A Randomized Controlled Trial of Topical Analgesia Post-Hemorrhoidectomy (TAPH Trial).

BACKGROUND: Postoperative pain remains the greatest problem after hemorrhoidectomy. Pain is hypothesized to arise from bacterial infection, sphincter spasm, and local inflammation. OBJECTIVE: A randomized controlled factorial trial was conducted to assess the effects of metronidazole, diltiazem, and lidocaine on post-hemorrhoidectomy pain. DESIGN: A double blinded randomized controlled factorial trial. SETTINGS: A multicenter trial was conducted in Auckland, New Zealand. PATIENTS: 192 Participants were randomized (1:1:1:1) into four parallel arms. INTERVENTIONS: Participants were randomized into one of four groups receiving topical treatment with 10% metronidazole (M), 10% metronidazole + 2% diltiazem (MD), 10% metronidazole + 4% lidocaine (ML), or 10% metronidazole + 2% diltiazem + 4% lidocaine (MDL). Participants were instructed to apply to the anal verge 3 times daily for 7 days. MAIN OUTCOME MEASURES: The primary outcome was pain on the visual analogue scale on day 4. The secondary outcomes included analgesia usage, pain on bowel motion, and functional recovery index. RESULTS: There was no significant difference in the pain and recovery scores when diltiazem or lidocaine was added to metronidazole (score difference between presence and absence of D in the formulation: -3.69, 95% CI: -13.3, 5.94, p = 0.46; between presence and absence of L: -5.67, 95% CI: -15.5, 3.80, p = 0.24). The combination of MDL did not further reduce pain. Secondary analysis revealed a significant difference between the best (ML) and worst (MDL) groups in both pain and functional recovery scores. There were no significant differences in analgesic usage, complications, or return to work between the groups. No clinically important adverse events were reported. The adverse event rate did not change in the intervention groups. LIMITATIONS: Topical metronidazole was utilized in the control group, rather than a pure placebo. CONCLUSION: There was no significant difference in pain when topical diltiazem or lidocaine, or both, was added to topical metronidazole. CLINICAL TRIAL REGISTRATION IDENTIFIER: NCT04276298.

Improving Golden Hour Care Coordination: Using Defined Roles to Improve Nurse Confidence and Care Coordination of Neonates Following Admission.

STUDY AIM: To investigate whether use of admission lanyards improves nurse confidence, care coordination, and infant health outcomes during neonatal emergency admissions. METHODS: Admission lanyards that defined team roles, tasks, and responsibilities were evaluated in a mixed-methods, historically controlled, and nonrandomized intervention study. Methods included (i) 81 pre- and postintervention surveys to explore nurse confidence, (ii) 8 postintervention semistructured interviews to elicit nurse perceptions of care coordination and nurse confidence, and (iii) a quantitative comparison of infant care coordination and health outcomes for 71 infant admissions before and 72 during the intervention. RESULTS: Nurse participants reported that using lanyards during neonatal admissions improved clarity of roles and responsibilities, communication, and task delegation, contributing to better admission flow, team leadership, accountability, and improved nurse confidence. Care coordination outcomes showed significantly improved time to stabilization for intervention infants. Radiographies for line placement were performed 14.4 minutes faster, and infants commenced intravenous nutrition 27.7 minutes faster from time of admission. Infant health outcomes remained similar between groups. CONCLUSION: Admission lanyards were associated with improved nurse confidence and care coordination during neonatal emergency admissions, significantly reducing time to stabilization for infants, shifting outcomes closer to the Golden Hour.

Tiotropium treatment for bronchiectasis: a randomised, placebo-controlled, crossover trial.

BACKGROUND: Tiotropium via the HandiHaler device is an established long-acting, anticholinergic bronchodilator that prevents exacerbations and improves lung function in patients with chronic obstructive pulmonary disease. We hypothesised that tiotropium would reduce pulmonary exacerbations and improve lung function in patients with stable bronchiectasis and airflow limitation, and assessed the effect of tiotropium on these outcomes. METHODS: In a randomised, double-blind, two-period crossover trial, we recruited adult patients from three hospitals in New Zealand. Patients were excluded if they had a smoking history of >20 pack-years. Patients were assigned to either the tiotropium-placebo or placebo-tiotropium sequence in a 1:1 ratio, using randomly permuted blocks stratified by centre. Participants and investigators were masked to treatment allocation. Eligible patients received tiotropium 18 µg via HandiHaler daily for 6 months followed by 6 months of placebo, or vice versa, with a washout period of 4 weeks. The primary end-point was rate of event-based exacerbations during the 6-month period. Primary analyses were carried out in an intention-to-treat set. RESULTS: 90 patients were randomly assigned and 85 completed both treatment cycles. The rate of exacerbations was 2.17 per year under the tiotropium treatment and 2.27 per year under placebo (rate ratio 0.96, 95% CI 0.72-1.27; p=0.77). Tiotropium, compared with placebo, improved forced expiratory volume in 1 s by 58 mL (95% CI 23-92 mL; p=0.002). Adverse events were similar under both treatments. CONCLUSIONS: Tiotropium via HandiHaler over 6 months significantly improved lung function but not frequency of exacerbations. Further research is required to understand the clinical context and significance of these findings.

