The revised criteria for the classification of rheumatoid arthritis (RA) were formulated from a computerized analysis of 262 contemporary, consecutively studied patients with RA and 262 control subjects with rheumatic diseases other than RA (non-RA). The new criteria are as follows: 1) morning stiffness in and around joints lasting at least 1 hour before maximal improvement; 2) soft tissue swelling (arthritis) of 3 or more joint areas observed by a physician; 3) swelling (arthritis) of the proximal interphalangeal, metacarpophalangeal, or wrist joints; 4) symmetric swelling (arthritis); 5) rheumatoid nodules; 6) the presence of rheumatoid factor; and 7) radiographic erosions and/or periarticular osteopenia in hand and/or wrist joints. Criteria 1 through 4 must have been present for at least 6 weeks. Rheumatoid arthritis is defined by the presence of 4 or more criteria, and no further qualifications (classic, definite, or probable) or list of exclusions are required. In addition, a "classification tree" schema is presented which performs equally as well as the traditional (4 of 7) format. The new criteria demonstrated 91-94% sensitivity and 89% specificity for RA when compared with non-RA rheumatic disease control subjects.

https://onlinelibrary.wiley.com/doi/pdf/10.1002/art.1780310302

The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis.

The 1971 preliminary criteria for the classification of systemic lupus erythematosus (SLE) were revised and updated to incorporate new immunologic knowledge and improve disease classification. The 1982 revised criteria include fluorescence antinuclear antibody and antibody to native DNA and Sm antigen. Some criteria involving the same organ systems were aggregated into single criteria. Raynaud's phenomenon and alopecia were not included in the 1982 revised criteria because of low sensitivity and specificity. The new criteria were 96% sensitive and 96% specific when tested with SLE and control patient data gathered from 18 participating clinics. When compared with the 1971 criteria, the 1982 revised criteria showed gains in sensitivity and specificity.

https://onlinelibrary.wiley.com/doi/pdf/10.1002/art.1780251101

The 1982 revised criteria for the classification of systemic lupus erythematosus

K/DOQI clinical practice guidelines for chronic kidney disease: Evaluation, classification, and stratification

In 1982, the Diagnostic and Therapeutic Criteria Committee of the American College of Rheumatology (ACR)published revised criteria for the classification of systemiclupus erythematosus (SLE) (1). During the ensuing decade several investigators, including Drs. Graham Hughes and Donato Alarcon-Segovia, among others, have described the presence and clinical associations or antiphospholipid antibodies in patients with SLE, as well as the occurrence of theprimary antiphospholipid syndrome (2-5). In 1992, Piette and colleagues suggested that the ACR revised criteria be reevaluated in light of the above discoveries (6).

https://onlinelibrary.wiley.com/doi/pdf/10.1002/art.1780400928

Updating the American College of Rheumatology revised criteria for the classification of systemic lupus erythematosus.

To develop criteria for the classification of fibromyalgia, we studied 558 consecutive patients: 293 patients with fibromyalgia and 265 control patients. Interviews and examinations were performed by trained, blinded assessors. Control patients for the group with primary fibromyalgia were matched for age and sex, and limited to patients with disorders that could be confused with primary fibromyalgia. Control patients for the group with secondary-concomitant fibromyalgia were matched for age, sex, and concomitant rheumatic disorders. Widespread pain (axial plus upper and lower segment plus left- and right-sided pain) was found in 97.6% of all patients with fibromyalgia and in 69.1% of all control patients. The combination of widespread pain and mild or greater tenderness in greater than or equal to 11 of 18 tender point sites yielded a sensitivity of 88.4% and a specificity of 81.1%. Primary fibromyalgia patients and secondary-concomitant fibromyalgia patients did not differ statistically in any major study variable, and the criteria performed equally well in patients with and those without concomitant rheumatic conditions. The newly proposed criteria for the classification of fibromyalgia are 1) widespread pain in combination with 2) tenderness at 11 or more of the 18 specific tender point sites. No exclusions are made for the presence of concomitant radiographic or laboratory abnormalities. At the diagnostic or classification level, the distinction between primary fibromyalgia and secondary-concomitant fibromyalgia (as defined in the text) is abandoned.

https://www.onlinelibrary.wiley.com/doi/pdf/10.1002/art.1780330203

The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee.

