Equivalency of the diagnostic accuracy of the PHQ-8 and PHQ-9: a systematic review and individual participant data meta-analysis.

BACKGROUND: Item 9 of the Patient Health Questionnaire-9 (PHQ-9) queries about thoughts of death and self-harm, but not suicidality. Although it is sometimes used to assess suicide risk, most positive responses are not associated with suicidality. The PHQ-8, which omits Item 9, is thus increasingly used in research. We assessed equivalency of total score correlations and the diagnostic accuracy to detect major depression of the PHQ-8 and PHQ-9. METHODS: We conducted an individual patient data meta-analysis. We fit bivariate random-effects models to assess diagnostic accuracy. RESULTS: 16 742 participants (2097 major depression cases) from 54 studies were included. The correlation between PHQ-8 and PHQ-9 scores was 0.996 (95% confidence interval 0.996 to 0.996). The standard cutoff score of 10 for the PHQ-9 maximized sensitivity + specificity for the PHQ-8 among studies that used a semi-structured diagnostic interview reference standard (N = 27). At cutoff 10, the PHQ-8 was less sensitive by 0.02 (-0.06 to 0.00) and more specific by 0.01 (0.00 to 0.01) among those studies (N = 27), with similar results for studies that used other types of interviews (N = 27). For all 54 primary studies combined, across all cutoffs, the PHQ-8 was less sensitive than the PHQ-9 by 0.00 to 0.05 (0.03 at cutoff 10), and specificity was within 0.01 for all cutoffs (0.00 to 0.01). CONCLUSIONS: PHQ-8 and PHQ-9 total scores were similar. Sensitivity may be minimally reduced with the PHQ-8, but specificity is similar.

The Accuracy of the Patient Health Questionnaire-9 Algorithm for Screening to Detect Major Depression: An Individual Participant Data Meta-Analysis.

BACKGROUND: Screening for major depression with the Patient Health Questionnaire-9 (PHQ-9) can be done using a cutoff or the PHQ-9 diagnostic algorithm. Many primary studies publish results for only one approach, and previous meta-analyses of the algorithm approach included only a subset of primary studies that collected data and could have published results. OBJECTIVE: To use an individual participant data meta-analysis to evaluate the accuracy of two PHQ-9 diagnostic algorithms for detecting major depression and compare accuracy between the algorithms and the standard PHQ-9 cutoff score of ≥10. METHODS: Medline, Medline In-Process and Other Non-Indexed Citations, PsycINFO, Web of Science (January 1, 2000, to February 7, 2015). Eligible studies that classified current major depression status using a validated diagnostic interview. RESULTS: Data were included for 54 of 72 identified eligible studies (n participants = 16,688, n cases = 2,091). Among studies that used a semi-structured interview, pooled sensitivity and specificity (95% confidence interval) were 0.57 (0.49, 0.64) and 0.95 (0.94, 0.97) for the original algorithm and 0.61 (0.54, 0.68) and 0.95 (0.93, 0.96) for a modified algorithm. Algorithm sensitivity was 0.22-0.24 lower compared to fully structured interviews and 0.06-0.07 lower compared to the Mini International Neuropsychiatric Interview. Specificity was similar across reference standards. For PHQ-9 cutoff of ≥10 compared to semi-structured interviews, sensitivity and specificity (95% confidence interval) were 0.88 (0.82-0.92) and 0.86 (0.82-0.88). CONCLUSIONS: The cutoff score approach appears to be a better option than a PHQ-9 algorithm for detecting major depression.

Overestimation of Postpartum Depression Prevalence Based on a 5-item Version of the EPDS: Systematic Review and Individual Participant Data Meta-analysis.

