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 November 30; Volume 13 (Issue 11); e058805.; DOI:10.1136/bmjopen-2021-058805
Lissouba P, Rücker SCM, Otieno LA, Akatukwasa C, Xulu S, et al.
BMJ Open. 2023 November 30; Volume 13 (Issue 11); e058805.; DOI:10.1136/bmjopen-2021-058805
OBJECTIVES
Evidence on the acceptability of urine-based assays for tuberculosis (TB) diagnosis among patients remains limited. We sought to describe patients’ experiences and perceptions of urine sampling for TB testing at point of care.
SETTING
Study sites in Kenya, Uganda, Mozambique and South Africa.
PARTICIPANTS
Adult ambulatory HIV patients enrolled in a TB diagnostic study were selected purposively.
INTERVENTION
For this qualitative descriptive study, audiorecorded individual interviews conducted with consenting participants were translated, transcribed and analysed using content analysis. Ethical agreement was obtained from relevant ethical review committees.
RESULTS
Fifty-eight participants were interviewed. Three domains were identified. Overall, participants described urine sampling as easy, rapid and painless, with the main challenge being lacking the urge. Urine was preferred to sputum sampling in terms of simplicity, comfort, stigma reduction, convenience and practicality. While perceptions regarding its trustworthiness for TB diagnosis differed, urine sampling was viewed as an additional mean to detect TB and beneficial for early diagnosis. Participants were willing to wait for several hours for same-day results to allay the emotional, physical and financial burden of having to return to collect results, and would rather not pay for the test. Facilitators of urine sampling included cleanliness and perceived privacy of sampling environments, comprehensive sampling instructions and test information, as well as supplies such as toilet paper and envelopes ensuring confort and privacy when producing and returning samples. Participants motivation for accepting urine-based TB testing stemmed from their perceived susceptibility to TB, the value they attributed to their health, especially when experiencing symptoms, and their positive interactions with the medical team.
CONCLUSIONS
This study suggests that urine sampling is well accepted as a TB diagnostic method and provides insights on how to promote patients’ uptake of urine-based testing and improve their sampling experiences. These results encourage the future broad use of urine-based assays at point of care.
Evidence on the acceptability of urine-based assays for tuberculosis (TB) diagnosis among patients remains limited. We sought to describe patients’ experiences and perceptions of urine sampling for TB testing at point of care.
SETTING
Study sites in Kenya, Uganda, Mozambique and South Africa.
PARTICIPANTS
Adult ambulatory HIV patients enrolled in a TB diagnostic study were selected purposively.
INTERVENTION
For this qualitative descriptive study, audiorecorded individual interviews conducted with consenting participants were translated, transcribed and analysed using content analysis. Ethical agreement was obtained from relevant ethical review committees.
RESULTS
Fifty-eight participants were interviewed. Three domains were identified. Overall, participants described urine sampling as easy, rapid and painless, with the main challenge being lacking the urge. Urine was preferred to sputum sampling in terms of simplicity, comfort, stigma reduction, convenience and practicality. While perceptions regarding its trustworthiness for TB diagnosis differed, urine sampling was viewed as an additional mean to detect TB and beneficial for early diagnosis. Participants were willing to wait for several hours for same-day results to allay the emotional, physical and financial burden of having to return to collect results, and would rather not pay for the test. Facilitators of urine sampling included cleanliness and perceived privacy of sampling environments, comprehensive sampling instructions and test information, as well as supplies such as toilet paper and envelopes ensuring confort and privacy when producing and returning samples. Participants motivation for accepting urine-based TB testing stemmed from their perceived susceptibility to TB, the value they attributed to their health, especially when experiencing symptoms, and their positive interactions with the medical team.
CONCLUSIONS
This study suggests that urine sampling is well accepted as a TB diagnostic method and provides insights on how to promote patients’ uptake of urine-based testing and improve their sampling experiences. These results encourage the future broad use of urine-based assays at point of care.
