Pub Date : 2022-04-01DOI: 10.1371/journal.pmed.1003980
B. Speich, D. Gryaznov, J. Busse, V. Gloy, S. Lohner, K. Klatte, Ala Taji Heravi, Nilabh Ghosh, Hopin Lee, A. Mansouri, I. Marian, R. Saccilotto, E. Nury, B. Kasenda, Elena Ojeda-Ruiz, S. Schandelmaier, Y. Tomonaga, A. Amstutz, C. Pauli-Magnus, K. Bischoff, K. Wollmann, Laura Rehner, J. Meerpohl, A. Nordmann, Jacqueline Wong, Ngai Chow, P. Hong, Kimberly Mc Cord-De Iaco, S. Sricharoenchai, A. Agarwal, M. Schwenkglenks, L. Hemkens, E. von Elm, Bethan Copsey, Alexandra N Griessbach, C. Schönenberger, D. Mertz, Anette Blümle, Belinda von Niederhäusern, S. Hopewell, A. Odutayo, M. Briel
Background We previously found that 25% of 1,017 randomized clinical trials (RCTs) approved between 2000 and 2003 were discontinued prematurely, and 44% remained unpublished at a median of 12 years follow-up. We aimed to assess a decade later (1) whether rates of completion and publication have increased; (2) the extent to which nonpublished RCTs can be identified in trial registries; and (3) the association between reporting quality of protocols and premature discontinuation or nonpublication of RCTs. Methods and findings We included 326 RCT protocols approved in 2012 by research ethics committees in Switzerland, the United Kingdom, Germany, and Canada in this metaresearch study. Pilot, feasibility, and phase 1 studies were excluded. We extracted trial characteristics from each study protocol and systematically searched for corresponding trial registration (if not reported in the protocol) and full text publications until February 2022. For trial registrations, we searched the (i) World Health Organization: International Clinical Trial Registry Platform (ICTRP); (ii) US National Library of Medicine (ClinicalTrials.gov); (iii) European Union Drug Regulating Authorities Clinical Trials Database (EUCTR); (iv) ISRCTN registry; and (v) Google. For full text publications, we searched PubMed, Google Scholar, and Scopus. We recorded whether RCTs were registered, discontinued (including reason for discontinuation), and published. The reporting quality of RCT protocols was assessed with the 33-item SPIRIT checklist. We used multivariable logistic regression to examine the association between the independent variables protocol reporting quality, planned sample size, type of control (placebo versus other), reporting of any recruitment projection, single-center versus multicenter trials, and industry versus investigator sponsoring, with the 2 dependent variables: (1) publication of RCT results; and (2) trial discontinuation due to poor recruitment. Of the 326 included trials, 19 (6%) were unregistered. Ninety-eight trials (30%) were discontinued prematurely, most often due to poor recruitment (37%; 36/98). One in 5 trials (21%; 70/326) remained unpublished at 10 years follow-up, and 21% of unpublished trials (15/70) were unregistered. Twenty-three of 147 investigator-sponsored trials (16%) reported their results in a trial registry in contrast to 150 of 179 industry-sponsored trials (84%). The median proportion of reported SPIRIT items in included RCT protocols was 69% (interquartile range 61% to 77%). We found no variables associated with trial discontinuation; however, lower reporting quality of trial protocols was associated with nonpublication (odds ratio, 0.71 for each 10% increment in the proportion of SPIRIT items met; 95% confidence interval, 0.55 to 0.92; p = 0.009). Study limitations include that the moderate sample size may have limited the ability of our regression models to identify significant associations. Conclusions We have observed that rat
{"title":"Nonregistration, discontinuation, and nonpublication of randomized trials: A repeated metaresearch analysis","authors":"B. Speich, D. Gryaznov, J. Busse, V. Gloy, S. Lohner, K. Klatte, Ala Taji Heravi, Nilabh Ghosh, Hopin Lee, A. Mansouri, I. Marian, R. Saccilotto, E. Nury, B. Kasenda, Elena Ojeda-Ruiz, S. Schandelmaier, Y. Tomonaga, A. Amstutz, C. Pauli-Magnus, K. Bischoff, K. Wollmann, Laura Rehner, J. Meerpohl, A. Nordmann, Jacqueline Wong, Ngai Chow, P. Hong, Kimberly Mc Cord-De Iaco, S. Sricharoenchai, A. Agarwal, M. Schwenkglenks, L. Hemkens, E. von Elm, Bethan Copsey, Alexandra N Griessbach, C. Schönenberger, D. Mertz, Anette Blümle, Belinda von Niederhäusern, S. Hopewell, A. Odutayo, M. Briel","doi":"10.1371/journal.pmed.1003980","DOIUrl":"https://doi.org/10.1371/journal.pmed.1003980","url":null,"abstract":"Background We previously found that 25% of 1,017 randomized clinical trials (RCTs) approved between 2000 and 2003 were discontinued prematurely, and 44% remained unpublished at a median of 12 years follow-up. We aimed to assess a decade later (1) whether rates of completion and publication have increased; (2) the extent to which nonpublished RCTs can be identified in trial registries; and (3) the association between reporting quality of protocols and premature discontinuation or nonpublication of RCTs. Methods and findings We included 326 RCT protocols approved in 2012 by research ethics committees in Switzerland, the United Kingdom, Germany, and Canada in this metaresearch study. Pilot, feasibility, and phase 1 studies were excluded. We extracted trial characteristics from each study protocol and systematically searched for corresponding trial registration (if not reported in the protocol) and full text publications until February 2022. For trial registrations, we searched the (i) World Health Organization: International Clinical Trial Registry Platform (ICTRP); (ii) US National Library of Medicine (ClinicalTrials.gov); (iii) European Union Drug Regulating Authorities Clinical Trials Database (EUCTR); (iv) ISRCTN registry; and (v) Google. For full text publications, we searched PubMed, Google Scholar, and Scopus. We recorded whether RCTs were registered, discontinued (including reason for discontinuation), and published. The reporting quality of RCT protocols was assessed with the 33-item SPIRIT checklist. We used multivariable logistic regression to examine the association between the independent variables protocol reporting quality, planned sample size, type of control (placebo versus other), reporting of any recruitment projection, single-center versus multicenter trials, and industry versus investigator sponsoring, with the 2 dependent variables: (1) publication of RCT results; and (2) trial discontinuation due to poor recruitment. Of the 326 included trials, 19 (6%) were unregistered. Ninety-eight trials (30%) were discontinued prematurely, most often due to poor recruitment (37%; 36/98). One in 5 trials (21%; 70/326) remained unpublished at 10 years follow-up, and 21% of unpublished trials (15/70) were unregistered. Twenty-three of 147 investigator-sponsored trials (16%) reported their results in a trial registry in contrast to 150 of 179 industry-sponsored trials (84%). The median proportion of reported SPIRIT items in included RCT protocols was 69% (interquartile range 61% to 77%). We found no variables associated with trial discontinuation; however, lower reporting quality of trial protocols was associated with nonpublication (odds ratio, 0.71 for each 10% increment in the proportion of SPIRIT items met; 95% confidence interval, 0.55 to 0.92; p = 0.009). Study limitations include that the moderate sample size may have limited the ability of our regression models to identify significant associations. Conclusions We have observed that rat","PeriodicalId":20368,"journal":{"name":"PLoS Medicine","volume":" ","pages":""},"PeriodicalIF":15.8,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48415122","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-04-01DOI: 10.1371/journal.pmed.1003963