OBJECTIVE: The Maternal Mental Health in Canada, 2018/2019, survey reported that 18% of 7,085 mothers who recently gave birth reported "feelings consistent with postpartum depression" based on scores ≥7 on a 5-item version of the Edinburgh Postpartum Depression Scale (EPDS-5). The EPDS-5 was designed as a screening questionnaire, not to classify disorders or estimate prevalence; the extent to which EPDS-5 results reflect depression prevalence is unknown. We investigated EPDS-5 ≥7 performance relative to major depression prevalence based on a validated diagnostic interview, the Structured Clinical Interview for DSM (SCID). METHODS: We searched Medline, Medline In-Process & Other Non-Indexed Citations, PsycINFO, and the Web of Science Core Collection through June 2016 for studies with data sets with item response data to calculate EPDS-5 scores and that used the SCID to ascertain depression status. We conducted an individual participant data meta-analysis to estimate pooled percentage of EPDS-5 ≥7, pooled SCID major depression prevalence, and the pooled difference in prevalence. RESULTS: A total of 3,958 participants from 19 primary studies were included. Pooled prevalence of SCID major depression was 9.2% (95% confidence interval [CI] 6.0% to 13.7%), pooled percentage of participants with EPDS-5 ≥7 was 16.2% (95% CI 10.7% to 23.8%), and pooled difference was 8.0% (95% CI 2.9% to 13.2%). In the 19 included studies, mean and median ratios of EPDS-5 to SCID prevalence were 2.1 and 1.4 times. CONCLUSIONS: Prevalence estimated based on EPDS-5 ≥7 appears to be substantially higher than the prevalence of major depression. Validated diagnostic interviews should be used to establish prevalence.

Accuracy of the PHQ-2 Alone and in Combination With the PHQ-9 for Screening to Detect Major Depression: Systematic Review and Meta-analysis.

Importance: The Patient Health Questionnaire depression module (PHQ-9) is a 9-item self-administered instrument used for detecting depression and assessing severity of depression. The Patient Health Questionnaire-2 (PHQ-2) consists of the first 2 items of the PHQ-9 (which assess the frequency of depressed mood and anhedonia) and can be used as a first step to identify patients for evaluation with the full PHQ-9. Objective: To estimate PHQ-2 accuracy alone and combined with the PHQ-9 for detecting major depression. Data Sources: MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, PsycINFO, and Web of Science (January 2000-May 2018). Study Selection: Eligible data sets compared PHQ-2 scores with major depression diagnoses from a validated diagnostic interview. Data Extraction and Synthesis: Individual participant data were synthesized with bivariate random-effects meta-analysis to estimate pooled sensitivity and specificity of the PHQ-2 alone among studies using semistructured, fully structured, or Mini International Neuropsychiatric Interview (MINI) diagnostic interviews separately and in combination with the PHQ-9 vs the PHQ-9 alone for studies that used semistructured interviews. The PHQ-2 score ranges from 0 to 6, and the PHQ-9 score ranges from 0 to 27. Results: Individual participant data were obtained from 100 of 136 eligible studies (44 318 participants; 4572 with major depression [10%]; mean [SD] age, 49 [17] years; 59% female). Among studies that used semistructured interviews, PHQ-2 sensitivity and specificity (95% CI) were 0.91 (0.88-0.94) and 0.67 (0.64-0.71) for cutoff scores of 2 or greater and 0.72 (0.67-0.77) and 0.85 (0.83-0.87) for cutoff scores of 3 or greater. Sensitivity was significantly greater for semistructured vs fully structured interviews. Specificity was not significantly different across the types of interviews. The area under the receiver operating characteristic curve was 0.88 (0.86-0.89) for semistructured interviews, 0.82 (0.81-0.84) for fully structured interviews, and 0.87 (0.85-0.88) for the MINI. There were no significant subgroup differences. For semistructured interviews, sensitivity for PHQ-2 scores of 2 or greater followed by PHQ-9 scores of 10 or greater (0.82 [0.76-0.86]) was not significantly different than PHQ-9 scores of 10 or greater alone (0.86 [0.80-0.90]); specificity for the combination was significantly but minimally higher (0.87 [0.84-0.89] vs 0.85 [0.82-0.87]). The area under the curve was 0.90 (0.89-0.91). The combination was estimated to reduce the number of participants needing to complete the full PHQ-9 by 57% (56%-58%). Conclusions and Relevance: In an individual participant data meta-analysis of studies that compared PHQ scores with major depression diagnoses, the combination of PHQ-2 (with cutoff ≥2) followed by PHQ-9 (with cutoff ≥10) had similar sensitivity but higher specificity compared with PHQ-9 cutoff scores of 10 or greater alone. Further research is needed to understand the clinical and research value of this combined approach to screening.

Apparent diffusion coefficient of different areas of brain in foetuses with intrauterine growth restriction.

