P.Mean:  Answers to Chapter 7 exercises in Statistical Evidence (created 2008-09-29).

Here are my proposed answers to the four questions at the end of Chapter 7 of my book, Statistical Evidence in Medical Trials, published by Oxford University Press.

1. You have a teenager who is trying to quit smoking and you want to see how group therapy might help compared to a nicotine replacement therapy like a patch or nasal spray. Write out a well focused question using the PICO format.

P = smokers between the ages of 13 and 18
I = group therapy
C = nicotine replacement therapy
O = smoking cessation rates

In smokers between the ages of 13 and 18, how effective is group therapy compared to nictoine replacement therapy in smoking cessation rates.

2. I recently attended a seminar on Reiki therapy. To prepare for the meeting, I wanted to see if there was any published evidence about whether this therapy works. Search for any peer-review articles about Reiki. Try first to find a systematic overview or meta-analysis. If you cannot find such an article, try to find a randomized trial.

This is a very general search, so there is no P, C, or O, just I (intervention). If you do a search using the words reiki therapy, you will get a disaster

There are 1379 choices (this was run on September 29, 2008). There are so many choices because PubMed tries to guess what you really want. If you click on the DETAILS button, you will find that PubMed searched using the following conditions:

"therapeutic touch"[MeSH Terms] OR ("therapeutic"[All Fields] AND "touch"[All Fields]) OR "therapeutic touch"[All Fields] OR ("reiki"[All Fields] AND "therapy"[All Fields]) OR "reiki therapy"[All Fields]

Normally, PubMed makes intelligent choices, but here there is a problem because I am trying to draw a distinction between Reiki and Therapeutic Touch (see below). This listing, however, gives you some clues about how to make a search the way you want it. The simplest choice is to place reiki in quote marks. That tells PubMed not to make any intelligent choices on your behalf.

When you click on the DETAILS button, you get the following conditions:

"reiki"[All fields]

You could try different choices at this point. Searching for "reiki therapy" yields only six articles, and searching for the word reiki only in the title or abstract ("reiki" [tiab]) yields 89 articles.

If you search on

"reiki"[All fields] AND "meta-analysis"[pt]

you will get no items. So the literature as of late September 2008 does not include any systematic overviews of Reiki.

3. Repeat this process using Therapeutic Touch.

If you do a simple PubMed search, you will get 1,365 articles.

The details of the search are instructive.

"therapeutic touch"[MeSH Terms] OR ("therapeutic"[All Fields] AND "touch"[All Fields]) OR "therapeutic touch"[All Fields]

Perhaps that middle term ("therapeutic"[All Fields] AND "touch"[All Fields]) might get you a few too many false positive results. For example, the abstract of the first article reads

Emotions in health organisations tend to remain tacit and in need of clarification. Often, emotions are made invisible in nursing and reduced to part and parcel of 'women's work' in the domestic sphere. Smith (1992) applied the notion of emotional labour to the study of student nursing, concluding that further research was required. This means investigating what is often seen as a tacit and uncodified skill. A follow-up qualitative study was conducted over a period of twelve months to re-examine the role of the emotional labour of nursing. Data were collected primarily from 16 in-depth and semi-structured interviews with nurses. Key themes elicited at interviews touch upon diverse topics in the emotional labour of nursing. In particular, this article will address nurse definitions of emotional labour; the routine aspects of emotional labour in nursing; traditional and modern images of nursing; and gender and professional barriers that involve emotional labour in health work. This is important in improving nurse training and best practice; investigating clinical settings of nurses' emotional labour; looking at changing techniques of patient consultation; and beginning to explore the potential therapeutic value of emotional labour.

Clearly, this is a false positive. A better search would leave out that middle term ("therapeutic touch"[MeSH Terms] OR  "therapeutic touch"[All Fields]), which yields 647 articles. There are a few Reiki articles in the mix, and it is possible to exclude these ("therapeutic touch" [tiab]) which yields 346 articles or ("therapeutic touch" NOT "reiki") which yields 415 articles.

A search on "therapeutic touch"[tiab] AND "meta-analysis"[pt] yields two hits

4. Starting in late 2004, a widely publicized series of randomized trials showed that certain drugs known as Cox-2 inhibitors had an increased risk of cardiac side effects. Was there any published data before 2004 that might suggest that these drugs had an increased risk? Write out an inquiry using the PICO format and search on PubMed for any randomized clinical trials on Cox-2 inhibitors that might answer this question.

P = human patients
I = taking Cox-2 inhibitor
C = placebo
O = cardiac side effects

To get studies on human patients (rather than animal studies), you could click on the LIMITS tab, or add "adult"[MeSH] to your search.

Perhaps you might want to specify the patient population a bit more narrowly, such as all patients needing pain relief. The comparison group might also include NSAIDs, a class of pain relievers that competes with Cox-2 inhibitors. To examine the year of publication, you can use the [PD] tag.

