A WHO rapid assessment of early impact of the COVID-19 pandemic on mental health services worldwide found a consistent pattern of degradation. In this context the MASC study aimed to: (1) identify the consequences of the pandemic for mental health services and people with pre-existing mental health conditions (MHCs) in 7 low- and middle-income countries; and (2) identify good practice to mitigate these impacts. The study was conducted in Chile, Ethiopia, Georgia, Nigeria, South Africa, Sri Lanka and Ukraine. This was an observational study, using a mixed-methods convergent design, triangulating data from: (1) 144 key informants participating in semi-structured interviews or focus groups and/or a self-completed survey; (2) routine service utilization data; (3) local grey literature; and (4) expert consultation. We found clear evidence in all sites that the pandemic exacerbated pre-existing disadvantages experienced by people with MHCs and led to a deterioration in the availability and quality of care, especially for psychosocial care. Alongside increased vulnerability to COVID-19, people with MHCs faced additional barriers to accessing prevention and treatment interventions compared to the general population. To varying extents, sites showed accelerated implementation of digital technologies, but with evidence of worsening inequities in access. Where primary care-based mental health care was more developed or prioritised, systems seemed more resilient and adaptive. Our findings have the following implications. First, mental health service reductions are clear examples of ‘structural stigma’, namely policy level decisions in healthcare which place a low priority upon services for people with MHCs. Second, integration of mental health care into all general health care settings is key to ensuring accessibility and parity of physical and mental health care. Third, digital innovations should be designed to strengthen and not fragment systems. We discuss these findings in terms of anticipating such challenges in future and preparing layers of resilience.
{"title":"Adverse sequelae of the COVID-19 pandemic on mental health care in seven low- and middle-income countries: MASC study","authors":"Charlotte Hanlon, Heidi Lempp, Atalay Alem, Azeb Asaminew Alemu, Ruben Alvarado, Olatunde Ayinde, Adekunle Adesola, Elaine Brohan, Thandi Davies, Wubalem Fekadu, Oye Gureje, Lucy Jalagania, Nino Makhashvili, Awoke Mihretu, Eleni Misganaw, Maria Milenova, Tamara Mujirishvili, Olha Myshakivska, Irina Pinchuk, Camila Solis-Araya, Katherine Sorsdahl, Gonzalo Soto-Brandt, Ezra Susser, Olga Toro-Devia, Nicole Votruba, Anuprabha Wickramasinghe, Shehan Williams, Graham Thornicroft","doi":"10.1101/2024.06.18.24309132","DOIUrl":"https://doi.org/10.1101/2024.06.18.24309132","url":null,"abstract":"A WHO rapid assessment of early impact of the COVID-19 pandemic on mental health services worldwide found a consistent pattern of degradation. In this context the MASC study aimed to: (1) identify the consequences of the pandemic for mental health services and people with pre-existing mental health conditions (MHCs) in 7 low- and middle-income countries; and (2) identify good practice to mitigate these impacts. The study was conducted in Chile, Ethiopia, Georgia, Nigeria, South Africa, Sri Lanka and Ukraine. This was an observational study, using a mixed-methods convergent design, triangulating data from: (1) 144 key informants participating in semi-structured interviews or focus groups and/or a self-completed survey; (2) routine service utilization data; (3) local grey literature; and (4) expert consultation. We found clear evidence in all sites that the pandemic exacerbated pre-existing disadvantages experienced by people with MHCs and led to a deterioration in the availability and quality of care, especially for psychosocial care. Alongside increased vulnerability to COVID-19, people with MHCs faced additional barriers to accessing prevention and treatment interventions compared to the general population. To varying extents, sites showed accelerated implementation of digital technologies, but with evidence of worsening inequities in access. Where primary care-based mental health care was more developed or prioritised, systems seemed more resilient and adaptive. Our findings have the following implications. First, mental health service reductions are clear examples of ‘structural stigma’, namely policy level decisions in healthcare which place a low priority upon services for people with MHCs. Second, integration of mental health care into all general health care settings is key to ensuring accessibility and parity of physical and mental health care. Third, digital innovations should be designed to strengthen and not fragment systems. We discuss these findings in terms of anticipating such challenges in future and preparing layers of resilience.","PeriodicalId":501556,"journal":{"name":"medRxiv - Health Systems and Quality Improvement","volume":"141 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141525539","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-19DOI: 10.1101/2024.06.18.24309119
Nyasha Mutanda, Allison Morgan, Aniset Kamanga, Linda Sande, Vinolia Vntjikelane, Mhairi Maskew, Prudence Haimbe, Priscilla Mulenga, Sydney Rosen, Nancy Scott