PURPOSE: This study aimed to compare the apparent diffusion coefficient (ADC) values of different brain areas between two groups of intrauterine growth restricted (IUGR) foetuses and control cases. MATERIAL AND METHODS: A total of 38 foetuses with IUGR and 18 normal control foetuses with similar gestational age were compared using a 3T magnetic resonance scanner. IUGR cases included 23 foetuses with clinical severity signs (group A) and 15 foetuses without clinical severity signs (group B). ADC values were measured in different brain regions and compared among groups. Foetuses with structural brain abnormalities were excluded from the study. RESULTS: All foetuses had normal foetal structural brain anatomy. Head circumference (HC) < 5% was more common in IUGR group A compared to IUGR group B (56.5% vs. 13.3%, p < 0.0001). In comparison to the normal group, the ADC values in IUGR foetuses were significantly lower in cerebellar hemispheres (CH) (1.239 vs. 1.280.5 × 10-3 mm2/s, p = 0.045), thalami (1.205 vs. 1.285 × 10-3 mm2/s, p = 0.031) and caudate nucleus (CN) (1.319 vs. 1.394 × 10-3 mm2/s, p = 0.04). However, there were no significant differences in ADC values between IUGR subtypes. Among all brain regions, pons had the lowest ADC values. CONCLUSIONS: ADC values of thalami, CN, and CH were significantly lower in IUGR than control foetuses, while there was no significant difference among IUGR groups. Further studies are needed to evaluate the prognostic value of ADC changes in IUGR foetuses.

Shortening self-report mental health symptom measures through optimal test assembly methods: Development and validation of the Patient Health Questionnaire-Depression-4.

BACKGROUND: The objective of this study was to develop and validate a short form of the Patient Health Questionnaire-9 (PHQ-9), a self-report questionnaire for assessing depressive symptomatology, using objective criteria. METHODS: Responses on the PHQ-9 were obtained from 7,850 English-speaking participants enrolled in 20 primary diagnostic test accuracy studies. PHQ unidimensionality was verified using confirmatory factor analysis, and an item response theory model was fit. Optimal test assembly (OTA) methods identified a maximally precise short form for each possible length between one and eight items, including and excluding the ninth item. The final short form was selected based on prespecified validity, reliability, and diagnostic accuracy criteria. RESULTS: A four-item short form of the PHQ (PHQ-Dep-4) was selected. The PHQ-Dep-4 had a Cronbach's alpha of 0.805. Sensitivity and specificity of the PHQ-Dep-4 were 0.788 and 0.837, respectively, and were statistically equivalent to the PHQ-9 (sensitivity = 0.761, specificity = 0.866). The correlation of total scores with the full PHQ-9 was high (r = 0.919). CONCLUSION: The PHQ-Dep-4 is a valid short form with minimal loss of information of scores when compared to the full-length PHQ-9. Although OTA methods have been used to shorten patient-reported outcome measures based on objective, prespecified criteria, further studies are required to validate this general procedure for broader use in health research. Furthermore, due to unexamined heterogeneity, there is a need to replicate the results of this study in different patient populations.

Probability of major depression diagnostic classification using semi-structured versus fully structured diagnostic interviews.