Damien Foo, M. Sarna, G. Pereira, H. Moore, A. Regan
Background Few studies have evaluated the effect of maternal influenza vaccination on the development of allergic and autoimmune diseases in children beyond 6 months of age. We aimed to investigate the association between in utero exposure to seasonal inactivated influenza vaccine (IIV) and subsequent diagnosis of allergic and autoimmune diseases. Methods and findings This longitudinal, population-based linked cohort study included 124,760 singleton, live-born children from 106,206 mothers in Western Australia (WA) born between April 2012 and July 2016, with up to 5 years of follow-up from birth. In our study cohort, 64,169 (51.4%) were male, 6,566 (5.3%) were Aboriginal and/or Torres Strait Islander children, and the mean age at the end of follow-up was 3.0 (standard deviation, 1.3) years. The exposure was receipt of seasonal IIV during pregnancy. The outcomes were diagnosis of an allergic or autoimmune disease, including asthma and anaphylaxis, identified from hospital and/or emergency department (ED) records. Inverse probability of treatment weights (IPTWs) accounted for baseline probability of vaccination by maternal age, Aboriginal and/or Torres Strait Islander status, socioeconomic status, body mass index, parity, medical conditions, pregnancy complications, prenatal smoking, and prenatal care. The models additionally adjusted for the Aboriginal and/or Torres Strait Islander status of the child. There were 14,396 (11.5%) maternally vaccinated children; 913 (6.3%) maternally vaccinated and 7,655 (6.9%) maternally unvaccinated children had a diagnosis of allergic or autoimmune disease, respectively. Overall, maternal influenza vaccination was not associated with diagnosis of an allergic or autoimmune disease (adjusted hazard ratio [aHR], 1.02; 95% confidence interval [CI], 0.95 to 1.09). In trimester-specific analyses, we identified a negative association between third trimester influenza vaccination and the diagnosis of asthma (n = 40; aHR, 0.70; 95% CI, 0.50 to 0.97) and anaphylaxis (n = 36; aHR, 0.67; 95% CI, 0.47 to 0.95).We did not capture outcomes diagnosed in a primary care setting; therefore, our findings are only generalizable to more severe events requiring hospitalization or presentation to the ED. Due to small cell sizes (i.e., <5), estimates could not be determined for all outcomes after stratification. Conclusions In this study, we observed no association between in utero exposure to influenza vaccine and diagnosis of allergic or autoimmune diseases. Although we identified a negative association of asthma and anaphylaxis diagnosis when seasonal IIV was administered later in pregnancy, additional studies are needed to confirm this. Overall, our findings support the safety of seasonal inactivated influenza vaccine during pregnancy in relation to allergic and autoimmune diseases in early childhood and support the continuation of current global maternal vaccine programs and policies.
{"title":"Prenatal influenza vaccination and allergic and autoimmune diseases in childhood: A longitudinal, population-based linked cohort study","authors":"Damien Foo, M. Sarna, G. Pereira, H. Moore, A. Regan","doi":"10.1371/journal.pmed.1003963","DOIUrl":"https://doi.org/10.1371/journal.pmed.1003963","url":null,"abstract":"Background Few studies have evaluated the effect of maternal influenza vaccination on the development of allergic and autoimmune diseases in children beyond 6 months of age. We aimed to investigate the association between in utero exposure to seasonal inactivated influenza vaccine (IIV) and subsequent diagnosis of allergic and autoimmune diseases. Methods and findings This longitudinal, population-based linked cohort study included 124,760 singleton, live-born children from 106,206 mothers in Western Australia (WA) born between April 2012 and July 2016, with up to 5 years of follow-up from birth. In our study cohort, 64,169 (51.4%) were male, 6,566 (5.3%) were Aboriginal and/or Torres Strait Islander children, and the mean age at the end of follow-up was 3.0 (standard deviation, 1.3) years. The exposure was receipt of seasonal IIV during pregnancy. The outcomes were diagnosis of an allergic or autoimmune disease, including asthma and anaphylaxis, identified from hospital and/or emergency department (ED) records. Inverse probability of treatment weights (IPTWs) accounted for baseline probability of vaccination by maternal age, Aboriginal and/or Torres Strait Islander status, socioeconomic status, body mass index, parity, medical conditions, pregnancy complications, prenatal smoking, and prenatal care. The models additionally adjusted for the Aboriginal and/or Torres Strait Islander status of the child. There were 14,396 (11.5%) maternally vaccinated children; 913 (6.3%) maternally vaccinated and 7,655 (6.9%) maternally unvaccinated children had a diagnosis of allergic or autoimmune disease, respectively. Overall, maternal influenza vaccination was not associated with diagnosis of an allergic or autoimmune disease (adjusted hazard ratio [aHR], 1.02; 95% confidence interval [CI], 0.95 to 1.09). In trimester-specific analyses, we identified a negative association between third trimester influenza vaccination and the diagnosis of asthma (n = 40; aHR, 0.70; 95% CI, 0.50 to 0.97) and anaphylaxis (n = 36; aHR, 0.67; 95% CI, 0.47 to 0.95).We did not capture outcomes diagnosed in a primary care setting; therefore, our findings are only generalizable to more severe events requiring hospitalization or presentation to the ED. Due to small cell sizes (i.e., <5), estimates could not be determined for all outcomes after stratification. Conclusions In this study, we observed no association between in utero exposure to influenza vaccine and diagnosis of allergic or autoimmune diseases. Although we identified a negative association of asthma and anaphylaxis diagnosis when seasonal IIV was administered later in pregnancy, additional studies are needed to confirm this. Overall, our findings support the safety of seasonal inactivated influenza vaccine during pregnancy in relation to allergic and autoimmune diseases in early childhood and support the continuation of current global maternal vaccine programs and policies.","PeriodicalId":20368,"journal":{"name":"PLoS Medicine","volume":" ","pages":""},"PeriodicalIF":15.8,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45994503","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-04-01DOI: 10.1371/journal.pmed.1003954
B. Fletcher, Sarah Damery, O. Aiyegbusi, N. Anderson, M. Calvert, P. Cockwell, James Ferguson, M. Horton, Muirne C. S. Paap, C. Sidey-Gibbons, A. Slade, Neil Turner, D. Kyte
