Protocol > Research Study
BMJ Open. 2020 October 10; Volume 10 (Issue 10); e036599.; DOI:10.1136/bmjopen-2019-036599
Sweeney S, Gomez G, Kitson N, Sinha A, Yatskevich N, et al.
BMJ Open. 2020 October 10; Volume 10 (Issue 10); e036599.; DOI:10.1136/bmjopen-2019-036599
INTRODUCTION
Current treatment regimens for multidrug-resistant tuberculosis (MDR-TB) are long, poorly tolerated and have poor outcomes. Furthermore, the costs of treating MDR-TB are much greater than those for treating drug-susceptible TB, both for health service and patient-incurred costs. Urgent action is needed to identify short, effective, tolerable and cheaper treatments for people with both quinolone-susceptible and quinolone-resistant MDR-TB. We present the protocol for an economic evaluation (PRACTECAL-EE substudy) alongside an ongoing clinical trial (TB-PRACTECAL) aiming to assess the costs to patients and providers of new regimens, as well as their cost-effectiveness and impact on participant poverty levels. This substudy is based on data from the three countries participating in the main trial.
METHODS AND ANALYSIS
Primary cost data will be collected from the provider and patient perspectives, following economic best practice. We will estimate the probability that new MDR-TB regimens containing bedaquiline, pretomanid and linezolid are cost-effective from a societal perspective as compared with the standard of care for MDR-TB patients in Uzbekistan, South Africa and Belarus. Analysis uses a Markov model populated with primary cost and outcome data collected at each study site. We will also estimate the impact of new regimens on prevalence of catastrophic patient costs due to TB.
ETHICS AND DISSEMINATION
Ethical approval has been obtained from the London School of Hygiene & Tropical Medicine and Médecins Sans Frontières. Local ethical approval will be sought in each study site. The results of the economic evaluation will be shared with the country health authorities and published in a peer-reviewed journal.
Current treatment regimens for multidrug-resistant tuberculosis (MDR-TB) are long, poorly tolerated and have poor outcomes. Furthermore, the costs of treating MDR-TB are much greater than those for treating drug-susceptible TB, both for health service and patient-incurred costs. Urgent action is needed to identify short, effective, tolerable and cheaper treatments for people with both quinolone-susceptible and quinolone-resistant MDR-TB. We present the protocol for an economic evaluation (PRACTECAL-EE substudy) alongside an ongoing clinical trial (TB-PRACTECAL) aiming to assess the costs to patients and providers of new regimens, as well as their cost-effectiveness and impact on participant poverty levels. This substudy is based on data from the three countries participating in the main trial.
METHODS AND ANALYSIS
Primary cost data will be collected from the provider and patient perspectives, following economic best practice. We will estimate the probability that new MDR-TB regimens containing bedaquiline, pretomanid and linezolid are cost-effective from a societal perspective as compared with the standard of care for MDR-TB patients in Uzbekistan, South Africa and Belarus. Analysis uses a Markov model populated with primary cost and outcome data collected at each study site. We will also estimate the impact of new regimens on prevalence of catastrophic patient costs due to TB.
ETHICS AND DISSEMINATION
Ethical approval has been obtained from the London School of Hygiene & Tropical Medicine and Médecins Sans Frontières. Local ethical approval will be sought in each study site. The results of the economic evaluation will be shared with the country health authorities and published in a peer-reviewed journal.
Protocol
BMJ Open. 2017 February 1; Volume 7 (Issue 2); e014067.; DOI:10.1136/bmjopen-2016-014067
Smith SL, Misago CN, Osrow RA, Franke MF, Iyamuremye JD, et al.
