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

ABSTRACT: 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.

SUBMITTER: Alemayehu C

PROVIDER: S-EPMC6794767 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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

Alemayehu Chalachew C Mitchell Geoff G Nikles Jane J Aseffa Abraham A Clavarino Alexandra A

BMC medical research methodology 20191015 1

<h4>Background</h4>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.<h4>Method</h4>We sought to assess the acceptability of, and explore barriers to, conduc ...[more]

PMID: 31615422

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Project description:BACKGROUND:Ethiopia is one of the countries with a high burden of tuberculosis (TB). Jimma Zone has the lowest TB case notification rate compared to the national and World Health Organization's (WHO) targets. The aim of the present study was to identify barriers, and explore the origin of these barriers in relation to TB case finding. METHODS:A qualitative study was conducted by using different data collection methods and sources. Sixty in-depth interviews with TB treatment providers, program managers and TB patients were included. In addition, 42 governmental health facilities were observed for availability of resources. Data obtained from the in-depth interviews were transcribed, coded, categorized and thematized. Atlas.ti version 7.1 software was used for the data coding and categorizing. RESULTS:Inadequate resources for TB case finding, such as a shortage of health-care providers, inadequate basic infrastructure, and inadequate diagnostic equipment and supplies, as well as limited access to TB diagnostic services such as an absence of nearby health facilities providing TB diagnostic services and health system delays in the diagnostic process, were identified as barriers for TB case finding. We identified the absence of trained laboratory professionals in 11, the absence of clean water supply in 13 and the electricity in seven health facilities. Furthermore, we found that difficult topography, the absence of proper roads, an inadequate collaboration with other sectors (such as education), a turnover of laboratory professionals, and a low community mobilization, as the origin of some of these barriers. CONCLUSION:Inadequate resources for TB case finding, and a limited access to diagnostic services, were major challenges affecting TB case finding. The optimal application of the directly observed treatment short course (Stop TB) strategy is crucial to increase the current low TB case notification rate. Practical strategies need to be designed to attract and retain health professionals in the health system.

Project description:ObjectivesClinical trials provide 'gold standard' evidence for policy, but insufficient locally relevant trials are conducted in low-income and middle-income countries. Local investigator-initiated trials could generate highly relevant data for national governments, but information is lacking on how to facilitate them. We aimed to identify barriers and enablers to investigator-initiated trials in Ethiopia to inform and direct capacity strengthening initiatives.DesignExploratory, qualitative study comprising of in-depth interviews (n=7) and focus group discussions (n=3).SettingFieldwork took place in Ethiopia during March 2011.ParticipantsLocal health researchers with previous experiences of clinical trials or stakeholders with an interest in trials were recruited through snowball sampling (n=20).Outcome measuresDetailed discussion notes were analysed using thematic coding analysis and key themes were identified.ResultsAll participants perceived investigator-initiated trials as important for generating local evidence. System and organisational barriers included: limited funding allocation, weak regulatory and administrative systems, few learning opportunities, limited human and material capacity and poor incentives for conducting research. Operational hurdles were symptomatic of these barriers. Lack of awareness, confidence and motivation to undertake trials were important individual barriers. Training, knowledge sharing and experience exchange were key enablers to trial conduct and collaboration was unanimously regarded as important for improving capacity.ConclusionsBarriers to trial conduct were found at individual, operational, organisational and system levels. These findings indicate that to increase locally led trial conduct in Ethiopia, system wide changes are needed to create a more receptive and enabling research environment. Crucially, the creation of research networks between potential trial groups could provide much needed practical collaborative support through sharing of financial and project management burdens, knowledge and resources. These findings could have important implications for capacity-strengthening initiatives but further research is needed before the results can be generalised more widely.

Project description:BACKGROUND:The number of patient portals is rising, and although portals can have positive effects, their implementation has major impacts on the providing health care institutions. However, little is known about the organizational factors affecting successful implementation. Knowledge of the specific barriers to and facilitators of various stakeholders is likely to be useful for future implementations. OBJECTIVE:The objective of this study was to identify the barriers to and facilitators of patient portal implementation facing various stakeholders within hospital organizations in the Netherlands. METHODS:Purposive sampling was used to select hospitals of various types. A total of 2 university medical centers, 3 teaching hospitals, and 2 general hospitals were included. For each, 3 stakeholders were interviewed: (1) medical professionals, (2) managers, and (3) information technology employees. In total, 21 semistructured interviews were conducted using the Grol and Wensing model, which describes barriers to and facilitators of change in health care practice at 6 levels: (1) innovation; (2) individual professional; (3) patient; (4) social context; (5) organizational context; and (6) economic and political context. Two researchers independently selected and coded quotes by applying this model using a (deductive) directed content approach. Additional factors related to technical and portal characteristics were added using the model of McGinn et al, developed for implementation of electronic health records. RESULTS:In total, we identified 376 quotes, 26 barriers, and 28 facilitators. Thirteen barriers and 12 facilitators were common for all stakeholder groups. The facilitators' perceived usefulness (especially less paperwork) was mentioned by all the stakeholders, followed by subjects' positive attitude. The main barriers were lack of resources (namely, lack of staff and materials), financial difficulties (especially complying with high costs, lack of reimbursements), and guaranteeing privacy and security (eg, strict regulations). Both similarities and differences were found between stakeholder groups and hospital types. For example, managers and information technology employees mainly considered guaranteeing privacy and security as a predominant barrier. Financial difficulties were particularly mentioned by medical professionals and managers. CONCLUSIONS:Patient portal implementation is a complex process and is not only a technical process but also affects the organization and its staff. Barriers and facilitators occurred at various levels and differed among hospital types (eg, lack of accessibility) and stakeholder groups (eg, sufficient resources) in terms of several factors. Our findings underscore the importance of involving multiple stakeholders in portal implementations. We identified a set of barriers and facilitators that are likely to be useful in making strategic and efficient implementation plans.

