Acceptability and barriers to implementation of N-of-1 tests in Ethiopia - a qualitative study.

BACKGROUND: Locally produced generic drugs offer a cost-effective alternative to imported drugs to treat patients in Ethiopia. However, due to a lack of bioequivalence testing, additional assurance tests are needed to build trust in cheaper, locally made drugs. By testing bioequivalence of local drugs to gold standard, N-of-1 tests have the potential to promote patient centred quality use of medicines. METHOD: We sought to assess the acceptability of, and explore barriers to, conducting N-of-1 tests to evaluate local medicines in a resource limited clinical setting. We conducted a descriptive qualitative study, analysing four focus group discussions and five key informant interviews. Participants were senior drug regulatory authority members, institutional review board members, physicians and patients. All interviews were audio taped and transcribed verbatim. Patient interviews were conducted in Amharic and translated to English prior to analysis. Data analysis used an inductive, thematic process. RESULTS: Five major themes were identified; (1) Appropriateness of N-of-1 tests to determine the therapeutic equivalence of local drugs, (2) N-of-1 therapeutic equivalence tests: clinical care or research? (3) Ethical and regulatory requirements (IRB), (4) Potential barriers to implementing N-of-1 tests and (5) Possible solutions to identified challenges. The study demonstrated considerable support for using N-of-1 tests for clinical equivalence studies between local and imported medicines, but important impediments were very likely to impact the feasibility of conducting N-of-1 tests in Ethiopia. Key informants from the regulatory authority did not support additional tests of local drugs. There were also mixed opinions regarding ethical requirements for conducting N-of-1 tests. The Institutional Review Board (IRB) members believed that IRB approval was sufficient to conduct N-of-1 tests, however, the regulatory authority members considered that N-of-1 tests constituted a clinical trial, and required approval at the regulatory level. CONCLUSION: This study showed that there were key uncertainties that could impact the feasiblity of using N-of-1 testing local drugs in Ethiopia. Therefore, a number of protocol amendments to address contextual threats and regulatory challenges, would be needed before progressing to conducting these tests.

Is care really shared? A systematic review of collaborative care (shared care) interventions for adult cancer patients with depression.

BACKGROUND: Collaborative care involves active engagement of primary care and hospital physicians in shared care of patients beyond usual discharge summaries. This enhances community-based care and reduces dependence on specialists and hospitals. The model, successfully implemented in chronic care management, may have utility for treatment of depression in cancer. The aim of this systematic review was to identify components, delivery and roles and responsibilities within collaborative interventions for depression in the context of cancer. METHODS: Medline, PsycINFO, CINAHL, Embase, Cochrane Library and Central Register for Controlled Trials databases were searched to identify studies of randomised controlled trials comparing a treatment intervention that met the definition of collaborative model of depression care with usual care or other control condition. Studies of adult cancer patients with major depression or a non-bipolar depressive disorder published in English between 2005 and January 2018 were included. Cochrane checklist for risk of bias was completed (Study Prospero registration: CRD42018086515). RESULTS: Of 8 studies identified, none adhered to the definition of 'collaborative care'. Interventions delivered were multi-disciplinary, with care co-ordinated by nurses (n = 5) or social workers (n = 2) under the direction of psychiatrists (n = 7). Care was primarily delivered in cancer centres (n = 5). Care co-ordinators advised primary care physicians (GPs) of medication changes (n = 3) but few studies (n = 2) actively involved GPs in medication prescribing and management. CONCLUSIONS: This review highlighted joint participation of GPs and specialist care physicians in collaborative care depression management is promoted but not achieved in cancer care. Current models reflect hospital-based multi-disciplinary models of care. PROTOCOL REGISTRATION: The protocol for this systematic review has been registered with PROSPERO. The registration number is CRD42018086515.

Tracking patients with advanced kidney disease in the last 12 months of life.

BACKGROUND: There is increasing recognition of the clinical need for timely and coordinated supportive and palliative care for those with terminal organ failure. OBJECTIVE: To describe symptoms, quality of life and supportive care needs in the anticipated 12-month period prior to death in adults with chronic kidney disease (CKD) stages 4 or 5. METHOD: An observational, prospective, longitudinal design was used to follow 19 patients. The measures used were the Chronic Kidney Disease-Symptom Burden Index (CKD-SBI), the Australian Karnofsky Performance Scale (AKPS), the Functional Assessment of Chronic illness Therapy Palliative-14 (FACIT PAL-14), the Assessment of Quality of Life 6 Dimensions (AQoL-6D) and the Sheffield Profile for Assessment and Referral for Care (SPARC). Data were collected at study entry and three monthly until death or study end. RESULTS: Patients' median age was 78 years (range 42-90), most were male (63%), 10 were receiving dialysis and seven died during the study. The most prevalent symptoms reported differed from those that were most troublesome. The median AKPS score did not change over time (60). Quality of life remained steady over time [FACIT-PAL median range: 43.5-46; AQoL-6D means range: 0.66 (SD 0.19) to 0.75 (SD 0.2)]. Supportive care needs were few. CONCLUSION: We found a substantial symptom burden and slow functional decline in this group of patients. Regular assessment of both symptoms and QOL is warranted particularly if clinical experience indicates that the person is likely to be in their last year of life. Integrated supportive care programmes could assist with easing symptom burden during this time.