Systematic reviews of diagnostic test accuracy (DTA) studies are fundamental to the decision making process in evidence based medicine. Although such studies are regarded as high level evidence, ...these reviews are not always reported completely and transparently. Suboptimal reporting of DTA systematic reviews compromises their validity and generalisability, and subsequently their value to key stakeholders. An extension of the PRISMA (preferred reporting items for systematic review and meta-analysis) statement was recently developed to improve the reporting quality of DTA systematic reviews. The PRISMA-DTA statement has 27 items, of which eight are unmodified from the original PRISMA statement. This article provides an explanation for the 19 new and modified items, along with their meaning and rationale. Examples of complete reporting are used for each item to illustrate best practices.
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BFBNIB, CMK, NMLJ, NUK, PNG, SAZU, UL, UM, UPUK
Depression symptom questionnaires are commonly used to assess symptom severity and as screening tools to identify patients who may have depression. They are not designed to ascertain diagnostic ...status and, based on published sensitivity and specificity estimates, would theoretically be expected to overestimate prevalence. Meta-analyses sometimes estimate depression prevalence based on primary studies that used screening tools or rating scales rather than validated diagnostic interviews. Our objectives were to determine classification methods used in primary studies included in depression prevalence meta-analyses, if pooled prevalence differs by primary study classification methods as would be predicted, whether meta-analysis abstracts accurately describe primary study classification methods, and how meta-analyses describe prevalence estimates in abstracts.
We searched PubMed (January 2008-December 2017) for meta-analyses that reported pooled depression prevalence in the abstract. For each meta-analysis, we included up to one pooled prevalence for each of three depression classification method categories: (1) diagnostic interviews only, (2) screening or rating tools, and (3) a combination of methods.
In 69 included meta-analyses (81 prevalence estimates), eight prevalence estimates (10%) were based on diagnostic interviews, 36 (44%) on screening or rating tools, and 37 (46%) on combinations. Prevalence was 31% based on screening or rating tools, 22% for combinations, and 17% for diagnostic interviews. Among 2094 primary studies in 81 pooled prevalence estimates, 277 (13%) used validated diagnostic interviews, 1604 (77%) used screening or rating tools, and 213 (10%) used other methods (e.g., unstructured interviews, medical records). Classification methods pooled were accurately described in meta-analysis abstracts for 17 of 81 (21%) prevalence estimates. In 73 meta-analyses based on screening or rating tools or on combined methods, 52 (71%) described the prevalence as being for "depression" or "depressive disorders." Results were similar for meta-analyses in journals with impact factor ≥ 10.
Most meta-analyses combined estimates from studies that used screening tools or rating scales instead of diagnostic interviews, did not disclose this in abstracts, and described the prevalence as being for "depression" or "depressive disorders " even though disorders were not assessed. Users of meta-analyses of depression prevalence should be cautious when interpreting results because reported prevalence may exceed actual prevalence.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
ObjectivesTo support the Zika virus (ZIKV) Individual Participant Data (IPD) Consortium’s efforts to harmonise and analyse IPD from ZIKV-related prospective cohort studies and surveillance-based ...studies of pregnant women and their infants and children; we developed and disseminated a metadata survey among ZIKV-IPD Meta-Analysis (MA) study participants to identify and provide a comprehensive overview of study-level heterogeneity in exposure, outcome and covariate ascertainment and definitions.SettingCohort and surveillance studies that measured ZIKV infection during pregnancy or at birth and measured fetal, infant, or child outcomes were identified through a systematic search and consultations with ZIKV researchers and Ministries of Health from 20 countries or territories.ParticipantsFifty-four cohort or active surveillance studies shared deidentified data for the IPD-MA and completed the metadata survey, representing 33 061 women (11 020 with ZIKV) and 18 281 children.Primary and secondary outcome measuresStudy-level heterogeneity in exposure, outcome and covariate ascertainment and definitions.ResultsMedian study sample size was 268 (IQR=100, 698). Inclusion criteria, follow-up procedures and exposure and outcome ascertainment were highly heterogenous, differing meaningfully across regions and multisite studies. Enrolment duration and follow-up for children after birth varied before and after the declaration of the Public Health Emergency of International Concern (PHEIC) and according to the type of funding received.ConclusionThis work highlights the logistic and statistical challenges that must be addressed to account for the multiple sources of within-study and between-study heterogeneity when conducting IPD-MAs of data collected in the research response to emergent pathogens like ZIKV.
