Australian And New Zealand Clinical Trials Registry Research Articles

Effectiveness of erector spinae plane block for rib fracture analgesia: a systematic review protocol.

This systematic review will investigate the effectiveness of the ultrasound-guided erector spinae plane block as an analgesic technique for patients with rib fractures compared with all other standard management techniques. Comparisons will be made with both nerve blocks (neuraxial techniques and peripheral nerve blocks) and systemic treatment (with patient-controlled analgesia and/or per required need analgesia for breakthrough pain). Erector spinae plane block is a well-established rescue analgesia option for patients with rib fractures. The use of ultrasound-guided erector spinae plane block in clinical practice has been largely based on observational data, with recent randomized controlled trials examining it against several other options for analgesic management. This review will compare the erector spinae against all other management techniques used in practice for rib fractures to determine whether this is the most effective analgesic technique. The review will include all randomized controlled and pseudo-randomized controlled trials examining ultrasound-guided erector spinae plane block for the analgesic management of traumatic rib fractures. All other study designs will be excluded. MEDLINE (PubMed), Embase (Ovid), CINAHL (EBSCOhost), the Cochrane Central Register of Controlled Trials, the Australian and New Zealand Clinical Trials Registry (ANZCTR), ClinicalTrials.gov, and the ISRCTN registry will be searched to identify all relevant ongoing clinical trials. Study selection, critical appraisal, and data extraction will be performed by 2 independent reviewers. Data will be extracted into software for statistical analysis (including meta-analysis where possible). PROSPERO CRD42023414849.

Effectiveness and Feasibility of a Self-guided Mobile App Targeting Emotional Well-being in Healthy Adults: 4-Week Randomized Controlled Trial.

Commercial smartphone apps designed to promote emotional well-being are becoming increasingly popular, but few apps have been empirically validated. This study examined the feasibility and effectiveness of a self-guided app designed to reduce daily stress via positive messaging and tailored short inspirational talks (ie, peps). A total of 166 participants (n=112, 67.5% female; mean age 38.48, SD 6.73 years) were recruited through social media advertising and randomized into an intervention (Hey Lemonade app plus twice daily mood monitoring using the Multidimensional Mood Questionnaire [MDMQ]) or active control (twice daily mood monitoring [MDMQ]) group. Primary (coping self-efficacy [CSE]; 3 subscales) and secondary outcomes (vitality, satisfaction with life, perceived stress, positive and negative affect, and hassles and uplifts) were measured at the baseline (week 1) and end point (week 4). The app evaluation questions were assessed at week 2. All interactions and measurements were collected on the internet and through the apps. In total, of 166 participants, 125 (75.3%) completed the trial. There were no differences in dropout rates between the groups (62/81, 76% intervention; 63/85, 74% control). There were significant group-by-time interactions for vitality and hassles but no significant effect for CSE total (P=.05). For the intervention group, the change from baseline to week 4 was significant for vitality (P=.002) and hassles (P=.004), CSE total (P=.008), and CSE Emotional subscale (P=.02). For the control group, any changes over 4 weeks were not significant for any outcome. There was a significant group-by-time interaction for MDMQ calmness (P=.04). By week 4, calmness was significantly higher in the intervention group (P=.046). Of those in the intervention group at week 2 (n=68), 39 (57%) participants recommended the app and 41 (60%) participants wanted to continue using it. Pep talks and customizable voice options were the most popular features. Participants who had access to the smartphone app on an as-needed basis over the 4-week trial showed significant improvements in emotional well-being indicators. More broadly, this suggests that simple accessible solutions may generate meaningful well-being outcomes. Whether these changes are sustained and can be generalized to other population groups is yet to be determined. Australian and New Zealand Clinical Trials Registry (ANZCTR) 12622001005741; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=384304&isReview=true.

Implementation of continuous temperature monitoring during perioperative care: a feasibility study

