Effects of a self-managed home-based walking intervention on psychosocial health outcomes for breast cancer patients receiving chemotherapy: a randomised controlled trial

Purpose

This study evaluated the effectiveness of a self-managed home-based moderate intensity walking intervention on psychosocial health outcomes among breast cancer patients undergoing chemotherapy.

Methods

The randomised controlled trial compared a self-managed, home-based walking intervention to usual care alone among breast cancer patients receiving chemotherapy. Outcome measures included changes in self-report measures of anxiety, depression, fatigue, self-esteem, mood and physical activity. Fifty participants were randomised to either the intervention group (n?=?25), who received 12 weeks of moderate intensity walking, or the control group (n?=?25) mid-way through chemotherapy. Participants in the intervention group were provided with a pedometer and were asked to set goals and keep weekly diaries outlining the duration, intensity and exertion of their walking. Levels of psychosocial functioning and physical activity were assessed pre- and post-intervention in both groups.

Results

The intervention had positive effects on fatigue (F?=?5.77, p?=?0.02), self-esteem (F?=?8.93, p?≤?0.001), mood (F?=?4.73, p?=?0.03) and levels of physical activity (x ²?=?17.15, p?=?0.0011) but not anxiety (F?=?0.90, p?=?0.35) and depression (F?=?0.26, p?=?0.60) as assessed using the HADS. We found an 80 % adherence rate to completing the 12-week intervention and recording weekly logs.

Conclusion

This self-managed, home-based intervention was beneficial for improving psychosocial well-being and levels of physical activity among breast cancer patients treated with chemotherapy.

Trial registration

Current Controlled Trials ISRCTN50709297.

     

Reproducibility of Contrast-Enhanced Ultrasound in Mice with Controlled Injection

Purpose

Sensitivity of contrast-enhanced ultrasound (CEUS) to microvascular flow modifications can be limited by intra-injection variability (injected dose, rate, volume).

Procedures

To evaluate the effect of injection variability on microvascular flow evaluation, CEUS was compared between controlled and manual injections where enhancement was assessed in vitro within a flow phantom, in normal murine kidney (N?=?12) and in murine ectopic tumors (N?=?10).

Results

For both in vitro and in vivo measurements in the renal cortex, controlled injections significantly improved reproducibility of functional parameter estimation. Their coefficient of variation (CV) in the renal cortex ranged from 4 to 19 % for controlled injection vs. 5 to 43 % for manual injections. For measurements in tumors, controlled injection only decreased the CV significantly for the mean transit time. In tumors, multiple injections of contrast agent with a 15-min delay between each were shown to strongly modify contrast uptake by facilitating penetration of microbubbles.

Conclusion

Improved reproducibility of CEUS assessments in murine models should provide more robust quantification of flow parameters and more sensitive evaluation of tumor modifications in therapeutic models.

     

Cerebrolysin for the Treatment of Aneurysmal Subarachnoid Hemorrhage in Adults: A Retrospective Chart Review

Introduction

Cerebrolysin is a neuroprotective drug used in the treatment of acute ischemic stroke. To our knowledge, this drug has never been evaluated in patients with aneurysmal subarachnoid hemorrhage (SAH). The aim of this study was to evaluate the effect of Cerebrolysin in patients with aneurysmal SAH.

Methods

Aneurysmal SAH patients who had their aneurysm obliterated at our institution from 2007 to 2016 were retrospectively studied. Patients received Cerebrolysin treatment or standard care only (control group). Subgroup analyses were performed according to Hunt and Hess grade (good grade?≤?2, N?=?216; poor grade?≥?3, N?=?246) and treatment procedure (clip or coil).

Results

In good-grade patients (N?=?216), clinical outcomes and mortality did not differ significantly between the control and Cerebrolysin groups. In poor-grade patients (N?=?246), the mortality rate was significantly lower in the Cerebrolysin group (8.7%) than in the control group (25.4%, p?=?0.006). In patients who received microsurgical clipping (N?=?328), the mortality rate was significantly lower in the Cerebrolysin group (7.3%) than in the control group (18.5%, p?=?0.016).

Conclusion

Cerebrolysin injection during the acute period of SAH appeared to reduce the mortality rate, especially in poor-grade patients. This study suggests the potential of Cerebrolysin for treating aneurysmal SAH. Further studies are needed to confirm our results.

