Measurement of Complement Activation via Plasma-Soluble C5b-9 Comparison with Terminal Complement Complex Staining in a Series of Kidney Biopsies.

INTRODUCTION: With the emergence of therapeutic complement inhibitors, there is a need to identify patients with complement-driven inflammation. C5b-9 is the terminal product of the three complement pathways and therefore a marker of total complement activation. We present a pilot study which aims to assess whether plasma soluble C5b-9 (sC5b-9) correlates with terminal complement complex (TCC) staining in kidney tissue. The secondary aim was to assess the utility of plasma sC5b-9 as part of routine workup in kidney patients undergoing kidney biopsy. METHODS: Thirty-seven patients undergoing kidney biopsy had plasma sC5b-9 and TCC staining on kidney tissue performed. Additional blood markers including creatinine, haemoglobin, CRP, factor H, factor I, and midkine levels were also taken. These parameters were correlated with the histological diagnoses. Patients were divided into a diseased group (n = 31) and a control group (n = 6) consisting of transplanted kidneys with minor or no changes. Of the biopsies in the control group, 50% were performed as per protocol, and the other 50% were performed due to clinical need. RESULTS: There was no correlation found between plasma sC5b-9 and TCC kidney staining. Elevated sC5b-9 levels were found in a heterogeneous group of patients but were associated with higher CRP and lower haemoglobin levels. Overall, there was more TCC kidney staining in the diseased group compared with the control group, and a trend was observed of diabetic, primary membranous nephropathy, and amyloidosis patients having more intense glomerular and peritubular/interstitial staining. CONCLUSION: Plasma sC5b-9 as a marker of total complement activation does not correlate with TCC kidney staining. This discordance suggests that plasma sC5b-9 and TCC staining are distinct markers of disease. TCC staining reflects chronicity and tissue deposition of complement over time. Conversely, plasma sC5b-9 concentrations change rapidly and reflect systemic complement activation. Complement activation was present in a heterogeneous group of kidney disease, indicating the underlying role of complement in many disorders.

Seroprevalence of Torque Teno Virus in hemodialysis and renal transplant patients in Australia: A cross-sectional study.

INTRODUCTION: Torque teno virus (TTV) is a non-pathogenic anellovirus commonly found in the blood of human beings. Emerging data suggest that TTV viral load is proportional to the degree of immunosuppression, but its seroprevalence is unknown in Australia. We aimed to determine the seroprevalence of TTV in an Australian population of renal patients. METHODS: We developed a real-time PCR to measure TTV viral load, using the TaqMan platform and previously published primers and probes. Following ethics approval and informed consent, we collected blood from hemodialysis patients not receiving immunosuppression, and renal transplant patients. All patients were recruited from a single teaching hospital in New South Wales. RESULTS: We enrolled 50 hemodialysis and 30 renal transplant patients. 56 (70%) were males, and the mean (sd) age was 61 (16) years. TTV was detectable in plasma of 40/50 (80%) of hemodialysis patients and 28/30 (93%) of transplant patients. The mean TTV viral load was higher in transplant patients than in dialysis patients (6.3 log versus 5.0 log copies/ml, P = .001). CONCLUSIONS: Torque teno virus is prevalent in Australian renal patients and thus may be a useful novel marker to help tailor immunosuppressive therapy in renal transplant patients. Further work is needed to establish TTV seroprevalence in other regions and patient groups, and to investigate whether there is correlation with clinically important events (infection and rejection episodes) in longitudinal studies.

Patient-reported outcome measures for hip-related pain: a review of the available evidence and a consensus statement from the International Hip-related Pain Research Network, Zurich 2018.