Background The importance of patient-reported outcome measurement in chronic kidney disease (CKD) populations has been established. However, there remains a lack of research that has synthesised data around CKD-specific symptom and health-related quality of life (HRQOL) burden globally, to inform focused measurement of the most relevant patient-important information in a way that minimises patient burden. The aim of this review was to synthesise symptom prevalence/severity and HRQOL data across the following CKD clinical groups globally: (1) stage 1–5 and not on renal replacement therapy (RRT), (2) receiving dialysis, or (3) in receipt of a kidney transplant. Methods and findings MEDLINE, PsycINFO, and CINAHL were searched for English-language cross-sectional/longitudinal studies reporting prevalence and/or severity of symptoms and/or HRQOL in CKD, published between January 2000 and September 2021, including adult patients with CKD, and measuring symptom prevalence/severity and/or HRQOL using a patient-reported outcome measure (PROM). Random effects meta-analyses were used to pool data, stratified by CKD group: not on RRT, receiving dialysis, or in receipt of a kidney transplant. Methodological quality of included studies was assessed using the Joanna Briggs Institute Critical Appraisal Checklist for Studies Reporting Prevalence Data, and an exploration of publication bias performed. The search identified 1,529 studies, of which 449, with 199,147 participants from 62 countries, were included in the analysis. Studies used 67 different symptom and HRQOL outcome measures, which provided data on 68 reported symptoms. Random effects meta-analyses highlighted the considerable symptom and HRQOL burden associated with CKD, with fatigue particularly prevalent, both in patients not on RRT (14 studies, 4,139 participants: 70%, 95% CI 60%–79%) and those receiving dialysis (21 studies, 2,943 participants: 70%, 95% CI 64%–76%). A number of symptoms were significantly (p < 0.05 after adjustment for multiple testing) less prevalent and/or less severe within the post-transplantation population, which may suggest attribution to CKD (fatigue, depression, itching, poor mobility, poor sleep, and dry mouth). Quality of life was commonly lower in patients on dialysis (36-Item Short Form Health Survey [SF-36] Mental Component Summary [MCS] 45.7 [95% CI 45.5–45.8]; SF-36 Physical Component Summary [PCS] 35.5 [95% CI 35.3–35.6]; 91 studies, 32,105 participants for MCS and PCS) than in other CKD populations (patients not on RRT: SF-36 MCS 66.6 [95% CI 66.5–66.6], p = 0.002; PCS 66.3 [95% CI 66.2–66.4], p = 0.002; 39 studies, 24,600 participants; transplant: MCS 50.0 [95% CI 49.9–50.1], p = 0.002; PCS 48.0 [95% CI 47.9–48.1], p = 0.002; 39 studies, 9,664 participants). Limitations of the analysis are the relatively few studies contributing to symptom severity estimates and inconsistent use of PROMs (different measures and time points) across the included literature, which h
背景:在慢性肾脏疾病(CKD)人群中，患者报告的结果测量的重要性已经确立。然而，仍然缺乏综合全球ckd特定症状和健康相关生活质量(HRQOL)负担数据的研究，以最大限度地减少患者负担的方式，为最相关的患者重要信息的集中测量提供信息。本综述的目的是综合全球以下CKD临床组的症状患病率/严重程度和HRQOL数据:(1)1 - 5期未接受肾脏替代治疗(RRT)，(2)接受透析治疗，或(3)接受肾移植。方法和研究结果检索MEDLINE、PsycINFO和CINAHL，检索2000年1月至2021年9月间发表的报告CKD患病率和/或症状严重程度和/或HRQOL的英文横断面/纵向研究，包括CKD成年患者，并使用患者报告的结果测量(PROM)测量症状患病率/严重程度和/或HRQOL。随机效应荟萃分析用于汇总数据，按CKD组分层:未接受RRT，接受透析或接受肾移植。纳入研究的方法学质量采用乔安娜布里格斯研究所报告患病率数据的研究关键评估清单进行评估，并对发表偏倚进行了探索。这项研究确定了1529项研究，其中449项，来自62个国家的199147名参与者，被纳入了分析。研究使用67种不同的症状和HRQOL结果测量，提供了68种报告症状的数据。随机效应荟萃分析强调了与CKD相关的相当大的症状和HRQOL负担，疲劳尤其普遍，无论是在未接受RRT的患者(14项研究，4139名参与者:70%，95% CI 60%-79%)还是接受透析的患者(21项研究，2943名参与者:70%，95% CI 64%-76%)。在移植后人群中，许多症状明显(经多次测试调整后p < 0.05)不那么普遍和/或不那么严重，这可能提示CKD的原因(疲劳、抑郁、瘙痒、活动能力差、睡眠差和口干)。透析患者的生活质量通常较低(36-Item Short - Form Health Survey [SF-36] Mental Component Summary [MCS] 45.7 [95% CI 45.5-45.8];SF-36物理部件概要[PCS] 35.5 [95% CI 35.3-35.6];91项研究，32,105名MCS和PCS患者)比其他CKD人群(未接受RRT的患者:SF-36 MCS 66.6 [95% CI 66.5-66.6]， p = 0.002;PCS 66.3 [95% CI 66.2-66.4]， p = 0.002;39项研究，24,600名参与者;移植:MCS 50.0 [95% CI 49.9-50.1]， p = 0.002;PCS 48.0 [95% CI 47.9-48.1]， p = 0.002;39项研究，9664名参与者)。分析的局限性是相对较少的研究有助于症状严重程度的估计，并且在所纳入的文献中使用的PROMs(不同的测量和时间点)不一致，这阻碍了解释。结论主要研究结果表明CKD患者有明显的症状和HRQOL负担。该综合报告提供了临床组间症状/HRQOL概况的详细概述，可以为医疗保健专业人员在讨论、测量和管理与CKD相关的潜在治疗负担时提供支持。协议注册PROSPERO CRD42020164737。
{"title":"Symptom burden and health-related quality of life in chronic kidney disease: A global systematic review and meta-analysis","authors":"B. Fletcher, Sarah Damery, O. Aiyegbusi, N. Anderson, M. Calvert, P. Cockwell, James Ferguson, M. Horton, Muirne C. S. Paap, C. Sidey-Gibbons, A. Slade, Neil Turner, D. Kyte","doi":"10.1371/journal.pmed.1003954","DOIUrl":"https://doi.org/10.1371/journal.pmed.1003954","url":null,"abstract":"Background The importance of patient-reported outcome measurement in chronic kidney disease (CKD) populations has been established. However, there remains a lack of research that has synthesised data around CKD-specific symptom and health-related quality of life (HRQOL) burden globally, to inform focused measurement of the most relevant patient-important information in a way that minimises patient burden. The aim of this review was to synthesise symptom prevalence/severity and HRQOL data across the following CKD clinical groups globally: (1) stage 1–5 and not on renal replacement therapy (RRT), (2) receiving dialysis, or (3) in receipt of a kidney transplant. Methods and findings MEDLINE, PsycINFO, and CINAHL were searched for English-language cross-sectional/longitudinal studies reporting prevalence and/or severity of symptoms and/or HRQOL in CKD, published between January 2000 and September 2021, including adult patients with CKD, and measuring symptom prevalence/severity and/or HRQOL using a patient-reported outcome measure (PROM). Random effects meta-analyses were used to pool data, stratified by CKD group: not on RRT, receiving dialysis, or in receipt of a kidney transplant. Methodological quality of included studies was assessed using the Joanna Briggs Institute Critical Appraisal Checklist for Studies Reporting Prevalence Data, and an exploration of publication bias performed. The search identified 1,529 studies, of which 449, with 199,147 participants from 62 countries, were included in the analysis. Studies used 67 different symptom and HRQOL outcome measures, which provided data on 68 reported symptoms. Random effects meta-analyses highlighted the considerable symptom and HRQOL burden associated with CKD, with fatigue particularly prevalent, both in patients not on RRT (14 studies, 4,139 participants: 70%, 95% CI 60%–79%) and those receiving dialysis (21 studies, 2,943 participants: 70%, 95% CI 64%–76%). A number of symptoms were significantly (p < 0.05 after adjustment for multiple testing) less prevalent and/or less severe within the post-transplantation population, which may suggest attribution to CKD (fatigue, depression, itching, poor mobility, poor sleep, and dry mouth). Quality of life was commonly lower in patients on dialysis (36-Item Short Form Health Survey [SF-36] Mental Component Summary [MCS] 45.7 [95% CI 45.5–45.8]; SF-36 Physical Component Summary [PCS] 35.5 [95% CI 35.3–35.6]; 91 studies, 32,105 participants for MCS and PCS) than in other CKD populations (patients not on RRT: SF-36 MCS 66.6 [95% CI 66.5–66.6], p = 0.002; PCS 66.3 [95% CI 66.2–66.4], p = 0.002; 39 studies, 24,600 participants; transplant: MCS 50.0 [95% CI 49.9–50.1], p = 0.002; PCS 48.0 [95% CI 47.9–48.1], p = 0.002; 39 studies, 9,664 participants). Limitations of the analysis are the relatively few studies contributing to symptom severity estimates and inconsistent use of PROMs (different measures and time points) across the included literature, which h","PeriodicalId":20368,"journal":{"name":"PLoS Medicine","volume":" ","pages":""},"PeriodicalIF":15.8,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41919368","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-04-01DOI: 10.1371/journal.pmed.1003966
Ashleigh Guillaumier, N. Spratt, M. Pollack, A. Baker, P. Magin, A. Turner, C. Oldmeadow, Clare E Collins, R. Callister, Christopher Levi, A. Searles, S. Deeming, Brigid Clancy, B. Bonevski
