Self-reported Clinical Outcomes Research Articles

Stride management assist exoskeleton vs functional gait training in stroke: A randomized trial.

To test the hypothesis that gait training with a hip-assistive robotic exoskeleton improves clinical outcomes and strengthens the descending corticospinal drive to the lower limb muscles in persons with chronic stroke. Fifty participants completed the randomized, single-blind, parallel study. Participants received over-ground gait training with the Honda Stride Management Assist (SMA) exoskeleton or intensity-matched functional gait training, delivered in 18 sessions over 6-8 weeks. Performance-based and self-reported clinical outcomes were measured at baseline, midpoint, and completion, and at a 3-month follow-up. Corticomotor excitability (CME) of 3 bilateral leg muscles was measured using transcranial magnetic stimulation. The primary outcome, walking speed, improved for the SMA group by completion of the program (0.24 ± 0.14 m/s difference, p < 0.001). Compared to the functional group, SMA users had greater improvement in walking endurance (46.0% ± 27.4% vs 35.7% ± 20.8%, p = 0.033), took more steps during therapy days (4,366 ± 2,426 vs 3,028 ± 1,510; p = 0.013), and demonstrated larger changes in CME of the paretic rectus femoris (178% ± 75% vs 33% ± 32%, p = 0.010). Participants with hemorrhagic stroke demonstrated greater improvement in balance when using the SMA (24.7% ± 20% vs 6.8% ± 6.7%, p = 0.029). Gait training with the SMA improved walking speed in persons with chronic stroke, and may promote greater walking endurance, balance, and CME than functional gait training. NCT01994395. This study provides Class I evidence that gait training with a hip-assistive exoskeleton increases clinical outcomes and CME in persons with chronic stroke, but does not significantly improve walking speeds compared to intensity-matched functional gait training.

Vitality Measured as Self-reported Energy Level and Clinical Outcomes in Hemodialysis Patients: The Japanese Dialysis Outcomes and Practice Pattern Study (J-DOPPS)

The infrequent assessment of vitality in clinical practice may be partially due to an inadequate understanding of vitality and the lack of a concise method of assessing it. This study aimed to examine the association of a simple 1-item "vitality" question measuring self-reported energy level with clinical outcomes. Prospective cohort study. 3,667 hemodialysis patientsparticipating in the Japanese Dialysis Outcomes and Practice Pattern Study (J-DOPPS), phases 3 to 4 (2005-2011). Responses to a single question from the 12-item Medical Outcomes Study Short Form survey, version 2.0: "How much time during the past 4 weeks did you have a lot of energy?," recorded using a 5-level Likert scale. All-cause mortality and a composite of cardiovascular hospitalizations and all-cause mortality. A pooled ordered logit model was fit to examine correlates of self-reported energy level. Cox and mixed-effects negative binomial regression models were fit for mortality and the composite outcome. Lower self-reported energy level was associated with tachycardia and use of benzodiazepines, hypnotics, and antidepressants. In contrast, higher energy was associated with higher single-pool Kt/V, serum albumin concentration, and body mass index. Compared to the lowest energy level, the second-highest and middle levels were associated with lower all-cause mortality (adjusted HRs [aHRs] of 0.66 [95% CI, 0.47-0.93] and 0.75 [95% CI, 0.59-0.96], respectively). Each 1-level higher self-reported energy was associated with lower mortality (aHR, 0.86; 95% CI, 0.78-0.96). Associations between self-reported energy level and multiple cardiovascular hospitalizations and mortality were similar to those between self-reported energy and mortality. No psychometric assessments were done for the Short Form survey. The response to a single "vitality" question addressing self-reported energy level is associated with adverse clinical outcomes and correlated with potentially modifiable factors.