Background: Disengagement from antiretroviral therapy (ART) is highest in the early treatment period (≤6 months after initiation/re-initiation), but low intensity models designed to increase retention generally exclude these clients. We describe client preferences for HIV service delivery in the early treatment period. Methods: From 9/2022-6/2023, we surveyed adult clients who were initiating or on ART for ≤6 months at primary health facilities in South Africa and Zambia. We collected data on experiences with and preferences for HIV treatment. Results: We enrolled 1,098 participants in South Africa (72% female, median age 33) and 771 in Zambia (67% female, median age 32), 38% and 34% of whom were initiating/re-initiating ART in each country, respectively. While clients expressed varied preferences, most participants (94% in South Africa, 87% in Zambia) were not offered choices regarding service delivery. 82% of participants in South Africa and 36% in Zambia reported receiving a 1-month supply of medication at their most recent visit; however, South African participants preferred 2- or 3-month dispensing (69%), while Zambian participants preferred 3-or 6-month dispensing (85%). Many South African participants (65%) would prefer to collect medication in community settings, while Zambian participants (70%) preferred clinic-based collection. Half of participants desired more one-on-one counselling and health information. Most participants reported positive experiences with providers, but long waiting queues were reported by South African participants. Conclusions: During the first six months on ART, many clients would prefer less frequent clinic visits, longer dispensing intervals, and frequent, high-quality counselling. Care models for the early treatment period should reflect these preferences.
{"title":"Experiences and preferences in Zambia and South Africa for delivery of HIV treatment during a clients first six months: a cross-sectional survey","authors":"Nyasha Mutanda, Allison Morgan, Aniset Kamanga, Linda Sande, Vinolia Vntjikelane, Mhairi Maskew, Prudence Haimbe, Priscilla Mulenga, Sydney Rosen, Nancy Scott","doi":"10.1101/2024.06.18.24309119","DOIUrl":"https://doi.org/10.1101/2024.06.18.24309119","url":null,"abstract":"Background: Disengagement from antiretroviral therapy (ART) is highest in the early treatment period (≤6 months after initiation/re-initiation), but low intensity models designed to increase retention generally exclude these clients. We describe client preferences for HIV service delivery in the early treatment period.\u0000Methods: From 9/2022-6/2023, we surveyed adult clients who were initiating or on ART for ≤6 months at primary health facilities in South Africa and Zambia. We collected data on experiences with and preferences for HIV treatment.\u0000Results: We enrolled 1,098 participants in South Africa (72% female, median age 33) and 771 in Zambia (67% female, median age 32), 38% and 34% of whom were initiating/re-initiating ART in each country, respectively. While clients expressed varied preferences, most participants (94% in South Africa, 87% in Zambia) were not offered choices regarding service delivery. 82% of participants in South Africa and 36% in Zambia reported receiving a 1-month supply of medication at their most recent visit; however, South African participants preferred 2- or 3-month dispensing (69%), while Zambian participants preferred 3-or 6-month dispensing (85%). Many South African participants (65%) would prefer to collect medication in community settings, while Zambian participants (70%) preferred clinic-based collection. Half of participants desired more one-on-one counselling and health information. Most participants reported positive experiences with providers, but long waiting queues were reported by South African participants.\u0000Conclusions: During the first six months on ART, many clients would prefer less frequent clinic visits, longer dispensing intervals, and frequent, high-quality counselling. Care models for the early treatment period should reflect these preferences.","PeriodicalId":501556,"journal":{"name":"medRxiv - Health Systems and Quality Improvement","volume":"67 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141531967","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Type 2 diabetes is ambulatory care sensitive and adequate outpatient primary care supported by strong functional health systems can reduce avoidable complications and related mortality. A large body of published evidence exists on pharmacological agents and non-pharmacological interventions for the management of type 2 diabetes. However, the evidence on health systems’ ability to support patients’ primary care needs, especially in West Africa, where non-communicable disease (NCD) is an increasingly important part of the disease burden is uncertain. This systematic review explores the current published evidence on health systems interventions to support primary health facilities for type 2 diabetes care and impact on health outcomes, service access and quality in West Africa. The World Health Organization health systems building blocks and other post building blocks health systems frameworks guided our search and analysis. Only three pilot studies, including two randomized controlled trials and one pre-post study, met all our first inclusion criteria. However, we included 12 other studies which did not meet all the inclusion criteria but reported on a health system intervention for complete analysis: (The criteria were expanded to include studies conducted outside primary care settings. The rationale was that findings from such studies may influence primary care. Also, non-randomized control trials were later included). Our results showed that interventions with significant impact on glycemic control, treatment adherence, health literacy, and other associated outcomes addressed intersections between the individual health system blocks/areas. Thus, four cross-cutting themes related to the building blocks were found during analysis. The first theme was on interventions targeting the availability of trained health workers and the quality of their services; the second was on interventions targeting institutional infrastructure and resources for management; the third was on interventions targeting leadership and organizational culture and; the fourth was interventions targeting relationships among stakeholders. A fifth theme highlighting patients and family empowerment for type 2 diabetes control was also found in most of the interventions.
