Contending paradigms for the interpretation of data on patient compliance with therapeutic drug regimens

Electronic and chemical marker methods provide the first reliable measurements of drug exposure in ambulatory trials. These data contradict the usual claim in published drug trials of > 90% of patients having been satisfactorily compliant with the protocol-specified dosing regimen. Such exaggerated claims are based, usually, on count of returned dosing forms, which afford patients easy ability to manipulate by discarding or hoarding untaken doses. Electronic monitoring provides, for the first time, data on intervals between doses, revealing the 'drug holiday'--3 or more consecutive days without dosing--as a basis not only for lapsed therapeutic action, but as a pharmacodynamic trigger for hazardous rebound effects on recurrent first dose effects. Another new findings is the evident non-specificity of poor or partial compliance, the range and distributions of which appear to be hardly affected by drug, disease, prognosis, or symptoms. This finding contradicts often repeated but unsupported claims that noncompliance is a specific response to drug action, disease, prognosis or other treatment-related factors. New statistical methods are needed for trial design and analysis, to use drug exposure data as covariate information, to incorporate into drug labelling estimates of dose-related efficacy, holiday-related hazard, the limits of safe variation in dose-timing, and what one should best do when those limits are exceeded. Oral contraceptive labelling in the U.K. and U.S. is exemplar for this next step toward full-disclosure labelling.     

Three books on patient compliance.

Reviews the books, New directions in patient compliance edited by S. Cohen (1979); Compliance in health care edited by R. Haynes, D. Taylor, and D. Sackett (1979); and Communication and compliance in a hospital setting edited by D. Withersty, J. Stevenson, and R. Waldman (1980). In the recent spate of writings about issues of patient compliance, three 1979-80 publications (Cohen, 1979; Haynes, Taylor, & Sackett, 1979; Withersty, Stevenson, & Waldman, 1980) warrant comparison with respect to scope, purposes, and usefulness. All three are edited works, the products of conferences with invited participants. To some degree, all three works sought to review, and add to, the literature on compliance. All three books contain a mix of articles--reviews of literature, commentary and conceptualization, practical applications, and reports of research. Although all three books have merits and demerits, Haynes must stand as the most valuable and comprehensive reference work in the area of patient compliance. However, the reviewer suggests that interested readers pick through all three for the substance and brush the dross aside. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

The impact of a relaxation technique on the lipid profile

In this study, a more subtle animal model of Menière's disease is investigated by damaging the distal portion of the endolymphatic sac by dissection or cauterization to produce mild dysfunction of endolymphatic outflow. Cauterization resulted in low degrees of hydrops without any correlation with the inflicted damage. Total dissection of the distal portion of the sac adjacent to the sigmoid sinus produced moderate to severe endolymphatic hydrops with interanimal variation. The consequences of these relatively severe effects, in relation to the mild damage of the endolymphatic sac, and the influence on damaged and undamaged parts of the endolymphatic sac will be discussed.     

The impact of therapist disclosure on patient disclosure.

Conducted a psychotherapy analog study with 90 female undergraduates to examine the effects of therapist disclosure on the S's disclosure to the therapist during a 1st interview. 3 levels of therapist disclosure, no disclosure, demographic disclosure, and personal disclosure, and 2 levels of therapist warmth were manipulated. Ss completed a modified version of the Jourard Self-Disclosure Questionnaire. Ss exposed to a warm therapist offering moderate self-disclosure (demographic disclosure) disclosed more to the therapist than Ss exposed to warm nondisclosing or personally disclosing therapists. No differences were found between nondisclosing and personally disclosing warm therapists. Ss exposed to a cold therapist offered uniformly low levels of disclosure regardless of the level of therapist disclosure. (17 ref) (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

The effect of an alphanumeric paging system on patient compliance with medicinal regimens

There are numerous actual and potential impediments to patient compliance with medicinal regimens. The implications of poor compliance include worsening disease states or symptoms, with resultant increased costs of care. Using a population of hospice patients at high risk for noncompliance, this study evaluated the use of an alphanumeric paging system as a memory prosthetic, finding that compliance rose from a mean of 56 percent to 96 percent when the system was used. We conclude that such a program is of use in this setting, and that these findings warrant study and suggest applications in other populations.     

The elderly patient with multiple complaints

"Thick chart" patients often have both a stated and an unstated agenda. Failure to recognize the latter can create a crisis of confidence that may prompt the patient to search for a more empathetic physician. So in addition to making a diagnosis in the face of confusing data, the physician must establish confidence by listening carefully and involving the patient in treatment decisions.     

Estrogen''s impact on cognitive functions in multiple sclerosis

Mutagenicity in the Ames assay is evaluated by comparing the number of revertants observed in treated cultures to those in untreated cultures. Often, some form of the '2-fold rule' is employed, whereby a compound is judged mutagenic if a 2-fold or greater increase is seen in a treated culture. In order to understand the underpinnings of this approach, we study some of its statistical properties. We assume that the number of revertants on any plate from a given two-group experiment follows a Poisson distribution and we address the following questions: (1) what is the false-positive error probability of observing at least a doubling of the number of colonies from the control to the treatment group?; (2) if a given mean number of colonies is postulated for a control group, what number of colonies above the observed control mean provides a false-positive rate of 5%? We also present results for question 1 in the case where the number of revertants follows a negative binomial distribution.     