Understanding Disease Burden Among Persons with Hemophilia Α without Inhibitors

Abstract Introduction Previous studies have reported significant disease burden in persons with hemophilia A (PwHA) who develop inhibitors to factor VIII. However, disease burden in PwHA without inhibitors (PwHA-WO) is not well understood across severities. The CHOICE Project was conducted in partnership between the US Centers for Disease Control and Prevention and the Hemophilia Federation of America to survey persons with bleeding disorders of varying severity, male and female, in the US. Participants in the CHOICE Project included both patients receiving care at federally funded hemophilia treatment centers (HTC) and those who do not receive care at HTCs. The objective of the study was to assess and characterize self-reported clinical outcomes, care, and quality of life (QoL) of PwHA-WO across all disease severities. Methods A retrospective analysis was conducted of data collected through the CHOICE Project, a cross-sectional survey, from April 2013 to July 2015. Adults (≥18 years) and caregivers of children with hemophilia A (HA) were recruited to take the 20-minute CHOICE survey, online or on paper, in English or Spanish. The overall response rate to survey questions was approximately 87%, but it varied by survey item, as participants could opt not to respond to certain questions. PwHA-WO were defined as HA persons that reported no current or past factor VIII inhibitors. In this analysis, self-reported demographics, bleed- and joint-related outcomes, treatment, and QoL among PwHA-WO were descriptively analyzed by self-reported disease severity. Results Of the total 429 PwHA surveyed, 328 (76%) reported no current or past inhibitors (PwHA-WO). The majority of PwHA-WO were adults (59%), males (80%), non-Hispanic (76%), or white (63%) and had commercial insurance (68%). More than a quarter reported depression or anxiety, while 13% and 23% reported diagnosis of human immunodeficiency virus and hepatitis C, respectively. Most patients reported seeking care from a hematologist (96%) or at an HTC (63%). Among PwHA-WO, a higher proportion reported having severe HA (severe, 63%; moderate, 15%; mild, 22%). Overall, 94% of PwHA-WO reported they had ever experienced a bleed (severe, 96%; moderate, 96%; mild, 88%; p=0.42), and more than 85% reported they had ever had a joint bleed (severe, 88%; moderate, 91%; mild, 72%; p=0.006). In the last 12 months, approximately 73% reported a joint bleed (severe, 76%; moderate, 78%; mild, 56%; p=0.025) and 65% reported a bleed in another location (severe, 70%; moderate, 62%; mild, 51%; p=0.17). About 15% and 22% of PwHA-WO reported a history of synovectomy (severe, 18%; moderate, 7%; mild, 11%; p=0.30) or joint replacement surgery (severe, 28%; moderate,19%; mild, 5%; p=0.015). Over 28% of PwHA-WO reported having joint problems such as pain, stiffness, and loss of motion "always" or "frequently" (severe, 32%; moderate, 29%; mild, 15%; p=0.23). About a quarter responded that these problems "always" or "frequently" limited their daily work/school, recreational, and/or self-care activities (severe, 29%; moderate, 24%; mild, 20%; p=0.46). On average, PwHA-WO reported 16 missed days from work, school, or usual activities due to their disease (severe, 12; moderate, 30; mild, 16; p=0.014). Nearly 66% of PwHA-WO reported using over-the-counter pain medication in the last 30 days (severe, 62%; moderate, 80%; mild, 67%; p=0.31) and over a third reported using prescription pain medication over the same period (severe, 44%; moderate, 30%; mild, 11%; p=0.01). Conclusions This study suggests that considerable clinical, emotional, and day-to-day disease burden exists in PwHA-WO, even among those with mild and moderate severity. Although joint bleed-related outcomes varied by severity, patients with moderate HA reported joint-related outcomes comparable to those with severe HA. However, limitation of daily activities did not differ by severity. PwHA-WO with mild, moderate and severe HA reported limitation in physical activities, which can impair their QoL. Better understanding of disease burden by severity among PwHA-WO will help in planning future interventions to address these burdens and improve health outcomes. Disclosures Owens: Divitius LLC: Employment; Genentech Inc.: Consultancy; HFA: Consultancy. Cyhaniuk:Independent Contractor: Consultancy; HFA: Employment; AC Analytical Solutions, LLC: Employment. Patel:Genentech Inc: Employment. Raimundo:Genentech Inc: Employment, Other: Ownership interests PLC. Chan:Hemophilia Federation of America: Employment. Ko:Genentech Inc: Employment; F. Hoffmann-La Roche Ltd: Other: Ownership interests non-PLC.

