ResearchMethods Reading 2 -exam 1

ResearchMethods Reading 2 -exam 1 - CH“3§AP?ER QU‘TUNE...

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Unformatted text preview: CH“3§AP?ER QU‘TUNE 0 Real—World Profile of Sylvester Colligan 0 The Placebo in Treatment and Research a Research Methods in Psychology 5’ Research Methods in Epidemiology 0 Determining Causation 9 Research Tools QUESTlQNS This chapter focuses on five basic questions: “it What are placebos, and how do they affect research and treatment? 5. How do theory and measurement contribute How does psychology research contribute to health knowledge? How has epidemiology contributed to health knowledge? How can scientists determine if a behavior causes a disease? to health psychology? Part 1 /Foundations of Health Psychology CHECK YOUR EELlEFS Check the items that are consistent with your beliefs. T] Ll 1. |\.) DJ . Information from longitu— :1 Placebo effects can influ— ence physical as well as psychological problems. Pain patients who expect a medication to relieve their pain often experience a reduction in pain, even after taking a “sugar pill.” Personal testimonials are a good Way to decide about treatment effectiveness. Newspaper and televi— sion reports of scientific research give an accurate picture of the importance of the research. dinal studies is generally more informative than information from the study of one person. . All scientific methods yield equally valuable results, so the research method is not important in determining the validity of results. . In determining important health information, studies with nonhuman subjects can be just as important as those with human partici- pants. . Results from experimental research are more likely than results from observa- tional research to suggest the underlying cause for a disease. . Valuable research is done by people outside the scientific community, but El 10. El 11. scientists try to discount the importance of such research. Scientific breakthroughs happen every day. New reports of health research often contradict previous findings, so there is no way to use this informa- tion to make good personal decisions about health. Items 1, 2, 5 , and 8 are consistent With sound scientific information, but each of the other items repre‘ sents a naive or unrealistic View of research that can make you an uninformed consumer of health re- search. Information in this chapter will help you become more sophis— ticated in your evaluation of and expectations for health research. : hearth/oath Preteens or $‘iLTJESTER Querieaa Sylvester Colligan was a 76—year—old man who had been having trouble with his right knee for five years (Talbot, 2000). His doctor diagnosed arthritis but had appearance of an active treatment and that may cause participants to improve or change because of their belief in the placebo’s efficacy. Moseley suspected that this type of expectation and not the surgery was producing improvements, so he designed a study in which half the participants received sham knee sur— geryuthey received anesthesia and surgical lesions to the knee, but no further treatment. The other half no treatment that would help. However, this physician told Colligan about an experimental study conducted by Dr. J. Bruce Moseley. Colligan talked to Moseley and reported,"l was very impressed with him, especially when l heard he was the team doctor with the [Houston] Rockets. . . . 50, sure, I went ahead and signed up for this new thing he was doing” (quoted in Talbot, 2000, p. 36). Moseley and his colleagues (2002) were conduct— ing a study of the effectiveness of arthroscopic knee surgery. This type of procedure is widely performed but expensive, and Moseley had doubts about its effectiveness (Talbot, 2000). So, Moseley decided to perform an experimental study that included a pla- cebo as well as real arthroscopic surgery. A placebo is an inactive substance or condition that has the ofthe participants received surgical treatment.The participants agreed to be in either group, knowing that they might receive sham surgery. The participants didn’t know for several years whether they were in the placebo or the arthroscopic surgery group. in Moseley’s study (Moseley et al., 2002), Sylvester Colligan was in the placebo group, but his knee im- provedTwo years after the surgery, Colligan reported that his knee hadn’t bothered him since the surgery. ”it’s just like my other knee now. 1 give a whole lot of credit to Dr. Moseley. Whenever i see him on the TV during a basketball game, i call the wife in and say, ’Hey, there’s the doctor that fixed my knee! ” (quoted in Talbot, 2000, p. 36). aolligan’s experience as a patient may be common: Belief in the effectiveness of x—J treatment boosts the treatment’s effective- ness. However, this effect presents a problem for researchers like Moseley, who want to determine which effects are due to treatment and which are attributable to expectation. This problem is one of the issues considered in this chapter. This chapter looks at the way