Background The aim of this trial was to evaluate the effectiveness of an online health behaviour change intervention—Prevent 2nd Stroke (P2S)—at improving health-related quality of life (HRQoL) amongst stroke survivors at 6 months of follow-up. Methods and findings A prospective, blinded-endpoint randomised controlled trial, with stroke survivors as the unit of randomisation, was conducted between March 2018 and November 2019. Adult stroke survivors between 6 and 36 months post-stroke with capacity to use the intervention (determined by a score of ≥4 on the Modified Rankin Scale) and who had access and willingness to use the internet were recruited via mail-out invitations from 1 national and 1 regional stroke registry. Participants completed baseline (n = 399) and 6-month follow-up (n = 356; 89%) outcome assessments via computer-assisted telephone interviewing (CATI). At baseline the sample had an average age of 66 years (SD 12), and 65% were male. Randomisation occurred at the end of the baseline survey; CATI assessors and independent statisticians were blind to group allocation. The intervention group received remote access for a 12-week period to the online-only P2S program (n = 199; n = 28 lost at follow-up). The control group were emailed and posted a list of internet addresses of generic health websites (n = 200; n = 15 lost at follow-up). The primary outcome was HRQoL as measured by the EuroQol Visual Analogue Scale (EQ-VAS; self-rated global health); the outcome was assessed for differences between treatment groups at follow-up, adjusting for baseline measures. Secondary outcomes were HRQoL as measured by the EQ-5D (descriptive health state), diet quality, physical activity, alcohol consumption, smoking status, mood, physical functioning, and independent living. All outcomes included the variable ‘stroke event (stroke/transient ischaemic attack/other)’ as a covariate, and analysis was intention-to-treat. At 6 months, median EQ-VAS HRQoL score was significantly higher in the intervention group than the control group (85 vs 80, difference 5, 95% CI 0.79–9.21, p = 0.020). The results were robust to the assumption the data were missing at random; however, the results were not robust to the assumption that the difference in HRQoL between those with complete versus missing data was at least 3 points. Significantly higher proportions of people in the intervention group reported no problems with personal care (OR 2.17, 95% CI 1.05–4.48, p = 0.0359) and usual activities (OR 1.66, 95% CI 1.06–2.60, p = 0.0256) than in the control group. There were no significant differences between groups on all other secondary outcomes. The main limitation of the study is that the sample comprises mostly ‘well’ stroke survivors with limited to no disability. Conclusions The P2S online healthy lifestyle program improved stroke survivors’ self-reported global ratings of HRQoL (as measured by EQ-VAS) at 6-month follow-up. Online platforms represent a promising tool
本试验的目的是评估在线健康行为改变干预-预防第二次卒中(P2S) -在改善中风幸存者6个月随访时与健康相关的生活质量(HRQoL)方面的有效性。方法和发现2018年3月至2019年11月进行了一项前瞻性、盲终点随机对照试验，以中风幸存者为随机化单位。中风后6至36个月有能力使用干预措施的成年中风幸存者(由修正兰金量表得分≥4分确定)，并有机会和意愿使用互联网，通过邮寄邀请从1个国家和1个地区中风登记处招募。参与者完成了基线(n = 399)和6个月的随访(n = 356;89%)通过计算机辅助电话访谈(CATI)进行结果评估。在基线时，样本的平均年龄为66岁(标准差12)，65%为男性。随机化发生在基线调查结束时;CATI评估人员和独立统计人员对分组分配不知情。干预组接受为期12周的远程访问在线P2S计划(n = 199;随访时N = 28)。对照组通过电子邮件发送并张贴一份通用健康网站的地址列表(n = 200;随访时丢失15例)。主要终点是HRQoL，由EuroQol视觉模拟量表(EQ-VAS;自评全球健康);在随访中评估治疗组之间的差异，并根据基线测量进行调整。次要结局为HRQoL，以EQ-5D(描述性健康状态)、饮食质量、身体活动、饮酒、吸烟状况、情绪、身体功能和独立生活来衡量。所有结果包括变量“卒中事件(卒中/短暂性缺血性发作/其他)”作为协变量，分析是意向治疗。6个月时，干预组EQ-VAS HRQoL中位数评分显著高于对照组(85 vs 80，差异5,95% CI 0.79 ~ 9.21, p = 0.020)。对于数据随机丢失的假设，结果是稳健的;然而，结果并不足以证明数据完整者与缺失者的HRQoL差异至少为3分。干预组患者在个人护理(OR 2.17, 95% CI 1.05-4.48, p = 0.0359)和日常活动(OR 1.66, 95% CI 1.06-2.60, p = 0.0256)方面没有出现问题的比例明显高于对照组。各组间其他次要结果无显著差异。该研究的主要局限性在于，样本大多是“健康”的中风幸存者，只有有限的残疾或没有残疾。结论P2S在线健康生活方式项目改善了脑卒中幸存者在6个月随访时自我报告的HRQoL总体评分(以EQ-VAS测量)。在线平台是吸引和支持一些中风幸存者的一个很有前途的工具。澳大利亚新西兰临床试验注册中心ACTRN12617001205325。
{"title":"Evaluation of an online intervention for improving stroke survivors’ health-related quality of life: A randomised controlled trial","authors":"Ashleigh Guillaumier, N. Spratt, M. Pollack, A. Baker, P. Magin, A. Turner, C. Oldmeadow, Clare E Collins, R. Callister, Christopher Levi, A. Searles, S. Deeming, Brigid Clancy, B. Bonevski","doi":"10.1371/journal.pmed.1003966","DOIUrl":"https://doi.org/10.1371/journal.pmed.1003966","url":null,"abstract":"Background The aim of this trial was to evaluate the effectiveness of an online health behaviour change intervention—Prevent 2nd Stroke (P2S)—at improving health-related quality of life (HRQoL) amongst stroke survivors at 6 months of follow-up. Methods and findings A prospective, blinded-endpoint randomised controlled trial, with stroke survivors as the unit of randomisation, was conducted between March 2018 and November 2019. Adult stroke survivors between 6 and 36 months post-stroke with capacity to use the intervention (determined by a score of ≥4 on the Modified Rankin Scale) and who had access and willingness to use the internet were recruited via mail-out invitations from 1 national and 1 regional stroke registry. Participants completed baseline (n = 399) and 6-month follow-up (n = 356; 89%) outcome assessments via computer-assisted telephone interviewing (CATI). At baseline the sample had an average age of 66 years (SD 12), and 65% were male. Randomisation occurred at the end of the baseline survey; CATI assessors and independent statisticians were blind to group allocation. The intervention group received remote access for a 12-week period to the online-only P2S program (n = 199; n = 28 lost at follow-up). The control group were emailed and posted a list of internet addresses of generic health websites (n = 200; n = 15 lost at follow-up). The primary outcome was HRQoL as measured by the EuroQol Visual Analogue Scale (EQ-VAS; self-rated global health); the outcome was assessed for differences between treatment groups at follow-up, adjusting for baseline measures. Secondary outcomes were HRQoL as measured by the EQ-5D (descriptive health state), diet quality, physical activity, alcohol consumption, smoking status, mood, physical functioning, and independent living. All outcomes included the variable ‘stroke event (stroke/transient ischaemic attack/other)’ as a covariate, and analysis was intention-to-treat. At 6 months, median EQ-VAS HRQoL score was significantly higher in the intervention group than the control group (85 vs 80, difference 5, 95% CI 0.79–9.21, p = 0.020). The results were robust to the assumption the data were missing at random; however, the results were not robust to the assumption that the difference in HRQoL between those with complete versus missing data was at least 3 points. Significantly higher proportions of people in the intervention group reported no problems with personal care (OR 2.17, 95% CI 1.05–4.48, p = 0.0359) and usual activities (OR 1.66, 95% CI 1.06–2.60, p = 0.0256) than in the control group. There were no significant differences between groups on all other secondary outcomes. The main limitation of the study is that the sample comprises mostly ‘well’ stroke survivors with limited to no disability. Conclusions The P2S online healthy lifestyle program improved stroke survivors’ self-reported global ratings of HRQoL (as measured by EQ-VAS) at 6-month follow-up. Online platforms represent a promising tool ","PeriodicalId":20368,"journal":{"name":"PLoS Medicine","volume":" ","pages":""},"PeriodicalIF":15.8,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48940128","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-04-01DOI: 10.1371/journal.pmed.1003982
R. Watkinson, Richard Williams, Stephanie Gillibrand, Caroline Sanders, Matt Sutton
[This corrects the article DOI: 10.1371/journal.pmed.1003932.].