{"title":"Impact of health systems interventions in primary health settings on type 2 diabetes care and health outcomes among adults in West Africa: a systematic review","authors":"Eugene Paa Kofi Bondzie, Kezia Amarteyfio, Yasmin Jahan, Nana Efua Enyimayew Afun, Mary Pomaa Agyekum, Ludovic Tapsoba, Dina Balabanova, Tolib Mirzoev, Irene Ayepong","doi":"10.1101/2024.05.28.24308066","DOIUrl":"https://doi.org/10.1101/2024.05.28.24308066","url":null,"abstract":"Type 2 diabetes is ambulatory care sensitive and adequate outpatient primary care supported by strong functional health systems can reduce avoidable complications and related mortality. A large body of published evidence exists on pharmacological agents and non-pharmacological interventions for the management of type 2 diabetes. However, the evidence on health systems’ ability to support patients’ primary care needs, especially in West Africa, where non-communicable disease (NCD) is an increasingly important part of the disease burden is uncertain. This systematic review explores the current published evidence on health systems interventions to support primary health facilities for type 2 diabetes care and impact on health outcomes, service access and quality in West Africa. The World Health Organization health systems building blocks and other post building blocks health systems frameworks guided our search and analysis. Only three pilot studies, including two randomized controlled trials and one pre-post study, met all our first inclusion criteria. However, we included 12 other studies which did not meet all the inclusion criteria but reported on a health system intervention for complete analysis: (The criteria were expanded to include studies conducted outside primary care settings. The rationale was that findings from such studies may influence primary care. Also, non-randomized control trials were later included). Our results showed that interventions with significant impact on glycemic control, treatment adherence, health literacy, and other associated outcomes addressed intersections between the individual health system blocks/areas. Thus, four cross-cutting themes related to the building blocks were found during analysis. The first theme was on interventions targeting the availability of trained health workers and the quality of their services; the second was on interventions targeting institutional infrastructure and resources for management; the third was on interventions targeting leadership and organizational culture and; the fourth was interventions targeting relationships among stakeholders. A fifth theme highlighting patients and family empowerment for type 2 diabetes control was also found in most of the interventions.","PeriodicalId":501556,"journal":{"name":"medRxiv - Health Systems and Quality Improvement","volume":"51 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141195268","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-05-29DOI: 10.1101/2024.05.28.24308067
Rosine Bigirinama, Ghislain Bisimwa, Samuel Makali, Aimé Cikomola, Janvier Barhobagayana, Jean-Corneille Lembebu, Christian Chiribagula, Pacifique Mwene-Batu, Abdon Mukalay, Denis Porignon, Albert Tambwe
Context In the rural Health Zone (HZ) of Walungu, eastern Democratic Republic of Congo, major constraints impede health outcomes. From 2015 to 2019, the “RIPSEC” program transformed Walungu into a Learning and Research Zone (LRZ) under the mentorship of a local university to enhance the leadership capabilities of HZ managers, focusing on managing challenges including the proliferation of Informal Healthcare Facilities (IHFs).
