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Quantifying the benefit-risk trade-off for individual patients in a clinical trial: principles and antithrombotic case study.
Get PDFBACKGROUND: A treatment's overall favorable benefit-risk profile does not imply that every individual patient will benefit from the treatment.
OBJECTIVES: To describe a statistical methodology for quantifying the benefit-risk trade-off in individual patients.
METHODS: The method requires a large randomized controlled trial containing a primary efficacy outcome and a primary safety outcome, for instance, the Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events-Thrombolysis in Myocardial Infarction 50 placebo-controlled trial of vorapaxar in 17 779 patients following myocardial infarction. Multivariate regression models predict each individual patient's risk of ischemic events (benefit) and major bleeding events (harm) based on their profile. Hence, each patient's predicted benefit from vorapaxar (reduction in ischemic events) and predicted risk (increase in bleeding events) were estimated. The relative importance of ischemic and bleeding events based on links to all-cause mortality was quantified, although the limitations of such weightings are noted.
RESULTS: Overall results demonstrated both clear benefit and harm from vorapaxar. Substantial interindividual variation in both benefit and risk facilitated distinguishing patients with a favorable benefit-risk trade-off from those who did not. Such findings were applied to recommend vorapaxar in as many as 98.3% of patients in which a favorable mortality-weighted benefit-risk trade-off was present, in 77.2% of patients with ischemic benefit 20% greater than bleeding risk, or in as few as 45.5% of patients if an annual decrease in ischemic risk of ≥0.5% was also required.
CONCLUSION: While overall randomized controlled trials of treatment benefit vs risk are valuable, models determining each individual patient's estimated absolute benefit and risk provide more useful insight regarding patient-specific benefit-risk trade-offs to better enable personalized therapeutic decision-making
Mental health status among chronic disease patients in Bangladesh during the COVID-19 Pandemic: Findings from a cross-sectional study.
Get PDFCONTEXT: The COVID-19 epidemic has had a substantial influence on the mental health of chronic disease patients. However, there is a scarcity of research on them in Bangladesh. AIMS: This study aims to explore the prevalence of and identify the risk factors for depression, anxiety, and stress symptoms during the COVID-19 pandemic among people with chronic diseases in Bangladesh.
MATERIALS AND METHODS: This cross-sectional study involving face-to-face and telephone interviews was carried out among Bangladeshi people diagnosed with chronic diseases between September and November 2020. The total sample size was 878, and a convenient sampling technique was used. Logistic regression analysis was performed to investigate potential influencing factors for depression, anxiety, and stress.
RESULTS: The mean age of respondents was 50.10 years. Among them, 35.0%, 36.0%, and 29.0% suffered from depression, anxiety, and stress symptoms, respectively. In multivariable logistic regression, depression had a significant positive association with higher age (≥60 years), lower income, rural residency, and loss of close family members due to COVID-19. Anxiety had a significant positive association with higher age (≥40 years), lower education, lower income, rural residency, and loss of close family members due to COVID-19. Stress had a significant positive association with higher age (≥40 years), no income, rural residency, and loss of close family members due to COVID-19.
CONCLUSION: It is urgent to consider the risk of developing mental health distress among chronic disease patients, especially aged people, by health service providers and generate effective programs for emergency situations
Sexual and reproductive health and rights of migrant women attending primary care in England: A population-based cohort study of 1.2 million individuals of reproductive age (2009-2018).
Get PDFBACKGROUND: Evidence on the sexual and reproductive health and rights (SRHR) of migrants is lacking globally. We describe SRHR healthcare resource use and long-acting reversible contraceptives (LARCs) prescriptions for migrant versus non-migrant women attending primary care in England (2009-2018).
METHODS: This population-based observational cohort study, using Clinical Practice Research Datalink (CPRD) GOLD, included females living in England aged 15 to 49. Migration was defined using a validated codelist. Rates per 100 person years at risk (pyar) and adjusted rate ratios (RRs) were measured in migrants versus non-migrants for consultations related to all-causes, six exemplar SRHR outcomes, and LARC prescriptions. Proportions of migrants and non-migrants ever prescribed LARC were calculated.