Project description:BACKGROUND:Insufficient communication and coordination is one of the most problematic issues in German health care delivery leading to detrimental effects on health care outcomes. As a consequence interprofessional continuing education (CIPE) is gathering momentum in German health policy and health care practice aiming to enhance service quality and patient safety. Nevertheless, there is limited evidence on the course of implementation and the perceived effectiveness/acceptance of CIPE in German health care. This paper describes the objectives and formal characteristics of CIPE trainings and maps important determinants influencing the success of CIPE implementation from the perspective of providers offering CIPE trainings for German health care professionals. METHODS:Forty-nine training institutions offering CIPE for health care professionals were identified by a structured web search including the websites of German medical education associations and public/private training institutions. Directors and managers of the identified institutions were invited to participate in a semi-structured interview. The interview guideline was developed using the SPSS method by Helferich and colleges. Interviews were analyzed using the summarizing content analysis developed by Mayring resulting in a paradigm that contextualizes hindering factors regarding the implementation of CIPE in the German health care system. RESULTS:Overall, 19 of the identified institutions agreed to participate with one director/manager per institution resulting in a response rate of almost 38.8%. The included institutions offer n?=?85 CIPE trainings for health care professionals. Trainings offered mainly address the enhancement of domain, social and personal competencies of the participating health care professionals and follow three main objectives comprising better care of severely ill patients, improvement of patient safety by sustained risk management as well as a more patient centered care. Implementation of CIPE in Germany is influenced by various hindering factors mostly coming from systemic (missing incentives), behavioral (hierarchy problems) and methodological (limited quality assurance) factors. CONCLUSION:CIPE is an evolving concept in the German health care system. There are various difficulties that impede a successful implementation of CIPE and might be mitigated by specific health policy interventions such as mandatory CIPE participation of health care professionals and comprehensive pre-license interprofessional education.

Project description:BackgroundKangaroo Mother Care (KMC) is a high impact, low technology and cost-effective intervention for the care of preterm and low birth weight newborn. Cote d'Ivoire adopted the intervention and opened the first KMC unit in 2019. This study aimed to assess barriers and facilitators of KMC implementation in Cote d'Ivoire, a year after its introduction, as well as proposed solutions for improving KMC implementation in the country.MethodThis was a qualitative study, using semi-structured interviews, carried out in September 2020 in the first KMC unit opened at the Teaching Hospital of Treichville. The study involved healthcare providers providing KMC and mothers of newborn who were receiving or received KMC at the unit. A thematic analysis was performed using both inductive and deductive (Consolidated Framework for Implementation Research-driven) approaches. NVivo 12 was used to assist with coding.ResultsA total of 44 semi-structured interviews were conducted, 12 with healthcare providers and 32 with mothers. The barriers identified were lack of supplies, insufficiency of human resources, lack of space for admission, lack of home visits, lack of food for mothers, lack of collaboration between health services involved in newborn care, increased workload, the beliefs of carrying the baby on the chest, father's resistance, low rate of exclusive breastfeeding, lack of community awareness. Facilitators identified were training of healthcare providers, strong leadership, the low cost of KMC, healthcare providers' perceived value of KMC, mothers-healthcare providers' relationship, mothers' adherence to KMC and the capacity of the KMC unit to network with external organizations. The proposed solutions for improving KMC implementation were volunteer staff motivation, intensifying education and counselling of mothers and families, the recruitment of a psychologist and the involvement of all stakeholders.ConclusionOur study highlighted the challenges to implement KMC in Cote d'Ivoire with unique and specific barriers to implementation. We recommend to researchers and decision makers to respectively design strategies and adopt intervention that specifically address these barriers and facilitators to a better uptake of KMC. Decision makers should also take into account the proposed solutions for a better implementation and scaling up of KMC.

Project description:Cardiopulmonary resuscitation (CPR) training in schools is recommended to increase bystander CPR and thereby survival of out-of-hospital cardiac arrest, but despite mandating legislation, low rates of implementation have been observed in several countries, including Denmark. The purpose of the study was to explore barriers to implementation of CPR training in Danish secondary schools.A qualitative study based on individual interviews and focus groups with school leadership and teachers. Thematic analysis was used to identify regular patterns of meaning both within and across the interviews.8 secondary schools in Denmark. Schools were selected using strategic sampling to reach maximum variation, including schools with/without recent experience in CPR training of students, public/private schools and schools near to and far from hospitals.The study population comprised 25 participants, 9 school leadership members and 16 teachers.School leadership and teachers considered it important for implementation and sustainability of CPR training that teachers conduct CPR training of students. However, they preferred external instructors to train students, unless teachers acquired the CPR skills which they considered were needed. They considered CPR training to differ substantially from other teaching subjects because it is a matter of life and death, and they therefore believed extraordinary skills were required for conducting the training. This was mainly rooted in their insecurity about their own CPR skills. CPR training kits seemed to lower expectations of skill requirements to conduct CPR training, but only among those who were familiar with such kits.To facilitate implementation of CPR training in schools, it is necessary to have clear guidelines regarding the required proficiency level to train students in CPR, to provide teachers with these skills, and to underscore that extensive skills are not required to provide CPR. Further, it is important to familiarise teachers with CPR training kits.

Dataset Information

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

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

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