BackgroundContinuous body temperature monitoring during perioperative care is enabled by using a non-invasive “zero-heat-flux” (ZHF) device. However, rigorous evaluation of whether continuous monitoring capability improves process of care and patient outcomes is lacking. This study assessed the feasibility of a large-scale trial on the impact of continuous ZHF monitoring on perioperative temperature management practices and hypothermia prevention.MethodsA feasibility study was conducted at a tertiary hospital. Participants included patients undergoing elective surgery under neuraxial or general anesthesia, and perioperative nurses and anesthetists caring for patient participants. Eighty-two patients pre and post introduction of the ZHF device were enrolled. Feasibility outcomes included recruitment and retention, protocol adherence, missing data or device failure, and staff evaluation of intervention feasibility and acceptability. Process of care outcomes included temperature monitoring practices, warming interventions and perioperative hypothermia.ResultsThere were no adverse events related to the device and feasibility of recruitment was high (60%). Treatment adherence varied across the perioperative pathway (43 to 93%) and missing data due to electronic transfer issues were identified. Provision of ZHF monitoring had most impact on monitoring practices in the Post Anesthetic Care Unit; the impact on intraoperative monitoring practices was minimal.ConclusionsEnhancements to the design of the ZHF device, particularly for improved data retention and transfer, would be beneficial prior to a large-scale evaluation of whether continuous temperature monitoring will improve patient outcomes. Implementation research designs are needed for future work to improve the complex area of temperature monitoring during surgery. Trial registrationProspective registration prior to patient enrolment was obtained from the Australian and New Zealand Clinical Trials Registry (ANZCTR) on 16th April 2021 (Registration number: ACTRN12621000438853).

An observational analysis of the trope "A p-value of < 0.05 was considered statistically significant" and other cut-and-paste statistical methods.

Appropriate descriptions of statistical methods are essential for evaluating research quality and reproducibility. Despite continued efforts to improve reporting in publications, inadequate descriptions of statistical methods persist. At times, reading statistical methods sections can conjure feelings of dèjá vu, with content resembling cut-and-pasted or "boilerplate text" from already published work. Instances of boilerplate text suggest a mechanistic approach to statistical analysis, where the same default methods are being used and described using standardized text. To investigate the extent of this practice, we analyzed text extracted from published statistical methods sections from PLOS ONE and the Australian and New Zealand Clinical Trials Registry (ANZCTR). Topic modeling was applied to analyze data from 111,731 papers published in PLOS ONE and 9,523 studies registered with the ANZCTR. PLOS ONE topics emphasized definitions of statistical significance, software and descriptive statistics. One in three PLOS ONE papers contained at least 1 sentence that was a direct copy from another paper. 12,675 papers (11%) closely matched to the sentence "a p-value < 0.05 was considered statistically significant". Common topics across ANZCTR studies differentiated between study designs and analysis methods, with matching text found in approximately 3% of sections. Our findings quantify a serious problem affecting the reporting of statistical methods and shed light on perceptions about the communication of statistics as part of the scientific process. Results further emphasize the importance of rigorous statistical review to ensure that adequate descriptions of methods are prioritized over relatively minor details such as p-values and software when reporting research outcomes.

Oral and intravenous tranexamic acid are equivalent at reducing blood loss following shoulder arthroplasty—A multicenter, double-blinded, randomized, placebo-controlled trial

BackgroundTranexamic acid (TXA) has been shown to reduce blood loss significantly in shoulder arthroplasty. Oral TXA is significantly cheaper than intravenous TXA, but there has been no published literature comparing oral and intravenous TXA in shoulder arthroplasty. The purpose of this study was to compare the efficacy and safety of oral versus intravenous TXA in shoulder arthroplasty. We hypothesized that oral and intravenous TXA are equivalent at reducing blood loss following shoulder arthroplasty. MethodsThis study was approved by the New Zealand Health and Disability Ethics Committee (HDEC) and registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR). Patients undergoing elective shoulder arthroplasties were prospectively randomized into one of two groups. In the oral TXA group, 2g of TXA was administered two hours prior to induction of anesthesia, and in the intravenous TXA group, 1.5g of TXA was administered as a bolus following induction of anesthesia. The primary outcome was a reduction in hemoglobin concentration. The secondary outcomes included drain output, number of blood units transfused, length of hospital stay, and complications. ResultsA total of 80 consecutive patients were randomized. The baseline demographics were comparable between the two groups. There was no difference in the primary outcome measure or any of the secondary outcome measures. With regards to the primary outcome measure, using a two one-sided test (TOST) for equivalence, with a P value of < 0.05 demonstrating equivalence, the mean reduction of hemoglobin was 23.30g/L (± 1.62) versus 22.45g/L (± 1.30) for the oral and the intravenous groups, respectively (P < .001). Postoperative drain output was 74.58mLs (± 11.27) versus 90.03mLs (± 14.53) for the oral and the intravenous groups, respectively (P = .41). Furthermore, there was no difference in the number of blood units transfused, length of hospital stay, and complications. DiscussionTo the best of our knowledge, this is the first study in the literature comparing oral and intravenous tranexamic in shoulder arthroplasty, and we found no difference in the efficacy of the two routes of administration. Surgeons should be encouraged to use the less expensive oral form of the medication as a means to minimize overall healthcare expenditure.

