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Medical Research
FLSAOM Medical Research Class Glossary terms for mid-term
| Term | Definition |
|---|---|
| Allocation Concealment | In RCTs allocation concealment is necessary so that researchers or those providing treatment do not influence who gets allocated to which group, this ensures randomization |
| Blinding/blinded | RCTs are fully blinded if all involved are unaware of which treatment group the participants are allocated; Acupuncturists cannot be blinded but it is best to attempt to blind patients during the trial. |
| Case Series | Repeated observations of more than one patient, often with data collected to identify whether there is an association between treatment and improvement. No control group. |
| Case Study | A report based on clinical observation of one patient, usually with some assessment of outcome. |
| Cohort Study | A study in which a group of people are identified who have something in common, for example, a new Dx of hepatitis C, and followed over time to observe the outcome, w/o any Tx or other intervention. Term not usually used for a study of outcome from Tx. |
| Complex Intervention | A description of a Tx that comprises multiple components or modalities and where it is not clear how to separate out indiv. components of Tx in order to measure specific effects. |
| Confidence Interval (CI) | A statistical calculation presenting the 'best guess' of the effect of an intervention w/ a range of likely effects known as the CI. Typically 95% CI means 95% chance the true size of effect is w/in the CI P value is less than 0.05 |
| Controlled Trial | Comparison b/w 2 or more different treatment groups, term is used for trials w/o randomization so there is potential selection bias d/t groups not being equivalent. Non-randomized controlled trials have weaker findings d/t possible bias. |
| Correlation | A quantification of the strength of an association b/w 2 variables. A correlation will not indicate whether there is causation |
| Cross-sectional Study | A study design that involves surveying a population at a single point in time. It can be used for assessing the prevalence of utilization of Tx or of a specific cond'n in the population. |
| Delphi Study | A consensus process designed to elicit expert opinion by asking participants to provide quantitative ratings. (see book for example) |
| Ecological Validity | The extent to which the patients, practitioners and style of acupuncture w/in a study reflect the context of normal practice. This is similar to external validity. |
| Effectiveness Trial | A trial to measure the therapeutic effect of an intervention when it is delivered as it would be in practice in the real world. Usually simpler design than efficacy trials, may include flexible Tx protocols and broader inclusion criteria. |
| What do effectiveness trials have that efficacy trials do not? | In general have better external validity than efficacy trials. |
| Effect Size | A measure of the size of the difference in effect b/w 2 variables. Commonly quantified as standardized mean difference. Can be used as a measure of mean change b/w groups or w/in one group b/w baseline and outcome. |
| Efficacy Trial | A trial to measure the therapeutic effect of an intervention in a rigorously controlled setting w/ optimal administration of Tx. Designed to include participants willing to adhere to Tx regimen so they can determine if Tx works among those who receive it. |
| What does not constitute an efficacy study? | The use of 'sham' or 'placebo' controls |
| Explanatory Trial | Trial to est. the specific component/s by which a therapy such as acupuncture may work. Controls for non-specific elements in order to evaluate the specific effects assoc. w/ the active ingredients of a Tx. |
| Tell me more about Explanatory Trials | Trials of acupuncture typically evaluate the effects of needling in the correct location compared to some form of sham acupuncture. Typically these trials have stringent inclusion criteria and objective outcomes.These charac lead to high internal validity |
| External Validity (Generalisability) | A measure of the validity of the results of a trial beyond that trial. If results are applicable to people encountered in regular clinical practice. Depends on pop. from which trial pop. was drawn, not just entry requirements. |
| How is external validity enhanced? | When the acupuncture provided w/in a trial is representative of the acupuncture that is normally provided in routine practice. |
| Forest Plot | A graphical method used in meta-analyses to show the variation in outcome b/w the individual studies under review. the plot also provides an estimate of the overall effect based on combining the results of all relevant studies. |
| Generalisability | External Validity |
| Intention to Treat (ITT) Analysis | Method used to analyze the data for all participants based on the group to which they were randomly allocated, whether or not they ceased or changed Tx during the trial. The analysis is not based on whether they completed the per-protocol course of Tx |
