Background Comorbid conditions, including solid and hematologic malignancies, may impact risk of contracting SARS CoV-2 or having severe COVID-19. Data specific to individual cancer types is essential to differentiate impact of patient, disease, and therapy specific factors on risk and outcomes, as the pandemic remains uncontrolled. Goal The primary goal of the CANDID study was to rapidly collect and analyze information on COVID-19 cases among CML pts to define prognosis, risk factors and outcome. Defining risk and predisposing features in CML patients could guide interventions, therapy modifications, and clinical management for patients and physicians. Methods From March 12, 2020, the iCMLf sent an anonymized case collection form to its global network of physicians treating CML pts and partner organizations. Forms were reviewed and cases tracked by an iCMLf data manager. Updates were provided weekly. Only confirmed cases or those with high level of suspicion were collected. Denominators regarding affected cohort (% tested, % affected in CML population) were not available in most instances. Results As of July 1, 2020, 110 cases of COVID-19 were reported to iCMLf from 20 countries: 61% from Europe, 15% from Asia, 12% from South America, 10% from North America, 2% from Africa and 1% from Oceania. COVID-19 was diagnosed by PCR and/or serology in 93 pts (85%) and clinically suspected in 17 pts (15%). Forty-six physicians reported 91 of the CML pts with COVID-19 out of a total of 12,236 CML pts that they were following (0.7%). Median age at the time of COVID-19 diagnosis was 54 years (range: 18-89) and 55% of pts were males. Median time from CML diagnosis to COVID-19 was 7 years (range: 0-25). CML treatment at the time of COVID-19 diagnosis consisted of hydroxyurea in 1 pt (1%) and TKI in 77 (70%). Five (5%) pts were taking bosutinib, 12 (11%) dasatinib, 39 (36%) imatinib, 17 (16%), nilotinib, 2 (2%) ponatinib, 1 (1%) HQP1315 and 1 pt (1%) was treated with an unknown TKI. Eighteen (16%) pts were untreated at the time of COVID-19 diagnosis, 8 due to elective treatment discontinuation (TFR) and 10 for other reasons (toxicity (5), stem cell transplantation (1), unknown (1) and newly diagnosed CML (3)). CML treatment information was lacking at the time of cut-off in 14 cases (13%). Thirty-three (30%) cases were reported as having interrupted TKI therapy during COVID-19. From 110 reports COVID-19 was asymptomatic in 8 cases (7%). In the 102 symptomatic pts (93%), COVID-19 was considered as mild (no hospitalization) in 49 cases (45%), moderate (hospitalization) in 19 cases (17%), severe (intensive care) in 19 cases (17%) and of unknown severity in 15 cases (14%). At the data cut-off date, COVID-19 was still active in 14 pts (13%) and outcome was unknown in 9 pts (8%). Among the 87 others, outcome was favorable in 75 pts (86%) and fatal in 12 (14%). We analyzed overall survival in the 87 patients with known outcome according to sex, age, CML duration, type of CML treatment, line of TKI therapy, history of smoking, comorbidities, TKI interruption due to COVID-19, administration of any treatment against COVID-19 (antimicrobial agents, steroids, oxygen or anti-IL-6 antibodies) and economic status of country. Univariate analysis identified older age (75 vs < 75 years; mortality rate: 60% vs 7%, p<0.001), severity of COVID-19 (severe v non-severe; mortality 63% vs 0%, p<0.001) and imatinib treatment (mortality: imatinib 25% vs 2nd gen TKI 3% vs no TKI 0%, p=0.003) as predictors for COVID-19 mortality (Figure 1). Notably, 25% of imatinib treated patients were over 75years old, compared to none of the patients treated with second generation TKI. Conclusion The CANDID study represents the largest global cohort study to date characterizing COVID-19 in CML. Currently, the mortality rate from COVID-19 in evaluable CML patients is 13.7%. Factors associated with a higher mortality rate are age and imatinib therapy. Imatinib may represent