Smartphone Psychological Therapy During COVID-19: A Study on the Effectiveness of Five Popular Mental Health Apps for Anxiety and Depression

The aims of this study were to examine the effectiveness of a range of smartphone apps for managing symptoms of anxiety and depression and to assess the utility of a single-case research design for enhancing the evidence base for this mode of treatment delivery. The study was serendipitously impacted by the COVID-19 pandemic, which allowed for effectiveness to be additionally observed in the context of significant community distress. A pilot study was initially conducted using theSuperBetter app to evaluate the proposed methodology, which proved successful with the four finishing participants. In the main study, 39 participants commenced (27 females and 12 males,MAge = 34.04 years,SD = 12.20), with 29 finishing the intervention phase and completing post-intervention measures. At 6-month follow-up, a further three participants could not be contacted. This study used a digitally enhanced, multiple baseline across-individuals single-case research design. Participants were randomly assigned to the following apps:SuperBetter (n = 8),Smiling Mind (n = 7),MoodMission (n = 8),MindShift (n = 8), andDestressify (n = 8). Symptomatology and life functioning were measured at five different time points: pre-baseline/screening, baseline, intervention, 3-week post-intervention, and 6-month follow-up. Detailed individual perceptions and subjective ratings of the apps were also obtained from participants following the study’s completion. Data were analyzed using visual inspection, time-series analysis, and methods of statistical and clinical significance. Positive results were observed for all apps. Overall, more favorable outcomes were achieved by younger participants, those concurrently undertaking psychotherapy and/or psychotropic medication, those with anxiety and mixed anxiety and depression rather than stand-alone depression, and those with a shorter history of mental illness. Outcomes were generally maintained at 6-month follow-up. It was concluded that a diverse range of evidence-based therapies offered via apps can be effective in managing mental health and improving life functioning even during times of significant global unrest and, like all psychotherapies, are influenced by client features. Additionally, this single-case research design is a low-cost/high value means of assessing the effectiveness of mental health apps.Clinical Trial Registration: The study is registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR), which is a primary registry in the World Health Organization Registry Network, registration number ACTRN12619001302145p (http://www.ANZCTR.org.au/ACTRN12619001302145p.aspx).

Effect of a suite of aggression management modules on health professions student knowledge, skills and confidence: an investigator-blinded, parallel-group randomised controlled trial protocol

&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Incidents of aggression are increasing in healthcare. Students are at higher risk of being on the receiving end of client aggression due to their lack of experience. Students also do not feel prepared to manage these situations.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Students of health professions in the School of Primary and Allied Health Care will be eligible and contacted within lectures/via the learning management system Moodle. A randomised controlled trial (RCT) will be conducted to evaluate a suite of online aggression management modules for health professions students prior to entering their clinical years of study. If students are able to undertake face to face simulations they will be assessed by academic staff members using the English modified de-escalating aggressive behaviour scale (EMDABS). Mock clients will assess the students using the consultation and relational empathy (CARE) measure. Students will complete a self-assessment using the confidence with coping with patient aggression instrument and a knowledge questionnaire.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conlusions: &lt;/strong&gt;This RCT will provide novel information on the effectiveness of delivering a suite of online aggression management modules to health professions students. There are three separate modules each of approximately 30 minutes duration such that the attention of students is maintained. The three modules are: 1. Recognising and preventing aggression-the basics, 2. Responding to aggression-the basics, 3. Aggression in healthcare-the basics (Case study).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration number: &lt;/strong&gt;This trial has been registered with the Australian and New Zealand clinical trials registry (ANZCTR) ACTRN12621000382875.&lt;/p&gt;

Implementation of a digital cognitive behavioral therapy for insomnia pathway in primary care

