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Procedures are controlled to ensure that all participants in all study groups are treated the same except for the factor that is unique to their group. The primary goal of conducting an RCT is to test whether an intervention works by comparing it to a control condition, usually either no intervention or an alternative intervention.
Over the years, use of RCTs has increased in the medical, social, and educational sciences.
Do you think that 2 participants per treatment group would be considered sufficient in a contemporary RCT? Random assignment ensures that known and unknown person and environment characteristics that could affect the outcome of interest are evenly distributed across conditions.
Random assignment equalizes the influence of nonspecific processes not integral to the intervention whose impact is being tested. Random assignment and the use of a control condition ensure that any extraneous variation not due to the intervention is either controlled experimentally or randomized. In sum, the use of an RCT design gives the investigator confidence that differences in outcome between treatment and control were actually caused by the treatment, since random assignment (theoretically) equalizes the groups on all other variables.
Some people have ethical concerns about denying the control group an intervention that they believe will be helpful. The most common use for RCTs in the behavioral and social sciences is to examine whether an intervention is effective in producing desired behavior change, symptom reduction, or improvement in quality of life. Cognitive-behavioral therapy (CBT) is a style of therapy that focuses on changing troublesome thoughts, feelings, and behavior. A systematic review combining evidence from many RCTs conducted in different settings, with different populations, and somewhat different protocols was commissioned by the Cochrane Collaboration. The usefulness of a trial depends on the extent to which it lets us validly infer that the experimental treatment caused an outcome. Bias is a systematic distortion of the real, true effect that results from the way a study was conducted.
External validity is the extent to which the results can be generalized to a population of interest. The question here is: to what extent can the intervention, rather than other influences, be considered to account for differing outcomes between the treatment and control groups? By employing a control group and random assignment, the RCT design minimizes bias and threats to internal validity by equalizing the conditions on all "other influences" except for the intervention.
History: external events that occur during the course of a study that could explain why people changed. Maturation: processes that occur within individuals over the course of study participation that provide an alternate explanation of why they changed.
Temporal Precedence: in order to establish a causal relation between the intervention and outcome, the intervention must occur before the outcome. Selection: another threat to validity may occur if the experimental and control groups differ at baseline. Regression to the Mean: this threat refers to the tendency for extreme scorers to regress to the mean on subsequent measurements. Attrition: refers to a rate of loss of participants from the study that differs between the intervention and control groups. Testing and Instrumentation: these threats refer to changes due to the nature of measurement rather than the intervention itself. The question here is: to what extent can the results be extended to people, settings, and interventionists different than those used in this particular study?
Sample Characteristics: the extent to which we can generalize from the study sample to the population as a whole (or the population of interest). Investigators must balance the need for control, rigor, and efficiency with a desire to have results be relevant to the broad range of settings and populations they could potentially benefit.
Effects Due to Testing: refers to the potential for participants to respond differently because they know they are being assessed as part of research.
Efficacy trials are sometimes called explanatory trials, whereas effectiveness trials are also known as pragmatic trials.
Very few trials actually fall wholly into one of these categories, but rather fall along a continuum of pragmatic-explanatory. Where the study falls on the continuum will depend on many factors, including the stage of intervention development, research question, and resources available. However, later in development, once the treatment's efficacy has been established, an investigator may want to know whether the intervention can be more broadly applied in other settings and delivered by nonprofessionals who have less experience with the treatment.
The PRECIS (Thorpe et al, 2009) is a tool that can help investigators design an RCT that falls where they want it to on the continuum between pragmatic and explanatory. PRECIS itemizes key parameters about which investigators will make different design decisions depending on whether they are planning an explanatory or a pragmatic trial.
You know that randomized controlled trials provide the most effective way to control for extraneous influences when testing whether a treatment works. The sample selected for the study should as closely approximate the population of interest as possible. Will the selected sample be representative of the population to which I want to generalize?
How many eligible participants do I expect to need to screen in order to randomize the sample size I need?
An investigator wants to test the effectiveness of a school-based violence prevention intervention. Will the sample selected be representative of the population the investigator wants to reach? If the investigator invites children with a certain cluster of risk factors for violence to participate, will the resulting sample reflect the broader population he wants to serve? Selection bias is a systematic distortion of evidence that arises because people with certain important characteristics were disproportionately more likely to wind up in one condition. Selection bias threatens the equivalency of the groups and means that the randomization was unsuccessful at balancing important variables across conditions.
Inclusion and exclusion criteria are criteria that an investigator develops before beginning the study that will define who can be included and who will be excluded from the study sample. It is important to choose reliable and valid measures of inclusion and exclusion criteria so that the study sample validly reflects the population of interest. In this comparison, outcomes for people randomly assigned to receive the new treatment are compared to those of people assigned to receive no treatment at all. In this comparison, people randomized to receive the new treatment are compared to those randomized to be on a wait-list to receive the new treatment. In this comparison, the new treatment is compared to a control intervention that delivers the same amount of support and attention from a practitioner, but none of the key active intervention ingredients by which the new treatment is expected to cause change in the outcomes under study. This approach involves a "head-to-head" comparison between two or more treatments, each of which is a contender to be the best practice or standard of care.
Parametric studies are usually done early in the development of a new treatment in order to determine the optimal "dose" or format of treatment. Also called "component analysis," in this approach, people randomized to receive the full efficacious intervention are compared to those randomized to receive a variant of that intervention minus one or more parts. The goal of randomization is to produce study groups that are comparable on known and unknown extraneous influences that could affect the study outcome.
Sometimes randomization is not possible, and it is necessary to consider alternative designs.
Contamination occurs when individuals randomized to the intervention condition and those randomized to control are exposed to the wrong condition through having contact with each other. In fixed allocation randomization, each participant has an equal probability of being assigned to either treatment or control and the probability remains constant over the course of the study. This refers to the most elementary form of randomization, in which, every time there is an eligible participant, the investigator flips a coin to determine whether the participant goes into the intervention or control group.