Use of a patient-centred educational exchange (PCEE) to improve patient’s self-management of medicines after a stroke: a randomised controlled trial study protocol

IntroductionNational and international guidelines make recommendations for secondary prevention of stroke including the use of medications. A strategy which engages patients in a conversation to personalise evidence-based educational material (patient-centred...

Associations Between Pain Patterns and Self-Reported Clinical Outcomes in Patients with Knee Osteoarthritis

To study pain locations and patterns in knee osteoarthritis (OA) and determine associations between knee pain patterns and pain characteristics, functional status, and psychological status. A cross-sectional study. A convenience sample of 203 patients with knee OA was recruited from two university-affiliated hospitals from July 2016 to July 2017. Pain locations were recorded with Photographic Knee Pain Map. Pain characteristics, functional dysfunction, pain catastrophizing, and pain self-efficacy were assessed, and demographic and radiographic data were also collected. Self-reported clinical outcomes across common pain patterns were compared. The medial joint line area (72.9%) was the most prevalent pain zone. The common pain patterns were diffuse (34.5%), isolated medial (22.7%), isolated anterior (9.9%), and medial-lateral pain (9.9%). Scores of intermittent pain (mean difference [MD] = 9.669, 95% confidence interval [CI] = 2.815 to 16.523) and knee-related function in daily living (MD = -10.353, 95% CI= -17.358 to -3.349) were worse in diffuse pain compared with isolated medial pain. Knee-related symptom scores were higher with isolated medial (MD = 13.146, 95% CI = 6.725 to 19.566), isolated anterior (MD = 15.102, 95% CI = 6.525 to 23.679), and medial-lateral (MD = 15.281, 95% CI = 6.704 to 23.857) pain relative to diffuse pain. Diffuse pain, after adjusting for confounding factors, was associated with more severe knee pain at rest, higher scores of constant and intermittent pain, lower knee-related function scores, higher pain catastrophizing, and lower pain self-efficacy scores (P < 0.05). The most common pattern is diffuse pain, which is associated with worse knee pain intensity at rest, constant and intermittent pain experiences, and worse physical and psychological status, compared with more localized patterns.

Platelet-rich plasma (PRP) therapy for knee arthritis: a feasibility study in primary care

BackgroundPlatelet-rich plasma (PRP) is a concentrate of autologous blood growth factors which has been shown to provide some symptomatic relief in early osteoarthritis (OA) of the knee. The objective of this study was to test the feasibility and efficacy potential of platelet rich plasma (PRP) in primary care. MethodsFeasibility study to assess safety of the intervention procedures and assess primary and secondary outcome measures. Consecutive patients presenting with symptomatic knee OA were recruited in a primary care setting in Ireland. All participants received three injections of PRP 4 weeks apart. The following self-reported clinical outcomes were evaluated before and after therapy (4 months): Pain and disability (ICOAP questionnaire); health utility (EUROQol); adverse events; patient satisfaction and goal-orientated outcomes.ResultsSeventeen potential patients were identified of whom 14 were eligible to participate. Twelve consented and completed the intervention and all outcome measures. There were no losses to follow-up. One patient reported pain and stiffness for 2 days after the first injection but did complete the study. No growth was detected from nine consecutive samples sent for microbiology analysis. Changes in constant, intermittent and total pain scores were reported; pain fully resolved in two patients. In addition, health utility, patient satisfaction and goal-orientated outcomes also demonstrated improvement.ConclusionsPlatelet-rich plasma therapy is a simple and minimally invasive intervention which is feasible to deliver in primary care to treat osteoarthritis of the knee joint. Well-designed randomised controlled trials are needed to measure outcomes, durability of effect and cost effectiveness.