Journal Article > ProtocolFull Text
BMJ Open. 2023 October 28; Volume 13 (Issue 10); e074679.; DOI:10.1136/bmjopen-2023-074679
Kumar R, Dahal P, Singh-Phulgenda S, Siddiqui NA, Munir A, et al.
BMJ Open. 2023 October 28; Volume 13 (Issue 10); e074679.; DOI:10.1136/bmjopen-2023-074679
INTRODUCTION
Visceral leishmaniasis (VL) is a parasitic disease with an estimated 30 000 new cases occurring annually. There is an observed variation in the efficacy of the current first-line therapies across different regions. Such heterogeneity could be a function of host, parasite and drug factors. An individual participant data meta-analysis (IPD-MA) is planned to explore the determinants of treatment outcomes.
METHODS AND ANALYSIS
The Infectious Diseases Data Observatory (IDDO) VL living systematic review (IDDO VL LSR) library is an open-access resource of all published therapeutic studies in VL since 1980. For this current review, the search includes all clinical trials published between 1 January 1980 and 2 May 2021. Studies indexed in the IDDO VL LSR library were screened for eligibility for inclusion in this IPD-MA. Corresponding authors and principal investigators of the studies meeting the eligibility criteria for inclusion were invited to be part of the collaborative IPD-MA. Authors agreeing to participate in this collaborative research were requested to share the IPD using the IDDO VL data platform. The IDDO VL data platform currently holds data sets from clinical trials standardised to a common data format and provides a unique opportunity to identify host, parasite and drug determinants of treatment outcomes. Multivariable regression models will be constructed to identify determinants of therapeutic outcomes using generalised linear mixed-effects models accounting for within-study site clustering.
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 04-07-2022. The results of this IPD-MA will be disseminated at conferences, IDDO website and any peer-reviewed publications. All publications will be open source. Findings of this research will be critically important for the control programmes at regional/global levels, policy makers and groups developing new VL treatments.
Visceral leishmaniasis (VL) is a parasitic disease with an estimated 30 000 new cases occurring annually. There is an observed variation in the efficacy of the current first-line therapies across different regions. Such heterogeneity could be a function of host, parasite and drug factors. An individual participant data meta-analysis (IPD-MA) is planned to explore the determinants of treatment outcomes.
METHODS AND ANALYSIS
The Infectious Diseases Data Observatory (IDDO) VL living systematic review (IDDO VL LSR) library is an open-access resource of all published therapeutic studies in VL since 1980. For this current review, the search includes all clinical trials published between 1 January 1980 and 2 May 2021. Studies indexed in the IDDO VL LSR library were screened for eligibility for inclusion in this IPD-MA. Corresponding authors and principal investigators of the studies meeting the eligibility criteria for inclusion were invited to be part of the collaborative IPD-MA. Authors agreeing to participate in this collaborative research were requested to share the IPD using the IDDO VL data platform. The IDDO VL data platform currently holds data sets from clinical trials standardised to a common data format and provides a unique opportunity to identify host, parasite and drug determinants of treatment outcomes. Multivariable regression models will be constructed to identify determinants of therapeutic outcomes using generalised linear mixed-effects models accounting for within-study site clustering.
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 04-07-2022. The results of this IPD-MA will be disseminated at conferences, IDDO website and any peer-reviewed publications. All publications will be open source. Findings of this research will be critically important for the control programmes at regional/global levels, policy makers and groups developing new VL treatments.
Journal Article > ProtocolFull Text
BMJ Open. 2023 August 23; Volume 13 (Issue 8); e071544.; DOI:10.1136/bmjopen-2022-071544
Bahati D, Sy H, Kalhor A, Marchal B
BMJ Open. 2023 August 23; Volume 13 (Issue 8); e071544.; DOI:10.1136/bmjopen-2022-071544
INTRODUCTION
In humanitarian settings, aid agencies are constantly challenged by difficult decisions such as when and how to terminate aid without harming the aid recipients, local institutions, staff members and the organisation. Despite important efforts devoted to responsibly leaving a setting, hurtful exits are still common in contemporary relief aid. Moreover, debates on how humanitarian aid agencies exit are limited, with no previous comprehensive evidence synthesis on the concept of ‘responsible exit’. The objective of this scoping review is to map evidence and knowledge gaps, to identify and describe concepts, theories and existing frameworks related to ‘responsible exit’ of humanitarian aid agencies.