     

Prospective,Randomized, Single Masked,Parallel Study Exploring the Effects of a Preservative-Free Ophthalmic Solution Containing Hyaluronic Acid 0.4% and Taurine 0.5% on the Ocular Surface of Glaucoma Patients Under Multiple Long-Term Topical Hypotensive Therapy

Introduction

To compare the effects of a preservative-free (PF) ophthalmic solution containing hyaluronic acid (HA) 0.4% and taurine (TAU) 0.5% with those of a PF ophthalmic solution containing HA 0.2% on ocular surface signs, symptoms, and morphological parameters in glaucoma patients under multiple long-term topical hypotensive therapy.

Methods

Eligible patients underwent evaluation of ocular surface parameters by ocular surface disease index (OSDI) and glaucoma symptom scale (GSS) questionnaires, breakup time test (BUT), Schirmer I test, corneal and conjunctival staining (Oxford scale), and conjunctival in vivo confocal microscopy (Heidelberg Retina Tomograph 3, Heidelberg Engineering GmbH, Heidelberg, Germany). After the baseline visit, patients were randomized to use a PF ophthalmic solution containing HA 0.4% and TAU 0.5%, QID, in both eyes (group 1) or to use a PF ophthalmic solution containing HA 0.2%, QID (group 2) in addition to the ongoing preserved hypotensive treatment. Follow-up visits were scheduled at 30 and 90 days.

Results

Thirty-nine eyes of 39 glaucoma patients were included in the study. At baseline, results of study tests of both groups were similar. After 90 days in group 1 the BUT (p?=?0.01), the Oxford score (p?=?0.03), the conjunctival goblet cells (CGC) density (p?=?0.0005) ,and the two questionnaires score significantly improved (OSDI, p?=?0.003; GSS, p?=?0.003) compared to baseline values, while in group 2 all these parameters did not differ from baseline (BUT, p?=?0.39; Oxford score, p?=?0.54; CGC density, p?=?0.33, OSDI p?=?0.65, GSS, p?=?0.25). The BUT and the CGC density were statistically different between groups both at 30 and 90 days (p?=?0.04 and p?=?0.04, respectively). The Schirmer I test did not statistically change after 90 days in both groups.

Conclusions

The PF ophthalmic solution with HA 0.4% and TAU 0.5% seems to improve CGC density and reduce signs and symptoms of dry eye in glaucoma patients under long-term multiple preserved hypotensive therapy.

Trial registration

ClinicalTrials.gov identifier, NCT03480295.

     

Long-term Efficacy of Safinamide on Parkinson’s Disease Chronic Pain

Introduction

Chronic pain is an important yet overlooked non-motor symptom of Parkinson’s disease (PD), caused by an imbalance of the dopaminergic and glutamatergic systems. Safinamide has a multimodal mechanism of action, dopaminergic (reversible MAO-B inhibition) and non-dopaminergic (modulation of the abnormal glutamate release), that might be beneficial for both motor and non-motor symptoms.

Objectives

To investigate the long-term (2-year) efficacy of safinamide on PD chronic pain and to confirm the positive effects observed after 6 months of treatment.

Methods

This is a post hoc analysis of the data from the 2-year study 018, focused on the reduction of concomitant pain treatments and on the scores of pain-related items of the Parkinson’s disease quality of life questionnaire (PDQ-39).

Results

Safinamide, compared with placebo, significantly improved the PDQ-39 items 37 (“painful cramps or spasm,” p?=?0.0074) and 39 (“unpleasantly hot or cold,” p?=?0.0209) and significantly reduced the number of concomitant pain treatments by 26.2% (p?=?0.005). A significantly greater proportion of patients in the safinamide group was not using pain drugs after 2 years of treatment (p?=?0.0478).

Conclusions

The positive effects of safinamide on PD chronic pain were maintained in the long term. Further investigations are desirable to confirm their clinical relevance.

Funding

Zambon SpA.

     

Differences in the working pattern among wound,ostomy, and continence nurses with and without conducting the specified medical act: a multicenter time and motion study

Background

To overcome the shortage of medical care delivery in the rapidly aging Japanese society, the Ministry of Health, Labour and Welfare in 2010 started to train the nurses to be able to conduct the specified medical acts. The Japanese Nursing Association conducted the educational program to train the wound, ostomy, and continence nurses for the specified medical act of wound care. However, the difference between wound, ostomy, and continence nurses who conducted the medical act and those who did not was not clear. The aim of this study was to determine how trained wound, ostomy, and continence nurses spend their time during their entire shift in an acute hospital setting.