Knee crepitus is prevalent in women with patellofemoral pain, but is not related with function, physical activity and pain

Objectives(i) To assess the reliability of knee crepitus measures, (ii) to investigate the association between knee crepitus and PFP; (iii) to investigate the relationship between knee crepitus with self-reported function, physical activity and pain. DesignCross-sectional. SettingLaboratory-based study. Participants165 women with PFP and 158 pain-free women. Main outcome measuresKnee crepitus test, anterior knee pain scale (AKPS) and self-reported worst knee pain in the last month, knee pain after 10 squats and knee pain after 10 stairs climbing. ResultsKnee crepitus clinical test presented high reliability Kappa value for PFP group was 0.860 and for pain-free group was 0.906. There is a significantly greater proportion of those with crepitus in the PFP group than in the pain-free group (OR = 4.19). Knee crepitus had no relationship with function (rpb = 0.03; p = 0.727), physical activity level (rpb = 0.010; p = 0.193), worst pain (rpb = 0.11; p = 0.141), pain climbing stairs (rpb = 0.10; p = 0.194) and pain squatting (rpb = 0.02; p = 0.802). ConclusionWomen who presents knee crepitus have 4 times greater odds to be in a group with PFP compared to those who do not. However, knee crepitus has no relationship with self-reported clinical outcomes of women with PFP.

Kinesio Taping Improves Perceptions of Pain and Function of Patients With Knee Osteoarthritis: A Randomized, Controlled Trial

Context: Although increasingly used for therapeutic treatment, only limited evidence exists regarding the effects of kinesio taping on patients with knee osteoarthritis (OA). Objective: To determine the effects of kinesio taping on pain, function, gait, and neuromuscular control concerning patients with knee OA. Design: Randomized sham-controlled trial. Setting: University laboratory. Participants: A total of 141 patients (65.1 [7.0] y) with a clinical and radiographic diagnosis of knee OA. Intervention: Kinesio tape, sham tape, or no tape for 3 consecutive days. Main Outcome Measures: Self-reported pain, stiffness, and function were measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Further tests included the Balance Error Scoring System, 10-m walk test, the maximum voluntary isometric contraction force of the quadriceps femoris, and knee active range of motion. Results: At baseline, there were no differences in all outcomes between groups except for knee flexion. Significant effects were found for WOMAC pain (tape vs sham, P = .05; tape vs control, P = .047), stiffness (tape vs sham, P = .01; tape vs control, P ≤ .001), and physical function (tape vs sham, P = .03; tape vs control P = .004). No interactions were found for balance, muscle strength, walking speed, or active range of motion. Conclusion: Wearing kinesio tape for 3 consecutive days had beneficial effects regarding self-reported clinical outcomes of pain, joint stiffness, and function. This emphasizes that kinesio taping might be an adequate conservative treatment for the symptoms of knee OA.

Corrigendum to "Self-Reported Adverse Drug Reactions, Medication Adherence, and Clinical Outcomes among Major Depressive Disorder Patients in Ethiopia: A Prospective Hospital Based Study".

[This corrects the article DOI: 10.1155/2017/5812817.].

A Pre-Operative Exercise Intervention Can Be Safely Delivered to People with Femoroacetabular Impingement and Improve Clinical and Biomechanical Outcomes.

Purpose: This study aimed to investigate the effects of a pre-hip arthroscopy exercise intervention on hip strength, pain, and function in individuals with femoroacetabular impingement (FAI). Methods: A total of 20 individuals with FAI completed a 10-week, partially supervised exercise programme; this included three phases of increasing resistance and functionality, consisting of four to six exercises per phase. Hip strength in all six directions; hip pain; function, as measured by the Hip disability and Osteoarthritis Outcome Score (HOOS); and objective physical function, as measured by the Timed Stair Climb test, were determined before and after the intervention. Results: Maximum isometric hip strength significantly increased in abduction (p=0.008), adduction (p=0.021), and internal rotation (p=0.006) at follow-up. Increases in flexion, extension, and external rotation strength did not reach statistical significance. Self-reported HOOS pain (p<0.01) and activities of daily living sub-scale scores (p<0.01) significantly improved at follow-up. Timed Stair Climb times (p<0.001) also significantly decreased at follow-up. Conclusion: A 10-week exercise programme can be safely completed by adults with FAI before surgery, and statistically significant changes in strength, function, and self-reported clinical outcomes can be achieved.