FINDINGS: There were 25,112,116 consultations across 1,246,353 eligible individuals. 98,214 (7.9 %) individuals were migrants. All-cause consultation rates were lower in migrants versus non-migrants (509 vs 583/100pyar;RR 0.9;95 %CI 0.9-0.9), as were consultations rates for emergency contraception (RR 0.7;95 %CI 0.7-0.7) and cervical screening (RR 0.96;95 %CI 0.95-0.97). Higher rates of consultations were found in migrants for abortion (RR 1.2;95 %CI 1.1-1.2) and management of fertility problems (RR 1.39;95 %CI 1.08-1.79). No significant difference was observed for chlamydia testing and domestic violence. Of 1,205,258 individuals eligible for contraception, the proportion of non-migrants ever prescribed LARC (12.2 %;135,047/1,107,894) was almost double that of migrants (6.91 %;6,728/97,364). Higher copper intrauterine devices prescription rates were found in migrants (RR 1.53;95 %CI 1.45-1.61), whilst hormonal LARC rates were lower for migrants: levonorgestrel intrauterine device (RR 0.63;95 %CI 0.60-0.66), subdermal implant (RR 0.72;95 %CI 0.69-0.75), and progesterone-only injection (RR 0.35;95 %CI 0.34-0.36).
INTERPRETATION: Healthcare resource use differs between migrant and non-migrant women of reproductive age. Opportunities identified for tailored interventions include access to primary care, LARCs, emergency contraception and cervical screening. An inclusive approach to examining health needs is essential to actualise sexual and reproductive health as a human right
Designathons in health research: a global systematic review.
Get PDFINTRODUCTION: A designathon is a three-stage participatory activity informed by design thinking. There is a growing literature on designathons in health. This study synthesised designathons' effectiveness and implementation-related factors to address health challenges.
METHODS: We searched Cochrane Library, Embase, PubMed, Scopus and the ClinicalTrials.gov registry for articles containing primary data on designathons for health from their dates of inception to 29 November 2022. We retrieved additional studies from citation searching and a complementary open call. We synthesised data on designathons' effectiveness (ie, engagement, outputs and implementation), required resources and implementation-related factors (ie, resources, facilitators, barriers, strengths and limitations). We assessed the risk of bias using a checklist adapted from Joanna Briggs Institute Critical Appraisal tools.
RESULTS: In total, 4973 citations were identified, and 42 studies were included. In total, 26 studies (62%) were from high-income countries. The median number of total participants was 49, divided into a median of 8 teams. The duration of the intensive collaboration phase ranged from 3 hours to 7 days. Common evaluation criteria were feasibility, innovation and impact. Idea and prototype outputs included mobile phone applications, educational programmes and medical devices. Interventions developed from a designathon was estimated to be highly cost-effective. The most common facilitators were interdisciplinary participants and high-quality mentorship. The most common barriers were suboptimal execution of the events, difficulties in balancing interdisciplinary participants across teams and limited support for participants along the process. There were limited data on required resources and further implementation of solutions after designathons.
CONCLUSION: Given designathons' adaptability in terms of budget, mode of delivery, type of output and involvement of diverse participants, including end users, designathons can be implemented in a wide range of contexts to address various health issues.
PROSPERO REGISTRATION NUMBER: CRD42023389685
Health system's availability and readiness of health facilities for chronic non-communicable diseases: Evidence from the Ethiopian national surveys.
Get PDFINTRODUCTION: Non-communicable diseases (NCDs) currently cause more deaths than all other causes of deaths. Cardiovascular disease, diabetes, cancer, and chronic respiratory diseases-threaten the health and economies of individuals and populations worldwide. This study aimed to assess the availability and readiness of health facilities for chronic non-communicable diseases (NCDs) and describe the changes of service availability for common NCDs in Ethiopia.
Methods: We used data from the 2014 Ethiopia Service Provision Assessment Plus (ESPA +) and 2016 and 2018 Service Availability and Readiness Assessment (SARA) surveys, which were cross-sectional health facility-based studies. A total of 873 health facilities in 2014, 547 in 2016, 632 in 2018 were included in the analysis. (ESPA+) and SARA surveys are conducted as a census or a nationally/sub-nationally representative sample of health facilities. Proportion of facilities that offered the service for diabetes, cardiovascular disease, chronic respiratory disease, cancer diseases, mental illness, and chronic renal diseases was calculated to measure health service availability. The health facility service readiness was measured using the mean availably of tracer items that are required to offer the service. Thus, 13 tracer items for diabetes disease, 12 for cardiovascular disease, 11 for chronic respiratory disease and 11 cervical cancer services were used.
RESULTS: The services available for diagnosis and management did not show improvement between 2014, 2016 and 2018 for diabetes (59%, 22% and 36%); for cardiovascular diseases (73%, 41% and 49%); chronic respiratory diseases (76%, 45% and 53%). Similarly, at the national level, the mean availability of tracer items between 2014, 2016 and 2018 for diabetes (37%, 53% and 48%); cardiovascular diseases (36%, 41% and 42%); chronic respiratory diseases (26%, 27% and 27%); and cancer diseases (6%, 72% and 51%). However, in 2014 survey year, the mean availability of tracer items was 7% each for mental illness and chronic renal diseases, respectively.