BMJ Open. 2017 February 1; Volume 7 (Issue 2); e014067.; DOI:10.1136/bmjopen-2016-014067
Integrating mental healthcare into primary care can reduce the global burden of mental disorders. Yet data on the effective implementation of real-world task-shared mental health programmes are limited. In 2012, the Rwandan Ministry of Health and the international healthcare organisation Partners in Health collaboratively adapted the Mentoring and Enhanced Supervision at Health Centers (MESH) programme, a successful programme of supported supervision based on task-sharing for HIV/AIDS care, to include care of neuropsychiatric disorders within primary care settings (MESH Mental Health). We propose 1 of the first studies in a rural low-income country to assess the implementation and clinical outcomes of a programme integrating neuropsychiatric care into a public primary care system.
METHODS AND ANALYSIS
A mixed-methods evaluation will be conducted. First, we will conduct a quantitative outcomes evaluation using a pretest and post-test design at 4 purposively selected MESH MH participating health centres. At least 112 consecutive adults with schizophrenia, bipolar disorder, depression or epilepsy will be enrolled. Primary outcomes are symptoms and functioning measured at baseline, 8 weeks and 6 months using clinician-administered scales: the General Health Questionnaire and the brief WHO Disability Assessment Scale. We hypothesise that service users will experience at least a 25% improvement in symptoms and functioning from baseline after MESH MH programme participation. To understand any outcome improvements under the intervention, we will evaluate programme processes using (1) quantitative analyses of routine service utilisation data and supervision checklist data and (2) qualitative semistructured interviews with primary care nurses, service users and family members.
ETHICS AND DISSEMINATION
This evaluation was approved by the Rwanda National Ethics Committee (Protocol #736/RNEC/2016) and deemed exempt by the Harvard University Institutional Review Board. Results will be submitted for peer-reviewed journal publication, presented at conferences and disseminated to communities served by the programme.
METHODS AND ANALYSIS
A mixed-methods evaluation will be conducted. First, we will conduct a quantitative outcomes evaluation using a pretest and post-test design at 4 purposively selected MESH MH participating health centres. At least 112 consecutive adults with schizophrenia, bipolar disorder, depression or epilepsy will be enrolled. Primary outcomes are symptoms and functioning measured at baseline, 8 weeks and 6 months using clinician-administered scales: the General Health Questionnaire and the brief WHO Disability Assessment Scale. We hypothesise that service users will experience at least a 25% improvement in symptoms and functioning from baseline after MESH MH programme participation. To understand any outcome improvements under the intervention, we will evaluate programme processes using (1) quantitative analyses of routine service utilisation data and supervision checklist data and (2) qualitative semistructured interviews with primary care nurses, service users and family members.
ETHICS AND DISSEMINATION
This evaluation was approved by the Rwanda National Ethics Committee (Protocol #736/RNEC/2016) and deemed exempt by the Harvard University Institutional Review Board. Results will be submitted for peer-reviewed journal publication, presented at conferences and disseminated to communities served by the programme.
Journal Article > ResearchFull Text
BMJ Open. 2022 September 20; Volume 12 (Issue 9); e060276.; DOI:10.1136/bmjopen-2021-060276
Dujmovic M, Roederer T, Frison S, Melki C, Lauvin T, et al.
BMJ Open. 2022 September 20; Volume 12 (Issue 9); e060276.; DOI:10.1136/bmjopen-2021-060276
INTRODUCTION
French nursing homes were deeply affected by the first wave of the COVID-19 pandemic, with 38% of all residents infected and 5% dying. Yet, little was done to prepare these facilities for the second pandemic wave, and subsequent outbreak response strategies largely duplicated what had been done in the spring of 2020, regardless of the unique needs of the care home environment.
METHODS
A cross-sectional, mixed-methods study using a retrospective, quantitative data from residents of 14 nursing homes between November 2020 and mid-January 2021. Four facilities were purposively selected as qualitative study sites for additional in-person, in-depth interviews in January and February 2021.