Here's a series of searches I ran (with the most recent search at the top).

It's difficult to show the full screenshot of all five publications, but here is what a brief display looks like:

5. Perform a web search on the phrase �Reiki Therapy� or �Cognitive Behavioral Therapy� and examine the first ten sites that appear. How many of these pages meet the standards of the HON Code? How far down in the search list do you have to go before you find a source about Reiki Therapy that you feel is fair and balanced?

As of September 30, 2008, I have only reviewed three of the Reiki websites and none of the Cognitive Behavioral Therapy sites. I will try to finish this when I can.

Here's the list I got when I searched on Reiki Therapy on Google on September 30, 2008.

1. Reiki Energy Therapy.
www.neurosurgical.com/neuro_medical_info/alternative_care/reiki_therapy.htm
2. Reiki Home, What Is Reiki, History of Reiki, Whole-Body Reiki ...
www.holisticonline.com/Reiki/hol_Reiki_home.htm
3. Discovery Health :: Reiki: Hype or Help?
health.discovery.com/centers/womens/althealth/reiki_therapy.html
4. Reiki Therapy
my.clevelandclinic.org/services/Reiki_Therapy/hic_Reiki_Therapy.aspx
5. Reiki Therapy
www.suite101.com/welcome.cfm/reiki_world
6. CIMER - Energy Therapies - Reiki Therapy - M. D. Anderson Cancer
www.mdanderson.org/departments/cimer/display.cfm?id=cd9d80bf-8ed1...
7. Saint Agnes Medical Center - REIKI THERAPY
www.samc.com/UMAP.asp?ID=1369
8. Integrative Therapies - Reiki Therapy
www.harthosp.org/integrativemed/therapies/reikitherapy/default.aspx
9. Help You Heal, Reiki Therapy, Flower Essence, Vicka Lanier
www.helpyouheal.com/
10. Reiki - Wikipedia, the free encyclopedia
en.wikipedia.org/wiki/Reiki

For each of the ten websites, I reviewed the page shown as well as any Reiki related pages that were easily navigated to from the page recommended by Google. I also explored any link that would indicate information about authorship, privacy policies, funding sources, etc. Just for the record, my website would not necessarily fare well in a similar review. Also, I have to admit that I did not spend more than 15 minutes at any particular website, so a more in-depth review might yield more favorable results for these sites.

The HON code has eight components.

Authoritative: Any medical or health advice provided and hosted on this site will only be given by medically trained and qualified professionals unless a clear statement is made that a piece of advice offered is from a non-medically qualified individual or organisation.

For the most part, the author/organization was clearly identified and was from well qualified professionals.

1. Northern California Neurosurgery Medical Group
2. The owner of the page is ICBS (Intenational Cyber Business Services, which is a professional web design service company. Clearly they are not the authors of the content about Reiki. It is impossible to assess the credentials of the authors of the Reiki material on this website.
3. The author is clearly a journalist, but she cites the credentials of all the individuals that she interviewed for the article.

Complementarity: The information provided on this site is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her existing physician.

This was also well done in most of the websites.

1. The quote "Please consult a qualified practitioner before you start with Reiki especially if you are suffering from serious conditions or diseases." was found on the Reiki page.
2. "This information is not a replacement for a thorough consultation and examination from a licensed health professional." was found on the "Terms of Use" page.
3. There is no explicit disclaimer about consulting a doctor, but the material is clearly intended to be supportive.

Privacy: Confidentiality of data relating to individual patients and visitors to a medical/health Web site, including their identity, is respected by this Web site. The Web site owners undertake to honour or exceed the legal requirements of medical/health information privacy that apply in the country and state where the Web site and mirror sites are located.

Privacy concerns were well addressed at most websites.

1. There was no explicit privacy policy, but this site did not appear to collect any health information from individual readers.
2. It took two clicks to get to a detailed privacy policy of this website.
3. It took one click to get to a very detailed privacy policy.

Attribution: Where appropriate, information contained on this site will be supported by clear references to source data and, where possible, have specific HTML links to that data. The date when a clinical page was last modified will be clearly displayed (e.g. at the bottom of the page).

This was a weak point at many of the ten sites.

1. No references or links were provided. The page was last modified on 08/07/08.
2. The record on this website is mixed. This site makes numerous statements without any supporting references. For example, "Reiki therapy can be a very useful adjunct for anyone taking a course of drugs. It can help reduce some of the side effects of drug therapy. Reiki helps the body in the recovery after drug therapy, after surgery and after chemotherapy. In all these cases, Reiki therapy supplies the body with extra life energy, enabling the body to bounce back more quickly from the burdens of surgery and chemicals." IN fact, this statement is contradicted on a separate page which states "The interaction between Reiki and drugs is neither well tested nor documented." Later, the site does discuss the evidence but does not provide any references. "The vast majority of reports on the effectiveness of Reiki appear in popular rather than scientific literature. Proponents of Reiki cite the growing body of research in the field of Therapeutic Touch as evidence of the therapeutic transfer of energy through touch. One California study showed that Reiki can increase hemoglobin and hematocrit levels. The study compared 47 people participating in Reiki training and a small control group of 9 healthy medical professionals. The study found a significant increase in hemoglobin and hematocrit levels among the Reiki group and no significant change in the control group."
3. Although specific studies about Reiki were mentioned, no references were provided.