| Internal Validity | A study is internally valid if it is designed and carried out in a way that provides results that are unbiased and gives an accurate estimate of the effects associated w/ the intervention. |
| Manualisation | The dev of guidelines for the implementation of an intervention for a clinical trial, w/ accurate descriptions for it to be delivered appropriately and replicated if needed. Flexiblity w/ indiv. Tx if maintain predetermined Tx style |
| Mechanism of Action | The series of physiological events by which a cause induces an effect. In acupuncture process by which needling induces changes in outcome. Distinguished from correlation which identifies association rather than causation |
| Meta-analysis | A quantitative method used to summarize the results of several clinical trials in a single estimate, weighted on the basis of the size or quality of each trial. Differs from a systematic review which is systematic search and appraisal of literature |
| Natural Hx of a Cond'n | Tendency of the severity of a cond'n to wax or wane over time. Patients normally come in an acute stage and natural Hx of cond'n may result in recovery over time regardless of intervention. Sometimes called non-specific or placebo effects |
| Non-specific effects | Contributions to outcome from anything other than the specific component that is being tested. These vary based on the hypothesis. Active/specific component in acupuncture trials is needling at specific locations, results from something else is non- |
| P Value | The probability that an observed difference occurred by chance, assuming there is no real difference b/w the effects. Significant if value is less than one chance in 20 or less than 0.05 |
| What do P values indicate? | The strength of the evidence of difference: greater than 0.1 = little or no evidence; b/w 0.05 and 0.1 = weak evidence; between 0.01 and 0.05 = evidence of a difference; less than 0.01 = strong evidence; less than 0.001 = very strong evidence |
| Pilot Study | Any study that is specifically designed as a small-scale forerunner of a larger, more definitive study, for example a RCT, to help dev and design it. |
| What do pilot studies address? | Numerous feasibility aspects of the research design like will patients agree to b e randomized to real vs sham acupuncture can be known as feasibility studies. |
| Placebo | Term used in drug trials to describe the substance that is given to the control group. Placebo is identical in appearance, taste and feel to the intervention and physiologically inert. Must not have effects assoc w/ the experimental Tx. |
| What is placebo referred to as in acupuncture trials? | Sham; expected to mirror all aspects of the intervention except those that are associated w/ the specific/active components being tested. Placebo cannot be assumed inert and phys. impact can be expected |
| Pragmatic Trial | AKA practical or management trial that assures the overall benefits of a routine Tx providing results are directly applicable to normal practice. Broader inclusion criteria. |
| What do Pragmatic RCTs not aim to do? | Separate the Tx into specific and non-specific components, and usually compare a Tx to another accepted Tx (active control) like standardized care or no Tx. |
| Prospective Studies | Any research design that is based on a pre-defined set of outcome measures to be assessed over a specific period of time. Prospective studies can be contrasted w/ retrospective studies. |
| Qualitative Study | Provides non-numerical data on qualities, from the perspectives of patients or acupuncturists. Can be collected to provide info on perception of patients, acceptability of Tx, factors assoc. w/ satisfaction, etc. |
| What can a qualitative study do? | Complement results based on quantitative data |
| Quantitative Study | An investigation that provides data on measured numerical quantities rather than qualities. Lends itself to statistical analyses. |
| Randomized Control Trial (RCT) | A test for differences in outcome b/w 2 or more groups. Allocation to groups is randomized so that patient groups are expected to be equivalent at baseline. |
| What is a benefit of an RCT? | Assessment of the relative benefits of interventions based on whether there are statistical differences in outcomes. Purpose is to minimize bias in order to better ascribe differences in outcome to the intervention. |
| Regression to the Mean | A statistical artifact whereby pre-selected extreme values when measured again later tend to regress towards the mean. In theory effects of regression are balanced out in RCTs |
| Sham Acupuncture Tx | A control placebo that is identical in appearance and experience to acupuncture but lacks any of the presumed Tx-specific effects. Can be invasive or non-invasive. There is a lack of accepted delineation of effects that should be excluded from sham |
| Significant Effects | A statistical test has shown a significance level of less than 5% (P value <0.05). Same as an observed difference b/w interventions that would only occur by chance one time in 20. Considered identical to having a 95% CI that does not include no effect |
