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Despite the acceptability and efficacy of e-patient-reported outcome (ePRO) systems, implementation in routine clinical care remains challenging. This pragmatic trial implemented the PROMPT-Care (Patient Reported Outcome Measures for Personalized Treatment and Care) web-based system into existing clinical workflows and evaluated its effectiveness among a diverse population of patients with cancer. Adult patients with solid tumors receiving active treatment or follow-up care in four cancer centers were enrolled. The PROMPT-Care intervention supported patient management through (1) monthly off-site electronic PRO physical symptom and psychosocial well-being assessments, (2) automated electronic clinical alerts notifying the care team of unresolved clinical issues following two consecutive assessments, and (3) tailored online patient self-management resources. Propensity score matching was used to match controls with intervention patients in a 4:1 ratio for patient age, sex, and treatment status. The primary outcome was a reduction in emergency department presentations. Secondary outcomes were time spent on chemotherapy and the number of allied health service referrals. From April 2016 to October 2018, 328 patients from four public hospitals received the intervention. Matched controls (n=1312) comprised the general population of patients with cancer, seen at the participating hospitals during the study period. Emergency department visits were significantly reduced by 33% (P=.02) among patients receiving the intervention compared with patients in the matched controls. No significant associations were found in allied health referrals or time to end of chemotherapy. At baseline, the most common patient reported outcomes (above-threshold) were fatigue (39%), tiredness (38.4%), worry (32.9%), general wellbeing (32.9%), and sleep (24.1%), aligning with the most frequently accessed self-management domain pages of physical well-being (36%) and emotional well-being (23%). The majority of clinical feedback reports were reviewed by nursing staff (729/893, 82%), largely in response to the automated clinical alerts (n=877). Algorithm-supported web-based systems utilizing patient reported outcomes in clinical practice reduced emergency department presentations among a diverse population of patients with cancer. This study also highlighted the importance of (1) automated triggers for reviewing above-threshold results in patient reports, rather than passive manual review of patient records; (2) the instrumental role nurses play in managing alerts; and (3) providing patients with resources to support guided self-management, where appropriate. Together, these factors will inform the integration of web-based PRO systems into future models of routine cancer care. Australian New Zealand Clinical Trials Registry ACTRN12616000615482; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370633. RR2-10.1186/s12885-018-4729-3.

IntroductionFirst steps for knee osteoarthritis (OA) is a cluster randomised implementation trial examining the effect of an educational reminder message included in knee X-ray reports on the proportion of people subsequently referred to exercise professionals for their knee OA. Evaluating the processes supporting the completion of the study and the efficacy of the reminder message is essential to interpreting the outcomes of the study and aiding translation into practice.Methods and analysisWe will conduct a concurrent process evaluation throughout the current study using a previously published framework for examining cluster randomised trials. This framework divides processes into those occurring at the cluster level and those at the target population level. For the current study, the cluster level is within radiology clinics. The target population is people with newly diagnosed radiologically evident, structural knee OA. A mixed methods design, incorporating survey data, administrative records, field notes and semi-structured interviews with representatives from radiology clinics and people with knee OA, will evaluate these processes. The focus of the evaluation will be recruitment and response processes of the radiology clinics and delivery and response processes for the people with knee OA. We will also describe the context and explore how the nudge theory of behavioural change influences the outcome of the study.Ethics and disseminationThe study protocol, inclusive of the process evaluation, was approved by Macquarie University Human Research Ethics Committee (#520221190343842). Findings will be disseminated through national and international conferences, national industry stakeholders and patient advocacy groups to reach all levels of healthcare. Staff at radiology clinics and people with knee OA involved in interviews provide written, informed consent to participate in the process evaluation. Specific findings will be incorporated into training modules aimed at radiology clinics and will be developed by our industry partners.Trial registrationProspectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12622001414707p). Registration occurred in December 2022

Background Total knee and hip arthroplasty are considered a clinically and cost-effective intervention, however, persistent pain post-surgery can occur, and some continue to take opioid medications long-term. One factor which has infrequently been included in prediction modelling is rehabilitation pathway, in particular, one which includes inpatient rehabilitation. As discharge to inpatient rehabilitation post-arthroplasty is common practice, we aimed to identify whether rehabilitation pathway (discharge to in-patient rehabilitation or not) predicts continued use of opioids at 3 months (90 days) post- total knee arthroplasty (TKA) and total hip arthroplasty (THA) whilst controlling for other covariates. Methods The study was nested within a prospective observational study capturing pre-operative, acute care and longer-term data from 1900 osteoarthritis (OA) patients who underwent primary TKA or THA. The larger study involved a part-random, part-convenience sample of 19 high-volume hospitals across Australia. Records with complete pre-and post-operative analgesic (35 days and 90 days) use were identified [1771 records (93% of sample)] and included in logistic regression analyses. Results Three hundred and thirteen people (17.8%) reported ongoing opioid use at 90 days post-operatively. In the adjusted model, admission to inpatient rehabilitation after surgery was identified as an independent and significant predictor of opioid use at 90-days. Inpatient rehabilitation was associated with almost twice the odds of persistent opioid use at 90-days compared to discharge directly home (OR = 1.9 (1.4, 2.5), p  < .001). Conclusion The inpatient rehabilitation pathway is a strong predictor of longer-term opioid use (90 days) post-arthroplasty, accounting for many known and possible confounders of use including sex, age, insurance status, major complications, smoking status and baseline body pain levels. Trial registration The study was nested within a prospective cohort observational study capturing pre-operative, acute-care and longer-term data from patients undergoing primary TKA or THA for osteoarthritis (ClinicalTrials.gov NCT01899443).

