Reading the News

1. Reading the News Thought Questions 1. Taste tests of new products are often done by having people taste both the new product and an old familiar standard. Do you think the results would be biasedif the person handing the products to the respondents knew which was which? Explain why or why not? 2. Nicotine patches are attached to the arm of someone who is trying to quit smoking and dispense nicotine into the blood. Suppose you read a study showing nicotine patches were twice as effective in getting people to quit smoking as “control” patches (made to look like the real thing). Further, suppose you are a smoker trying to quit. What questions would you want answered about how the study was done and its results before you decided whether to try the patches? 3. For a door-to-door survey on opinions about various political issues, do you think it matters who conducts the interviews? Give an example of how it might make a difference.

2. Reading the News • Three main reasons studies are conducted • By Government/Private Companies to make wise policy decisions. • Universities/Institutes paid to ask/answer questions about the world around us. • Companies to convince consumers their program or product is better. • Origins of News Stories • Academic Conferences • Published Articles in Scholarly Journals • Government and Private Agency Research Reports • University Media Office • Examples of New York Times & Time Magazine sources • New England Journal of Medicine • Annals of Internal Medicine • Journal of the American Medical Association • Archives of Pediatrics and Adolescent Medicine • Association for Professionals in Infection Control and Epidemiology • Center for Disease Control

3. Reading the News • Science Journalists face two important questions: • How do we decide what research findings are important and worth reporting? • How good and valid is a scientific study? • Question 1: In current practice, importance is largely dependent on • a)press releases from journals where the study is publicized • b) announcements from university, commercial and governmental research bodies • c) other commercial media sources (newspapers, magazines and television) • Usually, it does not take long for important findings to disseminate through electronic and • print media, and reactions of advocates, critics and detractors to be voiced. • But, simple repetition of assumed quality and importance of a finding can be a major disservice • as the numerous reassessments and even retractions of some research findings has shown. • Controversies and debate are good, bad research can be disastrous. Journalists play a crucial • gatekeeper role in the dissemination of science.

4. Reading the News • Question 2: How good and valid is a scientific study? • Good scientific journalism goes beyond simply reporting the findings of research scientists and clinical investigators that impact the health, life-styles and well-being of their readers. • It involves the presentation of important, interesting and objectively obtained information in a critical and understandable format. • It is crucial that a journalist not simply be a vehicle to transfer information from source to consumer. • Instead, information must be carefully and objectively assessed through consideration of how the information was obtained. • The question is: How do we do this?

5. Reading the News Seven Critical Components of a Statistical Study Component 1: The source of the research and of the funding. Component 2: The researchers who had contact with the participants. Component 3: The individualsor objects studied and how they were selected. Component 4: The exact nature of the measurements made or questions asked. Component 5: The setting in which the measurements were taken. Component 6: Differences in the groups being compared, in additionto the factor of interest. Component 7: The extent or size of any claimed effects or differences.

6. Reading the News The Power of Placebos – CNN Health, December 22nd 2010 • Hoping to get around the practice of deceiving patients with fake treatments, researchers tried to determine whether placebos, also known as dummy pills, would work even if the patients knew they weren't taking an active drug.  • Patients knowingly taking a placebo still found relief from symptoms of irritable bowel syndrome (IBS) a new study published in the journal PLoS ONE found. • Harvard Medical School and Beth Israel Deaconess Medical Center divided eighty IBS patients into two groups.  The control group got no treatment at all.  The other group of volunteers was told to take one sugar pill twice a day. All of the patients were monitored for three weeks. • "Not only did we make it absolutely clear that these pills had no active ingredient and were made from inert substances, but we actually had 'placebo' printed on the bottle," said Ted Kaptchuk, study author and Associate Professor of Medicine, Harvard Medical School and Beth Israel Deaconess Medical Center. "We told the patients that they didn't have to even believe in the placebo effect.  Just take the pills.“ • In fact, the placebo patients relief was equal to taking the most powerful IBS medications. They did, and nearly twice as many patients in the placebo group had reduced symptoms compared to the control group. 

7. Reading the News Placebos without Deception: A Randomized Controlled Trial in Irritable Bowel Syndrome • Component 1: The source of the research and of the funding. • Funding: This study was partially supported by grant K24 AT004095, R01 AT00402-01 and R01AT004662 from National Center for Complementary and Alternative Medicine-NIH and in part from a gift from The Bernard Osher Foundation. The opinions expressed by the authors are their views alone and do not reflect the official views or policy of the National Center for Complementary and Alternative Medicine, National Institutes of Health, Public Health Service or the U.S. Department of Health and Human Services. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. • Component 2: The researchers who had contact with the participants. • Patients were told that ‘‘placebo pills, something like sugar pills, have been shown in rigorous clinical testing to produce significant mind-body self-healing processes.’’ • The patient-provider relationship and contact time was similar in both groups. Study visits occurred at baseline (Day 1), midpoint (Day 11) and completion (Day 21). Assessment questionnaires were completed by patients with the assistance of a blinded assessor at study visits.