| When the word "significant" is being used, what does it mean? | The statistical sense of a significant effect. Differences that do not reach significance can be called trends |
| Specific Effect | In a trial this depends on the hypothesis being tested, specific effect can vary from study to study. Acupuncture trials these effects are often assumed to be the active effects from the insertion of needles at precise points w/ correct stimulation. |
| Standardized Mean Difference | A measure of a difference in means w/ the standard dev as a denominator to provide a dimensionless measure of an effect. Difference in outcomes/standard deviation, AKA effect size. |
| What can standardized mean difference be helpful for? | Making decisions about the size of an effect: 0.2 is a small effect, 0.5 is a moderate effect, and 1.0 is a large effect |
| Stratification | A procedure to generate equal #s of participants w/ a charac that is likely to be a predictor of outcome in each arm of a trial. Usually performed by using a separate randomization for those w/ and w/o the charac. |
| Systematic Review | A type of review in which pre-specified search and assessment criteria are employed to address a defined research question. A set of research studies, usually RCTs, are systematically identified, appraised and summarized. |
| Define gate theory. | Gate control in the dorsal horn of the spinal cord can be controlled by the descending pain pathway. Inhibitory neurons in the dorsal horn can close the gate and serotonin and noradrenaline are released exciting the inhibitory neuron suppressing pain |
| How does acupuncture influence gate theory? | Some acupuncture stimuli like de Qi excite the inhibitory neuron and invoke the descending inhibitory pathways. |
| Discuss A alpha (Type 1) nerve fibers. | Fastest and the thickest. Primary muscle spindle motor to skeletal muscles (myelinated = fast) Type 1a receptors of muscle spindle and Type 1b golgi tendon organ |
| Discuss beta (Type 2) nerve fibers. | Cutaneous touch/pressure afferents(myelinated, faster but not as fast as type 1) Pomeranz describes numbness |
| Discuss gamma nerve fibers. | Motor to muscle spindle (myelinated, slower than both type 1 and 2) |
| Discuss delta (Type 3) nerve fibers. | Mechanoreceptors, nociceptor (myelinated), free nerve endings of touch and pressure, cold sensation, nociceptors of the neospinothalamic tract; Pomeranz: heaviness, distention, aching |
| Discuss B fibers. | Sympathetic, preganglionic (myelinated) |
| Discuss C (Type 4) fibers. | Mechanoreceptor, nociceptor, sympathetic postganglionic (unmyelinated), nociceptors of paleosympathetic tract, warmth receptors; Pomeranz: soreness |
| What is acute pain? | Unpleasant w/ emotional, cognitive and sensory features from tissue trauma. Associated w/ significant tissue path. Resolves w/ healing. Protective fxn to protect for further injury. Reflexes: withdrawal, muscle spasm, autonomic rxns |
| What is acute pain often referred to as? | Physiological pain |
| What is chronic pain and what is it referred to as? | Pain lasting beyond expected recovery period and identifiable pathology insufficient to explain the pain state. Disrupts sleep and normal ADLs. Does not serve protective/adaptive fxn. Ref to as pathological pain; continues past when appears to resolve. |
| What is nociceptive pain? | Results form normal fxn of the nervous system. Caused when a noxious stimulus activates A-delta and C nociceptors (cell bodies in DRG). Visceral and somatic pain included here. |
| What is neuropathic pain? | Abnormal nociceptive signaling caused by an impairment of the nervous system. Serves no fxn'l or adaptive purpose. |
| What are causes and examples of neuropathic pain? | Metabolic: diabetic neuropathy Infectious: Herpes Zoster Trauma: Nerve entrapment |
| What is Nociception? | Process by which information about tissue damage reaches the CNS. Transduction, transmission, perception, modulation |
| Describe Type 3 fibers and their input for pain transduction. | A delta, small diameter, thinly myelinated, thermal and high threshold mechanical stimuli; activation effect: short, sharp, prickling pain. |
| Describe Type 4 fibers and their input for pain transduction. | C, small diameter, unmyelinated, polymodal: high-intensity mechanical, chemical, hot and cold; activation effect: more prolonged sensation of dull pain. |
| What occurs when nociceptors activated in pain TRANSDUCTION? | Do not spontaneously depolarize; send impulses only when stimulated. No specialized pain "receptors" receptor region of the nociceptor is the free terminal of the axon. |
| How does pain transduction occur w/ nociception? | Ion channels in nerve terminal open in response to noxious stimuli, initiating action potential (pain signal). |
| What is peripheral sensitization? | Local tissue injury w/ release of inflammatory mediators (like substance P; "sensitizing soup) can enhance nociceptor response. |
| What occurs with nociception and pain TRANSMISSION? | Primary sensory afferents (nociceptors) have cell body in DRG; synapse to second order neurons in dorsal horn of spinal cord. Pain impulses can trigger a withdrawal reflex via connections to motor neurons in the spinal cord. |