The impact of multiple bereavement in a gay male sample

In this study we explore the biographical disruption resulting from a diagnosis of an abnormal Pap smear and the consequent process of biographical reconstruction. This is a qualitative study of thirteen women between the ages of 19 and 54 years who were diagnosed with an abnormal Pap smear and underwent colposcopy treatment. Data collection was through individual in-depth interviews, which were transcribed and analyzed by a team of researchers for important themes. An opportunistic sampling strategy was used. The inherent ambiguity in the diagnosis, its treatment strategies, the prognosis of their condition, and patients' fear of cancer all made the process of biographical reconstruction more problematic. By putting their faith in medicine and mobilizing their personal resources, women attempted to reestablish a positive personal and social self. Further exploration of the long-term psychosocial impact of this diagnosis is warranted so that women's emotional as well as medical needs are adequately addressed.     

The impact of nosocomial infections on patient outcomes following cardiac surgery

STUDY OBJECTIVE: To evaluate the relationship between nosocomial infections and clinical outcomes following cardiac surgery, and to identify risk factors for the development of nosocomial infections in this patient population. DESIGN: Prospective cohort study. SETTING: Barnes-Jewish Hospital, St. Louis, a university-affiliated teaching hospital. PATIENTS: Six hundred five consecutive patients undergoing cardiac surgery. INTERVENTIONS: Prospective patient surveillance and data collection. MAIN OUTCOME MEASURES: Occurrence of nosocomial infections, multiorgan dysfunction, hospital mortality, and risk factors for the acquisition of nosocomial infections. RESULTS: One hundred thirty-one (21.7%) patients acquired at least one nosocomial infection following cardiac surgery. Four independent risk factors for the development of a nosocomial infection were identified: the duration of mechanical ventilation, postoperative empiric antibiotic administration, the duration of urinary tract catheterization, and female gender. Thirty (5.0%) patients died during their hospitalization. The mortality rate of patients acquiring a nosocomial infection (11.5%) was significantly greater than the mortality rate of patients without a nosocomial infection (3.2%) (odds ratio [OR]=4.0; 95% confidence interval [CI]=2.7 to 5.8; p<0.001). Multiorgan dysfunction was found to be the most important independent determinant of hospital mortality (adjusted OR=23.8; 95% CI=13.5 to 42.1; p<0.001) along with the aortic cross-clamp time (adjusted OR=2.3; 95% CI=1.7 to 3.0; p=0.002) and severity of illness as measured by APACHE II (acute physiology and chronic health evaluation) (adjusted OR=1.1; 95% CI=1.1 to 1.2; p=0.019). Ventilator-associated pneumonia, clinical sepsis, female gender, the cardiopulmonary bypass time, and severity of illness were identified as independent risk factors for the development of multiorgan dysfunction. Among hospital survivors, patients acquiring a nosocomial infection had longer hospital lengths of stay compared to patients without a nosocomial infection (20.1+/-13.0 days vs 9.7+/-4.5 days; p<0.001). CONCLUSIONS: Nosocomial infections, which are common following cardiac surgery, are associated with prolonged lengths of hospitalization, the development of multiorgan dysfunction, and increased hospital mortality. These data suggest potential interventions for the prevention of nosocomial infections following cardiac surgery that could substantially improve patient outcomes and decrease medical care costs.     

Contraceptive choice and patient compliance. The health care provider's challenge

Contraceptive compliance is a multifaceted issue that is influenced by many factors. These factors can directly affect the level of patient compliance, thereby affecting contraceptive method efficacy rates. A review of the literature reveals many studies about contraceptive compliance but a dearth of studies addressing how to change noncompliant behaviors. This article describes the contraceptive methods currently available and their efficacy rates. Patient characteristics and the components of compliance are described as they affect contraceptive efficacy and patient care. Suggestions are made for the use of alternative terminology to include adherence to or continuance of a contraceptive method. Health care providers should realize the impact they can have on a patient's education, decision-making process, and ultimate compliance with a contraceptive method. It is the patient, however, who ultimately makes the decision, either actively or passively, to comply or not and whether to have an unplanned pregnancy.     

The impact of outcome orientation and justice concerns on tax compliance: The role of taxpayers' identity.

Previous research has yielded inconsistent evidence for the impact of justice perceptions on tax compliance. This article suggests a more differentiated view on the basis of 2 congenial theories of procedural and distributive justice. The group-value model and a categorization approach argue that taxpayers are more concerned about justice and less about personal outcomes when they identify strongly with the inclusive category within which procedures and distributions apply. Regression analyses of survey data from 2,040 Australian citizens showed that 2 forms of tax compliance (pay-income reporting and tax minimization) were determined by self-interest variables. For 2 other forms (nonpay income and deductions), inclusive identification had an additional effect and moderated the effects of self-interest and justice variables as predicted. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

The sickness impact profile: validation of a health status measure

Postmortem concentration of the three immunoglobulins IgA, IgG and IgM has been studied by single radial immunodiffusion in 81 cases of sudden unexpected death in infancy and in 6 deaths between 2 and 11 years of age. The examinations of serum were repeated after several days after the sera had been kept at different temperatures. For comparison the serum immunoglobulin levels of IgA, IgG and IgM were determined in 11 corpses of adults directly after death and again 1 or 2 days later. Results: With the radial immunodiffusion method postmortem serum immunglobulins are determinable. A critical estimation of postmortem IgA-, IgG- and IgM serum levels has to consider postmortem protein modifications and keeping sera at higher temperatures (+44 degrees C., + 20 degrees C.) For determinations at a later date sera must be kept at -35 degrees C. The measured postmortem serum levels of IgA and IgG in cases of sudden unexpected death in infancy correspond with the normal variation of value in healthy children of the same age. The lowest concentrations of IgG were found about the 5th. month in infancy. Many of the IgM levels were higher than the normal mean value in healthy children of the same age. This is not caused by postmortem influences. The higher IgM concentration in sera suggest an active immunological reaction before death.