scientists work, emphasizing psychology from the behavioral sciences and epidemiology from the biomedical sciences. These two disciplines share some meth— ods for investigating health-related behaviors, but the two areas also have their own unique contributions to scientific methodology. Before we begin to examine the methods that psycholo- gists and epidemiologists use in their research, we need to consider the situation that Sylvester Colligan experiencedwimprovement due to the placebo effect. as massage an “teammates“ arse assesses Sylvester Colligan knows that his knee is better, and he attributes the improvement to Dr. Moseley and his surgery. Like many people receiving treat— ment, Colligan benefited from his positive expec— rations; he improved, even though he received sham surgery. However, these same expectations can become a disadvantage to scientists trying to evaluate the effectiveness of treatments. Thus, the placebo effect may be helpful to individuals who receive treatment but complicate the job of researchers; that is, it can have treatment benefits but research drawbacks. Treatment and the Placebo The potency of “sugar pills” has been recognized for years. Henry Beecher (1955) observed the effects of people’s beliefs and concluded that the therapeutic effect of the placebo was substan- tial—about 35% of patients showed improve- ment. A later review of more than 200 articles dealing with the placebo effect and pain (Turner, Deyo, Loeser, Von Korff, 6C Fordyce, 1994) re— vealed that some improvement rates were higher than 35%, but some were lower. For example, Chapter 2 /Conclucting Health Research 23 some researchers (Kirsch, Moore, Scoboria, 86 Nicholls, 2002) have argued that the placebo effect is responsible for up to 80% of the effec— tiveness of antidepressant drugs. A meta—analysis of migraine headache prevention (Macedo, Bafio, 85 Farré, 2008) indicated a placebo effect of 21%. However, placebos have little effect on broken bones (Kaptchuk, Eisenberg, 851(0mar0ff, zoozy Both physician and patient expectations can produce reductions in pain, and physicians who appear positive and hopeful about treat— ment prompt a stronger response in their patients (Moerman, 2003). Placebo responses are also re— lated to other characteristics of the practitioner, such as his or her reputation, attention, interest, and concern (Moerman 85 Jonas, 2002). The type of treatment is also a factor: Big pills are more ef- fective than little ones; colored pills work better than white tablets; capsules work better than tab— lets; two doses provoke a larger placebo response than one dose (Shapiro, 1970). An injection is more powerful than a pill, and surgery tends to ' prompt an even larger placebo response than an injection does. The underlying cause of the placebo effect has been the subject of intense debate and extensive research. Although improvements due to placebo treatments have been assumed to be psychologi— cally based—“It’s in people’s heads”-——a grow- ing body of research suggests that the effects have a physical as well as a psychological basis (Benedetti, 2006; Scott et al., 2008). For example, placebo analgesic can alter levels of brain activity in ways that are consistent with the activity that occurs during pain relief from analgesic drugs (V/ager et al., 2004). Placebo surgery has also demonstrated some effectiveness in alleviating the effects of Parkinson’s disease (de la Fuente- Fernandez, Schulzer, 85 Stoessl, 2004; McRae et al., 2004). Placebos have been found to reduce or cure a remarkable range of disorders and symptoms, including insomnia, low back pain, burn pain, headache, asthma, hypertension, and anxiety (Hrobjartsson 55 Gotzsche, 2001, 2004). These findings suggest that the underlying physiological mechanisms for placebo responses are the same as for drug treatments (Finniss <36 Benedetti, 2005). 22 Part I / Foundations of Health Psychology In addition, drugs that block the action of anal— gesic drugs also block the placebo response to analgesic drugs. Placebos can alter neurotrans— mitters, hormones, and endorphins, potentially producing a variety of perceptual, behavioral, and physical effects. Placebos are also capable of producing ad— verse effects, called the nocebo effect (Scott et al., 2008; Turner et al., 1994). Nearly 20% of healthy volunteers given a placebo in a double- blind study experienced some negative effect as a result of the nocebo effect. Sometimes, these negative effects appear as side effects to the pla— cebo drugs, which show the same symptoms as other drug side effects, such as headaches, nau- sea and other digestive problems, dry mouth, and sleep disturbances. The presence of negative effects demonstrates that the placebo effect is not merely improvement but includes any change resulting from receiving a treatment. Recent re— search (Scott et al., 2008) showed that the nocebo response also activates specific areas of the brain and acts on neurotransmitters, giving additional support to its physical reality. Expectancy