8. Reading the News Placebos without Deception: A Randomized Controlled Trial in Irritable Bowel Syndrome • Component 2: The researchers who had contact with the participants. • Forty-three patients saw the male physician for all three visits, 20 patients saw the female nurse-practitioner for all three visits, and 17 patients saw a combination of the two or missed a treatment session. • No significant differences were found between providers on the primary outcome measure, IBS-GIS (p = .57 at midpoint, and p = .51 at endpoint). Similarly, there were no significant differences between providers on any of the secondary outcome measures. • Component 3: The individualsor objects studied and how they were selected. • Participants were recruited from advertisements for ‘‘a novel mind-body management study of IBS’’ in newspapers and fliers and from referrals from healthcare professionals. • During the telephone screening, potential enrollees were told that participants would receive ‘‘either placebo (inert) pills, which were like sugar pills which had been shown to have self-healing properties’’ or no treatment. • Participants were adults (>18 years old) meeting the Rome III criteria for IBS with a score of >150 on the IBS Symptom Severity Scale (IBS-SSS)

9. Reading the News Placebos without Deception: A Randomized Controlled Trial in Irritable Bowel Syndrome • Component 4: The exact nature of the measurements made or questions asked. • Our primary outcome measure was the IBS Global Improvement Scale (IBS-GIS) which asks participants: • Compared to the way you felt before you entered the study, have your IBS symptoms over the past 7 days been: • Substantially Worse, 2) Moderately Worse, 3) Slightly Worse, 4) No Change, 5) Slightly Improved, • 6) Moderately Improved or 7) Substantially Improved. • The IBS Adequate Relief (IBS-AR) is a single dichotomous (yes or no) item that asks participants: • ‘‘Over the past week have you had adequate relief of your IBS symptoms?’’ • Given the unprecedented nature of the study, at the completion of the trial patients were given a short qualitative open-ended check-out questionnaire and asked for written responses.

10. Reading the News Placebos without Deception: A Randomized Controlled Trial in Irritable Bowel Syndrome • Component 5: The setting in which the measurements were taken. • All assessments were performed by a researcher who was blind to treatment assignment. All visits were in the context of a warm supportive patient-practitioner relationship. • Component 6: Differences in the groups being compared, in additionto the factor of interest. • Patients were allowed to continue IBS medications (e.g., fiber, anti-spasmodics, loperamide, etc.) as long as they had been on stable doses for at least 30 days prior to entering the study and agreed not to change medications or dosages during the trial. • Patients were asked to refrain from making any major life-style changes (e.g., starting a new diet or changing their exercise pattern) during the study. • Patients knew which treatment they were on – Placebo or Control. How could this make a difference?

11. Reading the News Placebos without Deception: A Randomized Controlled Trial in Irritable Bowel Syndrome • Component 7: The extent or size of any claimed effects or differences. • Patients treated with open label placebo had significantly greater scores than the no treatment control on the main outcome measure, Global Improvement Scale (IBS-GIS), at both the 11-day midpoint (5.2 +- 1.0 versus 4.0 +- 1.1, p,.001, d= 1.14) and: • The 21-day endpoint (5.0 +- 1.5 versus 3.9 +- 1.3, p= .002, d= 0.79). • 4: No Change versus 5: Slightly Improved • The magnitude of improvement reported by those on open-label placebo treatment was not only statistically significant but also clinically meaningful. • In addition, there were statistically significant differences at both time points on reduction in symptom severity (IBS-SSS) and adequate relief (IBS-AR), and a trend toward significance at the 21-day endpoint on improvement in quality of life (IBS-QOL).

12. Reading the News Placebos without Deception: A Randomized Controlled Trial in Irritable Bowel Syndrome • Limitations cited in the Journal Article • Small sample size and trial duration • Wishing to please the experimenter • Recruitment through an advertisement for a “novel mind-body” intervention • IBS is a poor illness to study placebo effects. Why?