Radiographic Analysis of the Lumbosacral Juncture: Is There a Critical Sacral Angle for Total Disc Replacement?

Study DesignRetrospective review of a patient cohort through a prospective study.PurposeTo determine whether there are correlations between radiographic measurements, including sacral slope (SS) and pelvic incidence (PI), and self-reported clinical outcomes among single-level L5/S1 ProDisc-L patients.Overview of LiteratureThe lumbosacral juncture presents unique biomechanical challenges with respect to artificial disc replacement (ADR) because of its orientation and consequential shear loading. Reports of inferior outcomes at L5/S1 compared to those of the outcomes at the levels above, including increased facet joint pain, suggest a relationship with the sacral inclination at L5/S1.MethodsPlain standing lateral radiographs of 71 patients (age, 26–65 years) who underwent ADR at L5/S1 for degenerative disc disease were reviewed. SS and PI were measured based on pretreatment and initial follow-up standing films. Patient's average adjusted self assessments included the Oswestry disability index and visual analog scale for pain 2 years after ADR. Correlation coefficients were computed to evaluate relationships between radiographic parameters and clinical outcomes. Analysis of covariance was used to evaluate multivariate relationships among factors, including radiographic parameters, body mass index (BMI), and clinical outcomes.ResultsSS and PI values were obtained from 71 patients. The average SS was 33.3° and average PI was 39.9°. At the 24-month follow-up, no significant correlations (p≥0.05) were observed between radiographic parameters and clinical outcomes. BMI, age, and sex did not explain any variability in the relationships between clinical outcomes and SS and PI.ConclusionsWe reviewed a large range of SS angles and found no associations between SS, PI, or BMI and clinical outcomes after ADR at L5/S1. These preliminary results demonstrate that ADR provided maintainence of pain relief and functional improvement for a wide range of SS angles, suggesting that steeper angles are not a contraindication for ADR.

Financial barriers and adverse clinical outcomes among patients with cardiovascular-related chronic diseases: a cohort study

BackgroundSome patients with cardiovascular-related chronic diseases such as diabetes and heart disease report financial barriers to achieving optimal health. Previous surveys report that the perception of having a financial barrier is associated with self-reported adverse clinical outcomes. We sought to confirm these findings using linked survey and administrative data to determine, among patients with cardiovascular-related chronic diseases, if there is an association between perceived financial barriers and the outcomes of: (1) disease-related hospitalizations, (2) all-cause mortality and (3) inpatient healthcare costs.MethodsWe used ten cycles of the nationally representative Canadian Community Health Survey (administered between 2000 and 2011) to identify a cohort of adults aged 45 and older with hypertension, diabetes, heart disease or stroke. Perceived financial barriers to various aspects of chronic disease care and self-management were identified (including medications, healthful food and home care) from the survey questions, using similar questions to those used in previous studies. The cohort was linked to administrative data sources for outcome ascertainment (Discharge Database, Canadian Mortality Database, Patient Cost Estimator). We utilized Poisson regression techniques, adjusting for potential confounding variables (age, sex, education, multimorbidity, smoking status), to assess for associations between perceived financial barriers and disease-related hospitalization and all-cause mortality. We used gross costing methodology and a variety of modelling approaches to assess the impact of financial barriers on hospital costs.ResultsWe identified a cohort of 120,752 individuals over the age of 45 years with one or more of the following: hypertension, diabetes, heart disease or stroke. One in ten experienced financial barriers to at least one aspect of their care, with the two most common being financial barriers to accessing medications and healthful food. Even after adjustment, those with at least one financial barrier had an increased rate of disease-related hospitalization and mortality compared to those without financial barriers with adjusted incidence rate ratios of 1.36 (95% CI: 1.29–1.44) and 1.24 (1.16–1.32), respectively. Furthermore, having a financial barrier to care was associated with 30% higher inpatient costs compared to those without financial barriers.DiscussionThis study, using novel linked national survey and administrative data, demonstrates that chronic disease patients with perceived financial barriers have worse outcomes and higher resource utilization, corroborating the findings from prior self-report studies. The overall exposure remained associated with the primary outcome even in spite of adjustment for income. This suggests that a patient’s perception of a financial barrier might be used in clinical and research settings as an additional measure along with standard measures of socioeconomic status (ie. income, education, social status).ConclusionsAfter adjusting for relevant covariates, perceiving a financial barrier was associated with increased rates of hospitalization and mortality and higher hospital costs compared to those without financial barriers. The demonstrable association with adverse outcomes and increased costs seen in this study may provide an impetus for policymakers to seek to invest in interventions which minimize the impact of financial barriers.