Development of a Bronchoscopy-Radiologic Skills and Task Assessment Tool (BRadSTAT): A Tool for Evaluating the Radiological Skills of Bronchoscopists with Different Experience.

BACKGROUND: Competency using radiologic images for bronchoscopic navigation is presumed during subspecialty training, but no assessments objectively measure combined knowledge of radiologic interpretation and ability to maneuver a bronchoscope into peripheral airways. OBJECTIVES: The objectives of this study were (i) to determine whether the Bronchoscopy-Radiology Skills and Tasks Assessment Tool (BRadSTAT) discriminates between bronchoscopists of various levels of experience and (ii) to improve construct validity using study findings. METHODS: BRadSTAT contains 10 questions that assess chest X-ray and CT scan interpretation using multiple images per question and 2 technical skill assessments. After administration to 33 bronchoscopists (5 Beginners, 9 Intermediates, 10 Experienced, and 9 Experts), discriminative power was strengthened using differential weighting on CT-related questions, producing the BRadSTAT-CT score. Cut points for both scores were determined via cross-validation. RESULTS: Mean BRadSTAT scores for Beginner, Intermediate, Experienced, and Expert were 74 (±13 SD), 78 (±14), 86 (±9), and 88 (±8), respectively. Statistically significant differences were noted between Expert and Beginner, Expert and Intermediate, and Experienced and Beginner (all p ≤ 0.05). Mean BRadSTAT-CT scores for Beginner, Intermediate, Experienced, and Expert were 63 (±14), 74 (±15), 82 (±13), and 90 (±9), respectively, all statistically significant (p ≤ 0.03). Cut points for BRadSTAT-CT had lower sensitivity but greater specificity and accuracy than for BRadSTAT. CONCLUSION: BRadSTAT represents the first validated assessment tool measuring knowledge and skills for bronchoscopic access to peripheral airways, which discriminates between bronchoscopists of various experience levels. Refining BRadSTAT produced the BRadSTAT-CT, which had higher discriminative power. Future studies should focus on their usefulness in competency-based bronchoscopy programs.

Effect of Low-Sodium versus Conventional Sodium Dialysate on Left Ventricular Mass in Home and Self-Care Satellite Facility Hemodialysis Patients: A Randomized Clinical Trial.

BACKGROUND: Fluid overload in patients undergoing hemodialysis contributes to cardiovascular morbidity and mortality. There is a global trend to lower dialysate sodium with the goal of reducing fluid overload. METHODS: To investigate whether lower dialysate sodium during hemodialysis reduces left ventricular mass, we conducted a randomized trial in which patients received either low-sodium dialysate (135 mM) or conventional dialysate (140 mM) for 12 months. We included participants who were aged >18 years old, had a predialysis serum sodium ≥135 mM, and were receiving hemodialysis at home or a self-care satellite facility. Exclusion criteria included hemodialysis frequency >3.5 times per week and use of sodium profiling or hemodiafiltration. The main outcome was left ventricular mass index by cardiac magnetic resonance imaging. RESULTS: The 99 participants had a median age of 51 years old; 67 were men, 31 had diabetes mellitus, and 59 had left ventricular hypertrophy. Over 12 months of follow-up, relative to control, a dialysate sodium concentration of 135 mmol/L did not change the left ventricular mass index, despite significant reductions at 6 and 12 months in interdialytic weight gain, in extracellular fluid volume, and in plasma B-type natriuretic peptide concentration (ratio of intervention to control). The intervention increased intradialytic hypotension (odds ratio [OR], 7.5; 95% confidence interval [95% CI], 1.1 to 49.8 at 6 months and OR, 3.6; 95% CI, 0.5 to 28.8 at 12 months). Five participants in the intervention arm could not complete the trial because of hypotension. We found no effect on health-related quality of life measures, perceived thirst or xerostomia, or dietary sodium intake. CONCLUSIONS: Dialysate sodium of 135 mmol/L did not reduce left ventricular mass relative to control, despite improving fluid status. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: The Australian New Zealand Clinical Trials Registry, ACTRN12611000975998.

Low dialysate sodium levels for chronic haemodialysis.