Methods

In this prospective observational study, we selected those wound, ostomy, and continence nurses who received advanced training in the wound management program (T-WN) in 2011–2012. Wound, ostomy, and continence nurses who did not receive the training (N-WN) were also recruited as controls. We conducted a time and motion study during subject's day shifts for 1 week. We calculated the time spent on tasks based on a task classification code that was created to facilitate a two-group comparison.

Results

Six T-WNs and five N-WNs were our analysis subjects. T-WNs spent significantly more time on direct care than did N-WNs (p?=?0.00). Moreover, in the sub-categories s of direct care, T-WN spent significantly more time on “treatment” than did N-WN (p?=?0.01). T-WN spent significantly more time on treatment with (p?=?0.03) or without (p?=?0.01) physicians than did N-WN. In the treatment activities, T-WN performed significantly more time on foot care (p?=?0.01), wound cleansing (p?=?0.01) and conservative sharp wound debridement (p?=?0.01) than did N-WN. Frequencies of direct care interventions for the patients was significantly different between T-WN and N-WN (p?=?0.04).

Conclusions

T-WNs frequently engaged in direct care provided treatment for patients with chronic wounds.

     

Selecting Tumor-Specific Molecular Targets in Pancreatic Adenocarcinoma: Paving the Way for Image-Guided Pancreatic Surgery

Purpose

The purpose of this study was to identify suitable molecular targets for tumor-specific imaging of pancreatic adenocarcinoma.

Procedures

The expression of eight potential imaging targets was assessed by the target selection criteria (TASC)—score and immunohistochemical analysis in normal pancreatic tissue (n?=?9), pancreatic (n?=?137), and periampullary (n?=?28) adenocarcinoma.

Results

Integrin α_vβ₆, carcinoembryonic antigen (CEA), epithelial growth factor receptor (EGFR), and urokinase plasminogen activator receptor (uPAR) showed a significantly higher (all p?<?0.001) expression in pancreatic adenocarcinoma compared to normal pancreatic tissue and were confirmed by the TASC score as promising imaging targets. Furthermore, these biomarkers were expressed in respectively 88 %, 71 %, 69 %, and 67 % of the pancreatic adenocarcinoma patients.

Conclusions

The results of this study show that integrin α_vβ₆, CEA, EGFR, and uPAR are suitable targets for tumor-specific imaging of pancreatic adenocarcinoma.

     

Validation trial for efficacy of ultrasonographic measurement method to predict ascitic volume using virtual ultrasonography

Purpose

The aim of this study was to clarify whether ultrasound quantitative methods were positively correlated with volume of ascites evaluated by whole abdominopelvic CT.

Methods

Sixty-eight patients with cirrhotic ascites were retrospectively analyzed. First, to confirm that virtual ultrasonography (VUS) is an alternative method to conventional ultrasound, 22 patients underwent both conventional ultrasonography and VUS. Second, the efficacy of US quantitative methods (3-point method, 4-point method, 5-point method, and Matsumoto’s method) was confirmed by VUS in 68 patients. We assessed whether the ascites volume predicted by VUS corresponded with that calculated by 3D-CT. Of the 68 patients, 23 patients were analyzed before and after administration of tolvaptan.

Results

The predictive volumes calculated by VUS were remarkably relative to those yielded by conventional US. Correlations between exact volume and those measured by VUS were significantly high (3-point method: r?=?0.882, p?<?0.001; 4-point method: r?=?0.797, p?<?0.001; 5-point method: r?=?0.836, p?<?0.001; Matsumoto’s method: r?=?0.453, p?<?0.001). Correlations between decreasing volume on 3D-CT and that measured by VUS were also significantly high in patients with administration of tolvaptan.

Conclusion

Ascites volume measured by ultrasound was effective, especially the 3-point and 5-point methods. It was useful to assess the efficacy of diuretics in cirrhotic patients.

     

Screening for psychological distress in follow-up care to identify head and neck cancer patients with untreated distress

Purpose

The purpose of the study is to investigate screening in follow-up care to identify head and neck cancer (HNC) patients with untreated psychological distress.