BackgroundInsomnia is a prevalent and debilitating disorder commonly managed by family physicians. Insomnia guidelines recommend cognitive behavioral therapy for insomnia (CBTi) as the ‘first-line’ treatment. However, family physicians report limited time, knowledge, access, support, and referral options to manage patients with CBTi. Consequently, many patients with insomnia are prescribed potentially harmful and addictive sedative-hypnotic medicines (e.g. benzodiazepines). Family physicians require an insomnia management pathway that is specifically tailored to the guideline-recommendations, time demands, and capacity of family practice.MethodsThis mixed-methods implementation trial will test the feasibility, acceptability and effectiveness of a comprehensive digital insomnia management pathway in family practice. This novel pathway includes digital recruitment of family physicians, automatic identification of patients whose electronic medical records contain recent sedative-hypnotic prescriptions using a software management pathway and real-time notifications prompting physicians to refer patients to a well-established digital CBTi program. At least 10 family physicians and 375 patients with insomnia will be recruited. Physicians will be provided with an eBook to guide gradual sedative-hypnotic withdrawal. Feasibility and acceptability will be assessed from the perspective of patients and physicians. Effectiveness will be determined by co-primary outcomes: cessation of sedative-hypnotic use, and improvement in self-reported insomnia symptoms from baseline to 12-month follow-up. Analysis of trends in costs, cost-effectiveness and cost-utility analyses will be conducted from a societal perspective.Results and discussionThis implementation trial will pave the way for future scaling-up of this insomnia management pathway to improve access to CBTi and reduce reliance on sedative-hypnotic medicines in family practice.Trial Registration: This trial was prospectively registered on the Australian and New Zealand Clinical Trials Registry (ANZCTR) (ACTRN12619001539123).

People living in nursing care facilities who are ambulant and fracture their hips: description of usual care and an alternative rehabilitation pathway

BackgroundLittle is known about treatment provided to people living in nursing care facilities (NCFs) after hospital admission for hip fracture. In addition, there are no clinical guidelines for rehabilitation and recovery following hip fracture for nursing home residents.MethodsAs part of a randomised trial (SACRED trial), which investigated the efficacy of a four week in-reach rehabilitation program, data were collected which described routine care for 240 people living in 76 nursing care facilities in South Australia who fractured their hips. The in-reach rehabilitation provided to 119 intervention participants is described, including intensity, type and methods used to encourage participation in rehabilitation. Adverse events that occurred, in particular falls, are also reported.ResultsNCF records indicated that, over the four weeks following discharge from hospital after hip fracture, 76% of patients receiving usual care had a consultation with their general practitioner. Physiotherapy was provided to 79% of patients in usual care (median of 1.96 h over the 4 weeks, which is less than 30 min each week of physiotherapy). In-reach rehabilitation was provided by the hospital team for 13 h over the 4 weeks with almost full attendance at physiotherapy sessions (median of 1 missed session, range 0–7 with a median of 14 physiotherapy sessions attended by participants, range 1–18). Experienced therapists provided a flexible approach to the rehabilitation to account for patients’ dementia and associated neuropsychiatric symptoms while providing dietetic support, mobility training and education to nursing home staff. The number of falls experienced by those in the intervention group was higher compared to those in usual care (Relative Risk 1.38 (95%CI 1.04–1.84, p = 0.03).ConclusionsRehabilitation can be provided to people living in NCFs following hip fracture, even when they have moderate to severe dementia but the model needs to be flexible. Provision of rehabilitation may increase the rate of falls in this population. Further studies are required to establish the feasibility of the intervention in other long term care settings. (327 words).Trial registrationACTRN12612000112864 registered on the Australian and New Zealand Clinical Trials Registry (ANZCTR).

Preventive Evidence into Practice: what factors matter in a facilitation intervention to prevent vascular disease in family practice?

BackgroundA perennial challenge of primary care quality improvement is to establish why interventions work in some circumstances, but not others. This study aimed to identify factors explaining variations in the impact on clinical practice of a facilitation led vascular health intervention in Australian family practice.MethodsOur mixed methods study was embedded within a cluster randomised controlled trial of a facilitation intervention designed to increase the uptake of evidence-based prevention of vascular disease in family practices. The study was set in four Australian states using eight of the study’s 16 intervention practices. Facilitators worked with intervention practices to develop and implement improvements in preventive care informed by a vascular risk factor audit. We constructed case studies of each practice’s “intervention narrative” from semi-structured interviews with clinicians, facilitators and other staff, practice observation, and document analysis of facilitator diaries. The intervention narratives were combined with pre- and post-intervention audit data to generate typologies of practice responses to the intervention.ResultsWe found substantial variability between practices in the changes made to vascular risk recording. Context (i.e. practice size), adaptive reserve (i.e. interpersonal relationships, manager and nurse involvement), and occasional data idiosyncrasies interacted to influence this variability.ConclusionThe findings emphasise the importance of tailoring facilitation interventions to practice size, clinician engagement and, critically, the organisation of, and relationships between, the members of the practice team.Trial registrationThe trial was registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12612000578808 (29/5/2012). This trial registration is retrospective as our first patient returned their consent on the 21/5/2012. Patient recruitment was ongoing until 31/10/2012.