Hip-related pain is a well-recognised complaint among active young and middle-aged active adults. People experiencing hip-related disorders commonly report pain and reduced functional capacity, including difficulties in executing activities of daily living. Patient-reported outcome measures (PROMs) are essential to accurately examine and compare the effects of different treatments on disability in those with hip pain. In November 2018, 38 researchers and clinicians working in the field of hip-related pain met in Zurich, Switzerland for the first International Hip-related Pain Research Network meeting. Prior to the meeting, evidence summaries were developed relating to four prioritised themes. This paper discusses the available evidence and consensus process from which recommendations were made regarding the appropriate use of PROMs to assess disability in young and middle-aged active adults with hip-related pain. Our process to gain consensus had five steps: (1) systematic review of systematic reviews; (2) preliminary discussion within the working group; (3) update of the more recent high-quality systematic review and examination of the psychometric properties of PROMs according to established guidelines; (4) formulation of the recommendations considering the limitations of the PROMs derived from the examination of their quality; and (5) voting and consensus. Out of 102 articles retrieved, 6 systematic reviews were selected and assessed for quality according to AMSTAR 2 (A MeaSurement Tool to Assess systematic Reviews). Two showed moderate quality. We then updated the most recent review. The updated literature search resulted in 10 additional studies that were included in the qualitative synthesis. The recommendations based on evidence summary and PROMs limitations were presented at the consensus meeting. The group makes the following recommendations: (1) the Hip and Groin Outcome Score (HAGOS) and the International Hip Outcome Tool (iHOT) instruments (long and reduced versions) are the most appropriate PROMs to use in young and middle-aged active adults with hip-related pain; (2) more research is needed into the utility of the HAGOS and the iHOT instruments in a non-surgical treatment context; and (3) generic quality of life measures such as the EuroQoL-5 Dimension Questionnaire and the Short Form Health Survey-36 may add value for researchers and clinicians in this field. We conclude that as none of the instruments shows acceptable quality across various psychometric properties, more methods studies are needed to further evaluate the validity of these PROMS-the HAGOS and iHOT-as well as the other (currently not recommended) PROMS.

Physiotherapist-led treatment for young to middle-aged active adults with hip-related pain: consensus recommendations from the International Hip-related Pain Research Network, Zurich 2018.

The 1st International Hip-related Pain Research Network meeting discussed four prioritised themes concerning hip-related pain in young to middle-aged adults: (1) diagnosis and classification of hip-related pain; (2) patient-reported outcome measures for hip-related pain; (3) measurement of physical capacity for hip-related pain; (4) physiotherapist-led treatment for hip-related pain. Thirty-eight expert researchers and clinicians working in the field of hip-related pain attended the meeting. This manuscript relates to the theme of physiotherapist-led treatments for hip-related pain. A systematic review on the efficacy of physiotherapist-led interventions for hip-related pain (published separately) was conducted and found that strong evidence for physiotherapist-led treatments was lacking. Prior to the meeting, draft consensus recommendations for consideration in the meeting were also developed based on the systematic review. The draft consensus recommendations were presented to all of the meeting participants via email, at least 1 week prior to the meeting. At the meeting, these recommendations were discussed, revised and voted on. Six recommendations for clinical practice and five recommendations for research were included and all gained consensus. Recommendations for clinical practice were that (i) Exercise-based treatments are recommended for people with hip-related pain. (ii) Exercise-based treatment should be at least 3 months duration. (iii) Physiotherapist-led rehabilitation after hip surgery should be undertaken. (iv) Patient-reported outcome measures, measures of physical impairment and measures of psychosocial factors should be used to monitor response to treatment. (v) Physical activity (that may include sport) is recommended for people with hip-related pain. (vi) Clinicians should discuss patient expectations, use shared-decision making and provide education. Recommendations for research were (i) Reporting of exercise programmes: Exercise descriptors such as load magnitude, number of repetitions and sets, duration of whole programme, duration of contractile element of exercise, duration of one repetition, time under tension, rest between repetitions, range of motion through which the exercise is performed, and rest between exercise sessions should be reported. (ii) Research should investigate the optimal frequency, intensity, time, type, volume and progression of exercise therapy. (iii) Research should examine the effect of patient education in people with hip-related pain. (iv) Research should investigate the effect of other treatments used in people with hip-related pain (for example: manual therapy, medications, injections). (v) Research should examine the impact of comorbidities and social determinants on treatment effectiveness in people with hip-related pain. Clinicians and researchers working with young to middle-aged active adults with hip-related pain may use these consensus recommendations to guide, develop, test and implement individualised, evidence-based physiotherapist-led rehabilitation programmes.

Consensus recommendations on the classification, definition and diagnostic criteria of hip-related pain in young and middle-aged active adults from the International Hip-related Pain Research Network, Zurich 2018.