Blocked randomization reduces the risk that different numbers of people will be assigned to the treatment (T) and control (C) groups. Blocked randomization offers the advantage that at any point in the trial, there will be a balance in the number of cases assigned to T versus C (which could be valuable if the trial needs to be stopped early). A disadvantage is that, with fixed blocks, research staff may be able to predict the group assignment of patients being randomized late in the block. In fixed allocation procedures, the probability of being assigned to any treatment stays constant over the course of the trial.
Minimization corrects (minimizes) imbalances that arise over the course of the study in the numbers of people allocated to the treatment and control.
In this procedure, if the imbalance in treatment assignments passes some threshold, the allocation is changed from chance to a bias in favor of the under-represented group. In minimization, a knowledge of the number (and sometimes the strata) of those already randomized shapes decisions about how the next participants will be allocated. In this procedure, like urn randomization, the first allocation is chosen at random from two different colored balls.
If after 10 randomizations, there are 7 patients assigned to intervention and 3 assigned to control, the coin toss will become biased. The investigator starts with off with an urn containing a red ball and a blue ball to represent each condition. Preferably, randomization should be completed by someone who has no other study responsibilities, because otherwise their knowledge of the patient's assignment could introduce bias. Allocation concealment means that the person who generates the random assignment remains blind to what condition the person will enter. Ideally, to minimize bias, both the participant and the investigator are kept blind to (ignorant of) the participant's random assignment. In double-blinding, neither the participants nor the investigator know the participants' treatment assignment.
Double-blinding is most feasible for drug trials, in which the effect of a medication is being compared to a placebo that looks similar. Even in placebo-controlled trials, guesswork about the drug assignment is often better than chance. Special care is needed to prevent staff and study participants from unblinding the outcome assessor. Especially when neither participant nor investigator can be blinded, it is best if participants and research staff hold equally positive expectations about the merits of the treatment and control conditions.
The state of equipoise, uncertainty about which intervention condition will work best, is also the ethical justification for conducting a trial. The outcome may be an event (or endpoint), such as death or hospitalization, or the onset or remission of a condition, like major depression.
The term intermediate endpoint or surrogate marker is sometimes used to designate an outcome that is correlated with but not identical to a clinical endpoint.
Biomarkers (like blood pressure, lipids, or obesity) or health risk behaviors (like smoking, eating a high fat diet, or being physically inactive) can be considered intermediate markers because they relate to disease.
Resource utilization and staff time can be monitored to measure the cost of implementing a new treatment. Many of the outcomes we measure in behavioral clinical trials are subjective (known only to the individual) and need to be measured by self-report. Q: If a person scores as depressed on a questionnaire but doesn't qualify for a depression diagnosis on a semi-structured interview, does the condition of depression exist in that individual?
Ongoing quality monitoring is necessary to detect errors and missing data in a timely manner that allows them to be corrected.
Some missing data are inevitable in a clinical trial; the goal is to minimize them as much as possible.
A thorough informed consent process that makes clear what is expected encourages participants to evaluate realistically whether they should enroll. A positive relationship with study staff is critically important for retaining participants. Because missing data truly convey no information and require making unverifiable assumptions, it is very important for research staff to elicit as much follow-up data as possible, even from participants who decline further participation in treatment.
Ongoing monitoring of missing data helps investigators understand and correct reasons for attrition. As the independent variable, the treatment plays the lead role in a trial testing whether an intervention works.
Conceptually, this means that the treatment protocol was operationalized and the interventionists delivered the active change ingredients specified by theory and did not deliver other change elements proscribed by the protocol. Differentiation also means that the control condition lacked the active change elements theorized to be integral to the intervention's effectiveness. Type I error, in which the researcher finds a significant treatment effect that does not really exist.
Type II error, in which case the researcher finds no treatment effect when an effect truly is present. Manuals help to standardize the delivery of a treatment and can be disseminated to facilitate the training of interventionists. Regardless of whether interventionists are professionals or peers, they need training in order to standardize treatment delivery. Supervise interventionists to ensure that they are delivering an intervention faithfully and without drift over time.
In addition to making efforts to induce fidelity, an investigator needs to assess whether those efforts were successful. Fidelity checklists specify stylistic and content elements that need to be implemented during the study to preserve treatment integrity. A checklist prescribes required treatment deliverables and proscribes elements that represent contamination (blending) from another study condition.
Achieving the competency standard may result in certification indicating that an interventionist is qualified to begin delivering treatment in a trial. How many study candidates will need to be screened in order to randomize the desired number? Studies with stringent exclusion criteria require a very large pool of potential participants because they screen out so many. Provider or colleague referrals, flyers and media advertising fall at the reactive end of the recruitment continuum. There are many reasons why participants drop out or fail to complete assessments in an RCT. It is critically important that research staff make every effort to complete outcome assessments with all randomized study participants a€“ including any who have stopped participating in treatment. Methods need to be in place to identify and report adverse events that occur during the course of a study. An adverse event (AE) is an undesirable health occurrence that occurs during the trial and that may or may not have a causal relationship to the treatment.
The reason to track adverse events is that they might suggest that there are risks associated with the intervention being studied.
Depending on the severity and frequency of adverse events, investigators and data safety monitors may have to decide to terminate the trial prematurely.
For most large RCTs, a data safety monitoring board (DSMB) (a group of people charged with monitoring participant safety and data quality) should be assembled before the trial begins. An investigator may hypothesize that a treatment works better for certain kinds of people or certain kinds of circumstances.
To test such hypotheses, the investigator pre-specifies the moderator variable of interest before the intervention is delivered.
Researchers often want to test whether their intervention produced the observed study outcome via the change mechanism that they hypothesized. An investigator wishes to understand how a parenting intervention improves symptoms of attention deficit hyperactivity disorder (ADHD) in children. Determination of whether a treatment works has been based traditionally on statistical significance testing. Recently, scientists have moved towards reporting effect sizes and confidence intervals, as these provide meaningful information about magnitude of change.