Cognitive behavior therapy for older adults with insomnia and depression: a randomized controlled trial in community mental health services.

To investigate whether cognitive behavior therapy was effective for older adults with comorbid insomnia and depression in a community mental health setting, and explore whether an advanced form of cognitive behavior therapy for insomnia produced better outcomes compared to a standard form of cognitive behavior therapy for insomnia. An 8-week randomized controlled clinical trial was conducted within community mental health services, Victoria, Australia. Seventy-two older adults (56% female, M age 75 ± 7 years) with diagnosed comorbid insomnia and depression participated. Three conditions were tested using a group therapy format: cognitive behavior therapy for insomnia (CBT-I, standard), cognitive behavior therapy for insomnia plus positive mood strategies (CBT-I+, advanced), psychoeducation control group (PCG, control). The primary outcomes were insomnia severity (Insomnia Severity Index) and depression severity (Geriatric Depression Scale). Primary and secondary measures were collected at pre (week 0), post (week 8), and follow-up (week 20). CBT-I and CBT-I+ both generated significantly greater reductions in insomnia and depression severity compared to PCG from pre to post (p < .001), which were maintained at follow-up. Although the differences between outcomes of the two treatment conditions were not statistically significant, the study was not sufficiently powered to detect either superiority of one treatment or equivalence of the two treatment conditions. CBT-I and CBT-I+ were both effective at reducing insomnia and depression severity for older adults. Mental health services that deliver treatment for comorbid insomnia with cognitive behavior therapy may improve recovery outcomes for older adults with depression. Trial Registration: Australian and New Zealand Clinical Trials Registry (ANZCTR); URL: https://www.anzctr.org.au; Trial ID: ACTRN12615000067572; Date Registered: December 12, 2014.

Nonpublication and discontinuation of randomised controlled trials in newborns.

To determine the rate of nonpublication and discontinuation of randomised controlled trials (RCTs) in newborns. This was a retrospective, cross-sectional study of RCTs registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR) between 2008 and 2012. Fifty trials were identified, of which 23 (46%) were retrospectively registered. Thirty trials (60%) were published. After a median follow-up of 8.0 (range 4.6-17.4) years from Research Ethics Committee approval, 15 of 41 completed trials (37%) remained unpublished, representing 5422 neonatal trial participants. Nine trials (18%) were discontinued, including four that were published. The most frequent reason for discontinuation was poor recruitment (n = 4). Sample size discrepancies between registration and publication were found in 17 (65%) of the 26 completed, published trials. In nine (35%) of these trials, the calculated sample size in the method section of the published article differed from the planned sample size in the trial registry (relative difference -20% to +33%). Nonpublication and discontinuation of RCTs conducted in newborns is common. Additional efforts are needed to minimise the number of neonatal trial participants that are exposed to interventions without subsequent publication.

Effect of azithromycin on asthma exacerbations and quality of life in adults with persistent uncontrolled asthma (AMAZES): a randomised, double-blind, placebo-controlled trial

Exacerbations of asthma cause a substantial global illness burden. Adults with uncontrolled persistent asthma despite maintenance treatment require additional therapy. Since macrolide antibiotics can be used to treat persistent asthma, we aimed to assess the efficacy and safety of oral azithromycin as add-on therapy in patients with uncontrolled persistent asthma on medium-to-high dose inhaled corticosteroids plus a long-acting bronchodilator. We did a randomised, double-blind, placebo controlled parallel group trial to determine whether oral azithromycin decreases the frequency of asthma exacerbations in adults (≥18 years) with symptomatic asthma despite current use of inhaled corticosteroid and long-acting bronchodilator, and who had no hearing impairment or abnormal prolongation of the corrected QT interval. Patients were randomly assigned (1:1) to receive azithromycin 500 mg or placebo three times per week for 48 weeks. Patients were centrally allocated using concealed random allocation from a computer-generated random numbers table with permuted blocks of 4 or 6 and stratification for centre and past smoking. Primary efficacy endpoints were the rate of total (severe and moderate) asthma exacerbations over 48 weeks and asthma quality of life. Data were analysed on an intention-to-treat basis. The trial is registered at the Australian and New Zealand Clinical Trials Registry (ANZCTR), number 12609000197235. Between June 12, 2009, and Jan 31, 2015, 420 patients were randomly assigned (213 in the azithromycin group and 207 in the placebo group). Azithromycin reduced asthma exacerbations (1·07 per patient-year [95% CI 0·85-1·29]) compared with placebo (1·86 per patient-year [1·54-2·18]; incidence rate ratio [IRR] 0·59 [95% CI 0·47-0·74]; p<0·0001). The proportion of patients experiencing at least one asthma exacerbation was reduced by azithromycin treatment (127 [61%] patients in the placebo group vs 94 [44%] patients in the azithromycin group, p<0·0001). Azithromycin significantly improved asthma-related quality of life (adjusted mean difference, 0·36 [95% CI 0·21-0·52]; p=0·001). Diarrhoea was more common in azithromycin-treated patients (72 [34%] vs 39 [19%]; p=0·001). Adults with persistent symptomatic asthma experience fewer asthma exacerbations and improved quality of life when treated with oral azithromycin for 48 weeks. Azithromycin might be a useful add-on therapy in persistent asthma. National Health and Medical Research Council of Australia, John Hunter Hospital Charitable Trust.