METHODS AND ANALYSIS
Our search uses searches of several bibliographic databases (CAB Direct (including Global Health), Web of Science, PubMed and Google Scholar) as well as manual searches of specific journals and retrieval of grey literature through searches of organisational websites and direct contact with experts and organisations. Reference tracking will be used to identify additional sources. Searches will cover papers available up to the dates of the searches (December 2022 to January 2023), with no date restrictions applied to the literature search. To be included, published or unpublished papers must explicitly discuss the exit of humanitarian aid agencies from humanitarian settings and be accessible. We will exclude all exits related to military, local and governmental humanitarian operations, education, development, employment, and business sectors. Only papers written in English and French will be considered. Three reviewers will conduct the selection process against the predefined criteria. Data will be extracted in an iterative process following pre-established items and the results will be presented in a Preferred Reporting Items for Systematic Reviews Extension for Scoping Reviews flow chart, tables and/or graphs, and descriptive formats.
ETHICS AND DISSEMINATION
Being a review, conducted on publicly available information, no ethical approval is required. The results will be disseminated through publication in an open access journal, scientific conferences, workshops, and via humanitarian aid agencies to facilitate further research and possible practical translations of generated knowledge.
In humanitarian settings, aid agencies are constantly challenged by difficult decisions such as when and how to terminate aid without harming the aid recipients, local institutions, staff members and the organisation. Despite important efforts devoted to responsibly leaving a setting, hurtful exits are still common in contemporary relief aid. Moreover, debates on how humanitarian aid agencies exit are limited, with no previous comprehensive evidence synthesis on the concept of ‘responsible exit’. The objective of this scoping review is to map evidence and knowledge gaps, to identify and describe concepts, theories and existing frameworks related to ‘responsible exit’ of humanitarian aid agencies.
METHODS AND ANALYSIS
Our search uses searches of several bibliographic databases (CAB Direct (including Global Health), Web of Science, PubMed and Google Scholar) as well as manual searches of specific journals and retrieval of grey literature through searches of organisational websites and direct contact with experts and organisations. Reference tracking will be used to identify additional sources. Searches will cover papers available up to the dates of the searches (December 2022 to January 2023), with no date restrictions applied to the literature search. To be included, published or unpublished papers must explicitly discuss the exit of humanitarian aid agencies from humanitarian settings and be accessible. We will exclude all exits related to military, local and governmental humanitarian operations, education, development, employment, and business sectors. Only papers written in English and French will be considered. Three reviewers will conduct the selection process against the predefined criteria. Data will be extracted in an iterative process following pre-established items and the results will be presented in a Preferred Reporting Items for Systematic Reviews Extension for Scoping Reviews flow chart, tables and/or graphs, and descriptive formats.
ETHICS AND DISSEMINATION
Being a review, conducted on publicly available information, no ethical approval is required. The results will be disseminated through publication in an open access journal, scientific conferences, workshops, and via humanitarian aid agencies to facilitate further research and possible practical translations of generated knowledge.
Journal Article > ResearchFull Text
BMJ Open. 2023 May 19; Volume 13 (Issue 5); e066937.; DOI:10.1136/bmjopen-2022-066937
Moretó-Planas L, Sagrado MJ, Mahajan R, Gallo J, Biague E, et al.
BMJ Open. 2023 May 19; Volume 13 (Issue 5); e066937.; DOI:10.1136/bmjopen-2022-066937
OBJECTIVE
Description of tuberculosis (TB)-focused point-of-care ultrasound (POCUS) findings for children with presumptive TB.
DESIGN
Cross-sectional study (July 2019 to April 2020).
