Rationale, baseline characteristics and methodology of the non-interventional VIVA study in postmenopausal osteoporosis

2014 ◽  
Vol 23 (01) ◽  
pp. 49-55
Author(s):  
L. C. Hofbauer ◽  
D. Felsenberg ◽  
M. Amling ◽  
A. Kurth ◽  
P. Hadji
Keyword(s):  
Quality Of Life ◽  
Postmenopausal Osteoporosis ◽  
Primary Outcome ◽  
Osteoporosis Treatment ◽  
Secondary Outcome ◽  
Matched Pairs ◽  
Fracture History ◽  
Baseline Characteristics ◽  
Study Inclusion

SummaryIt is important to understand compliance and persistence with medication use in the clinical practice of osteoporosis treatment. The purpose of this work is to describe the “intravenous ibandronate versus oral alendronate” (VIVA) study, a non-interventional trial to assess the compliance and persistence of osteopenic postmenopausal women with treatment via weekly oral alendronate or intravenous ibandronate (Bonviva®) every three months.4477 patients receiving ibandronate 3 mg i. v. quarterly and 1491 patients receiving alendronate 70 mg orally weekly were included in the study. Matched pairs of 901 subjects in each group were also generated. Matching was performed on the basis of age, body mass index, fracture history at study inclusion, prior treatment with bisphosphonates and the number of concomitant disorders. Secondary outcome measures of osteoporosis related fractures, mobility restriction and pain, analgesia, quality of life questionnaires as well as attitudes to medications were assessed. The primary outcome parameters of compliance and persistence will be tracked in these subjects.At baseline, the entire collectives differed significantly on body weight (less in ibandronate group), duration since osteo - porosis diagnosis (longer in ibandronate), and incidence of prior osteoporotic fracture (higher in ibandronate group). The matched-pairs differed only on mobility restriction and quality of life (both worse in ibandronate group).The results from the VIVA study trial will provide scientific rationale for clinical recommendations in the pharmacological treatment of postmenopausal osteoporosis.

A randomised controlled trial of perivenous tumescent anaesthesia in addition to general anaesthesia for surgical ligation and stripping of the great saphenous vein

2019 ◽  
Vol 35 (5) ◽  
pp. 305-315 ◽  
Author(s):  
Sandip Nandhra ◽  
Tom Wallace ◽  
Joseph El-Sheikha ◽  
Daniel Carradice ◽  
Ian Chetter
Keyword(s):  
Quality Of Life ◽  
General Anaesthesia ◽  
Saphenous Vein ◽  
Primary Outcome ◽  
Great Saphenous Vein ◽  
Bodily Pain ◽  
Secondary Outcome ◽  
Surgical Ligation ◽  
Significant Difference

Introduction Open surgical ligation and stripping of the great saphenous vein is a highly cost-effective treatment when compared with conservative management and foam sclerotherapy but has limitations including post-operative morbidity and pain. This study aims to identify if the addition of tumescent anaesthesia could improve patient outcomes following treatment. Methods Patients with primary superficial venous incompetence undergoing open surgical ligation and stripping of the great saphenous vein were randomised to either General Anaesthesia (GA) alone (GA) procedure or the addition of tumescent (G + T). The primary outcome was bodily pain (within SF-36) at one week. Additional outcomes included post-procedural pain score (100 mm visual analogue scale), complications and quality of life. Results A total of 90 patients were randomised for inclusion. There was no significant difference in primary outcome; bodily pain at one week. Secondary outcome of 4-h post-procedural scores were significantly lower in the G + T group (32 (20–54) mm vs. (GA alone) 56 (24–70) mm (P = 0.016)). Complications were minor and equivalent. Both groups saw a significant increase (worsening) in Aberdeen Varicose Vein Questionnaire scores at week 1 with the G + T group faring worse at six weeks (10.0 (Interquartile Range [IQR] 5.6–17.9) vs. 4.3 (IQR 2.7–7.9) P = 0.004). Conclusion The G + T group did not demonstrate a significant difference in the one-week bodily pain domain. The addition of tumescent anaesthesia does improve immediate post-operative pain but appears to negatively impact on six-week quality of life. EudraCT Number: 2011-005574-39

scholarly journals Transdiagnostic, Psychodynamic Web-Based Self-Help Intervention Following Inpatient Psychotherapy: Results of a Feasibility Study and Randomized Controlled Trial (Preprint)