There is no agreement on how to classify, define or diagnose hip-related pain-a common cause of hip and groin pain in young and middle-aged active adults. This complicates the work of clinicians and researchers. The International Hip-related Pain Research Network consensus group met in November 2018 in Zurich aiming to make recommendations on how to classify, define and diagnose hip disease in young and middle-aged active adults with hip-related pain as the main symptom. Prior to the meeting we performed a scoping review of electronic databases in June 2018 to determine the definition, epidemiology and diagnosis of hip conditions in young and middle-aged active adults presenting with hip-related pain. We developed and presented evidence-based statements for these to a panel of 37 experts for discussion and consensus agreement. Both non-musculoskeletal and serious hip pathological conditions (eg, tumours, infections, stress fractures, slipped capital femoral epiphysis), as well as competing musculoskeletal conditions (eg, lumbar spine) should be excluded when diagnosing hip-related pain in young and middle-aged active adults. The most common hip conditions in young and middle-aged active adults presenting with hip-related pain are: (1) femoroacetabular impingement (FAI) syndrome, (2) acetabular dysplasia and/or hip instability and (3) other conditions without a distinct osseous morphology (labral, chondral and/or ligamentum teres conditions), and that these terms are used in research and clinical practice. Clinical examination and diagnostic imaging have limited diagnostic utility; a comprehensive approach is therefore essential. A negative flexion-adduction-internal rotation test helps rule out hip-related pain although its clinical utility is limited. Anteroposterior pelvis and lateral femoral head-neck radiographs are the initial diagnostic imaging of choice-advanced imaging should be performed only when requiring additional detail of bony or soft-tissue morphology (eg, for definitive diagnosis, research setting or when planning surgery). We recommend clear, detailed and consistent methodology of bony morphology outcome measures (definition, measurement and statistical reporting) in research. Future research on conditions with hip-related pain as the main symptom should include high-quality prospective studies on aetiology and prognosis. The most common hip conditions in active adults presenting with hip-related pain are: (1) FAI syndrome, (2) acetabular dysplasia and/or hip instability and (3) other conditions without distinct osseous morphology including labral, chondral and/or ligamentum teres conditions. The last category should not be confused with the incidental imaging findings of labral, chondral and/or ligamentum teres pathology in asymptomatic people. Future research should refine our current recommendations by determining the clinical utility of clinical examination and diagnostic imaging in prospective studies.

Standardised measurement of physical capacity in young and middle-aged active adults with hip-related pain: recommendations from the first International Hip-related Pain Research Network (IHiPRN) meeting, Zurich, 2018.

Hip-related pain can significantly impact quality of life, function, work capacity, physical activity and family life. Standardised measurement methods of physical capacity of relevance to young and middle-aged active adults with hip-related pain are currently not established. The aim of this consensus paper was to provide recommendations for clinical practice and research on standardised measurement methods of physical capacity in young and middle-aged active adults with hip-related pain. Four areas of importance were identified: (1) clinical measures (range of motion, muscle strength, functional impairments), (2) laboratory-based measures (biomechanics and muscle function (muscle activity, size and adiposity)), (3) physical activity, and (4) return to sport/performance. The literature was reviewed, and a summary circulated to the working group to inform discussion at the consensus meeting. The working group developed clinical and research recommendations from the literature review, which were further discussed and modified within the working group at the consensus meeting. These recommendations were then presented to all 38 International Hip-related Pain Research Network (IHiPRN) participants for further discussion, refinement and consensus voting. Therefore, the recommendations voted on were based on a combination of current evidence and expert opinion. The consensus meeting voted on 13 recommendations, six of which were clinically orientated, and seven more research specific. We recommended that clinicians working with young and middle-aged active adults with hip-related pain assess strength using objective methods of measurement, and clinically assess performance of functional tasks, including walking and running. Physical activity should be quantified using both self-reported and objective measures, and patient expectations of recovery should be quantified prior to treatment. It was recommended that return to physical activity (including sport and occupation) be quantified, and sport-specific activities should be assessed prior to return to sport. The IHiPRN participants were uncertain regarding recommendations for range of motion assessment. Research recommendations were that the measurement properties of range of motion, strength and functional performance tests be investigated, reported and improved in both clinical and research settings. Reporting of movement-related parameters (biomechanics and muscle function) should be standardised and the relationship among movement-related parameters, symptoms, function, quality of life, and intra-articular and imaging findings should be investigated. Quantification of return to physical activity (including sport and occupational demands) is required in future research, and the return to sport continuum should be used. Future research is required to determine the best criteria for rehabilitation progression and return to physical activity following hip-related pain management.

Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial.