CONCLUSIONS: The majority of the health facilities have low and gradual decrement in the availability to provide NCDs services in Ethiopia. There is a need to increase NCD service availability and readiness at primary hospitals and health centers, and private and rural health facilities where majority of the population need the services
Early changes in estimated glomerular filtration rate post-initiation of empagliflozin in EMPEROR-Preserved.
Get PDFAIMS: Renal function (estimated glomerular filtration rate [eGFR]) changes early after the introduction of empagliflozin have not been described in heart failure with preserved ejection fraction (HFpEF). The aim of this study was to describe early eGFR changes, assess its determinants and its clinical impact on cardiovascular and renal outcomes in patients with HFpEF enrolled in EMPEROR-Preserved. METHODS AND RESULTS: Estimated glomerular filtration rate changes (absolute and relative) from randomization to week 4 were calculated and landmark analyses performed. Initial eGFR change was available in 5836 patients (97.5% of the population). Empagliflozin induced a mean eGFR change of -3.2 ml/min/1.73 m2 versus placebo from baseline to week 4. After week 4, in the empagliflozin group, the risk of the primary outcome (composite of heart failure hospitalization or cardiovascular death), cardiovascular, all-cause mortality and sustained ≥50% eGFR decrease or end-stage renal disease (ESRD) did not differ by eGFR change levels. In contrast, in the placebo group, patients included in the tertile with most profound eGFR decrease (i.e. ≥5.1% from baseline) had a higher risk of the primary outcome (hazard ratio [HR] 1.46, 95% confidence interval [CI] 1.17-1.82), cardiovascular mortality (HR 1.38, 95% CI 1.01-1.89) and sustained ≥50% eGFR decrease or ESRD (HR 2.20, 95% CI 1.20-4.04) versus tertile with eGFR increase. CONCLUSION: An initial relatively small eGFR decrease may be expected after empagliflozin initiation. Such small eGFR decrease was not associated with adverse cardiovascular outcomes with empagliflozin. In contrast, eGFR decrease was associated with poor cardiovascular outcomes with placebo
Prospects for the development of community-based care in remote rural areas: a stakeholder analysis in Laos.
Get PDFBACKGROUND: Community-based health programmes have been a cornerstone of primary care in Laos for decades. The study presented here aimed to document prospects for the development of current programmes, considering perceptions about health and health care priorities in the communities, implementation challenges, the policy landscape and opportunities associated with the availability of new technologies. METHODS: The research design primarily involved qualitative in-depth interviews with stakeholders (n = 35) responsible for the planning, management, or implementation of community-based care in Laos at different levels of the health system. These included health managers at central departments or institutes of the Ministry of Health, provincial health departments, district health offices, heads of health centres, village health volunteers, community representatives, and international stakeholders. RESULTS: There was consensus that service delivery is still a challenge in many areas, due to geographic inaccessibility of health facilities, communication barriers, health-seeking behaviour, trust, and gender discrimination, particularly among ethnic minorities. In these settings, community health workers have the potential to extend the reach of the formal health system, acting as cultural brokers across sectors of society, ethnicities, and worldviews. To maximise impact, planners need to carefully consider the implementation model, financing arrangements, health system integration, and changing health priorities in the communities. CONCLUSIONS: This study examined challenges to, and opportunities for, the expansion and health system integration of community-based care in Laos. Further development and horizontal integration of community-based care remains a complex financing and governance challenge, although the renewed emphasis on primary care and the ongoing process of decentralisation provide a favourable policy environment in the country to sustain and potentially expand existing programmes
Post-acute COVID-19 neuropsychiatric symptoms are not associated with ongoing nervous system injury.
Get PDFA proportion of patients infected with severe acute respiratory syndrome coronavirus 2 experience a range of neuropsychiatric symptoms months after infection, including cognitive deficits, depression and anxiety. The mechanisms underpinning such symptoms remain elusive. Recent research has demonstrated that nervous system injury can occur during COVID-19. Whether ongoing neural injury in the months after COVID-19 accounts for the ongoing or emergent neuropsychiatric symptoms is unclear. Within a large prospective cohort study of adult survivors who were hospitalized for severe acute respiratory syndrome coronavirus 2 infection, we analysed plasma markers of nervous system injury and astrocytic activation, measured 6 months post-infection: neurofilament light, glial fibrillary acidic protein and total tau protein. We assessed whether these markers were associated with the severity of the acute COVID-19 illness and with post-acute neuropsychiatric symptoms (as measured by the Patient Health Questionnaire for depression, the General Anxiety Disorder assessment for anxiety, the Montreal Cognitive Assessment for objective cognitive deficit and the cognitive items of the Patient Symptom Questionnaire for subjective cognitive deficit) at 6 months and 1 year post-hospital discharge from COVID-19. No robust associations were found between markers of nervous system injury and severity of acute COVID-19 (except for an association of small effect size between duration of admission and neurofilament light) nor with post-acute neuropsychiatric symptoms. These results suggest that ongoing neuropsychiatric symptoms are not due to ongoing neural injury
Safety of the novel oral poliovirus vaccine type 2 (nOPV2) in infants and young children aged 1 to <5 years and lot-to-lot consistency of the immune response to nOPV2 in infants in The Gambia: a phase 3, double-blind, randomised controlled trial.