[更正文章DOI: 10.1371/journal.pmed.1003932.]。
{"title":"Correction: Ethnic inequalities in COVID-19 vaccine uptake and comparison to seasonal influenza vaccine uptake in Greater Manchester, UK: A cohort study","authors":"R. Watkinson, Richard Williams, Stephanie Gillibrand, Caroline Sanders, Matt Sutton","doi":"10.1371/journal.pmed.1003982","DOIUrl":"https://doi.org/10.1371/journal.pmed.1003982","url":null,"abstract":"[This corrects the article DOI: 10.1371/journal.pmed.1003932.].","PeriodicalId":20368,"journal":{"name":"PLoS Medicine","volume":" ","pages":""},"PeriodicalIF":15.8,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48327650","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-04-01DOI: 10.1371/journal.pmed.1003975
R. Carrillo-Larco, W. C. Guzman-Vilca, D. Neupane
Background Simplified blood pressure (BP) screening approaches have been proposed. However, evidence is limited to a few countries and has not documented the cardiovascular risk amongst missed hypertension cases, limiting the uptake of these simplified approaches. We quantified the proportion of missed, over-diagnosed, and consistently identified hypertension cases and the 10-year cardiovascular risk in these groups. Methods and findings We used 60 WHO STEPS surveys (cross-sectional and nationally representative; n = 145,174) conducted in 60 countries in 6 world regions between 2004 and 2019. Nine simplified approaches were compared against the standard (average of the last 2 of 3 BP measurements). The 10-year cardiovascular risk was computed with the 2019 World Health Organization Cardiovascular Risk Charts. We used t tests to compare the cardiovascular risk between the missed and over-diagnosed cases and the consistent hypertension cases. We used Poisson multilevel regressions to identify risk factors for missed cases (adjusted for age, sex, body mass index, and 10-year cardiovascular risk). Across all countries, compared to the standard approach, the simplified approach that missed the fewest cases was using the second BP reading if the first BP reading was 130–145/80–95 mm Hg (5.62%); using only the second BP reading missed 5.82%. The simplified approach with the smallest over-diagnosis proportion was using the second BP reading if the first BP measurement was ≥140/90 mm Hg (3.03%). In many countries, cardiovascular risk was not significantly different between the missed and consistent hypertension groups, yet the mean was slightly lower amongst missed cases. Cardiovascular risk was positively associated with missed hypertension depending on the simplified approach. The main limitation of the work is the cross-sectional design. Conclusions Simplified BP screening approaches seem to have low misdiagnosis rates, and cardiovascular risk could be lower amongst missed cases than amongst consistent hypertension cases. Simplified BP screening approaches could be included in large screening programmes and busy clinics.
背景:简化的血压(BP)筛查方法已经被提出。然而，证据仅限于少数国家，并没有记录遗漏高血压病例中的心血管风险，限制了这些简化方法的采用。我们量化了这些组中漏诊、过度诊断和一致确定的高血压病例和10年心血管风险的比例。方法和发现我们使用了60项WHO STEPS调查(横断面和全国代表性;N = 145,174)，于2004年至2019年在6个世界地区的60个国家进行。将9种简化方法与标准方法(3次BP测量的最后2次的平均值)进行比较。10年心血管风险是根据2019年世界卫生组织心血管风险图表计算的。我们使用t检验比较漏诊和过度诊断病例与一贯高血压病例的心血管风险。我们使用泊松多水平回归来确定漏诊病例的危险因素(调整年龄、性别、体重指数和10年心血管风险)。在所有国家，与标准方法相比，如果第一次血压读数为130-145/80-95 mm Hg，则使用第二次血压读数的简化方法漏报率最少(5.62%);仅使用第二次BP读数就错过了5.82%。如果第一次血压测量≥140/90 mm Hg，则使用第二次血压读数(3.03%)是过度诊断比例最小的简化方法。在许多国家，漏诊组和持续高血压组之间的心血管风险没有显著差异，但漏诊病例的平均值略低。根据简化方法，心血管风险与漏诊高血压呈正相关。该作品的主要限制是截面设计。结论简化血压筛查方法的误诊率较低，漏诊病例的心血管风险低于一致性高血压病例。简化的BP筛查方法可以纳入大型筛查计划和繁忙的诊所。
{"title":"Simplified hypertension screening methods across 60 countries: An observational study","authors":"R. Carrillo-Larco, W. C. Guzman-Vilca, D. Neupane","doi":"10.1371/journal.pmed.1003975","DOIUrl":"https://doi.org/10.1371/journal.pmed.1003975","url":null,"abstract":"Background Simplified blood pressure (BP) screening approaches have been proposed. However, evidence is limited to a few countries and has not documented the cardiovascular risk amongst missed hypertension cases, limiting the uptake of these simplified approaches. We quantified the proportion of missed, over-diagnosed, and consistently identified hypertension cases and the 10-year cardiovascular risk in these groups. Methods and findings We used 60 WHO STEPS surveys (cross-sectional and nationally representative; n = 145,174) conducted in 60 countries in 6 world regions between 2004 and 2019. Nine simplified approaches were compared against the standard (average of the last 2 of 3 BP measurements). The 10-year cardiovascular risk was computed with the 2019 World Health Organization Cardiovascular Risk Charts. We used t tests to compare the cardiovascular risk between the missed and over-diagnosed cases and the consistent hypertension cases. We used Poisson multilevel regressions to identify risk factors for missed cases (adjusted for age, sex, body mass index, and 10-year cardiovascular risk). Across all countries, compared to the standard approach, the simplified approach that missed the fewest cases was using the second BP reading if the first BP reading was 130–145/80–95 mm Hg (5.62%); using only the second BP reading missed 5.82%. The simplified approach with the smallest over-diagnosis proportion was using the second BP reading if the first BP measurement was ≥140/90 mm Hg (3.03%). In many countries, cardiovascular risk was not significantly different between the missed and consistent hypertension groups, yet the mean was slightly lower amongst missed cases. Cardiovascular risk was positively associated with missed hypertension depending on the simplified approach. The main limitation of the work is the cross-sectional design. Conclusions Simplified BP screening approaches seem to have low misdiagnosis rates, and cardiovascular risk could be lower amongst missed cases than amongst consistent hypertension cases. Simplified BP screening approaches could be included in large screening programmes and busy clinics.","PeriodicalId":20368,"journal":{"name":"PLoS Medicine","volume":" ","pages":""},"PeriodicalIF":15.8,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44454997","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-03-15eCollection Date: 2022-03-01DOI: 10.1371/journal.pmed.1003940
Ali Mirzazadeh, Ingrid Eshun-Wilson, Ryan R Thompson, Atousa Bonyani, James G Kahn, Stefan D Baral, Sheree Schwartz, George Rutherford, Elvin H Geng
<p><strong>Background: </strong>Optimizing services to facilitate engagement and retention in care of people living with HIV (PLWH) on antiretroviral therapies (ARTs) is critical to decrease HIV-related morbidity and mortality and HIV transmission. We systematically reviewed the literature for the effectiveness of implementation strategies to reestablish and subsequently retain clinical contact, improve viral load suppression, and reduce mortality among patients who had been lost to follow-up (LTFU) from HIV services.