BACKGROUND: Cardiovascular (CV) disease is the leading cause of death in dialysis patients, and strongly associated with fluid overload and hypertension. It is plausible that low dialysate [Na+] may decrease total body sodium content, thereby reducing fluid overload and hypertension, and ultimately reducing CV morbidity and mortality. OBJECTIVES: This review evaluated harms and benefits of using a low (< 138 mM) dialysate [Na+] for maintenance haemodialysis (HD) patients. SEARCH METHODS: We searched the Cochrane Kidney and Transplant Register of Studies up to 7 August 2018 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov. SELECTION CRITERIA: Randomised controlled trials (RCTs), both parallel and cross-over, of low (< 138 mM) versus neutral (138 to 140 mM) or high (> 140 mM) dialysate [Na+] for maintenance HD patients were included. DATA COLLECTION AND ANALYSIS: Two investigators independently screened studies for inclusion and extracted data. Statistical analyses were performed using random effects models, and results expressed as risk ratios (RR) for dichotomous outcomes, and mean differences (MD) or standardised MD (SMD) for continuous outcomes, with 95% confidence intervals (CI). Confidence in the evidence was assessed using GRADE. MAIN RESULTS: We included 12 studies randomising 310 patients, with data available for 266 patients after dropout. All but one study evaluated a fixed concentration of low dialysate [Na+], and one profiled dialysate [Na+]. Three studies were parallel group, and the remaining nine cross-over. Of the latter, only two used a washout between intervention and control periods. Most studies were short-term with a median (interquartile range) follow-up of 3 (3, 8.5) weeks. Two were of a single HD session, and two of a single week's HD. Half of the studies were conducted prior to 2000, and five reported use of obsolete HD practices. Risks of bias in the included studies were often high or unclear, lowering confidence in the results.Compared to neutral or high dialysate [Na+], low dialysate [Na+] had the following effects on "efficacy" endpoints: reduced interdialytic weight gain (10 studies: MD -0.35 kg, 95% CI -0.18 to -0.51; high certainty evidence); probably reduced predialysis mean arterial blood pressure (BP) (4 studies: MD -3.58 mmHg, 95% CI -5.46 to -1.69; moderate certainty evidence); probably reduced postdialysis mean arterial BP (MAP) (4 studies: MD -3.26 mmHg, 95% CI -1.70 to -4.82; moderate certainty evidence); probably reduced predialysis serum [Na+] (7 studies: MD -1.69 mM, 95% CI -2.36 to -1.02; moderate certainty evidence); may have reduced antihypertensive medication (2 studies: SMD -0.67 SD, 95% CI -1.07 to -0.28; low certainty evidence). Compared to neutral or high dialysate [Na+], low dialysate [Na+] had the following effects on "safety" endpoints: probably increased intradialytic hypotension events (9 studies: RR 1.56, 95% 1.17 to 2.07; moderate certainty evidence); probably increased intradialytic cramps (6 studies: RR 1.77, 95% 1.15 to 2.73; moderate certainty evidence).Compared to neutral or high dialysate [Na+], low dialysate [Na+] may make little or no difference to: intradialytic BP (2 studies: MD for systolic BP -3.99 mmHg, 95% CI -17.96 to 9.99; diastolic BP 1.33 mmHg, 95% CI -6.29 to 8.95; low certainty evidence); interdialytic BP (2 studies:, MD for systolic BP 0.17 mmHg, 95% CI -5.42 to 5.08; diastolic BP -2.00 mmHg, 95% CI -4.84 to 0.84; low certainty evidence); dietary salt intake (2 studies: MD -0.21g/d, 95% CI -0.48 to 0.06; low certainty evidence).Due to very low quality of evidence, it is uncertain whether low dialysate [Na+] changed extracellular fluid status, venous tone, arterial vascular resistance, left ventricular mass or volumes, thirst or fatigue. Studies did not examine cardiovascular or all-cause mortality, cardiovascular events, or hospitalisation. AUTHORS' CONCLUSIONS: It is likely that low dialysate [Na+] reduces intradialytic weight gain and BP, which are effects directionally associated with improved outcomes. However, the intervention probably also increases intradialytic hypotension and reduces serum [Na+], effects that are associated with increased mortality risk. The effect of the intervention on overall patient health and well-being is unknown. Further evidence is needed in the form of longer-term studies in contemporary settings, evaluating end-organ effects in small-scale mechanistic studies using optimal methods, and clinical outcomes in large-scale multicentre RCTs.

Efficacy of a Web-Based Safety Decision Aid for Women Experiencing Intimate Partner Violence: Randomized Controlled Trial.

BACKGROUND: Intimate partner violence (IPV) is a human rights violation and leading health burden for women. Safety planning is a hallmark of specialist family violence intervention, yet only a small proportion of women access formal services. A Web-based safety decision aid may reach a wide audience of women experiencing IPV and offer the opportunity to prioritize and plan for safety for themselves and their families. OBJECTIVE: The aim of this study was to test the efficacy of a Web-based safety decision aid (isafe) for women experiencing IPV. METHODS: We conducted a fully automated Web-based two-arm parallel randomized controlled trial (RCT) in a general population of New Zealand women who had experienced IPV in the past 6 months. Computer-generated randomization was based on a minimization scheme with stratification by severity of violence and children. Women were randomly assigned to the password-protected intervention website (safety priority setting, danger assessment, and tailored action plan components) or control website (standard, nonindividualized information). Primary endpoints were self-reported mental health (Center for Epidemiologic Studies Depression Scale-Revised, CESD-R) and IPV exposure (Severity of Violence Against Women Scale, SVAWS) at 12-month follow-up. Analyses were by intention to treat. RESULTS: Women were recruited from September 2012 to September 2014. Participants were aged between 16 and 60 years, 27% (111/412) self-identified as Maori (indigenous New Zealand), and 51% (210/412) reported at baseline that they were unsure of their future plans for their partner relationship. Among the 412 women recruited, retention at 12 months was 87%. The adjusted estimated intervention effect for SVAWS was -12.44 (95% CI -23.35 to -1.54) for Maori and 0.76 (95% CI -5.57 to 7.09) for non-Maori. The adjusted intervention effect for CESD-R was -7.75 (95% CI -15.57 to 0.07) for Maori and 1.36 (-3.16 to 5.88) for non-Maori. No study-related adverse events were reported. CONCLUSIONS: The interactive, individualized Web-based isafe decision aid was effective in reducing IPV exposure limited to indigenous Maori women. Discovery of a treatment effect in a population group that experiences significant health disparities is a welcome, important finding. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12612000708853; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612000708853 (Archived by Webcite at http://www.webcitation/61MGuVXdK).