When testing interventions that address health problems, it is important to examine whether the observed change is clinically meaningful. The Number Needed to Treat (NNT) expresses the number of patients who need to receive the intervention to produce one good outcome compared to control.
In a multi-site study involving 5,000 women, an investigator studied the efficacy of an intervention to reduce depression among women with breast cancer.
Certain basic decisions need to be resolved before proceeding with data analysis for an RCT. It may seem odd to include people in the analysis who dropped out before receiving any treatment at all.
In an RCT testing whether a treatment works, the main study aim usually tests a predicted difference in the primary outcome between intervention and control at either 1) a final follow-up point or 2) the trajectory of change over time. Investigators should interpret non-primary analyses as post hoc and exploratory, especially if these were not planned in advance. A post hoc analysis of an RCT found an interaction indicating that treating depression after a heart attack decreased the risk of repeat heart attacks for white men, but increased the risk for white women. Type II error occurs when, based on study findings, the investigator fails to reject the null hypothesis.
To reduce the risk of a Type II error, the investigator should conduct a power analysis before doing the study, in order to determine the sample size needed to detect an effect of the expected size. Power calculations can be conducted using online or downloaded software packages such as G*Power or OpenStat.
The statistical method used in an RCT is designed to compare the intervention and control conditions' influence on the health outcome of interest to see if the effect differs.
In choosing an analytic technique, the first question that needs to be answered is whether the outcome varies continuously (like symptom severity) or categorically (like being hospitalized or quitting smoking). In an RCT with a continuous outcome, the study hypothesis usually predicts that treatment groups will differ on the study outcome at final follow-up. Although ANOVA is still used, newer statistical modeling strategies make less restrictive assumptions and have become more frequently used. Growth mixture models were developed to address the fact that intervention effects can vary for categories of people who are launched on different trajectories of change over time. The majority of patient's diets are rich in fats and low in carbohydrates and fibre 'western diet'.
Once the diagnosis established patients need information to help them understand the RISKS associated with diabetes and to help them make the appropriate lifestyle changes particularly with regard to diet and exercise. PRACTICE POINTThirsty patients often drink sweet juice to relieve thirst - simple advice on changing to low calorie drinks can dramatically reduce blood glucose. The following practical advice can be given initially to patients before their dietetic review.
Dietetic referral is mandatory for instruction on healthy eating, lifestyle change and probable calorie restriction. The majority of patients with Type 2 diabetes will ultimately require oral agents and many will eventually require insulin therapy therefore it is worth telling patients this at diagnosis.
If after three months diet and lifestyle changes are insufficient to achieve a target HbA1c of < 7% then an oral agent should be introduced. Initiation of dual therapy on diagnosis may be necessary for those with very high glucose concentrations and symptomatic. Various mechanisms of action have been proposed but it is thought that its main metabolic effect is mediated by an inhibition of hepatic gluconeogenesis and decrease hepatic output. The main mechanism of action of this group of drugs is to lower blood glucose by stimulating insulin secretion and hence their association with hypoglycaemia. Glimeperide 1 mg up to 4 mgs once daily may be useful in patients with adherence problems who find difficulty with multi-dosing. Postprandial glucose regulators such as Nateglinide or Repaglinide are second line drugs and not recommended without specialist consultation. Substitution of a Glitazone for metformin or sulphonylurea for those already on combination therapy is not recommended, as there is no evidence to support an improvement on glycaemic control.
The following paragraph has been taken from a press release from the European Medicines Agency (18th October 2007) following a review of this latest evidence. Having assessed all available data, the CHMP concluded that the benefits of both rosiglitazone and pioglitazone in the treatment of type 2 diabetes continue to outweigh their risks.


Remember peripheral edema and heart failure may be a side effects of glitazone therapy hence they are contraindicated if any history of liver disease or heart failure.
PRACTICE POINTThese agents take 4-6 weeks to attain maximal effect - do not expect an immediate response. Post prandial glucose regulators include Nateglinide or Repaglinide and are second line drugs. Acts by inhibiting glucose absorption and results in carbohydrate delivery to large bowel causing wind and cramps in a significant proportion of patients. Sitagliptin inhibits dipeptidyl peptidase 4 (DPP-IV) and thus prevents the degradation of incretin hormones, which are released from gut cells in response to a meal. The effects on glucose control seen with Exenatide treatment are thought to be due to several properties that are similar to those of the naturally occurring incretin hormone GLP-1.
Animal studies have shown that Exenatide helped preserve and form new beta cells, the insulin-producing cells in the pancreas, which fail as type 2 diabetes progresses. Exendin-4 was initially isolated from the venom found in the saliva of a poisonous lizard found in North America, known as the Gila monster.
Unlike most other oral hypoglycaemic drugs which work by a single mechanism, exendin-4 works by several mechanisms: it stimulates insulin secretion, slows emptying of the stomach and inhibits production of glucose by the liver. The Melanage Skin Lightening System is a superficial peel designed to improve the texture and appearance of hyperpigmented skin.
The mask is applied during an office visit, and removed by the patient at home after a required length of time, which will be designated by the Doctor. Results vary, but generally patients will see a significant improvement in the appearance of pigmented areas. One week before the treatment, we ask you to refrain from electrolysis, waxing, depilatory creams, laser hair removal treatments, cosmetic facials, Botox, etc. It is imperative that you use a sunscreen with an SPF of at least 30 and avoid direct sunlight for at least 1 week.
Patients with active cold sores or warts, skin with open wounds, sunburn, excessively sensitive skin, dermatitis or inflammatory rosacea, history of herpes simplex, pregnant or breast feeding (lactating) women, patients currently receiving chemotherapy or radiation, patients who have been on Accutane within the past year. Please feel free to use the blog below to share information about melanage peel or to ask Dr.
I had a melanage mini peel approximately two weeks ago for my melasma and I found some improvement but I would like to have the full melanage peel.
