary care patients on sick leave due to CMDs and data will mainly be collected through questionnaires at baseline and 3, 6, 12 and 24 months from the inclusion date. Inclusion is ongoing and expected to be completed during the fall of 2020. A process and health economic evaluation will also be conducted. ETHICS AND DISSEMINATION: This study was approved by the Regional Ethical Review Board in Gothenburg, Sweden. Results will be published in peer-reviewed scientific journals and presented at national and international scientific conferences. This project is part of a broader research programme conducted at the Gothenburg Centre for Person-Centred Care (GPCC), where extensive work is undertaken to disseminate knowledge on and implementation of PCC. TRIAL REGISTRATION NUMBER: NCT03404583.
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