a confounder as opposed to a true adverse prognostic predictor given the strong link between imatinib treatment and advanced age. Further case reports and longer follow up are needed to better ascertain independent risk factors, the impact of COVID-19, and the possible role that TKI type may play in this population. Acknowledgment The authors thank Arlene Harriss-Buchan from the iCMLf for case collection and reporting and the 61 physicians from 20 countries who contributed case reports. Disclosures Rea: Incyte: Honoraria, Membership on an entity's Board of Directors or advisory committees; Pfizer: Honoraria, Membership on an entity's Board of Directors or advisory committees; BMS: Membership on an entity's Board of Directors or advisory committees; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees. Mauro:Bristol-Myers Squibb: Consultancy, Honoraria, Other: Travel, Accommodation, Expenses, Research Funding; Pfizer: Consultancy, Honoraria, Other: Travel, Accommodation, Expenses, Research Funding; Sun Pharma/SPARC: Research Funding; Novartis: Consultancy, Honoraria, Other: Travel, Accommodation, Expenses, Research Funding; Takeda: Consultancy, Honoraria, Other: Travel, Accommodation, Expenses, Research Funding. Cortes:BiolineRx: Consultancy, Research Funding; Arog: Research Funding; Amphivena Therapeutics: Research Funding; Astellas: Research Funding; Telios: Research Funding; BioPath Holdings: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Sun Pharma: Research Funding; Takeda: Consultancy, Research Funding; Pfizer: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; Jazz Pharmaceuticals: Consultancy, Research Funding; Immunogen: Research Funding; Daiichi Sankyo: Consultancy, Research Funding; Bristol-Myers Squibb: Research Funding; Merus: Research Funding. Pagnano:Novartis: Other: Advisory Board; Astellas: Other: Advisory Board and lecture; Pintpharma: Other: Lecture; EMS: Other: Lecture. Hughes:Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Bristol-Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Foundation:Novartis: Other: Grants and sponsorship; BMS: Other: Grants and sponsorship; Pfizer: Other: Grants; Incyte: Other: Grants; Takeda: Other: Grants and sponsorship; Cepheid: Other: Grants and sponsorship.
Purpose Musculoskeletal (MSK) pain is a common cause of work absence. The recent SWAP (Study of Work And Pain) randomised controlled trial (RCT) found that a brief vocational advice service for primary care patients with MSK pain led to fewer days’ work absence and provided good return-on-investment. The I-SWAP (Implementation of the Study of Work And Pain) initiative aimed to deliver an implementation test-bed of the SWAP vocational advice intervention with First Contact Practitioners (FCP). This entailed adapting the SWAP vocational advice training to fit the FCP role. This qualitative investigation explored the implementation potential of FCPs delivering vocational advice for patients with MSK pain. Methods Semi-structured interviews and focus groups were conducted with 10 FCPs and 5 GPs. Data were analysed thematically and findings explored using Normalisation Process Theory (NPT). Results I-SWAP achieved a degree of ‘coherence’ (i.e. made sense), with both FCPs and GPs feeling FCPs were well-placed to discuss work issues with these patients. However, for many of the FCPs, addressing or modifying psychosocial and occupational barriers to return-to-work was not considered feasible within FCP consultations, and improving physical function was prioritised. Concerns were also raised that employers would not act on FCPs’ recommendations regarding return-to-work. Conclusion FCPs appear well-placed to discuss work issues with MSK patients, and signpost/refer to other services; however, because they often only see patients once they are less suited to deliver other aspects of vocational advice. Future research is needed to explore how best to provide vocational advice in primary care settings.