RESULTS
The average attack rate in the 14 participating nursing facilities was 39% among staff and 61% among residents. One-fifth (20) of infected residents ultimately died from COVID-19 and its complications. Failure to thrive syndrome (FTTS) was diagnosed in 23% of COVID-19-positive residents. Those at highest risk of death were men (HR=1.78; 95% CI: 1.18 to 2.70; p=0.006), with FTTS (HR=4.04; 95% CI: 1.93 to 8.48; p<0.001) or in facilities with delayed implementation of universal FFP2 masking policies (HR=1.05; 95% CI: 1.02 to 1.07; p<0.001). The lowest mortality was found in residents of facilities with a partial (HR=0.30; 95% CI: 0.18 to 0.51; p<0.001) or full-time physician on staff (HR=0.20; 95% CI: 0.08 to 0.53; p=0.001). Significant themes emerging from qualitative analysis centred on (1) the structural, chronic neglect of nursing homes, (2) the negative effects of the top-down, bureaucratic nature of COVID-19 crisis response, and (3) the counterproductive effects of lockdowns on both residents and staff.
CONCLUSION
Despite high resident mortality during the first pandemic wave, French nursing homes were ill-prepared for the second, with risk factors (especially staffing, lack of medical support, isolation/quarantine policy, etc) that affected case fatality and residents’ and caregivers’ overall well-being and mental health.
French nursing homes were deeply affected by the first wave of the COVID-19 pandemic, with 38% of all residents infected and 5% dying. Yet, little was done to prepare these facilities for the second pandemic wave, and subsequent outbreak response strategies largely duplicated what had been done in the spring of 2020, regardless of the unique needs of the care home environment.
METHODS
A cross-sectional, mixed-methods study using a retrospective, quantitative data from residents of 14 nursing homes between November 2020 and mid-January 2021. Four facilities were purposively selected as qualitative study sites for additional in-person, in-depth interviews in January and February 2021.
RESULTS
The average attack rate in the 14 participating nursing facilities was 39% among staff and 61% among residents. One-fifth (20) of infected residents ultimately died from COVID-19 and its complications. Failure to thrive syndrome (FTTS) was diagnosed in 23% of COVID-19-positive residents. Those at highest risk of death were men (HR=1.78; 95% CI: 1.18 to 2.70; p=0.006), with FTTS (HR=4.04; 95% CI: 1.93 to 8.48; p<0.001) or in facilities with delayed implementation of universal FFP2 masking policies (HR=1.05; 95% CI: 1.02 to 1.07; p<0.001). The lowest mortality was found in residents of facilities with a partial (HR=0.30; 95% CI: 0.18 to 0.51; p<0.001) or full-time physician on staff (HR=0.20; 95% CI: 0.08 to 0.53; p=0.001). Significant themes emerging from qualitative analysis centred on (1) the structural, chronic neglect of nursing homes, (2) the negative effects of the top-down, bureaucratic nature of COVID-19 crisis response, and (3) the counterproductive effects of lockdowns on both residents and staff.
CONCLUSION
Despite high resident mortality during the first pandemic wave, French nursing homes were ill-prepared for the second, with risk factors (especially staffing, lack of medical support, isolation/quarantine policy, etc) that affected case fatality and residents’ and caregivers’ overall well-being and mental health.
Journal Article > ResearchFull Text
BMJ Open. 2020 July 8; Volume 10 (Issue 7); e037545.; DOI:10.1136/bmjopen-2020-037545.
Keene CM, Zokufa N, Venables E, Wilkinson LS, Hoffman R, et al.
BMJ Open. 2020 July 8; Volume 10 (Issue 7); e037545.; DOI:10.1136/bmjopen-2020-037545.
OBJECTIVE
Longer intervals between routine clinic visits and medication refills are part of patient-centred, differentiated service delivery (DSD). They have been shown to improve patient outcomes as well as optimise health services—vital as ‘universal test-and-treat’ targets increase numbers of HIV patients on antiretroviral treatment (ART). This qualitative study explored patient, healthcare worker and key informant experiences and perceptions of extending ART refills to 6 months in adherence clubs in Khayelitsha, South Africa.