Repetitive reaching training combined with transcranial Random Noise Stimulation in stroke survivors with chronic and severe arm paresis is feasible: a pilot, triple-blind, randomised case series

BackgroundTherapy that combines repetitive training with non-invasive brain stimulation is a potential avenue to enhance upper limb recovery after stroke. This study aimed to investigate the feasibility of transcranial Random Noise Stimulation (tRNS), timed to coincide with the generation of voluntary motor commands, during reaching training.MethodsA triple-blind pilot RCT was completed. Four stroke survivors with chronic (6-months to 5-years) and severe arm paresis, not taking any medications that had the potential to alter cortical excitability, and no contraindications to tRNS or MRI were recruited. Participants were randomly allocated to 12 sessions of reaching training over 4-weeks with active or sham tRNS delivered over the lesioned hemisphere motor representation. tRNS was triggered to coincide with a voluntary movement attempt, ceasing after 5-s. At this point, peripheral nerve stimulation enabled full range reaching. To determine feasibility, we considered adverse events, training outcomes, clinical outcomes, corticospinal tract (CST) structural integrity, and reflections on training through in-depth interviews from each individual case.ResultsTwo participants received active and two sham tRNS. There were no adverse events. All training sessions were completed, repetitive practice performed and clinically relevant improvements across motor outcomes demonstrated. The amount of improvement varied across individuals and appeared to be independent of group allocation and CST integrity.ConclusionReaching training that includes tRNS timed to coincide with generation of voluntary motor commands is feasible. Clinical improvements were possible even in the most severely affected individuals as evidenced by CST integrity.Trial registrationThis study was registered on the Australian and New Zealand Clinical Trials Registry (ANZCTR) http://www.ANZCTR.org.au/ACTRN12614000952640.aspx. Registration date 4 September 2014, first participant date 9 September 2014.

Reverse Shoulder Arthroplasty for the treatment of Proximal humeral fractures in the Elderly (ReShAPE trial) : study protocol for a multicentre combined randomised controlled and observational trial

BackgroundProximal humeral fractures are common in older patients. The majority are minimally displaced and are associated with good outcomes after nonoperative treatment. Poorer outcomes are associated with displaced, multipart fractures. There is no clear benefit from surgical fracture fixation compared to nonoperative treatment. Replacement of the fractured humeral head with a hemiarthroplasty is another treatment option, but has not been shown to be clearly superior to nonoperative treatment or internal fixation. Recently, reverse total shoulder arthroplasty has been used to treat these fractures, particularly in the older population with several case series demonstrating good outcomes. No comparative trial has been performed to test the effectiveness of reverse total shoulder arthroplasty against nonoperative treatment.Methods/designReShAPE (Reverse Shoulder Arthroplasty for the treatment of Proximal humeral fractures in the Elderly) is a multicenter combined randomized and observational study. The primary objective is to compare pain and function 12 months post fracture using the American Shoulder and Elbow Society (ASES) score in patients aged 70 years or older with three- and four-part proximal humeral fractures treated by either reverse shoulder arthroplasty or nonoperative treatment. Secondary outcome measures will include the DASH (Disability of the Arm, Shoulder and Hand) score, the EQ-5D (EuroQol Health Survey), the EQ-VAS, pain, radiological parameters and complications.DiscussionThe study will assess the effectiveness of reverse shoulder arthroplasty for complex proximal humeral fractures and thereby guide treatment of a common injury in the older population.Trial registrationWorld Health Organization Universal Trial Number (WHO UTN): U1111-1180-5452. Registered on 10 March 2016.Australian and New Zealand Clinical Trials Registry (ANZCTR): 12616000345482. Registered on 16 March 2016.

