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An international qualitative study exploring patients' experiences of cutaneous leishmaniasis: study set-up and protocol.

ABSTRACT: INTRODUCTION:Lack of investments in drug development, lack of standardisation of clinical trials and the complexity of disease presentations contribute to the current lack of effective, safe and adapted treatments for cutaneous leishmaniasis (CL). One aspect concerns outcomes affecting patients' quality of life (QoL): these are hardly assessed in trials, despite potential functional and/or aesthetic impairment caused by CL, which typically affects disadvantaged and vulnerable people living in rural areas. Here, we describe the approach used to bring perspectives of patients with CL into designing and assessing treatments. METHODS AND ANALYSIS:This international qualitative study uses interviews with patients to explore their experiences with CL to (1) elicit outcomes and eligibility criteria for clinical trials important to them and (2) to better understand their needs and views about the disease and their requirements and expectations from treatment. Here, we describe the set-up of this collaborative study and the protocol. Data collection is ongoing.The protocol includes study design, preparation, conduct and analysis of individual interviews with approximately 80 patients in seven countries (Burkina Faso, Brazil, two sites in Colombia, Iran, Morocco, Peru and Tunisia) where CL is prevalent. Principal investigators and sites were selected through an open call, and two workshops were organised for protocol development and training in conduct and analysis of qualitative health research. Patient recruitment aims at covering a maximum variation of experiences. Transcripts will be analysed to identify outcomes and eligibility criteria as well as further topics that are expected to emerge from the interviews, such as direct and indirect costs related to CL, its psychological impact, preferred modes of drug administration and traditional treatments. ETHICS AND DISSEMINATION:The study received ethical approval by the responsible committees of each of the participating institutions. Findings will be disseminated through publication in peer-reviewed journals, scientific meetings and to participants and their communities.

SUBMITTER: Erber AC

PROVIDER: S-EPMC6009565 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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An international qualitative study exploring patients' experiences of cutaneous leishmaniasis: study set-up and protocol.

Erber Astrid Christine AC Arana Byron B Bennis Issam I Ben Salah Afif A Boukthir Aicha A Castro Noriega Maria Del Mar MDM Cissé Mamoudou M Cota Gláucia Fernandes GF Handjani Farhad F Kebede Mairie Guizaw MG Lang Trudie T López Carvajal Liliana L Marsh Kevin K Martinez Medina Dalila D Plugge Emma E Olliaro Piero P

BMJ open 20180615 6

<h4>Introduction</h4>Lack of investments in drug development, lack of standardisation of clinical trials and the complexity of disease presentations contribute to the current lack of effective, safe and adapted treatments for cutaneous leishmaniasis (CL). One aspect concerns outcomes affecting patients' quality of life (QoL): these are hardly assessed in trials, despite potential functional and/or aesthetic impairment caused by CL, which typically affects disadvantaged and vulnerable people livi ...[more]

PMID: 29909372

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Project description:BACKGROUND:Cutaneous leishmaniasis (CL) is a disease that often affects exposed skin areas and may heal leaving lifelong scars. Patients' expectations from treatment are rarely considered in drug development for CL. An initiative aiming to address shortcomings in clinical trial design and conduct for CL treatments involving the researchers' community is on-going. This manuscript presents patient-preferred outcomes for CL and an assessment on how to consider these in the conduct of future trials. METHODOLOGY/PRINCIPAL FINDINGS:We report preferred treatment outcomes by 74 patients with confirmed CL in endemic regions of Brazil, Burkina Faso, Colombia, Iran, Morocco, Peru and Tunisia during individual in-depth interviews. Beyond outcomes customarily considered in trials (such as lesion appearance and adverse events), patients talked about a large number of outcomes related to quality of life, such as pain, scar formation, and others affecting their work and daily activities. They also reported fears around getting rid of the parasite, disease recurrence, and possible sequelae. CONCLUSIONS/SIGNIFICANCE:The study results provide a rich insight into important outcomes for CL treatments, as well as related topics, from the perspective of a diverse patient population. Among the outcomes identified, we argue that those related to quality of life as well as recurrence should be included to a greater extent for assessment in clinical trials, and discuss the suitability of measurement instruments such as the Dermatology Quality of Life Index (DLQI). Interviews also point out the potential need to address concerns related to parasitological cure or scar formation, such as social stigmatization and disability. In addition, patients should be given information in order to clarify reported misconceptions. This study therefore suggests a methodology for consulting CL patients on outcomes as elements of clinical trial design, and how to incorporate these outcomes in trials. It also discusses how reported outcomes could be addressed in clinical care.