Anxiety and post-traumatic stress disorder (PTSD) contribute significantly to disability adjusted life years in low- to middle-income countries (LMICs). Screening has been proposed to improve ...identification and management of these disorders, but little is known about the validity of screening tools for these disorders. We conducted a systematic review of validated screening tools for detecting anxiety and PTSD in LMICs.
MEDLINE, EMBASE, Global Health and PsychINFO were searched (inception-April 22, 2020). Eligible studies (1) screened for anxiety disorders and/or PTSD; (2) reported sensitivity and specificity for a given cut-off value; (3) were conducted in LMICs; and (4) compared screening results to diagnostic classifications based on a reference standard. Screening tool, cut-off, disorder, region, country, and clinical population were extracted for each study, and we assessed study quality. Accuracy results were organized based on screening tool, cut-off, and specific disorder. Accuracy estimates for the same cut-off for the same screening tool and disorder were combined via meta-analysis.
Of 6322 unique citations identified, 58 articles including 77 screening tools were included. There were 46, 19 and 12 validations for anxiety, PTSD, and combined depression and anxiety, respectively. Continentally, Asia had the most validations (35). Regionally, South Asia (11) had the most validations, followed by South Africa (10) and West Asia (9). The Kessler-10 (7) and the Generalized Anxiety Disorder-7 item scale (GAD-7) (6) were the most commonly validated tools for anxiety disorders, while the Harvard Trauma Questionnaire (3) and Posttraumatic Diagnostic Scale (3) were the most commonly validated tools for PTSD. Most studies (29) had the lowest quality rating (unblinded). Due to incomplete reporting, we could meta-analyze results from only two studies, which involved the GAD-7 (cut-off ≥10, pooled sensitivity = 76%, pooled specificity = 64%).
Use of brief screening instruments can bring much needed attention and research opportunities to various at-risk LMIC populations. However, many have been validated in inadequately designed studies, precluding any general recommendation for specific tools in LMICs. Locally validated screening tools for anxiety and PTSD need further evaluation in well-designed studies to assess whether they can improve the detection and management of these common disorders.
PROSPERO registry number CRD42019121794 .
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Individual participant data meta-analyses (IPD-MAs), which involve harmonising and analysing participant-level data from related studies, provide several advantages over aggregate data meta-analyses, ...which pool study-level findings. IPD-MAs are especially important for building and evaluating diagnostic and prognostic models, making them an important tool for informing the research and public health responses to COVID-19.
We conducted a rapid systematic review of protocols and publications from planned, ongoing, or completed COVID-19-related IPD-MAs to identify areas of overlap and maximise data request and harmonisation efforts. We searched four databases using a combination of text and MeSH terms. Two independent reviewers determined eligibility at the title-abstract and full-text stages. Data were extracted by one reviewer into a pretested data extraction form and subsequently reviewed by a second reviewer. Data were analysed using a narrative synthesis approach. A formal risk of bias assessment was not conducted.
We identified 31 COVID-19-related IPD-MAs, including five living IPD-MAs and ten IPD-MAs that limited their inference to published data (e.g., case reports). We found overlap in study designs, populations, exposures, and outcomes of interest. For example, 26 IPD-MAs included RCTs; 17 IPD-MAs were limited to hospitalised patients. Sixteen IPD-MAs focused on evaluating medical treatments, including six IPD-MAs for antivirals, four on antibodies, and two that evaluated convalescent plasma.
Collaboration across related IPD-MAs can leverage limited resources and expertise by expediting the creation of cross-study participant-level data datasets, which can, in turn, fast-track evidence synthesis for the improved diagnosis and treatment of COVID-19.
10.17605/OSF.IO/93GF2.
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CEKLJ, DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
To systematically review evidence on depression screening in coronary heart disease (CHD) by assessing the (1) accuracy of screening tools; (2) effectiveness of treatment; and (3) effect of screening ...on depression outcomes.
A 2008 American Heart Association (AHA) Science Advisory recommended routine depression screening in CHD.