Methods

From November 2009 until December 2012, we investigated the use of OncoQuest (a touch screen computer system to monitor psychological distress (Hospital Anxiety and Depression Scale (HADS)) and quality of life (HRQOL; EORTC QLQ-C30 and H&N35 module) in routine follow-up care. Patients who screened positive for psychological distress (HADS-T >14, HADS-A >7, or HADS-D >7) were asked whether they received psychological or psychiatric treatment.

Results

During the study period of 37 months, OncoQuest was used by 720 individual HNC patients, of whom 714 had complete HADS data. Psychological distress was present in 206 patients (29 %). Of those patients who fulfilled in- and exclusion criteria (n?=?137), 25 received psychological treatment (18 %). Receipt of psychological treatment was significantly related to a higher score on the HADS total scale (19.6 vs. 16.9; p?=?0.019), a lower (worse) score on the EORTC QLQ-C30 scale emotional functioning (46.0 vs. 58.6; p?=?0.023), a higher (worse) score on fatigue (58.2 vs. 46.4; p?=?0.032), problems with sexuality (44.1 vs. 34.4; p?=?0.043), oral pain (43.8 vs. 28.8; p?=?0.011) and speech problems (37.0 vs. 25.3; p?=?0.042).

Conclusions

Screening for psychological distress via OncoQuest is beneficial because 82 % of HNC patients identified with an increased level of distress who do not yet receive mental treatment were identified. Patients who did receive treatment reported more distress and worse quality of life, which may be explained because patients with more severe problems maybe more inclined to seek help or might be detected easier by caregivers and referred to supportive care more often.

     

Implementation and feasibility of the stroke nursing guideline in the care of patients with stroke: a mixed methods study

Background

Nurses often have difficulties with using interdisciplinary stroke guidelines for patients with stroke as they do not focus sufficiently on nursing. Therefore, the Stroke Nursing Guideline (SNG) was developed and implemented. The aim of this study was to determine the implementation and feasibility of the SNG in terms of changes in documentation and use of the guideline in the care of stroke patients on Neurological and Rehabilitation wards, barriers and facilitators, and nurses’ and auxiliary nurses’ view of the implementation.

Methods

A sequential explorative mixed method design was used including pre-test post-test measures and post intervention focus groups interviews. For the quantitative part retrospective electronic record data of nursing care was collected from 78 patients and prospective measures with Barriers and Facilitators Assessment Instrument (BFAI) and Quality Indicator Tool (QIT) from 33 nursing staff including nurses and auxiliary nurses. In the qualitative part focus groups interviews were conducted with nursing staff on usefulness of the SNG and experiences with implementation.

Results

Improved nursing documentation was found for 23 items (N?=?37), which was significant for nine items focusing mobility (p?=?0.002, p?=?0.024, p?=?0.012), pain (p?=?0.012), patient teaching (p?=?0.001, p?=?0.000) and discharge planning (p?=?0.000, p?=?0.002, p?=?0.004). Improved guideline use was found for 20 QIT-items (N?=?30), with significant improvement on six items focusing on mobility (p?=?0.023), depression (p?=?0.033, p?=?0.025, p?=?0.046, p?=?0.046), discharge planning (p?=?0.012). Facilitating characteristics for change were significantly less for two of four BFAI-subscales, namely Innovation (p?=?0.019) and Context (p?=?0.001), whereas no change was found for Professional and Patient subscales. The findings of the focus group interviews showed the SNG to be useful, improving and providing consistency in care. The implementation process was found to be successful as essential components of nursing rehabilitation were defined and integrated into daily care.

Conclusion

Nursing staff found the SNG feasible and implementation successful. The SNG improved nursing care, with increased consistency and more rigorous functional exercises than before. The SNG provides nurses and auxiliary nurses with an important means for evidence based care for patients with stroke. Several challenges of implementing this complex nursing intervention surfaced which mandates ongoing attention.

     

Life and treatment goals of patients with advanced,incurable cancer

Purpose

Goals of care conversations have been suggested as a strategy for helping patients with advanced cancer manage the uncertainty and distress associated with end-of-life care. However, knowledge deficits about patient goals limit the utility of such conversations. We described the life and treatment goals of patients with incurable cancers, including goal values and expectancies. We examined the associations between paramount goals and patient prognosis, performance status, and psychological adjustment.