BACKGROUND: Different diagnostic interviews are used as reference standards for major depression classification in research. Semi-structured interviews involve clinical judgement, whereas fully structured interviews are completely scripted. The Mini International Neuropsychiatric Interview (MINI), a brief fully structured interview, is also sometimes used. It is not known whether interview method is associated with probability of major depression classification.AimsTo evaluate the association between interview method and odds of major depression classification, controlling for depressive symptom scores and participant characteristics. METHOD: Data collected for an individual participant data meta-analysis of Patient Health Questionnaire-9 (PHQ-9) diagnostic accuracy were analysed and binomial generalised linear mixed models were fit. RESULTS: A total of 17 158 participants (2287 with major depression) from 57 primary studies were analysed. Among fully structured interviews, odds of major depression were higher for the MINI compared with the Composite International Diagnostic Interview (CIDI) (odds ratio (OR) = 2.10; 95% CI = 1.15-3.87). Compared with semi-structured interviews, fully structured interviews (MINI excluded) were non-significantly more likely to classify participants with low-level depressive symptoms (PHQ-9 scores ≤6) as having major depression (OR = 3.13; 95% CI = 0.98-10.00), similarly likely for moderate-level symptoms (PHQ-9 scores 7-15) (OR = 0.96; 95% CI = 0.56-1.66) and significantly less likely for high-level symptoms (PHQ-9 scores ≥16) (OR = 0.50; 95% CI = 0.26-0.97). CONCLUSIONS: The MINI may identify more people as depressed than the CIDI, and semi-structured and fully structured interviews may not be interchangeable methods, but these results should be replicated.Declaration of interestDrs Jetté and Patten declare that they received a grant, outside the submitted work, from the Hotchkiss Brain Institute, which was jointly funded by the Institute and Pfizer. Pfizer was the original sponsor of the development of the PHQ-9, which is now in the public domain. Dr Chan is a steering committee member or consultant of Astra Zeneca, Bayer, Lilly, MSD and Pfizer. She has received sponsorships and honorarium for giving lectures and providing consultancy and her affiliated institution has received research grants from these companies. Dr Hegerl declares that within the past 3 years, he was an advisory board member for Lundbeck, Servier and Otsuka Pharma; a consultant for Bayer Pharma; and a speaker for Medice Arzneimittel, Novartis, and Roche Pharma, all outside the submitted work. Dr Inagaki declares that he has received grants from Novartis Pharma, lecture fees from Pfizer, Mochida, Shionogi, Sumitomo Dainippon Pharma, Daiichi-Sankyo, Meiji Seika and Takeda, and royalties from Nippon Hyoron Sha, Nanzando, Seiwa Shoten, Igaku-shoin and Technomics, all outside of the submitted work. Dr Yamada reports personal fees from Meiji Seika Pharma Co., Ltd., MSD K.K., Asahi Kasei Pharma Corporation, Seishin Shobo, Seiwa Shoten Co., Ltd., Igaku-shoin Ltd., Chugai Igakusha and Sentan Igakusha, all outside the submitted work. All other authors declare no competing interests. No funder had any role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript; and decision to submit the manuscript for publication.

Consistency and sources of divergence in recommendations on screening with questionnaires for presently experienced health problems or symptoms: a comparison of recommendations from the Canadian Task Force on Preventive Health Care, UK National Screening Committee, and US Preventive Services Task Force.

BACKGROUND: Recently, health screening recommendations have gone beyond screening for early-stage, asymptomatic disease to include "screening" for presently experienced health problems and symptoms using self-report questionnaires. We examined recommendations from three major national guideline organizations to determine the consistency of recommendations, identify sources of divergent recommendations, and determine if guideline organizations have identified any direct randomized controlled trial (RCT) evidence for the effectiveness of questionnaire-based screening. METHODS: We reviewed recommendation statements listed by the Canadian Task Force on Preventive Health Care (CTFPHC), the United Kingdom National Screening Committee (UKNSC), and the United States Preventive Services Task Force (USPSTF) as of 5 September 2016. Eligible recommendations focused on using self-report questionnaires to identify patients with presently experienced health problems or symptoms. Within each recommendation and accompanying evidence review we identified screening RCTs. RESULTS: We identified 22 separate recommendations on questionnaire-based screening, including three CTFPHC recommendations against screening, eight UKNSC recommendations against screening, four USPSTF recommendations in favor of screening (alcohol misuse, adolescent depression, adult depression, intimate partner violence), and seven USPSTF recommendations that did not recommend for or against screening. In the four cases where the USPSTF recommended screening, either the CTFPHC, the UKNSC, or both recommended against. When recommendations diverged, the USPSTF expressed confidence in benefits based on indirect evidence, evaluated potential harms as minimal, and did not consider cost or resource use. CTFPHC and UKNSC recommendations against screening, on the other hand, focused on the lack of direct evidence of benefit and raised concerns about harms to patients and resource use. Of six RCTs that directly evaluated screening interventions, five did not report any statistically significant primary or secondary health outcomes in favor of screening, and one trial reported equivocal results. CONCLUSIONS: Only the USPSTF has made any recommendations for screening with questionnaires for presently experienced problems or symptoms. The CTFPHC and UKNSC recommended against screening in all of their recommendations. Differences in recommendations appear to reflect differences in willingness to assume benefit from indirect evidence and different approaches to assessing possible harms and resource consumption. There were no examples in any recommendations of RCTs with direct evidence of improved health outcomes.

Depression Screening and Health Outcomes in Children and Adolescents: A Systematic Review.