CINAHL, Cochrane, EMBASE, ISI, MEDLINE, PsycINFO and SCOPUS databases searched through December 2, 2011; manual journal searches; reference lists; citation tracking; trial registries. Included articles (1) compared a depression screening instrument to a depression diagnosis; (2) compared depression treatment to placebo or usual care in a randomized controlled trial (RCT); or (3) assessed the effect of screening on depression outcomes in a RCT.
There were few examples of screening tools with good sensitivity and specificity using a priori-defined cutoffs in more than one patient sample among 15 screening accuracy studies. Depression treatment with antidepressants or psychotherapy generated modest symptom reductions among post-myocardial infarction (post-MI) and stable CHD patients (N = 6; effect size = 0.20-0.38), but antidepressants did not improve symptoms more than placebo in 2 heart failure (HF) trials. Depression treatment did not improve cardiac outcomes. No RCTs investigated the effects of screening on depression outcomes.
There is evidence that treatment of depression results in modest improvement in depressive symptoms in post-MI and stable CHD patients, although not in HF patients. There is still no evidence that routine screening for depression improves depression or cardiac outcomes. The AHA Science Advisory on depression screening should be revised to reflect this lack of evidence.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
More people with rare diseases likely receive disease education and emotional and practical support from peer-led support groups than any other way. Most rare-disease support groups are delivered ...outside of the health care system by untrained leaders. Potential benefits may not be achieved and harms, such as dissemination of inaccurate information, may occur. Our primary objective was to evaluate the effects of a rare-disease support group leader education program, which was developed collaboratively by researchers, peer support group leaders, and patient organization leaders, compared to waitlist control, on peer leader self-efficacy among scleroderma support group leaders. The trial was a pragmatic, two-arm partially nested randomised controlled trial with 1:1 allocation into intervention or waitlist control. Eligible participants were existing or candidate peer support group leaders affiliated with a scleroderma patient organization. Leader training was delivered in groups of 5-6 participants weekly for 13 weeks in 60-90 min sessions via the GoToMeetingR videoconferencing platform. The program included 12 general leader training modules and one module specific to scleroderma. Primary outcome was leader self-efficacy, measured by the Support Group Leader Self-efficacy Scale (SGLSS) immediately post-intervention. Secondary outcomes were leader self-efficacy 3 months post-intervention; emotional distress, leader burnout, and volunteer satisfaction post-intervention and 3 months post-intervention; and program satisfaction among intervention participants post-intervention. One hundred forty-eight participants were randomised to intervention (N = 74) or waitlist (N = 74). Primary outcome data were provided by 146 (99%) participants. Mean number of sessions attended was 11.4 (standard deviation = 2.6). Mean program satisfaction score (CSQ-8) was 30.3 (standard deviation = 3.0; possible range 8-32). Compared to waitlist control, leader self-efficacy was higher post-intervention SGLSS; 16.7 points, 95% CI 11.0-22.3; standardized mean difference (SMD) 0.84 and 3 months later (15.6 points, 95% CI 10.2-21.0; SMD 0.73); leader volunteer satisfaction was significantly higher at both assessments, emotional distress was lower post-intervention but not 3 months later, and leader burnout was not significantly different at either assessment. Peer support group leader education improved leader self-efficacy substantially. The program could be easily adapted for support group leaders in other rare diseases.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
Abstract
Women and gender-diverse individuals have faced disproportionate socioeconomic burden during COVID-19. There have been reports of greater negative mental health changes compared to men based ...on cross-sectional research that has not accounted for pre-COVID-19 differences. We compared mental health changes from pre-COVID-19 to during COVID-19 by sex or gender. MEDLINE (Ovid), PsycINFO (Ovid), CINAHL (EBSCO), EMBASE (Ovid), Web of Science Core Collection: Citation Indexes, China National Knowledge Infrastructure, Wanfang, medRxiv (preprints), and Open Science Framework Preprints (preprint server aggregator) were searched to August 30, 2021. Eligible studies included mental health symptom change data by sex or gender. 12 studies (10 unique cohorts) were included, all of which reported dichotomized sex or gender data. 9 cohorts reported results from March to June 2020, and 2 of these also reported on September or November to December 2020. One cohort included data pre-November 2020 data but did not provide dates. Continuous symptom change differences were not statistically significant for depression (standardized mean difference SMD = 0.12, 95% CI -0.09–0.33; 4 studies, 4,475 participants; I