Methods

Patients with advanced lung cancer, gastrointestinal cancer, or melanoma (N?=?84) completed measures of prognosis for 12-month survival, hope, optimism, depression, and anxiety. Oncologists provided patient performance status and prognosis for 12-month survival. We conducted interviews with a subset of patients (N?=?63), eliciting life and treatment goals, values, and expectancies.

Results

Patient life goals resembled goals among healthy populations; whereas, treatment goals were perceived as separate and more important. Cure and fight cancer emerged as the most important goals. Patients who valued cure the most had worse performance status (M?=?1.46 vs. 0.78) and more depressive symptoms (M?=?6.30 vs. 3.50). Patients who valued fight cancer the most had worse self-prognosis (M?=?69.23 % vs. 86.11 %), fewer treatment goals (M?=?2.08 vs. 3.16), and lower optimism (M?=?15.00 vs. 18.32).

Conclusions

Patients with advanced cancer perceive treatment goals as separate from and more important than life goals. They hold optimistic expectancies for achieving their goals and for survival. Valuing cure highly may put patients at risk for experiencing psychological maladjustment.

     

A Randomized Controlled Clinical Trial Comparing 20 Gauge and 23 Gauge Vitrectomy for Patients with Macular Hole or Macular Pucker

Introduction

To compare the transconjunctival sutureless 23 gauge (G) pars plana vitrectomy (PPV) with 20 G PPV regarding inflammation, safety, visual outcome and patient comfort.

Methods

We included 103 patients with symptomatic macular hole or macular pucker, scheduled for vitrectomy in this prospective, randomized, controlled, mono-center clinical trial. Patients were randomized 1:1 to either 20G PPV (n?=?51) or 23G PPV (n?=?52). All eyes underwent standard 20G or 23G PPV with membrane peeling. Primary outcome measure was change in aqueous humor flare 3 weeks after surgery compared with baseline. Secondary outcome measures were flare values 2 days and 26 weeks after surgery, subjective discomforts measured with a visual analog scale, best-corrected visual acuity, duration of surgery, intraocular pressure (IOP) and adverse events.

Results

There was no significant difference in change of flare 3 weeks after PPV [? 1.7, 95% CI (? 6.3 to 2.9), p?=?0.466]. Both groups showed a significant increase in flare 2 days after surgery (20G: p?<?0.001, 23G: p?=?0.002), but only the 20G group after 3 weeks (p?=?0.011). The gain in visual acuity after 3 weeks was higher after 23G PPV (4.2 95% CI (0.4–8.0, p?=?0.029), but without a difference after 6 months. The duration of surgery was shorter in the 23G group (p?<?0.001). Patient comfort 3 weeks after surgery was greater after 23G PPV (foreign body sensation p?=?0.002; itching: p?=?0.021). However, the rate of complications did not differ between the groups.

Conclusion

The primary aim, showing the superiority of the 23G group regarding the change of flare value from baseline to 3 weeks after surgery, was not met, but the level of inflammation decreased faster after 23G PPV. Clear advantages of the 23G PPV were a lower risk of postoperative IOP elevation, a shorter surgery time, faster visual recovery and greater patient comfort in the early postoperative phase.

Clinical Trial Registration Number

ClinicalTrials.gov NCT01969929.

     

Low-level laser therapy prevents severe oral mucositis in patients submitted to hematopoietic stem cell transplantation: a randomized clinical trial

Purpose

The purpose of this study is to evaluate the effectiveness of low-level laser therapy for the prevention of oral mucositis in patients undergoing hematopoietic stem cell transplantation.

Methods

This is a randomized, parallel, superiority trial including 35 patients divided into the following: laser (n?=?17) and sham (n?=?18). The variables assessed were oral mucositis (grade 2 of the World Health Organization oral toxicity scale), severe oral mucositis (grade 3 or 4), and pain (according to a visual analogue scale). In the laser group, a InGaAlP laser, wavelength of 650 nm, power 100 mW, energy per point of 2 J, time 20 s by point, extremity fiber optic 0.028 cm², and energy density 70 J/cm², was used, applied the first day of conditioning until D + 5, while the sham group received simulated laser over the same period.