Arthritis: A Comprehensive Guide

Ankylosing spondylitis: Discussions in patient management

The American Rheumatism Association Medical Information System (ARAMIS) is a consortium of North American rheumatic disease data banks. Founded in 1974, it has grown to include more than 16 centers, 22,000 patients, 140,000 patient encounters, and 80,000,000 observations. Traditionally, data storage and computer programs have resided on the IBM "2"-370 system at Stanford University. Distant peripheral centers have entered and retrieved data and performed analyses using proprietary long distance telephone networks. With growth, ARAMIS has placed strong emphasis on data quality and epidemiological soundness. "Core" groups at Stanford specifically address issues of quality control, biostatistics, health care economics, outcome assessment, study design, and administration. Advances in microcomputers and software has led ARAMIS to begin a migration from mainframe computing to distributed systems using IBM PC/XT/AT type computers and the Medlog software system. Substantial cost savings have been noted with distributed processing. The ability to easily transfer data and software forms a groundwork for international data banks and data exchange, but common vocabulary and common quality control procedures are essential for effective international cooperation and exchange.

ARAMIS today: Moving toward internationally distributed databank systems for follow-up studies

Physical function (PF) is a core patient-reported outcome domain in clinical trials in rheumatic diseases. Frequently used PF measures have ceiling effects, leading to large sample size requirements and low sensitivity to change. In most of these instruments, the response category that indicates the highest PF level is the statement that one is able to perform a given physical activity without any limitations or difficulty. This study investigates whether using an item format with an extended response scale, allowing respondents to state that the performance of an activity is easy or very easy, increases the range of precise measurement of self-reported PF. Three five-item PF short forms were constructed from the Patient-Reported Outcomes Measurement Information System (PROMIS®) wave 1 data. All forms included the same physical activities but varied in item stem and response scale: format A (“Are you able to …”; “without any difficulty”/“unable to do”); format B (“Does your health now limit you …”; “not at all”/“cannot do”); format C (“How difficult is it for you to …”; “very easy”/“impossible”). Each short-form item was answered by 2217–2835 subjects. We evaluated unidimensionality and estimated a graded response model for the 15 short-form items and remaining 119 items of the PROMIS PF bank to compare item and test information for the short forms along the PF continuum. We then used simulated data for five groups with different PF levels to illustrate differences in scoring precision between the short forms using different item formats. Sufficient unidimensionality of all short-form items and the original PF item bank was supported. Compared to formats A and B, format C increased the range of reliable measurement by about 0.5 standard deviations on the positive side of the PF continuum of the sample, provided more item information, and was more useful in distinguishing known groups with above-average functioning. Using an item format with an extended response scale is an efficient option to increase the measurement range of self-reported physical function without changing the content of the measure or affecting the latent construct of the instrument.

/pdf/varying-the-item-format-improved-the-range-of-measurement-in-39fx2jyh09.pdf

Varying the item format improved the range of measurement in patient-reported outcome measures assessing physical function

Informed consent is supposed to be a good thing, isn’t it? Motherhood, apple pie, and informed consent. After all, we don’t want the return of the bad old days when unwitting human guinea pigs were experimented upon without knowing what they were getting into. But there is another side to informed consent; in fact, there are perils to informed consent that ought to make the medical establishment think harder before continuing to uncritically accept it as a universal constant.

Some time ago, we wrote an editorial in Science entitled “Informed consent may be hazardous to your health” (1). There we pointed to the rather suggestible nature of the human mind. We know that plying people with certain kinds of information can make them believe that they experienced things that never happened. Studies on the malleability of human memory have shown that people can be led to believe that they saw stop signs instead of yield signs, that they got sick eating particular foods as children, and that they even had experiences that are highly implausible such as witnessing people being demonically possessed or being accosted by the Pluto character on a trip to a Disney resort (2).