13. Reading the News • Breast test furor fades but anger lingers - CNN Health, December 3rd, 2010 • Task force said last year women in their 40s should not automatically get mammograms • Doctors and patients still think mammograms in the 40s are important • Some women stop going because they are frustrated with the process or false positives • Who decides about mammograms? Inside the task force – CNN Health, November 19th, 2009 • The task force has private-sector experts in prevention and primary care • The members are not oncologists, but cancer experts reviewed the data • The task force has disagreed with major medical organizations before • Insurance companies view the task force with high regard • Task force defends mammogram guidelines, says it communicated poorly - CNN, Dec. 2nd, 2009 • Official says task force didn't say what it meant to say and will work on better communication • She says "screenings starting at 40 should not be automatic, nor should they be denied" • November 16 guidelines said women in their 40s shouldn't get routine mammograms • Those guidelines sparked outcry from cancer groups, survivors defending routine mammograms

14. Reading the News Mammograms effective from age 40, study says – CNN Health, September 30th, 2010 • Amid the controversy over the age at which women should begin having mammograms, a study from Sweden supports starting breast cancer screening at age 40. • Research presented this week in the journal Cancer compared breast cancer mortality in areas of Sweden where women 40 to 49 had been invited for mammograms against those in which women in this age group had not. • There were 7.3 million people included in the group that had mammograms in ages 40 to 49, and 8.8 million people in that sample that did not. • Researchers founded about a 26 percent reduction in the breast cancer death rate attributable to mammography. In order to save one life, 1,252 women had to be invited to get mammograms in the 40 to 49-year-old age. • The benefit appeared greater for women 45 to 49 than in the 40- to 44-year-old group. • Dr. Daniel Kopans, professor of radiology at Harvard Medical School, said that this study should "end the debate" about beginning mammograms at age 50.

15. Reading the News Swedish Study: Effectiveness of Population-Based Service Screening With Mammography for Women Ages 40 to 49 Years • Component 1: The source of the research and of the funding. • Corresponding author: BarbroNumanHellquist, MSc, Department of Radiation Sciences, Umea˚ University, Onkologiskt Centrum, NorrlandsUniversitetssjukhus, 901 85 Umea˚, Sweden • National Board of Health and Welfare in 1986 issued their guidelines recommending that the county councils invite women ages 40 to 54 years to screening every 18 months and women • ages 55 to 74 years every second year. • Thus, national service screening with mammography was initiated between 1986 and 1997. • Funding: Not disclosed • Component 2: The researchers who had contact with the participants. • Data on diagnosis and death were retrieved from the national Swedish Cancer Registry. • Population data that were used in the calculation of person-years were supplied by Statistics Sweden. • No information on researchers (doctors)

16. Reading the News Swedish Study: Effectiveness of Population-Based Service Screening With Mammography for Women Ages 40 to 49 Years • Component 3: The individualsor objects studied and how they were selected. • The study group included women who were living in areas that had service-screening programs • for the group ages 40 to 49 years for at least 6 years during the study period between 1986 and 2005. • The control group included women who were living in areas in which women ages 40 to 49 were not invited to attend service screening during the study period. • The study group and the control group constitute the Mammography Screening of Young Women (SCRY) cohort, which includes all Swedish counties. • Component 4: The exact nature of the measurements made or questions asked. • The mortality measure used was refined mortality, which means that the events were breast cancer deaths among women who had a breast cancer diagnosis at ages 40 to 49 years. Thus, there was no upper age limit for an event except for that determined by the end of follow- up. • A breast cancer death was defined as a death with breast cancer as the underlying cause according to the Swedish Cause of Death Register.

17. Reading the News Swedish Study: Effectiveness of Population-Based Service Screening With Mammography for Women Ages 40 to 49 Years • Component 5: The setting in which the measurements were taken. • No information given. • Component 6: Differences in the groups being compared, in additionto the factor of interest. • Because the current study was not an RCT, a possible bias may exist caused by differences between the study group and the control group other than screening. • Stockholm County contributed with 38% of the person-years to the control group and may differ from other control areas in terms of its big-city characteristics, eg, later childbirth and contamination from private screening. • Excluding Stockholm from the control group resulted in somewhat higher estimates of effectiveness.

18. Reading the News Swedish Study: Effectiveness of Population-Based Service Screening With Mammography for Women Ages 40 to 49 Years • Component 7: The extent or size of any claimed effects or differences. • There was no significant difference in breast cancer mortality during the prescreening period. • During the study period, there were 803 breast cancer deaths in the study group (7.3 million person-years) and 1238 breast cancer deaths in the control group (8.8 million person-years). • Study Group: 803/ 7,261,415 = 0.00011 Control Group: 1238/8,843,852 = 0.00014 • Per 100,000 Person-Years – Breast Cancer Deaths – Study Group : 11 versus Control Group: 14 • Person-Years Definition: The product of the number of years times the number of members of a population who have been affected by a certain condition (years of treatment with a given drug). • The estimated NNS during a 10-year period (corresponding to about 6 mammography episodes) to save 1 life was 1252 women.

19. Reading the News Writing a News Article Who? Who was involved? What? What happened (what's the story)? Where? Where did it take place? When? When did it take place? Why? Why did it happen? How? How did it happen?

20. Reading the News Text Questions – Page 33-34