is a major component of the pla— cebo effect (Finniss {SC Benedetti, 2005; Stewart— Williams, 2004). People act in ways that they thin/e they should. Thus, people who are treated without their knowledge do not benefit as much as those who know what to expect. In addition, cultural beliefs about what constitutes effective treatment are important in eliciting a placebo re- sponse (Moerman 86 Jonas, 2002). Learning and conditioning are also factors in the placebo re— sponse. Receiving treatment may evoke responses that people have associated with such procedures. That is, through classical and operant condition— ing, people associate treatment with getting better, creating situations in which receiving treatment leads to improvements. Thus, both expectancy and learning contribute to the placebo effect. When patients’ positive expectations increase their chances for improvement, the placebo is a valuable adjunct in treatment. Any factor that enhances effectiveness is a bonus. Indeed, in most situations involving medical treatment, patients’ improvements may result from a combination of treatment plus the placebo effect (Finniss 8C Benedetti, 2005). Placebo-induced cures are in- distinguishable from improvements that occur as a result of other treatments. A cure is a cure, and the method of cure makes no difference to patients’ well—being. Placebo effects are a tribute to the ability of humans to heal themselves, and practitioners can enlist this ability to help patients become healthier (Ezekiel 86 Miller, 2001; Walach 8c Jonas, 2004). Therefore, the placebo effect may be considered a positive factor in medical and be— ' havioral therapies, as it was for Sylvester Colligan, whose knee improved as a result of sham surgery. Research and the Placebo The therapeutic properties of the placebo may be a plus for treatment, but its effects present prob— lems in evaluating treatment effectiveness. For a treatment to be judged effective, it must show a higher rate of effectiveness than that produced by a placebo. This standard calls for researchers to use at least two groups: one that receives the treatment and another that receives a placebo. Both groups must have equal expectations con cerning the effectiveness of the treatment. In or- der to create equal expectancy, not only must the participants be ignorant of who is getting a pla— cebo and who is getting the treatment, but the ex— perimenters who dispense both conditions must also be “blind” as to which group is which. The arrangement in which neither participants nor experimenters know about treatment conditions is called a double-blind design. As the Would You Believe . . . P box points out, this design strategy presents ethical dilemmas. Psychological treatments such as counseling, hypnosis, biofeedback, relaxation training, mas- sage, and a variety of stress and pain management techniques also produce expectancy effects. That is, the placebo effect also applies to research in psychology, but double—blind designs are not so easy to perform with these treatments. Placebo pills can look the same as pills containing an ac— tive ingredient, but this situation is more difficult to arrange for behavioral treatments because the providers always know when they are providing a sham treatment. In these studies, researchers WQU Would j cal for I with tec to bc l)( ment ef need to allow tl effectiv effect 0 “In cont: expects cally us which 1 the exp partici; merit g. the pla merit p a grouj which ineffec He; posed 1 their p; new tfl onstrat placebt way to mess. I contra reconc Par tion lit researi (APA, sociati ineffec treatrr. ical if risks f use a sin do not inactive to treat Chapter 2 ./ Conducting Health Research 23 WOUlfi YQU BELEEVE . . . ? 'Would you believe that it is ethi— cal for researchers to treat people with techniques that they know to be bogus? To establish treat— ment effectiveness, researchers need to arrange conditions that allow them to establish that effectiveness, but the placebo effect complicates this process. In controlling for participants’ expectancies, researchers typi- cally use a double—blind design in which neither the participants nor the experimenters know which participants are in the new treat- ment group and which are in the placebo group. This arrange- ment places some participants in a group that receives a placebo, which is a treatment known to be ineffective. ' Health care providers are sup— posed to act in the best interest of ' their patients, yet research with new treatments demands dem- onstrations of effectiveness, and , placebo control designs are a good way to demonstrate such effective— ness. These two goals seem to be contradictory. How do researchers reconcile this ethical difficulty? ‘ Part of the answer tothat ques« tion lies in the rules governing _ _ research with human participants (APA, 2002; World Medical As— sociation, 2004). Providing an ineffective treatment—0r any other treatment-may be considered eth- ical if participants understand the risks fully and still agree