Cluster-randomised controlled trial of an occupational therapy intervention for children aged 11-13 years, designed to increase participation to prevent symptoms of mental illness.

BACKGROUND: The impact of occupational therapy on mental health outcomes for children is largely unexplored. The aim of this study was to investigate an evidence-based occupational therapy intervention designed to increase participation in daily occupations to prevent symptoms of mental illness for children and run in schools. METHODS: The study used a pragmatic, cluster-randomised controlled trial design with two arms. Fourteen clusters (schools), equating to 151 child participants, were stratified by school decile-rank category and block randomised. Blinding of participants post-randomisation was not feasible; however, outcomes assessors were blinded. Outcomes were measured at baseline, after the parallel and crossover phases, and at follow-up; and were anxiety symptoms (primary), depression symptoms, self-esteem, participation and wellbeing. Intention-to-treat analysis was applied and mixed linear modelling was used to account for clusters and repeated measures, and to adjust for covariates identified. RESULTS: This trial found significant positive effects of the intervention on child-rated satisfaction with their occupational performance and teacher-rated child anxiety. No evidence was found to support the effect of the intervention on anxiety and depression symptoms, self-esteem and wellbeing. CONCLUSIONS: This was the first known cluster-randomised controlled trial to investigate an occupational therapy intervention promoting emotional wellbeing in a non-clinical sample of children. No compelling evidence was found to support the use of the intervention in schools in its current format, however, results were promising that the focus on occupations influenced participation. Recommendations are made to redesign the intervention as an embedded intervention in the classroom, cotaught by teachers and including parental involvement.

The first metatarsophalangeal joint in gout: a systematic review and meta-analysis.

BACKGROUND: The aim of this review was to qualitatively synthesise studies that have investigated characteristics of the first metatarsophalangeal joint (1(st) MTP) in gout and to undertake a meta-analysis to estimate the average prevalence of acute 1(st) MTP arthritis across studies in people with gout. METHODS: Studies published in English were included if they involved participants who had a diagnosis of gout and presented original findings relating to the following outcome measures associated with the 1(st) MTP: epidemiology; clinical features; structural and functional characteristics; and microscopic and imaging features. RESULTS: Forty-five studies were included in the qualitative synthesis. 1(st) MTP pain was a prominent feature in people with gout. People with 1(st) MTP gout reported walking- and general-disability. Structural and functional characteristics of 1(st) MTP gout included hallux valgus, osteoarthritis, and restricted joint motion. Successful crystal aspiration ranged from 81 to 91 % and positive crystal identification via microscopy ranged from 83 to 93 % in patients with a history of 1(st) MTP gout. Imaging features were common at the 1(st) MTP including the double contour sign, tophi and erosions. Eleven studies involving 2,325 participants were included in the meta-analysis, providing an estimate of the average prevalence of acute 1(st) MTP arthritis across studies of 73 % (95 % prediction interval 40-92 %; range 48-97 %; I(2) = 93 %). CONCLUSIONS: 1(st) MTP acute arthritis is highly prevalent in people with gout and has a substantial impact on patient-reported pain and disability. Gout affects the structure and function of the 1(st) MTP. Microscopic and imaging studies have demonstrated crystal deposition and joint damage at the 1(st) MTP in people with gout.

Participant Recruitment and Engagement in Automated eHealth Trial Registration: Challenges and Opportunities for Recruiting Women Who Experience Violence.