Effectiveness of a multicomponent exercise program in the attenuation of frailty in long-term nursing home residents: study protocol for a randomized clinical controlled trial

BackgroundThere is increasing evidence suggesting that cognition and physical frailty interact within a cycle of decline associated with aging which has been called cognitive frailty. Exercise programs have demonstrated to be an effective tool to prevent functional and cognitive decline during aging, but little is known about their potential to restore or maintain functionality in individuals that require long-term nursing care. Besides, WHO has recently highlighted the importance of introducing systematic musculoskeletal health programs for older people living in residential care, as they represent a particularly vulnerable group for the development of noncommunicable diseases.MethodsThis is a multicentre randomized controlled trial. 114 participants will be randomly allocated to a usual care group or to an intervention group. Inclusion criteria are as follows: ≥ 70 years, ≥ 50 on the Barthel Index, ≥ 20 on MEC-35 who are capable to stand up and walk independently for 10 m. Subjects in the intervention group will add to the activities scheduled for the control group the participation in a 6 months long multicomponent exercise program designed to improve strength, balance and walking retraining. Study assessments will be conducted at baseline and at 3 and 6 months. The primary outcome is change in function assessed by Short Physical Performance Battery and secondary outcomes include other measurements to assess all together the condition of frailty, which includes functionality, sedentary behaviors, cognitive and emotional status and biological markers. The present study has been approved by the Committee on Ethics in Research of the University of the Basque Country (Humans Committee Code M10/2016/105; Biological Samples Committee Code M30/2016/106).DiscussionResults from this research will show if ageing related functional and cognitive deterioration can be effectively prevented by physical exercise in institutionalized elders. It is expected that the results of this research will guide clinical practice in nursing home settings, so that clinicians and policymakers can provide more evidence-based practice for the management of institutionalized elder people.Trial registrationThe protocol has been registered under the Australian and New Zealand Clinical Trials Registry (ANZCTR) with the identifier: ACTRN12616001044415.

Internet Cognitive Behavioral Therapy for Women With Postnatal Depression: A Randomized Controlled Trial of MumMoodBooster.

BackgroundThere are few published controlled trials examining the efficacy of Internet-based treatment for postnatal depression (PND) and none that assess diagnostic status (clinical remission) as the primary outcome. This is despite the need to improve treatment uptake and accessibility because fewer than 50% of postnatally depressed women seek help, even when identified as depressed.ObjectiveIn a randomized controlled trial (RCT), we aimed to test the efficacy of a 6-session Internet intervention (the MumMoodBooster program, previously evaluated in a feasibility trial) in a sample of postnatal women with a clinical diagnosis of depression. The MumMoodBooster program is a cognitive behavioral therapy (CBT) intervention, is highly interactive, includes a partner website, and was supported by low-intensity telephone coaching.MethodsThis was a parallel 2-group RCT (N=43) comparing the Internet CBT treatment (n=21) to treatment as usual (n=22). At baseline and at 12 weeks after enrollment, women’s diagnostic status was assessed by telephone with the Standardized Clinical Interview for DSM-IV (SCID-IV) and symptom severity with the Beck Depression Inventory (BDI-II). Depression symptoms were measured repeatedly throughout the study period with the Patient Health Questionnaire (PHQ-9).ResultsAt the end of the study, 79% (15/19) of women who received the Internet CBT treatment no longer met diagnostic criteria for depression on the SCID-IV (these outcome data were missing for 2 intervention participants). This contrasted with only 18% (4/22) remission in the treatment as usual condition. Depression scores on the BDI-II showed a large effect favoring the intervention group (d=.83, 95% CI 0.20-1.45). Small to medium effects were found on the PHQ-9 and on measures of anxiety and stress. Adherence to the program was very good with 86% (18/21) of users completing all sessions; satisfaction with the program was rated 3.1 out of 4 on average.ConclusionsOur results suggest that our Internet CBT program, MumMoodBooster, is an effective treatment option for women clinically diagnosed with PND. This is one of only two controlled evaluations of specialized online psychological treatment among women clinically diagnosed with PND. MumMoodBooster appears to be a feasible, effective treatment option, which is potentially accessible to large numbers of women in metropolitan, rural, and remote areas. Future work might be focused profitably on establishing comparability with face-to-face treatments and purely self-guided delivery. We have commenced a larger RCT comparing MumMoodBooster with face-to-face CBT.Trial RegistrationAustralian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12613000113752; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363561 (Archived by WebCite® at http://www.webcitation.org/6f64kuyLf).