</p><p><strong>Methods and findings: </strong>We searched 7 databases (PubMed, Cochrane, ERIC, PsycINFO, EMBASE, Web of Science, and the WHO regional databases) and 3 conference abstract archives (CROI, IAC, and IAS) to find randomized trials and observational studies published through 13 April 2020. Eligible studies included those involving children and adults who were diagnosed with HIV, had initiated ART, and were subsequently lost to care and that reported at least one review outcome (return to care, retention, viral suppression, or mortality). Data were extracted by 2 reviewers, with discrepancies resolved by a third. We characterized reengagement strategies according to how, where, and by whom tracing was conducted. We explored effects, first, among all categorized as LTFU from the HIV program (reengagement program effect) and second among those found to be alive and out of care (reengagement contact outcome). We used random-effect models for meta-analysis and conducted subgroup analyses to explore heterogeneity. Searches yielded 4,244 titles, resulting in 37 included studies (6 randomized trials and 31 observational studies). In low- and middle-income countries (LMICs) (N = 16), tracing most frequently involved identification of LTFU from the electronic medical record (EMR) and paper records followed by a combination of telephone calls and field tracing (including home visits), by a team of outreach workers within 3 months of becoming LTFU (N = 7), with few incorporating additional strategies to support reengagement beyond contact (N = 2). In high-income countries (HICs) (N = 21 studies), LTFU were similarly identified through EMR systems, at times matched with other public health records (N = 4), followed by telephone calls and letters sent by mail or email and conducted by outreach specialist teams. Home visits were less common (N = 7) than in LMICs, and additional reengagement support was similarly infrequent (N = 5). Overall, reengagement programs were able to return 39% (95% CI: 31% to 47%) of all patients who were characterized as LTFU (n = 29). Reengagement contact resulted in 58% (95% CI: 51% to 65%) return among those found to be alive and out of care (N = 17). In 9 studies that had a control condition, the return was higher among those in the reengagement intervention group than the standard of care group (RR: 1.20 (95% CI: 1.08 to 1.32, P < 0.001). There were insufficient data to generate pooled estimates of retenti
{"title":"Interventions to reengage people living with HIV who are lost to follow-up from HIV treatment programs: A systematic review and meta-analysis.","authors":"Ali Mirzazadeh, Ingrid Eshun-Wilson, Ryan R Thompson, Atousa Bonyani, James G Kahn, Stefan D Baral, Sheree Schwartz, George Rutherford, Elvin H Geng","doi":"10.1371/journal.pmed.1003940","DOIUrl":"10.1371/journal.pmed.1003940","url":null,"abstract":"<p><strong>Background: </strong>Optimizing services to facilitate engagement and retention in care of people living with HIV (PLWH) on antiretroviral therapies (ARTs) is critical to decrease HIV-related morbidity and mortality and HIV transmission. We systematically reviewed the literature for the effectiveness of implementation strategies to reestablish and subsequently retain clinical contact, improve viral load suppression, and reduce mortality among patients who had been lost to follow-up (LTFU) from HIV services.</p><p><strong>Methods and findings: </strong>We searched 7 databases (PubMed, Cochrane, ERIC, PsycINFO, EMBASE, Web of Science, and the WHO regional databases) and 3 conference abstract archives (CROI, IAC, and IAS) to find randomized trials and observational studies published through 13 April 2020. Eligible studies included those involving children and adults who were diagnosed with HIV, had initiated ART, and were subsequently lost to care and that reported at least one review outcome (return to care, retention, viral suppression, or mortality). Data were extracted by 2 reviewers, with discrepancies resolved by a third. We characterized reengagement strategies according to how, where, and by whom tracing was conducted. We explored effects, first, among all categorized as LTFU from the HIV program (reengagement program effect) and second among those found to be alive and out of care (reengagement contact outcome). We used random-effect models for meta-analysis and conducted subgroup analyses to explore heterogeneity. Searches yielded 4,244 titles, resulting in 37 included studies (6 randomized trials and 31 observational studies). In low- and middle-income countries (LMICs) (N = 16), tracing most frequently involved identification of LTFU from the electronic medical record (EMR) and paper records followed by a combination of telephone calls and field tracing (including home visits), by a team of outreach workers within 3 months of becoming LTFU (N = 7), with few incorporating additional strategies to support reengagement beyond contact (N = 2). In high-income countries (HICs) (N = 21 studies), LTFU were similarly identified through EMR systems, at times matched with other public health records (N = 4), followed by telephone calls and letters sent by mail or email and conducted by outreach specialist teams. Home visits were less common (N = 7) than in LMICs, and additional reengagement support was similarly infrequent (N = 5). Overall, reengagement programs were able to return 39% (95% CI: 31% to 47%) of all patients who were characterized as LTFU (n = 29). Reengagement contact resulted in 58% (95% CI: 51% to 65%) return among those found to be alive and out of care (N = 17). In 9 studies that had a control condition, the return was higher among those in the reengagement intervention group than the standard of care group (RR: 1.20 (95% CI: 1.08 to 1.32, P < 0.001). There were insufficient data to generate pooled estimates of retenti","PeriodicalId":20368,"journal":{"name":"PLoS Medicine","volume":"19 1","pages":"e1003940"},"PeriodicalIF":10.5,"publicationDate":"2022-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8923443/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66770058","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-03-15eCollection Date: 2022-03-01DOI: 10.1371/journal.pmed.1003946
Massimiliano Orri, Marilyn N Ahun, Sara Naicker, Sahba Besharati, Linda M Richter
Background: Although early life factors are associated with increased suicide risk in youth, there is a dearth of research on these associations for individuals growing up in disadvantaged socioeconomic contexts, particularly in low- and middle-income countries (LMICs). We documented the association between individual, familial, and environmental factors in childhood with suicidal ideation among South African youth.
Methods and findings: We used data from 2,020 participants in the Birth to Twenty Plus (Bt20+) study, a South African cohort following children born in Soweto, Johannesburg from birth (1990) to age 28 years (2018). Suicidal ideation was self-reported at ages 14, 17, 22, and 28 years, and the primary outcome of interest was suicidal ideation reported at any age. We assessed individual, familial, and socioeconomic characteristics at childbirth and during infancy, adverse childhood experiences (ACEs) between ages 5 and 13 years, and externalizing and internalizing problems between 5 and 10 years. We estimated odds ratios (ORs) of suicidal ideation for individuals exposed to selected childhood factors using logistic regression. Lifetime suicidal ideation was reported by 469 (23.2%) participants, with a 1.7:1 female/male ratio. Suicidal ideation rates peaked at age 17 and decreased thereafter. Socioeconomic adversity, low birth weight, higher birth order (i.e., increase in the order of birth in the family: first, second, third, fourth, or later born child), ACEs, and childhood externalizing problems were associated with suicidal ideation, differently patterned among males and females. Socioeconomic adversity (OR 1.13, CI 1.01 to 1.27, P = 0.031) was significantly associated with suicidal ideation among males only, while birth weight (OR 1.20, CI 1.02 to 1.41, P = 0.03), ACEs (OR 1.11, CI 1.01 to 1.21, P = 0.030), and higher birth order (OR 1.15, CI 1.07 to 1.243, P < 0.001) were significantly associated with suicidal ideation among females only. Externalizing problems in childhood were significantly associated with suicidal ideation among both males (OR 1.23, 1.08 to 1.40, P = 0.002) and females (OR 1.16, CI 1.03 to 1.30, P = 0.011). Main limitations of the study are the high attrition rate (62% of the original sample was included in this analysis) and the heterogeneity in the measurements of suicidal ideation.