BACKGROUND: Automated eHealth Web-based research trials offer people an accessible, confidential opportunity to engage in research that matters to them. eHealth trials may be particularly useful for sensitive issues when seeking health care may be accompanied by shame and mistrust. Yet little is known about people's early engagement with eHealth trials, from recruitment to preintervention autoregistration processes. A recent randomized controlled trial that tested the effectiveness of an eHealth safety decision aid for New Zealand women in the general population who experienced intimate partner violence (isafe) provided the opportunity to examine recruitment and preintervention participant engagement with a fully automated Web-based registration process. The trial aimed to recruit 340 women within 24 months. OBJECTIVE: The objective of our study was to examine participant preintervention engagement and recruitment efficiency for the isafe trial, and to analyze dropout through the registration pathway, from recruitment to eligibility screening and consent, to completion of baseline measures. METHODS: In this case study, data collection sources included the trial recruitment log, Google Analytics reports, registration and program metadata, and costs. Analysis included a qualitative narrative of the recruitment experience and descriptive statistics of preintervention participant engagement and dropout rates. A Koyck model investigated the relationship between Web-based online marketing website advertisements (ads) and participant accrual. RESULTS: The isafe trial was launched on September 17, 2012. Placement of ads in an online classified advertising platform increased the average number of recruited participants per month from 2 to 25. Over the 23-month recruitment period, the registration website recorded 4176 unique visitors. Among 1003 women meeting eligibility criteria, 51.55% (517) consented to participate; among the 501 women who enrolled (consented, validated, and randomized), 412 (82.2%) were accrued (completed baseline assessments). The majority (n=52, 58%) of the 89 women who dropped out between enrollment and accrual never logged in to the allocated isafe website. Of every 4 accrued women, 3 (314/412, 76.2%) identified the classified ad as their referral source, followed by friends and family (52/412, 12.6%). Women recruited through a friend or relative were more likely to self-identify as indigenous Maori and live in the highest-deprivation areas. Ads increased the accrual rate by a factor of 74 (95% CI 49-112). CONCLUSIONS: Print advertisements, website links, and networking were costly and inefficient methods for recruiting participants to a Web-based eHealth trial. Researchers are advised to limit their recruitment efforts to Web-based online marketplace and classified advertising platforms, as in the isafe case, or to social media. Online classified advertising in "Jobs-Other-volunteers" successfully recruited a diverse sample of women experiencing intimate partner violence. Preintervention recruitment data provide critical information to inform future research and critical analysis of Web-based eHealth trials. CLINICALTRIAL: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12612000708853; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612000708853 (Archived by WebCite at http://www.webcitation/6lMGuVXdK).

The effectiveness of the levonorgestrel intrauterine system in obese women with heavy menstrual bleeding.

INTRODUCTION: To evaluate the effectiveness of the levonorgestrel intrauterine system (LNG-IUS) in obese women with heavy menstrual bleeding in Counties Manukau Auckland area, New Zealand. METHODS: Prospective observational study in a tertiary teaching hospital. Twenty women with heavy menstrual bleeding (HMB) who agreed to treatment with the LNG-IUS and had a body mass index (BMI) of >30 kg/m2 were recruited between May and December 2014. The women completed two validated tools (Menstrual Impact Questionnaire and the Pictorial Bleeding Assessment Chart) at recruitment, 6 and 12 months follow-up. Demographic, medical and laboratory variables were obtained from the relevant CMH databases. Data on side effects and satisfaction were obtained from the women at 12 months. RESULTS: The median age (range) and BMI of the 20 women were 40.5 years (27-52 years) and 40.6 kg/m2 (30-68), respectively. Three LNG-IUS were removed due to infection and pain and these women were subsequently booked for a hysterectomy. The reduction in menstrual loss was estimated at 19.7% per month (95% CI (12.5%, 26.2%); P < 0.001), which translates to 73.2% per period of 6 months (95% CI (55.3%, 83.9%)) and 92.8% per period of 12 months (95% CI (80.0%, 97.4%)). The six items in the quality of life measure improved significantly in 14 women but only 12 women were satisfied with the treatment. CONCLUSION: The LNG-IUS was an effective treatment for 67% of obese women with heavy menstrual bleeding over a 12-month period, as assessed by the reduction in menstrual bleeding and the improvement in the quality of life measures.

A web-based intervention for abused women: the New Zealand isafe randomised controlled trial protocol.

BACKGROUND: Intimate partner violence (IPV) and its associated negative mental health consequences are significant for women in New Zealand and internationally. One of the most widely recommended interventions is safety planning. However, few women experiencing violence access specialist services for safety planning. A safety decision aid, weighing the dangers of leaving or staying in an abusive relationship, gives women the opportunity to prioritise, plan and take action to increase safety for themselves and their children. This randomised controlled trial is testing the effectiveness of an innovative, interactive web-based safety decision aid. The trial is an international collaborative concurrent replication of a USA trial (IRIS study NCT01312103), regionalised for the Aotearoa New Zealand culture and offers fully automated online trial recruitment, eligibility screening and consent. METHODS/DESIGN: In a fully automated web-based trial (isafe) 340 abused women will be randomly assigned in equal numbers to a safety decision aid intervention or usual safety planning control website. Intervention components include: (a) safety priority setting, (b) danger assessment and (c) an individually tailored safety action plan. Self-reported outcome measures are collected at baseline and 3, 6, and 12-months post-baseline. Primary outcomes are depression (measured by Center for Epidemiologic Studies Depression Scale, Revised) and IPV exposure (measured by Severity Violence Against Women Scale) at 12 months post-baseline. Secondary outcomes include PTSD, psychological abuse, decisional conflict, safety behaviors and danger in the relationship. DISCUSSION: This trial will provide much-needed information on the potential relationships among safety planning, improved mental health, reduced violence as well as decreased decisional conflict related to safety in the abusive relationship. The novel web-based safety decision aid intervention may provide a cost-effective, easily accessed safety-planning resource that can be translated into clinical and community practice by multiple health disciplines and advocates. The trial will also provide information about how women in abusive relationships safely access safety information and resources through the Internet. Finally, the trial will inform other research teams on the feasibility and acceptability of fully automated recruitment, eligibility screening, consent and retention procedures. TRIAL REGISTRATION: Trial registered on 03 July 2012 on the Australian New Zealand Clinical Trials Registry ACTRN12612000708853 .

