ABSTRACT
Background: Musculoskeletal conditions such as spinal pain and osteoarthritis are among the leading causes of years lived with disability worldwide. With the COVID-19 pandemic forcing many healthcare providers to change the way in which care for chronic conditions is delivered, telehealth is an alternative to face-to-face consultations that can be used for both assessment and provision of therapy and support. Objectives: To identify, appraise and synthesise findings from all randomised controlled trials (RCTs) that compared telehealth to face-to-face consultations for patients with any type of musculoskeletal condition. Methods: Systematic review and meta-analysis. We used the GRADE approach to assess the quality of evidence related to all outcomes. We searched three electronic databases (PubMed, Embase, CENTRAL), clinical trial registries and citing-cited references of included studies. Results: Five RCTs were includable: one in patients with osteoarthritis of the knee, one in patients with osteoarthritis of the knee or hip in preparation for a total joint arthroscopy and three after total knee replacement. Telehealth was conducted by video in four trials and by phone in one. A total of 402 participants were analysed across the five trials. There were no significant differences in pain outcomes (WOMAC) between telehealth and face-to-face therapy immediate post-intervention (mean difference (MD): 0.12 (95% CI −2.3 to 2.6, p =.92) or two months post-intervention (MD): 1.2, (95% CI: −2.7 to 5.1, p =.55). Similarly, outcomes related to function, quality of life and satisfaction were comparable between the two modes of delivery immediate post-intervention, with no significant differences reported. Conclusion: There is limited low quality evidence that there is no significant differences between telehealth-based delivery of rehabilitation to patients with osteoarthritis or following knee surgery and face-to-face therapy for pain, function, quality of life and satisfaction. These findings should be should be interpreted with caution due to the small number of included studies and small sample size. © 2023 Informa UK Limited, trading as Taylor & Francis Group.
ABSTRACT
The authors P. Orellana and N. El-Haj were inadvertently deleted in the original paper.
ABSTRACT
AVENuE - Avelumab in the frontline treatment of advanced classic Hodgkin lymphoma - a window study Background Response adapted ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) has become a standard of care in many countries for advanced stage classic Hodgkin Lymphoma (cHL), as investigated in the RATHL study: following 2 cycles of ABVD patients with negative (Deauville 1-3) interim PET (iPET2) proceeded to 4 cycles of AVD;those with positive (Deauville 4-5) iPET2 intensified therapy to escalated bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisolone (escBEACOPP) or BEACOPP every 14 days. Overall this strategy was associated with a 3-year progression free survival (PFS) of 82.6%, and outcomes for patients with positive iPET2 were disappointing with 3y progression-free survival (PFS) of 67.5%. More intensive treatment such as upfront use of escBEACOPP has been reported to produce higher PFS (89% at 5 years), but it is unclear whether overall survival (OS) is improved. More intensive treatment is, however, associated with higher risk of toxicity. Inhibitors of programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1) have established efficacy in relapsed / refractory cHL with response rates of 55-87%. In the front line setting PD-1 inhibitors have a reported complete metabolic response (CMR) rate of 18-37%. Response to PD-L1 inhibitors in the frontline setting has not been explored. Serial serum TARC (thymus and activation-regulated chemokine) is reported to be prognostic in the frontline treatment of cHL and may aid response assessment because PET interpretation with checkpoint inhibitors is often complex. In the context of PD-1 inhibition, PD-1 expression by immunohistochemistry (IHC) and 9p24.1 copy gain by fluorescence in situ hybridisation (FISH) are reported to correlate with response. Methods AVENuE is a Phase II single-arm multicentre study with sites in the UK and Australia assessing the safety and efficacy of 2 cycles (4 doses) of the PD-L1 inhibitor avelumab for untreated high-risk stage II-IV cHL prior to the iPET2 response adapted approach described above. Eligible patients must be 16-60 years, ECOG 0-1, and have adequate organ function. Patients with;compressive symptoms from lymphoma, autoimmune disorders or immunosuppressive treatment within 2 months are excluded. The primary endpoint is the centrally reviewed PET CMR rate to avelumab. Secondary endpoints are: the safety and tolerability of sequential avelumab and combination chemotherapy as assessed by CTCAE v 5.0;the iPET2 CMR rate after avelumab and 2 cycles of ABVD;PFS and OS at one year. Using a single stage A'hern design, target recruitment is 47 patients to give 90% power at a 0.05% one sided alpha to exclude an overall response rate (ORR) to 2 cycles of avelumab of < 20%;an ORR of 40% would be considered worthy of further study. Recruitment has continued during the COVID-19 pandemic. 