{"title":"The effect of mentorship as a means of strengthening leadership in the health system at the operational level: a case study of the Walungu rural health zone in the eastern Democratic Republic of Congo","authors":"Rosine Bigirinama, Ghislain Bisimwa, Samuel Makali, Aimé Cikomola, Janvier Barhobagayana, Jean-Corneille Lembebu, Christian Chiribagula, Pacifique Mwene-Batu, Abdon Mukalay, Denis Porignon, Albert Tambwe","doi":"10.1101/2024.05.28.24308067","DOIUrl":"https://doi.org/10.1101/2024.05.28.24308067","url":null,"abstract":"<strong>Context</strong> In the rural Health Zone (HZ) of Walungu, eastern Democratic Republic of Congo, major constraints impede health outcomes. From 2015 to 2019, the “RIPSEC” program transformed Walungu into a Learning and Research Zone (LRZ) under the mentorship of a local university to enhance the leadership capabilities of HZ managers, focusing on managing challenges including the proliferation of Informal Healthcare Facilities (IHFs).","PeriodicalId":501556,"journal":{"name":"medRxiv - Health Systems and Quality Improvement","volume":"34 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141195358","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-05-29DOI: 10.1101/2024.05.28.24307345
Jeremy Y. Ng, Henry Liu, Mehvish Masood, Jassimar Kochhar, David Moher, Alan Ehrlich, Alfonso Iorio, Kelly D. Cobey
Background Transparency within biomedical research is essential for research integrity, credibility, and reproducibility. To increase adherence to optimal scientific practices and enhance transparency, we propose the creation of a journal transparency tool (JTT) that will allow users to obtain information about a given scholarly journal’s operations and transparency policies. This study is part of a program of research to obtain user preferences to inform the proposed JTT. Here, we report on our consultation with clinicians and researchers.
{"title":"Researcher and Clinician Preferences for a Journal Transparency Tool: A Mixed-Methods Survey and Focus Group Study","authors":"Jeremy Y. Ng, Henry Liu, Mehvish Masood, Jassimar Kochhar, David Moher, Alan Ehrlich, Alfonso Iorio, Kelly D. Cobey","doi":"10.1101/2024.05.28.24307345","DOIUrl":"https://doi.org/10.1101/2024.05.28.24307345","url":null,"abstract":"<strong>Background</strong> Transparency within biomedical research is essential for research integrity, credibility, and reproducibility. To increase adherence to optimal scientific practices and enhance transparency, we propose the creation of a journal transparency tool (JTT) that will allow users to obtain information about a given scholarly journal’s operations and transparency policies. This study is part of a program of research to obtain user preferences to inform the proposed JTT. Here, we report on our consultation with clinicians and researchers.","PeriodicalId":501556,"journal":{"name":"medRxiv - Health Systems and Quality Improvement","volume":"59 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141195401","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-05-28DOI: 10.1101/2024.05.28.24308029
Lee Jones, Adrian Barnett, Dimitrios Vagenas
Background Decisions about health care, such as the effectiveness of new treatments for disease, are regularly made based on evidence from published work. However, poor reporting of statistical methods and results is endemic across health research and risks ineffective or harmful treatments being used in clinical practice. Statistical modelling choices often greatly influence the results. Authors do not always provide enough information to evaluate and repeat their methods, making interpreting results difficult. Our research is designed to understand current reporting practices and inform efforts to educate researchers.
{"title":"Linear regression reporting practices for health researchers, a cross-sectional meta-research study","authors":"Lee Jones, Adrian Barnett, Dimitrios Vagenas","doi":"10.1101/2024.05.28.24308029","DOIUrl":"https://doi.org/10.1101/2024.05.28.24308029","url":null,"abstract":"<strong>Background</strong> Decisions about health care, such as the effectiveness of new treatments for disease, are regularly made based on evidence from published work. However, poor reporting of statistical methods and results is endemic across health research and risks ineffective or harmful treatments being used in clinical practice. Statistical modelling choices often greatly influence the results. Authors do not always provide enough information to evaluate and repeat their methods, making interpreting results difficult. Our research is designed to understand current reporting practices and inform efforts to educate researchers.","PeriodicalId":501556,"journal":{"name":"medRxiv - Health Systems and Quality Improvement","volume":"40 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141195374","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-05-10DOI: 10.1101/2024.05.09.24307125
Zahra Rahemi, Juanita-Dawne R. Bacsu, Sophia Z. Shalhout, Morteza Sabet, Delaram Sirizi, Matthew Lee Smith, Swann Arp Adams
We aimed to examine past advance care planning (ACP) in U.S. older adults across different sociodemographic characteristics and cognition levels. We established the baseline trends from 10 years ago to assess if trends in 2024 have improved upon future data availability. We considered two legal documents in the Health and Retirement Study 2014 survey as measures for ACP: a living will and durable power of attorney for healthcare (DPOAH). Logistic regression models were fitted with outcome variables (living will, DPOAH, and both) stratified by cognition levels (dementia/impaired cognition versus normal cognition). Predictor variables included age, gender, ethnicity, race, education, marital status, rurality, everyday discrimination, social support, and loneliness. Age, ethnicity, race, education, and rurality were significant predictors of ACP (having a living will, DPOAH, and both the living will and DPOAH) across cognition levels. Participants who were younger, Hispanic, Black, had lower levels of education, or resided in rural areas were less likely to complete ACP. Examining ACP and its linkages to specific social determinants is essential to understanding disparities and educational strategies needed to facilitate ACP uptake among different population groups. Accordingly, this study aimed to examine past ACP disparities in relation to specific social determinants of health and different cognition levels. Future studies are required to evaluate whether existing disparities have improved over the last 10 years when 2024 data is released. Addressing ACP disparities among diverse populations, including racial and ethnic minorities with reduced cognition levels, is crucial for enhancing health equity and access to care.