Postoperative Systolic Blood Pressure as a risk factor for haematoma following thyroid surgery.

OBJECTIVES: To examine potential factors that may predict development of postoperative haematoma following thyroid surgery, with particular attention to postoperative systolic blood pressure. DESIGN: Retrospective, observational case-control study of patients undergoing thyroid surgery. SETTING: Secondary General Hospital. PARTICIPANTS: Patients attending Counties Manukau District Health Board (CMDHB) between 2002 and 2012. MAIN OUTCOME MEASURES: Post-operative Haematoma formation that required re-exploration of the wound. RESULTS: The overall rate of postoperative haematoma was 2.57% (16/621). Three patients bled immediately (i.e. after wound closure but while still on the operating table); 10 patients (1.6%) bled in the early postoperative period; and three others bled 24 h or more after surgery. The principal independent risk factor for postoperative haemorrhage that remained after multivariable regression was postoperative systolic blood pressure level. There was a 39% increase in risk of bleeding for every 10 points rise of highest blood pressure recordings in our patient population (OR 1.39; 95% CI = 1.09-1.8). CONCLUSIONS: This study identifies postoperative hypertension as significantly related to development of early postoperative haematoma. Cause for late post-thyroidectomy bleeding remains speculative.

Project Energize: whole-region primary school nutrition and physical activity programme; evaluation of body size and fitness 5 years after the randomised controlled trial.

Project Energize, a region-wide whole-school nutrition and physical activity programme, commenced as a randomised controlled trial (RCT) in the period 2004-6 in 124 schools in Waikato, New Zealand. In 2007, sixty-two control schools were engaged in the programme, and by 2011, all but two of the 235 schools in the region were engaged. Energizers (trained nutrition and physical activity specialists) work with eight to twelve schools each to achieve the goals of the programme, which are based on healthier eating and enhanced physical activity. In 2011, indices of obesity and physical fitness of 2474 younger (7·58 (sd 0·57) years) and 2330 older (10·30 (sd 0·51) years) children attending 193 of the 235 primary schools were compared with historical measurements. After adjusting for age, sex, ethnicity, socio-economic status (SES) and school cluster effects, the combined prevalence of obesity and overweight among younger and older children in 2011 was lower by 31 and 15 %, respectively, than that among 'unEnergized' children in the 2004 to 2006 RCT. Similarly, BMI was lower by 3·0 % (95 % CI - 5·8, - 1·3) and 2·4 % (95 % CI - 4·3, - 0·5). Physical fitness (time taken to complete a 550 m run) was significantly higher in the Energized children (13·7 and 11·3 %, respectively) than in a group of similarly aged children from another region. These effects were observed for boys and girls, both indigenous Maori and non-Maori children, and across SES. The long-term regional commitment to the Energize programme in schools may potentially lead to a secular reduction in the prevalence of overweight and obesity and gains in physical fitness, which may reduce the risk of developing obesity and type 2 diabetes.

Health and Wellness Coaching for 5-Year Projected Cardiovascular Health: A Randomized Controlled Trial.

Background and Objectives: Evidence of effective multifactorial lifestyle interventions for primary stroke prevention is lacking, despite the significant contribution of lifestyle to stroke burden. We aimed to determine the efficacy of health and wellness coaching (HWC) for primary stroke and cardiovascular disease (CVD) prevention in adults at a moderate-to-high CVD risk. Methods: This was a parallel, 2-arm, open-label, single-blinded, phase III randomized controlled trial to determine the efficacy of HWC for primary stroke prevention in individuals 30 years and older with a 5-year CVD risk ≥10% as measured by 5-year absolute CVD risk (as measured by the PREDICT tool) at 9 months post-randomization. Eligible participants were those with a 5-year CVD risk ≥10%, with no history of stroke, transient ischemic attack, or myocardial infarction. The relative risk reduction (RRR) and odds ratios (OR) were evaluated separately in those at moderate (10%-14%) 5-year CVD risk and those at high risk (≥15%) at baseline. The Life's Simple 7 (LS7) score for lifestyle-related CVD risk, as the indicator of cardiovascular health, was a key secondary outcome. Results: Of a total of 320 participants, 161 were randomized to the HWC group and 159 to the usual care (UC) group. HWC resulted in a statistically significant RRR of -10.9 (95% CI -21.0 to -0.9) in 5-year CVD risk in the higher CVD risk group but no change in the moderate risk group. An improvement in the total LS7 score was seen in the HWC group compared with the UC group (absolute difference = 0.485, 95% CI [0.073 to 0.897], p = 0.02). Improvement in blood pressure scores was statistically significantly greater in the HWC group than in the UC group for those at high risk of CVD (OR 2.28 [95% CI 1.12 to 4.63] and 1.55 [0.80 to 3.01], respectively). No statistically significant differences in mood scores, medication adherence, quality of life, and satisfaction with life scores over time or between groups were seen. Discussion: Health and wellness coaching resulted in a significant RRR in the 5-year CVD risk compared with UC at 9 months post-randomization in patients with a high baseline CVD risk. There was no improvement in CVD risk in the moderate risk group; hence, this study did not meet the primary hypothesis. However, this treatment effect is clinically significant (number needed to treat was 43). The findings suggest that HWC has potential if further refined to improve lifestyle risk factors of stroke.