OBJECTIVE: Depression screening among children and adolescents is controversial. In 2009, the United States Preventive Services Task Force first recommended routine depression screening for adolescents, and this recommendation was reiterated in 2016. However, no randomized controlled trials (RCTs) of screening were identified in the original 2009 systematic review or in an updated review through February 2015. The objective of this systematic review was to provide a current evaluation to determine whether there is evidence from RCTs that depression screening in childhood and adolescence improves depression outcomes. METHOD: Data sources included the MEDLINE, MEDLINE In-Process, EMBASE, PsycINFO, Cochrane CENTRAL and LILACS databases searched February 2, 2017. Eligible studies had to be RCTs that compared depression outcomes between children or adolescents aged 6 to 18 years who underwent depression screening and those who did not. RESULTS: Of 552 unique title/abstracts, none received full-text review. No RCTs that investigated the effects of screening on depression outcomes in children or adolescents were identified. CONCLUSIONS: There is no direct RCT evidence that supports depression screening among children and adolescents. Groups that consider recommending screening should carefully consider potential harms, as well as the use of scarce health resources, that would occur with the implementation of screening programs.

Comparison of Self-Efficacy for Managing Chronic Disease between patients with systemic sclerosis and other chronic conditions: a systematic review.

The complexity and burden of systemic sclerosis (SSc) pose challenges to developing and sustaining disease management self-efficacy. The objective of this systematic review was to compare scores on a commonly used self-efficacy measure, the Self-Efficacy for Managing Chronic Disease (SEMCD) Scale, between SSc and other diseases. Data sources included the CINAHL, EMBASE, MEDLINE, and Scopus databases, searched through January 25, 2016, and reference lists of included articles and relevant reviews. Studies in any language that reported total SEMCD scores or individual item scores in adult non-psychiatric medical patients were eligible. We identified one eligible non-intervention study of SSc patients (n = 553), 13 other non-intervention studies, and 21 studies with pre-intervention data for patients enrolled in a self-management program or a trial of a program. Of 13 non-intervention studies with published total score means in cancer, cardiovascular disease, Parkinson's disease, spinal cord injuries, organ transplant candidates and recipients, dialysis, and lupus, SEMCD scores were statistically significantly lower (poorer self-efficacy) in SSc than 6 other disease samples, not significantly different from 6, and significantly higher than lupus patients. Compared to 18 studies of patients in self-management programs or trials with published total score means, SSc patients were similar or lower than 9 samples and significantly higher than 9 samples. Compared to patients with other diseases not enrolled in programs to improve self-efficacy, SSc patients report lower self-efficacy scores than most patient groups. Rigorously tested self-care interventions designed to meet the unique needs of patients with SSc are needed.

Accuracy of Depression Screening Tools to Detect Major Depression in Children and Adolescents: A Systematic Review.

OBJECTIVE: Depression screening among children and adolescents is controversial, and no clinical trials have evaluated benefits and harms of screening programs. A requirement for effective screening is a screening tool with demonstrated high accuracy. The objective of this systematic review was to evaluate the accuracy of depression screening instruments to detect major depressive disorder (MDD) in children and adolescents. METHOD: Data sources included the MEDLINE, MEDLINE In-Process, EMBASE, PsycINFO, HaPI, and LILACS databases from 2006 to September 30, 2015. Eligible studies compared a depression screening tool to a validated diagnostic interview for MDD and reported accuracy data for children and adolescents aged 6 to 18 years. Risk of bias was assessed with QUADAS-2. RESULTS: We identified 17 studies with data on 20 depression screening tools. Few studies examined the accuracy of the same screening tools. Cut-off scores identified as optimal were inconsistent across studies. Width of 95% confidence intervals (CIs) for sensitivity ranged from 9% to 55% (median 32%), and only 1 study had a lower bound 95% CI ≥80%. For specificity, 95% CI width ranged from 2% to 27% (median 9%), and 3 studies had a lower bound ≥90%. Methodological limitations included small sample sizes, exploratory data analyses to identify optimal cut-offs, and the failure to exclude children and adolescents already diagnosed or treated for depression. CONCLUSIONS: There is insufficient evidence that any depression screening tool and cut-off accurately screens for MDD in children and adolescents. Screening could lead to overdiagnosis and the consumption of scarce health care resources.

The Era of Radial-Specific Catheters: A Multicenter Comparison of the Armadillo and RIST Catheters in Transradial Procedures.