Increased preoperative knowledge reduces surgery-related anxiety: a randomised clinical trial in 100 spinal stenosis patients.

To assess the impact of preoperative knowledge on anxiety, health-related quality of life (HRQoL), disability, and pain in surgically treated spinal stenosis patients. One hundred patients were randomised into an intervention group (IG, n=50) or control group (CG, n=50). Both groups received routine preoperative patient education. IG additionally underwent a feedback session based on a knowledge test. Primary outcome measure was anxiety at the time of surgery. HRQoL, disability, and pain constituted the secondary outcome measures during a 6-month follow-up. In IG, a significant reduction in anxiety was noted after the intervention, whereas in CG, anxiety reduced only after the surgery. In both groups, a significant improvement in HRQoL, disability, and pain was noticed at the 6-month follow-up, but there were no between-group differences. Higher knowledge level may reduce preoperative anxiety but does not seem to affect the self-reported clinical outcomes of surgery.

Risk adjustment of self-reported clinical outcomes in Dutch mental health care

Aim A meaningful comparison of clinical outcomes of mental health care providers requires risk adjustment of case mix variables that affect treatment outcome. The first goal of the present study was to describe the risk adjustment method we applied to routine outcome monitoring data in The Netherlands. Second, the consequences of risk adjustment for the ranking of providers were investigated.

Self-Reported Adverse Drug Reactions, Medication Adherence, and Clinical Outcomes among Major Depressive Disorder Patients in Ethiopia: A Prospective Hospital Based Study.

Background There is paucity of data on prevalence of Adverse Drug Reactions (ADRs) and adherence and clinical outcomes of antidepressants. The present study determined the magnitude of ADRs of antidepressants and their impact on the level of adherence and clinical outcome. Methods A prospective cross-sectional study was conducted among depression patients from September 2016 to January 2017 at Gondar University Hospital psychiatry clinic. The Naranjo ADR probability scale was employed to assess the ADRs. The rate of medication adherence was determined using Morisky Medication Adherence Measurement Scale-Eight. Results Two hundred seventeen patients participated in the study, more than half of them being males (122; 56.2%). More than one-half of the subjects had low adherence to their medications (124; 57.1%) and about 186 (85.7%) of the patients encountered ADR. The most common ADR was weight gain (29; 13.2%). More than one-half (125; 57.6%) of the respondents showed improved clinical outcome. Optimal level of medication adherence decreased the likelihood of poor clinical outcome by 56.8%. Conclusion ADRs were more prevalent. However, adherence to medications was very poor in the setup. Long duration of depression negatively affects the rate of adherence. In addition, adherence was found to influence the clinical outcome of depression patients.