BACKGROUND: Previous randomised renal denervation studies did not show consistent efficacy in reducing blood pressure. The objective of our study was to evaluate the effect of renal denervation on blood pressure in the absence of antihypertensive medications. METHODS: SPYRAL HTN-OFF MED was a multicentre, international, single-blind, randomised, sham-controlled, proof-of-concept trial. Patients were enrolled at 21 centres in the USA, Europe, Japan, and Australia. Eligible patients were drug-naive or discontinued their antihypertensive medications. Patients with an office systolic blood pressure (SBP) of 150 mm Hg or greater and less than 180 mm Hg, office diastolic blood pressure (DBP) of 90 mm Hg or greater, and a mean 24-h ambulatory SBP of 140 mm Hg or greater and less than 170 mm Hg at second screening underwent renal angiography and were randomly assigned to renal denervation or sham control. Patients, caregivers, and those assessing blood pressure were blinded to randomisation assignments. The primary endpoint, change in 24-h blood pressure at 3 months, was compared between groups. Drug surveillance was done to ensure patient compliance with absence of antihypertensive medication. The primary analysis was done in the intention-to-treat population. Safety events were assessed at 3 months. This study is registered with ClinicalTrials.gov, number NCT02439749. FINDINGS: Between June 25, 2015, and Jan 30, 2017, 353 patients were screened. 80 patients were randomly assigned to renal denervation (n=38) or sham control (n=42) and followed up for 3 months. Office and 24-h ambulatory blood pressure decreased significantly from baseline to 3 months in the renal denervation group: 24-h SBP -5·5 mm Hg (95% CI -9·1 to -2·0; p=0·0031), 24-h DBP -4·8 mm Hg (-7·0 to -2·6; p<0·0001), office SBP -10·0 mm Hg (-15·1 to -4·9; p=0·0004), and office DBP -5·3 mm Hg (-7·8 to -2·7; p=0·0002). No significant changes were seen in the sham-control group: 24-h SBP -0·5 mm Hg (95% CI -3·9 to 2·9; p=0·7644), 24-h DBP -0·4 mm Hg (-2·2 to 1·4; p=0·6448), office SBP -2·3 mm Hg (-6·1 to 1·6; p=0·2381), and office DBP -0·3 mm Hg (-2·9 to 2·2; p=0·8052). The mean difference between the groups favoured renal denervation for 3-month change in both office and 24-h blood pressure from baseline: 24-h SBP -5·0 mm Hg (95% CI -9·9 to -0·2; p=0·0414), 24-h DBP -4·4 mm Hg (-7·2 to -1·6; p=0·0024), office SBP -7·7 mm Hg (-14·0 to -1·5; p=0·0155), and office DBP -4·9 mm Hg (-8·5 to -1·4; p=0·0077). Baseline-adjusted analyses showed similar findings. There were no major adverse events in either group. INTERPRETATION: Results from SPYRAL HTN-OFF MED provide biological proof of principle for the blood-pressure-lowering efficacy of renal denervation. FUNDING: Medtronic.

What is the prevalence of imaging-defined intra-articular hip pathologies in people with and without pain? A systematic review and meta-analysis.

BACKGROUND: Intra-articular hip pathologies are thought to be associated with the development of hip and groin pain. A better understanding of the relationship between symptoms and imaging findings may improve the management of individuals with intra-articular hip pathologies. OBJECTIVE: To undertake a systematic review and meta-analysis to determine the prevalence of intra-articular hip pathologies in individuals with and without pain. METHODS: Seven electronic databases were searched in February 2017 for studies investigating the prevalence of intra-articular hip pathologies using MRI, MRA or CT. Two independent reviewers conducted the search, study selection, quality appraisal and data extraction. Meta-analysis was performed when studies were deemed homogenous, with a strength of evidence assigned to pooled results. RESULTS: In general, studies were moderate to high risk of bias, with only five studies adjudged to be low risk of bias. The 29 studies reporting on the prevalence of intra-articular hip pathologies identified limited evidence of a labral tear prevalence of 62% (95% CI 47% to 75%) in symptomatic individuals, with moderate evidence identifying a labral tear prevalence of 54% (95% CI 41% to 66%) in asymptomatic individuals. Limited evidence demonstrated a cartilage defect prevalence of 64% (95% CI 25% to 91%) in symptomatic individuals, compared with moderate evidence of a cartilage defect prevalence of 12% (95% CI 7% to 21%) in asymptomatic individuals. CONCLUSION: The prevalence of intra-articular hip pathologies is highly variable in both symptomatic and asymptomatic populations. The prevalence of intra-articular hip pathologies appears to be higher in symptomatic individuals. However, imaging-defined intra-articular hip pathologies are also frequently seen in asymptomatic individuals, highlighting a potential discordant relationship between imaging pathology and pain. PROSPERO REGISTRATION NUMBER: CRD42016035444.

High screen failure rate in patients with resistant hypertension: Findings from SYMPLICITY HTN-3.