2017 ◽  
Author(s):  
Rüdiger Zwerenz ◽  
Jan Becker ◽  
Robert Johansson ◽  
Ronald J Frederick ◽  
Gerhard Andersson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mental Disorders ◽  
Primary Outcome ◽  
Emotional Competence ◽  
Effect Sizes ◽  
Secondary Outcome ◽  
Web Based ◽  
Waiting Period ◽  
Self Help

BACKGROUND Mental disorders have become a major health issue, and a substantial number of afflicted individuals do not get appropriate treatment. Web-based interventions are promising supplementary tools for improving health care for patients with mental disorders, as they can be delivered at low costs and used independently of time and location. Although psychodynamic treatments are used frequently in the face-to-face setting, there has been a paucity of studies on psychodynamic Web-based self-help interventions. OBJECTIVE The objective of this study was to determine the feasibility and preliminary efficacy of a transdiagnostic affect-focused psychodynamic Web-based self-help intervention designed to increase emotional competence of patients with mental disorders. METHODS A total of 82 psychotherapy inpatients with mixed diagnoses were randomized into two groups. Following discharge, the intervention group (IG) got access to a guided version of the intervention for 10 weeks. After a waiting period of 10 weeks, the wait-list control group (WLCG) got access to an unguided version of the intervention. We reported the assessments at the beginning (T0) and at the end of the intervention, resp. the waiting period (T1). The primary outcome was satisfaction with the treatment at T1. Secondary outcome measures included emotional competence, depression, anxiety, and quality of life. Statistical analyses were performed with descriptive statistics (primary outcome) and analysis of covariance; a repeated measurement analysis of variance was used for the secondary outcomes. Effect sizes were calculated using Cohen d and data were analyzed as per protocol, as well as intention-to-treat (ITT). RESULTS Patients were chronically ill, diagnosed with multiple diagnoses, most frequently with depression (84%, 58/69), anxiety (68%, 47/69), personality disorder (38%, 26/69), and depersonalization-derealization disorder (22%, 15/69). A majority of the patients (86%, 36/42) logged into the program, of which 86% (31/36) completed the first unit. Satisfaction with the units mastered was rated as good (52%, 16/31) and very good (26%, 9/31). However, there was a steady decline of participation over the course of the program; only 36% of the participants (13/36) participated throughout the trial completing at least 50% of the sessions. According to the ITT analysis, participants improved statistically significantly and with moderate effect sizes (Cohen d) compared with the WLCG regarding depression (d=0.60), quality of life (d=0.53), and emotional competence (d=0.49). Effects were considerably stronger for the completers with respect to depression (d=1.33), quality of life (d=0.83), emotional competence (d=0.68), and general anxiety (d=0.62). CONCLUSIONS Although overall program satisfaction and benefit of the program were favorable with respect to the indicators of emotional disorders, the rate of completion was low. Our findings point to the need to target the intervention more specifically to the needs and capabilities of participants and to the context of the intervention. CLINICALTRIAL Clinicaltrials.gov NCT02671929; https://clinicaltrials.gov/ct2/show/NCT02671929 (Archived by WebCite at http://www.webcitation.org/6ntWg1yWb)

scholarly journals Does sex predict quality of life after acute coronary syndromes: an Australian, state-wide, multicentre prospective cohort study

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e034034 ◽  
Author(s):  
Youlin Koh ◽  
Julia Stehli ◽  
Catherine Martin ◽  
Angela Brennan ◽  
Diem T Dinh ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cohort Study ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Acute Coronary Syndromes ◽  
Primary Outcome ◽  
Secondary Outcome ◽  
Female Sex ◽  
Coronary Syndromes