DESIGN AND SETTING
In-depth interviews were conducted in isiXhosa with purposively selected patients and in English with healthcare workers and key informants. All transcripts were audio-recorded, transcribed and translated to English, manually coded and thematically analysed. The participants had been involved in a randomised controlled trial evaluating multi-month ART dispensing in adherence clubs, comparing 6-month and 2-month refills.
PARTICIPANTS
Twenty-three patients, seven healthcare workers and six key informants.
RESULTS
Patients found that 6-month refills increased convenience and reduced unintended disclosure. Contrary to key informant concerns about patients’ responsibility to manage larger quantities of ART, patients receiving 6-month refills were highly motivated and did not face challenges transporting, storing or adhering to treatment. All participant groups suggested that strict eligibility criteria were necessary for patients to realise the benefits of extended dispensing intervals. Six-month refills were felt to increase health system efficiency, but there were concerns about whether the existing drug supply system could adapt to 6-month refills on a larger scale.
CONCLUSIONS
Patients, healthcare workers and key informants found 6-month refills within adherence clubs acceptable and beneficial, but concerns were raised about the reliability of the supply chain to manage extended multi-month dispensing. Stepwise, slow expansion could avoid overstressing supply and allow time for the health system to adapt, permitting 6-month ART refills to enhance current DSD options to be more efficient and patient-centred within current health system constraints.
Longer intervals between routine clinic visits and medication refills are part of patient-centred, differentiated service delivery (DSD). They have been shown to improve patient outcomes as well as optimise health services—vital as ‘universal test-and-treat’ targets increase numbers of HIV patients on antiretroviral treatment (ART). This qualitative study explored patient, healthcare worker and key informant experiences and perceptions of extending ART refills to 6 months in adherence clubs in Khayelitsha, South Africa.
DESIGN AND SETTING
In-depth interviews were conducted in isiXhosa with purposively selected patients and in English with healthcare workers and key informants. All transcripts were audio-recorded, transcribed and translated to English, manually coded and thematically analysed. The participants had been involved in a randomised controlled trial evaluating multi-month ART dispensing in adherence clubs, comparing 6-month and 2-month refills.
PARTICIPANTS
Twenty-three patients, seven healthcare workers and six key informants.
RESULTS
Patients found that 6-month refills increased convenience and reduced unintended disclosure. Contrary to key informant concerns about patients’ responsibility to manage larger quantities of ART, patients receiving 6-month refills were highly motivated and did not face challenges transporting, storing or adhering to treatment. All participant groups suggested that strict eligibility criteria were necessary for patients to realise the benefits of extended dispensing intervals. Six-month refills were felt to increase health system efficiency, but there were concerns about whether the existing drug supply system could adapt to 6-month refills on a larger scale.
CONCLUSIONS
Patients, healthcare workers and key informants found 6-month refills within adherence clubs acceptable and beneficial, but concerns were raised about the reliability of the supply chain to manage extended multi-month dispensing. Stepwise, slow expansion could avoid overstressing supply and allow time for the health system to adapt, permitting 6-month ART refills to enhance current DSD options to be more efficient and patient-centred within current health system constraints.
Journal Article > ResearchFull Text
BMJ Open. 2018 January 11; Volume 8 (Issue 1); DOI:10.1136/bmjopen-2017-017405
Ballif M, Zurcher K, Reid SE, Boulle AM, Fox MP, et al.
BMJ Open. 2018 January 11; Volume 8 (Issue 1); DOI:10.1136/bmjopen-2017-017405
Seasonal variations in tuberculosis diagnoses have been attributed to seasonal climatic changes and indoor crowding during colder winter months. We investigated trends in pulmonary tuberculosis (PTB) diagnosis at antiretroviral therapy (ART) programmes in Southern Africa.