Melanage peel removes brown pigment from various sources, including post inflammatory changes associated with acne. I have used a derm prescribed 8% HQ 5% KA 1% HC cream for almost a decade with little success. Psychiatric disorders, particularly major depressive disorder (MDD), generalized anxiety disorder and eating disorders, are more prevalent in people with diabetes compared to the general population. People diagnosed with serious mental illnesses, such as MDD, bipolar disorder and schizophrenia, have a higher risk of developing diabetes than the general population.
All individuals with diabetes should be regularly screened for the presence of depressive and anxious symptoms. Compared to those with diabetes only, individuals with diabetes and mental health disorders have decreased medication adherence, decreased compliance with diabetes self-care, increased functional impairment, increased risk of complications associated with diabetes, increased healthcare costs and an increased risk of early mortality. The following treatment modalities should be incorporated into primary care and self-management education interventions to facilitate adaptation to diabetes, reduce diabetes-related distress and improve outcomes: motivational interventions, stress management strategies, coping skills training, family therapy and collaborative case management. Individuals taking psychiatric medications, particularly atypical antipsychotics, benefit from regular screening of metabolic parameters. Research is increasingly demonstrating a relationship between mental health disorders and diabetes. The prevalence of clinically relevant depressive symptoms among patients with diabetes is in the range of 30% (4–6).
Psychological stress, leading to chronic hypothalamic-pituitary-adrenal activation with cortisol release (20–25). Comorbid depression worsens clinical outcomes in diabetes, possibly because the accompanying lethargy lowers motivation for self-care, resulting in lowered physical and psychological fitness, higher use of healthcare services and reduced adherence to medication regimens (26,27). Patients with bipolar disorder have been found to have prevalence rates estimated to be double that of the general population for metabolic syndrome and triple for diabetes (34–36). The interplay between diabetes, major depressive disorder, and other psychiatric conditions. Eating disorders, such as anorexia nervosa, bulimia nervosa and binge eating, have been found to be more common in individuals with diabetes (both type 1 and type 2) than in the general population (39,40). Schizophrenia (SZ) and other psychotic disorders may contribute an independent risk factor for diabetes. Regular and comprehensive monitoring of metabolic parameters is recommended for all persons who receive antipsychotic medications, whether or not they have diabetes. Diabetes, both type 1 and 2, is a psychologically challenging disease for patients and their family members (57). Diabetes distress describes the despondency and emotional turmoil related specifically to having the condition, the need for continual monitoring and treatment, persistent concerns about complications and the potential erosion of personal and professional relationships. Individuals with diabetes should be regularly screened for psychological distress and psychiatric disorders via directed interviews. Table 2 illustrates the differences between the principal features and assessment methods of diabetes distress and MDD.
Given the burden associated with the demands of diabetes self-management, efforts to promote well-being and moderate distress should be incorporated into diabetes management for all individuals (86). Gains from treatment with psychotherapy are more likely to benefit psychological symptoms and glycemic control in adults than will psychiatric medications (which usually only reduce psychological symptoms) (98). Psychiatric medications have the capacity to affect metabolic parameters and cause changes in weight, glycemic control and lipid profile and, in some cases, can have immunomodulating effects (22,100–103). The CATIE study investigated 4 aspects of the effectiveness of antipsychotic medications: efficacy, tolerability, emergence of medical problems and patient choice (1,106). Individuals with diabetes should be regularly screened for subclinical psychological distress and psychiatric disorders (e.g. Austin started delivering her new treatment, and soon she observed that her patients seemed to get better.
Austin's measurements showed that, after receiving her treatment, the adolescents reported that their symptoms had improved and they were functioning better in their lives. Austin was pleased, but she couldn't be sure whether the improvement was actually caused by her new treatment or by other influencesa€”such as just getting attention from a therapist or the natural remission of symptoms over time.
However, the first instance of random allocation of patients to experimental and control conditions is attributed to James Lind, a naval surgeon, in 1747. The two patients who were given lemons and oranges recovered most quickly, suggesting a beneficial effect of citrus. The change reflects a growing recognition that observational studies without a randomly assigned control group are a poor way of testing whether an intervention works. The key methodological components of an RCT are (1) use of a control condition to which the experimental intervention is compared; and (2) random assignment of participants to conditions.
Nonspecific processes might include effects of participating in a study, being assessed, receiving attention, self-monitoring, positive expectations, etc. That allows the study's results to be causally attributed to differences between the intervention and control conditions. However, the reason for doing the RCT is that it isn't truly known whether the new treatment will help, harm, or have no effect. The review found remission of an anxiety disorder in 56% of anxious children treated with CBT - twice the remission rate found in controls (James, Soler, Weatherall, 2005). The ability to make valid inferences depends on how well the investigator designed, conducted, and reported various procedures to minimize bias in the study. The population of interest is usually defined as the people the intervention is intended to help.
Concern about external validity can arise when a study intervention is delivered by highly trained research staff in an academic setting. This choice often hinges on the stage of intervention development and where the particular study falls on the spectrum from testing efficacy to effectiveness. In the beginning stages, an investigator usually wants to know whether the treatment can work and, therefore, is worth developing further.
Entry and exclusion criteria, the expertise and training of interventionists, and the degree of flexibility they are allowed in administering the treatment differ in the two kinds of trials. In this module, you'll learn more about the important considerations that are involved in designing an RCT. He identifies his population of interest as public school children in grades 9-12 in the city where he lives, whose parents allow them to participate. Or will enrollment be restricted to only students with risk factors for violence or a history of violent behavior? How will he ensure an adequate number of girls and ethnic minorities (if he wants the intervention to help these groups)?
Although random assignment theoretically eliminates selection biases, a bias can still occur. Jones conducted a placebo-controlled RCT testing the efficacy of a new medication to prevent recurrent heart attacks. Important variables are any that relate theoretically or statistically to the study's outcome. The question is whether the new treatment produces any benefit at all, over and above change due to the passage of time or the effects of participating in a study. Using a wait-list control has the advantage of letting everyone in the study receive the new treatment (sooner or later). Treatment as usual helps to equalize groups on the expectation of benefit since both groups receive an intervention, although those randomized to the new intervention may still expect something special.