29 patients have been enrolled. Exploratory endpoints include correlating disease response with baseline PD-1 copy number by FISH and PD-1 expression by IHC. Serial serum TARC is being explored as an aid to response assessment and changes in peripheral blood immune cell subset are being investigated as possible biomarkers of response. Trial funder: Pfizer Ltd in alliance with Merck KGaA Pfizer Ltd is providing funding as part of an Alliance between Pfizer and Merck KGaA Clinical trials.gov NCT03617666 EUDRACT No.: 2018-002227-42 Disclosures: Hawkes: Roche: Membership on an entity's Board of Directors or advisory committees, Other: Travel and accommodation expenses, Research Funding, Speakers Bureau;Regeneron: Speakers Bureau;Merck KgA: Research Funding;Astra Zeneca: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau;Janssen: Speakers Bureau;Merck Sharpe Dohme: Membership on an entity's Board of Directors or advisory committees;Novartis: Membership on an entity's Board of Directors or advisory committees;Gilead: Membership on an entity's Boa d of Directors or advisory committees;Antigene: Membership on an entity's Board of Directors or advisory committees;Bristol Myers Squib/Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding;Specialised Therapeutics: Consultancy. Barrington: Bristol Myers Squibb international corporation: Research Funding;Pfizer Inc: Research Funding;Amgen Ltd: Research Funding;Takeda Speakers Bureau: Honoraria. McKay: Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees;Gilead: Honoraria, Other: Travel Support;KITE: Honoraria, Membership on an entity's Board of Directors or advisory committees;Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel Support;Janssen: Honoraria, Other: Travel Support;Beigene: Honoraria, Membership on an entity's Board of Directors or advisory committees;BMS/Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees. Iyengar: Janssen: Other: conference support, Speakers Bureau;Abbvie: Other: conference support;Beigene: Membership on an entity's Board of Directors or advisory committees;Gilead: Membership on an entity's Board of Directors or advisory committees, Other: conference support, Speakers Bureau;Takeda: Membership on an entity's Board of Directors or advisory committees, Other: conference support, Speakers Bureau. Radford: Takeda: Consultancy, Honoraria, Research Funding, Speakers Bureau;AstraZeneca: Current holder of individual stocks in a privately-held company;ADC Therapeutics: Consultancy, Current holder of individual stocks in a privately-held company, Honoraria, Speakers Bureau;BMS: Honoraria. Shah: Abbvie, Janssen and Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees. Clifton-Hadley: Bristol-Myers Squibb Pharmaceuticals Ltd.: Other: The haematology team at the CTC has received funding (which in part pays staff salary) to Sponsor and coordinate clinical trials.;Amgen: Other: The haematology team at the CTC has received funding (which in part pays staff salary) to Sponsor and coordinate clinical trials.;Celgene: Other: The haematology team at the CTC has received funding (which in part pays staff salary) to Sponsor and coordinate clinical trials.;Merck Sharp and Dohme: Other: The haematology team at the CTC has received funding (which in part pays staff salary) to Sponsor and coordinate clinical trials.;Janssen-Cilag: Other: The haematology team at the CTC has received funding (which in part pays staff salary) to Sponsor and coordinate clinical trials.;Pfizer: Other: The haematology team at the CTC has received funding (which in part pays staff salary) to Sponsor and coordinate clinical trials.;Millennium pharmaceutics inc.: Other: The haematology team at the CTC has received funding (which in part pays staff salary) to Sponsor and coordinate clinical trials. Collins: Beigene: Membership on an entity's Board of Directors or advisory committees;Novartis: Honoraria, Speakers Bureau;Pfizer: Honoraria;Celgene: Research Funding;Amgen: Research Funding;AstraZeneca: Honoraria, Research Funding;ADC Therapeutics: Honoraria, Membership on an entity's Board of Directors or advisory committees;Celleron: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding;Merck Sharp & Dohme: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding;Bristol Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau;Gilead: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau;Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau;Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel expenses, Speakers Bureau. OffLabel Disclosure: Avelumab prior to frontline chemotherapy in advanced stage classic Hodgkin lymphoma.