Lack of evidence contributes to unnecessary variation in treatment costs and outcomes. This study aimed to identify from interventions historically used for total knee or hip arthroplasty (TKA, THA): i) if routine use is supported by high-level evidence; ii) whether surgeon use aligns with the evidence. Part 1: Systematic search of electronic library databases for systematic reviews and practice guidelines concerning seven acute-care interventions. Intervention-specific recommendations concerning routine use were extracted by assessors. Part 2: Prospective medical record audit of the acute-care received by 1900 patients involving 120 orthopaedic surgeons. Surgeon use per intervention was summarized using caterpillar plots. Surgeon-specific routine and non-routine use was defined as use in ≥ 90% and ≤ 10% of patients, respectively. Primary analysis included only surgeons contributing ≥ 10 patients. Continuous passive motion (TKA): Routine use not recommended; 85.7% of surgeons did not use it routinely. Tranexamic Acid: Routine use recommended; 26.9% of surgeons used it routinely. Cryotherapy: Routine use not recommended; 45.7% of surgeons used it routinely for TKA; 31.8% used it routinely for THA. Intra-articular drainage: Routine use not recommended for TKA, but possible benefits for THA; 5.7% of surgeons used it routinely for TKA, 0.0% used it routinely for THA. Antibiotic loaded bone cement: Routine use for TKA not supported, recommendations for use for THA are inconsistent; 90.0% of surgeons used it routinely for TKA, 100.0% used it routinely for THA. Patella resurfacing (TKA): No recommendation could be made; 57.1% of surgeons routinely resurfaced the patella. Indwelling urinary catheterisation: Routine use recommended; 59.6% of surgeons used it routinely. Recommendations for routine use or not exist for some of the acute-care interventions examined. Surgeon practices vary widely even in the presence of high-level recommendations. It is unclear whether further evidence alone would lessen unwarranted practice variation.

IntroductionThis cluster randomised implementation trial will assess the effect of two behavioural change interventions on the proportion of people with structural knee osteoarthritis (OA) referred and attending exercise-based professionals (physiotherapists and exercise physiologists). The interventions are designed to increase awareness of guidelines, benefits and access pathways for exercise therapy. We hypothesise either strategy will result in more people with knee OA being referred and attending physiotherapy/exercise physiology than current standard of care.Methods and analysisWe will recruit 30 radiology clinics. 10 clinics will be randomly assigned to each trial arm with 1020 people with knee OA consecutively recruited (102 people per practice) into each arm. Intervention arm 1 is an educational reminder message targeted at primary care practitioners with a hyperlink to national guidelines regarding knee OA clinical management. It will be included in the reporting template of a plain knee X-ray. Intervention arm 2 is the reminder message and a patient-facing infographic explaining the benefits and access pathways for exercise. Both interventions will be delivered once, by the radiology clinics, when a person undergoes plain X-ray for non-traumatic knee pain/dysfunction. The primary outcome is referral to physiotherapist/exercise physiology. The secondary outcome is attendance to that appointment. Both outcomes are self-reported via an online survey administered 4 weeks after the X-ray. Additional survey questions explore facilitators and barriers to appointment attendance and acceptability of the interventions. A subsample of the intervention groups will be recruited for semistructured telephone-based interviews to further explore these latter outcomes.Ethics and disseminationThe study protocol was approved by Macquarie University Human Research Ethics Committee (#520221190343842) and prospectively registered with the Australian New Zealand Clinical Trials Registry. The findings of the trial will be disseminated through peer-reviewed scientific journals and conferences. We will engage with Australian physician colleges and main-stream media to distribute findings.Trial registration numberACTRN12622001414707p.