BackgroundInpatient child and adolescent mental health services are one part of a complex system, and exist to meet the needs of young people with the greatest mental health difficulties.ObjectivesThe research question was ‘What is known about the identification, assessment and management of risk (where “risk” is broadly conceived) in young people (aged 11–18 years) with complex mental health needs entering, using and exiting inpatient child and adolescent mental health services in the UK?’Data sourcesThe two-phase Evidence for Policy and Practice Information and Co-ordinating Centre approach was used. In phase 1, scoping searches were made using two databases with an end date of March 2013. Phase 2 centred on the search for citations relating to the risks to young people of ‘dislocation’ and ‘contagion’. Searches were made using 17 databases, with time limits from 1995 to September 2013. Websites were searched, a call for evidence circulated and references of included citations reviewed.Review methodsPriority risk areas for phase 2 were decided in collaboration with stakeholders including through consultations with young people and the mother of a child who had been in hospital. All types of evidence relating to outcomes, views and experiences, costs and cost-effectiveness, policies, and service and practice responses in the areas of ‘dislocation’ and ‘contagion’ for young people (11–18 years) using inpatient mental health services were considered. A staged approach to screening was used. Data were extracted into tables following guidance from the Centre for Reviews and Dissemination or tables developed for the review. Quality was assessed using appraisal checklists from the Effective Public Health Practice Project or the Critical Skills Appraisal Programme or devised by previous reviewers. No papers were excluded on the grounds of quality, and all materials identified were narratively synthesised.ResultsIn phase 1, 4539 citations were found and 124 included. Most were concerned with clinical risks. In phase 2, 15,662 citations were found and 40 addressing the less obvious risks of ‘dislocation’ and ‘contagion’ were included, supplemented by 20 policy and guidance documents. These were synthesised using these categories: Dislocation: Normal Life; Dislocation: Identity; Dislocation: Friends; Dislocation: Stigma; Dislocation: Education; Dislocation: Families; and Contagion. No studies included an economic analysis or economic evaluation. The importance to stakeholders of these less obvious risks contrasted with the limited quantity and quality of research capable of informing policy, services and practice in these areas.LimitationsIncluded studies were of variable quality. Data derived could not be used to inform an economic modelling of NHS costs or to analyse cost-effectiveness. Other limitations were the search for only English-language materials and the use of umbrella concepts (‘dislocation’ and ‘contagion’).ConclusionsThe less obvious risks are important, but little evidence exists to support their identification, assessment and management. This has implications for services, and a programme of research is recommended to generate new knowledge.FundingThe National Institute for Health Research Health Services and Delivery Research programme.
BackgroundYoung people with complex or severe mental health needs sometimes require care and treatment in inpatient settings. There are risks for young people in this care context, and this study addressed the question: ‘What is known about the identification, assessment and management of risk in young people (aged 11–18) with complex mental health needs entering, using and exiting inpatient child and adolescent mental health services in the UK?’MethodsIn phase 1 a scoping search of two electronic databases (MEDLINE and PsychINFO) was undertaken. Items included were themed and presented to members of a stakeholder advisory group, who were asked to help prioritise the focus for phase 2. In phase 2, 17 electronic databases (EconLit; ASSIA; BNI; Cochrane Library; CINAHL; ERIC; EMBASE; HMIC; MEDLINE; PsycINFO; Scopus; Social Care Online; Social Services Abstracts; Sociological Abstracts; OpenGrey; TRiP; and Web of Science) were searched. Websites were explored and a call for evidence was circulated to locate items related to the risks to young people in mental health hospitals relating to ‘dislocation’ and ‘contagion’. All types of evidence including research, policies and service and practice responses relating to outcomes, views and experiences, costs and cost-effectiveness were considered. Materials identified were narratively synthesised.ResultsIn phase 1, 4539 citations were found and 124 items included. Most were concerned with clinical risks. In phase 2, 15,662 citations were found, and 40 addressing the risks of ‘dislocation’ and ‘contagion’ were included supplemented by 20 policy and guidance documents. The quality of studies varied. Materials were synthesised using the categories: Dislocation: Normal Life; Dislocation: Identity; Dislocation: Friends; Dislocation: Stigma; Dislocation: Education; Dislocation: Families; and Contagion. No studies included an economic analysis. Although we found evidence of consideration of risk to young people in these areas we found little evidence to improve practice and services.ConclusionsThe importance to stakeholders of the risks of ‘dislocation’ and ‘contagion’ contrasted with the limited quantity and quality of evidence to inform policy, services and practice. The risks of dislocation and contagion are important, but new research is needed to inform how staff might identify, assess and manage them.
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