Project description:BACKGROUND: Few studies have addressed the challenges that international medical students face and there is a dearth of information on the behavioural strategies these students adopt to successfully progress through their academic program in the face of substantial difficulties of language barrier, curriculum overload, financial constraints and assessment tasks that require high proficiency in communication skills. METHODS: This study was designed primarily with the aim of enhancing understanding of the coping strategies, skill perceptions and knowledge of assessment expectations of international students as they progress through the third and fourth years of their medical degree at the School of Medicine, University of Tasmania, Australia. RESULTS: Survey, focus group discussion and individual interviews revealed that language barriers, communication skills, cultural differences, financial burdens, heavy workloads and discriminatory bottlenecks were key factors that hindered their adaptation to the Australian culture. Quantitative analyses of their examination results showed that there were highly significant (p < 0.001) variations between student performances in multiple choice questions, short answer questions and objective structured clinical examinations (70.3%, 49.7% & 61.7% respectively), indicating existence of communication issues. CONCLUSIONS: Despite the challenges, these students have adopted commendable coping strategies and progressed through the course largely due to their high sense of responsibility towards their family, their focus on the goal of graduating as medical doctors and their support networks. It was concluded that faculty needs to provide both academic and moral support to their international medical students at three major intervention points, namely point of entry, mid way through the course and at the end of the course to enhance their coping skills and academic progression. Finally, appropriate recommendations were made.

Project description:Leishmaniasis is a tropical infectious disease affecting some of the world's most economically disadvantaged and resource-poor regions. Cutaneous leishmaniasis (CL) is the most common out of the three clinical types of Leishmaniasis. Since 1904 this disease has been endemic in Sri Lanka. CL is considered a disfiguring stigmatising disease with a higher psychosocial burden. However, there needs to be a more in-depth, holistic understanding of the psychosocial burden of this disease, both locally and internationally. An in-depth understanding of the disease burden beyond morbidity and mortality is required to provide people-centred care. We explored the psychosocial burden of CL in rural Sri Lanka using a complex multimethod qualitative approach with community engagement and involvement. Data collection included participant observation, an auto-ethnographic diary study by community researchers with post-diary interviews, and a Participant Experience Reflection Journal (PERJ) study with post-PERJ interviews with community members with CL. The thematic analysis revealed three major burden-related themes on perceptions and reflections on the disease: wound, treatment, and illness-experience related burden. Fear, disgust, body image concerns, and being subjected to negative societal reactions were wound-related. Treatment interfering with day-to-day life, pain, the time-consuming nature of the treatment, problems due to the ineffectiveness of the treatment, and the burden of attending a government hospital clinic were the treatment-related burdens. Anxiety/worry due to wrongly perceived disease severity and negative emotions due to the nature of the disease made the illness experience more burdensome. Addressing the multifaceted psychosocial burden is paramount to ensure healthcare seeking, treatment compliance, and disease control and prevention. We propose a people-centred healthcare model to understand the contextual nature of the disease and improve patient outcomes.

Project description:ObjectiveThis work contributed to the development of a core outcome set (COS) for heavy menstrual bleeding (HMB). The objective was to determine which research outcomes best reflect how HMB affects women's lives and to identify additional research outcomes, not previously reported. It was important to explore and record participants' reasoning for prioritising outcomes and use this information to reinforce the patients' voice during later phases of the COS development.DesignPatient workshop discussions and telephone interviews.SettingEast London teaching hospital.ParticipantsInclusion criteria were that participants must be over 18 years old, that either they or their partner had a history of HMB and that they had a good understanding of written and spoken English.Results41 participants were recruited for the study. 8 women and 1 man completed the study. The eight female participants were representative of the different underlying causes and treatments for HMB. Participants ranged in age from their early 20s to their 60s and represented a range of ethnic groups. The five main themes that were identified as being important to patients were: 'restriction', 'relationships and isolation', 'emotions and self-perception', 'pain' and 'perceptions of treatment'. We identified eight coding nodes that did not correspond with our list of previously reported outcomes in studies of HMB. These nodes were consolidated and became five new outcomes for potential inclusion in the COS.ConclusionsHMB stops women living their lives as they would wish. It affects their relationships, education, careers, reproductive wishes, social life and mental health. This is a condition of girls and women in the prime of their lives, but for many, the constant threat of a heavy period starting means that they sacrifice that freedom. The societal and economic costs of women being incapacitated every month has an effect on everyone.Trial registrationThe COS study is registered with the COMET (Core Outcome Measures in Effectiveness Trials) Initiative-project reference number 789.