To detect a difference between conditions, comparative effectiveness trials require many, many participants in each treatment group. Different forms of the intervention varying on factors such as the number, length, or duration of sessions comprise the conditions to which people are randomly assigned.
Those in the experimental condition receive added treatment components that are hypothesized to add efficacy. Dismantling designs are usually used late in a treatment's development, after the intervention's efficacy is well-established. Randomization achieves this goal by giving all participants an equal chance of being in any condition. This prevents randomizing participants who drop out before participating in any of the study.
In quasi-experimental designs, participants are assigned to a study condition using some non-random (but systematic) procedure. Bear in mind, though, that non-random assignment heightens the risk of bias, so random assignment is preferable. Contamination can occur either inadvertently or intentionally as people discuss their experiences. However, it introduces the problem that settings can have unique properties whose influences become confounded with treatment assignment. However, she worries that if she randomizes teachers within a school to receive the intervention or not, there may be contamination. That can be achieved by using a table of random digits or randomization software (in SAS, SPSS, and other major software programs). A random process can result in the study winding up with different numbers of subjects in each group.
That risk is reduced by using the method of randomly permuted blocks and keeping research staff blind to the randomization process.
Before doing the trial, the investigator decides which strata are important and how many stratification variables can be considered given the proposed sample size. In adaptive procedures, the allocation probability changes in response to the balance, composition, or outcomes of the groups. In responsive adaptive randomization, knowledge of how the allocated participants have responded to the interventions influences the next allocation probability. If the participant has a positive response to the treatment, a ball of the same color is added to the urn. If the first draw pulls the red ball, then the red ball is replaced together with a blue ball, increasing the odds that blue will be chosen on the next draw. If allocation is not concealed, research staff is prone to assign "better" patients to intervention rather than control, which can bias the treatment effect upward by 20-30% (Wood, 2008). This level of blinding reduces the influence of expectations held by participants or by research staff about which treatment will have a better effect on the outcome. Masking can be improved by using an active placebo that has the same side effects as the drug but lacks its therapeutic effects. It is critically important that investigators think through and specify in advance the outcomes they plan to measure to test whether their treatment works. Symptoms of anxiety and perceived quality of life illustrate two outcomes that need to be self-reported. A device called a MEMS cap, which records the opening of a prescription bottle, measures medication compliance objectively. A semi-structured interview usually constitutes the gold standard for diagnosing a psychological condition. Conceptually, the integrity or construct validity of an intervention is the degree to which the treatment protocol operationalizes the influences that the theory posits cause change. In designs that test more than one active intervention condition, the theoretically active change ingredients should differ as intended.
The protocol specifies the components, sequence, and underlying rationale for the intervention. It explains the theory underlying the intervention well enough to help interventionists decide how to manage unexpected issues that arise during treatment.
Other interventions can be performed by less highly trained interventionists or even by peers.
Meeting pre-specified performance criteria on a checklist can be taken as evidence that interventionists have achieved competence in the intervention.
If fidelity falls below a certain criterion, interventionists will need to be retrained to eliminate drift.
Common recruitment sources include: clinics, private practices, community centers, schools, or media advertisements.
Active case finding via review of medical records or random digit dialing represent more proactive approaches.
Incentives make recruitment easier, but their use can also raise questions about the external validity of the trial. Burden and drop-out are reduced by keeping assessments brief and allowing as much flexibility as treatment fidelity can accommodate.
The SAE needs to be reported regardless of whether it bears any relationship to the treatment or the problem being studied. SAEs need to be reported immediately to the DSMB, the institutional review board, and the funding agency, which determine if any action needs to be taken. The DSMP may have one or two people or an institutional committee who are designated as data safety monitors.
The test of moderation is whether the variable influences the strength or direction of the association between the intervention and outcome. If so, the investigator hypothesizes mechanisms of change (mediators) and measures them over the course of the study.
The investigator hypothesizes that the intervention achieves its benefit by improving communication and decreasing conflict in the parent-child relationship.
In the case of RCTs, the effect size represents the magnitude of the difference between the control and intervention conditions on a key outcome variable adjusted for the standard deviation of either group. That policy, known as the intent to treat (ITT) analysis principle, is a cornerstone of good clinical trial practice.
When planning the trial, statistical power should be computed to choose a sample size adequate to detect the predicted effect, if one is present. There is great danger of cherry-picking or fishing by performing multiple comparisons and selectively reporting those that turn out as hoped.
However, it should be noted that any findings require replication because they may have arisen by chance alone. On the basis of that evidence, an insurance company decides not to pay for depression treatment for women who become depressed after having a heart attack. This error occurs when findings lead an investigator to reject the null hypothesis of no difference between treatment and control, when in fact there is no true difference between them. However, the null hypothesis should have been rejected because there is a real difference between treatment and control. It examines the effect of an independent categorical factor (such as treatment allocation) on a continuous outcome variable. That is, at least in part, because they make the less restrictive assumption that missing data are missing at random (MAR), rather than missing completely at random (MCAR). They allow for the estimation of individual means, variances, regression coefficients, and covariances for the randoma€”latent or unobserveda€”effects that characterize each individual's growth pattern.
For instance, a new depression treatment might be helpful for patients whose initial symptoms are high and improving. Diet and low levels of physical activity are the major causes of obesity and contributing factors to diabetes.
Drugs used to treat type 2 diabetes aims to correct the underlying abnormality, namely insulin resistance (metformin, glitazones) and insulin secretion (sulphonlyureas). Metformin has been shown to reduce blood glucose concentration by approximately 25% with a greater effect on postprandial readings.
The glucose lowering effect is mediated by activation of the PPARχ receptor, which results in, increased peripheral glucose disposal and decreased hepatic glucose output and subsequent decreased peripheral insulin resistance.
It is also suggested that Glitazone therapy be discontinued after 12 weeks if there is no observed benefit.