BACKGROUND AND OBJECTIVES: As the radial approach is gaining popularity in neurointervention, new radial-specific catheters are being manufactured while taking into consideration the smaller size of the radial artery, different trajectories of angles into the great vessels from the arm, and subsequent force vectors. We compared outcomes of transradial procedures performed using the Armadillo catheter (Q'Apel Medical Inc.) and the RIST radial guide catheter (Medtronic). METHODS: This is a retrospective multicenter study comparing outcomes of transradial neuroendovascular procedures using the Armadillo and RIST catheters at 2 institutions between 2021 and 2024. RESULTS: The study comprised 206 patients, 96 of whom underwent procedures using the Armadillo and 110 using the RIST. Age and sex were comparable across cohorts. In most procedures, 1 target vessel was catheterized (Armadillo: 94.8% vs 89.1%, P = .29) with no significant difference between cohorts. The use of an intermediate catheter was minimal in both cohorts (Armadillo 5.2% vs RIST: 2.7%, P = .36), and the median number of major vessel catheterization did not significantly differ between cohorts (Armadillo: 1 [1-4] vs RIST: 1 [0-6], P = .21). Failure to catheterize the target vessel was encountered in 1 case in each cohort (Armadillo: 1.0% vs RIST: 0.9%, P = .18), and the rate did not significantly differ between cohorts. Similarly, the rate of conversion to femoral access was comparable between cohorts (Armadillo: 2.1% vs RIST: 1.8%, P = .55). There was no significant difference in access site complications (Armadillo: 1% vs RIST: 2.8%, P = .55) or neurological complications (Armadillo: 3.1% vs RIST: 5.5%, P = .42) between cohorts. CONCLUSION: No significant difference in successful catheterization of target vessels, procedure duration, triaxial system use, complication rates, or the need for transfemoral cross-over was observed between both catheters. Both devices offer high and comparable rates of technical success and low morbidity rates.

Functional connectivity pre-post exercise intervention in individuals with relapsing-remitting multiple sclerosis.

OBJECTIVE: Exercise interventions have emerged as a promising approach for managing symptoms associated with multiple sclerosis (MS). However, changes in brain function underlying exercise-related improvements in symptoms of MS have not been fully investigated, and in no instances have they been investigated using a graph theory approach. For the first time, the effects of an exercise intervention on functional brain network connectivity were examined using graph theory analyses of resting-state functional MRI (fMRI) data among individuals with relapsing-remitting MS (RRMS). METHODS: Resting-state fMRI data were obtained from 10 participants before and after 12 weeks of a speeded walking intervention. Functional connectivity data were preprocessed in Data Processing Assistant for Resting-State fMRI Advanced (DPARSF A version 4.2) and analyzed in GraphVar2.02 to compute global and local graph theory metrics. To examine differences in graph metrics before and after the intervention, one-sample permutation tests were performed. RESULTS: There were no significant pre to post exercise intervention changes in global metrics. Changes in local metrics (i.e. clustering coefficient, local efficiency, degree centrality and betweenness centrality) were mixed, with both increases and decreases observed. CONCLUSION: Following a 12-week speeded walking exercise intervention, there were no significant increases or decreases in global graph metrics and results at the level of local metrics were equivocal in individuals with RRMS. Further research with experimental designs that include baseline and longitudinal follow-up, as well as larger sample sizes, is needed to understand the underlying mechanisms of symptom improvement following exercise in RRMS.

Depression prevalence based on the Edinburgh Postnatal Depression Scale compared to Structured Clinical Interview for DSM DIsorders classification: Systematic review and individual participant data meta-analysis.

OBJECTIVES: Estimates of depression prevalence in pregnancy and postpartum are based on the Edinburgh Postnatal Depression Scale (EPDS) more than on any other method. We aimed to determine if any EPDS cutoff can accurately and consistently estimate depression prevalence in individual studies. METHODS: We analyzed datasets that compared EPDS scores to Structured Clinical Interview for DSM (SCID) major depression status. Random-effects meta-analysis was used to compare prevalence with EPDS cutoffs versus the SCID. RESULTS: Seven thousand three hundred and fifteen participants (1017 SCID major depression) from 29 primary studies were included. For EPDS cutoffs used to estimate prevalence in recent studies (≥9 to ≥14), pooled prevalence estimates ranged from 27.8% (95% CI: 22.0%-34.5%) for EPDS ≥ 9 to 9.0% (95% CI: 6.8%-11.9%) for EPDS ≥ 14; pooled SCID major depression prevalence was 9.0% (95% CI: 6.5%-12.3%). EPDS ≥14 provided pooled prevalence closest to SCID-based prevalence but differed from SCID prevalence in individual studies by a mean absolute difference of 5.1% (95% prediction interval: -13.7%, 12.3%). CONCLUSION: EPDS ≥14 approximated SCID-based prevalence overall, but considerable heterogeneity in individual studies is a barrier to using it for prevalence estimation.