Conclusions: In this study from South Africa, we observed that early life social and environmental adversities as well as childhood externalizing problems are associated with increased risk of suicidal ideation during adolescence and early adulthood.
{"title":"Childhood factors associated with suicidal ideation among South African youth: A 28-year longitudinal study of the Birth to Twenty Plus cohort.","authors":"Massimiliano Orri, Marilyn N Ahun, Sara Naicker, Sahba Besharati, Linda M Richter","doi":"10.1371/journal.pmed.1003946","DOIUrl":"10.1371/journal.pmed.1003946","url":null,"abstract":"<p><strong>Background: </strong>Although early life factors are associated with increased suicide risk in youth, there is a dearth of research on these associations for individuals growing up in disadvantaged socioeconomic contexts, particularly in low- and middle-income countries (LMICs). We documented the association between individual, familial, and environmental factors in childhood with suicidal ideation among South African youth.</p><p><strong>Methods and findings: </strong>We used data from 2,020 participants in the Birth to Twenty Plus (Bt20+) study, a South African cohort following children born in Soweto, Johannesburg from birth (1990) to age 28 years (2018). Suicidal ideation was self-reported at ages 14, 17, 22, and 28 years, and the primary outcome of interest was suicidal ideation reported at any age. We assessed individual, familial, and socioeconomic characteristics at childbirth and during infancy, adverse childhood experiences (ACEs) between ages 5 and 13 years, and externalizing and internalizing problems between 5 and 10 years. We estimated odds ratios (ORs) of suicidal ideation for individuals exposed to selected childhood factors using logistic regression. Lifetime suicidal ideation was reported by 469 (23.2%) participants, with a 1.7:1 female/male ratio. Suicidal ideation rates peaked at age 17 and decreased thereafter. Socioeconomic adversity, low birth weight, higher birth order (i.e., increase in the order of birth in the family: first, second, third, fourth, or later born child), ACEs, and childhood externalizing problems were associated with suicidal ideation, differently patterned among males and females. Socioeconomic adversity (OR 1.13, CI 1.01 to 1.27, P = 0.031) was significantly associated with suicidal ideation among males only, while birth weight (OR 1.20, CI 1.02 to 1.41, P = 0.03), ACEs (OR 1.11, CI 1.01 to 1.21, P = 0.030), and higher birth order (OR 1.15, CI 1.07 to 1.243, P < 0.001) were significantly associated with suicidal ideation among females only. Externalizing problems in childhood were significantly associated with suicidal ideation among both males (OR 1.23, 1.08 to 1.40, P = 0.002) and females (OR 1.16, CI 1.03 to 1.30, P = 0.011). Main limitations of the study are the high attrition rate (62% of the original sample was included in this analysis) and the heterogeneity in the measurements of suicidal ideation.</p><p><strong>Conclusions: </strong>In this study from South Africa, we observed that early life social and environmental adversities as well as childhood externalizing problems are associated with increased risk of suicidal ideation during adolescence and early adulthood.</p>","PeriodicalId":20368,"journal":{"name":"PLoS Medicine","volume":" ","pages":"e1003946"},"PeriodicalIF":10.5,"publicationDate":"2022-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8923476/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48345628","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-03-01DOI: 10.1371/journal.pmed.1003947
Y. Wei, Cheng Chen, Motomori O Lewis, S. Schmidt, A. Winterstein
Background Despite the rising number of older adults with medical encounters for opioid misuse, dependence, and poisoning, little is known about patterns of prescription opioid dose and their association with risk for opioid-related adverse events (ORAEs) in older patients. The study aims to compare trajectories of prescribed opioid doses in 6 months preceding an incident ORAE for cases and a matched control group of older patients with chronic noncancer pain (CNCP). Methods and findings We conducted a nested case–control study within a cohort of older (≥65 years) patients diagnosed with CNCP who were new users of prescription opioids, assembled using a 5% national random sample of Medicare beneficiaries from 2011 to 2018. From the cohort with a mean follow-up of 2.3 years, we identified 3,103 incident ORAE cases with ≥1 opioid prescription in 6 months preceding the event, and 3,103 controls matched on sex, age, and time since opioid initiation. Key exposure was trajectories of prescribed opioid morphine milligram equivalent (MME) daily dosage over 6 months before the incident ORAE or matched controls. Among the cases and controls, 2,192 (70.6%) were women, and the mean (SD) age was 77.1 (7.1) years. Four prescribed opioid trajectories before the incident ORAE diagnosis or matched date emerged: gradual dose discontinuation (from ≤3 to 0 daily MME, 1,456 [23.5%]), gradual dose increase (from 0 to >3 daily MME, 1,878 [30.3%]), consistent low dose (between 3 and 5 daily MME, 1,510 [24.3%]), and consistent moderate dose (>20 daily MME, 1,362 [22.0%]). Few older patients (<5%) were prescribed a mean daily dose of ≥90 daily MME during 6 months before diagnosis or matched date. Patients with gradual dose discontinuation versus those with a consistent low dose, moderate dose, and increase dose were more likely to be younger (65 to 74 years), Midwest US residents, and receiving no low-income subsidy. Compared to patients with gradual dose discontinuation, those with gradual dose increase (adjusted odds ratio [aOR] = 3.4; 95% confidence interval (CI) 2.8 to 4.0; P < 0.001), consistent low dose (aOR = 3.8; 95% CI 3.2 to 4.6; P < 0.001), and consistent moderate dose (aOR = 8.5; 95% CI 6.8 to 10.7; P < 0.001) had a higher risk of ORAE, after adjustment for covariates. Our main findings remained robust in the sensitivity analysis using a cohort study with inverse probability of treatment weighting analyses. Major limitations include the limited generalizability of the study findings and lack of information on illicit opioid use, which prevents understanding the clinical dose threshold level that increases the risk of ORAE in older adults. Conclusions In this sample of older patients who are Medicare beneficiaries, 4 prescription opioid dose trajectories were identified, with most prescribed doses below 90 daily MME within 6 months before ORAE or matched date. An increased risk for ORAE was observed among older patients with a gradual increase in dose or among
{"title":"Trajectories of prescription opioid dose and risk of opioid-related adverse events among older Medicare beneficiaries in the United States: A nested case–control study","authors":"Y. Wei, Cheng Chen, Motomori O Lewis, S. Schmidt, A. Winterstein","doi":"10.1371/journal.pmed.1003947","DOIUrl":"https://doi.org/10.1371/journal.pmed.1003947","url":null,"abstract":"Background Despite the rising number of older adults with medical encounters for opioid misuse, dependence, and poisoning, little is known about patterns of prescription opioid dose and their association with risk for opioid-related adverse events (ORAEs) in older patients. The study aims to compare trajectories of prescribed opioid doses in 6 months preceding an incident ORAE for cases and a matched control group of older patients with chronic noncancer pain (CNCP). Methods and findings We conducted a nested case–control study within a cohort of older (≥65 years) patients diagnosed with CNCP who were new users of prescription opioids, assembled using a 5% national random sample of Medicare beneficiaries from 2011 to 2018. From the cohort with a mean follow-up of 2.3 years, we identified 3,103 incident ORAE cases with ≥1 opioid prescription in 6 months preceding the event, and 3,103 controls matched on sex, age, and time since opioid initiation. Key exposure was trajectories of prescribed opioid morphine milligram