Setting standards for severity of common symptoms in oncology using the PROMIS item banks and expert judgment

Background

Although the use of patient-reported outcome measures (PROs) has increased markedly, clinical interpretation of scores remains lacking. We developed a method to identify clinical severity thresholds for pain, fatigue, depression, and anxiety in people with cancer.

Methods

Using available Patient-Reported Outcomes Measurement Information System (PROMIS) item bank response data collected on 840 cancer patients, symptom vignettes across a range of symptom severity were developed and placed on index cards. Cards represented symptom severity at five-point intervals differences on the T score metric [mean = 50; standard deviation (SD) = 10]. Symptom vignettes for each symptom were anchored on these standardized scores at 0.5 SD increments across the full range of severity. Clinical experts, blind to the PROMIS score associated with each vignette, rank-ordered the vignettes by severity, then arrived at consensus regarding which two vignettes were at the upper and lower boundaries of normal and mildly symptomatic for each symptom. The procedure was repeated to identify cut scores separating mildly from moderately symptomatic, and moderately from severely symptomatic scores. Clinician severity rankings were then compared to the T scores upon which the vignettes were based.

Results

For each of the targeted PROs, the severity rankings reached by clinician consensus perfectly matched the numerical rankings of their associated T scores. Across all symptoms, the thresholds (cut scores) identified to differentiate normal from mildly symptomatic were near a T score of 50. Cut scores differentiating mildly from moderately symptomatic were at or near 60, and those separating moderately from severely symptomatic were at or near 70.

Conclusions

The study results provide empirically generated PROMIS T score thresholds that differentiate levels of symptom severity for pain interference, fatigue, anxiety, and depression. The convergence of clinical judgment with self-reported patient severity scores supports the validity of this methodology to derive clinically relevant symptom severity levels for PROMIS symptom measures in other settings.     

Facilitator report: Bloodborne pathogens exposure among health care workers

Several psychosocial and organizational factors have been identified as important correlates of compliance with safe work practices among health care workers. In particular, compliance with “universal precautions”—a set of work practices which were designed to minimize exposure to bloodborne pathogens—has been found to be associated with several potentially modifiable factors. The development of interventional strategies designed specifically to target these factors (e.g., HIV/AIDS attitudes, safety climate) are important objectives in the overall risk management approach to occupational exposure to bloodborne pathogens. © 1996 Wiley-Liss, Inc.     

Methodologic issues in intervention research—health care

To better understand the methodological challenges faced by intervention research in health care, workshops reviewed two intervention studies to reduce back injuries among nursing home staff and two studies on the use of precautions to prevent occupational transmission of bloodborne pathogens. These studies adapted rigorous designs to real-world settings and made good use of multiple measures to detect effects and communicate this information to policy makers. The studies grappled with issues about implementation integrity and would benefit from better theory of administrative practices associated with a safety-conscious work environment. © 1996 Wiley-Liss, Inc.     

Memory‐Based Deception Detection: Extending the Cognitive Signature of Lying From Instructed to Self‐Initiated Cheating

From a cognitive perspective, lying can be regarded as a complex cognitive process requiring the interplay of several executive functions. Meta‐analytic research on 114 studies encompassing 3,307 participants (Suchotzki, Verschuere, Van Bockstaele, Ben‐Shakhar, & Crombez, 2017) suggests that computerized paradigms can reliably assess the cognitive burden of lying, with large reaction time differences between lying and truth telling. These studies, however, lack a key ingredient of real‐life deception, namely self‐initiated behavior. Research participants have typically been instructed to commit a mock crime and conceal critical information, whereas in real life, people freely choose whether or not to engage in antisocial behavior. In this study, participants (n = 433) engaged in a trivia quiz and were provided with a monetary incentive for high accuracy performance. Participants were randomly allocated to either a condition where they were instructed to cheat on the quiz (mimicking the typical laboratory set‐up) or to a condition in which they were provided with the opportunity to cheat, yet without explicit instructions to do so. Assessments of their response times in a subsequent Concealed Information Test (CIT) revealed that both instructed cheaters (n = 107) and self‐initiated cheaters (n = 142) showed the expected RT‐slowing for concealed information. The data indicate that the cognitive signature of lying is not restricted to explicitly instructed cheating, but it can also be observed for self‐initiated cheating. These findings are highly encouraging from an ecological validity perspective.     

The use of an animal drawing test in the assessment and disposition of transsexualism

Reported results of a study that compared two projective techniques for a group of 19 transsexuals who were seeking sex reassignment surgery. The Draw-A-Person Test (DAP), widely used in clinical settings, was contrasted to the Animal and Opposite Drawing Technique (AODT), which is a relatively new and little-examined variation of the DAP. Discussion focuses on the use of both measures as predictors of those transsexuals to be recommended for surgery. Use of the AODT as an effective measure in the assessment of transsexualism is investigated.     

Assessment of radiologic progression in rheumatoid arthritis. A randomized, controlled trial

Radiologic assessment of progressive joint destruction in rheumatoid arthritis is generally considered to be the ultimate standard for evaluation of treatment. We compared alternative radiologic techniques by performing a randomized, controlled trial in which hand films of rheumatoid arthritis patients were read by several skilled observes. The number of joints evaluated (34 versus 18) was found to make relatively little difference, but the number of readers and their experience level was critical. Films should be read in pairs. Joint space narrowing and erosion scores were shown to contribute independent information. Use of recommended techniques can reduce the number of patients required and, thus, can reduce the cost of a clinical trial by more than half and can substantially increase the sensitivity and efficiency of a trial. Therefore, critical selection of the method of assessing study endpoint is of great importance.     

Imaging of stress fractures in the athlete

Osseous stress fractures and stress reactions represent the effect of abnormal repetitive stress on normal bone. An accurate and thorough clinical history and sequential radiographs often suffice 40 make the diagnosis especially when the fracture occurs in one of the common locations, such as the tibia, metatarsals, or calcaneus. In cases that are atypical in location or clinical presentation the authors rely more on MR imaging, radionuclide bone scanning, and occasionally CT. MR imaging detects early changes of osseous stress injury and allows precise definition of anatomy and extent of injury, and is the preferred modality for evaluating the continuum of osseous manifestations of stress injury. MR imaging is useful in evaluating shin splints, early osseous stress injuries, and overt stress fracture. In the elite athlete prompt diagnosis and early rehabilitation are the goals.     

Choledocholithiasis in infancy

Three cases of choledocholithiasis presenting with obstructive jaundice in infancy are reported. Ultrasonography demonstrated a grossly dilated common bile duct in all three cases. It failed, however, to demonstrate the calculi that were situated at the distal end of the common duct. Percutaneous transhepatic cholangiography was valuable in one patient in outlining the biliary tract and in identifying the cause of the obstruction. Endoscopic retrograde cholangiopancreatography (ERCP) was employed in a child, aged three years, in whom it was possible to proceed to endoscopic sphincterotomy with clearance of the common duct. In small infants, transduodenal sphincteroplasty would appear to be the procedure of choice.