Group sample sizes in nonregulated health care intervention trials described as randomized controlled trials were overly similar.

OBJECTIVES: We evaluated whether sample sizes in different arms of two-arm parallel group randomized controlled trials of nonregulated interventions were systematically closer in size than would plausibly occur by chance if simple randomization had been applied. STUDY DESIGN AND SETTING: We searched PubMed for trials of nonregulated health care interventions that did not report using restricted randomization from journals in behavioral sciences and psychology, nursing, nutrition and dietetics, rehabilitation, and surgery. We emailed trial authors to clarify randomization procedures. RESULTS: We identified 148 nonregulated intervention trials that indicated they used simple randomization. Difference in trial arm sizes was smaller than would be predicted by chance if simple randomization had occurred in all trials (P < 0.001). Rather than approximately half of the trials being within a 50% prediction interval for the difference, 96% had differences within this interval. Results were similar and statistically significant (P < 0.001) for trials that were published in journals with impact factors ≥ 4 and when stratified by type of nonregulated intervention. CONCLUSION: There is a need for education and better understanding of clinical trial methods to ensure that randomization procedures are implemented as intended and reported fully and accurately.

Depression prevalence using the HADS-D compared to SCID major depression classification: An individual participant data meta-analysis.

OBJECTIVES: Validated diagnostic interviews are required to classify depression status and estimate prevalence of disorder, but screening tools are often used instead. We used individual participant data meta-analysis to compare prevalence based on standard Hospital Anxiety and Depression Scale - depression subscale (HADS-D) cutoffs of ≥8 and ≥11 versus Structured Clinical Interview for DSM (SCID) major depression and determined if an alternative HADS-D cutoff could more accurately estimate prevalence. METHODS: We searched Medline, Medline In-Process & Other Non-Indexed Citations via Ovid, PsycINFO, and Web of Science (inception-July 11, 2016) for studies comparing HADS-D scores to SCID major depression status. Pooled prevalence and pooled differences in prevalence for HADS-D cutoffs versus SCID major depression were estimated. RESULTS: 6005 participants (689 SCID major depression cases) from 41 primary studies were included. Pooled prevalence was 24.5% (95% Confidence Interval (CI): 20.5%, 29.0%) for HADS-D ≥8, 10.7% (95% CI: 8.3%, 13.8%) for HADS-D ≥11, and 11.6% (95% CI: 9.2%, 14.6%) for SCID major depression. HADS-D ≥11 was closest to SCID major depression prevalence, but the 95% prediction interval for the difference that could be expected for HADS-D ≥11 versus SCID in a new study was -21.1% to 19.5%. CONCLUSIONS: HADS-D ≥8 substantially overestimates depression prevalence. Of all possible cutoff thresholds, HADS-D ≥11 was closest to the SCID, but there was substantial heterogeneity in the difference between HADS-D ≥11 and SCID-based estimates. HADS-D should not be used as a substitute for a validated diagnostic interview.

Patient Health Questionnaire-9 scores do not accurately estimate depression prevalence: individual participant data meta-analysis.

OBJECTIVES: Depression symptom questionnaires are not for diagnostic classification. Patient Health Questionnaire-9 (PHQ-9) scores ≥10 are nonetheless often used to estimate depression prevalence. We compared PHQ-9 ≥10 prevalence to Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID) major depression prevalence and assessed whether an alternative PHQ-9 cutoff could more accurately estimate prevalence. STUDY DESIGN AND SETTING: Individual participant data meta-analysis of datasets comparing PHQ-9 scores to SCID major depression status. RESULTS: A total of 9,242 participants (1,389 SCID major depression cases) from 44 primary studies were included. Pooled PHQ-9 ≥10 prevalence was 24.6% (95% confidence interval [CI]: 20.8%, 28.9%); pooled SCID major depression prevalence was 12.1% (95% CI: 9.6%, 15.2%); and pooled difference was 11.9% (95% CI: 9.3%, 14.6%). The mean study-level PHQ-9 ≥10 to SCID-based prevalence ratio was 2.5 times. PHQ-9 ≥14 and the PHQ-9 diagnostic algorithm provided prevalence closest to SCID major depression prevalence, but study-level prevalence differed from SCID-based prevalence by an average absolute difference of 4.8% for PHQ-9 ≥14 (95% prediction interval: -13.6%, 14.5%) and 5.6% for the PHQ-9 diagnostic algorithm (95% prediction interval: -16.4%, 15.0%). CONCLUSION: PHQ-9 ≥10 substantially overestimates depression prevalence. There is too much heterogeneity to correct statistically in individual studies.