{"title":"Past Disparities in Advance Care Planning Across Sociodemographic Characteristics and Cognition Levels in the United States","authors":"Zahra Rahemi, Juanita-Dawne R. Bacsu, Sophia Z. Shalhout, Morteza Sabet, Delaram Sirizi, Matthew Lee Smith, Swann Arp Adams","doi":"10.1101/2024.05.09.24307125","DOIUrl":"https://doi.org/10.1101/2024.05.09.24307125","url":null,"abstract":"We aimed to examine past advance care planning (ACP) in U.S. older adults across different sociodemographic characteristics and cognition levels. We established the baseline trends from 10 years ago to assess if trends in 2024 have improved upon future data availability. We considered two legal documents in the Health and Retirement Study 2014 survey as measures for ACP: a living will and durable power of attorney for healthcare (DPOAH). Logistic regression models were fitted with outcome variables (living will, DPOAH, and both) stratified by cognition levels (dementia/impaired cognition versus normal cognition). Predictor variables included age, gender, ethnicity, race, education, marital status, rurality, everyday discrimination, social support, and loneliness. Age, ethnicity, race, education, and rurality were significant predictors of ACP (having a living will, DPOAH, and both the living will and DPOAH) across cognition levels. Participants who were younger, Hispanic, Black, had lower levels of education, or resided in rural areas were less likely to complete ACP. Examining ACP and its linkages to specific social determinants is essential to understanding disparities and educational strategies needed to facilitate ACP uptake among different population groups. Accordingly, this study aimed to examine past ACP disparities in relation to specific social determinants of health and different cognition levels. Future studies are required to evaluate whether existing disparities have improved over the last 10 years when 2024 data is released. Addressing ACP disparities among diverse populations, including racial and ethnic minorities with reduced cognition levels, is crucial for enhancing health equity and access to care.","PeriodicalId":501556,"journal":{"name":"medRxiv - Health Systems and Quality Improvement","volume":"254 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140934339","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Laboratory Readiness and genomic surveillance of Covid-19 in the Capital of Brazil","authors":"Fabrício Vieira Cavalcante, Christina Pacheco Santos Martin, Gustavo Saraiva Frio, Rodrigo Guerino Stabeli, Leonor Maria Pacheco Santos","doi":"10.1101/2024.05.10.24307182","DOIUrl":"https://doi.org/10.1101/2024.05.10.24307182","url":null,"abstract":"<strong>Objective</strong> Analyze the diagnostic readiness to Covid-19 and the genomic surveillance of SARS-CoV-2 in Brasília, the capital of Brazil.","PeriodicalId":501556,"journal":{"name":"medRxiv - Health Systems and Quality Improvement","volume":"32 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140934256","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-05-09DOI: 10.1101/2024.05.06.24306755
Serena Uppal, Hadia Farrukh, Michelle Ghert
Background: Research study protocols are critical in study design, however study implementation can be subject to protocol deviations. The Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) trial assessed prophylactic intravenous antibiotics on the rate of surgical site infection in patients undergoing oncological endoprosthetic reconstruction of the lower extremity. The objective of this study was to identify the protocol deviations - missed antibiotic doses - in the PARITY trial, and determine the causes of the protocol deviations. Methods: This study is a secondary analysis of the PARITY trial data set. The patients in the original trial were randomized to receive either 24 hours or five days of postoperative intravenous antibiotics, for a total of 15 doses. Patients that missed doses and the reason for each missed dose were recorded in the database and summarized descriptively herein. This data was then compared between clinical sites with high and low volume, between nationalities and between the economic development status of the clinical site location. Results: The PARITY trial included 604 participants with 218 patients missing at least one antibiotic dose. The most common reason across all clinical sites was that patients were discharged earlier than the five-day protocol. This finding was consistent across high and low volume sites and across clinical sites in areas of different economic development. The reasons for protocol deviations varied across clinical sites of different nationalities. Conclusions: Protocol deviations - missed antibiotic doses - were common but of minimal severity in the PARITY trial. The most commonly reported reason for missed antibiotic doses was discharge earlier than the five-day protocol and not due to clinical site personnel error. Nevertheless, this study did identify actionable improvements to study protocol adherence such as careful monitoring of drug administration, investigator equipment, and availability of study drug.