Results

No statistically significant difference was found in the incidence of oral mucositis (p?=?0.146). Severe mucositis was found in 40 % of the patients (14/35), 3 in the intervention group (17.65 %) and 11 in the sham group (61.11 %) (p?=?0.015). The cumulative probability of survival with respect to the development of severe oral mucositis was >0.6 for the intervention group and 0 for the control group (p?=?0.0397). On the day on which pain was considered the worst, patients in the sham group were more likely to classify their pain as severe compared to those in the laser group (p?=?0.041).

Conclusion

Low-level laser therapy proved effective for the prevention of severe oral mucositis and intense oral pain in patients submitted to hematopoietic stem cell transplantation.

     

Quantitative [<Superscript>18</Superscript>F]FMISO PET Imaging Shows Reduction of Hypoxia Following Trastuzumab in a Murine Model of HER2+ Breast Cancer

Purpose

Evaluation of [¹⁸F]fluoromisonidazole ([¹⁸F]FMISO)-positron emission tomography (PET) imaging as a metric for evaluating early response to trastuzumab therapy with histological validation in a murine model of HER2+ breast cancer.

Procedures

Mice with BT474, HER2+ tumors, were imaged with [¹⁸F]FMISO-PET during trastuzumab therapy. Pimonidazole staining was used to confirm hypoxia from imaging.

Results

[¹⁸F]FMISO-PET indicated significant decreases in hypoxia beginning on day 3 (P?<?0.01) prior to changes in tumor size. These results were confirmed with pimonidazole staining on day 7 (P?<?0.01); additionally, there was a significant positive linear correlation between histology and PET imaging (r ² ?=?0.85).

Conclusions

[¹⁸F]FMISO-PET is a clinically relevant modality which provides the opportunity to (1) predict response to HER2+ therapy before changes in tumor size and (2) identify decreases in hypoxia which has the potential to guide subsequent therapy.

     

Effects of Tiotropium Combined with Theophylline on Stable COPD Patients of Group B,D and its Impact on Small Airway Function: A Randomized Controlled Trial

Introduction

Tiotropium bromide has been widely used in clinical practice, while theophylline is another treatment option for chronic obstructive pulmonary disease (COPD). However, only a few relevant studies have investigated the long-term outcomes and efficacy of both in patients with COPD. We evaluated the effects of tiotropium and low-dose theophylline on stable COPD patients of groups B and D.

Methods

Eligible participants (n?=?170) were randomized and received either tiotropium 18 µg once daily with theophylline 100 mg twice daily (Group I) or tiotropium 18 µg once daily (Group II) for 6 months. COPD assessment test (CAT), modified Medical Research Council (mMRC) dyspnea scores and pulmonary function tests were measured before randomization and during the treatment.

Results

After 6 months of treatment, the CAT scores in both groups decreased significantly (11.41?±?3.56 and 11.08?±?3.05, p?<?0.0001). The changes of CAT (p?=?0.028) and mMRC scores (p?=?0.049) between the two groups differed after 1 month of treatment. In Group I, forced expiratory flow after 25% of the FVC% predicted (MEF₂₅% pred) was significantly improved after 3 months (4.84?±?8.73%, p?<?0.0001) and 6 months (6.21?±?8.65%, p?<?0.0001). There was a significant difference in small airway function tests (MEF₅₀% pred, MEF₂₅% pred, and MMEF% pred) between the two groups after 6 month of treatment (p?=?0.003, p?<?0.0001, and p?=?0.021, respectively).

Conclusions

Tiotropium combined with low-dose theophylline significantly improved the symptoms and general health of patients with stable COPD of groups B and D after 6 months of follow-up. Additionally, this therapy also improved the indicators of small airway function.

Trial Registration

Chinese Clinical Trial Registry (Registry ID: ChiCTR1800019027).

     

Evaluating the Impact and Benefits of Fluticasone Furoate/Vilanterol in Individuals with Asthma or COPD: A Mixed-Methods Analysis of Patient Experiences

Introduction

This study evaluated patients’ experiences with fluticasone furoate/vilanterol (FF/VI) combination therapy in UK patients with asthma or chronic obstructive pulmonary disease (COPD).

Methods

Participants aged ≥?18 years, with self-reported, physician-diagnosed asthma or COPD (≥?1 year) who had been receiving FF/VI (≥?3 months) were recruited from UK primary care. This two-phase, mixed-methods study consisted of a semi-structured, telephone-interview phase (qualitative) and a self-completed online/paper-survey phase (quantitative).

