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  1. Mohd Sidik S, Arroll B, Goodyear-Smith F
    Med J Malaysia, 2012 Jun;67(3):309-15.
    PMID: 23082424 MyJurnal
    OBJECTIVE: This study was conducted to determine the validity of the 9-item Patient Health Questionnaire (PHQ-9) (Malay version) as a case-finding instrument for depression among women in a primary care clinic.
    METHODS: A cross sectional study was conducted in a primary care clinic in Malaysia. Consecutive adult women patients who attended the clinic during data collection were given self-administered questionnaires, which included the PHQ-9 (Malay version). Systematic weighted random sampling was used to select participants for Composite International Diagnostic Interviews (CIDI). The PHQ-9 was validated against the CIDI reference standard.
    RESULTS: The response rate was 87.5% for the questionnaire completion (895/1023), and 96.8% for the CIDI interviews (151/156). The prevalence of depression was 12.1% (based on PHQ-9 scores of 10 and above). The PHQ-9 had a sensitivity of 87% (95% confidence interval 71% to 95%), a specificity of 82% (74% to 88%), positive LR 4.8 (3.2 to 7.2) and negative LR 0.16 (0.06 to 0.40).
    CONCLUSIONS: The Malay version of the PHQ-9 was found to be a valid and reliable case-finding instrument for depression in this study. Together with its brevity, it is a suitable case-finding instrument to be used in Malaysian primary care clinics.
    Questionnaire: Patient Health Questionnaire; PHQ-9; General Health Questionnaire; GHQ-12; Composite International Diagnostic Interview; CIDI; Generalized Anxiety Disorder scale; GAD-7
  2. Mohd Sidik S, Arroll B, Goodyear-Smith F
    Br J Gen Pract, 2011 Jun;61(587):e326-32.
    PMID: 21801511 DOI: 10.3399/bjgp11X577990
    Background: This is the first study investigating Anxiety among women attending a primary care clinic
    in Malaysia.
    Aim: The objective was to determine the factors associated with anxiety among these women.
    Design: This cross-sectional study was conducted in a government-funded primary care clinic in Malaysia. Consecutive female patients attending the clinic during the data-collection period were invited to participate in the study.
    Method: Participants were given self-administered questionnaires, which included the validated Generalised Anxiety Disorder-7 questionnaire (GAD-7) Malay version to detect anxiety.
    Results: Of the 1023 patients who were invited, 895 agreed to participate (response rate 87.5%). The prevalence of anxiety in this study was 7.8%, based on the GAD-7 (score ≥8). Multiple logistic regression analysis found that certain stressful life events and the emotional aspect of domestic violence were significantly associated with anxiety (P<0.05).
    Conclusion: The prevalence of anxiety among women in this study is similar to that found in other countries.
    Factors found to be associated with anxiety, especially issues on domestic violence, need to be addressed andmanaged appropriately.
    Keywords: anxiety; Malaysia; prevalence; primary care; women.
    Questionnaire: Generalized Anxiety Disorder scale; GAD-7 (Malay version); Hark questionnaire
  3. Mohd Sidik S, Arroll B, Goodyear-Smith F
    J Prim Health Care, 2012 Mar;4(1):5-11, A1.
    PMID: 22377544
    Introduction: Anxiety is a common mental health disorder in primary care, with a higher prevalence among women compared to men.
    Aim: This is the first study to validate the Generalised Anxiety Disorder-7 questionnaire (GAD-7) as a case-finding instrument for anxiety in a primary care setting in Malaysia. The objective was to determine the diagnostic accuracy of the Malay version of the GAD-7 in detecting anxiety among women.
    Methods: This cross-sectional study was conducted in a government-funded primary care clinic in Malaysia. Consecutive women participants attending the clinic during data collection were given self-administered questionnaires including the GAD-7 (Malay version). Participants then were selected using systematic weighted random sampling for Composite International Diagnostic Interviews (CIDI). The GAD-7 was validated against the CIDI reference standard.
    Results: The response rate was 87.5% for the questionnaire completion (895/1023), and 96.8% for diagnostic interviews (151/156). The prevalence of anxiety was 7.8%. The GAD-7 had a sensitivity of 76% (95% CI 61%–87%), a specificity of 94% (88%–97%), positive LR 13.7 (6.2–30.5) and negative LR 0.25 (0.14–0.45).
    Discussion: The Malay version of the GAD-7 was found to be valid and reliable in case-finding for anxiety in this study. Due to its brevity, it is a suitable case-finding instrument for detecting anxiety in primary care settings in Malaysia.
    Keywords: Validation; anxiety; primary care; women; Malaysia
    Questionnaire: Generalised Anxiety Disorder questionnaire; GAD-7; Composite International Diagnostic Interviews; CIDI; Patient Health Questionnaire; PHQ-9; General Health Questionnaire; GHQ-12
  4. Mohd-Sidik S, Arroll B, Goodyear-Smith F, Zain AM
    Int J Psychiatry Med, 2011;41(2):143-54.
    PMID: 21675346 DOI: 10.2190/PM.41.2.d
    OBJECTIVE: To determine the diagnostic accuracy of the two questions with help question (TQWHQ) in the Malay language. The two questions are case-finding questions on depression, and a question on whether help is needed was added to increase the specificity of the two questions.
    METHOD: This cross sectional validation study was conducted in a government funded primary care clinic in Malaysia. The participants included 146 consecutive women patients receiving no psychotropic drugs and who were Malay speakers. The main outcome measures were sensitivity, specificity, and likelihood ratios of the two questions and help question.
    RESULTS: The two questions showed a sensitivity of 99% (95% confidence interval 88% to 99.9%) and a specificity of 70% (62% to 78%), respectively. The likelihood ratio for a positive test was 3.3 (2.5 to 4.5) and the likelihood ratio for a negative test was 0.01 (0.00 to 0.57). The addition of the help question to the two questions increased the specificity to 95% (89% to 98%).
    CONCLUSION: The two qeustions on depression detected most cases of depression in this study. The questions have the advantage of brevity. The addition of the help question increased the specificity of the two questions. Based on these findings, the TQWHQ can be strongly recommended for detection of depression in government primary care clnics in Malaysia. Translation did not apear to affect the validity of the TQWHQ.
  5. Mohd Sidik S, Arroll B, Goodyear-Smith F, Ahmad R
    Singapore Med J, 2012 Jul;53(7):468-73.
    PMID: 22815016
    Depression affects more women than men in Malaysia. The objective of this paper was to determine the prevalence of depression and its associated factors among women attending a government primary care clinic.
  6. Wu Y, Levis B, Riehm KE, Saadat N, Levis AW, Azar M, et al.
    Psychol Med, 2020 06;50(8):1368-1380.
    PMID: 31298180 DOI: 10.1017/S0033291719001314
    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.