All patients on glitazone treatment should be reviewed to ensure therapy is appropriate and within the product license. Do not use Rosigltazone in patients with pre-exsisting cardiovascular disease or PVD or in the elderly. Regular monitoring of liver function is required and outlined in the BNF (at baseline and every 2 months for the first year). It gives effective control of post prandial hyperglycaaemia but is poorly tolerated by most patients. GIP and GLP-1 (Glucagon like peptide) increase insulin release in the presence of elevated glucose thereby decreasing the post meal rise in glucose concentration and reducing fasting blood glucose. These actions include stimulating the insulin response in response to glucose and preventing glucagon (a hormone which raises blood sugar) release after meals.
Patients are then responsible for following an easy, at-home regimen, which involves the application of several Melanage products which will be provided during the office visit. Patients with serious mental illnesses, particularly those with depressive symptoms or syndromes, and patients with diabetes share reciprocal susceptibility and a high degree of comorbidity ( Figure 1). Some evidence shows that treatment for mental health disorders may actually increase the risk of diabetes, particularly when second-generation (atypical) antipsychotic agents are prescribed (1). The prevalence of major depressive disorder (MDD) is approximately 10% (7,8) , which is double the overall prevalence in people without a chronic medical illness. One study estimated that 14% of individuals with diabetes suffered from generalized anxiety disorder, with double this figure experiencing a subclinical anxiety disorder and triple this figure having at least some anxiety symptoms (38). Depressive symptoms are highly comorbid with eating disorders, affecting up to 50% of patients (41). A weight gain of between 2 to 3 kg was found within a 1-year time frame with amitriptyline, mirtazapine and paroxetine (51).
It interferes with quality of life and is a risk factor for diabetes-related distress as well as the psychiatric disorders listed above. Distinguishing between diabetes distress, MDD and the presence of depressive symptoms is important (72,73) because these psychological experiences are different, and, of the three, diabetes distress may be most strongly related to adverse diabetes outcomes (72,74,75). No data presently demonstrate the superiority of one particular depression screening tool over another (76).


Motivational interventions (68,87,88) , coping skills, self-efficacy enhancement, stress management (89,90) and family interventions (91–93) all have been shown to be helpful.
A meta-analysis of psychological interventions found that glycemic control (A1C) is improved in children and adolescents with type 1 diabetes (99).
The results did indicate that some antipsychotic medications were more likely to cause weight gain, worsen glycemic control and induce unfavourable changes in lipid profile.
Cognitive behaviour therapy (CBT) alone [Grade B, Level 2 (33)] or in combination with antidepressant medication [Grade A, Level 1 (95)] may be used to treat depression in individuals with diabetes.
Regular metabolic monitoring is recommended for patients with and without diabetes who are treated with such medications [Grade D, Consensus].
The trial, published in the British Medical Journal in 1948, tested whether streptomycin is effective in treating tuberculosis. However, once a treatment has shown efficacy, later effectiveness RCTs evaluate generalizability. As a result of the accumulation of high-quality evidence in this area, CBT is now considered the front-line treatment for childhood anxiety disorders. The change was not the result of some other extraneous factor, such as differences in assessment procedures between intervention and control participants. Negative life events, such as these, may offer an alternative explanation for study outcomes. Thus, if more children in the control than the treatment group reached puberty during the course of the study, that might explain why the control group finished the study with more depression than the treated group. A broadly representative sample enables the findings to be generalized to a diverse population.
The question is whether the intervention could be applied by less professionally credentialed staff in an under-resourced setting. She would like her findings to generalize to the broadest possible population of depressed adolescents, so she leans toward doing a pragmatic trial.
The investigator may opt to keep sample size manageable by conducting a very tightly controlled efficacy study.
Although he randomized patients to drug versus placebo, more overweight people were assigned to his placebo condition. The choice of a control condition usually depends on the specific question being asked and the state of existing knowledge about the intervention under study. A challenge with this control condition is that people randomized to no treatment may find their own treatment outside the bounds of the study. A limitation is that expectations of improvement differ between the treatment and control group. However, treatment as usual is particularly well-suited to answer the practical question of whether introducing the new treatment could improve outcomes over and above the current state of practice. That is because all of the interventions being compared are known to work, so the expected difference between them is relatively small.
An additive trial may be conducted early in treatment development or after a treatment is well-established, to see if its efficacy can be improved even further. This is important because everyone who gets randomized needs to be included in the study's analyses. The cost to internal validity is that people in the control condition receive part of the intervention. She fears that teachers will talk to each other about the study, and that control group teachers will observe intervention teachers' behavior and model it, even though they were not randomized to receive the intervention. For example, with a fixed block size of 4, then patients can be allocated in any of the orders: TTCC, TCTC, CTCT, TCCT, CTTC, or CCTT. However, this approach is complex to implement and may be inappropriate for smaller trials.
Adaptive randomization procedures remain controversial because they allocate patients not purely at random but partly dependent upon what has already occurred in the trial. Pragmatically, treatment fidelity describes whether the interventionist delivered the treatment as planned. Stylistic competences may include communication clarity, rapport-building, and clinical skills. That requires taping or coding live sessions on an ongoing basis using a fidelity checklist.
Click each item to learn more about steps that investigators can take to increase their odds of recruiting and retaining the desired sample. Reactive is ordinarily less expensive than proactive recruitment, but open to question about the representativeness of those who seek out research participation. There are, however, certain things that investigators can do to retain participants and, thereby, reduce drop-out and missing data. Conducting ongoing evaluation of progress toward interim recruitment goals helps to diagnose problems. Depending on the severity and frequency of adverse events, the DSMB is empowered to terminate the trial prematurely.
This change was statistically significant, probably due to the very large sample size and power to detect very small effects. All participants who were randomized and entered the trial need to be included in the analysis in the condition to which they were assigned, regardless of whether they completed the trial, or may even have switched over to receive the incorrect treatment.
The analysis addresses the question of whether the study treatment, if made available to the population, would be superior to an alternative intervention.