Background Degenerative rotator cuff tears are common and are often treated with surgical repair. Randomised trials have not shown a clear advantage to surgery over non-surgical treatment, but there have been no published placebo-controlled trials investigating rotator cuff repair. This study aims to compare arthroscopic shoulder surgery with rotator cuff repair to surgery without rotator cuff repair (placebo) for improving shoulder pain and function in people with shoulder pain and full-thickness degenerative rotator cuff tears. Methods The study is a multicentre two-parallel arm, blinded, individually randomised controlled trial (RCT). Participants will be people aged 40–75 years (inclusive) with more than 6 months of shoulder pain, a degenerative (non-traumatic) full thickness rotator cuff tear 1 to 4 cm in length for whom surgery is recommended and repair of the tear is the main reason for surgery. The intervention is arthroscopic surgery (including—as indicated—bursectomy, debridement, acromioclavicular joint resection, acromioplasty and biceps tenodesis or tenotomy) with rotator cuff repair. The control is the same arthroscopic shoulder surgery without rotator cuff repair. Participants will be randomised to cuff repair or no cuff repair in a 1:1 ratio intra-operatively, after all other surgical procedures have been performed. Participants, follow-up surgeons, physiotherapists, study staff and statisticians will be blinded. Post-surgical rehabilitation will be usual care for rotator cuff repair in both groups. The primary outcome will be shoulder pain and function measured using the Western Ontario Rotator Cuff Index at 6 months post-surgery. Discussion The ARC trial will provide low bias evidence on a common surgical procedure: rotator cuff repair for degenerative tears. Trial registration The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12620000789965) on 5 August 2020 and the WHO International Clinical Trials Registry Platform (universal trial number U1111-1251-6599).

Background Following traumatic hand injury, few studies have compared outcomes between people with and without a pre-morbid mental health diagnosis. This study aimed to compare sub-acute outcomes in a multicultural patient cohort with surgically managed traumatic hand injury with and without a pre-morbid mental health diagnosis. Methods A prospective, observational cohort study of people with traumatic hand injury presenting pre- surgically to a high-volume hand injury centre in a region of cultural and language diversity was conducted. Participants were assessed face-to-face (baseline) then via telephone (3-months post-surgery) and categorized according to a pre-morbid medically diagnosed mental health diagnosis. Baseline and follow-up assessments included global mental health, and the EuroQol (EQ) ‘Health Today’ analogue scale (0–100) and health domains. Return-to-work status, complications/symptomatic complaints, and hand function (QuickDASH) were also collected at follow-up. Adjusted analyses—accounting for covariates including cultural identity—were conducted to determine whether 3-month outcomes were associated with a pre-morbid mental health diagnosis. Results From 405 eligible patients, 386 were enrolled (76% male, mean age 38.9 (standard deviation 15.6)); 57% self-identified as Australian and 22% had a pre-morbid mental health diagnosis. Common injuries regardless of pre-morbid mental health diagnosis were skin (40%), tendon (17%) and bone (17%) injuries. None were complex mutilating injuries. Seventy-eight per cent of the cohort was followed-up. In adjusted analyses, a pre-morbid mental health diagnosis was associated with lower odds for reporting ‘good or better’ global mental health (Odds Ratio (OR) 0.23 (95% Confidence Interval (CI) 0.18, 0.47), p  < 0.001), ‘no’ anxiety or depression (OR 0.21 (0.11, 0.40), p  < 0.001) and no pain (OR 0.56 (0.31, 0.98), p  = 0.04)(EQ domains), and worse EQ ‘Health Today’ (10 points on average (95%CI -14.9, -5.1, p  < 0.001). QuickDASH scores, rates of complications/symptomatic complaints and return-to-work profiles were similar. Conclusions Despite reporting worse mental and health-related quality-of-life outcomes post-surgery, people with a pre-morbid mental health diagnosis regardless of cultural identity experienced similar clinical and return-to-work outcomes. Future research assessing the value of screening for pre-morbid mental health conditions on post-surgical outcomes is required and should include people with more complex hand injuries.