Project description:BackgroundCoronary heart disease (CHD) is one of the leading causes of death worldwide. Scientific literature shows that prevention of CHD is inadequate. The clinical pharmacist's role in patient-centred care has been shown favourable in a large amount of studies, also in relation to reduction of risk factors related to CHD. We developed and piloted a pharmacist-led follow-up program for patients with established CHD after hospital discharge from a hospital in North Norway. The aim of the present study was to explore how participants in the follow-up program experienced the program with regard to four main topics; medication knowledge, feeling of safety and comfort with medications, the functionality of the program and the clinical pharmacist's role in the interdisciplinary team.MethodsWe performed semi-structured thematic interviews with four patients included in the program. After verbatim transcribing, we analysed the interviews using "qualitative content analyses" by Graneheim and Lundman. Trial registration http://www.clinicaltrials.gov: NCT01131715.ResultsAll participants appreciated the follow-up program because their medication knowledge had increased, participation had made them feel safe, they were reassured about the appropriateness of their medications, and they had become more involved in their own medication. The participants reported that the program was well structured and the clinical pharmacist was said to be an important caretaker in the health-care system. The importance of collaboration between pharmacists and physicians, both in hospital and primary care, was emphasized.ConclusionOur results indicate that the follow-up program was highly appreciated among the four participants included in this study. The results must be interpreted in the context of the health care system in Norway today. Here, few pharmacists are working in hospitals or in close relation to the general practitioners. In addition, physicians are short of time in order to supply appropriate medication information, both in hospital and primary care. Involving pharmacists in follow-up of patients with CHD seems to be highly appreciated among patients and may be a step towards improving patient care. The study is limited by the low number of participants.

Project description:ObjectiveLong-term adherence to evidence-based medications in cardiometabolic diseases remains poor, despite extensive efforts to develop and test interventions and deploy clinician performance incentives. The limited success of interventions may be due to ignored factors such as patients' experience of medication-taking. Despite being potentially addressable by clinicians, these factors have not been sufficiently explored, which is particularly important as patients use increasing numbers of medications. The aim is to explore patient perspectives on medication-taking, medication properties that are barriers to adherence, and coping strategies for their medication regimen.DesignIndividual, in-person, semistructured qualitative interviews.SettingUrban healthcare system.ParticipantsTwenty-six adults taking ≥2 oral medications for diabetes, hypertension or hyperlipidaemia with non-adherence. Interviews were digitally recorded and transcribed. Data were analysed using developed codes to generate themes. Representative quotations were selected to illustrate themes.ResultsParticipants' mean age was 55 years, 46% were female and 39% were non-white. Six key themes were identified: (1) medication-taking viewed as a highly inconvenient action (that patients struggle to remember to do); (2) negative implications because of inconvenience or illness perceptions; (3) actual medication regimens can deviate substantially from prescribed regimens; (4) certain medication properties (especially size and similar appearance with others) may contribute to adherence deviations; (5) development of numerous coping strategies to overcome barriers and (6) suggestions to make medication-taking easier (including reducing drug costs, simplifying regimen or dosing frequency and creating more palatable medications).ConclusionPatients with poor adherence often find taking prescription medications to be undesirable and take them differently than prescribed in part due to properties of the medications themselves and coping strategies they have developed to overcome medication-taking challenges. Interventions that reduce the inconvenience of medication use and tailor medications to individual needs may be a welcome development.

Project description:IntroductionAntiretroviral treatment turned HIV infection into a chronic disease and improved quality of life for people living with HIV. Dual-drug combinations have been shown to be effective in suppressing viral replication and can potentially reduce long-term drug-associated toxicities. We aim to investigate patients' perceptions and experiences on the safety, effectiveness, tolerability and unmet needs of the dual-drug combination dolutegravir/lamivudine in Brighton and Hove, UK. In addition, we will conduct a comparative analysis between patients on dolutegravir/lamivudine and patients on other dual-drug and three-drug combinations. Finally, the study aims to provide recommendations to improve doctor-patient communication, knowledge and understanding of the treatment plan, and additional care that ought to be considered in patient-centred, holistic care plans.Methods and analysisOur qualitative methodological framework is based on three main methods: cultural domain analysis, focus group discussions and in-depth interviews. Cultural domain analysis employs a range of techniques (free listing, pile sorts and rankings) to elicit terms from informants regarding specific cultural domains (ie, groups of items that are perceived to be of the same kind). This framework has been codesigned with a patient representative to ensure relevance, suitability and coproduction of knowledge. All methods have been tested to take place online, as an option, via Zoom, Skype or Microsoft Teams. Padlet, an application to create online boards, will be used during the cultural domain analysis session. Data collected will be analysed following the completion of each method embracing an iterative approach through applied thematic analysis.Ethics and disseminationEthical approval was obtained from the Health Research Authority (Reference 21/NW/0070). Findings will be used to produce recommendations to improve doctor and patient communication by identifying patients' fears, worries, misconceptions and general concerns of their drug regimen. Conclusions will be disseminated via journal articles, conference papers and discussions through public engagement events.Project registration numberIRAS number: 286277. NCT04901728.

Dataset Information

An international qualitative study exploring patients' experiences of cutaneous leishmaniasis: study set-up and protocol.

Publications

An international qualitative study exploring patients' experiences of cutaneous leishmaniasis: study set-up and protocol.

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