Results

The telephone-interview phase included 50 individuals [asthma, n?=?25; COPD, n?=?25; mean age (SD) 56.7 years (13.3); 50% female]. Of these, 21 with asthma reported that their condition was stable/well controlled and 13 with COPD felt their condition was manageable. Most participants found FF/VI easy to use (asthma, 25; COPD, 23), easy to integrate into their daily routine (asthma, 25; COPD, 24), and able to control symptoms for ≥?24 h (asthma, 14; COPD, 16). During the survey phase, 199 individuals were recruited [asthma, n?=?100; COPD, n?=?99; mean age (SD) 63.6 years (15.1); 59.3% female]. Most participants were satisfied/very satisfied with the efficacy of FF/VI in terms of all-day symptom relief (asthma, 84%; COPD, 75%) and found FF/VI easy/very easy to fit into their daily routine (asthma, 99%; COPD, 96%), easy/very easy to use (asthma, 97%; COPD, 92%), and convenient/very convenient to take as instructed (asthma, 95%; COPD, 93%). Significantly more individuals with asthma (87% versus 46%, P?<?0.001) and numerically more individuals with COPD (84% versus 76%, P?=?0.055) were satisfied/very satisfied with FF/VI compared with their most recent previous maintenance medication.

Conclusion

The majority of individuals in this study had confidence in FF/VI and were satisfied or very satisfied with various key attributes of the treatment.

Trial Registration

GSK study HO-15-15503/204888.

Funding

GSK.

     

Lack of agreement between thermodilution and electrical velocimetry cardiac output measurements

Objective

The modified algorithm for the non-invasive determination of cardiac output (CO) by electrical bioimpedance—electrical velocimetry (EV^®)—has been reported to give reliable results in comparison with echocardiography and pulmonary arterial thermodilution (PA-TD) in patients either before or after cardiac surgery. The present study was designed to determine whether EV^®-CO measurements reflect intraindividual changes in CO during cardiac surgery.

Design

Prospective, observational study.

Setting

Operating room (OR) and intensive care unit (ICU) of a university hospital.

Patients

Twenty-nine patients undergoing elective cardiac surgery.

Interventions

None.

Measurements

CO was determined simultaneously by PA-TD and EV^® after induction of anesthesia (t1) and 4.9?±?3.5?h after ICU admission (t2).

Results

TD-CO was 3.9?±?1.4 and 5.4?±?1.1 l/min at t1 and t2 (?p?®-CO was 4.3?±?1.1 and 4.9?±?1.5 l/min at t1 and t2 (?p?=?0.013). Bland–Altman analysis showed a bias of ?0.4 l/min and 0.4 l/min and a precision of 3.2 and 3.6 l/min (34.3% and 67.4%) at t1 and t2, respectively. Analysis of the individual pre- to postoperative changes in CO with both methods revealed bidirectional changes in n?=?12 patients and unidirectional changes with a difference greater than 50% and less than 50% in n?=?9 and n?=?8 patients, respectively.

Conclusions

The disagreement between PA-TD and EV^®-CO measurements after anesthesia induction and after ICU admission, as well as the fact that thoracic bioimpedance did not adequately reflect pre- to postoperative changes in CO, questions the reliability of EV^®-CO measurements in cardiac surgery patients and contrasts sharply with previous studies.

     

Qualitative and Quantitative Assessment of Patient and Carer Experience of Chemotherapy (Docetaxel) in Combination with Androgen Deprivation Therapy (ADT) for the Treatment of Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Introduction

Recent studies suggest that docetaxel plus androgen deprivation therapy can prolong survival among men with metastatic hormone-sensitive prostate cancer (mHSPC). However, as a cytotoxic therapy, there is a need to understand the experiences of men with mHSPC receiving docetaxel and their carers in a real-world setting.

Methods

During phase 1, semi-structured qualitative interviews were conducted with men with mHSPC (n?=?31) and their carers (n?=?14) in Europe to elicit in-depth data concerning their experiences with docetaxel. Eighteen men were also asked to record their experiences in a diary for 7 days. During phase 2, men with mHSPC (n?=?161) and carers of men with mHSPC (n?=?135) completed an online survey comprising self-report questionnaires including the Cancer Therapy Satisfaction Questionnaire, Brief Fatigue Inventory, Functional Assessment of Cancer Therapy-Prostate, EuroQol-5-Dimensions and the Burden Scale for Family Caregivers (carers only).