Background Routine assessment and clinical utilisation of patient-reported outcome (PRO) measures can lead to improved patient outcomes. The PROMPT-Care eHealth system facilitates PRO data capture from cancer patients, data linkage and retrieval to support clinical decisions, patient self-management, and shared care. Pilot testing demonstrated acceptability and feasibility of PROMPT-Care Version 1.0. This study aims to implement PROMPT-Care Version 2.0 and determine its efficacy in reducing emergency department (ED) presentations, and improving chemotherapy delivery and health service referrals, compared to usual care. Methods Groups eligible to participate in the intervention arm of this controlled trial are patients receiving cancer care (including follow-up). PROMPT-Care patients will complete monthly assessments (distress, symptoms, unmet needs) until voluntary withdrawal or death. In Version 1.0, the care team accessed patients’ clinical feedback reports in ‘real time’ to guide their care, and patients received links to support their self-management, tailored to their PRO responses. Version 2.0 was extended to include: i) an additional alert system notifying the care team of ongoing unresolved clinical issues, ii) patient self-management resources, and iii) an auto-populated Treatment Summary and Survivorship Care Plan (SCP). The control population will be patients extracted from hospital databases of the general cancer patient population who were seen at the participating cancer therapy centres during the study period, with a ratio of 1:4 of intervention to control patients. A minimum sample size of 1760 (352 intervention and 1408 control) patients will detect a 14% reduction in the number of ED presentations (primary outcome) in the PROMPT-Care group compared with the control group. Intervention patients will provide feedback on system usability and value of the self-management materials; oncology staff will provide feedback on usefulness of PROMPT-Care reports, response to clinical alerts, impact on routine care, and usefulness of the SCPs; and GPs will provide feedback on the usefulness of the SCPs and attitudes towards shared-care models of survivorship care planning. Discussion This study will inform the PROMPT-Care system’s impact on healthcare utilisation and utility as an alternative model for ongoing supportive care. Trial registration Australian New Zealand Clinical Trials Registry ( ACTRN12616000615482 ) on 12th May 2016 ( www.anzctr.org.au ).

ObjectivesTo understand the views and motivations of healthcare workers at a vaccination hub who received a COVID-19 vaccination in March–May 2021.Study designThis is an observational study via an anonymous electronic survey of seven questions focus on where survey recipients received information about the vaccine roll-out, their motivations for receiving the vaccine and their level of comfort in receiving the vaccine.SettingThe Liverpool Vaccination Hub is located in South Western Sydney.ParticipantsParticipants were healthcare workers who received the first dose of a COVID-19 vaccine in the Australian Government’s Phase 1a and 1b priority categories. The majority of survey respondents (70%) were female (median aged between 35 and 44 years). The majority of survey respondents were clinical workers, such as nurse, paramedics and doctors.Outcome measuresχ2 analysis was used for analysis of survey responses in univariate analysis. Logistic regression was used to analyse survey responses, adjusting for week, type of health worker and age.Results4746 healthcare workers responded to the survey after receiving their first vaccine dose, a response rate of 23%. Over 90% of respondents said that COVID-19 vaccination information from their organisation was easily available. Most of them reported that they were comfortable receiving a COVID-19 vaccine. The majority of respondents were motivated to receive the vaccine due to concern about contracting COVID-19 themselves (75%), or concerns about transmitting it to other people such as patients (52%), family members (65%) or other community members (54%). Younger respondents were more likely to have preferred more information on vaccine safety (p<0.0001) and the effectiveness of the vaccine (p<0.0001).ConclusionThe majority of healthcare workers who received a COVID-19 vaccine reported that it was easy to find useful information about the vaccination roll-out and they had a positive experience being vaccinated.

IntroductionChronic disease is a leading cause of death and disability that disproportionately burdens culturally and linguistically diverse (CALD) communities. Self-management is a cornerstone of effective chronic disease management. However, research suggests that patients from CALD communities may be less likely to engage with self-management approaches. The Natural Helper Programme aims to facilitate patient engagement with self-management approaches (ie, ‘activation’) by embedding cultural mentors with lived experience of chronic disease into chronic disease clinics/programmes. The Natural Helper Trial will explore the effect of cultural mentors on patient activation, health self-efficacy, coping efforts and health-related quality of life (HRQoL) while also evaluating the implementation strategy.Methods and analysisA hybrid type-1 effectiveness-implementation cluster-randomised controlled trial (phase one) and a mixed-method controlled before-and-after cohort extension of the trial (phase 2). Hospital clinics in highly multicultural regions in Australia that provide healthcare for patients with chronic and/or complex conditions, will participate. A minimum of 16 chronic disease clinics (clusters) will be randomised to immediate (active arm) or delayed implementation (control arm). In phase 1, the active arm will receive a multifaceted strategy supporting them to embed cultural mentors in their services while the control arm continues with usual care. Each cluster will recruit an average of 15 patients, assessed at baseline and 6 months (n=240). In phase 2, clusters in the control arm will receive the implementation strategy and evaluate the intervention on an additional 15 patients per cluster, while sustainability in active arm clusters will be assessed qualitatively. Change in activation over 6 months, measured using the Patient Activation Measure will be the primary effectiveness outcome, while secondary effectiveness outcomes will explore changes in chronic disease self-efficacy, coping strategies and HRQoL. Secondary implementation outcomes will be collected from patient–participants, mentors and healthcare providers using validated questionnaires, customised surveys and interviews aligning with the Reach, Effectiveness, Adoption, Implementation, Maintenance framework to evaluate acceptability, reach, dose delivered, sustainability, cost-utility and healthcare provider determinants.Ethics and disseminationThis trial has full ethical approval (2021/ETH12279). The results from this hybrid trial will be presented at scientific meetings and published in peer-reviewed journals.Trial registration numberACTRN12622000697785.