SETTING
Simão Mendes hospital in Bissau, a setting with high TB, HIV, and malnutrition burdens.
PARTICIPANTS
Patients aged between 6 months and 15 years with presumptive TB.
INTERVENTIONS
Participants underwent clinical, laboratory and unblinded clinician-performed POCUS assessments, to assess subpleural nodules (SUNs), lung consolidation, pleural and pericardial effusion, abdominal lymphadenopathy, focal splenic and hepatic lesions and ascites. Presence of any sign prompted a POCUS positive result. Ultrasound images and clips were evaluated by expert reviewers and, in case of discordance, by a second reviewer. Children were categorised as confirmed TB (microbiological diagnosis), unconfirmed TB (clinical diagnosis) or unlikely TB. Ultrasound findings were analysed per TB category and risk factor: HIV co-infection, malnutrition and age.
RESULTS
A total of 139 children were enrolled, with 62 (45%) women and 55 (40%) aged <5 years; 83 (60%) and 59 (42%) were severely malnourished (SAM) and HIV-infected, respectively. TB confirmation occurred in 27 (19%); 62 (45%) had unconfirmed TB and 50 (36%) had unlikely TB. Children with TB were more likely to have POCUS-positive results (93%) compared with children with unlikely TB (34%). Common POCUS signs in patients with TB were: lung consolidation (57%), SUNs (55%) and pleural effusion (30%), and focal splenic lesions (28%). In children with confirmed TB, POCUS sensitivity was 85% (95% CI) (67.5% to 94.1%). In those with unlikely TB, specificity was 66% (95% CI 52.2% to 77.6%). Unlike HIV infection and age, SAM was associated with a higher POCUS-positivity. Cohen’s kappa coefficient for concordance between field and expert reviewers ranged from 0.6 to 0.9.
CONCLUSIONS
We found a high prevalence of POCUS signs in children with TB compared with children with unlikely TB. POCUS-positivity was dependent on nutritional status but not on HIV status or age. TB-focused POCUS could potentially play a supportive role in the diagnosis of TB in children.
Description of tuberculosis (TB)-focused point-of-care ultrasound (POCUS) findings for children with presumptive TB.
DESIGN
Cross-sectional study (July 2019 to April 2020).
SETTING
Simão Mendes hospital in Bissau, a setting with high TB, HIV, and malnutrition burdens.
PARTICIPANTS
Patients aged between 6 months and 15 years with presumptive TB.
INTERVENTIONS
Participants underwent clinical, laboratory and unblinded clinician-performed POCUS assessments, to assess subpleural nodules (SUNs), lung consolidation, pleural and pericardial effusion, abdominal lymphadenopathy, focal splenic and hepatic lesions and ascites. Presence of any sign prompted a POCUS positive result. Ultrasound images and clips were evaluated by expert reviewers and, in case of discordance, by a second reviewer. Children were categorised as confirmed TB (microbiological diagnosis), unconfirmed TB (clinical diagnosis) or unlikely TB. Ultrasound findings were analysed per TB category and risk factor: HIV co-infection, malnutrition and age.
RESULTS
A total of 139 children were enrolled, with 62 (45%) women and 55 (40%) aged <5 years; 83 (60%) and 59 (42%) were severely malnourished (SAM) and HIV-infected, respectively. TB confirmation occurred in 27 (19%); 62 (45%) had unconfirmed TB and 50 (36%) had unlikely TB. Children with TB were more likely to have POCUS-positive results (93%) compared with children with unlikely TB (34%). Common POCUS signs in patients with TB were: lung consolidation (57%), SUNs (55%) and pleural effusion (30%), and focal splenic lesions (28%). In children with confirmed TB, POCUS sensitivity was 85% (95% CI) (67.5% to 94.1%). In those with unlikely TB, specificity was 66% (95% CI 52.2% to 77.6%). Unlike HIV infection and age, SAM was associated with a higher POCUS-positivity. Cohen’s kappa coefficient for concordance between field and expert reviewers ranged from 0.6 to 0.9.