to par— use a single—blind design in which the participants do not know if they are receiving the active or inactive treatment, but the providers are not blind to treatment conditions. In single~blind designs, ticipate in the study. This element of research procedure, known as informed consent, stipulates that participants must be informed of factors in the research that may influence their willingness to par- ticipate before they consent to participate. Informed consent does not mandate that researchers tell participants exactly what will hap- pen to them, but participants must know about the risks so that they can decide if they want to partici- pate or to withdraw. When participants in a clinical trial agree to take part in the study, they receive information about the possibility of being assigned to a group that receives a placebo as well as learn about the risks as; sociated with the treatment. Those participants who find the chances of receiving a placebo unaccept- able may refuse to participate in the study. Sylvester Colligan, who participated in the study with arthroscopic knee surgery, was told that he might be included in a sham surgery group, and he con- sented (Talbot, 2000). However, 44% of those interviewed about that study declined to participate (Moseley et al., 2002). Some critics contend that informed consent is not adequate; researchers should also have the ethical obligation to protect participants from exploita— tion (Resnik, 2008). The use of placebos in clinical studies is controversial. Despite , ‘ the value of placebo controls in clinical research, some physicians and medical ethicists consider the use of ineffective treatment to be ethically unacceptable because the welfare of patients is not the primary concern. Rather, clmi al ,- studies are oriented toward estab- lishing the effectiveness of treat— ment, and patient-participants may not receive the accepted standard of care (Kottow, 2007). Critics (Miller 8C Wager, 2004; Polgar <36 Ng, 2005) find the use of sham surgery especially unacceptable, citing a series of studies involv- ing sham brain surgery (McRae et al., 2004) in which participants in the control group underwent anesthesia and had holes drilled in their skulls but did not have their brains operated on. Participants in the sham surgery still faced the risks of anesthesia andpotential infection but, critics argued, did not have a good chance of ben— efiting from theiprocedure. These critics contend that control groups should receive the standard treat- ment rather than a placebo, and that placebo treatment is accept- able only if no treatment exists, for the condition. Thus, opinion regarding the ethical acceptability of placebo treatment is divided, with some finding it acceptable and necessarwaor research and others objecting to the failure to provide an adequate standard of treatment. ' the control for expectancy is not as complete as in double-blind designs, but creating equal expectancies for participants is usually the more important control feature. A placebo is an inactive substance or condition hav~ ing the appearance of an active treatment. It may cause participants in an experiment to improve or change behavior because of their belief in the pla~ cebo’s effectiveness and their prior experiences with receiving effective treatment. Although placebos can have a positive effect from the patient’s point of view, they are a continuing problem for the re— searcher. In general, a placebo’s effects are estimated at about 35 0/o; its effects on reducing pain may be higher, whereas its effects on other conditions may be lower. Placebos have been known to influence a wide variety of disorders and diseases. Experimental designs that measure the efficacy of an intervention, such as a drug, typically use a placebo so that people in the control group (who receive the placebo) have the same expectations for success as do people in the experimental group (who receive the aCfive treatment). Drug studies are usually double-blind designs, meaning that neither the participants nor the people administer— ing the drug know who receives the placebo and ' who receives the active drug. Researchers in psy— chological treatment studies are often not “blind” concerning the treatment, but participants are, cre- ating a single—blind design for these studies. assesses Matrices its Psrcaeteev Health—related research reports appear daily, but most people have trouble understanding these technical reports (Kettesz, 2003). The reports often contain highly technical terminology and numbers, and many people have no point of ref~ erence to interpret these numbers in personally meaningful ways. Indeed, most people do not see these technical reports; rather, they get infor— mation about the findings from the media. The news media are in the business of getting peo- ple’s attention, so the headlines and news cover— age of health information may be misleading, because the emphasis is on the most ...
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