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Research Methodology and Epidemiology - 2 Basic epidemiological principles in psychiatry and psychiatric rating scales Sean Lynch Research Methodology and Epidemiology -2 This is the second part of the afternoon module and today we will look at some aspects of rating scales and theory In psychiatry Research Methodology and Epidemiology -2 Self-rated Scales • • • • • • • • • • Quick, save interviewer time Lack of bias Reliable Can be used for case detection Can be used as outcome measures Only as good as the questions they ask Problems with phrasing, ease of reading, language “Order effects” “Social desirability effects” “Central tendency” Research Methodology and Epidemiology -2 Self-rated Scales • Can be used for any diagnostic category, except arguably less well for psychosis, cognitive impairment • Can be used to study core symptom dimensions in depth e.g. sleep, energy Research Methodology and Epidemiology -2 Interview - Rated Scales • Can be used to help assess whether a mental disorder is present or not • Can be used to assess the severity of symptoms in a mental disorder • Can be used with a taxonomical system to make diagnosis • Can also be used to study certain dimensions of symptoms in great depth • Can be highly structured with pre-determined questions • Can be more flexible and allow more “open-ended” questions Research Methodology and Epidemiology -2 Interview - Rated Scales • Can be subject to observer bias • Different raters might disagree on assessment • Can be subject to changes in behaviour of the same rater over time • Can be flexible and obtain supplementary information • Probing questions can be used to ensure subject understand the questions • Some say these scales can be sensitive to “clinical change” Research Methodology and Epidemiology -2 Scales need to have an “anchor point” to distinguish between lack of pathology and an “extreme” to assess severe pathology Scales can be broad and have numerous intermediate points with phrases or words to help guide scoring of severity or degree Scales can be narrow and dichotomous Research Methodology and Epidemiology -2 Scales can suffer from “ceiling” and “floor” effects i.e. if measuring dimensions within less severe or more severe examples of pathology e.g. depressed mood. It can be hard to show improvement in an item where there is not much opportunity to show change! e.g. trials in mild severity depression Research Methodology and Epidemiology -2 Properties of Scales 1. Case finding Ability to detect “cases” (true positives) Ability to distinguish “non-cases” (true negatives) Performance on these with minimum of misclassification i.e. low false positive and low false negative The fine tuning of a scale cut-off point or score can be biased towards sensitivity (true positives/true positives and false negatives) in other words not “missing” too many cases, or specificity (true negatives/true negatives and false positives) in other words having a lower number of “non-cases” incorrectly identified as cases Research Methodology and Epidemiology -2 Properties of Scales 2. Assessing severity Can less severe and more severe cases be separated by the scale? Would similar scales or measures show agreement on severity? 3. Assessing change Is a reduction or increase in score on the scale associated with changes in the clinical picture? Research Methodology and Epidemiology -2 Reliability “It does what it says on the tin most times” Test-retest Inter-rater Internal Consistency Research Methodology and Epidemiology -2 Validity “It really tells you what is in the tin most times” Convergent Face Construct A scale can be highly reliable but measure such a narrow concept it is clinically meaningless i.e. not valid Research Methodology and Epidemiology -2 DEPRESSION RATING SCALES Interview-rated HAMILTON 17 and 21 item MONTGOMERY ASBERG 10 item Self-rated HAD (Hospital Anxiety and Depression) 7 item Beck (BDI) 21 and 13 item Research Methodology and Epidemiology -2 ANXIETY RATING SCALES Interview-rated HAMILTON 14 item Self-rated HAD (Hospital Anxiety and Depression) 7 item Research Methodology and Epidemiology -2 OBESSIONAL RATING SCALES Interview-rated Y-BOCS (Yale Brown) 10 item Self-rated OCI (Obsessive Compulsive Inventory) 42 item Research Methodology and Epidemiology -2 SCHIZOPHRENIA RATING SCALES Interview-rated PANSS SANS SAPS BPRS Research Methodology and Epidemiology -2 MANIA RATING SCALES Interview-rated YOUNG MANIA RATING