CONCLUSIONS
We found a high prevalence of POCUS signs in children with TB compared with children with unlikely TB. POCUS-positivity was dependent on nutritional status but not on HIV status or age. TB-focused POCUS could potentially play a supportive role in the diagnosis of TB in children.
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.
Journal Article > ResearchFull Text
BMJ Open. 2023 January 25; Volume 13 (Issue 1); e063668.; DOI:10.1136/bmjopen-2022-063668
Ansbro É, Masri S, Prieto-Merino D, Willis R, Aoun Bahous S, et al.
BMJ Open. 2023 January 25; Volume 13 (Issue 1); e063668.; DOI:10.1136/bmjopen-2022-063668
OBJECTIVES
This pre–post implementation study evaluated the introduction of fixed dose combination (FDC) medications for atherosclerotic cardiovascular disease (ASCVD) secondary prevention into routine care in a humanitarian setting.
SETTING
Two Médecins sans Frontières (MSF) primary care clinics serving Syrian refugee and host populations in north Lebanon.
PARTICIPANTS
Consenting patients ≥18 years with existing ASCVD requiring secondary prevention medication were eligible for study enrolment. Those with FDC contraindication(s) or planning to move were excluded. Of 521 enrolled patients, 460 (88.3%) were retained at 6 months, and 418 (80.2%) switched to FDC. Of these, 84% remained on FDC (n=351), 8.1% (n=34) discontinued and 7.9% (n=33) were lost to follow-up by month 12.
INTERVENTIONS
Eligible patients, enrolled February–May 2019, were switched to Trinomia FDC (atorvastatin 20 mg, aspirin 100 mg, ramipril 2.5/5/10 mg) after 6 months’ usual care. During the study, the COVID-19 pandemic, an economic crisis and clinic closures occurred.
OUTCOME MEASURES
Descriptive and regression analyses compared key outcomes at 6 and 12 months: medication adherence, non-high density lipoprotein cholesterol (non-HDL-C) and systolic blood pressure (SBP) control. We performed per-protocol, intention-to-treat and secondary analyses of non-switchers.
RESULTS
Among 385 switchers remaining at 12 months, total adherence improved 23%, from 63% (95% CI 58 to 68) at month 6, to 86% (95% CI 82 to 90) at month 12; mean non-HDL-C levels dropped 0.28 mmol/L (95% CI −0.38 to −0.18; p<0.0001), from 2.39 (95% CI 2.26 to 2.51) to 2.11 mmol/L (95% CI 2.00 to 2.22); mean SBP dropped 2.89 mm Hg (95% CI −4.49 to −1.28; p=0.0005) from 132.7 (95% CI 130.8 to 134.6) to 129.7 mm Hg (95% CI 127.9 to 131.5). Non-switchers had smaller improvements in adherence and clinical outcomes.
CONCLUSION
Implementing an ASCVD secondary prevention FDC improved adherence and CVD risk factors in MSF clinics in Lebanon, with potential for wider implementation by humanitarian actors and host health systems.
This pre–post implementation study evaluated the introduction of fixed dose combination (FDC) medications for atherosclerotic cardiovascular disease (ASCVD) secondary prevention into routine care in a humanitarian setting.
SETTING
Two Médecins sans Frontières (MSF) primary care clinics serving Syrian refugee and host populations in north Lebanon.
PARTICIPANTS
Consenting patients ≥18 years with existing ASCVD requiring secondary prevention medication were eligible for study enrolment. Those with FDC contraindication(s) or planning to move were excluded. Of 521 enrolled patients, 460 (88.3%) were retained at 6 months, and 418 (80.2%) switched to FDC. Of these, 84% remained on FDC (n=351), 8.1% (n=34) discontinued and 7.9% (n=33) were lost to follow-up by month 12.