Journal Article > ResearchFull Text
BMJ Open. 2022 January 11; Volume 12 (Issue 1); e053661.; DOI:10.1136/bmjopen-2021-053661
Van Boetzelaer E, Fotso A, Angelova I, Huisman G, Thorson T, et al.
BMJ Open. 2022 January 11; Volume 12 (Issue 1); e053661.; DOI:10.1136/bmjopen-2021-053661
OBJECTIVES
This study will contribute to the systematic epidemiological description of morbidities among migrants, refugees and asylum seekers when crossing the Mediterranean Sea.
SETTING
Since 2015, Médecins sans Frontières (MSF) has conducted search and rescue activities on the Mediterranean Sea to save lives, provide medical services, to witness and to speak out.
PARTICIPANTS
Between November 2016 and December 2019, MSF rescued 22 966 migrants, refugees and asylum seekers.
PRIMARY AND SECONDARY OUTCOME MEASURES
We conducted retrospective data analysis of data collected between January 2016 and December 2019 as part of routine monitoring of the MSF's healthcare services for migrants, refugees and asylum seekers on two search and rescue vessels.
RESULTS
MSF conducted 12 438 outpatient consultations and 853 sexual and reproductive health consultations (24.9% of female population, 853/3420) and documented 287 consultations for sexual and gender-based violence (SGBV). The most frequently diagnosed health conditions among children aged 5 years or older and adults were skin conditions (30.6%, 5475/17 869), motion sickness (28.6%, 5116/17 869), headache (15.4%, 2 748/17 869) and acute injuries (5.7%, 1013/17 869). Of acute injuries, 44.7% were non-violence-related injuries (453/1013), 30.1% were fuel burns (297/1013) and 25.4% were violence-related injuries (257/1013).
CONCLUSION
The limited testing and diagnostics capacity of the outpatient department, space limitations, stigma and the generally short length of stay of migrants, refugees and asylum seekers on the ships have likely led to an underestimation of morbidities, including mental health conditions and SGBV. The main diagnoses on board were directly related to journey on land and sea and stay in Libya. We conclude that this population may be relatively young and healthy but displays significant journey-related illnesses and includes migrants, refugees and asylum seekers who have suffered significant violence during their transit and need urgent access to essential services and protection in a place of safety on land.
This study will contribute to the systematic epidemiological description of morbidities among migrants, refugees and asylum seekers when crossing the Mediterranean Sea.
SETTING
Since 2015, Médecins sans Frontières (MSF) has conducted search and rescue activities on the Mediterranean Sea to save lives, provide medical services, to witness and to speak out.
PARTICIPANTS
Between November 2016 and December 2019, MSF rescued 22 966 migrants, refugees and asylum seekers.
PRIMARY AND SECONDARY OUTCOME MEASURES
We conducted retrospective data analysis of data collected between January 2016 and December 2019 as part of routine monitoring of the MSF's healthcare services for migrants, refugees and asylum seekers on two search and rescue vessels.
RESULTS
MSF conducted 12 438 outpatient consultations and 853 sexual and reproductive health consultations (24.9% of female population, 853/3420) and documented 287 consultations for sexual and gender-based violence (SGBV). The most frequently diagnosed health conditions among children aged 5 years or older and adults were skin conditions (30.6%, 5475/17 869), motion sickness (28.6%, 5116/17 869), headache (15.4%, 2 748/17 869) and acute injuries (5.7%, 1013/17 869). Of acute injuries, 44.7% were non-violence-related injuries (453/1013), 30.1% were fuel burns (297/1013) and 25.4% were violence-related injuries (257/1013).
CONCLUSION
The limited testing and diagnostics capacity of the outpatient department, space limitations, stigma and the generally short length of stay of migrants, refugees and asylum seekers on the ships have likely led to an underestimation of morbidities, including mental health conditions and SGBV. The main diagnoses on board were directly related to journey on land and sea and stay in Libya. We conclude that this population may be relatively young and healthy but displays significant journey-related illnesses and includes migrants, refugees and asylum seekers who have suffered significant violence during their transit and need urgent access to essential services and protection in a place of safety on land.