equivalent (MME) daily dosage over 6 months before the incident ORAE or matched controls. Among the cases and controls, 2,192 (70.6%) were women, and the mean (SD) age was 77.1 (7.1) years. Four prescribed opioid trajectories before the incident ORAE diagnosis or matched date emerged: gradual dose discontinuation (from ≤3 to 0 daily MME, 1,456 [23.5%]), gradual dose increase (from 0 to >3 daily MME, 1,878 [30.3%]), consistent low dose (between 3 and 5 daily MME, 1,510 [24.3%]), and consistent moderate dose (>20 daily MME, 1,362 [22.0%]). Few older patients (<5%) were prescribed a mean daily dose of ≥90 daily MME during 6 months before diagnosis or matched date. Patients with gradual dose discontinuation versus those with a consistent low dose, moderate dose, and increase dose were more likely to be younger (65 to 74 years), Midwest US residents, and receiving no low-income subsidy. Compared to patients with gradual dose discontinuation, those with gradual dose increase (adjusted odds ratio [aOR] = 3.4; 95% confidence interval (CI) 2.8 to 4.0; P < 0.001), consistent low dose (aOR = 3.8; 95% CI 3.2 to 4.6; P < 0.001), and consistent moderate dose (aOR = 8.5; 95% CI 6.8 to 10.7; P < 0.001) had a higher risk of ORAE, after adjustment for covariates. Our main findings remained robust in the sensitivity analysis using a cohort study with inverse probability of treatment weighting analyses. Major limitations include the limited generalizability of the study findings and lack of information on illicit opioid use, which prevents understanding the clinical dose threshold level that increases the risk of ORAE in older adults. Conclusions In this sample of older patients who are Medicare beneficiaries, 4 prescription opioid dose trajectories were identified, with most prescribed doses below 90 daily MME within 6 months before ORAE or matched date. An increased risk for ORAE was observed among older patients with a gradual increase in dose or among ","PeriodicalId":20368,"journal":{"name":"PLoS Medicine","volume":" ","pages":""},"PeriodicalIF":15.8,"publicationDate":"2022-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45834993","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-03-01DOI: 10.1371/journal.pmed.1003942
A. Heshmatollah, Yuan Ma, L. Fani, P. Koudstaal, M. A. Ikram, M. Ikram
Background Apart from blood pressure level itself, variation in blood pressure has been implicated in the development of stroke in subgroups at high cardiovascular risk. We determined the association between visit-to-visit blood pressure variability and stroke risk in the general population, taking into account the size and direction of variation and several time intervals prior to stroke diagnosis. Methods and findings From 1990 to 2016, we included 9,958 stroke-free participants of the population-based Rotterdam Study in the Netherlands. This is a prospective cohort study including participants aged 45 years and older. Systolic blood pressure (SBP) variability was calculated as absolute SBP difference divided by mean SBP over 2 sequential visits (median 4.6 years apart). Directional SBP variability was defined as SBP difference over 2 visits divided by mean SBP. Using time-varying Cox proportional hazards models adjusted for age, sex, mean SBP, and cardiovascular risk factors, hazard ratios (HRs) for stroke up to January 2016 were estimated per SD increase and in tertiles of variability. We also conducted analyses with 3-, 6-, and 9-year intervals between variability measurement and stroke assessment. These analyses were repeated for diastolic blood pressure (DBP). The mean age of the study population was 67.4 ± 8.2 years and 5,776 (58.0%) were women. During a median follow-up of 10.1 years, 971 (9.8%) participants had a stroke, including 641 ischemic, 89 hemorrhagic, and 241 unspecified strokes. SBP variability was associated with an increased risk of hemorrhagic stroke (HR per SD 1.27, 95% CI 1.05–1.54, p = 0.02) and unspecified stroke (HR per SD 1.21, 95% CI 1.09–1.34, p < 0.001). The associations were stronger for all stroke subtypes with longer time intervals; the HR for any stroke was 1.29 (95% CI 1.21–1.36, p < 0.001) at 3 years, 1.47 (95% CI 1.35–1.59, p < 0.001) at 6 years, and 1.38 (95%CI 1.24–1.51, p < 0.001) at 9 years. For DBP variability, we found an association with unspecified stroke risk. Both the rise and fall of SBP and the fall of DBP were associated with an increased risk for unspecified stroke. Limitations of the study include that, due to an average interval of 4 years between visits, our findings may not be generalizable to blood pressure variability over shorter periods. Conclusions In this population-based study, we found that visit-to-visit blood pressure variation was associated with an increased risk of unspecified and hemorrhagic stroke, independent of direction of variation or mean blood pressure.
{"title":"Visit-to-visit blood pressure variability and the risk of stroke in the Netherlands: A population-based cohort study","authors":"A. Heshmatollah, Yuan Ma, L. Fani, P. Koudstaal, M. A. Ikram, M. Ikram","doi":"10.1371/journal.pmed.1003942","DOIUrl":"https://doi.org/10.1371/journal.pmed.1003942","url":null,"abstract":"Background Apart from blood pressure level itself, variation in blood pressure has been implicated in the development of stroke in subgroups at high cardiovascular risk. We determined the association between visit-to-visit blood pressure variability and stroke risk in the general population, taking into account the size and direction of variation and several time intervals prior to stroke diagnosis. Methods and findings From 1990 to 2016, we included 9,958 stroke-free participants of the population-based Rotterdam Study in the Netherlands. This is a prospective cohort study including participants aged 45 years and older. Systolic blood pressure (SBP) variability was calculated as absolute SBP difference divided by mean SBP over 2 sequential visits (median 4.6 years apart). Directional SBP variability was defined as SBP difference over 2 visits divided by mean SBP. Using time-varying Cox proportional hazards models adjusted for age, sex, mean SBP, and cardiovascular risk factors, hazard ratios (HRs) for stroke up to January 2016 were estimated per SD increase and in tertiles of variability. We also conducted analyses with 3-, 6-, and 9-year intervals between variability measurement and stroke assessment. These analyses were repeated for diastolic blood pressure (DBP). The mean age of the study population was 67.4 ± 8.2 years and 5,776 (58.0%) were women. During a median follow-up of 10.1 years, 971 (9.8%) participants had a stroke, including 641 ischemic, 89 hemorrhagic, and 241 unspecified strokes. SBP variability was associated with an increased risk of hemorrhagic stroke (HR per SD 1.27, 95% CI 1.05–1.54, p = 0.02) and unspecified stroke (HR per SD 1.21, 95% CI 1.09–1.34, p < 0.001). The associations were stronger for all stroke subtypes with longer time intervals; the HR for any stroke was 1.29 (95% CI 1.21–1.36, p < 0.001) at 3 years, 1.47 (95% CI 1.35–1.59, p < 0.001) at 6 years, and 1.38 (95%CI 1.24–1.51, p < 0.001) at 9 years. For DBP variability, we found an association with unspecified stroke risk. Both the rise and fall of SBP and the fall of DBP were associated with an increased risk for unspecified stroke. Limitations of the study include that, due to an average interval of 4 years between visits, our findings may not be generalizable to blood pressure variability over shorter periods. Conclusions In this population-based study, we found that visit-to-visit blood pressure variation was associated with an increased risk of unspecified and hemorrhagic stroke, independent of direction of variation or mean blood pressure.","PeriodicalId":20368,"journal":{"name":"PLoS Medicine","volume":" ","pages":""},"PeriodicalIF":15.8,"publicationDate":"2022-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46234618","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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