ObjectiveWomen have reported higher mortality and major adverse cardiovascular events (MACE) following acute coronary syndromes (ACSs) compared with men. With this in mind, we aimed to identify predictors of poor quality of life (QoL) post-ACS as our primary outcome. We examined predictors of MACE, major cerebrovascular events and major bleeding as our secondary outcome.DesignProspective cohort study.Setting30 metropolitan centres across the Victorian Cardiac Outcomes Registry network.Participants16 517 patients treated with percutaneous coronary intervention (PCI) for ACS (22.9% females). Selection/inclusion criteria: consecutive patients with successful or attempted PCI for ACS from 2013 to 2016, alive at 30 days post-PCI. Exclusion criteria: patients not fulfilling ACS criteria. At 30 days, 2497 (64.7% females) completed the QoL EQ-5D-3L instrument.Primary and secondary outcome measuresQoL, assessed using the EuroQo-5Dimensions (EQ-5D-3L) instrument by telephone at 30 days. Independent predictors of QoL were identified by univariate and multivariate logistic regression analyses.ResultsWomen were significantly older with more diabetes, cerebrovascular disease and renal failure. Regarding the primary outcome, female sex was independently associated with moderate/severe impairment in all EQ-5D-3L domains including mobility (OR 2.38, 95% CI 2.06 to 2.75, p<0.001), personal care (OR 2.14, 95% CI 1.73 to 2.66, p<0.001), activities of daily living (OR 1.84, 95% CI 1.63 to 2.08, p<0.001), pain/discomfort (OR 1.44, 95% CI 1.24 to 1.67, p<0.001) and anxiety/depression (OR 1.49, 95% CI 1.30 to 1.70, p<0.001). Women had significantly lower self-rated Visual Analogue Scale scores (80.0 for both groups, IQR 60-85 vs 70-90, p<0.001). There was no significant difference between the sexes in secondary outcomes.ConclusionsFemale sex was a predictor of poorer QoL following PCI for ACS including significantly higher pain, anxiety and depression. This was independent of age, comorbidities and ACS presentation. There is a clinical need for a tailored approach in female ACS management, for example, emphasis on management of depressive and anxiety symptoms.

scholarly journals Transdiagnostic, Psychodynamic Web-Based Self-Help Intervention Following Inpatient Psychotherapy: Results of a Feasibility Study and Randomized Controlled Trial

2017 ◽  
Vol 4 (4) ◽  
pp. e41 ◽  
Author(s):  
Rüdiger Zwerenz ◽  
Jan Becker ◽  
Robert Johansson ◽  
Ronald J Frederick ◽  
Gerhard Andersson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mental Disorders ◽  
Primary Outcome ◽  
Emotional Competence ◽  
Effect Sizes ◽  
Secondary Outcome ◽  
Web Based ◽  
Waiting Period ◽  
Self Help