Journal Article > ResearchFull Text
BMJ Open. 2019 November 24; Volume 9 (Issue 11); DOI:10.1136/bmjopen-2019-030176
Ansbro É, Biringanine M, Caleo GNC, Prieto-Merino D, Sadique Z, et al.
BMJ Open. 2019 November 24; Volume 9 (Issue 11); DOI:10.1136/bmjopen-2019-030176
Journal Article > ResearchFull Text
BMJ Open. 2020 October 5; Volume 10 (Issue 10); e036179.; DOI:10.1136/bmjopen-2019-036179
Nair MM, Kumar P, Mahajan R, Harshana A, Richardson K, et al.
BMJ Open. 2020 October 5; Volume 10 (Issue 10); e036179.; DOI:10.1136/bmjopen-2019-036179
OBJECTIVES
This study aimed to assess the lived experiences of palliative care among critically unwell people living with HIV/AIDS (PLHA), caregivers and relatives of deceased patients. It also aimed to understand the broader palliative care context in Bihar.
DESIGN
This was an exploratory, qualitative study which used thematic analysis of semistructured, in-depth interviews as well as a focus group discussion.
SETTINGS
All interviews took place in a secondary care hospital in Patna, Bihar which provides holistic care to critically unwell PLHA.
PARTICIPANTS
We purposively selected 29 participants: 10 critically unwell PLHA, 5 caregivers of hospitalised patients, 7 relatives of deceased patients who were treated in the secondary care hospital and 7 key informants from community-based organisations.
RESULTS
Critically ill PLHA emphasised the need for psychosocial counselling and opportunities for social interaction in the ward, as well as a preference for components of home-based palliative care, even though they were unfamiliar with actual terms such as 'palliative care' and 'end-of-life care'. Critically unwell PLHA generally expressed preference for separate, private inpatient areas for end-of-life care. Relatives of deceased patients stated that witnessing patients' deaths caused trauma for other PLHA. Caregivers and relatives of deceased patients felt there was inadequate time and space for grieving in the hospital. While both critically ill PLHA and relatives wished that poor prognosis be transparently disclosed to family members, many felt it should not be disclosed to the dying patients themselves.
CONCLUSIONS
Despite expected high inpatient fatality rates, PLHA in Bihar lack access to palliative care services. PLHA receiving end-of-life care in hospitals should have a separate dedicated area, with adequate psychosocial counselling and activities to prevent social isolation. Healthcare providers should make concerted efforts to inquire, understand and adapt their messaging on prognosis and end-of-life care based on patients' preferences.
This study aimed to assess the lived experiences of palliative care among critically unwell people living with HIV/AIDS (PLHA), caregivers and relatives of deceased patients. It also aimed to understand the broader palliative care context in Bihar.
DESIGN
This was an exploratory, qualitative study which used thematic analysis of semistructured, in-depth interviews as well as a focus group discussion.
SETTINGS
All interviews took place in a secondary care hospital in Patna, Bihar which provides holistic care to critically unwell PLHA.
PARTICIPANTS
We purposively selected 29 participants: 10 critically unwell PLHA, 5 caregivers of hospitalised patients, 7 relatives of deceased patients who were treated in the secondary care hospital and 7 key informants from community-based organisations.
RESULTS
Critically ill PLHA emphasised the need for psychosocial counselling and opportunities for social interaction in the ward, as well as a preference for components of home-based palliative care, even though they were unfamiliar with actual terms such as 'palliative care' and 'end-of-life care'. Critically unwell PLHA generally expressed preference for separate, private inpatient areas for end-of-life care. Relatives of deceased patients stated that witnessing patients' deaths caused trauma for other PLHA. Caregivers and relatives of deceased patients felt there was inadequate time and space for grieving in the hospital. While both critically ill PLHA and relatives wished that poor prognosis be transparently disclosed to family members, many felt it should not be disclosed to the dying patients themselves.