Do peer-support groups for voice-hearers work? A small scale study of Hearing Voices Network support groups in Australia

Hearing Voices Network (HVN) support groups have proliferated in the last decade, with anecdotal evidence suggesting they contribute significantly to the recovery trajectory of the voice-hearer members who attend them. However, to date there remains little empirical research into the efficacy of these groups and the processes that might underpin their efficacy. This article describes a small project evaluating the HVN groups in the large Australian state of New South Wales. Twenty-nine group members completed questionnaires exploring self-reported recovery-related and clinical outcomes, aspects of group process, and the extent to which core HVN principles were promoted within the group. Results indicate that HVN groups are associated with reported improvements across a number of recovery-related outcomes including feeling less isolated and more skilled in being with others, having improved self-esteem, and having a better understanding of their voice experiences. Positive changes were also noted in outcomes that are more traditionally associated with clinical improvements, such as decreased need for emergency help and medication, and increased hope in personal recovery. Although this study is small and based on self-report, the findings are promising and contribute to the small but growing literature on peer-supported interventions for psychosis and psychotic-like experiences.

Impact of estrogen type on cardiovascular safety of combined oral contraceptives

ObjectivesThe International Active Surveillance study “Safety of Contraceptives: Role of Estrogens” (INAS-SCORE) investigated the cardiovascular risks associated with the use of a combined oral contraceptive (COC) containing dienogest and estradiol valerate (DNG/EV) compared to established COCs in a routine clinical setting. Study DesignTransatlantic, prospective, noninterventional cohort study conducted in the United States and seven European countries with two main exposure groups and one exposure subgroup: new users of DNG/EV and other COC (oCOC), particularly levonorgestrel-containing COCs (LNG). All self-reported clinical outcomes of interest (OoI) were validated via attending physicians and relevant source documents. Main OoI were serious cardiovascular events (SCE), particularly venous thromboembolic (VTEs) events. Comprehensive follow-up procedures were implemented. Statistical analyses were based on Cox regression models. ResultsA total of 50,203 new COC users were followed up for up to 5.5years (mean value, 2.1years). Overall 20.3% and 79.7% of these women used DNG/EV and oCOC (including 11.5% LNG users), respectively. A low loss to follow-up of 3.1% was achieved. Based on 47 (VTE) and 233 (SCE) events, the primary analysis (European data set) yielded adjusted hazard ratios for DNG/EV vs. oCOC of 0.4 and 0.5, respectively. The upper bounds of the 95% confidence intervals were 0.98 (VTE) and 0.96 (SCE). The corresponding hazard ratios for DNG/EV vs. LNG showed similar point estimates but the confidence intervals included unity. ConclusionDNG/EV is associated with similar or even lower cardiovascular risk compared to oCOC and LNG. Implication StatementA COC containing DNG and EV is associated with similar or even lower cardiovascular risk compared to COCs containing levonorgestrel or other progestogens.

The client “experiencing” scale as a predictor of treatment outcomes: A meta-analysis on psychotherapy process

Objective: The experiencing scale (EXP) is an often used measure of client's depth of processing and meaning-making in-session. While research suggests that “client experiencing” predicts psychotherapy outcomes, this relationship has never been summarized in a meta-analysis. We examine this specific client factor as an in-session process predictor of good treatment outcomes. Method: A meta-analysis quantified the relationship between client experiencing and therapy outcomes using a total of 10 studies and 406 clients. Results: Analysis indicated that client experiencing is a small to medium predictor of standardized symptom improvements at final treatment outcomes with an effect of r = −.19 (95% CI −.10 to −.29), which we consider a “best estimate” for robustly quantifying the association between EXP and self-reported clinical outcomes. However, effects were higher (i.e., r = −.25) when observational measures of outcome were also included: Subgroup analyses indicated that EXP effects were moderated by the modality of outcome measurement (i.e., symptom reports vs. observational measures). On the other hand, statistical index, treatment phase, or treatment approach did not have significant impacts, which addresses some perennial questions in the EXP literature. Conclusions: Client experiencing is a small to medium predictor of treatment outcomes and a probable common factor.