Background Mental disorders have become a major health issue, and a substantial number of afflicted individuals do not get appropriate treatment. Web-based interventions are promising supplementary tools for improving health care for patients with mental disorders, as they can be delivered at low costs and used independently of time and location. Although psychodynamic treatments are used frequently in the face-to-face setting, there has been a paucity of studies on psychodynamic Web-based self-help interventions. Objective The objective of this study was to determine the feasibility and preliminary efficacy of a transdiagnostic affect-focused psychodynamic Web-based self-help intervention designed to increase emotional competence of patients with mental disorders. Methods A total of 82 psychotherapy inpatients with mixed diagnoses were randomized into two groups. Following discharge, the intervention group (IG) got access to a guided version of the intervention for 10 weeks. After a waiting period of 10 weeks, the wait-list control group (WLCG) got access to an unguided version of the intervention. We reported the assessments at the beginning (T0) and at the end of the intervention, resp. the waiting period (T1). The primary outcome was satisfaction with the treatment at T1. Secondary outcome measures included emotional competence, depression, anxiety, and quality of life. Statistical analyses were performed with descriptive statistics (primary outcome) and analysis of covariance; a repeated measurement analysis of variance was used for the secondary outcomes. Effect sizes were calculated using Cohen d and data were analyzed as per protocol, as well as intention-to-treat (ITT). Results Patients were chronically ill, diagnosed with multiple diagnoses, most frequently with depression (84%, 58/69), anxiety (68%, 47/69), personality disorder (38%, 26/69), and depersonalization-derealization disorder (22%, 15/69). A majority of the patients (86%, 36/42) logged into the program, of which 86% (31/36) completed the first unit. Satisfaction with the units mastered was rated as good (52%, 16/31) and very good (26%, 9/31). However, there was a steady decline of participation over the course of the program; only 36% of the participants (13/36) participated throughout the trial completing at least 50% of the sessions. According to the ITT analysis, participants improved statistically significantly and with moderate effect sizes (Cohen d) compared with the WLCG regarding depression (d=0.60), quality of life (d=0.53), and emotional competence (d=0.49). Effects were considerably stronger for the completers with respect to depression (d=1.33), quality of life (d=0.83), emotional competence (d=0.68), and general anxiety (d=0.62). Conclusions Although overall program satisfaction and benefit of the program were favorable with respect to the indicators of emotional disorders, the rate of completion was low. Our findings point to the need to target the intervention more specifically to the needs and capabilities of participants and to the context of the intervention. Trial Registration Clinicaltrials.gov NCT02671929; https://clinicaltrials.gov/ct2/show/NCT02671929 (Archived by WebCite at http://www.webcitation.org/6ntWg1yWb)

scholarly journals Maintaining musculoskeletal health using a behavioural therapy approach: a population-based randomised controlled trial (the MAmMOTH Study)

2021 ◽  
pp. annrheumdis-2020-219091 ◽  
Author(s):  
Gary J Macfarlane ◽  
Marcus Beasley ◽  
Neil Scott ◽  
Huey Chong ◽  
Paul McNamee ◽  
...  
Keyword(s):  
Quality Of Life ◽  
High Risk ◽  
Primary Outcome ◽  
Population Based ◽  
Behavioural Therapy ◽  
Short Course ◽  
Life Years ◽  
Secondary Outcomes ◽  
Randomised Controlled

ObjectiveCognitive–behavioural therapy (CBT) has been shown to be effective in the management of chronic widespread pain (CWP); we now test whether it can prevent onset among adults at high risk.MethodsA population-based randomised controlled prevention trial, with recruitment through UK general practices. A mailed screening questionnaire identified adults at high risk of CWP. Participants received either usual care (UC) or a short course of telephone CBT (tCBT). The primary outcome was CWP onset at 12 months assessed by mailed questionnaire. There were seven secondary outcomes including quality of life (EuroQol Questionnaire-five dimensions-five levels/EQ-5D-5L) used as part of a health economic assessment.Results996 participants were randomised and included in the intention-to-treat analysis of which 825 provided primary outcome data. The median age of participants was 59 years; 59% were women. At 12 months there was no difference in the onset of CWP (tCBT: 18.0% vs UC: 17.5%; OR 1.05; 95% CI 0.75 to 1.48). Participants who received tCBT were more likely to report better quality of life (EQ-5D-5L utility score mean difference 0.024 (95% CI 0.009 to 0.040)); and had 0.023 (95% CI 0.007 to 0.039) more quality-adjusted life-years at an additional cost of £42.30 (95% CI −£451.19 to £597.90), yielding an incremental cost-effectiveness ratio of £1828. Most secondary outcomes showed significant benefit for the intervention.ConclusionsA short course of tCBT did not prevent onset of CWP in adults at high risk, but improved quality of life and was cost-effective. A low-cost, short-duration intervention benefits persons at risk of CWP.Trial registration numberClinicalTrials.gov Registry (NCT02668003).

scholarly journals Effectiveness of custom-made foot orthoses in patients with systemic lupus erythaematosus: protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e042627
Author(s):  
María Reina-Bueno ◽  
María del Carmen Vázquez-Bautista ◽  
Inmaculada C Palomo-Toucedo ◽  
Gabriel Domínguez-Maldonado ◽  
José Manuel Castillo-López ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Foot Orthoses ◽  
Systemic Lupus ◽  
Custom Made ◽  
Randomised Controlled