INTERVENTIONS
Eligible patients, enrolled February–May 2019, were switched to Trinomia FDC (atorvastatin 20 mg, aspirin 100 mg, ramipril 2.5/5/10 mg) after 6 months’ usual care. During the study, the COVID-19 pandemic, an economic crisis and clinic closures occurred.
OUTCOME MEASURES
Descriptive and regression analyses compared key outcomes at 6 and 12 months: medication adherence, non-high density lipoprotein cholesterol (non-HDL-C) and systolic blood pressure (SBP) control. We performed per-protocol, intention-to-treat and secondary analyses of non-switchers.
RESULTS
Among 385 switchers remaining at 12 months, total adherence improved 23%, from 63% (95% CI 58 to 68) at month 6, to 86% (95% CI 82 to 90) at month 12; mean non-HDL-C levels dropped 0.28 mmol/L (95% CI −0.38 to −0.18; p<0.0001), from 2.39 (95% CI 2.26 to 2.51) to 2.11 mmol/L (95% CI 2.00 to 2.22); mean SBP dropped 2.89 mm Hg (95% CI −4.49 to −1.28; p=0.0005) from 132.7 (95% CI 130.8 to 134.6) to 129.7 mm Hg (95% CI 127.9 to 131.5). Non-switchers had smaller improvements in adherence and clinical outcomes.
CONCLUSION
Implementing an ASCVD secondary prevention FDC improved adherence and CVD risk factors in MSF clinics in Lebanon, with potential for wider implementation by humanitarian actors and host health systems.
Journal Article > ResearchFull Text
BMJ Open. 2022 December 5; Volume 11 (Issue 4); e002013.; DOI:10.1136/bmjoq-2022-002013
Das S, Abdulwahid E, Moisan A, De Jesus AK
BMJ Open. 2022 December 5; Volume 11 (Issue 4); e002013.; DOI:10.1136/bmjoq-2022-002013
This safety improvement project used quality improvement methods in a Comprehensive Emergency Obstetric and Newborn Care facility in Yemen, managed by an international humanitarian non-governmental organisation. It is responsible for about 6500 deliveries per annum. Following a local review of maternal deaths and serious incidents in 2020–2021, care for women with severe hypertensive disease in pregnancy and postpartum haemorrhage were highlighted as potential areas for improvement. These are also the two most common reasons recorded for maternal mortality in Yemen (and in many low-income countries worldwide). We also wanted to foster an open and honest safety culture within the department that encouraged learning from error.
We used an inclusive approach in designing the improvements, with change ideas collated via frontline doctors, midwives and nurses working in the maternity unit. Data were collected via manual audit, and through routinely collected data. We focused on the following measures: number of incidents reported per month, documentation quality of antihypertensive prescriptions, fluid restriction practices in women with severe pre-eclampsia, number of minutes taken to control severe hypertensive episodes, postpartum haemorrhage identification rates and tranexamic acid stock usage. We evaluated the efficacy of team simulation training through precourse and postcourse questionnaires.
We found demonstrable improvement in our measures relating to treatment of women with hypertensive disorders of pregnancy, and in postpartum haemorrhage identification and treatment. Team simulation training was a difficult intervention to sustain but was received well with positive results during our test session. Incident reporting showed a temporary increase, but this effect was not sustained.
We concluded that quality improvement methodology is a valuable tool even in challenged healthcare settings such as this one, in an active conflict zone. Behaviour change in team culture and safety culture is harder to sustain and demonstrate without a long-term strategy.
We used an inclusive approach in designing the improvements, with change ideas collated via frontline doctors, midwives and nurses working in the maternity unit. Data were collected via manual audit, and through routinely collected data. We focused on the following measures: number of incidents reported per month, documentation quality of antihypertensive prescriptions, fluid restriction practices in women with severe pre-eclampsia, number of minutes taken to control severe hypertensive episodes, postpartum haemorrhage identification rates and tranexamic acid stock usage. We evaluated the efficacy of team simulation training through precourse and postcourse questionnaires.