Not only can people be led to believe that they experienced events that did not occur, but they can also be led to experience feelings and symptoms that they would not otherwise feel. That’s what placebos are all about. When a physician tells a patient or experimental subject that the drug being taken might cause nausea or dizziness, how many people develop the symptoms who wouldn’t do so from the drug or the medical procedure alone? We argued that simple inspection of informed consent documents reveals a purpose more directed at protecting the institution than protecting the experimental subject. We argued that perhaps these individuals would be better off if they got a description of the general level of risk, but detailed risk possibilities, or even very slight risks, ought to be reserved for those who request them. And if the detailed information is given, it ought to be accompanied by a discussion of placebo effects – why they occur, and how to guard against them.

Critics were quick to jump on these ideas, arguing that the “right to full information on matters which may affect our minds and bodies prevails” (3). They accused us of displaying a distressing failure to make a distinction between rights and benefits. We were astonished that our critics would so readily construe a statement intended to be made in favor of human rights as an attack upon such rights. Of course, people have the right to determine what is done to their minds and bodies, but this must extend to symptoms and illness actually caused by poorly executed disclosure. We question, informed by our knowledge of the power of placebos, whether the current legalistic ritual associated with informed consent is the best way to ensure that this human right is protected. We only ask that those whose task it is to formulate informed consent rituals pay some attention to the harm that may be caused by the ritual itself. One harm is the planting of suggested symptoms, some of which can be rather unpleasant, such as anxiety, or downright distressing, such as severe physiological reactions. Would the critics actually endorse the idea that those involved in formulating these rituals have a right to harm people? Patients and subjects might be far less damaged by smaller amounts of balanced information than by mammoth descriptions of remote possibilities. We always advocated supplying the information to those who choose to know all, but to include in the presentation of the “all” a discussion of placebo effects and their potential for adverse reactions.

At the time we were immersed in this issue, we conducted an unpublished pilot study with patients at Stanford University Medical School who had been diagnosed with scleroderma and were enrolled in an experiment testing the efficacy of a particular drug cocktail (propanolol and alpha-methyldopa). The known side effects of the drugs did include upset stomach, tearfulness, dizziness, and headache. Before beginning the clinical trial involving the drug or placebo, patients received either a standard informed consent message or a “special message.” Both messages informed them of possible side effects of the drug, and listed the known side effects, plus some implausible made-up ones that had not been associated with the drug (e.g., ringing in ears, burning sensation in feet).

Some of our subjects received a “special message” as part of their “informed consent.” It read as follows: “You should keep in mind one important point about these possible side effects. Research has shown that simply mentioning possible annoying symptoms causes some people to experience these symptoms – even when no drug is taken at all. This happens because mention of the symptoms causes some people to expect that they will experience them, and a person’s expectations can then lead to the actual experience. Very few people will actually have these problems and you can help yourself guard against these sorts of discomfort by keeping yourself optimistic and stopping yourself from expecting that side effects are going to happen to you.”

Our pilot study revealed, not surprisingly, that subjects experienced side effects, some of which were physiologically unlikely. The suggestion in the informed consent led even those given a placebo to this unpleasant fate. A special message that explained the powerful role that expectations can have in producing unlikely symptoms reduced the reported side effects, and also decreased somewhat the use of medications to treat those unlikely symptoms. Our hope is that future researchers will do a full scale study that tests the impact of variations in informed consent rituals. While our special message may not be the best message to accomplish these hoped-for benefits, and we did not study whether it will work with different kinds of drugs or patients, our preliminary result should pique the interest of future researchers in considering both the positive and negative impacts of information that they ply their subjects and patients with. One size is not likely to fit all. Flexibility in informed consent protocols might convey to patients and subjects their right to as little harm as possible.

/pdf/the-potential-perils-of-informed-consent-49f9uodixe.pdf

James F. Fries

Papers

Arthritis: A Comprehensive Guide

Ankylosing spondylitis: Discussions in patient management

ARAMIS today: Moving toward internationally distributed databank systems for follow-up studies

Varying the item format improved the range of measurement in patient-reported outcome measures assessing physical function

The Potential Perils of Informed Consent