Effect of tart cherry juice on recovery and next day performance in well-trained Water Polo players.

BackgroundTart Montmorency cherries contain high concentrations of phytochemicals and anthocyanins, which have recently been linked to improved athletic recovery and subsequent performance. To date however, previous work reporting promising results has focused on land-based endurance sports, with any potential benefits to team sports remaining unknown. As such, this investigation set-out to examine the effect of supplemental tart cherry juice (CJ) on recovery and next day athletic performance in highly-trained water-based team sport athletes over seven days.MethodsIn a randomised, double-blind, repeated measures, crossover design, nine male Water Polo athletes were supplemented with CJ or a placebo equivalent (PLA) for six consecutive days. Prior to, and at the completion of the supplementation period, water-based performance testing was conducted. On day 6, participants also undertook a fatiguing simulated team game activity. Venous blood samples were collected (Pre-exercise: day 1, 6 and 7; Post-exercise: day 6) to investigate markers of inflammation [Interleukin-6 (IL-6); C-reactive protein (CRP)] and oxidative stress [Uric Acid (UA); F2-Isoprostane (F2-IsoP)]. A daily diary was also completed (total quality of recovery, delayed onset muscle soreness) as a measure of perceptual recovery.ResultsIn both conditions, day 6 post-exercise IL-6 was significantly higher than pre-exercise and day 7 (p < 0.05); CRP was greater on day 7 as compared to day 6 pre- and post-exercise (p < 0.05); F2-IsoP was significantly lower on day 7 as compared to day 1 and day 6 (p < 0.05); UA remained unchanged (p > 0.05). No differences were found for any performance or recovery measures.ConclusionsThe lack of difference observed in the blood markers between groups may reflect the intermittent, non-weight bearing demands of Water Polo, with such activity possibly unable to create a substantial inflammatory response or oxidative stress (over 7 days) to impede performance; thereby negating any potential beneficial effects associated with CJ supplementation.Trial registrationThis trial was registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR). Registration number: ACTRN12616001080415. Date registered: 11/08/2016, retrospectively registered.

Prophylactic manual rotation for fetal malposition to reduce operative delivery.

Manual rotation is commonly performed to increase the chances of normal vaginal delivery and is perceived to be safe. Manual rotation has the potential to prevent operative delivery and caesarean section, and reduce obstetric and neonatal complications. To assess the effect of prophylactic manual rotation for women with malposition in labour on mode of delivery, and maternal and neonatal outcomes. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 October 2014), the Australian and New Zealand Clinical Trials Registry (ANZCTR), ClinicalTrials.gov, Current Controlled Trials and the WHO International Clinical Trials Registry Platform (ICTRP) (all searched 23 February 2014), previous reviews and, references of retrieved studies. Randomised, quasi-randomised or cluster-randomised clinical trials comparing prophylactic manual rotation in labour for fetal malposition versus expectant management, augmentation of labour or operative delivery. We defined prophylactic manual rotation as rotation performed without immediate assisted delivery. Two review authors independently assessed study eligibility and quality, and extracted data. We included only one small pilot study (involving 30 women). The study, which we considered to be at low risk of bias, was conducted in a tertiary referral hospital in Australia, and involved women with cephalic, singleton pregnancies. The primary outcome was operative delivery (instrumental delivery or caesarean section).In the manual rotation group, 13/15 women went on to have an instrumental delivery or caesarean section, whereas in the control group, 12/15 women had an operative delivery. The estimated risk ratio was 1.08 (95% confidence interval 0.79 to 1.49). There were no maternal or fetal mortalities in either groupThere were no clear differences for any of the secondary maternal or neonatal outcomes reported (e.g. perineal trauma, analgesia use duration of labour).In terms of adverse events, there were no reported cases of umbilical cord prolapse or cervical laceration and a single case of a non-reassuring or pathological cardiotocograph during the procedure. Currently, there is insufficient evidence to determine the efficacy of prophylactic manual rotation early in the second stage of labour for prevention of operative delivery. One additional study is ongoing. Further appropriately designed trials are required to determine the efficacy of manual rotation.