ABSTRACT
Objective: We conducted a survey to understand the challenges faced by the staff of residential aged care facilities (RACF), during the COVID-19 pandemic. Background: In the current pandemic, the RACF workforce has been required to work under stressful conditions, with immense mental and physical pressures, resulting in anxiety and stress felt towards their jobs. Study design and methods: We electronically surveyed both clinical and non-clinical staff at public and private RACFs in Australia in June and August 2020. The survey asked a mix of openended and closed questions about preparedness for the pandemic, information flow, experience with personal protective equipment (PPE), management of suspected COVID cases, restrictions on visitors, and impact on RACF staff personal and home life. Quantitative data were analysed in SPSS;qualitative data using content analysis. Results: We received 371 responses: 198 from clinical staff and 168 from non-clinical staff. Respondents were between 20-71 years old, and 87% were female most commonly from Victoria (28%) or New South Wales (28%). The majority (80%) felt that Australian RACFs were well-prepared for the pandemic and 87% agreed that relevant healthcare authorities were contactable for information needed. A total of 37% reported challenges in estimating and ordering appropriate quantities of protective equipment. Ninety percent of facilities reported screening residents for possible symptoms and 77% introduced precautions or quarantine measures to protect residents. Most participants (98%) reported their RACF implemented restrictions on visitor access and 43% reported unfair or abusive treatment by family or friends of the residents. Commonly reported personal impacts included: workload increase, stress, emotional toll, family issues and fatigue. Support from colleagues as well as training, de-brief sessions and frequent meetings were identified as helpful facilitators during this time. Conclusion: We identified a wide range of practices and coping strategies among Australian RACFs. Whilst a majority of respondents reported coping well, a large proportion reported struggling both mentally and physically. Factors reported as helpful by the respondents may assist RACFs in planning for future pandemics. Implications for research, policy and practice: Understanding the challenges faced by all levels of staff within RACFs may aid decision-makers on a range of different levels - researchers, aged care providers, local/regional/state health departments and national leaders within government to help inform the development of interventions that may help the sector to recover, as well as prepare for potential future outbreaks. Of particular importance, are interventions or initiatives that focus on supporting the physical and mental health of staff i.e. those that prevent or minimise worker fatigue, emotional burnout and stress. What is already known about the topic? Nursing staff in Australian RACFs did not feel prepared for the COVID outbreak in their workplace. Early in 2020, RACF nurses experienced a greater overall workload and some had their staff hours reduced by their employers due to financial constraints caused by the outbreak. What this paper adds This paper offers a comprehensive insight into how RACF staff coped both individually and as part of the facility overall during the COVID crisis. It identified that a commonly reported source of stress was first-hand verbal abuse from family or friends of residents in response to visitor and lockdown restrictions implemented by the authorities. The paper highlighted that whilst the majority of respondents felt that RACFs were well prepared for managing residents during the pandemic, some facilities experienced significant problems with workloads, PPE and human resourcing. Furthermore, the survey showed that on an individual level, some staff experienced significant mental and physical stress during the outbreak.