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Biomedical subjects

J Karlawish

Publications and source records attributed to J Karlawish.

9 recordsLinked to original sources
PubMed2001

Obtaining informed consent for clinical pain research: patients' concerns and information needs.

Investigators who conduct clinical pain research are required to obtain voluntary informed consent from patients. However, little is known about what information patients expect when they decide whether to enroll in such studies. It is important that investigators understand these information needs so they can effectively and clearly describe the research risks and potential benefits that matter to potential subjects. By understanding these needs for information, investigators may also be better able to anticipate patients' concerns and to recruit subjects more efficiently. This study was designed to define information needs that patients have when they decide whether to participate in clinical pain research. This paper describes these information needs, and identifies clinical and demographic variables associated with specific needs.

Adult↗
PubMed2001

Beyond informed consent: the ethical design of pain research.

In the wake of the rapid development of medical research over the past 50 years, investigators, clinicians, and ethicists have raised numerous concerns about the ethical conduct of research. Perhaps the single most important protective mechanism to emerge from the fray has been the requirement of informed consent. Certainly it has the longest history. However, even though informed consent has become the most widely recognized mechanism of protecting human subjects in research, there are limits to what the informed consent process can accomplish. Another, and more far-reaching, way to protect human subjects involved in research is to ensure that the study design is as consistent as possible with patients' preferences and goals. That is, pain investigators have a significant opportunity to improve the ethical rigor of their work by designing a study that offers a subject what is a reasonable balance of risks and benefits. This article suggests some specific ways in which investigators may design research that is more consistent with patient preferences. We describe several aspects of the ethical design of clinical pain research that appear to be important to patients, including the potential benefits for subjects, the benefits for future patients, the risks and burdens of research participation, and the voluntariness of a subject's choice whether to enroll. We conclude by discussing ways in which the ethical design of research might make the informed consent process more robust.

Journal Article↗
PubMed2001

Designing pain research from the patient's perspective: what trial end points are important to patients with chronic pain?

OBJECTIVES: The goals of this study were to define the endpoints of pain research that are important to patients with chronic pain and to identify clinical and demographic variables that are associated with patients' choices of endpoints. PATIENTS & SETTING: Interviews were completed with 40 patients seen at the anesthesia pain clinic of an urban tertiary care medical center. DESIGN: Each patient was presented with 4 brief (3-4 sentences) fixed information vignettes describing studies in which new medications would be evaluated. For each, patients were asked to describe how the medication being studied might offer an improvement over their current therapy. OUTCOME MEASURES: Measures included structured qualitative analysis of responses, the Brief Pain Inventory, and Global Distress Index of the Memorial Symptom Assessment Scale. RESULTS: Patients described a total of 20 endpoints. Individually, patients cited between 2 and 9 endpoints each (mean 4.9, standard deviation 1.7). Of these, the most commonly cited were decrease pain, decrease opioid dose, decrease frequency of scheduled dose, increased ability to function, decrease frequency of breakthrough dose, and improve sleep. Patients with severe pain cited more endpoints than did those with mild or moderate pain (mean 5.5 vs. 4.3; Rank sum test p = 0.01). CONCLUSIONS: These data suggest that empirical research can provide data to guide the choice of endpoints in clinical studies of pain interventions.

Journal Article↗
PubMed1994

The effect of total parenteral nutrition on serum albumin.

Our objective was to assess whether the serum albumin level rises in patients given total parenteral nutrition (TPN). All randomized controlled studies of TPN for at least 7 days versus oral therapy were reviewed. Data on serum albumin had to be available to be acceptable for analysis. Only trials of patients with cancer fulfilled these selection criteria for our analysis. None of the reported studies showed a significant rise in serum albumin with TPN when compared to controls. The mean change in serum albumin levels for all of the studies was -0.3 g/dl in the TPN group and -0.3 g/dl in the control group. In published randomized controlled studies of TPN versus oral diet, there is no significant increase in serum albumin levels in those receiving TPN or decrease in serum albumin in controls. Our study does not support the serum albumin level as a nutritional marker in patients with cancer.

Biomarkers, Tumor↗