Results

At the outset of therapy, men reported a willingness to take docetaxel to prolong their life, despite being fearful of the potential side effects and impacts on their daily lives. Patient and carer experiences were generally consistent with pre-treatment expectations. However, variations in individual experiences and their ability to tolerate side effects were evident. Fatigue emerged as a prominent symptom with the majority (n?=?98, 60.9%) of men reporting experiencing moderate-severe fatigue in the past 24 h. Participant ratings of fatigue were strongly correlated with health-related quality of life (r?=?? 0.82). Nausea, diarrhoea and sore mouth were also among the most bothersome symptoms for participants.

Conclusions

Findings from this study highlight that real-world experience of docetaxel may differ from that observed in clinical trials and that care must be taken to ensure that treatment options are tailored to the needs of individual patients to promote not only how long patients survive but also the quality of that survival.

Funding

Janssen

     

Prevalence of restless legs syndrome in migraine patients with and without aura: a cross-sectional,case-controlled study

Background

Although the comorbidity of migraine and restless legs syndrome (RLS) has been well-documented, the association between RLS and migraine frequency has yet to be elucidated. The present study aims to evaluate the prevalence of RLS among individuals who experience low-frequency, high-frequency, or chronic migraine presenting with and without aura.

Methods

We conducted a cross-sectional, case-controlled study involving 505 participants receiving outpatient headache treatment. Standardized questionnaires were administered to collect information on experiences of migraine, RLS, sleep quality, anxiety, depression, and demographics. Participants were categorized into low-frequency (1–8/month), high-frequency (9–14/month), and chronic (≥15/month) headache groups. RLS was diagnosed according to the criteria outlined by the International RLS Study Group (IRLSSG). The Pittsburgh Sleep Quality Index (PSQI) and Hospital Anxiety and Depression Scale (HADS) were used to assess sleep quality and identify symptoms of anxiety and depression. Associations between migraine frequency and RLS prevalence were investigated using multivariate linear and logistic regression.

Results

Univariate analysis revealed an effect of migraine frequency on RLS prevalence (p?=?0.026), though this effect did not persist following adjustment for baseline characteristics (p?=?0.256). The trend was robust in patients whose migraines presented with auras (p _univariate?=?0.002; p _multivariate?=?0.043) but not in those without auras (p _univariate and p _multivariate?>?0.05). Higher anxiety [odds ratio (OR)?=?1.18, p?=?0.019] and sleep disturbance (OR?=?1.17, p?=?0.023) scores were associated with higher RLS prevalence.

Conclusions

Higher migraine frequency correlates with a higher prevalence of RLS, particularly among patients with auras.

     

Preoperative pain treatment in acute abdomen in Osogbo,Nigeria: a randomized double-blind placebo-controlled study

Background

Withholding analgesics in acute abdomen for fear of masking clinical features and impairing diagnosis and decision-making is still being practiced despite recent evidence to the contrary. This study assesses the effect of preoperative analgesia on clinical findings, clinical diagnosis, and decision-making in patients with non-trauma acute abdomen.

Method

This is a randomized, double-blind, placebo-controlled study using Tramal, a brand of tramadol, at the ED of LAUTECH Teaching Hospital Osogbo, Nigeria. Ninety-five patients between 18–60 years received Tramal (n?=?46) or placebo (n?=?49). The pain score, clinical findings, provisional diagnosis, and treatment plan were noted before and 15–20 min after administration of the analgesic or placebo. The final diagnosis arrived at after adequate investigation or operation was considered the gold standard. The pain scores, diagnosis, treatment plan, and decision between the two groups were compared. Statistical analysis was by SPSS 16. Results were considered statistically significant at p?<?0.05.

Results

Demography and case distribution were similar in both groups. The improvement in pain was greater in the Tramal group (p?=?0.001). The abdominal palpation findings were also better in the Tramal group (p?=?0.02). There were more changes in the diagnosis after use of Tramal (p?=?0.01). There were more changes in the decision in the Tramal group (p?=?0.03). Most of the changes in diagnosis and decision in the Tramal group were for the better.

Conclusion

The preoperative use of Tramal in acute abdomen improved the experience of pain and did not adversely affect the accuracy of the diagnosis or decision-making.