Get PDFBACKGROUND: Novel oral poliovirus vaccine type 2 (nOPV2) has been engineered to improve the genetic stability of Sabin oral poliovirus vaccine (OPV) and reduce the emergence of circulating vaccine-derived polioviruses. This trial aimed to provide key safety and immunogenicity data required for nOPV2 licensure and WHO prequalification.
METHODS: This phase 3 trial recruited infants aged 18 to <52 weeks and young children aged 1 to <5 years in The Gambia. Infants randomly assigned to receive one or two doses of one of three lots of nOPV2 or one lot of bivalent OPV (bOPV). Young children were randomised to receive two doses of nOPV2 lot 1 or bOPV. The primary immunogenicity objective was to assess lot-to-lot equivalence of the three nOPV2 lots based on one-dose type 2 poliovirus neutralising antibody seroconversion rates in infants. Equivalence was declared if the 95% CI for the three pairwise rate differences was within the -10% to 10% equivalence margin. Tolerability and safety were assessed based on the rates of solicited adverse events to 7 days, unsolicited adverse events to 28 days, and serious adverse events to 3 months post-dose. Stool poliovirus excretion was examined. The trial was registered as PACTR202010705577776 and is completed.
FINDINGS: Between February and October, 2021, 2345 infants and 600 young children were vaccinated. 2272 (96·9%) were eligible for inclusion in the post-dose one per-protocol population. Seroconversion rates ranged from 48·9% to 49·2% across the three lots. The minimum lower bound of the 95% CIs for the pairwise differences in seroconversion rates between lots was -5·8%. The maximum upper bound was 5·4%. Equivalence was therefore shown. Of those seronegative at baseline, 143 (85·6%) of 167 (95% CI 79·4-90·6) infants and 54 (83·1%) of 65 (71·7-91·2) young children seroconverted over the two-dose nOPV2 schedule. The post-two-dose seroprotection rates, including participants who were both seronegative and seropositive at baseline, were 604 (92·9%) of 650 (95% CI 90·7-94·8) in infants and 276 (95·5%) of 289 (92·4-97·6) in young children. No safety concerns were identified. 7 days post-dose one, 78 (41·7%) of 187 (95% CI 34·6-49·1) infants were excreting the type 2 poliovirus.
INTERPRETATION: nOPV2 was immunogenic and safe in infants and young children in The Gambia. The data support the licensure and WHO prequalification of nOPV2.
FUNDING: Bill & Melinda Gates Foundation
Hepatitis B virus (HBV) screening, linkage and retention-in-care in inclusion health populations: Evaluation of an outreach screening programme in London.
Get PDFOBJECTIVES: We evaluated a hepatitis B virus (HBV) screening programme, delivered by a specialist pan-London multidisciplinary outreach team, to understand population characteristics and care cascade among people who experience extreme social exclusion (Inclusion Health (IH) groups).
METHODS: Point-of-care HBV screening was performed in temporary accommodation for people experiencing homelessness (PEH) and people seeking asylum (initial accommodation centres, IACs) via a mobile unit staffed by peers with lived experience, nurses, and doctors. We analysed demographics and HBV characteristics of adults screened between May 2020 and January 2022. We ascertained linkage-to-care (LTC), retention-in-care (RIC) and loss-to-follow-up (LTFU). People LTFU were contacted by peers to re-engage in care.
RESULTS: 2473 people were screened: 809 in IACs, 1664 in other temporary accommodation. Overall hepatitis B surface antigen (HBsAg) prevalence was 1.7% (43/2473), highest in IACs (3.5%, 28/809). LTC within 3 months was 56% (24/43) and RIC, 87% (26/30). LTC was higher when referred to a local IH-specialist hepatitis service, compared to other services (77%, 17/22 vs 33%, 7/21; p = 0.006). LTFU was 30% (13/43), reduced to 21% (9/43) after intervention by peers.
CONCLUSION: Our findings support outreach screening among IH populations and peer-supported linkage to IH-specialist hepatitis services. We recommend increased HBV testing and HBV-specific IH specialist services