Results of per protocol analysis represent the best case treatment results that could be achieved if the study sample were retained and remained compliant with treatment. In that case, testing a hypothesized treatment by demographic group interaction would be a primary aim that definitely needs be tested.
A good starting point in the management of type 2 diabetes is dietary modification with a reduction in energy intake promoting weight loss and alleviation of diabetic symptoms. It does not tend to lower blood glucose reading below normal and thus the risk of hypoglycaemia is minimal.
The second generation sulphonlyureas such as glibenclamide and glipizide have shorter half-life's that for example chlorpropamide or tolbutamide and hence of greater importance when hypoglycaemia is a side effect. Troglitazone was the first drug in this class to be introduced however it was withdrawn from the market due to serious hepatotoxic effects. In fact Pioglitazone was found to have a significantly lower risk of death, myocardial infarction, or stroke among a diverse population of patients with diabetes. In addition, the combination of rosiglitazone and insulin should only be used in exceptional cases and under close supervision. They are possibly advantageous in the avoidance of hypoglyacemia and control of post prandial glucose excursions particularly in the elderly where hypoglycaemia is a concern. There is no pain and little-to-no irritation during the application of the mask, and the irritation level on the following days is like a sunburn.
This complimentary take-home product kit is tailored to maximize the results of your treatment.
The fee for localized microdermabrasion on the chin is $50 and for a localized glycolic acid peel to chin it is also $50. Biochemical changes due to the mental health disorders themselves also may play a role (2). Individuals with depression have an approximately 60% increased risk of developing type 2 diabetes (9). One study found that the requirement for insulin was the factor associated with the highest rate of depression, regardless of the type of diabetes involved (14). Treating depressive symptoms more reliably improves mood than it does glycemic control (30–33). Type 1 diabetes in young adolescent women appears to be a risk factor for development of an eating disorder, both in terms of an increased prevalence of established eating disorder features (42,43) as well as through deliberate insulin omission or underdosing (called diabulimia). The Clinical Antipsychotic Trials for Intervention Effectiveness (CATIE) study found, at baseline, that of the individuals with SZ who participated in the study, 11% had diabetes (type 1 and 2 combined) (1). A study of patients with type 2 diabetes and SZ who were treated with antipsychotic medications also showed worsening glycemic control requiring the addition of insulin therapy over a 2-year period with a hazard ratio of 2.0 (52).
Challenges accompanying the diagnosis of diabetes include adjustment to the disease, adherence to the treatment regimen and psychosocial difficulties at both a personal and an interpersonal level (58,59).
Currently available screening instruments have a sensitivity of between 80% and 90% and a specificity of 70% to 85% (76).
Case management by a nurse working with the patient’s primary care physician and providing guideline-based, patient-centred care resulted in improved glycated hemoglobin (A1C), lipids, blood pressure and depression scores (94). Furthermore, evidence suggests interventions are best implemented in a collaborative fashion and when combined with self-management interventions (95). The consensus statement issued by the American Diabetes Association in 2004 contains recommendations regarding almost all of the atypical agents currently available in Canada (55) , as does the Canadian Diabetes Association position paper from 2005 (105).
However, when these effects were considered in the context of efficacy, tolerability and patient choice, no conclusive statements could be made about which medications to clearly use or which to clearly avoid. Austin got approval from her university and consent from her adolescent patients and their parents to measure the patients' symptoms and functioning before and after they received the treatment. Because the drug was in short supply, Hill devised randomization partly as a strategy to keep doctors from trying to maneuver their patients into the streptomycin arm of the trial. Inferences about validity fall into four primary categories: internal, external, statistical conclusion, and construct validity.
Consequently, it is very useful that random assignment equalizes these occurrences across the treatment and control conditions. Austin's control group and none of the children in her treatment group had a parent laid off in the shutdown. It may also allow the investigators to explore whether the treatment appears more or less effective with some population subgroups. However, she has doubts about whether the treatment will work with adolescents who have substance abuse disorders or symptoms of antisocial personality. Should the investigator send study staff to the school to do the recruitment or should he rely on school personnel? Because being overweight heightens the risk of heart attack, a lower heart attack rate among drug- than placebo-treated patients could occur for one of two reasons. Nevertheless, investigators need to measure these characteristics at baseline to evaluate their equivalency across conditions. The control group knows that they are not yet receiving an active treatment and has no reason to expect positive change.
The questions in comparative effectiveness are usually: (1) which intervention works better?; and (2) at what relative costs? One variant of a dismantling design aims to find the "MINC" a€“ the minimum intervention needed to produce change.
In response, the researcher decides to randomize different schools to receive the teacher intervention or no intervention. The aim of adaptive procedures is efficiently to increase the sample's probability of being assigned to the best treatment. This procedure is meant to maximize the number of participants receiving the "superior" intervention. However, the staff who assess the study outcome can and should be kept blind to the patient's treatment condition. So, in this case, in the absence of other valid evidence suggesting depression, we would conclude that the person is not currently depressed.
Most important is that study personnel establish a positive relationship with research participants. However, even though depression scores decreased after the intervention, the average score remained in the clinical range, indicating severe depression. Offering an intervention that many people would elect not to undergo represents poor public health policy, even if those who did complete the treatment fared very well. The important caveat is the need to remember that unplanned subgroup analyses are done in the context of discovery rather than confirmation. Regular exercise in conjunction with calorie restriction will enhance weight loss but must be tailored to the individual.
Currently there are two glitazones licensed for use in the UK namely Rosiglitazone and Pioglitazone.
The position statement by the Association of British Clinical Diabetologists (ABCD) advocates the addition of a glitazone to metformin as a second line agent, as this combination tackles insulin resistance and thus may benefit cardiovascular risk factors and metabolic syndrome.
Serious heart failure is increased by pioglitazone, although without an associated increase in mortality (JAMA Volume 298(10), p 1180¡V1188).
These changes will be introduced in forthcoming regulatory procedures for rosiglitazone-containing medicines.