SCALE Research Methodology and Epidemiology -2 DIAGNOSTIC INTERVIEWS SCAN (Wing et al ) - ICD SCID - DSM Research Methodology and Epidemiology -2 Disease concepts for diagnosis • Competing paradigms were reductionist or more pragmatic and multidimensional • Hierachical approach (Foulds) • Multiaxial approach (DSM) • Now concepts of subsyndromal disorder Levels of psychological disturbance - severity • Normal distress • Monosymptomatic - but recognisable • Subsyndromal - collection of several symptoms which fails to meet diagnostic criteria • Syndrome Other qualifying criteria • Frequency and persistence of symptom • Functional impairment or disability • Symptom duration Factors affecting agreement on diagnosis 1. Can have the same information but different disease concepts 2. Can evaluate the same information in a different way 3. Can elicit different information from the same patient 4. Can have changes in the clinical condition of the patient at different times Factors affecting agreement on diagnosis 1. Different raters have different levels of knowledge and expertise e.g. differences between primary and secondary care 2. Our diagnoses have a degree of inbuilt uncertainty 3. How confident are we that our diagnosis is right? 4. How often will our colleagues agree with us? Agreement on diagnosis - case example Man of 40 who presents to GP Insomnia for ten days Panic attacks for three weeks Irritability at work for two weeks Reduced libido for ten days Agreement on diagnosis - case example Man of 40 who presents to GP Insomnia for ten days Panic attacks for three weeks Irritability at work for two weeks Reduced libido for ten days Hopelessness about future (week) Appetite reduced (two weeks) Reduced energy (two weeks) Agreement on diagnosis - case example BUT has auditory hallucinations in third person for three days! Agreement on diagnosis • What is a psychiatric case? “Gold standard” Kendell, Shepherd • Inter-rater reliability • Intra-rater reliability • Diagnostic interviews and index of definition • “Cut-offs” based on symptom severity on rating instruments • Computerised Agreement on diagnosis • Generally improved with more severe illness • Difficulty in milder illness levels distinguishing from the normal range • More difficult for certain diagnostic concepts e.g. personality disorder and new DSM V Usefulness of diagnosis • Categorical verus dimensional models of illness • Hypertension is not “all-or-nothing” but spectrum form obvious disease to normal range • Rose “not important if he has it, the question is how much of it he has” • Bentall - distribution of psychotic symptoms Prevalence • The number of defined cases of disease in an area • Includes older and more recently diagnosed cases • Can be influenced by the chronicity of illness more than the incidence of illness • Cases can develop and remit (or die) and influence prevalence Prevalence • Point prevalence • Period prevalence • “Life-time rates” Prevalence - interpreting changes • Can be due to true changes in incidence • Can be due to changes in effectiveness of interventions • Can be due to changes in nature or course of illness • Can be due to changes in detection rate Incidence • The number of new cases of illness in an area over a period of time • Changes more likely to reflect influences on causation or associated risk • Does not in itself give information on total number of cases in community • Changes can be due to changes in detection rate • Problem of including relapses inadvertently Incidence • Diseases with low incidence can become prevalent in community if chronic illnesses • Prevalence can change without change in incidence necessarily e.g. change in severity of illness or effectiveness of treatment Methods to assess incidence and prevalence • A case register to document all contacts over a defined period • “Observatory” method • Case notification methods • Population based studies Methods to assess incidence and prevalence • These methods can have limitations in diseases with low incidence rates and prevalence rates • The first three methods are particularly prone to error if there are problems (or there is not full consensus) on the case definition • The detection rate of cases should also be measured to assess accuracy (against best available standards) Methods to assess incidence and prevalence • • • • Case ascertainment methods Prodromal phases Changes to case definition Need to have reliable and valid raw data to review estimates Methods to assess incidence