{"title":"Reasons for Protocol Deviations & Missed Antibiotic Doses in Patients Undergoing Oncological Endoprosthetic Reconstruction","authors":"Serena Uppal, Hadia Farrukh, Michelle Ghert","doi":"10.1101/2024.05.06.24306755","DOIUrl":"https://doi.org/10.1101/2024.05.06.24306755","url":null,"abstract":"Background: Research study protocols are critical in study design, however study implementation can be subject to protocol deviations. The Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) trial assessed prophylactic intravenous antibiotics on the rate of surgical site infection in patients undergoing oncological endoprosthetic reconstruction of the lower extremity. The objective of this study was to identify the protocol deviations - missed antibiotic doses - in the PARITY trial, and determine the causes of the protocol deviations. Methods: This study is a secondary analysis of the PARITY trial data set. The patients in the original trial were randomized to receive either 24 hours or five days of postoperative intravenous antibiotics, for a total of 15 doses. Patients that missed doses and the reason for each missed dose were recorded in the database and summarized descriptively herein. This data was then compared between clinical sites with high and low volume, between nationalities and between the economic development status of the clinical site location. Results: The PARITY trial included 604 participants with 218 patients missing at least one antibiotic dose. The most common reason across all clinical sites was that patients were discharged earlier than the five-day protocol. This finding was consistent across high and low volume sites and across clinical sites in areas of different economic development. The reasons for protocol deviations varied across clinical sites of different nationalities. Conclusions: Protocol deviations - missed antibiotic doses - were common but of minimal severity in the PARITY trial. The most commonly reported reason for missed antibiotic doses was discharge earlier than the five-day protocol and not due to clinical site personnel error. Nevertheless, this study did identify actionable improvements to study protocol adherence such as careful monitoring of drug administration, investigator equipment, and availability of study drug.","PeriodicalId":501556,"journal":{"name":"medRxiv - Health Systems and Quality Improvement","volume":"31 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140934264","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-05-07DOI: 10.1101/2024.05.07.24306984
R Sippy, L Efstathopoulou, E Simes, M Davis, S Howell, B Morris, O Owrid, N Stoll, A Moore, P Fonagy
Aims Developing integrated mental health services that focus on the needs of children and young people is a key policy goal in England. The THRIVE Framework and its associated implementation programme, i-THRIVE, are now used in areas covering over 65% of England’s children. This study explores the experiences of staff involved with the i-THRIVE programme, assesses its effectiveness, and examines how local system working relationships influence the programme’s success.
{"title":"Effect of a needs-based model of care on the characteristics of healthcare services in England: the i-THRIVE National Implementation Programme","authors":"R Sippy, L Efstathopoulou, E Simes, M Davis, S Howell, B Morris, O Owrid, N Stoll, A Moore, P Fonagy","doi":"10.1101/2024.05.07.24306984","DOIUrl":"https://doi.org/10.1101/2024.05.07.24306984","url":null,"abstract":"<strong>Aims</strong> Developing integrated mental health services that focus on the needs of children and young people is a key policy goal in England. The THRIVE Framework and its associated implementation programme, i-THRIVE, are now used in areas covering over 65% of England’s children. This study explores the experiences of staff involved with the i-THRIVE programme, assesses its effectiveness, and examines how local system working relationships influence the programme’s success.","PeriodicalId":501556,"journal":{"name":"medRxiv - Health Systems and Quality Improvement","volume":"97 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140934204","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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