BACKGROUND: The SYMPLICITY HTN-3 trial, which randomized subjects to renal denervation (RDN) or sham control, was designed to evaluate the efficacy and safety of RDN for the treatment of resistant hypertension. Outcomes were previously reported. This retrospective analysis evaluated reasons for screen failure (SF) for randomization in the trial. METHODS: SYMPLICITY HTN-3 enrolled subjects with office systolic blood pressure (SBP) ≥160 mmHg on stable and maximal doses of ≥3 antihypertensive medication classes. Blood pressure was measured during screening visit (SV) 1 and SV2 a minimum of 2 weeks later to ensure resistant hypertension and to exclude white-coat hypertension. We analyzed baseline characteristics and reasons for SF at each SV and changes in BP between SVs. RESULTS: Among 1,415 patients screened, 880 (62%) did not meet criteria for randomization. Compared with randomized patients, those in the SF cohort were more likely to be older (58.7 vs. 57.4 years, P=.029), current smokers (14.5% vs. 10.7%, P=.041), and prescribed fewer antihypertensive medications (4.7 vs. 5.1, P<.001). The predominant reason for SF at SV2 was office SBP <160 mmHg despite office SBP ≥160 mmHg at SV1. CONCLUSION: Screening patients with resistant hypertension on maximal doses of ≥3 antihypertensive drugs led to a high SF rate. Screen failures were most common at SV1 and were due to failing the office SBP entry criteria. Not meeting ambulatory SBP criteria at SV2 was a secondary reason for SF, often due to white-coat hypertension; thus, 24-hour ambulatory monitoring is important to validate resistant hypertension.

A Systematic Review on the Effectiveness of Interventions to Improve Hand Hygiene Compliance of Nurses in the Hospital Setting.

PURPOSE: The purpose of the present systematic review is to identify the interventions that improve hand hygiene compliance (HHC) specifically among nurses. METHODS: A systematic review was performed guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses to evaluate the short and long-term effects of interventions to promote hand hygiene practices among nurses in the hospital setting. A search of the Cumulative Index to Nursing and Allied Health Literature, Medline Global Health, and Embase was conducted in addition to studies identified by the most recent systematic review. Six studies met inclusion criteria: three randomized controlled trials (RCTs), one controlled before and after studies (CBAs), and two interrupted times series (ITS). FINDINGS: One RCT reported effectiveness and 6-month sustainability of the effect related to multimodal-directed and multimodal with team leadership-directed strategies. The other two RCTs found positive effect of education and feedback on compliance; however, compliance rates declined after 1 month. Education was also found to improve HHC up to 3 months postintervention. An electronic reminder and feedback system evaluated by an ITS improved HHC and detected variation in HHC through the day. CONCLUSIONS: This review showed that single and combined interventions do improve hand hygiene practices among nurses; however, there is a need for more methodologically robust studies to define the most effective and sustainable interventions. CLINICAL RELEVANCE: Although hand hygiene is the most effective measure to prevent healthcare-associated infections, compliance with hand hygiene remains low. Nurses are among the healthcare providers who spend the most time in direct patient contact. Therefore, there is a need for research to identify the interventions that improve HHC in this group.

What are participant beliefs regarding physical therapy led treatment? A qualitative study of people living with femoroacetabular impingement syndrome.

BACKGROUND: Physical therapist-led treatment programs are recommended for patients with femoroacetabular impingement (FAI) syndrome. Views of people with FAI syndrome regarding such interventions are currently unknown, including perceptions of potential barriers and facilitators to participation and adherence to exercise programs. OBJECTIVES: To explore participant perceptions of physical therapist-led programs for FAI syndrome, including barriers and facilitators for accessing physical therapy, and adhering to a rehabilitation program. METHODS: Our qualitative study used semi-structured interviews to explore the perceptions of patients with FAI syndrome undertaking physical therapy-led treatment, where treatment was ceased due to Coronavirus Disease 2019 (COVID-19). The interview topic guide was informed by the Theoretical Domain Framework. Interviews were transcribed verbatim and data categories were developed using inductive thematic analysis. Themes were discussed between researchers until consensus was reached. RESULTS: Fourteen participants (mean age: 30 years) with a range of physical activity backgrounds undertook interviews. We identified four key themes, 1) Patients believed their hip pain was caused by structural damage worsened through exercise; 2) Barriers and facilitators on the feasibility of physical therapist-led programs; 3) Participants held beliefs regarding the importance of adjunct treatments to exercise; and 4) Impact of FAI syndrome on physical activity participation. CONCLUSION: People with FAI syndrome believe they have structural damage which leads to their hip pain and are often afraid to exercise due to fear of causing more damage to their hip. Our findings suggest that people with FAI syndrome want clear education about exercise, imaging, and expectations of cost and duration of treatment.

Will you get what you want? Treatment goals and expectations of patients with femoroacetabular impingement syndrome regarding physiotherapist-led treatment.