| What are the ascending tracts of pain transmission and where do they go? | Spinothalamic tract -> thalamus (pain perception, temp.); spinohypothalamic tract -> hypothalamus; spinomesencephalic tract -> mesencephalon; spinoreticular tract -> reticular formation of brainstem |
| Which tract is the central role in pain perception and what does it "feel"? | Spinothalamic Tract! Pain, cold, warmth, touch |
| Does acupuncture anesthesia exist? | No! But acupuncture analgesia is real; acupuncture can down-regulate the amygdala to cause the analgesic effect. |
| What neurotransmitters are involved in gate control? | Endogenous opiates (enkephalans, dynorphins, beta-endorphins), serotonin, norepinephrine. |
| Describe the endorphin hypothesis. | Acupuncture analgesia is initiated by the stimulation of small diameter nerves in mm. which send impulses to the SC. 3 neural centers (SC, midbrain, pituitary) are activated to release transmitter chemicals (endogenous opioids) which block pain messages. |
| What circuits do needles close to the pain site influence (3)? | Endorphenergic cells in SC: enkaphlin, B-endorphin; Raphe nucleus (at MO to DLT): serotonic, norepinephrine; Pituitary: B-endorphin |
| What do needles distal to pain site influence (3)? | Midbrain and hypothalamus; Raphe nucleus (at MO to DLT): serotonin and norepinephrine; Pituitary: B-endorphin |
| What does low frequency (2-4 Hz) high intensity needling act on and what is the result? | All three centers; slower onset, longer duration. |
| What does high frequency (50-200 Hz) low intensity needling act on and what is the result? | Only 7 and 11 (see diagram), it bypasses the endorphin system. |
| What did Pomeranz and Chiu find about acupuncture analgesia? | Naloxone blocked AA; sham EZ w/o effect; naloxone little hyperalgesia; Indirect evidence for "opiate" or endorphin effects produced by AA; AA is not "psychological" |
| What did Mayer find about acupuncture analgesia? | AA induced w/ twirling needles LI4; Double blind, IV naloxone and IV saline; saline group normal induction of AA in 30 min w/ 1 hour duration; Naloxone group no induction (blocked endorphins). |
| What is fMRI? | fMRI uses a magnetic field and rf transmission and reception to detect changes in the flow of oxygenated and unoxygenated blood in the brain, assuming that these levels are representative of neural activation or deactivation. |
| Briefly explain what Napadow found relating to acupuncture and CTS. | Acupuncture decreased Sx of CTS and less cortical plasticity signs of CTS; Painful cond'ns experience acupuncture differently than "healthy" pt's; brain effects are positive and different compared to healthy. |
| What is a somatotopic map and how are digits represented? | A homunculus; the digits occupy a significant portion of the human homunculus and represented in consecutive order along the postcentral gyrus, w/ D1 most ventrolateral and D5 most dorsomedial. |
| What is somatotopy? | Mapping the sensations from the surface of the body onto a brain structure. |
| What is cortical map plasticity? | Cortical maps are dynamic or changeable and depend on the amount and character of sensory experience (homunculus can change based on pt's experience; i.e. CTS). |
| What did napadow say about neuroplasticity? (This may not be important but ties things together) | It is widely known that altered afferent input patterns drive neuroplasticity in the cerebral cortex...Infact, aberrant somatopy has been described for other chronic pain states, such as CRPS. |
| Why is aberrant somatopy important? | It is important to chronic pain - Napadow's study states acupuncture corrects thus changing the plasticity and relieving pain. |
| Review fMRI notes for discussion on interventions, limbic system and study quotes. | Basically acupuncture works and we really need this break!! |
| What is the difference b/w a narrative and a systematic review? | Narrative does not typically include a specific methodology and may support bias; systematic approaches study reports w/ a specific and typically delineated methodology. |
| What does a systematic review involve? | The application of scientific strategies, in ways that limit bias, to the assembly, critical appraisal, and synthesis of all relevant studies that address a specific clinical question. |
| What does a quantitative systematic review provide? | Unspecified measurements as part of its report on the studies reviewed. |
| What is a meta-analysis? | A type of systematic review that uses statistical methods to combine and summarize the results of several primary studies; is a specific statistical technique of pooling data. |
| What is the goal of a meta-analysis? | To calculate a summary effect size and provide a confidence interval. |
| What are systematic reviews good for? | Used to inform medical decision making, plan future research agendas, and establish clinical policy, systematic reviews may strengthen the link b/w research evidence and optimal health care (design better studies w/ better intent). |
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kabrown
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