  7. Levis B, Benedetti A, Riehm KE, Saadat N, Levis AW, Azar M, et al.
    Br J Psychiatry, 2018 06;212(6):377-385.
    PMID: 29717691 DOI: 10.1192/bjp.2018.54
    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.

  8. He C, Levis B, Riehm KE, Saadat N, Levis AW, Azar M, et al.
    Psychother Psychosom, 2020;89(1):25-37.
    PMID: 31593971 DOI: 10.1159/000502294
    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.

  9. Levis B, Bhandari PM, Neupane D, Fan S, Sun Y, He C, et al.
    JAMA Netw Open, 2024 Nov 04;7(11):e2429630.
    PMID: 39576645 DOI: 10.1001/jamanetworkopen.2024.29630
    IMPORTANCE: Test accuracy studies often use small datasets to simultaneously select an optimal cutoff score that maximizes test accuracy and generate accuracy estimates.

    OBJECTIVE: To evaluate the degree to which using data-driven methods to simultaneously select an optimal Patient Health Questionnaire-9 (PHQ-9) cutoff score and estimate accuracy yields (1) optimal cutoff scores that differ from the population-level optimal cutoff score and (2) biased accuracy estimates.

    DESIGN, SETTING, AND PARTICIPANTS: This study used cross-sectional data from an existing individual participant data meta-analysis (IPDMA) database on PHQ-9 screening accuracy to represent a hypothetical population. Studies in the IPDMA database compared participant PHQ-9 scores with a major depression classification. From the IPDMA population, 1000 studies of 100, 200, 500, and 1000 participants each were resampled.

    MAIN OUTCOMES AND MEASURES: For the full IPDMA population and each simulated study, an optimal cutoff score was selected by maximizing the Youden index. Accuracy estimates for optimal cutoff scores in simulated studies were compared with accuracy in the full population.

    RESULTS: The IPDMA database included 100 primary studies with 44 503 participants (4541 [10%] cases of major depression). The population-level optimal cutoff score was 8 or higher. Optimal cutoff scores in simulated studies ranged from 2 or higher to 21 or higher in samples of 100 participants and 5 or higher to 11 or higher in samples of 1000 participants. The percentage of simulated studies that identified the true optimal cutoff score of 8 or higher was 17% for samples of 100 participants and 33% for samples of 1000 participants. Compared with estimates for a cutoff score of 8 or higher in the population, sensitivity was overestimated by 6.4 (95% CI, 5.7-7.1) percentage points in samples of 100 participants, 4.9 (95% CI, 4.3-5.5) percentage points in samples of 200 participants, 2.2 (95% CI, 1.8-2.6) percentage points in samples of 500 participants, and 1.8 (95% CI, 1.5-2.1) percentage points in samples of 1000 participants. Specificity was within 1 percentage point across sample sizes.

    CONCLUSIONS AND RELEVANCE: This study of cross-sectional data found that optimal cutoff scores and accuracy estimates differed substantially from population values when data-driven methods were used to simultaneously identify an optimal cutoff score and estimate accuracy. Users of diagnostic accuracy evidence should evaluate studies of accuracy with caution and ensure that cutoff score recommendations are based on adequately powered research or well-conducted meta-analyses.

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