CONCLUSIONS
Despite expected high inpatient fatality rates, PLHA in Bihar lack access to palliative care services. PLHA receiving end-of-life care in hospitals should have a separate dedicated area, with adequate psychosocial counselling and activities to prevent social isolation. Healthcare providers should make concerted efforts to inquire, understand and adapt their messaging on prognosis and end-of-life care based on patients' preferences.
Journal Article > ProtocolFull Text
BMJ Open. 2023 December 14; Volume 13 (Issue 12); e074841.; DOI:10.1136/bmjopen-2023-074841
Munir A, Dahal P, Kumar R, Singh-Phulgenda S, Siddiqui NA, et al.
BMJ Open. 2023 December 14; Volume 13 (Issue 12); e074841.; DOI:10.1136/bmjopen-2023-074841
INTRODUCTION
Visceral leishmaniasis (VL) is a parasitic disease with an estimated 30,000 new cases occurring annually. Despite anaemia being a common haematological manifestation of VL, the evolution of different haematological characteristics following treatment remains poorly understood. An individual participant data meta-analysis (IPD-MA) is planned to characterise the haematological dynamics in patients with VL.
METHODS AND ANALYSIS
The Infectious Diseases Data Observatory (IDDO) VL data platform is a global repository of IPD from therapeutic studies identified through a systematic search of published literature (PROSPERO registration: CRD42021284622). The platform currently holds datasets from clinical trials standardised to a common data format. Corresponding authors and principal investigators of the studies indexed in the IDDO VL data platform meeting the eligibility criteria for inclusion were invited to be part of the collaborative IPD-MA. Mixed-effects multivariable regression models will be constructed to identify determinants of haematological parameters by taking clustering within study sites into account.
ETHICS AND DISSEMINATION
This IPD-MA meets the criteria for waiver of ethical review as defined by the Oxford Tropical Research Ethics Committee (OxTREC) granted to IDDO, as the research consists of secondary analysis of existing anonymised data (exempt granted on 29 March 2023, OxTREC REF: IDDO). Ethics approval was granted by the ICMR-Rajendra Memorial Research Institute of Medical Sciences ethics committee (letter no.: RMRI/EC/30/2022) on 4 July 2022. The results of this analysis will be disseminated at conferences, the IDDO website and peer-reviewed publications in open-access journals. The findings of this research will be critically important for control programmes at regional and global levels, policymakers and groups developing new VL treatments.
Visceral leishmaniasis (VL) is a parasitic disease with an estimated 30,000 new cases occurring annually. Despite anaemia being a common haematological manifestation of VL, the evolution of different haematological characteristics following treatment remains poorly understood. An individual participant data meta-analysis (IPD-MA) is planned to characterise the haematological dynamics in patients with VL.
METHODS AND ANALYSIS
The Infectious Diseases Data Observatory (IDDO) VL data platform is a global repository of IPD from therapeutic studies identified through a systematic search of published literature (PROSPERO registration: CRD42021284622). The platform currently holds datasets from clinical trials standardised to a common data format. Corresponding authors and principal investigators of the studies indexed in the IDDO VL data platform meeting the eligibility criteria for inclusion were invited to be part of the collaborative IPD-MA. Mixed-effects multivariable regression models will be constructed to identify determinants of haematological parameters by taking clustering within study sites into account.
ETHICS AND DISSEMINATION
This IPD-MA meets the criteria for waiver of ethical review as defined by the Oxford Tropical Research Ethics Committee (OxTREC) granted to IDDO, as the research consists of secondary analysis of existing anonymised data (exempt granted on 29 March 2023, OxTREC REF: IDDO). Ethics approval was granted by the ICMR-Rajendra Memorial Research Institute of Medical Sciences ethics committee (letter no.: RMRI/EC/30/2022) on 4 July 2022. The results of this analysis will be disseminated at conferences, the IDDO website and peer-reviewed publications in open-access journals. The findings of this research will be critically important for control programmes at regional and global levels, policymakers and groups developing new VL treatments.