Evaluating Tissue Heterogeneity in the Radiologically Normal-Appearing Tissue in IPF Compared to Healthy Controls.

RATIONALE AND OBJECTIVES: Idiopathic Pulmonary Fibrosis (IPF) is a progressive interstitial lung disease characterised by heterogeneously distributed fibrotic lesions. The inter- and intra-patient heterogeneity of the disease has meant that useful biomarkers of severity and progression have been elusive. Previous quantitative computed tomography (CT) based studies have focussed on characterising the pathological tissue. However, we hypothesised that the remaining lung tissue, which appears radiologically normal, may show important differences from controls in tissue characteristics. MATERIALS AND METHODS: Quantitative metrics were derived from CT scans in IPF patients (N = 20) and healthy controls with a similar age (N = 59). An automated quantitative software (CALIPER, Computer-Aided Lung Informatics for Pathology Evaluation and Rating) was used to classify tissue as normal-appearing, fibrosis, or low attenuation area. Densitometry metrics were calculated for all lung tissue and for only the normal-appearing tissue. Heterogeneity of lung tissue density was quantified as coefficient of variation and by quadtree. Associations between measured lung function and quantitative metrics were assessed and compared between the two cohorts. RESULTS: All metrics were significantly different between controls and IPF (p < 0.05), including when only the normal tissue was evaluated (p < 0.04). Density in the normal tissue was 14% higher in the IPF participants than controls (p < 0.001). The normal-appearing tissue in IPF had heterogeneity metrics that exhibited significant positive relationships with the percent predicted diffusion capacity for carbon monoxide. CONCLUSION: We provide quantitative assessment of IPF lung tissue characteristics compared to a healthy control group of similar age. Tissue that appears visually normal in IPF exhibits subtle but quantifiable differences that are associated with lung function and gas exchange.

Quantitative Analysis of Lung Shape in Idiopathic Pulmonary Fibrosis: Insights Into Disease- and Age-Associated Patterns.

RATIONALE AND OBJECTIVES: Fibrotic scarring in idiopathic pulmonary fibrosis (IPF) typically develops first in the posterior-basal lung tissue before advancing to involve more of the lung. The complexity of lung shape in the costo-diaphragmatic region has been proposed as a potential factor in this regional development. Intrinsic and disease-related shape could therefore be important for understanding IPF risk and its staging. We hypothesized that lung and lobe shape in IPF would have important differences from controls. MATERIALS AND METHODS: A principal component (PC) analysis was used to derive a statistical shape model (SSM) of the lung for a control cohort aged > 50 years (N = 39), using segmented lung and fissure surface data from CT imaging. Individual patient shape models derived for baseline (N = 18) and follow-up (N = 16) CT scans in patients with IPF were projected to the SSM to describe shape as the sum of the SSM average and weighted PC modes. Associations between the first four PC shape modes, lung function, percentage of fibrosis (fibrosis%) and pulmonary vessel-related structures (PVRS%), and other tissue metrics were assessed and compared between the two cohorts. RESULTS: Shape was different between IPF and controls (P < 0.05 for all shape modes), with IPF shape forming a distinct shape cluster. Shape had a negative relationship with age in controls (P = 0.013), but a positive relationship with age in IPF (P = 0.026). Some features of shape changed on follow-up. Shape in IPF was associated with fibrosis% (P < 0.05) and PVRS% (P < 0.05). CONCLUSION: Quantitative comparison of lung and lobe shape in IPF with controls of a similar age reveals shape differences that are strongly associated with age and percent fibrosis. The clustering of IPF cohort shape suggests that it could be an important feature to describe disease.

Clinical trial participation improves outcome: a matched historical cohort study.

BACKGROUND: Well-conducted, investigator-led randomized controlled trials (RCTs) are the gold standard for evaluating the efficacy of new treatments and are a key component of evidence-based medicine. It is unclear whether participating in an RCT is beneficial to the individual before the results of RCTs are known. PURPOSE: In a matched historical cohort study, we examined whether participation in RCTs was associated with improved health outcomes. METHODS: Participants in the Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation (ADVANCE), Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial (ONTARGET), or Telmisartan Randomized Assessment Study in ACE-intolerant Subjects with Cardiovascular Disease (TRANSCEND) studies and non-participant controls were selected from patients attending outpatient clinics at Middlemore Hospital between 2001 and 2003. RESULTS: A total of 251 RCT participants and 502 randomly selected patients not enrolled in a trial but who met study entry criteria were matched for age, gender, and ethnicity. There was a significant difference in all-cause mortality for trial participants versus non-participants over the study period (unadjusted relative risk reduction (RRR) = 63%; 95% confidence interval (CI) = 28%-81%) and a significant reduction in cardiovascular mortality (unadjusted RRR = 81%; 95% CI = 17%-95%) favouring RCT participants. Allowing for co-morbidity, the adjusted RRR of all-cause mortality associated with trial participation was 55% (95% CI = 10%-77%). Active treatment in an RCT was found to be less explanatory than trial participation. The adjusted RRR for cardiovascular mortality associated with active treatment in a trial was 86% (95% CI = -2% to 98%), with trial participation found to be less explanatory than active treatment. LIMITATIONS: The main limitations of this trial relate to its design as a retrospective study with a historical cohort comparison group. Limitations include lack of complete data for some patients, bias in selection of the comparison group, and the effects of confounding variables. However, the study design and analysis were planned so as to minimize these as much as possible. CONCLUSION: This study revealed significantly lower all-cause mortality among participants in industry-sponsored RCTs compared with non-participants who received routine hospital outpatient care. This effect was independent of study drug.