We found demonstrable improvement in our measures relating to treatment of women with hypertensive disorders of pregnancy, and in postpartum haemorrhage identification and treatment. Team simulation training was a difficult intervention to sustain but was received well with positive results during our test session. Incident reporting showed a temporary increase, but this effect was not sustained.
We concluded that quality improvement methodology is a valuable tool even in challenged healthcare settings such as this one, in an active conflict zone. Behaviour change in team culture and safety culture is harder to sustain and demonstrate without a long-term strategy.
Journal Article > ResearchFull Text
BMJ Open. 2022 October 5; Volume 12 (Issue 10); e061673.; DOI:10.1136/bmjopen-2022-061673
Debellut F, Tang K, Clark A, Pecenka C, Assao B, et al.
BMJ Open. 2022 October 5; Volume 12 (Issue 10); e061673.; DOI:10.1136/bmjopen-2022-061673
OBJECTIVES
To evaluate the cost-effectiveness of alternative rotavirus vaccines in Niger, using UNIVAC, a proportionate outcomes model.
SETTING
The study leverages global, regional and local data to inform cost-effectiveness modelling. Local data were collected as part of a clinical trial taking place in the Madarounfa district, Maradi region, Niger.
PARTICIPANTS
The study models impact of infants vaccination on rotavirus gastroenteritis in children under 5 years of age.
INTERVENTIONS
We compared the use of ROTARIX (GlaxoSmithKline, Belgium), ROTAVAC (Bharat Biotech, India) and ROTASIIL (Serum Institute, India) to no vaccination and to each other over a 10-year period starting in 2021.
RESULTS
We estimated that ROTARIX, ROTAVAC and ROTASIIL would each prevent 13 million cases and 20 000 deaths of children under 5 years over a 10-year period in Niger. Compared with no vaccination, the cost to avert a disability-adjusted life-year was US$146 with ROTARIX, US$107 with ROTASIIL and US$76 with ROTAVAC from the government perspective. ROTAVAC dominated ROTARIX and ROTASIIL (eg, provided similar or higher benefits at a lower cost) and had 90% chance to be cost-effective at a US$100 willingness-to-pay threshold.
CONCLUSIONS
This study can inform decision-making around rotavirus vaccination policy in Niger, demonstrating that ROTAVAC is likely the most cost-effective option. Alternative products (ROTASIIL and ROTARIX) may also be considered by decision-makers if they are priced more competitively, or if their cold chain requirements could bring additional economic benefits.
To evaluate the cost-effectiveness of alternative rotavirus vaccines in Niger, using UNIVAC, a proportionate outcomes model.
SETTING
The study leverages global, regional and local data to inform cost-effectiveness modelling. Local data were collected as part of a clinical trial taking place in the Madarounfa district, Maradi region, Niger.
PARTICIPANTS
The study models impact of infants vaccination on rotavirus gastroenteritis in children under 5 years of age.
INTERVENTIONS
We compared the use of ROTARIX (GlaxoSmithKline, Belgium), ROTAVAC (Bharat Biotech, India) and ROTASIIL (Serum Institute, India) to no vaccination and to each other over a 10-year period starting in 2021.
RESULTS
We estimated that ROTARIX, ROTAVAC and ROTASIIL would each prevent 13 million cases and 20 000 deaths of children under 5 years over a 10-year period in Niger. Compared with no vaccination, the cost to avert a disability-adjusted life-year was US$146 with ROTARIX, US$107 with ROTASIIL and US$76 with ROTAVAC from the government perspective. ROTAVAC dominated ROTARIX and ROTASIIL (eg, provided similar or higher benefits at a lower cost) and had 90% chance to be cost-effective at a US$100 willingness-to-pay threshold.
CONCLUSIONS
This study can inform decision-making around rotavirus vaccination policy in Niger, demonstrating that ROTAVAC is likely the most cost-effective option. Alternative products (ROTASIIL and ROTARIX) may also be considered by decision-makers if they are priced more competitively, or if their cold chain requirements could bring additional economic benefits.
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.