OBJECTIVE: To (i) investigate the goals and expectations of participants enrolled in a clinical trial of physiotherapist-led treatment for femoroacetabular impingement (FAI) syndrome and (ii) explore associations between their expectations and self-reported hip burden and kinesiophobia. METHODS: Data from 150 participants with FAI syndrome who participated in a clinical trial were analysed. Participants described their most important treatment goal and the expectation of achieving this goal throughout physiotherapy treatment. The International Hip Outcome Tool (iHOT-33) subscales were used to assess self-reported hip burden. The Tampa Scale for Kinesiophobia was used to assess kinesiophobia. Participants goals were qualitatively analysed using content analysis. Linear regression was used to explore associations between patient expectations and iHOT and Tampa Scale for Kinesiophobia scores. RESULTS: Participants with FAI syndrome reported goals relating to exercise (52%), improving activities of daily living quality (23%), improving physical function (15%), and reducing pain (10%). Negative expectations regarding physiotherapist-led treatment were reported by 68% of participants. Those with negative expectations reported worse scores for the iHOT-Total score (mean difference = 12 points, 95%CI = [4 to 19]), and iHOT-Symptoms (14 points, [7 to 21]) and iHOT-Social (11 points, [2 to 21]) subscales compared to those with positive expectations. Treatment expectations were not associated with iHOT-Sport, iHOT-Job, and Tampa Scale for Kinesiophobia scores (p > 0.05). CONCLUSION: Patients with FAI syndrome had a generally negative expectation of physiotherapist-led treatment. There was a mismatch between patients' goals and current treatment approaches. Participants with FAI syndrome and negative expectations reported worse quality of life, symptoms, and social concerns than those with positive expectations.

Patient Preferences for Pharmaceutical and Device-Based Treatments for Uncontrolled Hypertension: Discrete Choice Experiment.

BACKGROUND: Discrete choice experiment is a survey method used to understand how individuals make decisions and to quantify the relative importance of features. Using discrete choice experiment methods, we quantified patient benefit-risk preferences for hypertension treatments, including pharmaceutical and interventional treatments, like renal denervation. METHODS: Respondents from the United States with physician-confirmed uncontrolled hypertension selected between treatments involving a procedure or pills, using a structured survey. Treatment features included interventional, noninterventional, or no hypertension treatment; number of daily blood pressure (BP) pills; expected reduction in office systolic BP; duration of effect; and risks of drug side effects, access site pain, or vascular injury. The results of a random-parameters logit model were used to estimate the importance of each treatment attribute. RESULTS: Among 400 patients completing the survey between 2020 and 2021, demographics included: 52% women, mean age 59.2±13.0 years, systolic BP 155.1±12.3 mm Hg, and 1.8±0.9 prescribed antihypertensive medications. Reduction in office systolic BP was the most important treatment attribute. The remaining attributes, in decreasing order, were duration of effect, whether treatment was interventional, number of daily pills, risk of vascular injury, and risk of drug side effects. Risk of access site pain did not influence choice. In general, respondents preferred noninterventional over interventional treatments, yet only a 2.3 mm Hg reduction in office systolic BP was required to offset this preference. Small reductions in office systolic BP would offset risks of vascular injury or drug side effects. At least a 20% risk of vascular injury or drug side effects would be tolerated in exchange for improved BP. CONCLUSIONS: Reduction in systolic BP was identified as the most important driver of patient treatment preference, while treatment-related risks had less influence. The results indicate that respondents would accept interventional treatments in exchange for modest reductions in systolic BP compared with those observed in renal denervation trials.

The relationship between kinesiophobia and self-reported outcomes and physical function differs between women and men with femoroacetabular impingement syndrome.

BACKGROUND: There is no evidence whether kinesiophobia affects women and men with femoroacetabular impingement (FAI) syndrome differently. OBJECTIVE: To explore the association between kinesiophobia, quality of life (QoL), pain, and physical function in people with FAI syndrome, and to compare the level of kinesiophobia between women and men with FAI syndrome. METHODS: One-hundred-fifty participants with FAI syndrome (51% women) completed assessment of the following: kinesiophobia with the Tampa Scale for Kinesiophobia; patient reported outcome measures (PROMs) (pain, physical function, health- and hip-related QoL); physical function (side bridge, hop for distance, and one leg rise); and active hip range of motion (flexion, external rotation, internal rotation). RESULTS: Greater kinesiophobia was correlated with worse hip-related QoL (rho=-0.58; p<0.001), self-reported physical function (rho=-0.42; p<0.001), health-related QoL (rho=-0.46; p<0.001), and pain levels (rho=-0.46; p<0.001). In women, kinesiophobia was also associated with worse physical function (hop for distance r=-0.38; p=0.001 and side bridge rho=-0.24; p=0.036) explaining 36% of the variation of the hip-related QoL, 29% of the health-related QoL, and 27% of the self-reported physical function. In men, kinesiophobia explained 35%, 12%, and 10%, respectively. CONCLUSION: In people with FAI syndrome, greater kinesiophobia was associated with worse PROMs, but not with hip range of motion. No sex-related differences in mean kinesiophobia scores were found. In women, an association was found between kinesiophobia and worse performance in physical tests. These findings might indicate that kinesiophobia plays a more important role in the clinical presentation of women with FAI syndrome than men.