IntroductionSystemic lupus erythaematosus (SLE) is a chronic autoimmune disease of heterogeneous involvement. The disease may affect feet with a high prevalence of symptoms such as, for example, pain, forefoot and rearfoot deformities, and biomechanics dysfunctions. Custom-made foot orthoses (CMFO) have been previously reported to be effective in patients with other rheumatic diseases. However, as far as the authors know, there exist no studies about their effectiveness in SLE. This study aims at determining the effect of CMFO versus placebo flat cushioning insoles on pain, foot functionality, fatigue and quality of life in patients with SLE.Methods and analysisA randomised controlled trial would compare the effects of (1) CMFO and group B, which received a placebo, flat cushioning insoles, for 3 months. The main outcome measures are foot pain, foot functionality and foot-related disability. The secondary outcome measures are fatigue and quality of life.Ethics and disseminationThe study has been approved by the Portal de Ética de la Investigación Biomédica de Andalucía ethical committee 1494-N-19. The results will be disseminated regardless of the magnitude or direction of effect.Trial registartion numberClinicaltrials.gov identifier NCT04098055.

scholarly journals Acceptability and Feasibility of a Mindfulness Intervention Delivered via Videoconferencing for People With Parkinson’s

2021 ◽  
pp. 089198872098890
Author(s):  
Angeliki Bogosian ◽  
Catherine S. Hurt ◽  
John V. Hindle ◽  
Lance M. McCracken ◽  
Debora A. Vasconcelos e Sa ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cost Effectiveness ◽  
Qualitative Interviews ◽  
Quality Adjusted Life Year ◽  
Secondary Outcome ◽  
Structured Interviews ◽  
Potential Cost ◽  
Mindfulness Intervention ◽  
Related Quality

Mindfulness-based group therapy is a rapidly growing psychological approach that can potentially help people adjust to chronic illness and manage unpleasant symptoms. Emerging evidence suggests that mindfulness-based interventions may benefit people with Parkinson’s. The objective of the paper is to examine the appropriateness, feasibility, and potential cost-effectiveness of an online mindfulness intervention, designed to reduce anxiety and depression for people with Parkinson’s. We conducted a feasibility randomized control trial and qualitative interviews. Anxiety, depression, pain, insomnia, fatigue, impact on daily activities and health-related quality of life were measured at baseline, 4, 8, and 20 weeks. Semi-structured interviews were conducted at the end of the intervention. Participants were randomized to the Skype delivered mindfulness group (n = 30) or wait-list (n = 30). Participants in the mindfulness group were also given a mindfulness manual and a CD with mindfulness meditations. The intervention did not show any significant effects in the primary or secondary outcome measures. However, there was a significant increase in the quality of life measure. The incremental cost-effectiveness ratio was estimated to be £27,107 per Quality-Adjusted Life Year gained. Also, the qualitative study showed that mindfulness is a suitable and acceptable intervention. It appears feasible to run a trial delivering mindfulness through Skype, and people with Parkinson’s found the sessions acceptable and helpful.

scholarly journals Quality of life among adult patients living with diabetes in Rwanda: a cross-sectional study in outpatient clinics

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e043997
Author(s):  
Charilaos Lygidakis ◽  
Jean Paul Uwizihiwe ◽  
Michela Bia ◽  
Francois Uwinkindi ◽  
Per Kallestrup ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Diabetes Mellitus ◽  
Cross Sectional Study ◽  
Diabetes Control ◽  
Outpatient Clinics ◽  
Secondary Outcome ◽  
Sectional Study ◽  
Cross Sectional ◽  
Social Burden