The effects of commercially available footwear on foot pain and disability in people with gout: a pilot study.

BACKGROUND: There is limited evidence on non-pharmacological interventions for gout. The aim of the study was to determine whether a footwear intervention can reduce foot pain and musculoskeletal disability in people with gout. METHODS: Thirty-six people with gout participated in a prospective intervention study over 8 weeks. Participants selected one of 4 pairs of shoes and thereafter wore the shoes for 8 weeks. The primary outcome was foot pain using a 100 mm visual analogue scale. Secondary outcomes related to function and disability were also analysed. RESULTS: The Cardio Zip shoe was selected by 58% of participants. Compared with baseline, overall scores for all shoes at 8-weeks demonstrated a decrease in foot pain (p = 0.03), general pain (p = 0.012), Health Assessment Questionnaire (HAQ)-II (p = 0.016) and Leeds Foot Impact Scale (LFIS) impairment subscale (p = 0.03). No significant differences were observed in other patient reported outcomes including patient global assessment, LFIS activity subscale, and Lower Limb Task Questionnaire subscales (all p > 0.10). We observed significant improvements between baseline measurements using the participants' own shoes and the Cardio Zip for foot pain (p = 0.002), general pain (p = 0.001), HAQ-II (p = 0.002) and LFIS impairment subscale (p = 0.004) after 8 weeks. The other three shoes did not improve pain or disability. CONCLUSIONS: Footwear with good cushioning, and motion control may reduce foot pain and disability in people with gout.

The effectiveness of peer-led interventions to improve work-related psychosocial outcomes and reduce turnover of support workers in residential aged care: A systematic review and meta-analysis.

Background: Support workers are central to the delivery of residential aged care, but the workforce is facing increasing work demands and widespread shortages. This contributes to high rates of burnout, decreased job satisfaction and high staff turnover. Peer-led interventions are reported to be effective but it is necessary to use evidence-based interventions to support this key workforce group. Objective: This study aimed to evaluate the scientific evidence on effectiveness of strategies improving psychosocial and turnover-related outcomes for support workers in aged care that could be incorporated into a peer-led intervention. Design: Systematic review and meta-analyses of experimental and quasi-experimental studies. Setting: Residential aged care. Methods: A systematic literature review was conducted using MEDLINE (via PubMed), EMBASE (via Scopus), and CINAHL (via EBSCO). We included studies examining the effectiveness of workplace interventions aiming to reduce aged care support workers' turnover rates and/or improve their work-related psychosocial outcomes (such as work stress, job satisfaction, self-esteem, and other). A number of meta-analyses using a mixed-effects model were performed to calculate standardized mean differences and odds ratios. Results: Fifty-one studies were included: 15 randomised controlled trials (RCTs), 19 non-RCTs and 17 Pre-Post studies. Most of the studies were rated as having 'high' or 'very high risk of bias'. The studies were clustered by intervention type: 1) knowledge-based, 2) interpersonal skills-based, 3) team-building, and 4) self-care. Knowledge-based interventions were the most used approach, with 26 studies in this category, and frequently reported improvements in stress- and satisfaction-related outcomes. There were twelve interpersonal skills-based and nine team-building interventions, which often reported decreased work stress, staff turnover, and intention to quit. There were four self-care interventions of which only one reported improvements in stress-related outcomes. Meta-analyses showed that only knowledge-based interventions resulted in statistically significant improvements: lower staff turnover rates (OR 0.47, 95 %CI: 0.37, 060), and higher scores for job/life satisfaction (SMD 0.26, 95 % CI: 0.05, 0.46) and staff attitude (SMD 0.23, 95 % CI: 0.05, 0.45). Conclusion: This review found numerous strategies that have been trialled to improve support workers' psychosocial- and turnover-related outcomes. Most studies reported improvements in outcomes. However, our meta-analyses suggest that the effect sizes were small and mostly non-significant, with the evidence being of low certainty. The evidence for effectiveness of knowledge-based interventions appears the most convincing, with statistically significant improvements reported for turnover rates, job/life satisfaction and staff attitude. More high-quality studies are needed to consolidate the existing evidence. PROSPERO registration number: CRD42017059007; 02 June 2017.Tweetable abstract: Knowledge-based interventions most promising in improving support workers' outcomes in aged care. #agedcare #staffturnover.