and prevalence Other problems in psychiatry:• “Diagnostic overlapping” • Cultural influences on case ascertainment • Co-morbidity • Diagnostic stability over time • Social changes (“pathoplastic”) Methods to assess incidence and prevalence “Head count” methods in psychiatry:• Case notification depends on accuracy of diagnostic assessment and health seeking behaviour • Case registers depend on capturing all cases and do not cope well with migration effects and changes to housing or centres of population Methods to assess incidence and prevalence Survey methods in psychiatry:• Need to carefully define area studied • Feasible methods of case detection • Often expensive as need to cover large areas and numbers • Need to have accurate estimate of population base Methods to assess incidence and prevalence Survey methods in psychiatry:• Catchment area and “house to house” methods • Telephone methods • For less prevalent conditions and low incidence conditions will need to screen a large number of “normals” • Need a socially acceptable screening tool Methods to assess incidence and prevalence Survey methods in psychiatry:• Much more problematic for more severe illness • Problems of selection bias e.g. “cold-spots” of participation, wrong time of day Methods to assess incidence and prevalence Other methods • Postal questionnaire • Two-stage screening • Representative sample e.g. random selection as per some marketing approaches • Quota samples • Convenience samples • Consecutive attendances Methods to assess incidence and prevalence Error rate in study has to be defined. Common methods:• Reference to “gold standard” • With reference to known reliability and stability of case definition • Random resampling • Non-participation and non-completion rates • Estimates of “double counting” or “missing” cases Causation Confounding variables “Latent” variables Interactions Protective factors Causative factors Causation Consider the following hypothesis:The risk of lung cancer is 100 times higher in men aged 30-35 who smoke than in non-smokers. Smokers on average watch 50% more television than non-smokers. Smokers watching only the average amount of television of non-smokers could reduce their risk of lung cancer by one third. Television might also be a causal factor in lung cancer. Causation Is there an argument to support this conclusion? Is the evidence convincing? Can you see any flaws in this argument? Are there alternative methods of studying the causal relationship between smoking, television viewing and lung cancer? Exposure and risks Case control method is classical method It gives an indication of differences in the rate of disease on exposure to a potential risk factor Cross-sectional studies only give information on association Longitudinal studies give some more information on causation Exposure or “at risk” studies give the best quality information Exposure and risks There are several assumptions:• An equal chance of exposure to a risk factor in all the population? • Controls are “normal” • We can measure the level of risk or exposure • Exposure levels might vary in intensity • Duration of exposure might be relevant Exposure and risks Risk measures:These attempt to quantify the increase in the number or proportion of cases in a population exposed to the risk factor, compared to those not exposed • Odds ratio • Relative risk ratio • Attributable risk Exposure and risks • These are quite useful concepts but rely on assessing one risk factor at a time • In psychiatry multiple risk factors might be expected. Sometimes it is as useful to assess interaction between factors • We will discuss multivariate models in later sessions EBM terminology Adverse event CONTROL TREATMENT YES a b NO c d pc = proportion of controls with adverse event pc= b/ (b+d) pt = proportion of treatment group with adverse event pt = a/(a+c) Relative risk of event RRe = pt/pc Relative risk of no event or RRne =(1-pt/ 1-pc) EBM terminology Odds ratio (OR) - (a x d) / (b x c) Relative risk reduction RRR = (pc-pt)/ pc + 1-RRe Absolute risk reduction (ARR) / risk difference (RD) = pc-pt Number needed to treat NNT NNT (risk difference) = 1/RD NNT (relative risk of event) = 1 / (pc x RRR) NNT (relative risk of no event) = 1 / (1-pc) x (RRne-1) NNT (odds ratio) = (1-(pc x (1-OR)) / (pc x (1-pc) * (1-OR)) Other important related concepts We will discuss these more fully when discussing rating scales • Sensitivity • Specificity • Misclassification rate • Predictive value • Efficiency