Probability of major depression diagnostic classification based on the SCID, CIDI and MINI diagnostic interviews controlling for Hospital Anxiety and Depression Scale - Depression subscale scores: An individual participant data meta-analysis of 73 primary studies.

OBJECTIVE: Two previous individual participant data meta-analyses (IPDMAs) found that different diagnostic interviews classify different proportions of people as having major depression overall or by symptom levels. We compared the odds of major depression classification across diagnostic interviews among studies that administered the Depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). METHODS: Data accrued for an IPDMA on HADS-D diagnostic accuracy were analysed. We fit binomial generalized linear mixed models to compare odds of major depression classification for the Structured Clinical Interview for DSM (SCID), Composite International Diagnostic Interview (CIDI), and Mini International Neuropsychiatric Interview (MINI), controlling for HADS-D scores and participant characteristics with and without an interaction term between interview and HADS-D scores. RESULTS: There were 15,856 participants (1942 [12%] with major depression) from 73 studies, including 15,335 (97%) non-psychiatric medical patients, 164 (1%) partners of medical patients, and 357 (2%) healthy adults. The MINI (27 studies, 7345 participants, 1066 major depression cases) classified participants as having major depression more often than the CIDI (10 studies, 3023 participants, 269 cases) (adjusted odds ratio [aOR] = 1.70 (0.84, 3.43)) and the semi-structured SCID (36 studies, 5488 participants, 607 cases) (aOR = 1.52 (1.01, 2.30)). The odds ratio for major depression classification with the CIDI was less likely to increase as HADS-D scores increased than for the SCID (interaction aOR = 0.92 (0.88, 0.96)). CONCLUSION: Compared to the SCID, the MINI may diagnose more participants as having major depression, and the CIDI may be less responsive to symptom severity.

Evaluation of Journal Registration Policies and Prospective Registration of Randomized Clinical Trials of Nonregulated Health Care Interventions.

Importance: Many interventions that are important to the health care of patients are not subject to regulation by the US Food and Drug Administration (FDA) or comparable regulatory bodies in other nations. Objective: To determine whether specialty journals that publish trials of primarily nonregulated health care interventions require prospective registration and whether the prospective registration policies are associated with the publication of prospectively registered trials, trials with adequately registered outcomes, and trials with primary outcomes consistent with the registered primary outcomes. Design and Methods: PubMed was searched daily, from March 18, 2016, to September 17, 2016, for nonregulated intervention randomized clinical trials. The search included all journals in the Clarivate Analytics Science Citation Index Expanded categories of behavioral sciences, nursing, nutrition and dietetics, psychology, rehabilitation, and surgery. Trials of interventions not subject to FDA regulation were included. One investigator extracted journal registration policy and trial registration status. Two investigators independently extracted trial registration and publication characteristics. Main Outcomes and Measures: For journals, the main outcome was the trial registration policy. For trials, the main outcomes were prospective registration, adequacy of outcome registration, and concordance of registered with published primary outcomes. Results: In total, 953 nonregulated intervention trials published in 254 journals were identified. Prospective registration was required for publication by 29 (11.4%) of 254 journals, and an additional 12 journals (4.7%) had conditional date-based requirements. Only 189 (19.8%) of the 953 trials were registered prospectively, including 33 of 98 published in journals with prospective registration policies as compared with 156 of 855 in journals without policies (33.7% vs 18.2%; P = .004). Among the 17 journals that required prospective registration and had at least 2 included trials, none had a prospective registration of more than 50%. In journals with policies, only 3 of 98 trials included primary outcomes consistent with prospectively, adequately registered outcomes, as compared with 34 of 852 trials in journals without policies (3.1% vs 4.0%; P = .62). Conclusions and Relevance: Few journals in behavioral sciences or psychology, nursing, nutrition and dietetics, rehabilitation, and surgery require prospective trial registration, and those with existing registration policies rarely enforce them; this finding suggests that strategies for encouraging prospective registration of clinical trials not subject to FDA regulation should be developed and tested.