Journal Article > ResearchFull Text
BMJ Open. 2023 January 30; Volume 13 (Issue 1); e059134.; DOI:10.1136/bmjopen-2021-059134
Mashe T, Chaibva BV, Nair P, Sani KA, Jallow M, et al.
BMJ Open. 2023 January 30; Volume 13 (Issue 1); e059134.; DOI:10.1136/bmjopen-2021-059134
OBJECTIVES
This study was conducted to explore the epidemiology and microbiological pattern of the cholera outbreaks that occurred in Zimbabwe from 2018 to 2019.
STUDY SETTING AND DESIGN
This descriptive study used secondary data of 9971 out of 10 730 suspected cases from the Zimbabwean National Diseases Surveillance system and microbiology data of 241 out of 371 patients from the National Microbiology Reference Laboratory in Harare, for the period 5 September 2018 and 3 January 2019. Descriptive analysis was performed to describe the characteristics of the outbreak in terms of person, place and time.
RESULTS
A cumulative total of 10 730 suspected, 371 laboratory-confirmed cholera cases and 68 deaths were reported in Zimbabwe through the situation analysis report (sitrep). The attack rate during the outbreak was 174.6 per 100 000 with a case fatality rate of 0.63%. Most cases seen were among adults from Harare province. Antimicrobial sensitivity testing results showed that a multidrug resistant strain of Vibrio cholerae O1, Ogawa serotype was responsible for the outbreak. The treatment of cases was changed from the standard recommended medicine ciprofloxacin to azithromycin as confirmed by the antimicrobial sensitivity test results. Strategies employed to contain the outbreak included mass oral cholera vaccination in the hotspot areas of Harare, provision of improved and appropriate sanitation measures, provision of safe and adequate water, chlorination of water and improved waste management practice.
CONCLUSIONS
The recurrence of a cholera outbreak is a global concern, especially with the emergence of multi-drug resistant strains of the causal organism. Improving water, sanitation, hygiene infrastructure, health system strengthening measures and inter-sectoral collaboration in responding to the cholera outbreak was key to controlling the outbreak.
This study was conducted to explore the epidemiology and microbiological pattern of the cholera outbreaks that occurred in Zimbabwe from 2018 to 2019.
STUDY SETTING AND DESIGN
This descriptive study used secondary data of 9971 out of 10 730 suspected cases from the Zimbabwean National Diseases Surveillance system and microbiology data of 241 out of 371 patients from the National Microbiology Reference Laboratory in Harare, for the period 5 September 2018 and 3 January 2019. Descriptive analysis was performed to describe the characteristics of the outbreak in terms of person, place and time.
RESULTS
A cumulative total of 10 730 suspected, 371 laboratory-confirmed cholera cases and 68 deaths were reported in Zimbabwe through the situation analysis report (sitrep). The attack rate during the outbreak was 174.6 per 100 000 with a case fatality rate of 0.63%. Most cases seen were among adults from Harare province. Antimicrobial sensitivity testing results showed that a multidrug resistant strain of Vibrio cholerae O1, Ogawa serotype was responsible for the outbreak. The treatment of cases was changed from the standard recommended medicine ciprofloxacin to azithromycin as confirmed by the antimicrobial sensitivity test results. Strategies employed to contain the outbreak included mass oral cholera vaccination in the hotspot areas of Harare, provision of improved and appropriate sanitation measures, provision of safe and adequate water, chlorination of water and improved waste management practice.
CONCLUSIONS
The recurrence of a cholera outbreak is a global concern, especially with the emergence of multi-drug resistant strains of the causal organism. Improving water, sanitation, hygiene infrastructure, health system strengthening measures and inter-sectoral collaboration in responding to the cholera outbreak was key to controlling the outbreak.