This drug are currently not on the BJF but may be used in special situations where the clinician feels that benefit may be derived from its use. Studies have shown that patients receiving Exenatide achieve weight loss in the region of 2.5kg, whereas those treated with insulin gain weight to a similar degree. It is not licensed for combination with glitazones (Rosiglitazone or Pioglitazone) or insulin. I experienced minor peeling (which has stopped) and I do not have any residual redness or irritation. Lifestyle changes and symptoms of mental health disorders are also likely to contribute (3). The prognosis for comorbid depression and diabetes is worse than when each illness occurs separately (10). Night eating syndrome (NES) has been noted to occur in individuals with type 2 diabetes who have depressive symptoms. The prevalence of metabolic syndrome was approximately twice that of the general population (47). Stress, deficient social supports and negative attitudes toward diabetes can impact on self-care and glycemic control (60–64). A website that contains a wide variety of downloadable scales that are in the public domain is available here. A comprehensive review and meta-analysis looked at the effect of antidepressants on body weight (51).
Consequently, all 4 aspects are important and reinforce the need for regular and comprehensive metabolic monitoring. Earlier in his career, Hill believed that simply alternating the assignment of hospital admissions to drug versus control worked well enough.
If the treated children were less depressed than the control children at the end of the study, Dr. After talking with a statistician, she realizes that she would need a much larger sample size to conduct a pragmatic trial, because she expects the treatment effect to be less consistent than it would be in an efficacy trial. Other possible threats are that people content to sit on a waiting list may be atypical (unusually cooperative), or they may seek other "off-study" treatments on their own.
Some countries and some insurers use comparative effectiveness findings to determine which treatments to pay for. The aim, from a public health perspective, is often to find a low-cost, minimally intensive intervention that improves outcomes for a small percent of the population, which equates in absolute numbers to a large number of people being helped.
Adaptive methods were developed in response to ethical concerns about assigning participants to conditions that are known to be inferior. For that reason, the disposition of the sample from the moment they learn their allocation is relevant to evaluating the treatment.
Furthermore weight loss will have a positive effect on blood pressure (BP) and lipid profile thus favorably altering the cardiovascular risk profile associated with type 2 diabetes. Metformin is the drug of first choice in all patients with diabetes to which a sulphonlyurea or pioglitazone or sitagliptin can be added if it fails to achieve good glycaemic control.
However given that the plasma levels of most short acting sulphonlyureas will have fallen to a low trough before breakfast it may be sensible to advise taken the dose 30 minutes before breakfast and subsequent doses with meals. No changes to the prescribing information for medicines containing pioglitazone were considered necessary. However, they do not lower the HbA1c any more than exsisting therapies, have cost implications and limited long term safety data. This is characterized by the consumption of >25% of daily caloric intake after the evening meal and waking at night to eat, on average, at least 3 times per week.
Whether the increased prevalence of diabetes is due to the effect of the illness, antipsychotic medications or other factors, individuals with psychotic disorders represent a particularly vulnerable population. Olanzapine and clozapine have been shown to have the greatest weight gain, with a mean increase of >6 kg over a 1-year span compared with 2 to 3 kg for quetiapine and risperidone, and 1 kg for aripiprazole and ziprasidone, also over a 1-year time frame. Diabetes management strategies ideally incorporate a means of addressing the psychosocial factors that impact on individuals and their families.
Evidence from systematic reviews of randomized controlled trials supports cognitive behaviour therapies (CBT) and antidepressant medication, both solely or in combination (33,95). Should medical problems arise while a patient is taking psychiatric medications, clinical judgement will dictate, on a case-by-case basis, as to whether modifications such as diet or exercise, adding a medication to address the emergent issue (e.g. Her treatment combines a few techniques that have previously been shown to be effective with ideas of her own about what might be helpful. Later he recognized that simple alternation led to selection bias because the sequence was too easy to predict. She decides that her first priority is to learn whether her treatment can work, and conducts an efficacy trial. Alternatively, patients randomized to the drug treatment group could have been less at risk because they were less overweight.
A challenge is that the outcome of each treatment is often not known at the time that the next patients need to be assigned.
Smoking poses a significant cardiovascular risk and therefore must be discouraged in all diabetic patients.
A sulphonlyurea would be the drug of choice in those who are intolerant of metformin and as add on therapy if Metformin alone fails to achieve adequate control. Pioglitazone has recently been licensed for use with insulin Scottish Medicines Consortium pioglitazone (Actos). Please use adequate zinc or titanium dioxide containing sunscreens or sunscreens made by Anthelios or products by Johnson and Johnson that show the Helioplex sign.
Episodes of MDD in individuals with diabetes are likely to last longer and have a higher chance of recurrence compared to those without diabetes (12). NES can result in weight gain, poor glycemic control and an increased number of diabetic complications (44).
The main impact on lipid profile is an increase in triglyceride and total cholesterol levels, especially with clozapine, olanzapine and quetiapine (1,53). No evidence presently shows that the combination of CBT and medication is superior to these treatments given individually.
That realization led to the use of a random numbers table to generate the numeric series by which patients would be assigned to conditions. A pilot study of 50 patients with type 2 diabetes who initially had a moderate level of depression at baseline showed an improvement in the severity of their depression (moving to the mild range) with a 12-week intervention of 10 CBT sessions combined with exercise in the form of 150 minutes of aerobic activity weekly. Handbooks are available that allow clinicians to quickly review the major side effect profiles of psychiatric medications (108,109).
Just as plausibly it might have been that the children in her treatment experienced a lower number of stressful life events than the control children. Fortunately, randomizing patients to conditions increases the probability that the treatment and control groups will have similar exposure to extraneous events.
Gliclazide, Glipizide, Glimepiride) in addition to Exenatide, may suffer from hypoglycaemia. Given that the person with diabetes carries out 95% of diabetes management (65) , identifying depressive syndromes in diabetes is important since depression is a risk factor for poor diabetes self-management (66–68) and outcomes, including early mortality (69,70). The SMC has accepted Exenatide for restricted use for the treatment of type 2 diabetes mellitus.



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