Does the use of i-FACTOR bone graft affect bone healing in those undergoing periacetabular osteotomy (PAO) for developmental dysplasia of the hip (DDH)? A retrospective study.

The aims of this study were to compare, in patients with and without the use of i-FACTOR bone graft during periacetabular osteotomy (PAO) surgery for developmental dysplasia of the hip (DDH), (i) bone healing at six-weeks post-operatively (ii) rate of complications. This was a retrospective review of case records. Participants were people aged 15-50 years undergoing rectus-sparing minimally invasive PAO surgery for DDH. Group 1: patients with i-FACTOR, Group 2: No i-FACTOR. The primary outcome was the rate of bone healing on radiographs at 6 weeks. The likelihood of bone healing was compared using logistic regression with Generalised Estimating Equations (GEE) and expressed as odds ratios (95% confidence intervals (CIs; P < 0.05)). The occurrence of complications was extracted from surgical records. The i-FACTOR group had 3-times greater odds of partial/full union than those without [adjusted odds ratio (95% CIs, P-value)]: [3.265 (1.032 to 10.330, P = 0.044)]. The i-FACTOR group had 89% partial/full union at 6-weeks, compared to 69% of the non-i-FACTOR group. Half of the patients had leaking of bone graft in the i-FACTOR group versus 10% in the non-i-FACTOR group, 26% of the i-FACTOR group and 12% of the non-i-FACTOR group had neuropraxia of the lateral femoral cutaneous nerve (LFCN). Complication rates were low, and similar between groups. However, the rate of LFCN neuropraxia and bone graft leakage was higher in the i-FACTOR. These findings should be confirmed in a future prospective randomised clinical trial and include outcomes such as pain and quality of life.

Relationship between hip muscle strength and hip biomechanics during running in people with femoroacetabular impingement syndrome.

BACKGROUND: Hip muscle weakness and altered hip biomechanics during walking are often observed in people with femoroacetabular impingement syndrome, although little is known about biomechanics during higher impact tasks. The aim of our study was to explore relationships between hip muscle strength and hip biomechanics during running in people with femoroacetabular impingement syndrome, including exploring sex as an effect-modifier of this relationship. METHODS: Forty-two adults with unilateral femoroacetabular impingement syndrome (20 females; age 18-50 years; alpha angle ≥60°) completed assessments of hip muscle strength and hip biomechanics during running. Strength was assessed using a hand-held dynamometer for the hip flexors, extensors, abductors, adductors, internal rotators, and external rotators. Hip biomechanics were assessed during overground running (3-3.5 m/s) using three-dimensional motion capture and a force plate. Linear models assessed the relationships between hip strength and hip biomechanics of the symptomatic limb, controlling for body mass and running velocity along with an interaction term (strength*sex). FINDINGS: A significant negative relationship was observed between hip external rotator strength and hip frontal plane range of motion (i.e., excursion), independent of sex (estimate = -0.039, 95%CI -0.071 to -0.008, P = 0.02). Four sex-specific interactions were observed, with a significant positive relationship between hip external rotator strength and peak hip extension moment in women (estimate = -0.413, 95%CI -0.713 to -0.114, P = 0.01) but not in men. INTERPRETATION: We found significant relationships between hip external rotator strength and stance phase running biomechanics, providing further understanding on two impaired physical measures that may inform exercise-based management strategies in femoroacetabular impingement syndrome.

Ethiopian Pediatric Society Quality Improvement Initiative: a pragmatic approach to facility-based quality improvement in low-resource settings.