2
= 69.0%) and stress (SMD = − 0.10, 95% CI -0.21–0.01; 4 studies, 1,533 participants; I
2
= 0.0%), but anxiety (SMD = 0.15, 95% CI 0.07–0.22; 4 studies, 4,344 participants; I
2
= 3.0%) and general mental health (SMD = 0.15, 95% CI 0.12–0.18; 3 studies, 15,692 participants; I
2
= 0.0%) worsened more among females/women than males/men. There were no significant differences in changes in proportions above cut-offs: anxiety (difference = − 0.05, 95% CI − 0.20–0.11; 1 study, 217 participants), depression (difference = 0.12, 95% CI -0.03–0.28; 1 study, 217 participants), general mental health (difference = − 0.03, 95% CI − 0.09–0.04; 3 studies, 18,985 participants; I
2
= 94.0%), stress (difference = 0.04, 95% CI − 0.10–0.17; 1 study, 217 participants). Mental health outcomes did not differ or were worse by small amounts among women than men during early COVID-19.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
Transrectal ultrasound (TRUS) guided biopsy for prostate cancer is prone to random and systemic error and has been shown to have a negative predictive value of 70%. PRECISION and PRECISE are among ...the first randomised studies to evaluate the new MRI-targeted biopsy (MRI-TB) pathway with a non-paired design to detect clinically significant prostate cancer and avoid unnecessary treatment. The trials' results individually demonstrated non-inferiority of MRI-TB compared to TRUS biopsy. An individual patient data (IPD) meta-analysis was planned from the outset of the two trials in parallel and this IPD meta-analysis aims to further elucidate the utility of MRI-TB as the optimal diagnostic pathway for prostate cancer.
This study is registered on PROSPERO (CRD42021249263). A search of Medline, Embase, Cochrane Central Register of Registered Trials (CENTRAL), Web of Science, and ClinicalTrials.gov was performed up until 4th February 2021. Only randomised controlled trials (PRECISE, PRECISION and other eligible trials) comparing the MRI-targeted biopsy pathway and traditional TRUS biopsy pathway will be included. The primary outcome of the review is the proportion of men diagnosed with clinically significant prostate cancer in each arm (Gleason ≥ 3+4 = 7). IPD and study-level data and characteristics will be sought from eligible studies. Analyses will be done primarily using an intention-to-treat approach, and a one-step IPD meta-analysis will be performed using generalised linear mixed models. A non-inferiority margin of 5 percentage points will be used. Heterogeneity will be quantified using the variance parameters from the mixed model. If there is sufficient data, we will investigate heterogeneity by exploring the effect of the different conducts of MRIs, learning curves of MRI reporting and MRI targeted biopsies.
This systematic review is registered on PROSPERO (CRD42021249263).
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Abstract
Objectives
Optimal cutoff thresholds are selected to separate ‘positive’ from ‘negative’ screening results. We evaluated how depression screening tool studies select optimal cutoffs.
Methods
...We included studies from previously conducted meta‐analyses of Patient Health Questionnaire‐9, Edinburgh Postnatal Depression Scale, or Hospital Anxiety and Depression Scale—Depression accuracy. Outcomes included whether an optimal cutoff was selected, method used, recommendations made, and reporting guideline and protocol citation.
Results
Of 212 included studies, 172 (81%) attempted to identify an optimal cutoff, and 147 of these 172 (85%) reported one or more methods. Methods were heterogeneous with Youden's J (
N
= 35, 23%) most common. Only 23 of 147 (16%) studies described a rationale for their method. Rationales focused on balancing sensitivity and specificity without describing why desirable. 131 of 172 studies (76%) identified an optimal cutoff other than the standard; most did not make use recommendations (
N
= 56; 43%) or recommended using a non‐standard cutoff (
N
= 53; 40%). Only 4 studies cited a reporting guideline, and 4 described a protocol with optimal cutoff selection methods, but none used the protocol method in the published study.
Conclusions
Research is needed to guide how selection of cutoffs for depression screening tools can be standardized and reflect clinical considerations.
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DOBA, FZAB, GIS, IJS, IZUM, KILJ, NLZOH, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBMB, SIK, UILJ, UKNU, UL, UM, UPUK
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