Cardiovascular risks associated with the use of drospirenone-containing combined oral contraceptives

ObjectivesThe “Long-term Active Surveillance Study for Oral Contraceptives” investigated the risks of long-term use of a 21-day regimen of drospirenone and ethinylestradiol (DRSP) compared to established oral contraceptives (OCs) in a routine clinical setting. Study designProspective, controlled, non-interventional cohort study conducted in seven European countries with three main exposure groups: new users of DRSP, levonorgestrel-containing OCs (LNG), and OCs containing other progestogens (Other OCs). All self-reported clinical outcomes of interest (OoI) were validated via attending physicians and relevant source documents. Main OoI were serious clinical outcomes, in particular cardiovascular events. Comprehensive follow-up procedures were implemented. Statistical analyses were based on Cox regression models. ResultsA total of 1,113 study centers enrolled 59,510 women. Overall 28%, 26% and 45% of these women used DRSP, LNG and Other OCs, respectively. Study participants were followed for up to ten years (mean value, 5.4years), which generated 318,784 woman-years (WY) of observation. Low loss to follow-up and drop-out rates of 2.9% and 16.8% were achieved. DRSP, LNG, and Other OCs showed similar incidence rates of venous thromboembolism. Corresponding hazard ratios (HRs) were close to unity. For arterial thromboembolic events (ATE) and initiation of antihypertensive treatment statistically significant lower risks were found for DRSP compared to LNG and Other OCs. ConclusionDRSP use was associated with similar general health risks and a low risk of ATE compared to OCs containing other progestogens. Implication statementThe 21-day regimen of drospirenone-containing combined oral contraceptives is associated with similar risk of VTE compared to other combined oral contraceptives as well as potentially with a lower risk of ATE.

Determination of Giardia duodenalis assemblages and multi-locus genotypes in patients with sporadic giardiasis from England.

BackgroundThe protozoan Giardia duodenalis is a common but highly diverse human parasite that comprises a complex of seven morphologically identical genetic assemblages, further divided into sub-assemblages. There is very little information available on the diversity of Giardia sub-assemblages and multi-locus genotypes infecting people in the United Kingdom. In this study we studied the molecular epidemiology of Giardia in symptomatic patients from North West England.MethodsWhole faecal DNA was extracted from the faecal samples of 406 Giardia cases and the parasites assemblage, sub-assemblage and multi-locus genotype were determined using PCR amplification, DNA sequencing and phylogenetic analysis of the beta-giardin, glutamate dehydrogenase, triose-phosphate isomerase and small-subunit ribosomal RNA genes. Information about age, gender and self-reported clinical outcomes was also collected from the patients to check for differences associated with the infecting Giardia assemblage.ResultsOur results showed a difference in the age prevalence of the two assemblages, with assemblage A being more common in older cases. Cases infected with assemblage B more often reported vomiting and a longer illness than cases infected with assemblage A. The majority of infections (64 %) were caused by assemblage B followed by assemblage A (33 %), while mixed-assemblage infections were rare (3 %). Assemblage A isolates mostly belonged to the sub-assemblage AII and showed completed identity with previously described isolates. The level of genetic sub-structuring was significantly higher in assemblage B isolates, since a higher proportion of novel assemblage B sequences was detected compared to assemblage A. A high number of assemblage B sequences showed heterogeneous nucleotide positions that prevented the unambiguous assignment to a specific sub-assemblage. Both previously described and novel multi-locus genotypes were described in both assemblages, and up to 17 different assemblage B multi-locus genotypes were found.ConclusionsWe have produced the first data on the parasite multi-locus genotypes in the UK and have demonstrated that the molecular diversity of Giardia is similar to other developed countries. Furthermore, we showed that the parasite assemblages infecting humans may be associated with patients of different ages and with different clinical outcomes.Electronic supplementary materialThe online version of this article (doi:10.1186/s13071-015-1059-z) contains supplementary material, which is available to authorized users.