OBJECTIVES: To describe critical features of the Ethiopian Pediatric Society (EPS) Quality Improvement (QI) Initiative and to present formative research on mentor models. SETTING: General and referral hospitals in the Addis Ababa area of Ethiopia. PARTICIPANTS: Eighteen hospitals selected for proximity to the EPS headquarters, prior participation in a recent newborn care training cascade and minimal experience with QI. INTERVENTIONS: Education in QI in a 2-hour workshop setting followed by implementation of a facility-based QI project with the support of virtual mentorship or in-person mentorship. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome-QI progress, measured using an adapted Institute for Healthcare Improvement Scale; secondary outcome-contextual factors affecting QI success as measured by the Model for Understanding Success in Quality. RESULTS: The dose and nature of mentoring encounters differed based on a virtual versus in-person mentoring approach. All QI teams conducted at least one large-scale change. Education of staff was the most common change implemented in both groups. We did not identify contextual factors that predicted greater QI progress. CONCLUSIONS: The EPS QI Initiative demonstrates that education in QI paired with external mentorship can support implementation of QI in low-resource settings. This pragmatic approach to facility-based QI may be a scalable strategy for improving newborn care and outcomes. Further research is needed on the most appropriate instruments for measuring contextual factors in low/middle-income country settings.

Informed consent rates for neonatal randomized controlled trials in low- and lower middle-income versus high-income countries: A systematic review.

OBJECTIVE: Legal, ethical, and regulatory requirements of medical research uniformly call for informed consent. We aimed to characterize and compare consent rates for neonatal randomized controlled trials in low- and lower middle-income countries versus high-income countries, and to evaluate the influence of study characteristics on consent rates. METHODS: In this systematic review, we searched MEDLINE, EMBASE and Cochrane for randomized controlled trials of neonatal interventions in low- and lower middle-income countries or high-income countries published 01/01/2013 to 01/04/2018. Our primary outcome was consent rate, the proportion of eligible participants who consented amongst those approached, extracted from the article or email with the author. Using a generalised linear model for fractional dependent variables, we analysed the odds of consenting in low- and lower middle-income countries versus high-income countries across control types and interventions. FINDINGS: We screened 3523 articles, yielding 300 eligible randomized controlled trials with consent rates available for 135 low- and lower middle-income country trials and 65 high-income country trials. Median consent rates were higher for low- and lower middle-income countries (95.6%; interquartile range (IQR) 88.2-98.9) than high-income countries (82.7%; IQR 68.6-93.0; p<0.001). In adjusted regression analysis comparing low- and lower middle-income countries to high-income countries, the odds of consent for no placebo-drug/nutrition trials was 3.67 (95% Confidence Interval (CI) 1.87-7.19; p = 0.0002) and 6.40 (95%CI 3.32-12.34; p<0.0001) for placebo-drug/nutrition trials. CONCLUSION: Neonatal randomized controlled trials in low- and lower middle-income countries report consistently higher consent rates compared to high-income country trials. Our study is limited by the overrepresentation of India among randomized controlled trials in low- and lower middle-income countries. This study raises serious concerns about the adequacy of protections for highly vulnerable populations recruited to clinical trials in low- and lower middle-income countries.

Physiotherapist-led treatment for femoroacetabular impingement syndrome (the PhysioFIRST study): a protocol for a participant and assessor-blinded randomised controlled trial.

INTRODUCTION: This double-blind, randomised controlled trial (RCT) aims to estimate the effect of a physiotherapist-led intervention with targeted strengthening compared with a physiotherapist-led intervention with standardised stretching, on hip-related quality of life (QOL) or perceived improvement at 6 months in people with femoroacetabular impingement (FAI) syndrome. We hypothesise that at 6 months, targeted strengthening physiotherapist-led treatment will be associated with greater improvements in hip-related QOL or greater patient-perceived global improvement when compared with standardised stretching physiotherapist-led treatment. METHODS AND ANALYSIS: We will recruit 164 participants with FAI syndrome who will be randomised into one of the two intervention groups, both receiving one-on-one treatment with the physiotherapist over 6 months. The targeted strengthening physiotherapist-led treatment group will receive a personalised exercise therapy and education programme. The standardised stretching physiotherapist-led treatment group will receive standardised stretching and personalised education programme. Primary outcomes are change in hip-related QOL using International Hip Outcome Tool-33 and patient-perceived global improvement. Secondary outcomes include cost-effectiveness, muscle strength, range of motion, functional task performance, biomechanics, hip cartilage structure and physical activity levels. Statistical analyses will make comparisons between both treatment groups by intention to treat, with all randomised participants included in analyses, regardless of protocol adherence. Linear mixed models (with baseline value as a covariate and treatment condition as a fixed factor) will be used to evaluate the treatment effect and 95% CI at primary end-point (6 months). ETHICS AND DISSEMINATION: The study protocol was approved (La Trobe University Human Ethics Committee (HEC17-080)) and prospectively registered with the Australian New Zealand Clinical Trials Registry. The findings of this RCT will be disseminated through peer reviewed scientific journals and conferences. Patients were involved in study development and will receive a short summary following the completion of the RCT. TRIAL REGISTRATION NUMBER: ACTRN12617001350314.