Justifiability: Any claims relating to the benefits/performance of a specific treatment, commercial product or service will be supported by appropriate, balanced evidence in the manner outlined above in Principle 4.

This was another weak point at many of the ten sites.

1. This page uses the word "claim" to avoid seeming to endorse Reiki, but offers no support for or against the claim. "Reiki involves the transfer of energy from practitioner to patient and claims to enhance the body's natural ability to heal itself through the balancing of energy.
2. The material on this site is entirely positive, with no discussion of side effects, or limitations of the technique. The reader is given the impression that Reiki can treat just about any illness.
3. The article is mostly uncritical, but does cite one critic of Reiki "Despite its increasing acceptance by the healthcare community, Reiki has its share of critics. Chief among them is Eric Krieg with the Philadelphia Association for Critical Thinking, whose 150 members include scientists and educators who seek to 'provide a rational response to such energy field work claims.'" Later the article mentions the difficulties posed by the lack of a plausible biological mechanism, though it makes this sound like this is a limitation of the critics rather than a limitation of Reiki. "'Many medical practitioners are troubled by the fact that no one has a clue of the mechanism. It's energy healing, but that sometimes infuriates people with a scientifically oriented mind. Often, when such people take Reiki classes, they have trouble learning it,' says Ameling."

Transparency: The designers of this Web site will seek to provide information in the clearest possible manner and provide contact addresses for visitors that seek further information or support. The Webmaster will display his/her E-mail address clearly throughout the Web site.

This was well done at almost all of the websites.

1. The site listed "Northern California Neurosurgery Medical Group" as the copyright holder of this material, but did not offer anyway to contact them through email. It took a separate Google search to find more contact information.
2. There is an email address listed at the bottom of each page.
3. There is no obvious way to contact the author of the particular article. The contact information for the entire site health.discovery.com was at the bottom of the main page.

Financial disclosure: Support for this Web site will be clearly identified, including the identities of commercial and non-commercial organisations that have contributed funding, services or material for the site.

This was not explicitly addressed at most website.

1. Although there was no explicit disclosure, the sole sponsor of this website appears to be the Northern California Neurosurgery Medical Group.
2. There is no explicit page describing sources of funding. Some funding sources were mentioned on the privacy policy page.
3. The sponsors of this website are clearly identified at the bottom of the page.

Advertising policy: If advertising is a source of funding it will be clearly stated. A brief description of the advertising policy adopted by the Web site owners will be displayed on the site. Advertising and other promotional material will be presented to viewers in a manner and context that facilitates differentiation between it and the original material created by the institution operating the site.

Although most sites did have explicit advertisements, there was usually a clear separation between that and the editorial content. For some sites, the editorial material was intended to promote the organization's reputation, but this was a benign promotion.

1. There was no explicit advertising policy, but advertising was clearly separated from editorial content. The website provides an implicit endorsement of the Northern California Neurosurgery Medical Group, but this is a benign association. There are banner ads on every page.
2. The main page for the entire website (www.holisticonline.com) includes prominent links to several commercial websites. There does appear to be a clear separation between editorial content and advertising.
3. There were several pop-up windows offering advertisements and banner ads throughout the site. There does appear to be clear separation between editorial content and advertising.

Here's the list I got when I searched for Cognitive Behavioral Therapy on Google on September 30, 2008.

1. Cognitive behavioral therapy - Wikipedia, the free encyclopedia.
en.wikipedia.org/wiki/Cognitive_behavioral_therapy
2. What is Cognitive-Behavioral Therapy?
www.nacbt.org/whatiscbt.htm
3. Cognitive-behavioral therapy - definition of Cognitive-behavioral ...
medical-dictionary.thefreedictionary.com/Cognitive-Behavioral+Therapy
4. NAMI | Cognitive-Behavioral Therapy
5. Anxiety Therapy: Cognitive-Behavioral Therapy (CBT)
www.anxietynetwork.com/hcbt.html
6. Cognitive Therapy & CBT
counsellingresource.com/types/cognitive-therapy/
7. Cognitive-behavioral therapy
www.healthatoz.com/healthatoz/Atoz/common/standard/transform.jsp?requestURI=/...
8. Cognitive Therapy, Cognitive Behavioral Therapy - American ...
www.cognitivetherapynyc.com/
9. NIDA - Publications - A Cognitive-Behavioral Approach: Treating ...
www.drugabuse.gov/txmanuals/cbt/cbt1.html
10. Anxiety Disorder Clinic
www.uh.edu/anxiety/cbt.htm