ObjectivesTo report on the disease-related quality of life of patients living with diabetes mellitus in Rwanda and identify its predictors.DesignCross-sectional study, part of the baseline assessment of a cluster-randomised controlled trial.SettingOutpatient clinics for non-communicable diseases of nine hospitals across Rwanda.ParticipantsBetween January and August 2019, 206 patients were recruited as part of the clinical trial. Eligible participants were those aged 21–80 years and with a diagnosis of diabetes mellitus for at least 6 months. Illiterate patients, those with severe hearing or visual impairments, those with severe mental health conditions, terminally ill, and those pregnant or in the postpartum period were excludedPrimary and secondary outcome measuresDisease-specific quality of life was measured with the Kinyarwanda version of the Diabetes-39 (D-39) questionnaire. A glycated haemoglobin (HbA1c) test was performed on all patients. Sociodemographic and clinical data were collected, including medical history, disease-related complications and comorbidities.ResultsThe worst affected dimensions of the D-39 were ‘anxiety and worry’ (mean=51.63, SD=25.51), ‘sexual functioning’ (mean=44.58, SD=37.02), and ‘energy and mobility’ (mean=42.71, SD=20.69). Duration of the disease and HbA1c values were not correlated with any of the D-39 dimensions. A moderating effect was identified between use of insulin and achieving a target HbA1c of 7% in the ‘diabetes control’ scale. The most frequent comorbidity was hypertension (49.0% of participants), which had a greater negative effect on the ‘diabetes control’ and ‘social burden’ scales in women. Higher education was a predictor of less impact on the ‘social burden’ and ‘energy and mobility’ scales.ConclusionsSeveral variables were identified as predictors for the five dimensions of quality of life that were studied, providing opportunities for tailored preventive programmes. Further prospective studies are needed to determine causal relationships.Trial registration numberNCT03376607.

Abstract 202: Endovascular Therapy for Acute Ischemic Stroke With Distal Large Vessel Occlusion in the Anterior Circulation

Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Amrou Sarraj ◽  
Navdeep Sangha ◽  
Muhammad Shazam Hussain ◽  
Dolora Wisco ◽  
Nirav Vora ◽  
...  
Keyword(s):  
Endovascular Therapy ◽  
Primary Outcome ◽  
Large Vessel ◽  
Secondary Outcome ◽  
Large Vessel Occlusion ◽  
Anterior Circulation ◽  
Vessel Occlusion ◽  
Good Outcome ◽  
Baseline Characteristics ◽  
Iv Tpa

Introduction: Five RCTs demonstrated the superiority of endovascular therapy (EVT) over best medical management (MM) for acute ischemic strokes (AIS) with large vessel occlusion (LVO) in the anterior circulation. Patients with M2 occlusions, however, were underrepresented (95 randomized; 51 EVT treated). Evidence from RCTs of the benefit of EVT for M2 occlusions is lacking, as reflected in the recent AHA guidelines. Methods: A retrospective cohort was pooled from 10 academic centers from 1/12 to 4/15 of AIS patients with LVO isolated to M2 presenting within 8 hours from last known normal (LKN). Patients were divided into EVT and MM groups. Primary outcome was 90 day mRS (good outcome 0-2); secondary outcome was sICH. Logistic regression compared the 2 groups. Univariate and multivariate analyses evaluated predictors of good outcome in the EVT group. Results: Figure 1 shows participating centers, 522 patients (288 EVT and 234 MM) were identified. Table (1) shows baseline characteristics. MM treated patients were older and had higher IV tPA treatment rates, otherwise the 2 groups were balanced. 62.7 % EVT patients had mRS 0-2 at 90 days compared to 35.4 % MM (figure 2). EVT patients had 3 times the odds of good outcome as compared to MM patients (OR: 3.1, 95% CI:2.1-4.4, P <0.001) even after adjustment for age, NIHSS, ASPECTS, IV tPA and LKN to door time (OR: 3.2, 95%CI: 2-5.2, P<0.001). sICH rate was 5.6 %, which was not statistically different than the MM group (table 1, P=0.1). Age, NIHSS, good ASPECTS, LKN to reperfusion time and successful reperfusion mTICI ≥ 2b were independent predictors of good outcome in EVT patients. There was a linear relationship between good outcome and time LKN to reperfusion (Figure 3). Conclusion: Despite inherent limitations of its retrospective design, our study suggests that EVT may be effective and safe for distal LVO (M2) relative to best MM. A trial randomizing M2 occlusions to EVT vs. MM is warranted to confirm these findings.

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